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HIMSS weighs in on FDA software pre-cert program
Healthcare IT News: The FDA's software precertification program aims to take a new approach to regulation for a health technology space that's evolving at dizzying speed. It's meant to offer a voluntary pathway that can keep tabs on the safety and efficacy of new software and devices without stifling innovation or hindering patient access.
For vendors that have demonstrated an ongoing "culture of quality and organizational excellence," FDA is exploring ways to take a lighter regulatory approach toward mobile apps meant to treat, diagnose, cure, mitigate or prevent disease – technology it calls software as a medical device, or SaMD.
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