On March 15, 2024, FDA’s medical product centers – CBER, CDER, and CDRH – along with the Office of Combination Products (OCP) published a paper outlining their key areas of focus for the development and use of artificial intelligence (AI)
Covington Digital Health, published by Covington & Burling LLP, focuses on legal and regulatory developments at the intersection of digital health, biotechnology, and life sciences. The blog covers topics such as regulatory compliance for AI-enabled medical devices, data protection and privacy in clinical trials, FDA policies on digital therapeutics and health technology, and innovations in healthcare data interoperability. It also addresses emerging issues related to artificial intelligence in healthcare, real-world evidence generation, and the evolving regulatory landscape for digital health technologies. The blog serves as a resource for companies navigating complex legal frameworks in digital health and life sciences sectors.
On March 15, 2024, FDA’s medical product centers – CBER, CDER, and CDRH – along with the Office of Combination Products (OCP) published a paper outlining their key areas of focus for the development and use of artificial intelligence (AI)…
On March 11, 2024, the UK Government published its response (“Government Response”) to an independent review on equity in medical devices commissioned by the Department of Health and Social Care (“Review”). The Government Response is not guidance nor policy rather…
Senator Bill Cassidy (R-LA), the Ranking Member of the U.S. Senate Health, Education, Labor, and Pensions (“HELP”) Committee, published on February 21, 2024, a white paper with various proposals to update privacy protections for health data. In Part 1 of…
On February 21, 2024, Senator Bill Cassidy (R-LA), the Ranking Member of the U.S. Senate Health, Education, Labor, and Pensions (“HELP”) Committee, issued a white paper, “Strengthening Health Data Privacy for Americans: Addressing the Challenges of the Modern Era,”…
On February 16, 2024, the U.S. Department of Health and Human Services (“HHS”) published a final rule to amend the Confidentiality of Substance Use Disorder (“SUD”) Patient Records regulations (“Part 2”) to more closely align Part 2 with the Health…
On December 5, 2023, the Spanish presidency of the Council of the EU issued a declaration to strengthen collaboration with Member States and the European Commission to develop a leading quantum technology ecosystem in Europe.
The declaration acknowledges the revolutionary…
Earlier today, the White House issued a Fact Sheet summarizing its Executive Order on a comprehensive strategy to support the development of safe and secure artificial intelligence (“AI”). The Executive Order follows a number of actions by the Biden Administration…
On September 15, the Federal Trade Commission (“FTC”) and U.S. Department of Health and Human Services (“HHS”) announced an updated joint publication describing the privacy and security laws and rules that impact consumer health data. Specifically, the “Collecting, Using…
On September 6, Senator Bill Cassidy (R-LA), the Ranking Member of the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee, issued a white paper about the oversight and legislative role of Congress related to the deployment of artificial intelligence…