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Federal Food Drug and Cosmetic Act (FFDCA) EHR

Akin Gump Strauss Hauer & Feld LLP

The 21st Century Cures Medical Software Provisions: Additional Clarity for Digital Health, but Also More Questions

Key Points - - Although the Cures medical software provisions largely align with FDA's current policies, certain of the Cures exemptions may be broader than those under current agency policy. - Many clinical...more

Dorsey & Whitney LLP

Medical Software and the 21st Century Cures Act

Dorsey & Whitney LLP on

The 21St Century Cures Act, Pub. L. No. 114-255, 130 Stat. 1033, was signed into law on December 13, 2016. This expansive statute addresses topics ranging from investigational drug clinical trial design, mental health...more

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