The Department of Health and Human Services (HHS) recently issued a rule making clear that not all “guidance” from the agency creates obligations on hospitals and other healthcare organizations.1

The new rule clarifies that some guidance from the agency is just that — only guidance, not a binding requirement. The agency wanted to clarify that “HHS guidance documents do not impose obligations on regulated parties that are not already reflected in statutes or regulations,” HHS said in a statement accompanying the rule.2

“For too long, federal agencies have succumbed to the temptation to create law without notice and comment or public participation,” HHS Chief of Staff Brian Harrison said.2 “Our Good Guidance Practices regulation empowers and protects those we regulate by requiring increased transparency and raising the standards for issuing significant guidance.”


  1. HHS final rule for Executive Order 13891.
  2. HHS finalizes Good Guidance Practices rule and issues advisory opinion regarding compliance with notice-and-comment obligations. Dec. 3, 2020.