foundations

FAQ: What is a covered entity?

Where to begin when determining whether an organization may be subject to HIPAA.

Nonbinding guidance Identifier FAQ-COVERED-ENTITY Version 1.0

The answer depends on the organization’s role and activities. Review the definitions and applicability provisions in the current regulation and use official HHS explanations as orientation.

This FAQ is educational and cannot determine coverage for a particular organization.

Authority and source

Authority: Primary source
Citation: 45 CFR Part 164
Publisher: Office of the Federal Register
Source identifier: 45-CFR-164
Source status: verified

Open primary source

Change and publication history

Initial reviewed publication — Sep 5, 2026