Manufacturers, Data Security, Medical Devices

Navigating HIPAA and State Privacy Laws for Drug and Device Manufacturers

Gardner Law on 6/12/2024

The Health Insurance Portability and Accountability Act of 1996 as amended and implemented through regulations at 45 C.F.R. §§ 160 and 164 (“HIPAA”) regulates the privacy and security of health information. For drug and...more

New WA Privacy Law ‘Turns The Beat Around’ on Drug and Device Makers

Gardner Law on 6/14/2023

The Washington My Health My Data Act ("MHMDA") may not have been written by Earth, Wind, & Fire, but it is certainly poised to make medical device and pharmaceutical manufacturers move to a new beat like a classic disco hit....more

“Remanufacturing” or “Servicing”? New FDA guidance clarifies distinction for medical devices

Hogan Lovells on 6/23/2021

On June 18, 2021, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Remanufacturing of Medical Devices,” which aims to help clarify the point when manipulation or repair of a medical device becomes...more

FDA Issues New Draft Cybersecurity Guidance for Medical Devices

Sheppard Mullin Richter & Hampton LLP on 11/30/2018

The Food & Drug Administration has recently released for comment a draft expansion of guidance regarding Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Although the FDA issued existing...more

FDA, DHS Increase Coordination Over Medical Device Cybersecurity Risks to Patient Safety

Holland & Knight LLP on 10/19/2018

The U.S. Food and Drug Administration (FDA) is moving aggressively in the month of October to continue to raise concerns about cybersecurity risks to medical devices, with three recent updates. The FDA just released new draft...more

Manufacturers › Data Security › Medical Devices

Navigating HIPAA and State Privacy Laws for Drug and Device Manufacturers

New WA Privacy Law ‘Turns The Beat Around’ on Drug and Device Makers

“Remanufacturing” or “Servicing”? New FDA guidance clarifies distinction for medical devices

FDA Issues New Draft Cybersecurity Guidance for Medical Devices

FDA, DHS Increase Coordination Over Medical Device Cybersecurity Risks to Patient Safety

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