Friday morning, the U.S. Department of Health and Human Services’ Office of the National Coordinator for Health Information Technology finalized a rule designed to enhance the organizations oversight of health IT products and improve overall patient safety.
The “ONC Health IT Certification Program: Enhanced Oversight and Accountability” rule will allow the ONC to request noncompliant products be taken off the market. It will also afford transparency to providers when deciding on health IT products, said Vindell Washington, M.D., National Coordinator for Health Information Technology, during a media briefing Friday.
Providers looking at the certified health IT product list will be able to have a “good idea” about whether a tool they’re using, or plan to purchase, has had problems or has received a good safety rating, said Washington.
“What we’ve heard is there’s this gap between what may happen in a testing lab and what may happen in the field,” said Washington. The ability to provide more direct oversight on products will have a positive affect on the day to day operations of providers, he added.
The final rule is to be published on Oct. 19 and focuses on three 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 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.