Bonnie Odom

Bonnie Odom

Epstein Becker & Green

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Sharing Scientific Information with HCPs on Unapproved Uses of Medical Products: Dos and Don’ts Under FDA’s New Draft Guidance

In October 2023, the FDA released draft guidance entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers...more

11/21/2023  /  Food and Drug Administration (FDA) , Health Care Providers , Healthcare , Information Sharing , Life Sciences , Medical Devices , Pharmaceutical Industry

Podcast: DOJ Goes After Civil Cyber-Fraud - Diagnosing Health Care [Video]

How does the U.S. Department of Justice (DOJ) intend to leverage its enforcement authority under the False Claims Act to advance DOJ’s recently announced Civil Cyber-Fraud Initiative? In this episode of Diagnosing Health...more

3/31/2022  /  Cybersecurity , Department of Justice (DOJ) , Electronic Protected Health Information (ePHI) , Enforcement Authority , False Claims Act (FCA) , Fraud , Health Care Providers , Risk Mitigation
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