The 21st Century Cures Act is a sweeping U.S. law signed on December 13, 2016, designed to speed up the development of new drugs, medical devices, and treatments and get them to patients faster. It touches nearly every corner of American healthcare, from how clinical trials are run to whether you can access your own medical records on your phone. The law directed billions of dollars toward major research initiatives and reshaped how the FDA approves new therapies.
Faster Drug and Device Approvals
One of the law’s central goals is cutting the time it takes for promising treatments to reach patients. It does this in several ways. First, it allows the FDA to consider “real-world evidence,” meaning data gathered from actual patient care rather than only from traditional clinical trials, to support approval of new uses for drugs that are already on the market. This is a significant shift from the previous standard, where nearly all approval decisions relied on controlled trial data alone.
The law also created two new fast-track programs. The Breakthrough Devices Program speeds review of medical devices that treat life-threatening or irreversibly debilitating conditions, as long as the device represents a genuine technological leap, has no existing alternative, or offers a major advantage over what’s already available. The Regenerative Medicine Advanced Therapy (RMAT) designation does something similar for treatments like cell therapies and tissue-engineered products that aim to treat, reverse, or cure serious diseases. To qualify, a therapy needs preliminary clinical evidence showing it could fill an unmet medical need.
Beyond these programs, the law gives the FDA new authority to hire and retain scientific experts, helping the agency keep pace with increasingly complex therapies in areas like gene editing and personalized medicine.
Billions for Cancer, Brain, and Precision Medicine Research
The Cures Act authorized $4.8 billion in new funding for the National Institutes of Health, with the money directed toward three flagship initiatives. The Cancer Moonshot received $1.8 billion over seven years, with annual allocations ranging from $195 million to $400 million depending on the fiscal year. That funding supports collaborative research aimed at accelerating progress against cancer on multiple fronts, from early detection to treatment.
The BRAIN Initiative, focused on mapping the human brain and developing new tools to treat neurological disorders, and the Precision Medicine Initiative (now called the All of Us Research Program), which collects health data from a million or more volunteers to tailor treatments to individuals, also received dedicated funding streams under the law.
Your Right to Access Your Health Records
For many people, the most tangible impact of the Cures Act is the set of rules it created around electronic health records. The law requires healthcare systems to adopt standardized technology interfaces (APIs) that let you securely access your complete medical records, including lab results, clinical notes, and imaging reports, through smartphone apps. This access must be provided at no cost to you.
To make this work, the law introduced the concept of “information blocking,” which refers to any practice by a hospital, health system, or technology vendor that improperly prevents the sharing of electronic health information. Since October 6, 2022, the scope of protected data has expanded beyond a core set of standardized elements to include essentially all electronic health information a provider holds. There are nine narrow exceptions that allow organizations to restrict access in specific circumstances, such as preventing harm to a patient, but the default expectation is that your data flows freely to you and to other providers involved in your care.
Incorporating the Patient’s Voice
The Cures Act formalized something that had previously been informal: patient experience data now plays a defined role in how the FDA evaluates new treatments. The law requires the agency to consider data about how patients experience their disease and its treatments when designing clinical trials, selecting what outcomes to measure, and weighing the benefits and risks of a new therapy. This means things like patient-reported symptoms, quality-of-life measures, and daily functioning can directly influence whether a drug gets approved and for what conditions.
Stronger Privacy for Research Participants
Before the Cures Act, researchers could voluntarily obtain a Certificate of Confidentiality to protect the identity of study participants. The law made these certificates mandatory for any federally funded research that collects identifiable, sensitive information. It also gave the certificates real teeth. Protected information cannot be disclosed in any federal, state, or local legal proceeding without the participant’s consent. It is inadmissible as evidence in court. Researchers are prohibited from sharing participant names or identifiable data with anyone outside the research team unless a specific statutory exception applies. These protections last in perpetuity, covering all copies of the data, regardless of how much time passes.
Clinical Trial Diversity Requirements
The law requires the NIH to update its guidelines for including women, minorities, and people of all ages in clinical research. Since January 2019, researchers applying for NIH funding must justify the age range of their study participants and specifically explain any decision to exclude children (under 18) or older adults (65 and older). Exclusions based on age need a scientific or ethical justification, and researchers must report the ages of enrolled participants in their progress reports. The goal is to ensure that the evidence supporting new treatments reflects the full range of people who will actually use them.
Opioid Crisis and Mental Health Funding
The Cures Act included $1 billion in grants to help states combat the opioid epidemic, funding that has since been renewed and expanded. By fiscal year 2025, the federal government was distributing over $1.5 billion annually through State Opioid Response and Tribal Opioid Response grants. These programs fund prevention, treatment, and recovery services. Outcomes data from grant recipients show improvements in depression, anxiety, behavioral control, and reductions in suicide attempts among participants.
What Happened to Cures 2.0
A follow-up bill called the Cures 2.0 Act was introduced in the 117th Congress to build on the original law. As of mid-2024, the bill had not passed as a single package, but several of its provisions were moving through Congress individually or had been addressed through agency action. Among the standalone bills introduced in the 118th Congress are the PASTEUR Act, which targets development of new antibiotics, and the Telehealth Modernization Act, which would make permanent certain telehealth flexibilities that expanded during the pandemic.