Digital illustration of a futuristic medical device with regulatory symbols.

21st Century Cures Act: Revolutionizing Healthcare or a Risky Gamble?

Lena Voss monogram
Lena Voss in Health & Wellness October 2026 • 4 min read.

"Examining the Impact of the 21st Century Cures Act on Medical Device Regulation and Patient Care."


In late 2016, the 21st Century Cures Act was signed into law, promising to revolutionize healthcare by speeding up the development and approval of new medical treatments and devices. This ambitious legislation sought to fast-track innovative medical technologies, with the goal of improving patient access to cutting-edge care and accelerating medical breakthroughs. However, the Cures Act's impact, particularly on the regulation of medical devices, has been a subject of intense debate.

The core of the Cures Act's strategy involved modifications to the pre-market approval processes of the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS). These changes aimed to streamline the pathway for new medical devices and pharmaceutical products to reach the market more quickly. This shift was driven by the desire to bring life-saving treatments to patients faster and foster innovation in the medical field.

This article provides an in-depth analysis of the 21st Century Cures Act, focusing specifically on its provisions related to medical device regulation. We will explore the key changes introduced by the Act, analyze the controversies surrounding its implementation, and evaluate its potential impact on patient safety, innovation, and the overall healthcare landscape. Our goal is to provide a comprehensive understanding of this complex legislation and its implications for the future of medicine.

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A Broad Healthcare Impact

The 21st Century Cures Act affects biomedical research, medical-product development, patient data access, and healthcare innovation. Its overall impact is substantial but difficult to summarize with a single statistic because the law covers multiple policy areas. Benefits and risks may vary across patients, researchers, clinicians, regulators, and healthcare organizations.

Modernizing Regulatory Methods

The 21st Century Cures Act, signed into law on December 13, 2016, sought to accelerate the discovery, development, and delivery of new cures. It amended the Federal Food, Drug, and Cosmetic Act, including provisions intended to create a more efficient process for updating antimicrobial-resistance susceptibility-test interpretive criteria. The FDA described the law as amending several sections of the Federal Food, Drug, and Cosmetic Act, while the statute itself framed its purpose around faster medical innovation. These changes pursue efficiency, but faster regulatory processes can create continuing questions about how to balance speed with evidentiary rigor.

From H.R. 34 to Federal Law

The Cures Act, formally known as H.R. 34, was signed into law by President Barack Obama on December 13, 2016. The House passed the House amendment to the Senate amendment to H.R. 34 on November 30, 2016, by a vote of 392 to 26. The National Institutes of Health describes the law as providing tools and resources spanning foundational basic research through advanced clinical trials. One summary reports that the act authorized $6.3 billion in funding, mostly for the NIH.

Decoding the Cures Act: Key Provisions and Their Implications

Digital illustration of a futuristic medical device with regulatory symbols.

The 21st Century Cures Act introduced several significant changes to the medical device regulatory landscape. These changes primarily targeted the FDA's approval processes, aiming to reduce the time and cost associated with bringing new medical devices to market. Understanding these key provisions is essential for evaluating the Act's overall impact.

One of the most notable provisions is the 'Breakthrough Devices' program, designed to expedite the development and review of innovative medical technologies that address life-threatening or irreversibly debilitating conditions. The Act also increases the number of humanitarian device exemptions, allowing for faster approval of devices for rare diseases. Other provisions focus on streamlining processes, such as recognizing standards established by nationally or internationally recognized organizations, and improving the classification of medical devices.

  • Breakthrough Devices: Expedited review for innovative devices targeting serious conditions.
  • Humanitarian Device Exemption: Faster approval for devices treating rare diseases.
  • Recognition of Standards: Streamlining the review process by recognizing industry standards.
  • Least Burdensome Review: FDA must consider the least burdensome approach to ensure device safety and effectiveness.
  • Medicare and Medicaid Improvements: Provisions to improve Medicare and Medicaid to ensure coverage for new technologies.
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Expanding Patient Participation

Recent discussion presents the Cures Act as legislation that increases patient involvement in medical care and research. A review reports that, as of April 2021, patients were entitled to immediate electronic access to their medical records, including clinical documentation notes from genetic care. The proposed Cures 2.0 initiative, introduced in 2021, built on the original law's successes, and major components included establishing the Advanced Research Projects Agency for Health, or ARPA-H. The Cures 2.0 white paper also reports that its authors received more than 300 stakeholder responses while considering next steps.

Unresolved Tradeoffs

The Cures Act illustrates a recurring policy tension between accelerating medical innovation and maintaining strong safeguards. Faster development and review may improve access to promising products, but speed alone does not establish that benefits will outweigh risks. The law's results should therefore be assessed not only by innovation milestones, but also by the quality of evidence, implementation, and patient outcomes. Available information supports a cautious assessment rather than a definitive judgment that the initiative has either succeeded or failed.

Cures Act and HIPAA

The Cures Act and HIPAA address different but related aspects of health information and healthcare regulation. Guidance on the Cures Act focuses on amendments to the Federal Food, Drug, and Cosmetic Act, while practical comparisons with HIPAA emphasize information blocking, patient API access, electronic health information, and compliance. Another explanation characterizes the Cures Act as establishing a legal right to electronically access virtually all health information without delay and at no cost. Together, these sources frame the Cures Act primarily around access and interoperability, rather than treating it as interchangeable with HIPAA's broader privacy framework.

These provisions reflect a clear intention to reduce the regulatory burden on medical device manufacturers, encourage innovation, and accelerate patient access to new technologies. However, the impact of these changes has sparked considerable debate. Some argue that the streamlined processes may compromise patient safety by potentially reducing the rigor of pre-market evaluations. Others counter that the changes are necessary to foster innovation and ensure that patients can benefit from cutting-edge medical advancements.

The Future of Medical Device Regulation: Navigating Innovation and Safety

The 21st Century Cures Act represents a pivotal moment in the evolution of medical device regulation. While it aims to accelerate innovation and improve patient access to life-saving technologies, it also raises important questions about the balance between speed, safety, and cost-effectiveness. The ultimate impact of the Cures Act will depend on ongoing monitoring, evaluation, and adaptation. As medical technology continues to advance, regulators, manufacturers, and healthcare providers must work collaboratively to ensure that innovation benefits patients while upholding the highest standards of safety and quality.

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Innovation With Accountability

The Cures Act represents an effort to move medical research and product development more quickly through the healthcare system. Its promise depends on whether faster pathways remain compatible with reliable evidence and meaningful patient protections. A balanced interpretation recognizes that innovation and oversight are not mutually exclusive, but that both require sustained implementation. The law's ultimate value therefore remains connected to how its authorities are applied in practice.

The Next Phase of Cures

Future efforts related to the Cures Act will likely continue to focus on medical innovation, patient participation, and the use of health information. New initiatives may extend the law's original emphasis on accelerating research and development. At the same time, policymakers will need to evaluate whether emerging approaches preserve transparency, evidence quality, and patient trust. The direction of this next phase remains dependent on implementation and subsequent policy choices.

A Double-Edged Policy

The Cures Act has been described as a double-edged policy: it can support government research funding and medical innovation while also raising concerns about the level of evidence required for approving prescription drugs and medical devices. The legislation passed overwhelmingly in the House and Senate during the final days of the 114th Congress. Its immediate electronic-record-access requirements also have important implications for children, adolescents, and young adults with cancer and their families. These examples show how a law designed to accelerate innovation can create both system-wide opportunities and practical challenges for care.

Patients at the Center

The law's human impact is most visible in its emphasis on patient involvement and access to health information. Patients may benefit when medical records and clinical documentation become available electronically and without unnecessary delay. However, the practical value of access depends on whether people can understand, use, and act on the information they receive. The effects may also differ across patient groups, families, clinicians, and healthcare systems.

Patient note sharing before and after the rule

  • 11-foldPatient views of notes rose from 99 in March 2021 to 1,126 in April 2021, an 11-fold increase; views later peaked at 2,613 in October 2021.[1]

How the findings fit the rule's implementation

The Information Blocking Rule took effect on April 5, 2021, and established a core set of electronic health information that must be made available to patients in a timely fashion. At the institution described, inpatient access changed from discharge summaries to immediate release of progress notes, imaging narratives, test results, and consult notes.[1]

FDA describes the Cures Act as supporting modernized clinical-trial designs, including real-world evidence and clinical outcome assessments, in developing and reviewing medical products. This is a broader regulatory aim than the patient note-sharing changes measured in the hospital findings.[2]

Follow-up research reported that patients preferred continuing immediate access to electronic health information 95% of the time, while also identifying a risk of increased physician work. This preference result sits alongside the separate finding that complaint rates did not change at the academic center.[3]

Questions the evidence leaves open

  • How should the costs and benefits of patient-access initiatives be evaluated across the different stakeholders in healthcare?[4]
  • How can patients be informed about information-sharing rules when patients interviewed in cancer care generally had not heard of the rule before it was explained?[5]

Sources

  1. The 21st Century Cures Act: Inpatient Clinician Perceptions of Changes to Information Sharing at an Academic Medical Center (pmc.ncbi.nlm.nih.gov)
  2. 21st Century Cures Act | FDA (www.fda.gov)
  3. Unsolicited Patient Complaints Following the 21st Century Cures Act Information-Blocking Rule (pmc.ncbi.nlm.nih.gov)
  4. Impact of patient access to their electronic health record: systematic review. (pubmed.ncbi.nlm.nih.gov)
  5. Understanding the Cures Act Information Blocking Rule in cancer care: a mixed methods exploration of patient and clinician perspectives and recommendations for policy makers (pmc.ncbi.nlm.nih.gov)

About this Article -

Written with AI assistance from published research, and reviewed by the Mystum team. See our About page for more information.

Everything You Need To Know

1

What is the primary goal of the 21st Century Cures Act, and how does it intend to achieve this concerning medical devices?

The 21st Century Cures Act aims to revolutionize healthcare by accelerating the development and approval of new medical treatments and devices. It primarily seeks to achieve this by modifying the pre-market approval processes of the Food and Drug Administration (FDA) to streamline the pathway for innovative medical devices and pharmaceutical products to reach the market more quickly. The intention is to foster medical innovation and improve patient access to cutting-edge care.

2

Can you describe the 'Breakthrough Devices' program introduced by the 21st Century Cures Act and its significance?

The 'Breakthrough Devices' program, a key provision of the 21st Century Cures Act, is designed to expedite the development and review of innovative medical technologies that address life-threatening or irreversibly debilitating conditions. Its significance lies in its potential to accelerate access to critical medical devices for patients with serious conditions, providing them with potentially life-saving or life-altering treatment options sooner than would have been possible under previous regulatory pathways. The program aims to strike a balance between ensuring safety and fostering innovation.

3

How does the 21st Century Cures Act address the approval process for devices intended to treat rare diseases, and what are the implications of this approach?

The 21st Century Cures Act addresses the approval process for devices intended to treat rare diseases by increasing the number of humanitarian device exemptions. This allows for faster approval of devices that target conditions affecting smaller patient populations. The implication is that patients with rare diseases may gain access to potentially beneficial devices more quickly, addressing a critical unmet need. However, it also raises questions about the level of evidence required for approval and the potential for unforeseen risks, necessitating careful post-market surveillance.

4

What are some concerns about the streamlined processes for medical device approval introduced by the 21st Century Cures Act?

Some concerns revolve around whether the streamlined processes implemented to speed up medical device approval, as outlined in the 21st Century Cures Act, may compromise patient safety. Critics argue that reducing the rigor of pre-market evaluations could lead to potentially unsafe devices reaching the market. There are fears that the drive to accelerate innovation might overshadow the need for thorough testing and validation, potentially exposing patients to unforeseen risks and complications. Monitoring and post-market surveillance are critical to address these concerns.

5

Beyond the FDA approval processes, how does the 21st Century Cures Act influence Medicare and Medicaid, and why is this relevant to the adoption of new medical technologies?

The 21st Century Cures Act includes provisions to improve Medicare and Medicaid coverage for new technologies. This is relevant because coverage decisions by these large payers significantly impact the adoption and accessibility of new medical devices. Even if a device gains FDA approval, its widespread use depends on whether Medicare and Medicaid will reimburse healthcare providers for its use. Improvements to coverage pathways can encourage manufacturers to develop innovative technologies, knowing that there is a viable path to market adoption, ultimately benefiting patients by providing access to a broader range of advanced medical treatments.

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