The Office of the National Coordinator for Health Information Technology (ONC) has announced its final rule codifying modifications and requirements under the ONC Health IT Certification Programme. The initiative is part of an effort to upgrade the transparency and accountability of certified HIT. It has also been devised to protect the health and safety of the public.
The ONC said the Enhanced Oversight and Accountability Rule is a central facet 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.”
The final rule puts three areas on the agenda:
Provides a regulatory framework for ONC to directly review certified HIT products and take whatever action necessary in situations where products or services could pose risks to public health and safety. It also provides a framework for ONC-Authorised Certification Bodies (ONC-ACBs) when challenges arise that involve multiple certified functionalities or products that have been certified by multiple ONC-ACBs.
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Consistent authorisation and oversight:
This art of the rule sets out the process for ONC to authorise and oversee accredited testing laboratories (ONC-ATLs) to coordinate with the present oversight of ONC-ACBs. It also and facilitates ONC’s ability to directly, and precisely address testing and performance issues in a swift manner.
Increased transparency and accountability:
To provide customers and users with valuable information about the performance of certified HIT, this segment makes identifiable surveillance results of certified HIT publicly available.
Healthcare response to the final rule has been mixed with some sections of the C-Suite commending the focus on oversight of health IT in the service of patient safety and public health. Others have expressed concern over the ONC positioning itself as a regulator like the FDA and accused it of overstepping its
Source: Health Data Management
Image Credit: ONC