The HIMSS Electronic Health Record Association has responded to a new request for information from the U.S. Department of Health and Human Services, seeing it as a critical opportunity to examine regulations that don't reflect current technology or market realities, and to correct "misaligned" approaches to rulemaking.
The EHRA submitted comments about its reform and deregulatory priorities to the HHS in response to its RFI, "Ensuring Lawful Regulation and Unleashing Innovation To Make America Healthy Again Request for Information."
WHY IT MATTERS
The coalition of health technology vendors has long held that an expansion of Food & Drug Administration oversight of medical device regulation to technology already subject to oversight through the Office of the National Coordinator for Health Information Technology Certification Program is beyond the statutory boundaries of the 21st Century Cures Act.
"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's position is that EHR systems should not be regulated as medical devices, and certain guidance issued in 2022 is having "a chilling effect on developers' willingness to invest" in tools needed to support public health and value-based care programs.
"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Instead, the EHR Association said the FDA should "reinstate or revise the 2019 draft guidance" to "explicitly exclude CDS functionality embedded in certified EHRs" and eliminate new regulatory constructs, including time-critical decision-making and automation bias, introduced in the latest guidance.
The trade organization also said other HHS regulations and policies also fall within the deregulatory scope outlined in the Trump administration's Executive Order 14212.
These include clarifying Predetermined Change Control Plans requirements, addressing bias in classifying products as devices that impose user fees, modifying outdated HIT certification testing tools and better defining certain interoperability requirements.
The organization also urged HHS to clarify electronic case reporting requirements – automated reporting of public health conditions, including chronic disease indicators – and "provide adequate funding and technical support" for the Centers for Disease Control and state, tribal, local and territorial authorities.
"Instead of deregulation in this case, success relies on stability, coordination and capacity building," the EHR Association said.
THE LARGER TREND
The FDA said in January that while it is committed to deploying new medical devices faster, it will take a science-based approach to its requirements for medical devices powered by artificial intelligence and machine learning.
Then, in April, the Assistant Secretary for Technology Policy updated guidance that healthcare organizations use to assess and optimize the safety of their EHRs. The 2025 Safety Assurance Factors for EHR Resilience Guides contain CURES Act revisions, including the use of AI for clinical care, cybersecurity and integration of FDA-approved medical device data into EHRs.
ON THE RECORD
"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 EHRA said in its letter. "The recommendations in this response reflect the practical realities our member companies face in delivering high-quality, interoperable and patient-centered digital health tools."
Andrea Fox is senior editor of Healthcare IT News.
Email: afox@himss.org
Healthcare IT News is a HIMSS Media publication.
