Health Insurance Portability and Accountability Act (HIPAA), Manufacturers, Food and Drug Administration (FDA)

Why Every Manufacturer Needs a Robust Information Security Program

Gardner Law on 7/31/2025

Drug and device manufacturers are increasingly targeted by cyber threats that can compromise patient safety, intellectual property, and other critical data and systems, while also facing new regulatory demands. As regulators...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

eDiscovery and Life Sciences Industry - Challenges and Solutions

Ankura on 5/5/2023

The life science industry is a significant contributor to the global market, with companies developing and manufacturing a wide range of medical products and devices. However, due to the complex and highly regulated processes...more

Transatlantic Legal-Regulatory Update: Live from the Heart of Silicon Valley

Gardner Law on 12/2/2022

US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more

FDA Strives to Adapt Regulatory Approach to Rapidly Evolving Digital Health Space

Skadden, Arps, Slate, Meagher & Flom LLP on 6/20/2018

Just two months after taking office, in July 2017, Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced the agency’s Digital Health Innovation Action Plan, which recognized that “digital technology has...more

21st Century Cures: A Closer Look

McDermott Will & Schulte on 1/21/2017

On December 7, 2016, the US Congress enacted the 21st Century Cures Act, substantial legislation intended to accelerate “discovery, development and delivery” of medical therapies by encouraging biomedical research investment,...more

FDA Issues Draft Guidance on Dissemination of Patient-Specific Information from Devices

Knobbe Martens on 7/5/2016

On June 10, 2016, the U.S. Food and Drug Administration (FDA) issued a draft guidance advising manufacturers on appropriate and responsible dissemination of patient-specific information from medical devices....more

FDA Clarifies Policy for Sharing Patient-Specific Data from Devices

Morgan Lewis on 6/15/2016

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

HIPAA/HITECH Compliance Strategies for Medical Device Manufacturers

Sheppard Mullin Richter & Hampton LLP on 8/21/2013

As computing power continues to become cheaper and more powerful, medical devices are increasingly capable of handling larger and larger sets of data. This provides the ability to log ever expanding amounts of information...more

Health Insurance Portability and Accountability Act (HIPAA) › Manufacturers › Food and Drug Administration (FDA)

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