Final Rule Issued for Health IT Certification Program


ONC issued a final rule stressing the importance of public health while improving accountability and transparency in its Health IT program.

The U.S. Department of Health and Human Services’ (HHS) Office of the National Coordinator for Health Information Technology (ONC) issued a final rule that emphasizes the importance of protecting public health and safety while also strengthening transparency and accountability in the ONC Health IT Certification Program (“Program”).

The “ONC Health IT Certification Program: Enhanced Oversight and Accountability” final rule will enable the ONC Health IT Certification Program to better support physicians and hospitals – the vast majority of whom use certified electronic health records (EHRs) –  and the rapid pace of innovation in the health information technology (health IT) market.

“More transparency and accountability in health IT is good for consumers, physicians, and hospitals,” said Vindell Washington, MD, MHCM., national coordinator for health IT. “Today’s final rule strengthens the program by ensuring that certified health IT helps clinicians and individuals use and exchange electronic health information safely and reliably.”

The final rule focuses on three key areas:

Direct Review

Provides a regulatory framework for ONC to directly review certified health IT products and take necessary action in circumstances involving:

  1. potential risks to public health and safety
  2. circumstances that present practical challenges for ONC-Authorized Certification Bodies (ONC-ACBs)—such as when issues arise involving multiple certified functionalities or products that have been certified by multiple ONC-ACBs.

The final rule also focuses on corrective action plans to address issues and includes an appeals process under the Program for health IT developers that have products under direct review.

Consistent Authorization and Oversight

Establishes a process for ONC to authorize and oversee accredited testing laboratories (ONC-ATLs) to align with ONC’s existing oversight of ONC-ACBs, and facilitates ONC’s ability to quickly, directly, and precisely address testing and performance issues.

Increased Transparency and Accountability

Makes identifiable surveillance results of certified health IT publicly available to advance ONC’s overall commitment to transparency and provide customers and users with valuable information about the performance of certified health IT, including illuminating good performance and continued conformance with Program requirements.

More information on the ONC Health IT Certification Program can be found online.


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