The HHS Good Guidance Rule

Guidance documents are instructions or clarifications provided by the U.S. Department of Health and Human Services (HHS) to help healthcare entities understand and comply with laws and regulations. They are not laws themselves but offer guidance on following the rules. The HHS Good Guidance Rule changes how these documents are created and used. It also serves as a component of HHS's broader regulatory reform initiative, aligning with the requirements of Executive Order 13891, “Promoting the Rule of Law Through Improved Agency Guidance Documents”.

How is the rule enforced?

The Office of the General Counsel (OGC) ensures compliance by determining whether they qualify as guidance or require a formal rulemaking process. HHS must allow public comments on important guidance documents and add non-binding disclaimers, with internal procedures and oversight to enforce them. While there are no outside penalties for breaking this rule, it is part of HHS's legal and regulatory duties.

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What are the key components of the rule?

The rule applies to all HHS components except for the Food and Drug Administration (FDA), which has its own set of guidance practices. This distinction ensures a uniform approach across the department while respecting existing structures which include:

1. Public notice and comment: The rule requires a public notice and comment period before finalization for significant guidance documents. This process allows stakeholders and the general public to provide input, ensuring broader participation in developing these documents.
2. Non-binding disclaimer: Guidance documents must include a clear disclaimer stating that they do not carry the force of law, unless explicitly authorized by statute. This ensures that recipients understand these documents are meant for guidance only and are not legally binding requirements.
3. Inclusion in an HHS repository: The rule mandates that all active guidance documents be listed in a designated HHS repository. This requirement ensures transparency, making it easier for the public to access and review these documents.
4. Process for exemption: There are provisions for exempting certain guidance documents from the full requirements of the rule, particularly in situations where a rapid response is needed, such as a public health emergency.
5. Review and rescind mechanism: The rule includes a mechanism for periodically reviewing guidance documents to determine if they should be modified, replaced, or rejected, ensuring that the guidance remains relevant and effective.

See also: HIPAA Compliant Email: The Definitive Guide

The effect of the rule on regulatory practice and compliance

The rule allows healthcare providers and industry stakeholders to actively shape the guidance that affects them by requiring public comments on significant documents. This involvement is expected to lead to more practical and well-understood guidance, which can improve compliance. The rule also clearly states that these guidance documents are not legally binding, except when a law specifies otherwise, helping entities understand that following these guidelines is advisable but optional. 

Additionally, by making all active guidance documents easily accessible in a public repository, the rule ensures that regulated entities can quickly find and use the most current and relevant information. 

See also: HHS seeks to strengthen HIPAA Privacy Rule for reproductive health care