Health and Human Services Department Proposed Rule

2016-04531: ONC Health IT Certification Program: Enhanced Oversight and Accountability

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Summary

This notice of proposed rulemaking ("proposed rule") introduces modifications and new requirements under the ONC Health IT Certification Program ("Program"), including provisions related to the Office of the National Coordinator for Health Information Technology (ONC)'s role in the Program. The proposed rule proposes to establish processes for ONC to directly review health IT certified under the Program and take action when necessary, including requiring the correction of non-conformities found in health IT certified under the Program and suspending and terminating certifications issued to Complete EHRs and Health IT Modules. The proposed rule includes processes for ONC to authorize and oversee accredited testing laboratories under the Program. It also includes a provision for the increased transparency and availability of surveillance results.

The agency’s own summary, as published.

What this changes

Amends 1 part of the Code of Federal Regulations — the standing rules this notice rewrites.

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