Guidance

Taking effect immediately, on January 12, 2021, the Trump Administration approved a rule which through HHS which makes it more difficult for regulators to harass individuals and organizations for alleged violations of guidance documents.

"HHS can only apply standards or practices that have been publicly stated in a manner that would not cause unfair surprise," HHS declared. Moreover, HHS announced that it will do civil administrative inspections if its inspection process is publicly available:

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Whenever HHS relies on a document arising out of litigation to establish jurisdiction in future civil enforcement actions, HHS must publish that document and an explanation of the document's jurisdictional implications.

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The rule also requires HHS to provide individuals and organizations with written notice of any alleged violation of a guidance, and an opportunity to respond, before taking legal action.

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A cornerstone of fair governance is transparency — regulated parties need to know in advance the standards by which the government will judge their conduct.

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