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Cures Act21st Century Cures Act

In short

The 21st Century Cures Act is a December 2016 US federal law covering biomedical research, drug and device approval, mental health and care delivery. For interoperability, its Title IV is the legal basis for information blocking, TEFCA, the statutory definition of interoperability and new conditions for certified health IT. ONC and other HHS rules implement it.

Type
Legal framework
Steward
U.S. Congress; implementing rules: ONC and CMS (HHS)
Current version
Pub. L. 114-255
Jurisdiction
United States
Reviewed
October 25, 2026

Explanation

What it is

The 21st Century Cures Act is Public Law 114-255, signed on 13 December 2016 (bill H.R. 34). It is not only a health IT law. Its Division A has five titles (innovation projects and state responses to opioid abuse, discovery, development, delivery and savings); Division B covers mental health and Division C Medicare and other programmes.

Title IV and interoperability

SectionWhat it does
4001Goal of reducing regulatory and administrative burdens relating to the use of electronic health records
4002Conditions of certification for developers: among them, providing application programming interfaces (APIs) that allow information to be accessed, exchanged and used "without special effort" and testing real-world interoperability
4003Defines interoperability and directs the convening of a trusted exchange framework and common agreement (TEFCA)
4004Defines information blocking and its penalties
4006Promotes patient access to their electronic health information
4007 and 4008GAO studies on patient matching and patient access

The Act defines interoperable health IT as technology that enables the secure exchange and use of electronic health information without special effort on the part of the user, allows complete access to all electronically accessible health information for authorized use, and does not constitute information blocking.

How it is applied

The Act amends the Public Health Service Act, and its health IT provisions are codified in Title 42 of the US Code. ONC (formerly ASTP/ONC; HHS restored that name on 1 April 2026) implements them through rules such as the 2020 final rule on interoperability, information blocking and certification. In 2024, HHS set disincentives for providers that commit information blocking.

Amendments

The information blocking section (42 U.S.C. 300jj-52) was last amended by Public Law 116-321 of 5 January 2021, according to the 2024 edition of the Code on govinfo; as of October 2026, later editions of the U.S. Code were not reviewed.

Common misconceptions

  • Believing it is only an IT law. Title IV is one of five titles in Division A, and the Act has two other divisions.
  • Confusing the Act with its rules. The information blocking exceptions, for example, are in 45 CFR part 171, not in the Act.
  • Believing it requires joining TEFCA. The Act states that nothing requires a health information network to adopt the framework or the common agreement.

Usage examples

  1. Section 4004 is the legal basis for the information blocking rules in 45 CFR part 171.

  2. Section 4003 directed ONC to convene a trusted exchange framework and a common agreement among health information networks, now TEFCA.

  3. Section 4002 created certification conditions on APIs, which ONC's final rule of 1 May 2020 implemented.

  4. The HHS rule of July 2024 set disincentives in Medicare programmes for providers that commit information blocking.

  5. Section 4007 asked the Government Accountability Office (GAO) for a study on patient matching.

Relation to other terms

Relies on0

This term does not rely on other glossary terms.

Depend on this one2

  • Information blockingRequired

    The statutory definition of information blocking and its penalties come from section 4004 of the 21st Century Cures Act.

  • TEFCARequired

    Section 4003 of the 21st Century Cures Act directed the convening of the trusted exchange framework and common agreement (42 U.S.C. 300jj-11).

Sources

  1. Public Law 114-255 — 21st Century Cures Act (govinfo)govinfo.gov
  2. Congress.gov — H.R. 34, 21st Century Cures Act (114th Congress)congress.gov
  3. 42 U.S.C. 300jj-52 — Information blocking (U.S. Code, 2024 edition, govinfo)govinfo.gov
  4. Federal Register — 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program (85 FR 25642, 1 May 2020)federalregister.gov
  5. Federal Register — Establishment of Disincentives for Health Care Providers That Have Committed Information Blocking (89 FR 54662, 1 July 2024)federalregister.gov
  6. Federal Register — HHS Statement of Organization: Office of the National Coordinator for Health IT (91 FR 16204, 1 April 2026)federalregister.gov
Health interoperability glossary