News & Analysis as of

Federal Food Drug and Cosmetic Act (FFDCA) Data Collection

Gardner Law

Med-Tech Meets High-tech: Privacy, Cybersecurity and Ai in Connected Devices

Gardner Law on

...Innovation in connected medical devices is critical to advances in health care outcomes, user experience, and reducing costs. These exciting technologies also can be challenging when it comes to navigating the complex...more

Foley Hoag LLP

Information Collection Request for Drug Price Negotiation Program Data Elements

Foley Hoag LLP on

On March 21, 2023, CMS published in the Federal Register the Information Collection Request (ICR) Form, as required by the Paperwork Reduction Act, for Negotiation Data Elements under Sections 11001 and 11002 of the Inflation...more

Morgan Lewis

FDA Clarifies Policy for Sharing Patient-Specific Data from Devices

Morgan Lewis on

Device manufacturers may share patient-specific information from a device with the patient without violating federal privacy requirements....more

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