HHS Targets Information Blocking With New Enforcement
Health IT developers and providers face up to $1 million in fines for blocking patient data access.
Updated on Oct. 21, 2026 in Healthcare
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The U.S. Department of Health and Human Services has issued seven letters of potential nonconformity to companies suspected of information blocking. This enforcement action highlights increased scrutiny for health IT developers and providers under rules established by the 21st Century Cures Act.
Why it matters
Federal officials are prioritizing compliance efforts by helping developers align with data-sharing rules before escalating to maximum penalties. Operators must ensure their health IT systems facilitate, rather than restrict, patient data access to avoid potential regulatory scrutiny.
HHS issued seven notices of nonconformity regarding information blocking, backed by federal rules allowing civil penalties of up to $1 million per violation. Officials have also held two multi-stakeholder troubleshooting calls to resolve stalled record requests.
The players
HHS
The federal department overseeing health-related rulemaking and the enforcement of data-sharing standards.
Thomas Keane
A federal official who disclosed the status of ongoing information blocking enforcement actions.
CMS
A federal agency that facilitates direct troubleshooting sessions between patients, providers, and software vendors.
The details
Under the 21st Century Cures Act of 2016, information blocking is prohibited to ensure seamless data flow between providers and patients. HHS works alongside the Office of Inspector General, the Justice Department, and the Federal Trade Commission to enforce these standards. The agency's current approach emphasizes troubleshooting sessions where patients, providers, and EHR vendors can address data-sharing barriers before regulators pursue formal enforcement actions.
Timeline
September 2025: HHS launched an enforcement push against information blocking.
June 2026: HHS began issuing notices of nonconformity.
October 15, 2026: Thomas Keane disclosed the total count of nonconformity letters issued.
Market Landscape
This enforcement action marks a definitive move to operationalize the information-sharing requirements of the 21st Century Cures Act of 2016. It underscores a shift from policy guidance to active compliance monitoring for all health IT developers.
Health IT operators should immediately review their data-access protocols to ensure full compliance with the 21st Century Cures Act. Consult with legal counsel to assess whether current system configurations risk being flagged as information blocking.
The takeaway
The majority of firms contacted by HHS have already acknowledged their compliance gaps and initiated corrective measures. Operators should audit their record-sharing workflows now to proactively address any barriers before they trigger a federal inquiry.
Further reading
For more on regulatory impacts, visit the Healthcare section.
Source note: This article includes information reported by Becker's Hospital Review | Healthcare News & Analysis.
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Do you trust that government enforcement effectively prevents health companies from blocking your medical record access?
