Covington Digital Health

Developments and Trends in Digital Health, eHealth and Health IT

On Friday, April 26, 2024, the Federal Trade Commission (“FTC”) voted 3-2 to issue a final rule (the “final rule”) that expands the scope of the Health Breach Notification Rule (“HBNR”) to apply to health apps and similar technologies and broadens what constitutes a breach of security, among other updates.  We previously covered the proposed

On April 22, 2024, the European Federation of Pharmaceutical Industries and Associations (“EFPIA”) issued a statement on the application of the AI Act in the medicinal product lifecycle. The EFPIA statement highlights that AI applications are likely to play an increasing role in the development and manufacture of medicines.  As drug development is already governed

In early March 2024, the EU lawmakers reached agreement on the European Health Data Space (EHDS).  For now, we only have a work-in-progress draft version of the text, but a number of interesting points can already be highlighted. This article focuses on the implications for “wellness applications” and medical devices; for an overview of the EHDS

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) across the medical product life cycle.  The paper, entitled “Artificial Intelligence & Medical Products:

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 this blog series (see here), we discussed the first section of Senator Cassidy’s February

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,” which proposes several updates to the privacy protections for health data. This follows Senator Cassidy’s

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 Insurance Portability and Accountability Act of 1996, as amended, and its implementing regulations (collectively, “HIPAA”)