March 1, 2021

Volume XI, Number 60

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March 01, 2021

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February 26, 2021

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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including all regulations that have been sent to the Office of the Federal Register, but not yet published, are to be withdrawn until a department or agency head appointed by President Biden reviews and approves the rule.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. 

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©1994-2020 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.National Law Review, Volume XI, Number 21
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About this Author

Dianne Borque, Health Care, licensure, risk management, attorney, Mintz
Of Counsel

Dianne advises a variety of health care clients on a broad range of issues, including licensure, regulatory, contractual, and risk management matters, and patient care. As former in-house counsel to an academic medical center, a large part of her practice involves counseling researchers and research sponsors in matters related to FDA and OHRP regulated clinical research, including patient consent, access to and use of tissue and associated patient information, and the Institutional Review Board process. In addition, Dianne currently serves as a Vice Chair of AHLA's...

(617) 348-1614
Cassandra L. Paolillo, Health care lawyer, Mintz Levin Law Firm
Associate

Cassie’s practice primarily involves advising health care clients on transactional and regulatory matters, including mergers and acquisitions, regulatory compliance, and general contracting.

Throughout her career, Cassie has worked with providers, payors, and individual patients, so she understands the unique challenges facing clients in the ever-changing health care landscape.

Prior to joining Mintz, Cassie worked as in-house counsel at a national senior living company. There she advised the business on matters related to state and federal health care regulations, physician...

617-348-1828
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