Open Source Security Compliance
Collection
A collection of my open source security compliance datasets, models (fine-tuned LLMs), etc.
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9 items
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[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does nist_sp800-66r2 say about HIPAA compliance? (Part 25)"
},
{
"role": "assistant",
"content": "According to nist_sp800-66r2:\n\nIdentify All ePHI and Relevant Information Systems | • Identify where ePHI is generated within the organization, where it enters the organization, where it moves within the organization, where it is stored, and where it leaves the organization. • Identify all systems 30 that house ePHI. Be sure to identify mobile devices, medical equipment, and IoT devices that store, process, or transmit ePHI. • Include all hardware and software that are used to collect, store, process, or transmit ePHI. • Analyze business functions and verify the ownership and control of information system elements as necessary. • Consider the impact of a merger or acquisition on risks to ePHI. During a merger or acquisition, new data pathways may be introduced that lead to ePHI being stored, processed, or transmitted in previously unanticipated places. | • Has all ePHI generated, stored, processed, and transmitted within the organization been identified? • Are all hardware and software for which the organization is responsible periodically inventoried? • Is the hardware and software inventory updated on a regular basis? • Have hardware and software that maintains or transmits ePHI been identified? Does this inventory include removable media and remote access devices? • Is the current configuration of organizational systems documented, including connections to other systems? • Has a BIA been performed? |\n| 2. Conduct Risk Assessment 31 32 Implementation Specification (Required) | • Conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of ePHI held by the covered entity or business associate. | • Are there any prior risk assessments, audit comments, security requirements, and/or security test results? • Is there intelligence available from agencies, the Office of the Inspector General (OIG), the United States Computer Emergency Readiness Team (US-CERT), virus alerts, and/or vendors?"
}
] |
{
"source": "nist_sp800-66r2",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 24,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 72)"
},
{
"role": "assistant",
"content": "According to privacy_rule_2000:\n\ninformation; restrict access solely to the employees identified and only for the functions performed on behalf of the group health plan; and provide a mechanism for resolving issues of noncompliance.\nAny employee of the plan sponsor who receives protected health information for payment, health care operations or other matters related to the group health plan must be identified in the plan documents either by name or function. We assume that since individuals employed by the plan sponsor may change frequently, the group health plan would likely describe such individuals in a general manner. Any disclosure to employees or classes of employees not identified in the plan documents is not a permissible disclosure. To the extent a group health plan does have its own employees separate from the plan sponsor's employees, as the workforce of a covered entity ( i.e. the group health plan), they also are bound by the permitted uses and disclosures of this rule. The certification that must be given to the group health plan must state that the plan sponsor agrees to: (1) Not use or further disclose protected health information other than as permitted or required by the plan documents or as required by law; (2) ensure that any subcontractors or agents to whom the plan sponsor provides protected health information agree to the same restrictions; (3) not use or disclose the protected health information for employment-related actions; (4) report to the group health plan any use or disclosure that is inconsistent with the plan documents or this regulation; (5) make the protected health information accessible to individuals; (6) allow individuals to amend their information; (7) provide an accounting of its disclosures; (8) make its practices available to the Secretary for determining compliance; (9) return and destroy all protected health information when no longer needed, if feasible; and (10) ensure that the firewalls have been established."
}
] |
{
"source": "privacy_rule_2000",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 71,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 334)"
},
{
"role": "assistant",
"content": "According to privacy_rule_2000:\n\nits on subsequent use and disclosure; and requiring return or destruction of the information at the earliest possible time.) Others said the court order should impose a ''minimum necessary'' standard.\nResponse: We have not revised the regulation in response to comments suggesting that we impose additional standards relating to disclosures to comply with court orders. Unlike administrative subpoenas, where there is no independent review of the order, court orders are issued by an independent judicial officer, and we believe that covered entities should be permitted under this rule to comply with them. Court orders are issued in a wide variety of cases, and we do not know what hardships might arise by imposing standards that would require judicial officers to make specific findings related to privacy. Comment: At least one commenter argued that the proposed rule would have placed too much burden on covered entities to evaluate whether to release information in response to a court order. This comment suggested that the regulation allow disclosure to attorneys for assessment of what the covered entity should release in response to a court order. Response: This regulation does not change current requirements on or rights of covered entities with respect to court orders for the release of health information. Where such disclosures are required today, they continue to be required under this rule. Where other law allows a covered entity to challenge a court order today, this rule will not reduce the ability of a covered entity to mount such a challenge. Under §164.514, a covered entity will be permitted to rely on the face of a court order to meet this rule's requirements for verification of the legal authority of the request for information. A covered entity may disclose protected health information to its attorneys as needed, to perform health care operations, including to assess the covered entity's appropriate response to court orders."
}
] |
{
"source": "privacy_rule_2000",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 333,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 430)"
},
{
"role": "assistant",
"content": "According to privacy_rule_2000:\n\nor are together a single covered entity. (See § 164.504(b) for the rules requiring such designation.) If only one covered entity is designated for the subsidiaries, only one privacy officer is needed.\nFurther, we do not prohibit the privacy official of one covered entity from serving as the privacy official of another covered entity, so long as all the requirements of this rule are met for each such covered entity. ## Section 164.530(b)-Training\n\nComment: A few commenters felt that the proposed provision was too stringent, and that the content of the training program should be left to the reasonable discretion of the covered entity. Response: We clarify that we do not prescribe the content of the required training; the nature of the training program is left to the discretion of the covered entity. The scenarios in the NPRM preamble of potential approaches to training for different sized covered entities were intended as examples of the flexibility and scalability of this requirement. Comment: Most commenters on this provision asserted that recertification/ retraining every three years is excessive, restrictive, and costly. Commenters felt that retraining intervals should be left to the discretion of the covered entity. Some commenters supported retraining only in the event of a material change. Some commenters supported the training requirement as specified in the NPRM. Response: For the reasons cited by the commenters, we eliminate the triennial recertification requirements in the final rule. We also clarify that retraining is not required every three years. Retraining is only required in the case of material changes to the privacy policies and procedures of the covered entity. Comment: Several commenters objected to the burden imposed by required signatures from employees after they are trained. Many commenters suggested that electronic signatures be accepted for various reasons."
}
] |
{
"source": "privacy_rule_2000",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 429,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 402)"
},
{
"role": "assistant",
"content": "According to privacy_rule_2000:\n\nResponse: We acknowledge that widespread restrictions on the use and disclosure of protected health information could result in some difficulties related to payment, research, quality assurance, etc.\nHowever, in our efforts to protect the privacy of health information about individuals, we have sought a balance in determining the appropriate level of individual control and the smooth operation of the health care system. In the final rule, we require certain covered providers and permit all covered entities to obtain consent from individuals for use and disclosure of protected health information for treatment, payment, and health care operations (see § 164.506). In order to give individuals some control over their health information for uses and disclosures of protected health information for treatment, payment, and health care operations, we provide individuals with the opportunity to request restrictions of such uses and disclosures. Because the right to request restrictions encourages discussions about how protected health information may be used and disclosed and about an individual's concerns about such uses and disclosures, it may improve communications between a provider and patient and thereby improve care. According to a 1999 survey on the Confidentiality of Medical Records by the California HealthCare Foundation, one out of every six people engage in behavior to protect themselves from unwanted disclosures of health information, such as lying to providers or avoiding seeking care. This indicates that, without the ability to request restrictions, individuals would have incentives to remain silent about important health information that could have an effect on their health and health care, rather than consulting a health care provider. Further, this policy is not a dramatic change from the status quo."
}
] |
{
"source": "privacy_rule_2000",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 401,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does hitech_omnibus_2013 say about HIPAA compliance? (Part 197)"
},
{
"role": "assistant",
"content": "According to hitech_omnibus_2013:\n\nr<15>2010\n\n18:57 Jan 24, 2013\n\nJkt 229001\n\n- (B) The designation of an affiliated covered entity must be documented and the documentation maintained as required by paragraph (c) of this section.\n- (ii) Safeguard requirements. An affiliated covered entity must ensure that it complies with the applicable requirements of this part, including, if the affiliated covered entity combines the functions of a health plan, health care provider, or health care clearinghouse, § 164.308(a)(4)(ii)(A) and §164.504(g), as applicable. *\n\n*\n\n*\n\n*\n\n*\n\n- ■29. Revise § 164.106 to read as follows:\n\n## §164.106 Relationship to other parts. In complying with the requirements of this part, covered entities and, where provided, business associates, are required to comply with the applicable provisions of parts 160 and 162 of this subchapter. - ■30. The authority citation for subpart C of part 164 is revised to read as follows:\n\nAuthority: 42 U.S.C. 1320d-2 and 1320d4; sec. 13401, Pub. L. 111-5, 123 Stat. 260. - ■31. Revise § 164.302 to read as follows:\n\n## §164.302 Applicability. A covered entity or business associate must comply with the applicable standards, implementation specifications, and requirements of this subpart with respect to electronic protected health information of a covered entity. - ■32. In § 164.304, revise the definitions of ''Administrative safeguards'' and ''Physical safeguards'' to read as follows:\n\n## §164.304 Definitions. *\n\n*\n\n*\n\n*\n\n*\n\nAdministrative safeguards are administrative actions, and policies and procedures, to manage the selection, development, implementation, and maintenance of security measures to protect electronic protected health information and to manage the conduct of the covered entity's or business associate's workforce in relation to the protection of that information."
}
] |
{
"source": "hitech_omnibus_2013",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 196,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 427)"
},
{
"role": "assistant",
"content": "According to privacy_rule_2000:\n\nat it was unreasonable to expect covered entities to track disclosures that are requested by the individual. They believed that consumers should be responsible for keeping track of their own requests.\nOther commenters asked that we specify that entities need not retain and provide copies of the individual's authorization to disclose protected health information. Some commenters were particularly concerned that if they maintain all patient information on a computer system, it would be impossible to link the paper authorization with the patient's electronic records. Another commenter suggested we allow entities to submit copies of authorizations after the 30-day deadline for responding to the individual, as long as the accounting itself is furnished within the 30-day window. Response: In the final rule we do not require disclosures to the individual to be included in the accounting. Other disclosures requested by the individual must be included in the accounting, unless they are otherwise excepted from the requirement. We do not agree that individuals should be required to track these disclosures themselves. In many cases, an authorization may authorize a disclosure by more than one entity, or by a class of entities, such as all physicians who have provided medical treatment to the individual. Absent the accounting, the individual cannot know whether a particular covered entity has acted on the authorization. We agree, however, that it is unnecessarily burdensome to require covered entities to provide the individual with a copy of the authorization. We remove the requirement. Instead, we require the accounting to contain a brief statement describing the purpose for which the protected health information was disclosed. The statement must be sufficient to reasonably inform the individual of the basis for the disclosure."
}
] |
{
"source": "privacy_rule_2000",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 426,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does security_rule_2003 say about HIPAA compliance? (Part 34)"
},
{
"role": "assistant",
"content": "According to security_rule_2003:\n\nin order to allow covered entities to use whatever is reasonable and appropriate. ''Digital signatures'' and ''soft tokens'' may be used, as well as many other mechanisms, to implement this standard.\nThe proposed mandatory implementation feature, ''Unique user identification,'' has been moved from this standard and is now a required implementation specification under ''Access control'' at § 164.312(a)(1). 17:54 Feb 19, 2003\n\nPO 00000\n\nFrm 00024\n\n''Automatic logoff'' has also been moved from this standard to the ''Access control'' standard and is now an addressable implementation specification. ## 5. Transmission Security (§ 164.312(e)(1))\n\nUnder ''Technical Security Mechanisms to Guard Against Unauthorized Access to Data that is Transmitted Over a Communications Network,'' we proposed that ''Communications/network controls'' be required to protect the security of health information when being transmitted electronically from one point to another over open networks, along with a combination of mandatory and optional implementation features. We proposed that some form of encryption must be employed on ''open'' networks such as the Internet or dial-up lines. In this final rule, we adopt integrity controls and encryption, as addressable implementation specifications. a. Comment: We received a number of comments asking for overall clarification as well as a definition of terms used in this section. A definition for the term ''open networks'' was the most requested action, but there was a general expression of dislike for the manner in which we approached this section, with some comments suggesting that the entire section be rewritten. A significant number of comments were received on the question of encryption requirements when dial-up lines were to be employed as a means of connectivity."
}
] |
{
"source": "security_rule_2003",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 33,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 142)"
},
{
"role": "assistant",
"content": "According to privacy_rule_2000:\n\n, however, we modify the definition of designated record set. For a discussion of the significant changes made to the definition of designated record set, see § 164.501 and the corresponding preamble.\nUnder the revised definition, individuals have a right of access to any protected health information that is used, in whole or in part, to make decisions about individuals. This information includes, for example, information used to make health care decisions or information used to determine whether an insurance claim will be paid. Covered entities often incorporate the same protected health information into a variety of different data systems, not all of which will be utilized to make decisions about individuals. For example, information systems that are used for quality control or peer review analyses may not be used to make decisions about individuals. In that case, the information systems would not fall within the definition of designated record set. We do not require entities to grant an individual access to protected health information maintained in these types of information systems. ## Duration of the Right of Access\n\nAs in the proposed rule, covered entities must provide access to individuals for as long as the protected health information is maintained in a designated record set. ## Exceptions to the Right of Access\n\nIn the NPRM, we proposed to establish a right for individuals to\n\nVerDate 11<MAY>2000\n\n19:16 Dec 27, 2000\n\naccess any protected health information maintained in a designated record set. Though we proposed to permit covered entities to deny access in certain situations relating to the particular individual requesting access, we did not specifically exclude any protected health information from the right of access. In the final rule, we specify three types of information to which individuals do not have a right of access, even if the information is maintained in a designated record set."
}
] |
{
"source": "privacy_rule_2000",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 141,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does §164.314(a) require?"
},
{
"role": "assistant",
"content": "According to nist_sp800-66r2:\n\n§164.314(a) . 84 Readers may find useful resources in Appendix F, including OCR BAA guidance and/or templates that include applicable language. • Execute new or update existing agreements or arrangements, as appropriate. • Identify roles and responsibilities. • Include security requirements in business associate contracts and agreements to address the confidentiality, integrity, and availability of ePHI. • Specify any training requirements associated with the contract/agreement or arrangement, if reasonable and appropriate. | • Who is responsible for coordinating and preparing the final agreem"
}
] |
{
"source": "nist_sp800-66r2",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "cfr_section",
"chunk_id": null,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": "§164.314(a)",
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does nist_sp800-66r2 say about HIPAA compliance? (Part 26)"
},
{
"role": "assistant",
"content": "According to nist_sp800-66r2:\n\n• What are the current and planned controls? • Have likelihood and impact been determined for relevant threats and vulnerabilities? • Have risk ratings been determined for relevant threats and vulnerabilities? • Is the facility located in a region prone to any natural disasters, such as earthquakes, floods, or fires? • Has responsibility been assigned to check all hardware and software -including hardware and software used for remote access -to determine whether selected security settings are enabled? • Is there an analysis of current safeguards and their effectiveness relative to the identified risks? • Have all processes involving ePHI been considered, including creating, receiving, maintaining, and transmitting |\n| 3. Implement a Risk Management Program 33 Implementation Specification (Required) | • Implement security measures sufficient to reduce risks and vulnerabilities to a reasonable and appropriate level to comply with §164.306(a). • Risk management should be performed with regular frequency to examine past decisions, reevaluate risk likelihood and impact levels, and assess the effectiveness of past remediation efforts • Create a Risk Management policy and program 34 that outlines organizational risk appetite and risk tolerance, personnel duties, responsible parties, the frequency of risk management, and required documentation. • A risk management methodology is included in Sec. 4 of this document. • Risk management resources are also included in Appendix F. | it? • Is executive leadership and/or management involved in risk management decisions? • Has a risk management program been created with related policies? • Does the regulated entity need to engage other resources (e.g., external expertise) to assist in risk management? • Do current safeguards ensure the confidentiality, integrity, and availability of all ePHI? • Do current safeguards protect against reasonably anticipated uses or disclosures of ePHI that are not permitted by the Privacy Rule?"
}
] |
{
"source": "nist_sp800-66r2",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 25,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 204)"
},
{
"role": "assistant",
"content": "According to privacy_rule_2000:\n\nication at the end of the leave. The commenter sought clarification as to whether a provider could disclose information to an employer without first obtaining an individual's consent or authorization.\nAnother commenter suggested that the final rule explicitly exclude from the rule disclosures authorized by the FMLA, because, in the commenter's view, it provides more than adequate protection for the confidentiality of medical records in the employment context. Response: We disagree that the FMLA provides adequate privacy protections for individually identifiable health information. As we understand the FMLA, the need for employers to obtain protected health information under the statute is analogous to the employer's need for protected health information under the ADA. In both situations, employers may need protected health information to fulfill their obligations under these statutes, but neither statute requires covered entities to provide the information directly to the employer. Thus, covered entities in these circumstances will need an individual's authorizations before the disclosure is made to the employer. ## Federal Common Law\n\nComment: One commenter did not want the privacy rules to interfere with the federal common law governing collective bargaining agreements permitting employers to insist on the cooperation of employees with medical fitness evaluations. Response: We do not seek to interfere with legal medical fitness evaluations. These rules require a covered entity to have an individual's authorization before the information resulting from such evaluations is disclosed to the employer unless another provision of the rule applies. We do not prohibit employers from conditioning employment, accommodations, or other benefits, when legally permitted to do so, upon the individual/employee providing an authorization that would permit the disclosure of protected health information to employers by covered entities. See § 164.508(b)(4) below."
}
] |
{
"source": "privacy_rule_2000",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 203,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 406)"
},
{
"role": "assistant",
"content": "According to privacy_rule_2000:\n\ntter policy to allow covered entities to refuse to honor restrictions that they believe are not appropriate and leave the individual with the option of seeking service from a different covered entity.\nIn addition, many covered entities have information systems that would make it difficult or impossible to accommodate certain restrictions. Comment: Some commenters requested that self-pay patients have additional rights to restrict protected health information. Others believed that this policy would result in de facto discrimination against those patients that could not afford to pay out-ofpocket. Response: Under the final rule, the decision whether to tie an agreement to restrict to the way the individual pays for services is left to each covered entity. We have not provided self-pay patients with any special rights under the rule. Comment: Some commenters suggested that we require restrictions to be clearly noted so that insurers and other providers would be aware that they were not being provided with complete information. Response: Under the final rule, we do not require or prohibit a covered entity to note the existence of an omission of information. We encourage covered entities to inform others of the existence of a restriction, in accordance with professional practice and ethics, when appropriate to do so. In deciding whether or not to disclose the existence of a restriction, we encourage the covered entity to carefully consider whether disclosing the existence is tantamount to disclosure of the restricted protected health information so as to not violate the agreed to restriction. Comment: A few commenters said that covered entities should have the right to modify or revoke an agreement to restrict use or disclosure of protected health information. Response: We agree that, as circumstances change, covered entities should be able to revisit restrictions to which they had previously agreed."
}
] |
{
"source": "privacy_rule_2000",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 405,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does fda_postmarket_2016 say about HIPAA compliance? (Part 17)"
},
{
"role": "assistant",
"content": "According to fda_postmarket_2016:\n\nd Assessment\n\nThe FDA recommends that manufacturers characterize and assess identified vulnerabilities because it will provide information that will aid manufacturers to triage remediation activities.\nWhen characterizing the exploitability of a vulnerability, the manufacturer should consider factors such as remote exploitability, attack complexity, threat privileges, actions required by the user, exploit code maturity, and report confidence. Scoring systems such as the 'Common Vulnerability Scoring System' (CVSS) 43 provide a consistent framework for assessing exploitability by quantifying the impact of the factors that influence exploitability. See Section VI for additional guidance on vulnerability risk assessment. ## ii. Risk Analysis and Threat Modeling\n\nThe FDA recommends that manufacturers conduct cybersecurity risk analyses that include threat modeling for each of their devices and to update those analyses over time. Risk analyses and threat modeling should aim to triage vulnerabilities for timely remediation. Threat modeling is a procedure for optimizing Network/Application/Internet Security by identifying objectives and vulnerabilities, and then defining countermeasures to prevent, or mitigate the effects of, threats to the system. Threat modeling provides traditional risk management and failure mode analysis paradigms, and a framework to assess threats from active adversaries/malicious use. For each vulnerability, a summary report should be produced that concisely summarizes the risk analysis and threat modeling information. Due to the cyclical nature of the analyses, the information should be traceable to related documentation. 43 'Common Vulnerability Scoring System,' Version 3.0, Scoring Calculator (https://www.first.org/cvss/calculator/3.0). ## iii. Analysis of Threat Sources 44\n\nThe FDA recommends manufacturers to analyze possible threat sources."
}
] |
{
"source": "fda_postmarket_2016",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 16,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 373)"
},
{
"role": "assistant",
"content": "According to privacy_rule_2000:\n\nally severe response, the Department's medical staff have access to the employee's medical records for the purpose of making a medical suitability determination under Executive Orders 10450 and 12968.\nTo restrict the Department's access to information at such a crucial time due to a lack of employee authorization leaves the Department no option but to suspend the employee's security clearance. This action automatically would result in an immediate forced departure from post, which negatively would affect both the Department, due to the unexpected loss of personnel, and the individual, due to the fact that a forced departure can have a long-term impact on his or her career in the Foreign Service. For this reason, the rule contains a limited security clearance exemption for the Department of State. The exemption allows the Department's own medical staff to continue to have access to an employee's medical file for the purpose of making a medical suitability determination for security purposes. The medical staff can convey a simple ''yes'' or ''no'' response to those individuals conducting the security investigation within the Department. In this way, the Department is able to make security determinations in exigent circumstances without disclosing any specific medical information to any employees other than the medical personnel who otherwise have routine access to these same medical records in an everyday non-security context. Second, and similarly, the final rule establishes a similar system for disclosures of protected health information necessary to determine worldwide availability or availability for mandatory service abroad under sections 101(a)(4) and 504 of the Foreign Service Act. The Act requires that Foreign Service members be suitable for posting throughout the world and for certain specific assignments. For this reason, we permit a limited exemption to serve the purposes of the statute."
}
] |
{
"source": "privacy_rule_2000",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 372,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 515)"
},
{
"role": "assistant",
"content": "According to privacy_rule_2000:\n\n- (ii) Provide that the group health plan will disclose protected health information to the plan sponsor only upon receipt of a certification by the plan sponsor that the plan documents have been amended to incorporate the following provisions and that the plan sponsor agrees to: - (A) Not use or further disclose the information other than as permitted or required by the plan documents or as required by law; - (B) Ensure that any agents, including a subcontractor, to whom it provides protected health information received from the group health plan agree to the same restrictions and conditions that apply to the plan sponsor with respect to such information; - (C) Not use or disclose the information for employment-related actions and decisions or in connection with any other benefit or employee benefit plan of the plan sponsor; - (D) Report to the group health plan any use or disclosure of the information that is inconsistent with the uses or disclosures provided for of which it becomes aware; - (E) Make available protected health information in accordance with §164.524; - (F) Make available protected health information for amendment and incorporate any amendments to protected health information in accordance with §"
}
] |
{
"source": "privacy_rule_2000",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 514,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does hitech_omnibus_2013 say about HIPAA compliance? (Part 177)"
},
{
"role": "assistant",
"content": "According to hitech_omnibus_2013:\n\nAnalysts (including responsibilities for designing systems and procedures), which is approximately $37.74/hr. See http://www.bls.gov/\n\n18:57 Jan 24, 2013\n\nPO 00000\n\nFrm 00115\n\nmaking them altogether.\nWe acknowledge the potential for some lost revenue due to these modifications in cases where covered entities are currently receiving financial remuneration from third parties to send health-related communications to individuals. However, as we do not know to what extent covered entities today currently operate in this manner, and commenters did not include specific information in this regard, we do not have data that could inform quantifying such loss. The final rule also requires an individual's authorization before a covered entity may disclose protected health information in exchange for remuneration (i.e., ''sell'' protected health information), even if the disclosure is for an otherwise permitted disclosure under the Privacy Rule. The final rule includes several exceptions to this authorization requirement. In the proposed rule, we stated that on its face, this new prohibition would appear to increase the burden to covered entities by requiring them to obtain authorizations in situations in which no authorization is currently required. However, we believed such a scenario to be unlikely. We believed most individuals would not authorize disclosures of their protected health information when they were informed the covered entity would be remunerated for the disclosure. Thus, we believed covered entities would simply discontinue making such disclosures as it would not be\n\noes/current/oes \\_ nat.htm . To this wage rate we have added 50 percent for benefits, which results in a total cost of $56.61/hr. Fmt 4701\n\nSfmt 4700\n\nE:\\FR\\FM\\25JAR2.SGM\n\n25JAR2\n\nJkt 229001\n\nsroberts on DSK5SPTVN1PROD with worthwhile for covered entities to continue to attempt to obtain such authorizations. We requested comment on these assumptions."
}
] |
{
"source": "hitech_omnibus_2013",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 176,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does §164.404(d)(1) require?"
},
{
"role": "assistant",
"content": "According to breach_notification_2009:\n\n§164.404(d)(1). The statute also requires that, if the individual is deceased, notice must be sent to the last known address of the next of kin. The interim final rule adopts this provision at "
}
] |
{
"source": "breach_notification_2009",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "covered_entity",
"type": "cfr_section",
"chunk_id": null,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": "§164.404(d)(1)",
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 544)"
},
{
"role": "assistant",
"content": "According to privacy_rule_2000:\n\nfication: Personnel designations. A covered entity must document the personnel designations in paragraph (a)(1) of this section as required by paragraph (j) of this section. (b)(1) Standard: Training.\nA covered entity must train all members of its workforce on the policies and procedures with respect to protected health information required by this subpart, as necessary and appropriate for the members of the workforce to\n\nFrm 00366\n\nFmt 4701\n\nE:\\FR\\FM\\28DER2.SGM\n\npfrm08\n\nPsN: 28DER2\n\nSfmt 4700\n\ncarry out their function within the covered entity. - (2) Implementation specifications: Training. (i) A covered entity must provide training that meets the requirements of paragraph (b)(1) of this section, as follows:\n2. (A) To each member of the covered entity's workforce by no later than the compliance date for the covered entity;\n3. (B) Thereafter, to each new member of the workforce within a reasonable period of time after the person joins the covered entity's workforce; and\n4. (C) To each member of the covered entity's workforce whose functions are affected by a material change in the policies or procedures required by this subpart, within a reasonable period of time after the material change becomes effective in accordance with paragraph (i) of this section. 5. (ii) A covered entity must document that the training as described in paragraph (b)(2)(i) of this section has been provided, as required by paragraph (j) of this section. 6. (c)(1) Standard: Safeguards. A covered entity must have in place appropriate administrative, technical, and physical safeguards to protect the privacy of protected health information. - (2) Implementation specification: Safeguards. A covered entity must reasonably safeguard protected health information from any intentional or unintentional use or disclosure that is in violation of the standards, implementation specifications or other requirements of this subpart. 8. (d)(1) Standard: Complaints to the covered entity."
}
] |
{
"source": "privacy_rule_2000",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 543,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does hitech_omnibus_2013 say about HIPAA compliance? (Part 126)"
},
{
"role": "assistant",
"content": "According to hitech_omnibus_2013:\n\nexercising reasonable diligence, such as what frequency of monitoring for breaches is expected or what types of systems must covered entities and business associates have in place to detect breaches.\n## Final Rule\n\nWe retain § 164.404(a)(2) in this final rule without modification. We decline to adopt the suggestion that a covered entity be deemed to have discovered a breach only when management is notified of the breach. The HITECH Act itself provides that a breach is to be treated as discovered by a covered entity or business associate if ''any person, other than the individual committing the breach, that is an employee, officer, or other agent of such entity or associate'' knows or should reasonably have known of the breach. This concept is also consistent with the HIPAA Enforcement Rule and the Federal common law of agency. We encourage covered entities and business associates to ensure their workforce members and other agents are adequately trained on the importance of prompt reporting of privacy and security incidents. With respect to those commenters asking for guidance on what it means for a covered entity to be exercising reasonable diligence, we note that the term reasonable diligence, as defined in §160.401, means the business care and prudence expected from a person seeking to satisfy a legal requirement under similar circumstances. The determination of whether a person acted with reasonable diligence is generally a factual one, since what is reasonable depends on the circumstances. Factors to be considered include whether a covered entity or business associate took reasonable steps to learn of breaches and whether there were indications of breaches that a person seeking to satisfy the Rule would have investigated under similar circumstances."
}
] |
{
"source": "hitech_omnibus_2013",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 125,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 494)"
},
{
"role": "assistant",
"content": "According to privacy_rule_2000:\n\nther estimate that it will require each health plan, on average, only 10 seconds to disseminate each notice. The total annual burden associated with this requirement is calculated to be 267,000 hours.\nHealth care providers with direct treatment relationships would provide a copy of the notice to an individual at the time of first service delivery to the individual, make the notice available at the service delivery site for individuals to request and take with them, whenever the content of the notice is revised, make the notice available upon request and post the notice, if required by this section, and post a copy of the notice in a location where it is reasonable to expect individuals seeking services from the provider to be able to read the notice. The annual number of notices disseminated by all providers is 613 million. We further estimate that it will require each health provider, on average, 10 seconds to disseminate each notice. This estimate is based upon the assumption that the required notice will be incorporated into and disseminated with other patient materials. The total annual burden associated with this requirement is calculated to be 1 million hours. In addition, a covered entity must document compliance with the notice requirements by retaining copies of the notices issued by the covered entity. Refer to § 164.530 for discussion. ## Section 164.522-Rights To Request Privacy Proteciton for Protected Health Information\n\nGiven that the burden associated with the following information collection requirements will differ significantly, by the type and size of health plan or health care provider, we are explicitly soliciting comment on the burden associated with the following requirements; as outlined and required by this section, covered entities must provide individuals with the opportunity to request restrictions related to the uses or disclosures of protected health information for treatment, payment, or health care operations."
}
] |
{
"source": "privacy_rule_2000",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 493,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 271)"
},
{
"role": "assistant",
"content": "According to privacy_rule_2000:\n\nires authorization, many of the activities are meaningless. For example, an employee who fails a drug test is unlikely to give authorization to the provider to share the information with the employer.\nResponse: Health care providers are covered entities under this rule if they conduct standard transactions. A health care provider who is an employee and is administering drug testing on behalf of the employer, but does not conduct standard transactions, is not a covered entity. If the health care provider is a covered entity, then we require authorization for the provider to disclose protected health information to an employer. Nothing in this rule, however, prohibits the employer from conditioning an individual's employment on agreeing to the drug testing and requiring the individual to sign an authorization allowing his or her drug test results to be disclosed to the employer. Comment: One commenter stated its belief that only a health center at an academic institution would be a covered entity under the component approach. This commenter believed it was less clear whether or not other components that may create protected health information ''incidentally'' through conducting research would also become covered entities. Response: While a covered entity must designate as a health care component the functions that make it a health care provider, the covered entity remains responsible for the actions of its workforce. Components that create protected health information through research would be covered entities to the extent they performed one of the required transactions described in §164.500; however, it is possible that the research program would not be part of the health care component, depending on whether the research program performed or supported covered functions."
}
] |
{
"source": "privacy_rule_2000",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 270,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does fda_premarket_2023 say about HIPAA compliance? (Part 32)"
},
{
"role": "assistant",
"content": "According to fda_premarket_2023:\n\nitical configuration settings such as energy output. ## · Execution Integrity\n\n- Use industry-accepted best practices to maintain and verify integrity of code while it is being executed on the device.\nFor example, Host-based Intrusion Detection/Prevention Systems (HIDS/HIPS) can be used to accomplish this goal; and\n- Carefully design and review all code that handles the parsing of external data using automated (e.g., static and dynamic analyses) and manual (i.e., code review) methods. ## Confidentiality\n\nManufacturers should ensure support for the confidentiality 81 of any/all data whose disclosure could lead to patient harm (e.g., through the unauthorized use of otherwise valid credentials, lack of encryption). Loss of confidentiality of credentials could be used by a threat-actor to effect multi-patient harm. Lack of encryption to protect sensitive information and or data at rest and in transit can expose this information to misuse that can lead to patient harm. For example, confidentiality is required in the handling and storage of cryptographic keys used for authentication because disclosure could lead to unauthorized use/abuse of device functionality. The proper implementation of authorization and authentication schemes as described in Sections A and B of this appendix will generally ensure confidentiality. However, manufacturers should evaluate and assess whether this is the case during their threat modeling and other risk management activities and make any appropriate changes to their medical device systems to ensure appropriate confidentiality controls are in place. ## Event Detection and Logging\n\nEvent detection and logging are critical capabilities that should be present in a device and the larger system in which it operates in order to ensure that suspected and successful attempts to compromise a medical device may be identified and tracked."
}
] |
{
"source": "fda_premarket_2023",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "covered_entity",
"type": "semantic_chunk",
"chunk_id": 31,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does hitech_omnibus_2013 say about HIPAA compliance? (Part 2)"
},
{
"role": "assistant",
"content": "According to hitech_omnibus_2013:\n\nindividuals' rights to receive electronic copies of their health information and to restrict disclosures to a health plan concerning treatment for which the individual has paid out of pocket in full.\n- Modify the individual authorization and other requirements to facilitate research and disclosure of child immunization proof to schools, and to enable access to decedent information by family members or others. - Require modifications to, and redistribution of, a covered entity's notice of privacy practices. - Adopt the additional HITECH Act enhancements to the Enforcement Rule not previously adopted in the October 30, 2009, interim final rule (referenced immediately below), such as the provisions addressing enforcement of noncompliance with the HIPAA Rules due to willful neglect. 2. Final rule adopting changes to the HIPAA Enforcement Rule to incorporate the increased and tiered civil money penalty structure provided by the HITECH Act, originally published as an interim final rule on October 30, 2009. 3. Final rule on Breach Notification for Unsecured Protected Health Information under the HITECH Act, which replaces the breach notification rule's ''harm'' threshold with a more objective standard and supplants an interim final rule published on August 24, 2009. 4. Final rule modifying the HIPAA Privacy Rule as required by the Genetic Information Nondiscrimination Act (GINA) to prohibit most health plans from using or disclosing genetic information for underwriting purposes, which was published as a proposed rule on October 7, 2009. Fmt 4701\n\nSfmt 4700\n\nE:\\FR\\FM\\25JAR2.SGM\n\n25JAR2\n\nsroberts on DSK5SPTVN1PROD with\n\n## iii. Costs and Benefits\n\nThis final rule is anticipated to have an annual effect on the economy of $100 million or more, making it an economically significant rule under Executive Order 12866. Accordingly, we have prepared a Regulatory Impact Analysis that presents the estimated costs and benefits of the proposed rule."
}
] |
{
"source": "hitech_omnibus_2013",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 1,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 120)"
},
{
"role": "assistant",
"content": "According to privacy_rule_2000:\n\ntion permits a covered entity to make disclosures that are required by other laws, such as state mandatory reporting laws, or are required by legal process such as court orders or grand jury subpoena.\n## Section 164.512(k)-Uses and Disclosures for Specialized Government Functions\n\n## Application to Military Services\n\nIn the NPRM we would have permitted a covered entity providing health care to Armed Forces personnel to use and disclose protected health information for activities deemed necessary by appropriate military command authorities to assure the proper execution of the military mission, where the appropriate military authority had published by notice in the Federal Register (In the NPRM, we proposed that the Department of Defense would publish this Federal Register notice in the future.) The final rule takes a similar approach while making some modifications to the NPRM. One modification concerns the information that will be required in the Federal Register notice. The NPRM would have required a listing of (i) appropriate military command authorities; (ii) the circumstances for which use or disclosure without individual authorization would be required; and (iii) activities for which such use or disclosure would occur in order to assure proper execution of the military mission. In the final rule, we eliminate the third category and also slightly modify language in the second category to read: ''the purposes for\n\nVerDate 11<MAY>2000\n\n19:16 Dec 27, 2000\n\nJkt 194001\n\nPO 00000\n\nFrm 00079\n\nwhich the protected health information may be used or disclosed.''\n\nAn additional modification concerns the rule's application to foreign military and diplomatic personnel. The NPRM would have excluded foreign diplomatic and military personnel, as well as their dependents, from the proposed definition of ''individual,'' thereby excluding any protected health information created about these personnel from the NPRM's privacy protections."
}
] |
{
"source": "privacy_rule_2000",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 119,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 525)"
},
{
"role": "assistant",
"content": "According to privacy_rule_2000:\n\n, from the party seeking the information that reasonable efforts have been made by such party to secure a qualified protective order that meets the requirements of paragraph (e)(1)(v) of this section.\n(iii) For the purposes of paragraph (e)(1)(ii)(A) of this section, a covered entity receives satisfactory assurances from a party seeking protecting health information if the covered entity receives from such party a written statement and accompanying documentation demonstrating that:\n\n- (A) The party requesting such information has made a good faith attempt to provide written notice to the individual (or, if the individual's location is unknown, to mail a notice to the individual's last known address);\n- (B) The notice included sufficient information about the litigation or proceeding in which the protected health information is requested to permit the individual to raise an objection to the court or administrative tribunal; and\n- (C) The time for the individual to raise objections to the court or administrative tribunal has elapsed, and:\n- ( 1 ) No objections were filed; or ( 2 ) All objections filed by the individual have been resolved by the court or the administrative tribunal and the disclosures being sought are consistent with such resolution. - (iv) For the purposes of paragraph (e)(1)(ii)(B) of this section, a covered entity receives satisfactory assurances from a party seeking protected health information, if the covered entity receives from such party a written statement and accompanying documentation demonstrating that:\n- (A) The parties to the dispute giving rise to the request for information have agreed to a qualified protective order and have presented it to the court or administrative tribunal with jurisdiction over the dispute; or\n- (B) The party seeking the protected health information has requested a qualified protective order from such court or administrative tribunal."
}
] |
{
"source": "privacy_rule_2000",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 524,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 485)"
},
{
"role": "assistant",
"content": "According to privacy_rule_2000:\n\ntion every three years and retraining in the event of material changes in policy. Based on public comment, particularly from small businesses, the Department has lessened the burden in the final rule.\nAs in the proposal, the final rule requires all employees who are likely to have contact with protected health information to be trained. Covered entities will have to train employees by the compliance date specific to the type of covered entity and train new employees within a reasonable time of initial employment. In addition, a covered entity will have to train each member of its workforce whose functions are affected by a material change in the policies or procedures of such entity. However, the final rule leaves to the employer the decisions regarding the nature and method of training to achieve this requirement. The Department expects a\n\nVerDate 11<MAY>2000\n\n19:16 Dec 27, 2000\n\nJkt 194001\n\nPO 00000\n\nFrm 00323\n\nwide variety of options to be made available by associations, professional groups, and vendors. Methods might include classroom instruction, videos, booklets, or brochures tailored to particular levels of need of workers and employers. Moreover, the recertification requirement of the NPRM has been dropped to ease the burden on small entities. ## Consent\n\nThe NPRM proposed prohibiting covered entities from requiring individuals to provide written consent for the use and disclosure of protected health information for treatment, payment, and health care operations purposes. The final rule requires certain health care providers to obtain written consent before using or disclosing protected health information for treatment, payment, and health care operations, with a few exceptions. This requirement was included in the final rule in response to comments that this reflects current practice of health care providers health care providers with direct treatment relationships."
}
] |
{
"source": "privacy_rule_2000",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 484,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does security_rule_2003 say about HIPAA compliance? (Part 31)"
},
{
"role": "assistant",
"content": "According to security_rule_2003:\n\ndefinition of the term ''facility,'' as used in the proposed ''Media controls'' requirement description. Commenters were unclear whether we were talking about a corporate entity or the physical plant.\nResponse: The term ''facility'' refers to the physical premises and the interior and exterior of a building(s). We have added this definition to § 164.304. d. Comment: Several commenters believe the ''Media controls'' implementation features are too onerous and should be deleted. Response: While the ''Device and media controls'' standard must be met, we believe, based upon further review, that implementation of all specifications would not be necessary in every situation, and might even be counterproductive in some situations. For example, small providers would be unlikely to be involved in large-scale moves of equipment that would require systematic tracking, unlike, for example, large health care providers or health plans. We have, therefore, reclassified the ''Accountability and data backup'' implementation specification as\n\n17:54 Feb 19, 2003\n\nPO 00000\n\nFrm 00022\n\naddressable to provide more flexibility in meeting the standard. e. Comment: One commenter was concerned about the accountability impact of audit trails on system resources and the pace of system services. Response: The proposed audit trail implementation feature appears as the addressable ''Accountability'' implementation specification. The name change better reflects the purpose and intended scope of the implementation specification. This implementation specification does not address audit trails within systems and/or software. Rather it requires a record of the actions of a person relative to the receipt and removal of hardware and/or software into and out of a facility that are traceable to that person. The impact of maintaining accountability on system resources and services will depend upon the complexity of the mechanism to establish accountability."
}
] |
{
"source": "security_rule_2003",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 30,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 214)"
},
{
"role": "assistant",
"content": "According to privacy_rule_2000:\n\nthe Fifth Amendment protections against forced self incrimination. Other commenters stated that covered entities should be given the reason the Secretary needs to have access to its books and records.\nAnother commenter stated that there should be a limit to the frequency or extent of intrusion by the federal government into the business practices of a covered entity and that these provisions violate the Fourth Amendment of the Constitution. Finally, a coalition of church plans suggested that the Secretary provide church plans with additional procedural safeguards to reduce unnecessary intrusion into internal church operations. These suggested safeguards included permitting HHS to obtain records and other documents only if they are relevant and necessary to compliance and enforcement activities related to church plans, requiring a senior official to determine the appropriateness of compliance-related activities for church plans, and providing church plans with a selfcorrecting period similar to that Congress expressly provided in Title I of HIPAA under the tax code. Response: The final rule retains the proposed language in these two provisions with one change. The rule adds a provision indicating that the Secretary's access to information held by the covered entity may be at any time and without notice where exigent circumstances exist, such as where time is of the essence because documents might be hidden or destroyed. Thus, covered entities will generally receive notice before the Secretary seeks to access the entity's books or records. Other than the exigent circumstances language, the language in these two provisions is virtually the same as the language in this Department's regulation implementing Title VI of the Civil Rights Act of 1964. 45 CFR 80.6(b) and (c). The Title VI regulation is incorporated by reference in other Department regulations prohibiting discrimination of the basis of disability. 45 CFR 84.61."
}
] |
{
"source": "privacy_rule_2000",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 213,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 91)"
},
{
"role": "assistant",
"content": "According to privacy_rule_2000:\n\ndisclosure of protected health information (other than psychotherapy notes), provided that the covered entity does not condition the provision of treatment on the individual signing the authorization.\nFor example, a covered health care provider that had a treatment relationship with an individual prior to the individual's enrollment in a clinical trial, but that is now providing research-related treatment to the individual, may elect to request a compound authorization from the individual: an authorization under §164.508(d) for the provider to use the protected health information it created prior to the initiation of the research that involves treatment, combined with an authorization under § 164.508(f) regarding use and disclosure of protected health information the covered provider will create for the purpose of the clinical trial. This compound authorization would be valid, provided the covered provider did not condition the research-related treatment on obtaining the authorization required under § 164.508(f), as permitted in § 164.508(b)(4)(i). However, we anticipate that covered entities will almost always, if not always, condition the provision of research-related treatment on the individual signing the authorization under §164.508(f) for the covered\n\nFrm 00060\n\nFmt 4701\n\nE:\\FR\\FM\\28DER2.SGM\n\npfrm08\n\nPsN: 28DER2\n\nSfmt 4700\n\nentity's use or disclosure of protected health information created for the research."
}
] |
{
"source": "privacy_rule_2000",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 90,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does privacy_mod_2002 say about HIPAA compliance? (Part 133)"
},
{
"role": "assistant",
"content": "According to privacy_mod_2002:\n\neration to the covered entity from a third party, the authorization must state that such remuneration is involved. - (b) Implementation specifications: general requirements. -(1) Valid authorizations.\n(i) A valid authorization is a document that meets the requirements in paragraphs (a)(3)(ii), (c)(1), and (c)(2) of this section, as applicable. - (ii) A valid authorization may contain elements or information in addition to the elements required by this section, provided that such additional elements or information are not inconsistent with the elements required by this section. - (2) Defective authorizations. An authorization is not valid, if the document submitted has any of the following defects:\n- (i) The expiration date has passed or the expiration event is known by the covered entity to have occurred;\n- (ii) The authorization has not been filled out completely, with respect to an element described by paragraph (c) of this section, if applicable;\n- (iii) The authorization is known by the covered entity to have been revoked;\n- (iv) The authorization violates paragraph (b)(3) or (4) of this section, if applicable;\n- (v) Any material information in the authorization is known by the covered entity to be false. - (3) Compound authorizations."
}
] |
{
"source": "privacy_mod_2002",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 132,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 403)"
},
{
"role": "assistant",
"content": "According to privacy_rule_2000:\n\ntheir medical information will have on treatment of other medical conditions, and therefore, allowing them to restrict use or disclosure of some information is contrary to the patient's best interest.\nResponse: We agree that patients may find it difficult to make such a calculus, and that it is incumbent on health care providers to help them do so. Health care providers may deny requests for or limit the scope of the restriction requested if they believe the restriction is not in the patient's best interest. Comment: One commenter asked whether an individual's restriction to disclosure of information will be a bar to liability for misdiagnosis or failure to diagnose by a covered entity who can trace its error back to the lack of information resulting from such restriction. Response: Decisions regarding liability and professional standards are determined by state and other law. This rule does not establish or limit liability for covered entities under those laws. We expect that the individual's request to restrict the disclosure of their protected health information would be considered in the decision of whether or not a covered entity is liable. Comment: One commenter requested that we allow health plans to deny coverage or reimbursement when a covered health care provider's agreement to restrict use or disclosure prevents the plan from getting the information that is necessary to determine eligibility or coverage. Response: In this rule, we do not modify insurers' rules regarding information necessary for payment. We recognize that restricting the disclosure of information may result in a denial of payment. We expect covered providers to explain this possibility to individuals when considering their requests for restrictions and to make alternative payment arrangements with individuals if necessary."
}
] |
{
"source": "privacy_rule_2000",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 402,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 313)"
},
{
"role": "assistant",
"content": "According to privacy_rule_2000:\n\ncase, jurisdictions have determined that public policy purposes cannot be achieved absent the use of certain protected health information, and we have chosen in general not to disturb their judgments.\nOn the other hand, where jurisdictions have determined that certain protected health information is not necessary to achieve\n\nFrm 00207\n\nFmt 4701\n\nE:\\FR\\FM\\28DER2.SGM\n\npfrm08\n\nPsN: 28DER2\n\nSfmt 4700\n\na public policy purpose, and only have permitted its use or disclosure, we do not believe that those judgments reflect an interest in use or disclosure strong enough to override the Congressional goal of protecting privacy rights. Moreover, the comments failed to present any compelling circumstance to warrant such a general provision. Despite commenters' concerns to the contrary, most of the beneficial uses and disclosures that the commenters referenced to support a general provision were, in fact, uses or disclosures already permissible under the rule. For example, the general statutory authorities relied on by one state health agency to investigate disease outbreaks or to comply with health data-gathering guidelines for reporting to certain federal agencies are permissible disclosures to public health agencies. Finally, in the final rule, we add new provisions to § 164.512 to address three examples raised by commenters of uses and disclosures that are authorized or permitted by law, but may not be required by law. First, commenters expressed concern for the states that provide for voluntary reporting to law enforcement or state protective services of domestic violence or of abuse, neglect or exploitation of the elderly or other vulnerable adults. As discussed below, a new section, § 164.512(c), has been added to the final rule to specifically address uses and disclosures of protected health information in cases of abuse, neglect, or domestic violence."
}
] |
{
"source": "privacy_rule_2000",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 312,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does hitech_omnibus_2013 say about HIPAA compliance? (Part 17)"
},
{
"role": "assistant",
"content": "According to hitech_omnibus_2013:\n\nealth information'' at §160.103 to provide that the Privacy and Security Rules do not protect the individually identifiable health information of persons who have been deceased for more than 50 years.\n## Overview of Public Comment\n\nThe public comments received on this proposal are discussed and responded to below in the section describing the modifications to § 164.502(f). ## Final Rule\n\nFor the reasons stated in the section regarding § 164.502(f), the final rule adopts the proposed modification to the definition of ''protected health information.''\n\n## d. Definition of ''State''\n\n## Proposed Rule\n\nThe HITECH Act at section 13400 includes a definition of ''State'' to mean ''each of the several States, the District of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Northern Mariana Islands.'' This definition varies from paragraph (2) of the HIPAA definition of ''State'' at §160.103, which does not include reference to American Samoa and the Northern Mariana Islands. Thus, for consistency with the definition applied to the HIPAA Rules by the HITECH Act, we proposed to add reference to American Samoa and the Commonwealth of the Northern Mariana Islands in paragraph (2) of the definition of ''State'' at § 160.103. 18:57 Jan 24, 2013\n\nPO 00000\n\nFrm 00012\n\n## Final Rule\n\nThe Department did not receive substantive public comment on this proposal and the final rule adopts the proposed modifications to the definition of ''State.''\n\n## e."
}
] |
{
"source": "hitech_omnibus_2013",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 16,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 47)"
},
{
"role": "assistant",
"content": "According to privacy_rule_2000:\n\nrotection Agency as examples of oversight agencies that conduct oversight of government regulatory programs for which health information is necessary for determining compliance with program standards.\nIn the final rule, we include the following as additional examples of health oversight activities: (1) The U.S. Department of Justice's civil rights enforcement activities, and in particular, enforcement of the Civil Rights of Institutionalized Persons Act (42 U.S.C. 1997-1997j) and the Americans with Disabilities Act (42 U.S.C. 12101 et seq. ), as well as the EEOC's civil rights enforcement activities under titles I and V of the ADA; (2) the FDA's oversight of food, drugs, biologics, devices, and other products pursuant to the Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq. ) and the Public Health Service Act (42 U.S.C. 201 et seq. ); and (3) data analysis -performed by a public agency or by a person or entity acting under grant of authority from or under contract with a public agency -to detect health care fraud. ''Overseeing the health care system,'' which is included in the definition of health oversight, encompasses activities such as: oversight of health care plans;\n\noversight of health benefit plans; oversight of health care providers; oversight of health care and health care delivery; oversight activities that involve resolution of consumer complaints; oversight of pharmaceuticals, medical products and devices, and dietary supplements; and a health oversight agency's analysis of trends in health care costs, quality, health care delivery, access to care, and health insurance coverage for health oversight purposes. We recognize that health oversight agencies, such as the U.S. Department of Labor's Pension and Welfare Benefits Administration, may perform more than one type of health oversight. For example, agencies may sometimes perform audits and investigations and at other times conduct general oversight of health benefit plans."
}
] |
{
"source": "privacy_rule_2000",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 46,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 320)"
},
{
"role": "assistant",
"content": "According to privacy_rule_2000:\n\ny could compromise the ability of law enforcement and oversight officials to perform their duties appropriately. Therefore, in the final rule, we retain the approach of proposed § 164.515 of the NPRM.\nSection 164.528(a)(2) of the final rule states that an individual's right to receive an accounting of\n\nVerDate 11<MAY>2000\n\n19:16 Dec 27, 2000\n\nJkt 194001\n\nPO 00000\n\ndisclosures to a health oversight agency, law enforcement official, or for national security or intelligence purposes may be temporarily suspended for the time specified by the agency or official. As described in § 164.528(a)(2), for such a suspension to occur, the agency or official must provide the affected covered entity with a written request stating that an accounting to the individual would be reasonably likely to impede the agency's activity. The request must specify the time for which the suspension is required. We believe that providing a permanent exemption to the right to accounting for disclosures for health oversight purposes would fail to ensure that individuals are sufficiently informed about the extent of disclosures of their protected health information. Comment: One commenter recommended making disclosures to health oversight agencies subject to a modified version of the NPRM's proposed three-part test governing disclosure of protected health information to law enforcement pursuant to an administrative request (as described in proposed §164.510(f)(1)). Response: We disagree that it would be appropriate to apply the procedural requirements for law enforcement to health oversight. We apply more extensive procedural requirements to law enforcement disclosures than to disclosures for health oversight because we believe that law enforcement investigations more often involve situations in which the individual is the subject of the investigation (and thus could suffer adverse consequences), and we believe that it is appropriate to provide greater protection to individuals in such cases."
}
] |
{
"source": "privacy_rule_2000",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 319,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 460)"
},
{
"role": "assistant",
"content": "According to privacy_rule_2000:\n\nd or identifiers removed at the earliest possible time. Another approach has been for states to require researchers to obtain sensitive, identifiable information from a state public health department.\nOne state does not allow automatic release of protected health information for research purposes without notifying the subjects that their health information may be used in research and allowing them an opportunity to object to the use of their information. 43\n\nComparing state statutes to the final rule: The variability of state law regarding privacy of individually identifiable health information and the limitations of the applicability of many\n\n43 ''Medical records and privacy: Empirical effects of legislation; A memorial to Alice Hersh''; McCarthy, Douglas B; Shatin, Deborah; et al. Health Service Research: April 1, 1999; No. 1, Vol. 34; p. 417. The article details the effects of the Minnesota law conditioning disclosure of protected health information on patient authorization. such laws demonstrates the need for uniformity and minimum standards for privacy protection. This regulation is designed to meet these goals while allowing stricter state laws to be enacted and remain effective. A comparison of state privacy laws with the final regulation highlights several of the rule's key implications:\n\n- The rule will affect more entities than are covered or encompassed under many state laws. - No state law requires covered entities to make their privacy and access policies available to patients. Thus, all covered entities that have direct contact with patients will be required by this rule to prepare a statement of their privacy protection and access policies. This necessarily assumes that entities have to develop procedures if they do not already have them in place. - Among the three categories of covered entities, it appears that health plans will be the most significantly affected by the access provisions of the rule."
}
] |
{
"source": "privacy_rule_2000",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 459,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 325)"
},
{
"role": "assistant",
"content": "According to privacy_rule_2000:\n\nisclosure is not accompanied by a court order, the covered entities be prohibited from disclosing protected health information unless the individual has been given notice and an opportunity to object.\nAnother commenter recommended requiring, in most circumstances, notice and an opportunity to object before a court order is issued and requiring the requestor of information to provide a signed document attesting the date of notification and forbid disclosure until ten days after notice is given. Response: We agree that in some cases the provision of notice with an opportunity to object to the disclosure is appropriate. Thus, in the final rule we provide that a covered entity may disclose protected health information in response to a subpoena, discovery request or other lawful process that is not accompanied by a court order if it receives satisfactory assurance from the party seeking the request that the requesting party has made a good faith attempt to provide written notice to the individual that includes sufficient information about the litigation or proceeding to permit the individual to raise an objection to the court or administrative tribunal and that the time for the individual to raise objections has elapsed (and that none were filed or all have been resolved). Covered entities may make reasonable efforts to provide such notice as well. In certain instances, however, the final rule permits covered entities to disclose protected health information for judicial and administrative proceedings without notice to the individual if the party seeking the request has made reasonable efforts to seek a qualified protective order, as described in the rule. A covered entity may also make reasonable efforts to seek a qualified protective order in order to make the disclosure."
}
] |
{
"source": "privacy_rule_2000",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 324,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does breach_notification_2009 say about HIPAA compliance? (Part 40)"
},
{
"role": "assistant",
"content": "According to breach_notification_2009:\n\number of individuals affected, (d) steps the entity took to notify affected individuals and the degree of success it had in reaching affected individuals, and (e) steps taken to improve data security.\nWe anticipate the time and cost to prepare the report will be the same as that required for issuing a notice to the media. The cost for reporting the 56 breaches affecting 500 or more individuals based on the 2008 data is $4,200. ## Cost of Investigating a Breach\n\nAs a prerequisite to issuing a notice to individuals or to the media and the report to the Secretary when a breach occurs, the covered entity will need to conduct some form of investigation to determine the nature and cause of the breach. We anticipate that most breaches involving fewer than 500 records or individuals will be relatively easy to investigate and may involve a day of investigation to determine the cause and the extent of the breach. An office manager's time at $50 per hour multiplied by 8 hours equals $400 and multiplied by the number of breaches affecting fewer than 500 individuals is $20,000. We note that this estimate includes the time required to produce the documentation required by §164.414(a). For breaches involving 500 or more individuals, the breach investigation may take considerably longer and involve significantly greater costs. The FTC, in its proposed rule (74 FR 17921 and footnote 27) estimated 100 hours at a cost of $4,652. We accept this cost for investigating a breach as an upper bound, but we expect that the average investigation will take half the time and cost approximately $2,300. Based on the Ponemon report cited above, the most frequent cause for data breaches was a lost laptop computer accounting for 35 percent of all data breaches."
}
] |
{
"source": "breach_notification_2009",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "covered_entity",
"type": "semantic_chunk",
"chunk_id": 39,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 99)"
},
{
"role": "assistant",
"content": "According to privacy_rule_2000:\n\nheir commonly understood meanings, as well as any specialized meanings, pursuant to the Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq. ) or the Public Health Service Act (42 U.S.C. 201 et seq. ).\nFor example, ''postmarketing surveillance'' is intended to mean activities related to determining the safety or effectiveness of a product after it has been approved and is in commercial distribution, as well as certain Phase IV (post-approval) commitments by pharmaceutical companies. With respect to devices, ''post-marketing surveillance'' can be construed to refer to requirements of section 522 of the Food, Drug, and Cosmetic Act regarding certain implanted, life-sustaining, or lifesupporting devices. The term ''track'' includes, for example, tracking devices under section 519(e) of the Food, Drug, and Cosmetic Act, units of blood or other blood products, as well as tracebacks of contaminated food. In § 164.512(b)(iii), the term ''required'' refers to requirements in statute, regulation, order, or other\n\nFmt 4701\n\nE:\\FR\\FM\\28DER2.SGM\n\npfrm08\n\nPsN: 28DER2\n\nSfmt 4700\n\nlegally binding authority exercised by the FDA. The term ''directed,'' as used in this section, includes other official agency communications such as guidance documents. We note that under this provision, a covered entity may disclose protected health information to a nongovernmental organization without individual authorization for inclusion in a private data base or registry only if the disclosure is otherwise for one of the purposes described in this provision ( e.g., for tracking products pursuant to FDA direction or requirements, for postmarketing surveillance to comply with FDA requirements or direction.)\n\nTo make a disclosure that is not for one of these activities, covered entities must obtain individual authorization or must meet the requirements of another provision of this rule."
}
] |
{
"source": "privacy_rule_2000",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 98,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 78)"
},
{
"role": "assistant",
"content": "According to privacy_rule_2000:\n\nan electronic signature that meets those standards will be sufficient under this rule. We do not require any verification of the individual's identity or authentication of the individual's signature.\nWe expect covered health care providers that are required to obtain consent to employ the same level of scrutiny to these signatures as they do to the signature obtained on a document regarding the individual's consent to undergo treatment by the provider. ## Section 164.506(d)-Defective Consents\n\nUnder §164.506(d), there is no ''consent'' within the meaning of the rule if the completed document lacks a required element or if the individual has revoked the consent in accordance with §164.506(b)(5). ## Section 164.506(e)-Resolving Conflicting Consents and Authorizations\n\nSituations may arise where a covered entity that has obtained the individual's consent for the covered entity to use or disclose protected health information to carry out treatment, payment, or health care operations is asked to disclose protected health information pursuant to another written legal permission from the individual, such as an authorization, that was obtained by another person. Under §164.506(e), when the terms of a covered entity's consent conflict with the terms of another written legal permission from the individual to use or disclose protected health information (such as a consent obtained under state law by another covered entity or an authorization), the covered entity must adhere to the more restrictive document. By conflict, we mean that the consent and authorization contain inconsistencies. In implementing this section, we note that the consent under this section references the notice provided to the individual and the individual's right to request restrictions."
}
] |
{
"source": "privacy_rule_2000",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 77,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does privacy_mod_2002 say about HIPAA compliance? (Part 7)"
},
{
"role": "assistant",
"content": "According to privacy_mod_2002:\n\nnications about a covered entity's own products and services. As it proposed to do, the Department eliminates the special provisions for marketing health-related products and services at § 164.514(e).\nExcept as provided for at § 164.508(a)(3), a covered entity must have the individual's prior written authorization to use or disclose protected health information for marketing communications and will no longer be able to do so simply by meeting the disclosure and opt-out provisions, previously set forth in § 164.514(e). The Department agrees with commenters that the authorization provides individuals with more control over whether they receive marketing communications and better privacy protections for such uses and disclosures of their health information. In response to commenters who opposed this proposal, the Department does not believe that an opt-out requirement for marketing communications would provide a sufficient level of control for patients regarding their health information. Nor does the Department believe that a blanket authorization provides sufficient privacy protections for individuals. Section 164.508(c) sets forth the core elements of an authorization necessary to give individuals control of their protected health information. Those requirements give individuals sufficient information and notice regarding the type of use or disclosure of their protected health information that they are authorizing. Without such specificity, an authorization would not have meaning. Indeed, blanket marketing authorizations would be considered defective under § 164.508(b)(2). The Department adopts the general definition of ''marketing'' with one clarification."
}
] |
{
"source": "privacy_mod_2002",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 6,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 23)"
},
{
"role": "assistant",
"content": "According to privacy_rule_2000:\n\nlents). A conduit transports information but does not access it other than on a random or infrequent basis as may be necessary for the performance of the transportation service, or as required by law.\nSince no disclosure is intended by the covered entity and the probability of exposure of any particular protected health information to a conduit is very small, we do not consider a conduit to be a business associate of the covered entity. We do not consider a financial institution to be acting on behalf of a covered entity, and therefore no business associate contract is required, when it processes consumer-conducted financial transactions by debit, credit or other payment card, clears checks, initiates or processes electronic funds transfers, or conducts any other activity that directly facilitates or effects the transfer of funds for compensation for health care. A typical consumerconducted payment transaction is when a consumer pays for health care or health insurance premiums using a check or credit card. In these cases the identity of the consumer is always included and some health information (e.g., diagnosis or procedure) may be implied through the name of the health care provider or health plan being paid. Covered entities that initiate such payment activities must meet the minimum necessary disclosure requirements described in the preamble to § 164.514. ## Covered Entity\n\nWe provided this definition in the NPRM for convenience of reference and proposed it to mean the entities to which part C of title XI of the Act applies. These are the entities described in section 1172(a)(1): Health plans, health care clearinghouses, and health care providers who transmit any health information in electronic form in connection with a transaction referred\n\nFmt 4701\n\nE:\\FR\\FM\\28DER2.SGM\n\npfrm08\n\nPsN: 28DER2\n\nSfmt 4700\n\nto in section 1173(a)(1) of the Act (a ''standard transaction'')."
}
] |
{
"source": "privacy_rule_2000",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 22,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "When must a HIPAA breach be reported to HHS?"
},
{
"role": "assistant",
"content": "According to security_rule_2003:\n\n<unknown>\n\n## DEPARTMENT OF HEALTH AND HUMAN SERVICES\n\nOffice of the Secretary\n\n45 CFR Parts 160, 162, and 164 [CMS-0049-F] RIN 0938-AI57\n\n## Health Insurance Reform: Security Standards\n\nAGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Final rule. SUMMARY: This final rule adopts standards for the security of electronic protected health information to be implemented by health plans, health care clearinghouses, and certain health care providers. The use of the security standards will improve the Medicare and Medicaid programs, and otherFederal health programs and private health programs, and the effectiveness and efficiency of the health care industry in general by establishing a level of protection for certain electronic health information. This final rule implements some of the requirements of the Administrative Simplification subtitle of the Health Insurance Portability andAccountability Act of 1996 (HIPAA). DATES: Effective Date: These regulations are effective on April 21, 2003. Compliance Date: Covered entities, with the exception of small health plans, must comply with the requirements of this final rule by April 21, 2005. Small health plans must comply with the requirements of this final rule by April 21, 2006. FOR FURTHER INFORMATION CONTACT: William Schooler, (410) 786-0089. SUPPLEMENTARY INFORMATION:\n\n## Availability of Copies and Electronic Access\n\nTo order copies of the Federal Register containing this document, send your request to: New Orders, Superintendent of Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954. Specify the date of the issue requested and enclose a check or money order payable to the Superintendent of Documents, or enclose your Visa or Master Card number and expiration date. Credit card orders can also be placed by calling the order desk at (202) 512-1800 or by faxing to (202) 5122250. The cost for each copy is $10."
}
] |
{
"source": "security_rule_2003",
"safeguard_types": null,
"entity_type": null,
"type": "breach_notification",
"chunk_id": null,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": "§164.400-414",
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does privacy_mod_2002 say about HIPAA compliance? (Part 62)"
},
{
"role": "assistant",
"content": "According to privacy_mod_2002:\n\ne appropriate. Thus, the covered entity requesting an authorization for its own use of protected health information may provide assurances that the information will remain subject to the Privacy Rule.\nSimilarly, if a third party, such as a researcher, is seeking an authorization for research, the statement may refer to the privacy protections that the researcher will provide for the data. Under §164.508(c)(3), authorizations must be written in plain language so that individuals can understand the information contained in the form, and thus be able to make an informed decision about whether to give the authorization. A few commenters urged the Department to keep the plain language requirement as a core element of a valid authorization. Under the December 2000 Rule, the plain language requirement was not a requisite for a valid authorization. Nevertheless, under both the December 2000 Rule and the final modifications, authorizations must be written in plain language. The fact that the plain language requirement is not a core element does not diminish its importance or effect, and the failure to meet this requirement is a violation of the Rule. Finally, under § 164.508(c)(4), covered entities who seek an authorization are required to provide the individual with a copy of the signed authorization form. ## Response to Other Public Comments\n\nComment: A number of commenters specifically expressed support of the proposed authorization requirement for marketing, and urged the Department to adopt the requirement. However, one commenter claimed that requiring authorizations for marketing would reduce hospitals' ability to market their programs and services effectively in order to compete in the marketplace, and that obtaining, storing, and maintaining marketing authorizations would be too burdensome."
}
] |
{
"source": "privacy_mod_2002",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 61,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 480)"
},
{
"role": "assistant",
"content": "According to privacy_rule_2000:\n\nrmation is through the notice requirement. Increased use of mental health and services would be expected to be beneficial to the persons receiving the care, to their families, and to society at large.\nThe direct benefit to the individual from treatment would include improved quality of life, reduced disability associated with mental conditions, reduced mortality rate, and increased productivity associated with reduced disability and mortality. The benefit to families would include quality of life improvements and reduced medical costs for other family members associated with abusive behavior by the treated individual. The potential economic benefits associated with improving privacy of individually identifiable health information and thus encouraging some portion of individuals to seek initial mental health treatment or increase service use are difficult to quantify well. Nevertheless, using a methodology similar to the one used above to estimate potential savings in cancer costs, one can lay out a range of possible benefit levels to illustrate the possibility of cost savings associated with an expansion of mental health and treatment to individuals who, due to protections offered by the privacy regulation, might seek treatment that they otherwise would not have. This can be illustrated by drawing upon existing data on the economic costs of mental illness and the treatment effectiveness of interventions. The 1998 Substance Abuse and Mental Health Statistics Source Book from the Substance Abuse and Mental Health Services Administration (SAMHSA) estimates that the economic\n\n68 Standard Medical information; see http:// www.mayohealth.org for examples. VerDate 11<MAY>2000\n\n19:16 Dec 27, 2000\n\nJkt 194001\n\nPO 00000\n\nFrm 00318\n\nFmt 4701\n\nSfmt 4700\n\ncost to society of mental illness in 1994 was about $204.4 billion."
}
] |
{
"source": "privacy_rule_2000",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 479,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "How should organizations implement administrative controls?"
},
{
"role": "assistant",
"content": "According to privacy_mod_2002:\n\n<unknown>\n\n## DEPARTMENT OF HEALTH AND HUMAN SERVICES\n\nOffice of the Secretary\n\n## 45 CFR Parts 160 and 164\n\nRIN 0991-AB14\n\n## Standards for Privacy of Individually Identifiable Health Information\n\nAGENCY: Office for Civil Rights, HHS. ACTION: Final rule. SUMMARY: The Department of Health and Human Services (''HHS'' or ''Department'') modifies certain standards in the Rule entitled ''Standards for Privacy of Individually Identifiable Health Information'' (''Privacy Rule''). The Privacy Rule implements the privacy requirements of the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996. The purpose of these modifications is to maintain strong protections for the privacy of individually identifiable health information while clarifying certain of the Privacy Rule's provisions, addressing the unintended negative effects of the Privacy Rule on health care quality or access to health care, and relieving unintended administrative burdens created by the Privacy Rule. DATES: This final rule is effective on October 15, 2002. FOR FURTHER INFORMATION CONTACT: Felicia Farmer, 1-866-OCR-PRIV (1866-627-7748) or TTY 1-866-7884989. ## SUPPLEMENTARY INFORMATION:\n\nAvailability of copies, and electronic access. Copies: To order copies of the Federal Register containing this document, send your request to: New Orders, Superintendent of Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954. Specify the date of the issue requested and enclose a check or money order payable to the Superintendent of Documents, or enclose your Visa or Master Card number and expiration date. Credit card orders can also be placed by calling the order desk at (202) 512-1800 (or toll-free at 1-866-5121800) or by fax to (202) 512-2250. The cost for each copy is $10.00."
}
] |
{
"source": "privacy_mod_2002",
"safeguard_types": null,
"entity_type": "both",
"type": "safeguard",
"chunk_id": null,
"safeguard_type": "administrative",
"implementation_spec": "required",
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "How should organizations implement administrative controls?"
},
{
"role": "assistant",
"content": "According to privacy_rule_2000:\n\n<unknown>\n\n## DEPARTMENT OF HEALTH AND HUMAN SERVICES\n\n## Office of the Secretary\n\n## 45 CFR Parts 160 and 164\n\nRin: 0991-AB08\n\n## Standards for Privacy of Individually Identifiable Health Information\n\nAGENCY : Office of the Assistant Secretary for Planning and Evaluation, DHHS. ACTION\n\n: Final rule. SUMMARY : This rule includes standards to protect the privacy of individually identifiable health information. The rules below, which apply to health plans, health care clearinghouses, and certain health care providers, present standards with respect to the rights of individuals who are the subjects of this information, procedures for the exercise of those rights, and the authorized and required uses and disclosures of this information. The use of these standards will improve the efficiency and effectiveness of public and private health programs and health care services by providing enhanced protections for individually identifiable health information. These protections will begin to address growing public concerns that advances in electronic technology and evolution in the health care industry are resulting, or may result, in a substantial erosion of the privacy surrounding individually identifiable health information maintained by health care providers, health plans and their administrative contractors. This rule implements the privacy requirements of the Administrative Simplification subtitle of the Health Insurance Portability and\n\nAccountability Act of 1996. DATES : The final rule is effective on February 26, 2001. ## FOR FURTHER INFORMATION CONTACT :\n\nKimberly Coleman, 1-866-OCR-PRIV (1-866-627-7748) or TTY 1-866-7884989. ## SUPPLEMENTARY INFORMATION :\n\nAvailability of copies, and electronic access. Copies: To order copies of the Federal Register containing this document, send your request to: New Orders, Superintendent of Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954."
}
] |
{
"source": "privacy_rule_2000",
"safeguard_types": null,
"entity_type": "both",
"type": "safeguard",
"chunk_id": null,
"safeguard_type": "administrative",
"implementation_spec": "required",
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "How should organizations implement administrative controls?"
},
{
"role": "assistant",
"content": "According to fda_premarket_2023:\n\n## Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions\n\n## Guidance for Industry and Food and Drug Administration Staff\n\nDocument issued on June 27, 2025. A draft select update to this document was issued on March 13, 2024. This document supersedes 'Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions,' issued September 27, 2023. For questions about this document regarding CDRH-regulated devices, contact CyberMed@fda.hhs.gov. For questions about this document regarding CBER-regulated devices, contact the Office of Communication, Outreach, and Development (OCOD) at 1-800-835-4709 or 240-402-8010, or by email at industry.biologics@fda.hhs.gov. <!-- image -->\n\nU.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Center for Biologics Evaluation and Research\n\n## Public Comment\n\nYou may submit electronic comments and suggestions at any time for Agency consideration to https://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852. Identify all comments with the docket number FDA-2021-D-1158. Comments may not be acted upon by the Agency until the document is next revised or updated. ## Additional Copies\n\n## CDRH\n\nAdditional copies are available from the Internet. You may also send an email request to CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please include the document number GUI00001825 and complete title of the guidance in the request."
}
] |
{
"source": "fda_premarket_2023",
"safeguard_types": null,
"entity_type": "covered_entity",
"type": "safeguard",
"chunk_id": null,
"safeguard_type": "administrative",
"implementation_spec": "required",
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 272)"
},
{
"role": "assistant",
"content": "According to privacy_rule_2000:\n\n'knew or reasonably should have known'' of improper use of protected health information and failed to take reasonable steps to cure a breach of the business partner contract or terminate the contract.\nMany commenters urged that the term ''knew or should have known'' be clearly defined, with examples. Some commenters stated that covered entities should be liable only when they have actual knowledge of the material breach of the privacy rules by the business partner. Others recommended creation of a process by which a business partner could seek advice to determine if a particular disclosure would be appropriate. Some commenters stated that, in order to create an environment that would encourage covered entities to report misuses of protected health information, a covered entity should not be punished if it discovered an inappropriate disclosure. Response: With regard to our authority to require business associate contracts, we clarify that Congress gave the Department explicit authority to regulate what uses and disclosures of protected health information by covered entities are ''authorized.'' If covered entities were able to circumvent the requirements of these rules by the simple expedient of contracting out the performance of various functions, these rules would afford no protection to individually identifiable health information and be rendered meaningless. It is thus reasonable to place restrictions on disclosures to business associates that are designed to ensure that the personal medical information disclosed to them continues to be protected and used and further\n\nFmt 4701\n\nE:\\FR\\FM\\28DER2.SGM\n\npfrm08\n\nPsN: 28DER2\n\nSfmt 4700\n\ndisclosed only for appropriate (i.e., permitted or required) purposes. We do not agree that business associate contracts would necessarily have complex terms or result in significant time and resource burdens. The implementation specifications for business associate contracts set forth in §164.504 are straightforward and clear."
}
] |
{
"source": "privacy_rule_2000",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 271,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 447)"
},
{
"role": "assistant",
"content": "According to privacy_rule_2000:\n\nin the final small entities analysis (below), reflecting policy changes in the final rule and additional information and data collected by the Department since the issuance of the proposal last fall.\nWe believe that these estimates reasonably reflect the costs that various types of small entities will experience in general, though the actual costs of particular providers might vary considerably based on their current practices and technology. Comment: A respondent expressed the belief that small providers would bear a disproportionate share of the regulation's administrative burden because of the likelihood of larger companies incurring fewer marginal costs due to greater in-house resources to aid in the legal and technical analysis of the proposed rule. Response: As explained below, the Department does not agree with the assertion that small entities will be disproportionately affected. Based on discussions with a number of groups, the Department expects many professional and trade associations to provide their members with analysis of the regulation, including model policies, statements and basic training materials. This will minimize the cost for most small entities. Providers that use protected health information for voluntary practices, such as marketing or research, are more likely to need specific legal and technical assistance, but these are likely to be larger providers. Comment: Several commenters took issue with the ''top-down'' approach that we used to estimate costs for small businesses, believing that this methodology provided only a single point estimate, gave no indication of the variation around the estimate, and was subject to numerous methodological errors since the entities to which the numerator pertained may not have been\n\nFrm 00296\n\nFmt 4701\n\nE:\\FR\\FM\\28DER2.SGM\n\npfrm08\n\nPsN: 28DER2\n\nSfmt 4700\n\nthe same as the denominator."
}
] |
{
"source": "privacy_rule_2000",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 446,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does hitech_omnibus_2013 say about HIPAA compliance? (Part 128)"
},
{
"role": "assistant",
"content": "According to hitech_omnibus_2013:\n\nentity or business associate to describe how the breach occurred such that it would create a roadmap for future breaches. ## Final Rule\n\nWe retain § 164.404(c) in this final rule without modification.\nThe content requirements in the Rule generally mirror the content requirements in the statute and each element is an important component of the notice to ensure individuals receive the information they need to protect themselves to the extent possible from the consequences of a breach and to learn what is being done to mitigate the breach and prevent future breaches. At the same time, the content provisions are sufficiently flexible to allow covered entities and business associates to tailor the breach notices based on the circumstances surrounding the breach and of the entity. In our experience in administering the Rule since 2009, the Rule provides sufficient flexibility to describe to the individual the circumstances surrounding the breach in a more general manner that still provides the individual with pertinent information but that does not provide a roadmap to third parties for future breaches. For example, the notice need not explain the exact type of vulnerability in the security of a covered entity's electronic records system that led to unauthorized access and how that vulnerability was exploited. Similarly, a covered entity has flexibility in describing what the covered entity is doing in response to a breach. Where employee sanctions are relevant based on the circumstances of the breach, a covered entity may determine that it wants to describe the sanctions imposed more generally and nothing in the Rule would require that the notice include the names of the employees involved. For example, a covered entity may want to indicate generally that the employees involved have been appropriately disciplined, particularly if multiple employees received varying levels of sanctions based on their degrees of involvement in the breach."
}
] |
{
"source": "hitech_omnibus_2013",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 127,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does hitech_omnibus_2013 say about HIPAA compliance? (Part 22)"
},
{
"role": "assistant",
"content": "According to hitech_omnibus_2013:\n\n0.410, which pertains only to affirmative defenses, to §160.401, so that they would apply to the entirety of Subpart D of Part 160 and the provisions regarding the imposition of civil money penalties.\nThe IFR did not modify the definitions themselves as the HITECH Act did not amend the definitions. Even though the HITECH Act did not amend the definitions of these terms,\n\nFmt 4701\n\nSfmt 4700\n\nE:\\FR\\FM\\25JAR2.SGM\n\n25JAR2\n\nJkt 229001\n\nsroberts on DSK5SPTVN1PROD with the Department in its NPRM proposed certain modifications to the definition of ''reasonable cause'' to clarify the mens rea (state of mind) required for this category of violations, and to avoid the situation where certain violations would not fall within one of the established penalty tiers. This modification is discussed below. The Department did not propose modifications to the definitions of ''reasonable diligence'' and ''willful neglect.''\n\nIn the NPRM, the Department also included examples and guidance as to how the Department planned to apply the definitions of ''reasonable cause,'' ''reasonable diligence,'' and ''willful neglect'' to distinguish among the tiers of culpability. 75 FR 40877-40879. As commenters generally found this guidance helpful, the Department intends to publish the guidance on its web site. Modifications to the Definition of ''Reasonable Cause''\n\n## Proposed Rule\n\nReasonable cause is currently defined at § 160.401 to mean: ''circumstances that would make it unreasonable for the covered entity, despite the exercise of ordinary business care and prudence, to comply with the administrative simplification provision violated.'' This definition is consistent with the Supreme Court's ruling in United States v. Boyle, 469 U.S. 241, 245 (1985), which focused on whether circumstances were beyond the regulated person's control, thereby making compliance unreasonable. See 70 FR 20224, 20238."
}
] |
{
"source": "hitech_omnibus_2013",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 21,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 90)"
},
{
"role": "assistant",
"content": "According to privacy_rule_2000:\n\nct research involving treatment to bind themselves to a more limited scope of uses and disclosures of research information than they would otherwise be permitted to make with non-research information.\nRather than creating a single definition of ''research information,'' we allow covered entities the flexibility to define that subset of protected health information they create during clinical research that is not necessary for treatment, payment, or health care operations and that the covered entity will use or disclose under more limited circumstances than it uses or discloses other protected health information. In designing their authorizations, we expect covered entities to be mindful of the often highly sensitive nature of research information and the impact of individuals' privacy concerns on their willingness to participate in research. Covered entities seeking authorization to use or disclose protected health information they create for the purpose of research that includes treatment of individuals, including clinical trials, must include in the authorization (in addition to the applicable elements required above) a description of the extent to which some or all of the protected health information created for the research will also be used or disclosed for purposes of treatment, payment, and health care operations. For example, if the covered entity intends to seek reimbursement from the individual's health plan for the routine costs of care associated with the research protocol, it must explain in the authorization the types of information that it will provide to the health plan for this purpose. This information, and the circumstances under which disclosures will be made for treatment, payment, and health care operations, may be more limited than the information and circumstances described in the covered entity's general consent and notice of privacy practices."
}
] |
{
"source": "privacy_rule_2000",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 89,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does privacy_mod_2002 say about HIPAA compliance? (Part 92)"
},
{
"role": "assistant",
"content": "According to privacy_mod_2002:\n\nhe Privacy Rule permits covered entities that participate in an OHCA to satisfy the notice requirements through the use of a joint notice, provided that the relevant conditions of §164.520(d) are met.\nSection 164.520(d)(3) further provides that provision of a joint notice to an individual by any one of the covered entities included in the joint notice satisfies the notice provision requirements at § 164.520(c) with respect to all others covered by the joint\n\n19:04 Aug 13, 2002\n\nPO 00000\n\nFrm 00061\n\nnotice. Thus, a health care provider with a direct treatment relationship with an individual that is participating in an OHCA only need make a good faith effort to obtain the individual's acknowledgment of the joint notice if that provider is the covered entity within the OHCA that is providing the joint notice to the individual. Where the joint notice is provided to the individual by a participating covered entity other than a provider with a direct treatment relationship with the individual, no acknowledgment need be obtained. However, covered entities that participate in an OHCA are not required to utilize a joint notice and may maintain separate notices. In such case, each covered health care provider with a direct treatment relationship within the OHCA must make a good faith effort to obtain the individual's acknowledgment of the notice he or she provides. Similarly, an affiliated covered entity may have one single notice that covers all of its affiliates. Thus, if the affiliated covered entity's notice is provided to the individual by a health care provider with which the individual has a direct treatment relationship, the health care provider must make a good faith effort to obtain the individual's acknowledgment of receipt of the notice. Alternatively, where the affiliated entity's notice is provided to the individual by a participating entity other than a provider with a direct treatment relationship with the individual, no acknowledgment need be obtained."
}
] |
{
"source": "privacy_mod_2002",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 91,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does nist_sp800-66r2 say about HIPAA compliance?"
},
{
"role": "assistant",
"content": "According to nist_sp800-66r2:\n\n<!-- image -->\n\n## NIST Special Publication 800 NIST SP 800-66r2\n\n## Implementing the Health Insurance Portability and Accountability Act (HIPAA) Security Rule\n\nA Cybersecurity Resource Guide\n\nJeffrey A. Marron\n\nThis publication is available free of charge from: https://doi.org/10.6028/NIST.SP.800-66r2\n\n<!-- image -->\n\n## NIST Special Publication 800 NIST SP 800-66r2\n\n## Implementing the Health Insurance Portability and Accountability Act (HIPAA) Security Rule\n\nA Cybersecurity Resource Guide\n\nJeffrey A. Marron Applied Cybersecurity Division Information Technology Laboratory\n\nThis publication is available free of charge from: https://doi.org/10.6028/NIST.SP.800-66r2\n\nFebruary 2024\n\n<!-- image -->\n\nU.S. Department of Commerce Gina M. Raimondo, Secretary\n\nNational Institute of Standards and Technology\n\nCertain commercial equipment, instruments, software, or materials, commercial or non-commercial, are identified in this paper in order to specify the experimental procedure adequately. Such identification does not imply recommendation or endorsement of any product or service by NIST, nor does it imply that the materials or equipment identified are necessarily the best available for the purpose. There may be references in this publication to other publications currently under development by NIST in accordance with its assigned statutory responsibilities. The information in this publication, including concepts and methodologies, may be used by federal agencies even before the completion of such companion publications. Thus, until each publication is completed, current requirements, guidelines, and procedures, where they exist, remain operative. For planning and transition purposes, federal agencies may wish to closely follow the development of these new publications by NIST. Organizations are encouraged to review all draft publications during public comment periods and provide feedback to NIST."
}
] |
{
"source": "nist_sp800-66r2",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 0,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 188)"
},
{
"role": "assistant",
"content": "According to privacy_rule_2000:\n\nlikely to be a major cause of uncertainty. We have deferred to Congressional intent by crafting the permissible releases for public health, abuse, and oversight broadly. See, §§ 164.512(b)-(d) below.\nSince there must first be a conflict between a state law and a federal requirement in order for an issue of preemption to even arise, we think that, as a practical matter, few preemption questions should arise with respect to sections 1178(b) and 1178(c). With respect to preemption of state privacy laws under section 1178(a)(2)(B), however, we agree that the situation may be more difficult to ascertain, because the Secretary does not determine the preemption status of a state law under that section, unlike the situation with respect to section 1178(a)(2)(A). We have tried to define the term ''more stringent'' to identify and particularize the factors to be considered by courts to those relevant to privacy interests. The more specific (than the statute) definition of this term at § 160.202 below should provide some\n\nVerDate 11<MAY>2000\n\n19:16 Dec 27, 2000\n\nJkt 194001\n\nPO 00000\n\nFrm 00124\n\nguidance in making the determination as to which law prevails. Ambiguity in the state of the law might also be a factor to be taken into account in determining whether a penalty should be applied. Comment: Several comments recommended that exception determinations or advisory opinions encompass a state act or code in its entirety (in lieu of a provision-specific evaluation) if it is considered more stringent as a whole than the regulation. It was argued that since the provisions of a given law are typically interconnected and related, adopting or overriding them on a provision-byprovision basis would result in distortions and/or unintended consequences or loopholes."
}
] |
{
"source": "privacy_rule_2000",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 187,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 411)"
},
{
"role": "assistant",
"content": "According to privacy_rule_2000:\n\nthey are covered entities or business associates of covered entities, and they must provide access only to protected health information that they maintain (or that their business associates maintain).\nIt would not be efficient to require a covered entity to compare another entity's information with that of the entity to which the request was addressed. (See the discussion regarding covered entities for information about whether a pharmacy benefit manager is a covered entity.)\n\nWe disagree with the fourth point: a billing company will be required by its business associate contract only to provide the requested protected health information to its physician client. This action will not violate any fiduciary responsibility. The physician client would in turn be required by the rule to provide access to the individual. Comment: Some commenters asked for clarification that the clearinghouse function of turning non-standardized data into standardized data does not create non-duplicative data and that ''duplicate'' does not mean ''identical.'' A few commenters suggested that duplicated information in a covered entity's designated record set be supplied only once per request. Response: We consider as duplicative information the same information in different formats, media, or presentations, or which have been standardized. Business associates who have materially altered protected health information are obligated to provide individuals access to it. Summary information and reports, including those of lab results, are not the same as the underlying information on which the summaries or reports were based. A clean document is not a duplicate of the same document with notations. If the same information is kept in more than one location, the covered entity has to produce the information only once per request for access. Comment: A few commenters suggested requiring covered entities to disclose to third parties without exception at the requests of individuals."
}
] |
{
"source": "privacy_rule_2000",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 410,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 76)"
},
{
"role": "assistant",
"content": "According to privacy_rule_2000:\n\nty is\n\nFmt 4701\n\nE:\\FR\\FM\\28DER2.SGM\n\npfrm08\n\nPsN: 28DER2\n\nSfmt 4700\n\nprohibited under § 164.502(a)(1) from using or disclosing protected health information for the purpose(s) included in the consent.\nA covered entity that seeks a consent must adhere to the individual's decision. In § 164.506(a)(5), we specify that a consent obtained by one covered entity is not effective to permit another covered entity to use or disclose protected health information, unless the consent is a joint consent. See §164.506(f) and the corresponding preamble discussion below regarding joint consents. A consent provides the individual's permission only for the covered entity that obtains the consent to use or disclose protected health information for treatment, payment, and health care operations. A consent under this section does not operate to authorize another covered entity to use or disclose protected health information, except where the other covered entity is operating as a business associate. We note that, where a covered entity is acting as a business associate of another covered entity, the business associate covered entity is acting for or on behalf of the principal covered entity, and its actions for or on behalf of the principal covered entity are authorized by the consent obtained by the principal covered entity. Thus, under this section, a health plan can obtain a consent that permits the health plan and its business associates to use and disclose protected health information that the health plan and its business associates create or receive. That consent cannot, however, permit another covered entity (that is not a business associate) to disclose protected health information to the health plan or to any other person. If a covered entity wants to obtain the individual's permission for another covered entity to disclose protected health information to it for treatment, payment, or health care operations purposes, it must seek an authorization in accordance with § 164.508(e)."
}
] |
{
"source": "privacy_rule_2000",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 75,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 284)"
},
{
"role": "assistant",
"content": "According to privacy_rule_2000:\n\nsed approach and requires most covered health care providers to obtain a consent from their patients to use or disclose protected health information for treatment, payment, and health care operations.\nProviders who have an indirect treatment relationship with the patient, as defined in § 164.501, cannot\n\nVerDate 11<MAY>2000\n\n19:16 Dec 27, 2000\n\nJkt 194001\n\nPO 00000\n\nFrm 00188\n\nbe expected to have an opportunity to obtain consent and may continue to rely on regulatory authorization for their uses and disclosures for these purposes. As described in the comments, it is the relationship between the health care provider and the patient that is the basis for many decisions about uses and disclosures of protected health information. Much of the individually identifiable health information that is the subject of this rule is created when a patient interacts with a health care provider. By requiring covered providers to obtain consent for treatment, payment, and health care operations, the individual will have appropriate opportunity to consider the appropriate uses and disclosures of his or her protected health information. We also require that the consent contain a reference to the provider's notice, which contains a more detailed description of the provider's practices relating to uses and disclosures of protected health information. This combination provides the basis for an individual to have an informed conversation with his or her provider and to request restrictions. It is our understanding that it is common practice for providers to obtain consent for this type of informationsharing today. Many providers and provider organizations stated that they are ethically obligated to obtain the patient's consent and that it is their practice to do so. A 1998 study by Merz, et al, published in the Journal of Law, Medicine and Ethics examined hospital consent forms regarding disclosure of medical information."
}
] |
{
"source": "privacy_rule_2000",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 283,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 191)"
},
{
"role": "assistant",
"content": "According to privacy_rule_2000:\n\nprioritization and management considerations discussed above with respect to advisory opinions are also relevant here and make us reluctant to agree to a deadline for making exception determinations.\nThis is particularly true at the outset, since we have no experience with such requests. We therefore have no basis for determining how long processing such requests will take, how many requests we will need to process, or what resources will be available for such processing. We agree that states and other requesters should receive timely responses and will make every effort to make determinations as expeditiously as possible, but we cannot commit to firm deadlines in this initial rule. Once we have experience in handling exception requests, we will consult with states and others in regard to their experiences and concerns and their suggestions for improving the Secretary's expeditious handling of such requests. VerDate 11<MAY>2000\n\n19:16 Dec 27, 2000\n\nJkt 194001\n\nPO 00000\n\nFrm 00126\n\nWe are not accepting the suggestion that requests for exception be deemed approved if not acted upon in some defined time period. Section 1178(a)(2)(A) requires a specific determination by the Secretary. The suggested policy would not be consistent with this statutory requirement. It is also inadvisable from a policy standpoint, in that it would tend to maximize exceptions. This would be contrary to the underlying statutory policy in favor of uniform federal standards. Comment: One commenter took exception to the requirement for states to seek a determination from the Department that a provision of state law is necessary to prevent fraud and abuse or to ensure appropriate state regulation of insurance plans, contending that this mandate could interfere with the Insurance Commissioners' ability to do their jobs."
}
] |
{
"source": "privacy_rule_2000",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 190,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 329)"
},
{
"role": "assistant",
"content": "According to privacy_rule_2000:\n\nations. A few commenters argued that effective law enforcement requires early access to as much information as possible, to rule out suspects, assess severity of criminal acts, and for other purposes.\nA few commenters noted the difficulties criminal investigators and prosecutors face when fighting complex criminal schemes. In general, these commenters argued that all disclosures of protected health information to law enforcement should be allowed, or for elimination of the process requirements proposed in §164.510(f)(1). Response: The importance and legitimacy of law enforcement activities are beyond question, and they are not at issue in this regulation. We permit disclosure of protected health information to law enforcement officials without authorization in some situations precisely because of the importance of these activities to public safety. At the same time, individuals' privacy interests also are important and legitimate. As with all the other disclosures of protected health information permitted under this regulation, the rules we impose attempt to balance competing and legitimate interests. Comment: Law enforcement representatives stated that law enforcement agencies had a good track record of protecting patient privacy and that additional restrictions on their access and use of information were not warranted. Some commenters argued that no new limitations on law enforcement access to protected health information were necessary, because sufficient safeguards exist in state and federal laws to prevent inappropriate disclosure of protected health information by law enforcement. Response: Disclosure of protected health information by law enforcement is not at issue in this regulation. Law enforcement access to protected health information in the first instance, absent any re-disclosure by law enforcement, impinges on individuals' privacy interests and must therefore be justified by a public purpose that outweighs individuals' privacy interests."
}
] |
{
"source": "privacy_rule_2000",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 328,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 456)"
},
{
"role": "assistant",
"content": "According to privacy_rule_2000:\n\ncorrecting the market failure also have practical implications. Where patients are concerned about lack of privacy protections, they might fail to get medical treatment that they would otherwise seek.\nThis failure to get treatment may be especially likely for certain conditions, including mental health, and HIV. Similarly, patients who are concerned about lack of privacy protections may report health information inaccurately to their providers when they do seek treatment. For instance, they might decide not to mention that they are taking prescription drugs that indicate that they have an embarrassing condition. These inaccurate reports may lead to mis-diagnosis and less-than-optimal treatment, including inappropriate additional medications. In short, the lack of privacy safeguards can lead to efficiency losses in the form of forgone or inappropriate treatment. In summarizing the economic arguments supporting the need for this regulation, the discussion here has emphasized the market failures that will be addressed by this regulation. These arguments become considerably stronger with the shift from predominantly paper to predominantly electronic records. As discussed in the benefits section below, the proposed privacy protections may prevent or reduce the risk of unfair treatment or discrimination against vulnerable categories of persons, such as those who are HIV positive, and thereby, foster better health. The proposed regulation may also help educate providers, health plans, and the general public about how protected health information is used. This education, in turn, may lead to\n\nVerDate 11<MAY>2000\n\n19:16 Dec 27, 2000\n\nJkt 194001\n\nPO 00000\n\nFrm 00302\n\nbetter information practices in the future. ## D. Baseline Privacy Protections\n\nAn analysis of the costs and benefits of the regulation requires a baseline from which to measure the regulation's effects. For some regulations, the baseline is relatively straightforward."
}
] |
{
"source": "privacy_rule_2000",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 455,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does fda_postmarket_2016 say about HIPAA compliance? (Part 7)"
},
{
"role": "assistant",
"content": "According to fda_postmarket_2016:\n\na medical device as a vector to compromise a connected device or system. ## F. Patient Harm\n\nHarm 15 is the physical injury or damage to the health of people, or damage to property or the environment.\nPatient harm is defined as physical injury or damage to the health of patients, including death. Risks to health posed by the device may result in patient harm. This guidance outlines the assessment of whether the risk 16 of patient harm is sufficiently controlled or uncontrolled. This assessment is based on an evaluation of the likelihood of exploit, the impact of exploitation on the device's safety and essential performance, and the severity of patient harm if exploited (see section VI). Other harms, such as loss of confidential information, including compromise of protected health information (PHI), are not considered 'patient harms' for the purposes of this guidance. 13 ICS-CERT - Industrial Control Systems Cyber Emergency Response Team\n\n14 See Department of Homeland Security, 'Frequently Asked Questions about Information Sharing and Analysis Organizations (ISAOs).'\n\n15 ANSI/AAMI/ISO 14971: 2007/(R)2010: Medical Devices - Application of Risk Management to Medical Devices, section 2.2 - definition of harm. 16 ANSI/AAMI/ISO 14971: 2007/(R)2010: Medical Devices - Application of Risk Management to Medical Devices, section 2.16 - definition of risk. ## Contains Nonbinding Recommendations\n\nNevertheless, the FDA recommends that manufacturers consider protecting the confidentiality of such information as part of their overall comprehensive risk management program."
}
] |
{
"source": "fda_postmarket_2016",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 6,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does breach_notification_2009 say about HIPAA compliance? (Part 9)"
},
{
"role": "assistant",
"content": "According to breach_notification_2009:\n\nlations at 42 CFR part 2. These provisions require the confidentiality of substance abuse patient records. VerDate Nov<24>2008\n\nharm-especially in light of fears about employment discrimination.\nWe also address impermissible uses and disclosures involving limited data sets (as the term is used at 45 CFR 164.514(e) of the Privacy Rule), in paragraph (1) of the definition of ''breach'' at § 164.402 of the interim final rule. In the RFI discussed above, we asked for public comment on whether limited data sets should be considered unusable, unreadable, or indecipherable and included as a methodology in the guidance. A limited data set is created by removing the 16 direct identifiers listed in §164.514(e)(2) from the protected health information. 9 These direct identifiers include the name, address, social security number, and account number of an individual or the individual's relative, employer, or household member. When these 16 direct identifiers are removed from the protected health information, the information is not completely deidentified pursuant to 45 CFR 164.514(b). In particular, the elements of dates, such as dates of birth, and zip codes, are allowed to remain within the limited data set, which increase the potential for re-identification of the information. Because there is a risk of re-identification of the information within a limited data set, the Privacy Rule treats this information as protected health information that may only be used or disclosed as permitted by the Privacy Rule. Several commenters suggested that the limited data set should not be included in the guidance as a method to render protected health information unusable, unreadable, or indecipherable to unauthorized individuals such that breach notification is not required."
}
] |
{
"source": "breach_notification_2009",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "covered_entity",
"type": "semantic_chunk",
"chunk_id": 8,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 154)"
},
{
"role": "assistant",
"content": "According to privacy_rule_2000:\n\nies workforce will also be covered by the policies and procedures for ''minimum necessary'' use of protected health information, pursuant to § 164.514(d). We expect these provisions to work in tandem.\nWe do not prescribe the particular measures that covered entities must take to meet this standard, because the nature of the required policies and procedures will vary with the size of the covered entity and the type of activities that the covered entity undertakes. (That is, as with other provisions of this rule, this requirement is ''scalable.'') Examples of appropriate safeguards include requiring that documents containing protected health information be shredded prior to disposal, and requiring that doors to medical records departments (or to file cabinets housing such records) remain locked and limiting which personnel are authorized to have the key or pass-code. We intend this to be a common sense, scalable, standard. We do not require covered entities to guarantee the safety of protected health information against all assaults. Theft of protected health information may or may not signal a violation of this rule, depending on the circumstances and whether the covered entity had reasonable policies to protect against theft. Organizations such as the Association for Testing and Materials (ASTM) and the American Health Information Management Association (AHIMA) have developed a body of recommended practices for handling of protected health information that covered entities may find useful. We note that the proposed HIPAA Security Standards would require covered entities to safeguard the privacy and integrity of health information. For electronic information, compliance with both regulations will be required. In § 164.518(c)(2) of the NPRM we proposed requirements for verification procedures to establish identity and authority for permitted disclosures of protected health information. In the final rule, this material has been moved to § 164.514(h)."
}
] |
{
"source": "privacy_rule_2000",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 153,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does 45cfr160 say about HIPAA compliance?"
},
{
"role": "assistant",
"content": "According to 45cfr160:\n\n[Skip to main content](#main-content)\n\nMenu\n\n[](/)\n[Search](#searchHolder)\n\n* Browse\n + [A to Z](/browse-a-z)\n + [Category](/app/browse/category)\n + [Date](/app/browse/date)\n + [Committee](/browse/committee)\n + [Author](/app/browse/author)\n* About\n + [About](/about)\n + [Policies](/about/policies)\n + [Authentication](/about/authentication)\n + [Digital Preservation](/about/digital-preservation)\n + [History](/about/history)\n + [Agency Submission](/about/agency-submission)\n + [U.S. Government Information](/about/us-gov-info)\n + [FDsys Retirement](/about#fdsys-transition)\n* Developers\n + [Developer Hub](/developers)\n + [API](https://api.govinfo.gov/docs)\n + [Bulk Data Repository](%20/bulkdata)\n + [Link Service](/link-docs)\n + [Feeds](/feeds)\n + [Sitemaps](/sitemaps)\n + [System Design](/developers/system-design)\n* Features\n + [All Features](/features)\n + [Featured Content](/features/featured-content)\n + [News](/features/news)\n + [Release Notes](/features/release-notes)\n + [Finding Publications](/features/finding-publications)\n* Help\n + [Help](/help)\n + [Finding Information](%20/help/finding-info)\n + [What's Available](/help/whats-available)\n + [Tutorials and Handouts](/help/tutorials-handouts)\n + [Other Resources](%20/help/other-resources)\n* Feedback\n + [Submit Feedback](https://www.surveymonkey.com/r/govinfo-feedback-survey)\n + [Contact Us](/contact)\n\n* [Toggle the Search Widget\n Search](#searchHolder)\n\n# Page Not Found\n\n\n\n\n\n[Help](/help/other)\n\n---\n\n**Error occurred."
}
] |
{
"source": "45cfr160",
"safeguard_types": [
"unknown"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 0,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 55)"
},
{
"role": "assistant",
"content": "According to privacy_rule_2000:\n\ncourtordered warrants, and subpoenas issued by a court. We note that disclosures ''required by law'' include disclosures of protected health information required by this regulation in § 164.502(a)(2).\nIt does not include contracts between private parties or similar voluntary arrangements. This list is illustrative only and is not intended in any way to limit the scope of this paragraph or other paragraphs in § 164.512 that permit uses or disclosures to the extent required by other laws. We note that nothing in this rule compels a covered entity to make a use or disclosure required by the legal demands or prescriptions listed in this clarification or by any other law or legal process, and a covered entity remains free to challenge the validity of such laws and processes. ## Research\n\nWe proposed to define ''research'' as it is defined in the Federal Policy for the Protection of Human Subjects, at 45 CFR part 46, subpart A (referred to elsewhere in this rule as ''Common Rule''), and in addition, elaborated on the meaning of the term ''generalizable knowledge.'' In §164.504 of the proposed rule we defined research as ''* * * a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. 'Generalizable knowledge' is knowledge related to health that can be applied to populations outside of the population served by the covered entity.''\n\nThe final rule eliminates the further elaboration of ''generalizable knowledge.'' Therefore, the rule defines ''research'' as the term is defined in the Common Rule: a systematic investigation, including research\n\nVerDate 11<MAY>2000\n\n19:16 Dec 27, 2000\n\nJkt 194001\n\nPO 00000\n\ndevelopment, testing and evaluation, designed to develop or contribute to generalizable knowledge. ## Research Information Unrelated to Treatment\n\nWe delete this definition and the associated requirements from the final rule."
}
] |
{
"source": "privacy_rule_2000",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 54,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does nist_sp800-66r2 say about HIPAA compliance? (Part 3)"
},
{
"role": "assistant",
"content": "According to nist_sp800-66r2:\n\n...........38 |\n| 5.1.5. Security Awareness and Training (§ 164.308(a)(5)) ...................................................................41 |\n| 5.1.6.\nSecurity Incident Procedures (§ 164.308(a)(6)) .........................................................................44 |\n| 5.1.7. Contingency Plan (§ 164.308(a)(7))............................................................................................47 |\n| 5.1.8. Evaluation (§ 164.308(a)(8)).......................................................................................................51 |\n| 5.2.1. Facility Access Controls (§ 164.310(a)).......................................................................................56 |\n| 5.1.9. Business Associate Contracts and Other Arrangements (§ 164.308(b)(1))................................54 |\n| 5.2.2. Workstation Use (§ 164.310(b)).................................................................................................59 |\n| 5.2.3. Workstation Security (§ 164.310(c)) ..........................................................................................61 |\n\n| 5.2.4. Device and Media Controls (§ 164.310(d)).................................................................................63 |\n|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|\n| 5.3.1."
}
] |
{
"source": "nist_sp800-66r2",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 2,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 168)"
},
{
"role": "assistant",
"content": "According to privacy_rule_2000:\n\nactually subject to the regulation. Response: We reject the commenter's suggestion. We believe it is clear in the final rule that the entities subject to the regulation are those listed at § 160.102.\nHowever, we acknowledge that how the rule applies to integrated or other complex health systems needs to be addressed; we have done so in § 164.504 and in other provisions, such as those addressing organized health care arrangements. Comment: The preamble should clarify that self-insured group health and workmen's compensation plans are not covered entities or business partners. Response: In the preamble to the proposed rule we stated that certain types of insurance entities, such as workers' compensation, would not be covered entities under the rule. We do not change this position in this final rule. The statutory definition of health plan does not include workers' compensation products, and the regulatory definition of the term specifically excludes them. However, HIPAA specifically includes most group health plans within the definition of ''health plan.''\n\nComment: A health insurance issuer asserted that health insurers and third party administrators are usually required by employers to submit reports describing the volume, amount, payee, basis for services rendered, types of claims paid and services for which payment was requested on behalf of it covered employees. They recommended that the rule permit the disclosure of protected health information for such purposes. Response: We agree that health plans should be able to disclose protected health information to employers sponsoring health plans under certain circumstances. Section 164.504(f) explains the conditions under which protected health information may be disclosed to plan sponsors. We believe that this provision gives sponsors access to the information they need, but protects individual's information to the extent possible under our legislative authority."
}
] |
{
"source": "privacy_rule_2000",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 167,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does security_rule_2003 say about HIPAA compliance? (Part 56)"
},
{
"role": "assistant",
"content": "According to security_rule_2003:\n\nt specifications in the HIPAA, the purpose of the law, and principles that support the regulatory philosophy set forth in the E.O. 12866 of September 30, 1993, and the Paperwork Reduction Act of 1995.\nIn order to be designated as such, a standard should do the following:\n\n- Meet the needs of the health data standards user community, particularly health care providers, health plans, and health care clearinghouses. This principle supports the regulatory goal of cost-effectiveness. - Improve the efficiency and effectiveness of the health care system by leading to cost reductions for or improvements in benefits from electronic health care transactions. This principle supports the regulatory goals of cost-effectiveness and avoidance of burden. - Be consistent and uniform with the other HIPAA standards (that is, their data element definitions and codes, and their privacy and security requirements) and, secondarily, with other private and public sector health data standards. This principle supports the regulatory goals of consistency and avoidance of incompatibility, and it establishes a performance objective for the standard. - Be supported by an ANSIaccredited standards developing organization or other private or public organization that would ensure continuity and efficient updating of the standard over time. This principle supports the regulatory goal of predictability. - Have timely development, testing, implementation, and updating procedures to achieve administrative simplification benefits faster. This\n\nFmt 4701\n\nSfmt 4700\n\nE:\\FR\\FM\\20FER2.SGM\n\n20FER2\n\n- Have low additional development and implementation costs relative to the benefits of using the standard. This principle supports the regulatory goals of cost-effectiveness and avoidance of burden. Jkt 200001\n\nprinciple establishes a performance objective for the standard. - Be precise and unambiguous but as simple as possible. This principle supports the regulatory goals of predictability and simplicity."
}
] |
{
"source": "security_rule_2003",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 55,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 306)"
},
{
"role": "assistant",
"content": "According to privacy_rule_2000:\n\nappeared that an unconscious patient had been abused and disclosing that the individual is in the facility could give the attacker sufficient information to seek out the person and repeat the abuse).\nUnder the final rule, when the opportunity to object to uses and disclosures for a facility's directory cannot practicably be provided due to an individual's incapacity or an emergency treatment circumstance, covered health care providers may use or disclose some or all of the protected health information that the rule allows to be included in the directory, if the disclosure is: (1) consistent with the individual's prior expressed preference, if known to the covered health care provider; and (2) in the individual's best interest, as determined by the covered health care provider in the exercise of professional judgement. The rule allows covered health care providers making decisions about incapacitated patients to include some portions of the patient's information (such as name) but not other information (such as location in the facility) to protect patient interests. Section 164.510(b)-Uses and Disclosures for Involvement in the Individual's Care and Notification Purposes\n\nComment: A number of comments supported the NPRM's proposed approach, which would have allowed covered entities to disclose protected health information to the individual's next of kin, family members, or other close personal friends when the individual verbally agreed to the disclosure. These commenters agreed that the presumption should favor disclosures to the next of kin, and they believed that health care providers should encourage individuals to share genetic information and information about transmittable diseases with family members at risk. Others agreed with the general approach but suggested the individual's agreement be noted in the medical record."
}
] |
{
"source": "privacy_rule_2000",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 305,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 119)"
},
{
"role": "assistant",
"content": "According to privacy_rule_2000:\n\nrly, in situations involving a serious and imminent threat to public health or safety, law enforcement officials may be seeking protected health information from covered entities to locate a fugitive.\nIn the final rule, we clarify that if a situation fits one section of the rule (for example, § 164.512(j) on serious and imminent threats to health or safety), covered entities may disclose protected health information pursuant to that section, regardless of whether the disclosure also could be made pursuant to another section ( e.g., §164.512(f)), regarding disclosure to law enforcement officials). The proposed rule did not address situations in which covered entities could make disclosures to law enforcement officials about oral statements admitting participation in violent conduct or about escapees. In the final rule we permit, but do not require, covered entities to use or disclose protected health information, consistent with applicable law and standards of ethical conduct, in specific situations in which the covered entity, in good faith, believes the use or disclosure is necessary to permit law enforcement authorities to identify or apprehend an individual. Under paragraph (j)(1)(ii)(A) of this section, a covered entity may take such action because of a statement by an individual admitting participation in a violent crime that the covered entity reasonably believes may have resulted in serious physical harm to the victim. The\n\nFmt 4701\n\nE:\\FR\\FM\\28DER2.SGM\n\npfrm08\n\nPsN: 28DER2\n\nSfmt 4700\n\nprotected health information that is disclosed in this case is limited to the statement and to the protected health information included under the limited identifying and location information in §164.512(f)(2), such as name, address, and type of injury. Under paragraph (j)(1)(ii)(B) of this section, a covered entity may take such action where it appears from all the circumstances that the individual has escaped from a correctional institution or from lawful custody."
}
] |
{
"source": "privacy_rule_2000",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 118,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
[
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What does hitech_omnibus_2013 say about HIPAA compliance? (Part 7)"
},
{
"role": "assistant",
"content": "According to hitech_omnibus_2013:\n\nds or implementation specifications (as the terms are defined at § 160.103). Such provisions are in effect and apply at the time the final rule becomes effective or as otherwise specifically provided.\nIn addition, as explained above, our general rule for a 180-day compliance period for new or modified standards would not apply where we expressly provide a different compliance period in\n\nFmt 4701\n\nSfmt 4700\n\nE:\\FR\\FM\\25JAR2.SGM\n\n25JAR2\n\nJkt 229001\n\nsroberts on DSK5SPTVN1PROD with the regulation for one or more provisions. For purposes of this rule, the 180-day compliance period would not govern the time period required to modify those business associate agreements that qualify for the longer transition period in § 164.532, as we discuss further below. Finally, the provisions of section 13402(j) of the HITECH Act apply to breaches of unsecured protected health information discovered on or after September 23, 2009, the date of the publication of the interim final rule. Thus, during the 180 day period before compliance with this final rule is required, covered entities and business associates are still required to comply with the breach notification requirements under the HITECH Act and must continue to comply with the requirements of the interim final rule. We believe that this transition period provides covered entities and business associates with adequate time to come into compliance with the revisions in this final rule and at the same time to continue to fulfill their breach notification obligations under the HITECH Act. ## IV. Modifications to the HIPAA Privacy, Security, and Enforcement Rules Under the HITECH Act; Other Modifications to the HIPAA Rules\n\nThe discussion below provides a section-by-section description of the final rule, as well as responds to public comments where substantive comments were received regarding particular provisions. ## A."
}
] |
{
"source": "hitech_omnibus_2013",
"safeguard_types": [
"physical",
"technical",
"administrative"
],
"entity_type": "both",
"type": "semantic_chunk",
"chunk_id": 6,
"safeguard_type": null,
"implementation_spec": null,
"cfr_section": null,
"nist_control": null
}
|
End of preview. Expand
in Data Studio
HIPAA Compliance Training Dataset
Dataset Description
The first comprehensive HIPAA compliance training dataset for LLM fine-tuning, covering the Security Rule, Privacy Rule, Breach Notification Rule, and implementation guidance from NIST and FDA.
Dataset Summary
- Total Examples: 1,287 (1,029 train / 258 validation)
- Source Documents: 9 federal publications (~5.6 MB extracted content)
- Format: JSONL with chat-formatted messages
- License: CC0-1.0 (Public Domain)
- Coverage: Security Rule, Privacy Rule, Breach Notification, NIST implementation, FDA medical device guidance
Why This Dataset?
Healthcare organizations need practical HIPAA compliance guidance, but most LLMs lack deep knowledge of:
- The distinction between required vs addressable implementation specifications
- Covered entity vs business associate obligations
- Administrative, physical, and technical safeguards
- Breach notification thresholds and procedures
- Practical implementation of NIST SP 800-66 recommendations
This dataset fills that gap with 1,287 high-quality Q&A pairs derived from authoritative federal sources.
Dataset Structure
Data Fields
messages: List of chat messages (system, user, assistant)metadata: Source attribution and HIPAA-specific classificationsource: Source document titlecfr_section: CFR section number (e.g., §164.308) if applicablesafeguard_type: administrative | physical | technical | unknownimplementation_spec: required | addressable | bothentity_type: covered_entity | business_associate | bothtype: Question type (cfr_section, safeguard, implementation, breach_notification, etc.)nist_control: NIST control ID (e.g., AC-1) if from SP 800-66
Example
{
"messages": [
{
"role": "system",
"content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."
},
{
"role": "user",
"content": "What's the difference between required and addressable implementation specifications?"
},
{
"role": "assistant",
"content": "According to HITECH Omnibus Final Rule (2013):\n\nUnder the HIPAA Security Rule, implementation specifications are either Required or Addressable. Required specifications must be implemented as written. Addressable specifications require a more flexible approach: covered entities and business associates must assess whether each addressable specification is a reasonable and appropriate safeguard in their environment. If reasonable and appropriate, they must implement the specification as written. If not, they must document why the specification is not reasonable and appropriate, and implement an equivalent alternative measure if reasonable and appropriate, or document why no alternative measure is reasonable and appropriate and accept the residual risk. This risk-based, scalable approach allows entities of different sizes and complexities to implement appropriate security measures."
}
],
"metadata": {
"source": "HITECH Omnibus Final Rule (2013)",
"implementation_spec": "both",
"safeguard_types": ["administrative", "physical", "technical"],
"type": "implementation"
}
}
Source Documents
Federal Register Preambles (5 documents)
These provide the rationale and implementation guidance behind HIPAA regulations:
Security Rule Final Rule (2003) - 344 KB
- Security standards rationale
- Administrative, physical, and technical safeguards
- Required vs addressable specifications
Privacy Rule Final Rule (2000) - 2.6 MB
- Privacy standards and uses/disclosures
- Individual rights (access, amendment, accounting)
- Minimum necessary standard
Privacy Rule Modifications (2002) - 672 KB
- Clarifications and corrections
- Business associate provisions
- De-identification standards
HITECH Omnibus Final Rule (2013) - 1.0 MB
- HITECH Act modifications
- Business associate direct liability
- Breach notification updates
- Enhanced enforcement
Breach Notification Rule (2009) - 228 KB
- Breach definition and risk assessment
- Notification requirements (HHS, individuals, media)
- 500+ individual threshold
NIST Implementation Guidance (1 document)
- NIST SP 800-66 Rev. 2: Implementing the HIPAA Security Rule (2024) - 497 KB
- Step-by-step implementation guidance
- Control mapping (NIST 800-53 → HIPAA)
- Risk analysis methodology
- Practical examples and recommendations
FDA Medical Device Cybersecurity (2 documents)
FDA Cybersecurity in Medical Devices: Quality System Considerations (2023) - 211 KB
- Device security requirements
- Cybersecurity bill of materials (SBOM)
- Premarket submission requirements
FDA Postmarket Management of Cybersecurity in Medical Devices (2016) - 84 KB
- Vulnerability management
- Patching and updates
- Incident response for devices
Documents Excluded (Extraction Failures)
The following 4 documents failed to extract properly and are not included:
- 45 CFR Part 160, 162, 164 (data format errors - extracted HTML navigation only)
- FDA Content of Premarket Submissions Draft Guidance (2022) (extraction failed - 71 bytes)
These will be added in v1.1 using alternative extraction methods.
Q&A Generation Strategies
Examples were generated using 7 complementary strategies:
1. CFR Section-Based Q&A
Extract specific regulatory requirements by CFR section number.
Example: "What does §164.308(a)(1)(i) require?" → Security Management Process details
2. Safeguard-Based Q&A
Focus on administrative, physical, and technical safeguards.
Example: "What are the technical safeguards under HIPAA?" → Access control, audit controls, integrity, transmission security
3. Implementation Specification Q&A
Clarify required vs addressable distinctions.
Example: "How do I determine if an addressable specification must be implemented?" → Risk assessment process
4. Entity Type Q&A
Distinguish covered entity vs business associate obligations.
Example: "What are business associate obligations under HIPAA?" → Direct liability, security, privacy, breach notification
5. Breach Notification Q&A
Explain breach determination and notification procedures.
Example: "When must a HIPAA breach be reported to HHS?" → 60-day timeline, 500+ threshold, risk assessment
6. NIST Control Q&A
Map NIST 800-53 controls to HIPAA requirements (from SP 800-66).
Example: "How does NIST SP 800-66 recommend implementing control AC-2?" → Account management for HIPAA
7. Semantic Chunking
General content preservation with context.
Example: "What does [document] say about HIPAA compliance?" → Contextual excerpts
Use Cases
Healthcare Providers
- Internal HIPAA chatbot: Answer staff questions about compliance
- Training assistant: Onboard new employees on HIPAA requirements
- Policy generation: Draft security policies based on HIPAA guidance
Health Tech Companies
- Compliance review: Check product features against HIPAA requirements
- Risk assessment: Identify gaps in HIPAA implementation
- BAA review: Understand business associate obligations
Medical Device Manufacturers
- Device security: Implement FDA cybersecurity requirements
- SBOM generation: Create cybersecurity bills of materials
- Vulnerability management: Follow FDA postmarket guidance
HIPAA Compliance Officers
- Breach determination: Assess if incidents require notification
- Audit preparation: Review requirements before assessments
- Implementation planning: Prioritize required vs addressable specs
Legal & Consulting
- Client advisory: Provide accurate HIPAA interpretations
- Incident response: Guide breach notification decisions
- Contract review: Verify BAA compliance
Dataset Statistics
Source Documents: 9 (5 preambles, 1 NIST, 2 FDA, 1 report)
Total Examples: 1,287
Training Examples: 1,029 (80%)
Validation Examples: 258 (20%)
Avg Example Length: ~400 tokens (estimated)
By Safeguard Type:
Administrative: 8 documents
Physical: 8 documents
Technical: 8 documents
Unknown: 3 documents
By Entity Type:
Both (CE & BA): 9 documents
Covered Entity: 2 documents
Breach-Related: 8 documents
By Implementation Spec:
Both (Required & Addressable): 5 documents
Required only: 6 documents
Model Training
Recommended Configuration
This dataset is designed for LoRA fine-tuning of 7B parameter models:
base_model: mlx-community/Qwen2.5-Coder-7B-Instruct-4bit
lora_rank: 16
lora_alpha: 32
num_layers: 16
batch_size: 4
learning_rate: 1e-5
num_iterations: 500-1000
Expected Training Time
- 7B model on M4 Max: ~45-90 minutes (500-1000 iterations)
- Memory required: 15-20 GB
- Tokens/sec: 130-160
Training Command
python -m mlx_lm lora \
--model mlx-community/Qwen2.5-Coder-7B-Instruct-4bit \
--train \
--data data/hipaa/training \
--iters 1000 \
--batch-size 4 \
--lora-layers 16 \
--adapter-path models/hipaa-expert-lora
Quick Start
Load Dataset
import jsonlines
# Load training data
with jsonlines.open('train.jsonl') as reader:
train_data = list(reader)
print(f"Training examples: {len(train_data)}")
print(f"First example: {train_data[0]}")
Filter by Metadata
# Find all breach notification examples
breach_examples = [
ex for ex in train_data
if ex['metadata'].get('type') == 'breach_notification'
]
# Find technical safeguard examples
technical_examples = [
ex for ex in train_data
if 'technical' in ex['metadata'].get('safeguard_types', [])
]
# Find business associate-specific content
ba_examples = [
ex for ex in train_data
if ex['metadata'].get('entity_type') == 'business_associate'
]
Limitations
Coverage Gaps
Missing CFR Regulations: The actual 45 CFR Part 160, 162, 164 text failed to extract (data format errors). Dataset relies on preambles and guidance, which provide implementation context but not the bare regulatory text.
Preamble-Heavy: 5 of 9 documents are Federal Register preambles. These provide rationale and interpretation but may be verbose compared to concise regulatory text.
No OCR Guidance: HHS Office for Civil Rights FAQs and guidance documents are not included (would require web scraping).
Limited Medical Device Coverage: Only 2 FDA guidance documents vs comprehensive device security library.
No State Law Extensions: California CMIA, Massachusetts 201 CMR 17.00, etc. not included.
Model Limitations
- Not Legal Advice: Outputs should not be considered legal advice
- May Hallucinate: Model may generate plausible but incorrect CFR sections
- Context Window: Limited to base model's context (typically 4K-8K tokens)
- No Real-Time Updates: Trained on documents up to 2024; regulations may change
Recommended Mitigations
- RAG Integration: Use with vector database of actual HIPAA regulations
- Citation Verification: Always verify CFR sections in official sources
- Human Review: Have compliance officers review model outputs
- Regular Updates: Retrain annually as regulations evolve
Roadmap
v1.1 (Planned)
- Re-extract CFR regulations using alternative methods (PDF repair tools)
- Add OCR guidance via web scraping HHS.gov/hipaa
- Expand FDA coverage with additional medical device guidance
- Target: +500-1,000 examples
v1.2 (Planned)
- State-specific HIPAA extensions (CA CMIA, MA 201 CMR 17.00, NY SHIELD Act)
- CMS security standards
- FTC Health Breach Notification Rule
- Target: +300-500 examples
v2.0 (Future)
- Full OCR guidance library (200-400 FAQs)
- Settlement agreement case studies
- Enforcement examples
- Synthetic scenario generation
- Target: +1,000-2,000 examples
Citation
If you use this dataset, please cite:
@dataset{hipaa_compliance_2025,
title={HIPAA Compliance Training Dataset},
author={Troy, Ethan Oliver},
year={2025},
publisher={HuggingFace},
note={Derived from federal HIPAA regulations and guidance (Public Domain)}
}
License
CC0-1.0 (Public Domain) - All source documents are U.S. Federal Government works not subject to copyright protection under 17 U.S.C. §105.
You are free to:
- Use commercially
- Modify and distribute
- Create derivative works
- No attribution required (though appreciated!)
Acknowledgments
This dataset is built from publications by:
- HHS Office for Civil Rights (OCR) - HIPAA regulations and guidance
- National Institute of Standards and Technology (NIST) - SP 800-66 implementation guide
- U.S. Food and Drug Administration (FDA) - Medical device cybersecurity guidance
- Federal Register - Official regulatory preambles
Contact
For questions, issues, or contributions:
- GitHub: https://github.com/ethanolivertroy/nist-tuned-model
- HuggingFace: https://huggingface.co/ethanolivertroy
- Dataset Issues: Open an issue on GitHub
Version History
- v1.0 (January 2025): Initial release
- 1,287 examples from 9 federal documents
- Coverage: Security Rule, Privacy Rule, Breach Notification, NIST SP 800-66, FDA guidance
- Known limitation: CFR regulations failed to extract (data format errors)
Last Updated: January 2025
- Downloads last month
- 19
Size of downloaded dataset files:
3.28 MB
Size of the auto-converted Parquet files:
1.16 MB
Number of rows:
1,287