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Proposed Rule Seeks to Expand Government Oversight of EHR Vendors

Posted in Electronic Health Records, Hospitals and Institutions, Legislation and Public Policy

On March 2, the Office of the National Coordinator for Health Information Technology (ONC) of the U.S. Department of Health and Human Services (HHS) published a proposed rule (the “Rule”) entitled “Health IT Certification Program: Enhanced Oversight and Accountability.” The Rule would further modify the ONC’s health information technology certification program that was established in 2010 and modified several times since.

The Rule gives ONC broad discretion to directly review health information technology certified under the program and to take action when necessary, including requiring the correction of nonconformities and suspension or termination of certifications. The Rule would allow ONC to review how certified health information technology products interact with other products, specifically regarding data blocking and patient safety. The Rule also sets forth the process for ONC to authorize and oversee accredited testing laboratories and addresses transparency and availability of surveillance results.

The Rule was issued two days after HHS announced that companies that provide 90% of the electronic health records used by hospitals nationwide, along with the five largest healthcare systems in the U.S. and several advocacy groups, have pledged to help patients more easily access their electronic health information and transfer it to any other provider or data user.

Comments on the Rule are due by May 2, 2016.

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