The US Department of Health and Human Services (HHS) announced, on September 3, 2025, a major enforcement initiative targeting “information blocking” – the practice of restricting access, exchange, or use of electronic health information (EHI). The move reflects a shift in regulatory focus under Secretary Robert F. Kennedy Jr., who has directed HHS to deploy increased resources to enforce the information blocking provisions of the 21st Century Cures Act (Cures Act) [1], citing a new zero tolerance policy [2]. The HHS Office of the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT (ASTP/ONC) [3] and Office of the Inspector General (OIG) [4] will lead these efforts.
Background
Widespread information blocking has been well documented [5]. Ensuring access to EHI, particularly where it empowers individuals to take control of their health, is a key feature of Secretary Kennedy’s Make America Healthy Again initiative. In addition, the ONC Cures Act Final Rule [6], published in 2020 during the first Trump Administration, provides that patients should have easy electronic access to their EHI at no cost, including via apps of their choice, and that health care providers should be able to choose the digital tools that allow them to provide the best care, without excessive costs or technical barriers.
“Unblocking the flow of health information is critical to unleashing health IT innovation and transforming our healthcare ecosystem,” said Deputy Secretary of Health and Human Services Jim O’Neill in the announcement. “We will take appropriate action against any health care actors who are found to be blocking health data for patients, caregivers, providers, health innovators, and others” [7].
HHS also encourages patients, providers, innovators trying to improve health care or reduce costs, and others who have experienced or observed information blocking to report it through ASTP/ONC’s Reporting Information Blocking Portal. The reference to health innovators signals recognition by the Trump Administration of the key role these entities serve on behalf of patients who rely on health apps to secure access to, and facilitate the sharing of, their health information.
Potential risks for entities
As enforcement picks up under this renewed focus, potential consequences for entities subject to information blocking regulations include:
- Health care providers participating in certain Centers for Medicare and Medicaid Services (CMS) programs could be subject to disincentives under those programs.
- Health IT developers of certified health IT, or those which meet the definition of a health information network or health information exchange, could face a substantial civil monetary penalty of up to $1,000,000 per violation.
- Developers with product(s) certified under the ONC Health IT Certification Program could have their certifications terminated and be banned from the Certification Program.
Key takeaways
With the imminent threat of significant civil penalties and removal from government programs, HHS aims to move the needle on compliance and free up EHI. Companies subject to the Cures Act are encouraged to review their information sharing practices and ensure they have taken appropriate steps to comply with any information blocking provisions.
In addition, heightened enforcement of the Cures Act, in connection with other HHS initiatives aimed at promoting interoperability such as the recent announcement of CMS’ Health Tech Ecosystem initiative, will pave the way for patients and – perhaps more importantly given their role as facilitators – mobile health apps to access and share EHI. Taken together, they represent a major opportunity for health information technology companies to capitalize on governmental initiatives to free up health information.
[1] Public Law 114–255.
[2] See, Secretary Kennedy on X, Sep. 3, 2025.
[3] The principal federal entity charged with coordination of nationwide efforts to implement and use the most advanced health information technology and the electronic exchange of health information.
[4] The primary investigative division of HHS.
[5] See, eg, Information Blocking Claims: By the Numbers | HealthIT.gov (1,336 possible claims of information blocking received through the Report Information Blocking Portal since April 2021).
[6] Federal Register: 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program.
[7] See, HHS Announces Crackdown on Health Data Blocking | HHS.gov, Sep. 3, 2025.
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