ONC final rule updated to include Health IT Standards to improve security, accountability

ONC final rule updated to include Health IT Standards to improve security, accountability

The U.S. Department of Health and Human Services (HHS) has released its Office of the National Coordinator for Health Information Technology (ONC) Health IT Certification Program: Enhanced Oversight and Accountability 2017 Final Rule.




The ONC Health IT Certification Program is a voluntary program to provide for the certification of health IT standards, and “to provide assurance to purchasers and other users that a system meets the technological capability, functionality, and security requirements adopted by HHS as described by HealthIT.gov.

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; or (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.




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