Medical Device Legal News with Sam Bernstein: Episode 11
On August 21, the National Institute of Standards and Technology (NIST) released the second draft of its revised Digital Identity Guidance, which NIST first published in 2004 and last revised in 2017. The draft guidance...more
The Department of Commerce released three final guidance documents incorporating public comments from earlier this spring which provide recommendations for managing AI risk, securing AI software development processes, and...more
European Data Protection Board Publishes Strategy for 2024-27 - The European Data Protection Board (“EDPB” - the EU body tasked with promoting consistency and cooperation in enforcement of the GDPR) has outlined its...more
As artificial intelligence technology evolves on a seemingly minute-by-minute basis, the U.S. FDA’s regulatory approach continues to evolve in an effort to keep pace. “The promise of artificial intelligence in medicine is...more
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
On April 8, 2022, FDA issued new, long-awaited draft guidance “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (Draft Cybersecurity Guidance). 1 This draft guidance...more
As anticipated, on January 10, 2020, the Department of Justice (DOJ) and the Federal Trade Commission (FTC) (collectively, the Agencies) released Draft Vertical Merger Guidelines (Draft Guidelines), marking the first update...more
In this month's edition of our Privacy & Cybersecurity Update, we take a look at guidance on artificial intelligence released by the U.K. Information Commissioner's Office and the Turing Institute, as well as guidance...more
This week in Washington: The House and Senate are out for Thanksgiving recess this week. Congress - Hearings/Markups - House Committee on the Judiciary: “The Patent Trial and Appeal Board and the Appointments Clause:...more
ESMA published a consultation (the “Consultation”) on draft guidelines for UCITS performance fees (the “Draft Guidelines”) on the 16 July 2019. The objective of the Consultation is to obtain stakeholder feedback on the...more
On May 21, 2019, the Ministry of Economy, Trade and Industry ("METI"), Japan Fair Trade Commission ("JFTC") and Ministry of Internal Affairs and Communications ("MIC") jointly published reports that provide options for...more
The Association of Air Pollution Control Agencies (“AAPCA”) submitted October 31st comments on the United States Environmental Protection Agency’s (“EPA”) Draft FY 2018 – 2022 Strategic Plan (“Plan”). EPA states the Plan...more