Definition
21st Century Cures Act
The 21st Century Cures Act is a broad federal law enacted in December 2016 that funded biomedical research, changed how the FDA develops and reviews drugs and devices, and set national rules for health IT interoperability and information blocking.
1 min readReviewed September 14, 2026
Also known as: Cures Act, Public Law 114-255, H.R. 34 (114th Congress)
Key facts
- Public law
- Public Law 114-255
- Enacted
- December 13, 2016
- FDA provisions
- Division A, Title III (Development)
- Health IT provisions
- Division A, Title IV (Delivery)
- Health IT implementing rule
- ONC 21st Century Cures Act Final Rule, published in 2020
What is the 21st Century Cures Act?
Congress passed the Cures Act with bipartisan support to speed up medical innovation and improve how health information is shared. It combined research funding, FDA reforms, mental health legislation and Medicare and Medicaid changes in one package.
The law authorized funding for National Institutes of Health (NIH) initiatives, including the Precision Medicine Initiative, the BRAIN Initiative and the Cancer Moonshot, and grants to states to respond to opioid misuse. Many provisions took effect through later HHS regulations and guidance.
Main parts of the Cures Act
The provisions most relevant to health data and life sciences fall into these areas:
- Research: NIH innovation funding and research policy changes, including automatic certificates of confidentiality for federally funded research.
- FDA: provisions on patient experience data, real-world evidence, the Breakthrough Devices Program and regenerative medicine advanced therapy (RMAT) designation.
- Health IT: a statutory definition of interoperability, information blocking prohibitions, TEFCA, Conditions of Certification for health IT developers and patient access to electronic health information.
- Mental health: the Helping Families in Mental Health Crisis Reform Act, included as a separate division.
- Medicaid and Medicare: provisions such as electronic visit verification for Medicaid personal care and home health services.
Why the Cures Act matters
Much of today's health data policy traces back to this law:
- Pharma and device teams: breakthrough device and RMAT pathways, and FDA's real-world evidence program, rest on Cures Act provisions.
- Health IT companies: the 2020 Cures Act Final Rule required standardized FHIR APIs in certified EHRs and set the information blocking rules.
- Providers: patients gained faster electronic access to results and notes, since delaying their release can raise information blocking questions.
- Data users: patient access and API requirements expanded the flow of clinical data to apps and third parties that patients choose.