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Protected Health Information › Federal Food Drug and Cosmetic Act (FFDCA)

King & Spalding

FDA Issues Final Rule Permitting IRB Waiver or Alteration of Informed Consent for Certain Minimal Risk Clinical Investigations

King & Spalding on

The Food and Drug Administration (FDA) has issued a final rule, Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations, which allows an exception from the requirement to...more

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

Ankura

FDA Authorized to Establish New Cybersecurity Standards for Medical Devices: What it Means for Industry

Ankura on

On December 29, 2022, President Biden signed a new statute that will significantly impact medical device cybersecurity regulation. Section 3305 of the Consolidated Appropriations Act of 2023 (“Section 3305”) authorizes the...more

Robinson+Cole Data Privacy + Security Insider

FTC, ONC, OCR and FDA release online tool for mobile health app developers

Robinson+Cole Data Privacy + Security Insider on

While attending the International Association of Privacy Professionals annual global event, and listening to Chairwoman Edith Ramirez discuss the Federal Trade Commission’s (FTC) concerns about consumer privacy, the FTC, the...more

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