New rule makes it harder for HHS to penalize guidance violations

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HHS officials bolstered President Donald Trump’s deregulation agenda on Tuesday, signing off on a rule that makes it more difficult for regulators to go after individuals and organizations for not following standards laid out in guidance documents.

The rule effectively bans the department from penalizing individuals and organizations for noncompliance with a standard or practice if HHS only announced it in a guidance document. It also lays out a substantial process HHS must follow to carry out civil enforcement actions for potential violations. HHS said the rule is necessary to ensure fairness.

“HHS can only apply standards or practices that have been publicly stated in a manner that would not cause unfair surprise,” according to a department statement.

In addition, HHS can only carry out civil administrative inspections if the department’s inspection process is publicly available.

“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,” the department said in a statement.

The rule also requires HHS to provide individuals and organizations with written notice of a guidance violation and a chance to respond before pursuing legal action.

“A cornerstone of fair governance is transparency—regulated parties need to know in advance the standards by which the government will judge their conduct,” HHS Chief of Staff Brian Harrison said in a statement.

The rule takes effect immediately.

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