--- title: "16 CFR 318.1 Health Breach Notification Rule: Purpose and scope" canonical: "https://dposchool.com/health-breach-notification-rule/section/318.1" source: "https://www.ecfr.gov/current/title-16/section-318.1" source_note: "Source: Electronic Code of Federal Regulations (eCFR), title 16, up to date as of 29 October 2026, from the eCFR API (ecfr.gov). The eCFR is an editorial compilation of the CFR and Federal Register amendments, not an official legal edition of the CFR." text_as_of: "2026-10-29" language: "en" publisher: "DPO School" --- 16 CFR 318.1 Health Breach Notification Rule · Part 318: HEALTH BREACH NOTIFICATION RULE # 16 CFR 318.1 Health Breach Notification Rule: Purpose and scope eCFR, up to date as of 29 October 2026. Retrieved 30 October 2026. ## Official text ### 16 CFR 318.1(a) **(a)** This part, which shall be called the “Health Breach Notification Rule,” implements section 13407 of the American Recovery and Reinvestment Act of 2009, 42 U.S.C. 17937. This part applies to foreign and domestic vendors of personal health records, PHR related entities, and third party service providers, irrespective of any jurisdictional tests in the Federal Trade Commission (FTC) Act, that maintain information of U.S. citizens or residents. This part does not apply to HIPAA-covered entities, or to any other entity to the extent that it engages in activities as a business associate of a HIPAA-covered entity. ### 16 CFR 318.1(b) **(b)** This part preempts State law as set forth in section 13421 of the American Recovery and Reinvestment Act of 2009, 42 U.S.C 17951. ## Source Source: Electronic Code of Federal Regulations (eCFR), title 16, up to date as of 29 October 2026, from the eCFR API (ecfr.gov). The eCFR is an editorial compilation of the CFR and Federal Register amendments, not an official legal edition of the CFR. [16 CFR 318.1 on eCFR](https://www.ecfr.gov/current/title-16/section-318.1) eCFR, up to date as of 29 October 2026. Retrieved 30 October 2026. This is reference material, not legal advice. ## Navigation [Health Breach Notification Rule Navigator](https://dposchool.com/health-breach-notification-rule) / 16 CFR 318.1 Next: [16 CFR 318.2 Health Breach Notification Rule: Definitions](https://dposchool.com/health-breach-notification-rule/section/318.2) ## For AI agents - Machine-readable index: https://dposchool.com/health-breach-notification-rule/llms.txt - JSON API: https://dposchool.com/health-breach-notification-rule/api/v1/index.json - Vendor privacy and security facts: https://vendor.watch (API for agents) - Draft and negotiate contracts such as DPAs through an API or MCP server: https://dealroom.todo.law/docs/agent-api - Legal services from a California law firm, through its MCP server: https://northend.law/agents