Any person conducting scientific research using patient identifying information obtained under paragraph (a) of this section that requests linkages to data sets from a data repository(ies) holding patient identifying information must: (iii) Ensure that patient identifying information is not redisclosed for data linkage purposes other than as provided in paragraph (c) of this section. Demonstrate excellence and best practices in service management. [154] The Department also proposes to replace several instances of the phrase individual or entity with the term person, which would encompass both individuals and entities, and to replace the term individual with the term person.. based on weighing the public interest in the need for disclosure against the injury to the patient, physician patient relationship and treatment services)[49] However, the Department estimates that as a result of changes to the requirement to obtain consent for disclosures related to TPO, Part 2 programs and covered entities and business associates would experience cost savings from a significant reduction in the number of needed consent forms. Definitions, contact the publishing agency. 2.25Accounting of disclosures. notices, Average cost to further facilitate the exchange of Part 2 records in new models of care, including those involving an HIE, a research institution providing treatment, an accountable care organization, or a care management organization. L. 104-191, 110 Stat. L. 91-616, 84 Stat. [80], Prior to amendment by the CARES Act, section 290dd-2 provided that records could be disclosed only with the patient's specific written consent for each disclosure, with limited exceptions. Part 2 programs may benefit from increased frequency of patients paying in full out of pocket, which could decrease the time spent by staff in billing and claims activities. Additionally, recipients of Part 2 records that are covered entities or business associates must obtain consent for redisclosure of these records. Deliver safe, healthy dining experiences for your customers, employees, students, patients or residents, robust food safety practices. In this NPRM, the Department is revising certain information collection requirements and, as such, is revising the information collection last prepared in 2020 and previously approved under OMB control #0930-0092. 2.68Report to the Secretary (Proposed Heading), A. 27. and Standard: Waiver of rights. Excluding covered entities from the restrictions applied to other third-party payers in paragraph (d)(2) of this section would reduce burden on covered entities that are health plans because they will be permitted to disclose records for a wider range of health care operations than under the current regulation. The Department would add the term use to make clear that authorized uses and disclosures are prohibited by this part. However, a court order under 2.66 may authorize use and disclosure of records to investigate or prosecute such persons who are holding the records. Subparagraph (e) of 2.65 sets forth requirements for the content of a court order authorizing the use or disclosure of patient records for the criminal investigation or prosecution of the patient. Explanation of Estimated Capital Expenses for, 3. 654, 112 Stat. 2.66 and https://oig.hhs.gov/oei/reports/OEI-09-21-00120.pdf, (FY 2020 Medicaid fraud convictions and civil penalties against outpatient SUD treatment providers included 9 criminal convictions and 7 civil settlements, for a total of 16). could include investigations by a protective services agency, for example, unless pursuant to a court order or with the patient's consent. electronic version on GPOs govinfo.gov. adds a new paragraph (1), 9. For example, once a HIPAA covered entity or business associate disclosed PHI to a person who was not a covered entity or business associate, the information was no longer protected by the Privacy Rule, and thus the Privacy Rule's limitations on uses and disclosures did not apply. The application for the court order must occur within a reasonable period of time, but not more than 120 days after discovering it received part 2 records; or, (iii) If the agency does not seek a court order in accordance with paragraph (a)(3)(ii) of this section, the agency must either return the records to the part 2 program or person holding the records, if it is legally permissible to do so, within a reasonable period of time, but not more than 120 days after discovering it received part 2 records; or. Pressing enter in the search box 5301 Adult patients who lack capacity to make health care decisions. The Department proposes these modifications to align with 42 U.S.C. The above-noted proposed modifications to 2.65(d) and (d)(2), 2.65(e), and 2.65(e)(1) and (e)(2), each would add the use and disclosure of testimony relaying the information in patient records to the protections already afforded Part 2 records under the regulations. The Department also requests comment on whether it should modify Part 2 to apply the same or similar safeguards requirements to electronic Part 2 records as the Security Rule applies to ePHI or whether other safeguards should be applied to electronic Part 2 records. The accuracy of the agency's estimate of the information collection burden; 3. 290dd-2(b), as amended by section 3221(b) of the CARES Act, and to align the language of this provision with the Privacy Rule, the Department proposes to add the term use in paragraphs (a) and (b) to clarify that requirements related to consent given by minor patients would apply to both uses and disclosures of records. Modify the Part 2 confidentiality notice requirements (hereinafter, Patient Notice) to align with the Notice of Privacy Practices (NPP) and address protections required by 42 U.S.C. 31. Qualified service organization. The term does not include a number assigned to a patient by a part 2 program, for internal use only by the part 2 program, if that number does not consist of or contain numbers (such as a social security, or driver's license number) that could be used to identify a patient with reasonable accuracy from sources external to the part 2 program. 42 CFR 2.11. Patients with SUD who are currently using illegal drugs are not protected from discrimination on the basis of their illegal drug use under existing law of the Rehabilitation Act of 1973,[105] 1302(a); 42 U.S.C. Thus, the regulations do not require use or disclosure under any circumstance other than when disclosure is required by the Secretary to investigate or determine a person's compliance with this part pursuant to 2.3(c) of this part. 165. (29) 2.62Order not applicable to records disclosed without consent to researchers, auditors, and evaluators. A sponsor shall select only investigators qualified by training and experience as appropriate experts to investigate the drug. 201 note). The Department proposes that such reports would be due within 60 days following the end of the calendar year. or existing codification. Use the navigation links in the gray bar above to view the table of contents that this content belongs to. (h) [9] The Department proposes to require that a Part 2 program include in the Patient Notice statements of patients' rights with respect to Part 2 records. https://www.govinfo.gov/content/pkg/FR-2013-01-25/pdf/2013-01073.pdf). 59. The Electronic Code of Federal Regulations (eCFR) is a continuously updated online version of the CFR. The Department requests comment on whether it would be appropriate to include a definition of lawful holderand, if so, what persons should be considered lawful holders. (C) If a use or disclosure for any purpose described in paragraphs (b)(1)(ii)(A) or (B) of this section is prohibited or materially limited by other applicable law, such as 42 CFR part 2, the description of such use or disclosure must reflect the more stringent law as defined in 160.202 of this subchapter. The Department requests comment on its proposal to permit disclosures only of de-identified records for public health purposes without patient consent. 87. The NSF mark is your assurance that the product has been tested by one of the most respected independent certification organizations in existence today. 290dd-2(c). The Department believes that this combination of modifications would promote the understanding of both Part 2 and the HIPAA Rules and requests comment on whether this or other approaches would provide more clarity. to a heading titled "Published Edition". See e.g., Adding in alphabetical order definitions of Breach; Business associate; Covered entity; Health care operations; HIPAA; HIPAA regulations; b. 21 CFR Part 11 is not a static document. The Department requests comment on the proposed definition of investigative agency and any concerns about including local agencies in the term, such as lack of uniform procedures, inconsistency across a state, or examples of local investigative agencies involvement in investigating Part 2 programs. The Department also estimates costs for hiring a contractor to create a breach portal or a Part 2 module for the existing HIPAA breach portal. The Department does not have data to predict how many patients will sign up for credit monitoring or other identity protections after receiving a notification of breach of their Part 2 records; however, the Department believes that the costs to patients of taking these actions[207] The Department proposes to clarify that the good cause criteria for a court order in paragraph (c)(2) includes circumstances when obtaining the evidence another way would yield incomplete evidence. The Department also proposes to create a new paragraph (c)(4) addressing investigative agencies' belated applications for a court order authorizing placement of an undercover informant or agent to investigate a Part 2 program or its employees. [128] Qualified service organization 179. 160. The Department intends to implement the CARES Act antidiscrimination provisions in a separate rulemaking. This would be offset by an estimated annual savings of $12,755,378 for a total of $63,776,888 over five years. 155. (proposed heading). The Department requests comments and data on the extent to which covered entities currently receive requests from patients to restrict disclosures of patient identifying information for TPO purposes, how covered entities document such requests, and the procedures and mechanisms used by covered entities to ensure compliance with patient requests to which they have agreed or that they are otherwise required to comply with by law. To implement the change from U.S. Attorney enforcement, the Department proposes to re-title the heading to this section, replacing Reports of violations with Complaints of violations, and to replace the existing provisions about directing reports of Part 2 violations to the U.S. Attorney's Office and to SAMHSA with provisions about filing complaints of potential violations with a Part 2 program or the Secretary. Start Printed Page 74257 records of SUD treatment by a Part 2 program that are transmitted or maintained by or for covered entities). The proposed narrowing of the definition of third-party payer in 2.11 would exclude covered entity health plans from the limits on redisclosure of Part 2 records in paragraph (d)(2) of 2.12. (proposed heading). 226. 290dd-2. The definition of records specifies the scope of information that Part 2 protects. Patient identifying information (a) Under 42 U.S.C. If the part 2 program knows that the email transmission has failed, a paper copy of the notice must be provided to the patient. (2) Provide, for each disclosure, the name(s) of the entity(ies) to which the disclosure was made, the date of the disclosure, and a brief description of the patient identifying information disclosed. 145. The Breach Notification Rule also requires a covered entity's business associate that experiences a breach of unsecured PHI to notify the covered entity of the breach. Start Printed Page 74231. Executive Orders 12866 and 13563 and Related Executive Orders on Regulatory Review, 4. Section 3221(b) of the CARES Act is codified at 42 U.S.C. See60 FR 22296 (May 5, 1995). The Department also proposes a wording change to replace the phrase individual or entity with the term person as now proposed to comport with the HIPAA meaning of the term. The edits do not require any changes to existing Part 2 requirements.
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