Your EHR vendors may have to make sudden changes -- or even lose their certification -- if the Office of the National Coordinator of Health IT (ONC) finalizes its new proposed rule, which gives ONC a more active "direct review" of electronic health record (EHR) products and relationships, more control over lab testing of products for certification and power to post quarterly "surveillance results" for the public.
The proposed rule issued on Tuesday by ONC, which certifies EHR and other health IT (HIT) products, proposes to "expand ONC’s role" in running its HIT Certification Program.
Its first proposal is a new direct review process. The current process is not designed to address "non-conformities resulting from the interaction of certified and uncertified capabilities within the certified health IT or the interaction of a certified health IT’s capabilities with other products," says the rule, and these non-conformities "may pose a risk to public health or safety."
The rule proposes that ONC would judge products on "the interaction of certified and uncertified capabilities within the certified health IT and to the interaction of a certified health IT’s capabilities with other products."
The direct review would be set off "whenever [ONC] becomes aware of information" that a product or the interaction of one product with another, "may not conform to the requirements of its certification." The review's result may require "corrective action" such as "notifying affected customers; fully correcting identified issues across a health IT developer’s customer base; and taking other appropriate remedial actions." In extreme cases, ONC would suspend or terminate an EHR's certification.
Also, ONC proposes to switch from indirect to direct oversight of testing labs under the program.
And to "enhance transparency and the accountability of health IT developers to their customers," ONC proposes to make identifiable surveillance results publicly available quarterly. ONC hopes thatwill "reassure customers and users of certified health IT" and "motivate some health IT developers to improve their maintenance efforts."
Official publication of the proposed rule will be on March 2, at which time comments will be invited.