EHRA Urges HHS to Reform "Outdated" Health Record Regulations

The Electronic Health Record Association (EHRA) has urged the U.S. Department of Health and Human Services (HHS) to reform outdated regulations that hinder healthcare innovation, particularly regarding electronic health records (EHRs). In their comments on the HHS's request for information, the EHRA argues that classifying EHR systems as medical devices overlaps regulatory authority and discourages investment in essential health technologies. They specifically call for the rescission of the FDA's 2022 guidance on clinical decision support software, citing that it lacks legal clarity and undermines the goals of the 21st Century Cures Act. By advocating for these changes, the EHRA emphasizes the importance of aligning regulations with contemporary health technology advancements to enhance public health and value-based care efforts.

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