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General Data Protection Regulation (GDPR) › Food and Drug Administration (FDA)

Follow this channel for updates and analysis on all aspects of the European Union's General Data Protection Regulation, a reform of EU's data protection rules that impacts... more +
Follow this channel for updates and analysis on all aspects of the European Union's General Data Protection Regulation, a reform of EU's data protection rules that impacts individuals throughout the Union and all businesses operating therein. less -
Gardner Law

AI Regulation and Legal Trends in the U.S and Abroad

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The Evolving Role of AI/ML in Healthcare - The use of artificial intelligence/machine learning (AI/ML) in healthcare is evolving rapidly and introducing new challenges. Not only are medical devices using AI for diagnostics,...more

Gardner Law

Effective Clinical Trial Agreements: What You Need to Know

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Clinical trial agreements (CTAs) form the foundation of any clinical research initiative, establishing the legal and operational framework essential for a study's success. Crafting, reviewing, and negotiating CTAs require...more

Mintz - Health Care Viewpoints

OHRP Workshop Highlights Artificial Intelligence Uses, Concerns in Human Research

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The Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) recently held its 2024 Exploratory Workshop titled “The Evolving Landscape of Human Research with AI – Putting Ethics to Practice”...more

Jones Day

Vital Signs: Digital Health Law Update | Spring 2024

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Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on recent developments in the U.S. Food and Drug Administration's ("FDA") regulatory...more

Gardner Law

FDA Regulatory, Compliance, and Privacy Due Diligence — Finding Your Goldilocks Zone

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When conducting due diligence of an FDA-regulated company, there are several important questions that should be posed. These include questions relating to regulatory, compliance, and privacy matters. For example, questions...more

Gardner Law

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

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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

Ankura

eDiscovery and Life Sciences Industry - Challenges and Solutions

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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

Sheppard Mullin Richter & Hampton LLP

Eye On Privacy: 2021 Year in Review

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Just as we thought 2022 was going to be significantly different than 2021, December 2021 and January 2022 events have thrown us for another (pandemic) loop. We anticipate that some of the privacy and cybersecurity...more

MoFo Life Sciences

Global Healthtech CEO Connect: Software As A Medical Device In The U.S. And EU Recap

MoFo Life Sciences on

On Friday, March 26, 2021, over 180 attendees worldwide attended McKinsey & Company’s first Global HealthTech CEO Connect of 2021. The discussion focused on regulatory and legal considerations for software as a medical device...more

Arnall Golden Gregory LLP

I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Data Privacy Issues Life Sciences Companies May Encounter

Arnall Golden Gregory LLP on

In this episode, AGG’s Food & Drug team leader, Alan G. Minsk, and co-chair of AGG's Data Privacy practice, Kevin L. Coy, discuss U.S. and international privacy and data security law issues life sciences companies may...more

Skadden, Arps, Slate, Meagher & Flom LLP

Protecting Lives Without Destroying Jobs — Using Technology To Suppress COVID-19

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Many countries around the world are being forced to watch as the only tool they have to suppress COVID-19 — social distancing — causes unprecedented damage to their economies. Because suppression measures may be required...more

Hogan Lovells

Life Sciences and Health Care Horizons - 2020

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We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more

Jones Day

Jones Day Global Privacy & Cybersecurity Update | Vol. 24

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UNITED STATES - Regulatory—Policy, Best Practices, and Standards - FTC Submits Comment on the Preliminary Draft for the NIST Privacy Framework - On October 24, 2019, the Federal Trade Commission ("FTC") announced that...more

Akin Gump Strauss Hauer & Feld LLP

MedTech Update 2020: Legal and Regulatory Issues to Watch For in the Medical Technology Industry in the New Year

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Medical device and diagnostics companies and laboratories should anticipate significant legal, regulatory and market changes in 2020 that will have a lasting impact on the industry. From revisions to how the government...more

Morgan Lewis

Life Science International Review Q3 - Nov. 2019

Morgan Lewis on

Welcome to the Q3 2019 issue of our Life Sciences International Review. This issue covers new developments within Europe, Asia, and the United States in intellectual property, regulatory, pricing, and international trade,...more

Skadden, Arps, Slate, Meagher & Flom LLP

A Dialogue With Corporate Counsel: Skadden’s Eighth Annual Pharmaceutical and Medical Device Seminar

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On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more

Hogan Lovells

Best practices for managing cybersecurity risks related to IoT-connected medical devices

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Connected medical devices deliver numerous benefits not available before, including improved monitoring of patient welfare and a wealth of vital data. But for all the advantages available through these devices, their...more

Alston & Bird

Cyber Alert: 2016 Breach Roundup, Part II: U.S. and EU Data Breach Notification Regulations Highlights and Trends

Alston & Bird on

Frameworks requiring breach notifications of various kinds significantly expanded in scope in 2016 at both the state and federal levels. However, at least in the U.S., some of the new federal requirements may not be in place...more

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