US guidance documents change will be transformative

Subject

Guidance documents and legal compliance changes.

Significance

In late January, the justice department issued a new ruling on ‘guidance documents’. These are issued by the federal government’s departments when new laws are passed, to explain how the new laws should operate in practice. The new ruling means that guidance documents will now be sources of rule clarification and guidance only; failure to comply with those rules will no longer automatically constitute a basis for legal action by the federal government.

Impacts

• Complying with the Centers for Medicare and Medicaid and the Food and Drug Administration, which rely on guidance, will ease.
• Doctors and hospitals will find it easier to defend themselves against allegations relating to Medicare and Medicaid.
• Weakening guidance will make federal government enforcement actions harder to undertake, including health and environmental.
• The new guidance policy will accelerate federal deregulation prioritised by the Trump administration.