NCHR Comments on Changes to Medical Software Policies Due to 21st Century Cures Act

February 15, 2018. The draft guidance Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act removes FDA evaluation of EHRs and leaves only certification by the Office of the National Coordinator for Health Information Technology (ONC) to ensure that software is both functional for providers and safe for patients. However, ONC certification is not sufficient to protect patients from problems with EHR software.   For that reason, the draft guidance as written puts patients’ lives at risk.

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