HHS Sends Letters of Nonconformity to Suspected Information Blockers

The U. S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health IT (ONC) has sent warning letters to seven health IT companies suspected of engaging in information blocking, in violation of the information blocking rules of the 21 st Century Cures Act.

The recipients of the letters of nonconformity have not been named, as the HHS declines to make such information public when there are active investigations; however, the companies will be named if there are any corrective actions, financial penalties, suspensions, or terminations due to noncompliance. In September last year, the HHS announced that it would be actively enforcing compliance with the information blocking regulations and would take action against any entity that blocks patients, providers, or other entities from legally obtaining access to health information.

The maximum penalty for an information blocking violation is $1 million per violation; however, no penalties for information blocking have been imposed to date, and there have been no suspensions or terminations. At the annual ADAPT conference on October 15, Thomas Keane, HHS National Coordinator for Health IT, said most of the recipients of the letters of nonconformity have responded by remediating the allegations of restricted data access and have agreed to change their data sharing practices.

Keane said his office is keen to work with health IT companies to ensure that they understand the requirements but will adopt an enforcement stance if data sharing practices are not voluntarily changed. Keane confirmed that ONC is working with the Justice Department, HHS Office of Inspector General, and the Federal Trade Commission to enforce the information blocking regulations.

Amy Gleason, administrator of the U. S. DOGE Service and Chief Product Officer at the Centers for Medicare and Medicaid Services (CMS), said the CMS is taking troubleshooting calls to help get patient data flowing, stating that there have only been two such calls to date.

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