HHS Final Rule Aids Protection of Health Information

HHS says the final rule allows the program to better support physicians and hospitals – the vast majority of whom use certified electronic health records – and the fast pace of innovation in health IT.

The U.S. Department of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) issued a final rule on Oct. 14 that emphasizes the importance of protecting public health and safety and strengthens transparency and accountability in the ONC Health IT Certification Program, according to the agency's announcement.

It says the final rule allows the program to better support physicians and hospitals – the vast majority of whom use certified electronic health records – and the fast pace of innovation in health IT. "More transparency and accountability in health IT is good for consumers, physicians, and hospitals," said Dr. Vindell Washington, M.D., 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 rule focuses on these three key areas:

  • Direct review: Allows ONC to directly review certified health IT products and take necessary action in circumstances involving potential risks to public health and safety or circumstances that present practical challenges for ONC-Authorized Certification Bodies, such as when issues arise involving multiple certified functionalities or products that have been certified by multiple ONC-ACBs.
  • Consistent authorization and oversight: Establishes a process for ONC to authorize and oversee accredited testing laboratories to align with ONC’s existing oversight of ONC-ACBs.
  • 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.
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