ONC releases final rule for Health IT Certification Program
The Office of the National Coordinator for Health Information Technology today released a final rule codifying modifications and new requirements under the ONC Health IT Certification Program in an effort to protect public health and safety as well strengthen the accountability and transparency of certified HIT.
ONC’s National Coordinator Vindell Washington, MD, said the Enhanced Oversight and Accountability Rule is a key part of the agency’s “commitment to accelerate the interoperable flow of electronic health information while supporting the reliable and safe use of certified health IT to ensure that these products operate appropriately in the field.”
According to Washington, the final rule focuses on three major areas:
- Direct review: Provides a regulatory framework for ONC to directly review certified HIT products and take necessary action in circumstances involving either potential risks to public health and safety; or 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 HIT 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 HIT publicly available to advance ONC’s overall commitment to transparency and provide customers and users with valuable information about the performance of certified HIT, including illuminating good performance and continued conformance with program requirements.
Washington said the new Enhanced Oversight and Accountability Rule builds on ONC’s release last year of its 2015 Edition of Health IT Certification Criteria.
However, industry reaction to the final rule has been mixed.
Doug Fridsma, president and CEO of the American Medical Informatics Association, said his organization supports the general approach taken by the final rule to focus its authorities on oversight of health IT in the service of patient safety and public health.
“We believe this rule provides a sensible process through which known and potential harms to patient safety can be identified and corrected,” said Fridsma. “We are glad to see improvements in scope and in process with this final rule, and believe this regulatory framework gives ONC the tools they need to better ensure patient safety.”
But, Health IT Now, a coalition of patient, provider and payer groups, was decidedly negative about the ONC’s Enhanced Oversight and Accountability Rule.
“We are very disappointed that ONC has decided to move in this direction,” said Robert Horne, executive director of HITN. “Health IT Now is reviewing these rules. However, our chief concern is the potential for negative consequences from the ONC final rule. Simply put, the Office of the National Coordinator for Health IT was not created by Congress to be a regulator like the Food and Drug Administration.”
Horne charged that ONC is “clearly overstepping its statutory authority by moving forward with direct review of uncertified functionalities and products, in addition to certified products” and that, by focusing on safety issues, the agency is “encroaching on the regulatory functions of other federal agencies like the FDA.”
As a result, he said HITN is urging the White House to reconsider this approach and is asking Congress to use its authority to prevent the rule from being implemented, including withholding congressional appropriations.