ONC's final rule on Health IT certification leaves questions

From the moment the Office of the National Coordinator for Health Information Technology unveiled its proposed rule to expand oversight and health IT certification in March, there was no lack of discussion on how it would work.

That trend didn't change when ONC unveiled the final rule on Oct. 14.

The office has been working to not only spur the use of electronic health records, but ensure their ubiquity across health IT systems while preventing information blocking that could hamper those goals.

To do that, the final rule empowers ONC with three components:

Direct review: It allows ONC to review certified health IT products and electronic health records systems to assess risks to public health and safety, working with its authorized certification bodies to conduct the reviews.

Enhanced oversight: It gives ONC greater purview over health IT testing bodies to address issues that arise in the testing process.

Greater transparency and accountability: It makes information on performance and compliance of certified health IT available to the public. 

But the rule also raises questions about how ONC and HHS will enforce and track the newly instituted oversight.

While the rule establishes a regulatory framework for direct review of IT products — providing avenues for oversight and even termination of product certification, as well as an appeals process for industry — it doesn't spell out how much manpower within HHS will be needed to monitor those products.

When pressed on a conference call, Vindell Washington, national coordinator for health IT, said that ONC has always had mechanisms to track the safety of health IT products, but with the expansion of those products, HHS is still addressing the specifics of oversight.

"We certainly do have a larger playing field," he said. "We do think that the actual triggering of the direct oversight will be relatively rare, but to some degree, we are in an operational phase as we are building out the details of how this works."

Washington added that those details include direct engagement with industry to identify where product problems may occur, but that the process isn’t new to HHS, merely expanded.

"This, in my mind is more of a refinement of that activity," he said. "The focus on this is really around items that affect patient safety and items that are in this category of things that are certified by multiple [ONC-Authorized Certification Bodies], which is likely different than feedback from the field on the sort of general growing pains of EHR adoption."

The ONC chief said that the final rule provided a good regulatory framework for the oversight system, but more details on the specifics would be forthcoming.

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