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.[1]
"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:
| “ | 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 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.
| “ | A cornerstone of fair governance is transparency — regulated parties need to know in advance the standards by which the government will judge their conduct.[2] | ” |
References
- ↑ https://www.modernhealthcare.com/law-regulation/new-rule-makes-it-harder-hhs-penalize-guidance-violations?utm_source=modern-healthcare-am-wednesday&utm_medium=email&utm_campaign=20210112&utm_content=article1-headline
- ↑ HHS Chief of Staff Brian Harrison said this in a statement.