Amid Reproductive Health Proposed Rule, 2021 Privacy Changes on Hold

With the overturning of Roe. v. Wade and the continuing opioid crisis, the HHS Office for Civil Rights (OCR) has decided to focus on safeguards for reproductive health and substance use disorder records and won’t be finalizing revisions to the Privacy Rule proposed in 2021 anytime soon.

At a recent conference sponsored by the Health Care Compliance Association, publisher of RRC, OCR Director Melanie Fontes Rainer said finalizing the proposed rule “is not a top priority for us this year with our limited resources.”[1]

But OCR has signaled it will continue to bring enforcement actions when covered entities violate patients’ or family members’ rights to access their medical records. In fact, the agency recently announced its 44th such action.

Hospitals and other medical providers affiliated with research institutions may recall OCR published a proposed rule on Jan. 21, 2021, the day after President Joe Biden was inaugurated.[2] OCR formally began the process of revising the Privacy Rule in December 2018 under then-Director Roger Severino, with the publication of a request for information. Drafted by the Trump administration, publication under Biden was seen as a tacit endorsement of the proposed rule by the current administration.

The proposed rule eliminated the requirement for providers to obtain a signature when they distribute their notices of privacy practices, a change popular among providers. It also addressed a range of topics, many more than the typical rule—problems OCR officials said at the time were long-standing.

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