EHR Association Urges HHS to Address Regulatory Conflicts and Clarify Healthcare Tech Rules

The HIMSS Electronic Health Record Association has submitted comprehensive comments to the U.S. Department of Health and Human Services, identifying critical regulatory misalignments that the organization believes are hampering innovation in healthcare technology. The submission, responding to HHS's "Ensuring Lawful Regulation and Unleashing Innovation To Make America Healthy Again Request for Information," outlines specific areas where current regulations fail to reflect technological realities or market conditions.

Central to EHRA's concerns is the expansion of Food and Drug Administration oversight into areas already regulated by the Office of the National Coordinator for Health Information Technology Certification Program. The association maintains this dual oversight exceeds the statutory boundaries established by the 21st Century Cures Act and creates unnecessary regulatory burden for technology developers.

"As the federal government seeks to modernize its regulatory approach and support innovation across healthcare, we urge HHS to focus on clarity, alignment with statutory intent and the elimination of low-value or duplicative regulatory requirements," the EHR Association said in its July 14 comment letter.

The organization specifically targets FDA's 2022 Final Guidance on Clinical Decision Support Software, arguing it has created "a chilling effect on developers' willingness to invest" in essential tools for public health and value-based care programs. EHRA contends the guidance conflicts with principles outlined in Executive Order 14219, lacking statutory grounding while introducing legal ambiguity, imposing excessive costs, and deterring innovation.

"The EHR Association urges HHS to rescind the FDA's Final Guidance on Clinical Decision Support Software, which clearly conflicts with the seven principles outlined in Executive Order 14219," the organization said. "Most notably, the guidance lacks statutory grounding, introduces legal ambiguity, imposes excessive costs and deters innovation."

Instead, EHRA recommends reinstating or revising the 2019 draft guidance to explicitly exclude CDS functionality embedded in certified EHRs and eliminate regulatory constructs such as time-critical decision-making and automation bias introduced in the current guidance.

Beyond CDS concerns, the association identified additional areas requiring attention, including clarifying Predetermined Change Control Plans requirements, addressing bias in product classification that triggers user fees, modernizing outdated HIT certification testing tools, and better defining interoperability requirements.

The organization also emphasized the need for clarity regarding electronic case reporting requirements for automated public health condition reporting. EHRA urged HHS to "provide adequate funding and technical support" for the Centers for Disease Control and state, tribal, local and territorial authorities, noting that "Instead of deregulation in this case, success relies on stability, coordination and capacity building."

"The recommendations in this response reflect the practical realities our member companies face in delivering high-quality, interoperable and patient-centered digital health tools," the EHRA stated, positioning its recommendations as essential for fostering innovation while maintaining appropriate oversight in the evolving healthcare technology landscape.

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