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HIPAA Amendments and Other Trump Regulatory Actions on Hold

In the waning days of the Trump administration, the Office for Civil Rights (“OCR”) announced a number of new initiatives, including proposed HIPAA amendments, discussed here, and a very recent COVID-19 related Notice of Enforcement Discretion.  Under the Notice of Enforcement Discretion, published on January 19, 2021, OCR announced that it would not impose penalties for non-compliance with HIPAA on covered entities making good faith use of online or web-based applications for COVID-19 vaccination scheduling.  With the swearing in of President Biden, these and other regulatory initiatives, including all regulations that have been sent to the Office of the Federal Register, but not yet published, are to be withdrawn until a department or agency head appointed by President Biden reviews and approves the rule. 

The freeze was announced in a Whitehouse memo to the heads of executive departments and agencies (the “Memo”) which also suggests delaying the effective dates of rules that were published by the Trump administration, but that have not yet taken effect, for purposes of reviewing questions of fact, policy and law that the rules may raise.  The Memo not only applies to rules, but any substantive action by an agency, including advance notice of proposed rulemaking, guidance document or statement of policy on a statutory, regulatory or technical issue. 

There is an exception in the Memo for emergency or other urgent circumstances related to health, safety, environmental, financial or national security matters.  It is possible that the HIPAA Notice of Enforcement Discretion for COVID vaccination scheduling would fall under this exception.  However, as of this blog publication, the notice was no longer available on the Office for Civil Rights Website. 

Stay tuned as we continue to monitor and report on these developments. 

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Dianne specializes in counseling researchers and research sponsors in matters related to FDA and OHRP regulated clinical research, and counsels health care clients on the HIPAA Privacy Rule and Security Standards.
Cassandra L. Paolillo is Of Counsel at Mintz whose practice involves advising health care clients on transactional and regulatory matters, including mergers and acquisitions, regulatory compliance, and general contracting. Cassie primarily works with providers and payors.