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The U.S. Division of Well being and Human Providers (“HHS”) has announced proposed changes (the “Proposed Rule”) to 42 C.F.R. Half 2 (“Half 2”). Whereas the Well being Insurance coverage Portability and Accountability Act (“HIPAA”) governs the privateness and safety of protected well being info usually, Half 2 particularly governs the medical information of federally assisted substance use remedy applications (“SUD Information”).
Half 2 was applied to encourage sufferers to hunt substance abuse remedy with out worry of prosecution by limiting a remedy program’s potential to make use of or disclose SUD Information. Through the years, and as exacerbated by the COVID-19 pandemic, the necessity for streamlined coordination of care usually conflicted with Half 2’s restrictions. As well as, suppliers topic to HIPAA had been additionally required to adjust to Half 2 for SUD Information, which compelled these suppliers to adjust to usually inconsistent requirements for various kinds of well being info. Naturally, the presence of two competing requirements brought on confusion, elevated administrative burdens, and sometimes obstructed supplier entry to affected person info.
At its core, the Proposed Rule seeks to create higher flexibility for sufferers and suppliers aligning Half 2 extra intently with HIPAA. The Proposed Rule identifies quite a few significant revisions, together with by means of instance:
- Aligning the content material necessities of a Half 2 consent with HIPAA’s authorization necessities and permitting disclosure to classes of designated recipients.
- Permitting use of a single affected person consent for future makes use of and disclosures of SUD Information and increasing redisclosure choices.
- Making HIPAA’s civil and legal penalties out there for Half 2 violations.
- Empowering sufferers to request sure restrictions on disclosures of their SUD Information in addition to to request an accounting of disclosures.
- Making use of HIPAA’s breach notification obligations to Half 2 applications and requiring discover to sufferers the place their information are compromised.
- Updating Half 2’s confidentiality discover necessities to extra intently align with HIPAA’s commonplace for Discover of Privateness Practices.
Public feedback relating to the Proposed Rule may be submitted as much as January 31, 2023. Thereafter, we anticipate that HHS will subject a Ultimate Rule in 2023. Because the Proposed Rule isn’t remaining, we’ll proceed to watch and supply updates to maintain you knowledgeable about new developments.
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