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June 20, 2023

We appreciate ONC taking into account our prior comments supporting enhanced harmonization of policies among agencies including the Food and Drug Administration (FDA), the Federal Trade Commission (FTC), and the Centers for Medicare and Medicaid Services (CMS). We also strongly support the use of updated vocabulary standards as found in the most current versions of SNOMED CT, LOINC, CDC race and ethnicity standards, etc.

AMIA appreciates ONC’s goal of building on the digital foundation to make interoperability easier through bolstering the use of FHIR API requirements, promoting information sharing, and ensuring appropriate use. We recognize much of this rule is geared toward developers of health information technology, and establishing an approach that will reduce burden yet spur advancements. Our concerns are primarily directed to the time and resource constraints needed for hospitals and health systems to collaborate with health information technology developers to effectively implement provisions proposed in this rule making.

We have overall concern about the ability of any stakeholder to meet the January 2025 timeline especially given that many hospitals and health systems do not have the resources to implement these rules. Hospitals and health systems will need a clear value proposition for what operational effects and improvements will result for end-user clinicians because of these certification requirements. We have further concerns about not seeing the overall picture of effort required in the near future, given that two additional ONC NPRMs are expected to be released in 2023. This makes it more difficult to submit meaningful comments on ONC’s proposed overall regulatory scheme.