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Final Rules Software Cybersecurity

Gardner Law

FDA Finalizes Cybersecurity Premarket Guidance: What It Means for Medical Device Makers

Gardner Law on

The FDA has finalized its guidance on cybersecurity for medical device premarket submissions, providing additional insight into the agency’s expectations for how manufacturers integrate cybersecurity risk management into...more

McDermott Will & Emery

Stark and AKS Final Rules Will Facilitate Donations of EHR and Cybersecurity Technology and Services

McDermott Will & Emery on

On November 20, 2020, the Centers for Medicare and Medicaid Services and Office of Inspector General released final rules amending the regulations to the Stark Law and the Anti-Kickback Statute and Beneficiary Inducement...more

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