ONC seeks comments on draft EHR reporting criteria for vendors
The first draft of a set of criteria that developers of electronic health records will be required to report on as part of certification with a federal program has been released for public comment, but the new reporting requirements likely won’t take hold until at least 2024.
The Urban Institute, a Washington, D.C.-based think tank contracted to create HHS’ EHR reporting program, on Wednesday opened public comment for the draft version of interoperability measures that EHR software developers will have to report on, as mandated under the 21st Century Cures Act.
Under the Cures Act, HHS is required to collect data on health IT software certified by the department’s Office of the National Coordinator for Health Information Technology, with a goal of being able to publish interoperability, usability, security and other data from EHR users and developers to measure health IT product performance and provide a window into how such software is being used.
ONC tapped the Urban Institute and consulting firm HealthTech Solutions to develop the program in 2018.
Once the EHR reporting program is finalized, EHR developers will be required to report on the program’s developer criteria to maintain certification with ONC’s health IT certification program.
The Urban Institute expects the EHR reporting program to begin collecting data in 2024 or 2025, as the program needs to go through federal rulemaking.
After reviewing public comments on the draft released this week, the Urban Institute plans to publish a revised set of developer measures in December. ONC in 2022 will introduce a federal rule that establishes those finalized measures as part of its health IT certification. That notice and comment rulemaking process can take multiple months or years.
Additional measures will likely be added through future rulemaking.
“This is an incremental start,” said Michael Wittie, program lead at ONC, at a monthly meeting of the federal Health Information Technology Advisory Committee on Wednesday. He noted some topics outlined in the Cures Act are not yet included. “We expect in the future—some years from now—to iterate on that.”
Measures included in the draft focus on four areas of interoperability: patient access, public health information exchange, clinical care information exchange and standards adoption.
The patient access measures specifically focus on how developers are implementing ONC’s data-sharing regulations by asking what technologies patients are using to access data held in their health IT systems, whether patient-facing apps are registered with certification outlined in ONC’s health IT certification program and whether such registered apps include publicly available privacy policies.
ONC and the Urban Institute are requesting feedback on various issues, including how frequently developers should be asked to report on the measures; whether developers should report metrics for specific products or across their product base; and whether the measures could pose a reporting burden for smaller developers and startups.
The Urban Institute in October released the final version of a separate portion of the EHR reporting program, which focuses on gathering data from end-users that could be used to compare different products. That user-reported component of the EHR reporting program, under which clinicians, pharmacists and hospital IT staff would evaluate the EHR software they use, is voluntary.
ONC doesn’t have plans to implement that voluntary user-reported criteria. The agency doesn’t have resources to do so, according to Wittie. But the measures are “in the public domain,” he said. “We encourage anybody who’s excited about them … to take them up and collect data on them, and hopefully share the data.”
The public comment period for the EHR reporting program’s draft measures for software developers, which will not be voluntary, closes in September.