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hipaa-compliance-training

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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 privacy_rule_2000 say about HIPAA compliance? (Part 502)" }, { "role": "assistant", "content": "According to privacy_rule_2000:\n\nexcept a provision of State law from preemption under §160.203(a) may be submitted to the Secretary. A request by a State must be submitted through its chief elected official, or his or her designee.\nThe request must be in writing and include the following information:\n\n- (1) The State law for which the exception is requested;\n- (2) The particular standard, requirement, or implementation specification for which the exception is requested;\n- (3) The part of the standard or other provision that will not be implemented based on the exception or the additional data to be collected based on the exception, as appropriate;\n\n(4) How health care providers, health plans, and other entities would be affected by the exception;\n\n- (5) The reasons why the State law should not be preempted by the federal standard, requirement, or implementation specification, including how the State law meets one or more of the criteria at § 160.203(a); and\n- (6) Any other information the Secretary may request in order to make the determination. 3. (b) Requests for exception under this section must be submitted to the Secretary at an address that will be published in the Federal Register . Until the Secretary's determination is made, the standard, requirement, or implementation specification under this subchapter remains in effect. 4. (c) The Secretary's determination under this section will be made on the basis of the extent to which the information provided and other factors demonstrate that one or more of the criteria at § 160.203(a) has been met. ## §160.205 Duration of effectiveness of exception determinations." } ]
{ "source": "privacy_rule_2000", "safeguard_types": [ "physical", "technical", "administrative" ], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 501, "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 40)" }, { "role": "assistant", "content": "According to privacy_mod_2002:\n\ninformation to a plan sponsor provided that, among other requirements, the plan documents are amended appropriately to reflect and restrict the plan sponsor's uses and disclosures of such information.\nThe Department further determined that there were two situations in which protected health information could be shared between the group health plan and the plan\n\n19:04 Aug 13, 2002\n\nPO 00000\n\nFrm 00027\n\nsponsor without individual authorization or an amendment to the plan documents. First, § 164.504(f) permits the group health plan to share summary health information (as defined in § 164.504(a)) with the plan sponsor. Second, a group health plan is allowed to share enrollment or disenrollment information with the plan sponsor without amending the plan documents as required by § 164.504(f). As explained in the preamble to the December 2000 Privacy Rule, a plan sponsor is permitted to perform enrollment functions on behalf of its employees without meeting the requirements of § 164.504(f), as such functions are considered outside of the plan administration functions. However, the second exception was not stated in the regulation text. March 2002 NPRM. The ability of group health plans to disclose enrollment or disenrollment information without amending the plan documents was addressed only in the preamble to the Privacy Rule. The absence of a specific provision in the regulation text caused many entities to conclude that plan documents would need to be amended for enrollment and disenrollment information to be exchanged between plans and plan sponsors. To remedy this misunderstanding and make its policy clear, the Department proposed to add an explicit exception at §164.504(f)(1)(iii) to clarify that group or HMOs with respect to group health plans, as appropriate) are permitted to disclose enrollment or disenrollment information to a plan sponsor without health plans (or health insurance issuers meeting the plan document amendment and other related requirements." } ]
{ "source": "privacy_mod_2002", "safeguard_types": [ "physical", "technical", "administrative" ], "entity_type": "both", "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_mod_2002 say about HIPAA compliance? (Part 83)" }, { "role": "assistant", "content": "According to privacy_mod_2002:\n\nnecessary requirement to keep the Rule simple while avoiding abuse. Birth date should only be disclosed where the researcher and covered entity agree that it is needed for the purpose of the research.\nFurther, even though birth date may be included with a limited data set, the Department clarifies, as it did in the preamble to the proposed rulemaking, that the Privacy Rule allows the age of an individual to be expressed in years or in months, days, or hours as appropriate. Moreover, the limited data set may include the five-digit zip code or any other geographic subdivision, such as State, county, city, precinct and their equivalent geocodes, except for street address. We substitute for street address the term postal address information, other than city, State and zip code in order to make clear that individual elements of postal address such as street name by itself are also direct identifiers. Commenters identified a variety of needs for various geographical codes (county, city, neighborhood, census tract, precinct) to support a range of essential research, public health and health care operations activities. Some of the examples provided included the need to analyze local geographic variations in disease burdens or in the provision of health services, conducting research looking at pathogens or patterns of health risks which may need to compare areas within a single zip code, or studies to examine data by county or neighborhood when looking for external causes of disease, as would be the case for illnesses and diseases such as bladder cancer that may have environmental links. The Department agrees with these commenters that a variety of geographical designations other than five-digit zip code are needed to permit useful and significant studies and other research to go forward unimpeded." } ]
{ "source": "privacy_mod_2002", "safeguard_types": [ "physical", "technical", "administrative" ], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 82, "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 102)" }, { "role": "assistant", "content": "According to privacy_mod_2002:\n\nd impose unnecessary burdens on researchers, IRBs, and Privacy Boards, with respect to the few research studies that would fall in this category. ## 2. Business Associates\n\nDecember 2000 Privacy Rule.\nThe Privacy Rule at § 164.502(e) permits a covered entity to disclose protected health information to a business associate who performs a function or activity on behalf of, or provides a service to, the covered entity that involves the creation, use, or disclosure of, protected health information, provided that the covered entity obtains satisfactory assurances that the business associate will appropriately safeguard the information. The Department recognizes that most covered entities do not perform or carry out all of their health care activities and functions by themselves, but rather use the services of, or receive assistance from, a variety of other persons or entities. Given this framework, the Department intended these provisions to allow such business relationships to continue while ensuring that identifiable health information created or shared in the course of the relationships was protected. The Privacy Rule requires that the satisfactory assurances obtained from the business associate be in the form of a written contract (or other written arrangement, as between governmental entities) between the covered entity and the business associate that contains the elements specified at § 164.504(e). For example, the agreement must identify the uses and disclosures of protected health information the business associate is permitted or required to make, as well as require the business associate to put in place appropriate safeguards to protect against a use or disclosure not permitted by the contract or agreement." } ]
{ "source": "privacy_mod_2002", "safeguard_types": [ "physical", "technical", "administrative" ], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 101, "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 19)" }, { "role": "assistant", "content": "According to privacy_rule_2000:\n\ntion, employers today are moving toward simplified enrollment forms, using check-off boxes and similar devices. The opportunity for any meaningful consideration or interaction at that point is slight.\nFor these and other reasons, we decided that, to the extent a consent can accomplish the goal sought by individuals and providers, it must be focused on the direct interaction between an individual and provider. The comments and fact-finding indicate that our approach will not significantly change the administrative aspect of consent as it exists today. Most direct treatment providers today obtain some type of consent for some uses and disclosures of health information. Our regulation will ensure that those consents cover the routine uses and disclosures of health information, and provide an opportunity for individuals to obtain further information and have further discussion, should they so desire. ## Administrative Costs\n\nSection 1172(b) of the Act provides that ''[a]ny standard adopted under this part [part C of title XI of the Act] shall be consistent with the objective of reducing the administrative costs of providing and paying for health care.'' The privacy and security standards are the platform on which the remaining standards rest; indeed, the design of part C of title XI makes clear that the various standards are intended to function together. Thus, the costs of privacy and security are properly attributable to the suite of administrative simplification regulations as a whole, and the cost savings realized should likewise be calculated on an aggregated basis, as is done below." } ]
{ "source": "privacy_rule_2000", "safeguard_types": [ "physical", "technical", "administrative" ], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 18, "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 2)" }, { "role": "assistant", "content": "According to security_rule_2003:\n\ne XI consists of sections 1171 through 1179 of the Act. These sections define various terms and impose requirements on HHS, health plans, health care clearinghouses, and certain health care providers.\nThese statutory sections are discussed in the Transactions Rule, at 65 FR 50312, on pages 50312 through 50313, and in the final rules adopting Standards for Privacy of Individually Identifiable Health Information, published on December 28, 2000 at 65 FR 82462 (Privacy Rules), on pages 82470 through 82471, and on August 14, 2002 at 67 FR 53182. The reader is referred to those discussions. Section 1173(d) of the Act requires the Secretary of HHS to adopt security standards that take into account the technical capabilities of record systems used to maintain health information, the costs of security measures, the need to train persons who have access to health information, the value of audit trails in computerized record systems, and the needs and capabilities of small health care providers and rural health care providers. Section 1173(d) of the Act also requires that the standards ensure that a health care clearinghouse, if part of a larger organization, has policies and security procedures that isolate the activities of the clearinghouse with respect to processing information so as to prevent unauthorized access to health information by the larger organization. Section 1173(d) of the Act provides that covered entities that maintain or transmit health information are required to maintain reasonable and appropriate administrative, physical, and technical safeguards to ensure the integrity and confidentiality of the information and to protect against any reasonably anticipated threats or hazards to the security or integrity of the information and unauthorized use or disclosure of the information. These safeguards must also otherwise ensure compliance with the statute by the officers and employees of the covered entities. ## II." } ]
{ "source": "security_rule_2003", "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 is considered a breach under HIPAA?" }, { "role": "assistant", "content": "According to fda_postmarket_2016:\n\ntional copies are available from the Center for Biologics Evaluation and Research (CBER), by written request, Office of Communication, Outreach, and Development (OCOD), 10903 New Hampshire Ave., Bldg.\n71, Room 3128, Silver Spring, MD 209930002, or by calling 1-800-835-4709 or 240-402-8010, by email, ocod@fda.hhs.gov or from the Internet at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/G uidances/default.htm. ## Preface\n\n## Contains Nonbinding Recommendations\n\n## Table of Contents\n\n| I. | ................................................................ INTRODUCTION ................................ ............................... | 4 |\n|-------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|\n| II. | BACKGROUND................................................................................................................................. | 5 |\n| III. | SCOPE.............................................................................................................................................. | 8 |\n| IV. | DEFINITIONS..............................................................................................................................." } ]
{ "source": "fda_postmarket_2016", "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 139)" }, { "role": "assistant", "content": "According to privacy_mod_2002:\n\nd or modified from\n\nFmt 4701\n\nSfmt 4700\n\nE:\\FR\\FM\\14AUR4.SGM\n\npfrm17\n\nPsN: 14AUR4\n\nJkt 197001\n\nOctober 15, 2002, until the compliance date set forth in § 164.534. (2) Limited deemed compliance period.\nA prior contract or other arrangement that meets the qualification requirements in paragraph (e) of this section, shall be deemed compliant until the earlier of:\n\nVerDate Aug<2,>2002\n\n- (i) The date such contract or other arrangement is renewed or modified on or after the compliance date set forth in §164.534; or\n- (ii) April 14, 2004. - (3) Covered entity responsibilities. Nothing in this section shall alter the requirements of a covered entity to\n\n19:04 Aug 13, 2002\n\nPO 00000\n\nFrm 00093\n\ncomply with part 160, subpart C of this subchapter and §§ 164.524, 164.526, 164.528, and 164.530(f) with respect to protected health information held by a business associate. [FR Doc. 02-20554 Filed 8-9-02; 2:00 pm]\n\nBILLING CODE 4153-01-P\n\nFmt 4701\n\nSfmt 4700\n\nE:\\FR\\FM\\14AUR4.SGM\n\npfrm17\n\nPsN: 14AUR4\n\nJkt 197001" } ]
{ "source": "privacy_mod_2002", "safeguard_types": [ "physical", "technical", "administrative" ], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 138, "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 14)" }, { "role": "assistant", "content": "According to breach_notification_2009:\n\nprotected health information from the patient. If the nurse can reasonably conclude that the patient could not have read or otherwise retained the information, then this would not constitute a breach.\nWith respect to any of the three exceptions discussed above, a covered entity or business associate has the burden of proof, pursuant to §164.414(b) (discussed below), for showing why breach notification was not required. Accordingly, the covered entity or business associate must document why the impermissible use or disclosure falls under one of the above exceptions. Based on the above, we envision that covered entities and business associates will need to do the following to determine whether a breach occurred. First, the covered entity or business associate must determine whether there has been an impermissible use or disclosure of protected health information under the Privacy Rule. Second, the covered entity or business associate must determine, and document, whether the impermissible use or disclosure compromises the security or privacy of the protected health information. This occurs when there is a significant risk of financial, reputational, or other harm to the individual. Lastly, the covered entity or business associate may need to determine whether the incident falls under one of the exceptions in paragraph (2) of the breach definition. We treat the breach as having occurred at the time of the impermissible use or disclosure (or in the case of the exceptions listed at paragraphs (2)(i) and (ii) of the definition of ''breach,'' at the time of the ''further'' impermissible use or disclosure), but recognize that a covered entity or business associate may require a reasonable amount of time to confirm whether the incident qualifies as a breach. As discussed below, a breach is considered discovered when the incident becomes known, not when the covered entity or business associate concludes the above analysis of whether the facts constitute a breach. ## 2." } ]
{ "source": "breach_notification_2009", "safeguard_types": [ "physical", "technical", "administrative" ], "entity_type": "covered_entity", "type": "semantic_chunk", "chunk_id": 13, "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 113)" }, { "role": "assistant", "content": "According to privacy_mod_2002:\n\nacy Rule focused on the key policy\n\n19:04 Aug 13, 2002\n\nPO 00000\n\nFrm 00075\n\nareas addressed by the privacy standards, some of which are affected by the modifications adopted in this rulemaking. ## B.\nProposed Modifications To Prevent Barriers to Access to or Quality of Health Care\n\nThe modifications adopted in this rulemaking are intended to address the possible adverse effects of the final privacy standards on an individual's access to, or the quality of, health care. The modifications touch on five of the key policy areas addressed by the final regulatory impact analysis, including consent, research, marketing, notice, and business associates. The Department received few comments on this section of the March 2002 proposal. Most of the comments on the cost implications of the modifications indicated a general belief that the costs would be higher than the Department estimated. None of commenters, however, provided sufficient specific information concerning costs to permit the Department to adjust its estimates. The public comment on each of the key policy areas is summarized in the following sections. However, the estimated cost impact of each area has not changed. ## 1. Consent\n\nUnder the December 2000 Privacy Rule, a covered health care provider with a direct treatment relationship with an individual must have obtained the individual's prior written consent for use or disclosure of protected health information for treatment, payment, or health care operations, subject to a limited number of exceptions. Other covered health care providers and health plans may have obtained such a consent if they so chose. The initial cost of the consent requirement was estimated in December 2000 to be $42 million. Based on assumptions for growth in the number of patients, the total costs for ten years was estimated to be $103 million. See 65 FR 82771 (December 28, 2000). 2\n\nThe modifications eliminate the consent requirement." } ]
{ "source": "privacy_mod_2002", "safeguard_types": [ "physical", "technical", "administrative" ], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 112, "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 13)" }, { "role": "assistant", "content": "According to security_rule_2003:\n\nn records covered by the Family and Educational Rights and Privacy Act (FERPA); (2) records described in 20 U.S.C. 1232g(a)(4)(B)(iv); and (3) employment records. (see the Privacy Rule at 65 FR 82496.\nSee also 67 FR 53191 through 53193). The scope of information covered in the Privacy Rule is referred to as ''protected health information.'' Based upon the comments we received, we align the requirements of the Security and Privacy Rules with regard to the scope of information covered, in order to eliminate confusion and ease implementation. Thus, this final rule requires protection of the same scope of information as that covered by the Privacy Rule, except that it only covers that information if it is in electronic form. We note that standards for the security of all health information or protected health information in nonelectronic form may be proposed at a later date. a. Comment: One commenter stated that the rule should apply to aggregate information that is not identifiable to an individual. In contrast, another commenter asked that health information used for statistical analysis be exempted if the covered entity may reasonably expect that the removed information cannot be used to reidentify an individual. Response: As a general proposition, any electronic protected health information received, created, maintained, or transmitted by a covered entity is covered by this final rule. We agree with the second commenter that certain information, from which identifiers have been stripped, does not come within the purview of this final rule. Information that is de-identified, as defined in the Privacy Rule at §164.502(d) and § 164.514(a), is not\n\nVerDate Jan<31>2003\n\n''individually identifiable'' within the meaning of these rules and, thus, does not come within the definition of ''protected health information.'' It accordingly is not covered by this final rule." } ]
{ "source": "security_rule_2003", "safeguard_types": [ "physical", "technical", "administrative" ], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 12, "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 82)" }, { "role": "assistant", "content": "According to hitech_omnibus_2013:\n\nn 13406(b) of the HITECH Act that provides that an election by an individual not to receive further fundraising communications shall be treated as a revocation of authorization under the Privacy Rule.\nFurther, we proposed to provide that a covered entity may not send fundraising communications to an individual who has elected not to receive such communications. This would strengthen the current requirement at § 164.514(f)(2)(iii) that a covered entity make ''reasonable efforts'' to ensure that those individuals who have opted out of receiving fundraising communications are not sent such communications. The NPRM proposed stronger language to make clear the expectation that covered entities abide by an individual's decision not to receive fundraising communications, as well as to make the fundraising opt out operate more like a revocation of authorization, consistent with the statutory language and legislative history of section 13406(b) of the HITECH Act discussed above. With respect to the operation of the opt out, we requested comment regarding to what fundraising communications the opt out should apply (i.e., should the opt out apply to all future fundraising communications or should and can the opt out be structured in a way to apply only to the particular fundraising campaign described in the letter). We also requested comment on whether the Rule\n\nVerDate Mar<15>2010\n\nshould allow a similar method, short of the individual signing an authorization, by which an individual who has previously opted out can put his or her name back on an institution's fundraising list. We proposed to retain the requirement that a covered entity that intends to contact the individual to raise funds under these provisions include a statement to that effect in its notice of privacy practices. However, we proposed that the required statement also inform individuals that they have a right to opt out of receiving such communications." } ]
{ "source": "hitech_omnibus_2013", "safeguard_types": [ "physical", "technical", "administrative" ], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 81, "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 88)" }, { "role": "assistant", "content": "According to privacy_mod_2002:\n\neceipt of the provider's notice of privacy practices. Other covered entities, such as health plans, would not be required to obtain this acknowledgment from individuals, but could do so if they chose.\nThe Department proposed to strengthen the notice requirements in order to preserve a valuable aspect of the consent process. The notice acknowledgment proposal was intended to create the ''initial moment'' between a covered health care provider and an individual, formerly a result of the consent requirement, when individuals may focus on information practices and privacy rights and discuss with the\n\nFmt 4701\n\nSfmt 4700\n\nE:\\FR\\FM\\14AUR4.SGM\n\npfrm17\n\nPsN: 14AUR4\n\nJkt 197001\n\nprovider any concerns related to the privacy of their protected health information. This ''initial moment'' also would provide an opportunity for an individual to make a request for additional restrictions on the use or disclosure of his or her protected health information or for additional confidential treatment of communications, as permitted under §164.522. With one exception for emergency treatment situations, the proposal would require that the good faith effort to obtain the written acknowledgment be made no later than the date of first service delivery, including service delivered electronically. To address potential operational difficulties with implementing these notice requirements in emergency treatment situations, the Department proposed in § 164.520(c)(2) to delay the requirement for provision of notice until reasonably practicable after the emergency treatment situation, and exempt health care providers with a direct treatment relationship with the individual from having to make a good faith effort to obtain the acknowledgment altogether in such situations. Other than requiring that the acknowledgment be in writing, the proposal would not prescribe other details of the form of the acknowledgment or limit the manner in which a covered health care provider could obtain the acknowledgment." } ]
{ "source": "privacy_mod_2002", "safeguard_types": [ "physical", "technical", "administrative" ], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 87, "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 257)" }, { "role": "assistant", "content": "According to privacy_rule_2000:\n\nly lack the authority under HIPAA to regulate the practices of this industry, the final rule addresses when covered entities may disclose protected health information to property and casualty insures.\nWe believe that the final rule permits property and casualty insurers to obtain the protected health information that they need to maintain their promises to their policyholders. For example, the rule permits a covered entity to use or disclose protected health information relating to an individual when authorized by the individual. Property and casualty insurers are free to obtain authorizations from individuals for release by covered entities of the health information that the insurers need to administer claims, and this rule does not affect their ability to condition payment on obtaining such an authorization from insured individuals. Property and casualty insurers providing payment on a third-party basis have an opportunity to obtain authorization from the individual and to condition payment on obtaining such authorization. The final rule also permits covered entities to make disclosures to obtain payment, whether from a health plan or from another person such as a property and casualty insurer. For example, where an automobile insurer is paying for medical benefits on a first-party basis, a health care provider may disclose protected health information to the insurer as part of a request for payment. We also include in the final rule a new provision that permits covered entities to use or disclose protected health information as authorized by workers' compensation or similar programs established by law addressing work-related injuries or illness. See § 164.512(l). These statutory programs establish channels of information sharing that are necessary\n\nFrm 00170\n\nFmt 4701\n\nE:\\FR\\FM\\28DER2.SGM\n\npfrm08\n\nPsN: 28DER2\n\nSfmt 4700\n\nto permit compensation of injured workers." } ]
{ "source": "privacy_rule_2000", "safeguard_types": [ "physical", "technical", "administrative" ], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 256, "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 310)" }, { "role": "assistant", "content": "According to privacy_rule_2000:\n\ncal treatment. This commenter also proposed stating that mentally retarded individuals who are able to provide agreement have the right to control the disclosure of their protected health information.\nThe commenter expressed concern that the parent, relative, or other person acting in loco parentis may not have the individual's best interest in mind in seeking or authorizing for the individual the disclosure of protected health information. Response: The final rule regulates only uses and disclosures of protected health information, not the delivery of health care. Under the final rule's section on personal representatives (§ 164.502(g)), a person with authority to make decisions about the health care of an individual, under applicable law, may make decisions about the protected health information of that individual, to the extent that the protected health information is relevant to such person's representation. Fmt 4701\n\nE:\\FR\\FM\\28DER2.SGM\n\npfrm08\n\nPsN: 28DER2\n\nSfmt 4700\n\nIn the final rule, § 164.510(b) may apply to permit disclosures to a person other than a personal representative. Under §164.510(b), when an individual is present and has the capacity to make his or her own decisions, a covered entity may disclose protected health information only if the covered entity: (1) Obtains the individual's agreement to disclose protected health information to the third parties involved in the individual's care; (2) provides the individual with an opportunity to object to such disclosure, and the individual does not express an objection; or (3) reasonably infers from the circumstances, based on the exercise of professional judgment, that the individual does not object to the disclosure. These conditions apply to disclosure of protected health information about individuals with mental retardation as well as to disclosures about all other individuals." } ]
{ "source": "privacy_rule_2000", "safeguard_types": [ "physical", "technical", "administrative" ], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 309, "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 11)" }, { "role": "assistant", "content": "According to fda_premarket_2023:\n\nifications [510(k)].'\n\n22 Addressing cybersecurity risks is in addition to addressing other risks, including software, biocompatibility, sterilization, and electromagnetic compatibility, among others.\n## Contains Nonbinding Recommendations\n\nthen be managed (e.g., installed, configured, updated, review of device logs) through the device design and associated labeling by the device manufacturers and/or users (e.g., patients, healthcare facilities). For healthcare facilities, these devices can also be managed within their own cybersecurity risk management frameworks, such as the National Institute of Standards and Technology (NIST) Framework for Improving Critical Infrastructure Cybersecurity, generally referred to as the NIST Cybersecurity Framework or NIST CSF. 23\n\nFDA recommends that manufacturers use device design processes such as those described in the QS regulation to support secure product development and maintenance. To preserve flexibility for manufacturers, manufacturers may use other existing frameworks that satisfy the QS regulation and align with FDA's recommendations for using an SPDF. Possible frameworks to consider include, but are not limited to, the medical device-specific framework that can be found in the Medical Device and Health IT Joint Security Plan (JSP2) 24 and IEC 81001-5-1. Frameworks from other sectors may also comply with the QS regulations, like the framework provided in ANSI/ISA 62443-4-1 Security for industrial automation and control systems Part 41: Product security development life-cycle requirements . 25\n\nThe following subsections provide recommendations for using SPDF processes that FDA believes provide important considerations for the development of devices that are safe and effective, how these processes can complement the QS regulation, and the documentation FDA recommends manufacturers provide for review as part of premarket submissions." } ]
{ "source": "fda_premarket_2023", "safeguard_types": [ "physical", "technical", "administrative" ], "entity_type": "covered_entity", "type": "semantic_chunk", "chunk_id": 10, "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 19)" }, { "role": "assistant", "content": "According to nist_sp800-66r2:\n\nExamples of adverse impacts | Type of Impact | Impact | |--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Harm to Operations | • Inability to perform current mission or business functions o In a sufficiently timely manner o With sufficient confidence and/or correctness o Within planned resource constraints • Inability or limited ability to restore mission or business functions in the future o In a sufficiently timely manner o With sufficient confidence and/or correctness o Within planned resource constraints • Harms (e.g., financial costs, sanctions) due to noncompliance o With applicable laws or regulations o With contractual requirements or other requirements in other binding agreements (e.g., liability) • Direct financial costs • Relational harms | | Type of Impact | Impact | |-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | o Damage to trust relationships o Damage to image or reputation (and, hence, future or potential trust relationships) | | Harm to Assets | • Damage to or loss of physical facilities • Damage to or loss of information systems or networks • Damage to or loss of information technology or equipment • Damage to or loss of component parts or supplies • Damage to or loss of information assets • Loss of intellectual property | | Harm to Individuals" } ]
{ "source": "nist_sp800-66r2", "safeguard_types": [ "physical", "technical", "administrative" ], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 18, "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 70)" }, { "role": "assistant", "content": "According to hitech_omnibus_2013:\n\nthat the brochure or information sheet is incorporated by reference into the authorization/consent form such that it is considered to be part of the form (even if not physically attached to the form).\nIn addition, if the brochure or information sheet includes required elements of the authorization (or informed consent), and authorization/consent has not been altered by an Institutional Review Board, then the brochure or information sheet must be made available to\n\nVerDate Mar<15>2010\n\npotential research participants before they are asked to sign the authorization/ consent document (unless the authorization form itself includes the required elements). Finally, in such cases, a covered entity must keep not only the signed authorization/consent form, but also a copy of the brochure or information sheet, in order to be in compliance with the documentation requirements at § 164.530(j). Comment: The Secretary's Advisory Committee on Human Research Protections requested confirmation that the compound authorization proposal would not affect the waiver provisions currently existing in the Privacy Rule, such that such provisions could be used, if appropriate, for new studies distinct from both the original study and the banking activity. Response: The new compound authorization provision does not affect the waiver of authorization provisions in the Privacy Rule." } ]
{ "source": "hitech_omnibus_2013", "safeguard_types": [ "physical", "technical", "administrative" ], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 69, "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 466)" }, { "role": "assistant", "content": "According to privacy_rule_2000:\n\nion is deidentified (i.e., that it is not individually identifiable health information) if certain conditions are met. Currently, some entities release de-identified information for research purposes.\nDeidentified information may originate from automated systems (such as records maintained by pharmacy benefit managers) and non-automated systems (such as individual medical records maintained by providers). As compared with current practice, the rule requires that an expanded list of identifiers be removed for the data (such as driver's license numbers, and detailed geographic and certain age information). For example, as noted in a number of public comments, currently complete birth dates (day, month, and year) and zip codes are often included in deidentified information. The final rule requires that only the year of birth (except in certain circumstances) and the first three digits of the zip code can be included in de-identified information. These changes will not require extensive change from current practice. Providers generally remove most of the 19 identifiers listed in the final rule. The Department relied on Gartner Group estimates that some additional programmer time will be required by covered entities that produce deidentified information to make revisions in their procedures to eliminate additional identifiers. Entities that deidentify information will have to review existing and future data flows to assure compliance with the final rule. For example, an automated system may need to be re-programmed to remove additional identifiers from otherwise protected health information. (The costs of educating staff about the deidentification requirements are included in the cost estimate for training staff on privacy policies.)\n\nThe Department was not able to obtain any reliable information on the volume of medical data that is currently de-identified." } ]
{ "source": "privacy_rule_2000", "safeguard_types": [ "physical", "technical", "administrative" ], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 465, "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 37)" }, { "role": "assistant", "content": "According to privacy_rule_2000:\n\novisions that require covered entities or others to use or\n\nVerDate 11<MAY>2000\n\n19:16 Dec 27, 2000\n\nJkt 194001\n\nPO 00000\n\nFrm 00025\n\ndisclose protected health information for specific purposes.\nWhen a covered entity is faced with a question as to whether the privacy regulation would prohibit the disclosure of protected health information that it seeks to disclose pursuant to a federal law, the covered entity should determine if the disclosure is required by that law. In other words, it must determine if the disclosure is mandatory rather than merely permissible. If it is mandatory, a covered entity may disclose the protected health information pursuant to § 164.512(a), which permits covered entities to disclose protected health information without an authorization when the disclosure is required by law. If the disclosure is not required (but only permitted) by the federal law, the covered entity must determine if the disclosure comes within one of the other permissible disclosures. If the disclosure does not come within one of the provisions for permissible disclosures, the covered entity must obtain an authorization from the individual who is the subject of the information or de-identify the information before disclosing it. If another federal law prohibits a covered entity from using or disclosing information that is also protected health information, but the privacy regulation permits the use or disclosure, a covered entity will need to comply with the other federal law and not use or disclose the information. ## Federal Disability Nondiscrimination Laws\n\nThe federal laws barring discrimination on the basis of disability protect the confidentiality of certain medical information. The information protected by these laws falls within the larger definition of ''health information'' under this privacy regulation. The two primary disability nondiscrimination laws are the Americans with Disabilities Act (ADA), 42 U.S.C. 12101 et seq." } ]
{ "source": "privacy_rule_2000", "safeguard_types": [ "physical", "technical", "administrative" ], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 36, "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 43)" }, { "role": "assistant", "content": "According to breach_notification_2009:\n\nons within 180 days of enactment to require HIPAA covered entities and their business associates to notify affected individuals and the Secretary of breaches of unsecured protected health information.\nSection 164.404 of this interim final regulation requires HIPAA covered entities to notify affected individuals of a breach of their unsecured protected health information without reasonable delay and in any case within 60 days of discovery of the breach, and, in some cases, to notify the media of such breaches pursuant to § 164.406. Section 164.408 requires covered entities to provide the Secretary with immediate notice of all breaches of unsecured protected health information involving more than 500 individuals. Additionally, the Act requires covered entities to provide the Secretary with an annual log of all breaches of unsecured protected health information that involve less than 500 individuals. Finally, covered entities must maintain appropriate documentation under §164.530(j) to comply with their burden of proof under § 164.414. The estimated annualized burden table below was developed using the same estimates and workload assumptions in the impact statement in section V, above. erowe on DSK5CLS3C1PROD with RULES\\_2\n\n## List of Subjects\n\n## 45 CFR Part 160\n\nAdministrative practice and procedure, Computer technology, Electronic information system, Electronic transactions, Employer benefit plan, Health, Health care, Health facilities, Health insurance, Health records, Hospitals, Investigations, Medicaid, Medical research, Medicare, Penalties, Privacy, Reporting and recordkeeping requirements, Security. ## 45 CFR Part 164\n\nAdministrative practice and procedure, Computer technology, Electronic information system, Electronic transactions, Employer benefit plan, Health, Health care, Health facilities, Health insurance, Health records, Hospitals, Medicaid, Medical research, Medicare, Privacy, Reporting and recordkeeping requirements, Security." } ]
{ "source": "breach_notification_2009", "safeguard_types": [ "physical", "technical", "administrative" ], "entity_type": "covered_entity", "type": "semantic_chunk", "chunk_id": 42, "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 114)" }, { "role": "assistant", "content": "According to privacy_mod_2002:\n\ncost savings associated with the elimination of the consent requirement. The comments did not include any reliable estimation that would cause the Department to reevaluate its savings estimate. ## 2.\nNotice\n\nIn eliminating the consent requirement, the Department preserves the opportunity for a covered health care provider with a direct treatment relationship with an individual to engage in a meaningful communication about the provider's privacy practices and the individual's rights by strengthening the notice requirements. Under the Privacy Rule, these health care providers are required to distribute to individuals their notice of privacy practices no later than the date of the first service delivery after the compliance date. The modifications do not change this distribution requirement, but add a new documentation requirement. A covered health care provider with a direct treatment relationship is required to make a good faith effort to obtain the individual's acknowledgment of receipt of the notice provided at the first service delivery. The form of the acknowledgment is not prescribed and can be as unintrusive as retaining a copy of the notice initialed by the individual. If the provider's good faith effort fails, documentation of the attempt is all that is required. Since the modification does not require any change in the form of the notice or its distribution, the tenyear cost estimate of $391 million for these areas in the Privacy Rule's impact analysis remains the same. See 65 FR 82770. However, the additional effort by direct treatment providers in obtaining and documenting the individual's acknowledgment of receipt of the notice adds costs. This new requirement attaches only to the initial provision of notice by a direct treatment provider to an individual after the compliance date. Under the modification, providers have considerable flexibility on how to achieve this." } ]
{ "source": "privacy_mod_2002", "safeguard_types": [ "physical", "technical", "administrative" ], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 113, "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 44)" }, { "role": "assistant", "content": "According to breach_notification_2009:\n\nnal, civil, or administrative proceeding arising from an alleged violation of law. *\n\n*\n\n*\n\n*\n\n*\n\n- ■ 8. In § 164.304, revise the definition of ''Access'' to read as follows:\n\n## §164.304 Definitions.\n*\n\n*\n\n*\n\n*\n\n*\n\nAccess means the ability or the means necessary to read, write, modify, or communicate data/information or otherwise use any system resource. (This definition applies to ''access'' as\n\nPO 00000\n\nFrm 00029\n\n- used in this subpart, not as used in subparts D or E of this part.)\n\n*\n\n*\n\n*\n\n*\n\n*\n\n- ■ 9. Add a new subpart D to part 164 to read as follows:\n\n## Subpart D-Notification in the Case of Breach of Unsecured Protected Health Information\n\nSec. 164.400\n\nApplicability. 164.402\n\nDefinitions. 164.404 Notification to individuals. 164.406 Notification to the media. 164.408 Notification to the Secretary. 164.410\n\nNotification by a business\n\nassociate. 164.412\n\nLaw enforcement delay. 164.414 Administrative requirements and burden of proof. Authority: Secs. 13400 and 13402, Pub. L. 111-5, 123 Stat. 258-263. ## Subpart D-Notification in the Case of Breach of Unsecured Protected Health Information\n\n## §164.400 Applicability. The requirements of this subpart shall apply with respect to breaches of protected health information occurring on or after September 23, 2009. ## §164.402 Definitions. As used in this subpart, the following terms have the following meanings:\n\nBreach means the acquisition, access, use, or disclosure of protected health information in a manner not permitted under subpart E of this part which compromises the security or privacy of the protected health information. - (1)(i) For purposes of this definition, compromises the security or privacy of the protected health information means poses a significant risk of financial, reputational, or other harm to the individual." } ]
{ "source": "breach_notification_2009", "safeguard_types": [ "physical", "technical", "administrative" ], "entity_type": "covered_entity", "type": "semantic_chunk", "chunk_id": 43, "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 210)" }, { "role": "assistant", "content": "According to hitech_omnibus_2013:\n\nby the individual, if it is readily producible in such form and format; or, if not, in a readable hard copy form or such other form and format as agreed to by the covered entity and the individual. 2.\n(ii) Notwithstanding paragraph (c)(2)(i) of this section, if the protected health information that is the subject of a request for access is maintained in one or more designated record sets electronically and if the individual requests an electronic copy of such information, the covered entity must provide the individual with access to the protected health information in the electronic form and format requested by the individual, if it is readily producible in such form and format; or, if not, in a readable electronic form and format as agreed to by the covered entity and the individual. *\n\n*\n\n*\n\n*\n\n*\n\n- (3) Time and manner of access. (i) The covered entity must provide the access as requested by the individual in a timely manner as required by paragraph (b)(2) of this section, including arranging with the individual for a convenient time and place to inspect or obtain a copy of the protected health information, or mailing the copy of the protected health information at the individual's request. The covered entity may discuss the scope, format, and other aspects of the request for access with the individual as necessary to facilitate the timely provision of access. 2. (ii) If an individual's request for access directs the covered entity to transmit the copy of protected health information directly to another person designated by the individual, the covered entity must provide the copy to the person designated by the individual. The individual's request must be in writing, signed by the individual, and clearly identify the designated person and where to send the copy of protected health information." } ]
{ "source": "hitech_omnibus_2013", "safeguard_types": [ "physical", "technical", "administrative" ], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 209, "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 technical controls?" }, { "role": "assistant", "content": "According to hitech_omnibus_2013:\n\n<unknown>\n\n## DEPARTMENT OF HEALTH AND HUMAN SERVICES\n\nOffice of the Secretary\n\n45 CFR Parts 160 and 164\n\n## RIN 0945-AA03\n\nModifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules Under the Health Information Technology for Economic and Clinical Health Act and the Genetic Information Nondiscrimination Act; Other Modifications to the HIPAA Rules\n\nAGENCY: Office for Civil Rights, Department of Health and Human Services. ACTION: Final rule. SUMMARY: The Department of Health and Human Services (HHS or ''the Department'') is issuing this final rule to: Modify the Health Insurance Portability and Accountability Act (HIPAA) Privacy, Security, and Enforcement Rules to implement statutory amendments under the Health Information Technology for Economic and Clinical Health Act (''the HITECH Act'' or ''the Act'') to strengthen the privacy and security protection for individuals' health information; modify the rule for Breach Notification for Unsecured Protected Health Information (Breach Notification Rule) under the HITECH Act to address public comment received on the interim final rule; modify the HIPAA Privacy Rule to strengthen the privacy protections for genetic information by implementing section 105 of Title I of the Genetic Information Nondiscrimination Act of 2008 (GINA); and make certain other modifications to the HIPAA Privacy, Security, Breach Notification, and Enforcement Rules (the HIPAA Rules) to improve their workability and effectiveness and to increase flexibility for and decrease burden on the regulated entities. DATES: Effective date: This final rule is effective on March 26, 2013. Compliance date: Covered entities and business associates must comply with the applicable requirements of this final rule by September 23, 2013. FOR FURTHER INFORMATION CONTACT: Andra Wicks 202-205-2292. SUPPLEMENTARY INFORMATION:\n\nVerDate Mar<15>2010\n\n18:57 Jan 24, 2013\n\nJkt 229001\n\nsroberts on DSK5SPTVN1PROD with\n\n## I." } ]
{ "source": "hitech_omnibus_2013", "safeguard_types": null, "entity_type": "both", "type": "safeguard", "chunk_id": null, "safeguard_type": "technical", "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 fda_premarket_2023 say about HIPAA compliance? (Part 5)" }, { "role": "assistant", "content": "According to fda_premarket_2023:\n\nitecture View ............................................................... | 47 |\n| Appendix 3. Submission Documentation for Investigational Device Exemptions....................... | Appendix 3.\nSubmission Documentation for Investigational Device Exemptions....................... | 50 |\n| Appendix 4. General Premarket Submission Documentation Elements and Scaling with Risk .. | Appendix 4. General Premarket Submission Documentation Elements and Scaling with Risk .. | 51 |\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\nThis guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff or Office responsible for this guidance as listed on the title page. ## I. Introduction\n\nWith the increasing integration of wireless, Internet- and network-connected capabilities, portable media (e.g., USB or CD), and the frequent electronic exchange of medical devicerelated health information and other information, the need for robust cybersecurity controls to ensure medical device safety and effectiveness has become more important. In addition, cybersecurity threats to the healthcare sector have become more frequent and more severe, carrying increased potential for clinical impact. Cyber incidents have rendered medical devices and hospital networks inoperable, disrupting the delivery of patient care across healthcare facilities in the U.S. and globally. Such cyber incidents and exploits may lead to patient harm as a result of clinical hazards, such as delay in diagnoses and/or treatment." } ]
{ "source": "fda_premarket_2023", "safeguard_types": [ "physical", "technical", "administrative" ], "entity_type": "covered_entity", "type": "semantic_chunk", "chunk_id": 4, "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 152)" }, { "role": "assistant", "content": "According to hitech_omnibus_2013:\n\nssociated with Huntington's disease), and the results of the examination do not support a diagnosis of Huntington's disease, then Huntington's disease is not manifested with respect to the individual.\nIn contrast, if the individual exhibits additional neurological and behavioral symptoms, and the results of the examination support a diagnosis of Huntington's disease by the neurologist, then Huntington's disease is manifested with respect to the individual. Frm 00100\n\nmanifested disease with respect to the individual. In contrast, if the individual undergoes a colonoscopy or other medical tests that indicate the presence of HNPCC, and the individual's physician makes a diagnosis of HNPCC, HNPCC is a manifested disease with respect to the individual. · If a health care professional with appropriate expertise makes a diagnosis based on the symptoms of the patient, and uses genetic tests to confirm the diagnosis, the disease will be considered manifested, despite the use of genetic information. For example, if a neurologist sees a patient with uncontrolled movements, a loss of intellectual faculties, and emotional disturbances, and the neurologist suspects the presence of Huntington's disease, the neurologist may confirm the diagnosis with a genetic test. While genetic information is used as part of the diagnosis, the genetic information is not the sole or principal basis for the diagnosis, and, therefore, the Huntington's disease would be considered a manifested disease of the patient. As with the definition of ''genetic test,'' the Department declines to include these examples in the regulatory text as this is inconsistent with the approach generally taken in the HIPAA Privacy Rule. The Department intends to issue future guidance on its web site with respect to the Rule's protections for genetic information. ## g." } ]
{ "source": "hitech_omnibus_2013", "safeguard_types": [ "physical", "technical", "administrative" ], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 151, "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 322)" }, { "role": "assistant", "content": "According to privacy_rule_2000:\n\nthorization. As discussed in greater detail in § 164.514, the final rule's minimum necessary standard applies to disclosures under § 164.512 unless the disclosure is required by law under §164.512(a).\nFrm 00213\n\nFmt 4701\n\nE:\\FR\\FM\\28DER2.SGM\n\npfrm08\n\nPsN: 28DER2\n\nSfmt 4700\n\nComment: A large number of commenters expressed concern about the potential for health oversight agencies to become, in effect, the ''back door'' for law enforcement access to such information. The commenters suggested that health oversight agencies could use their relatively unencumbered access to protected health information to circumvent the more stringent process requirements that otherwise would apply to disclosures for law enforcement purposes. These commenters urged us to prohibit health oversight agencies from re-disclosing protected health information to law enforcement. Response: As indicated above, we do not intend for the rule's permissive approach to health oversight or the absence of specific documentation to permit the government to gather large amounts of protected health information for purposes unrelated to health oversight as defined in the rule, and we do not intend for these oversight provisions to serve as a ''back door'' for law enforcement access to protected health information. While we do not have the statutory authority to regulate law enforcement and oversight agencies' re-use and re-disclosure of protected health information, we strongly support enactment of comprehensive privacy legislation that would govern public agencies' re-use and re-disclosure of this information. Furthermore, in an effort to prevent health oversight provisions from becoming the back door to law enforcement access to protected health information, the President is issuing an Executive Order that places strict limitations on the use of protected health information gathered in the course of an oversight investigation for law enforcement activities." } ]
{ "source": "privacy_rule_2000", "safeguard_types": [ "physical", "technical", "administrative" ], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 321, "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 are the physical safeguards under HIPAA?" }, { "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": "physical", "implementation_spec": "required", "cfr_section": null, "nist_control": null }