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 5, 2025, the final text of the European Health Data Space (EHDS) was published in the EU Official Journal (see here). In April 2024,we wrote several blog posts on EHDS based on a provisional compromise text. We have now updated those to reflect the final version and included references to the correct
In March, the Shanghai Market Supervision Bureau and the Shanghai Medical Products Administrative Bureau jointly issued the “Shanghai Cosmetic Industry Advertising Compliance Guidelines” (“Guidelines”). The Guidelines are based on the national Advertisement Law (as amended 2021) and Cosmetic Labeling Administration Provisions issued by the National Medical Products Administration in 2021. The Guidelines offer practical guidance
On April 15, the U.S. Supreme Court declined a request by Visa and Mastercard to review a D.C. Circuit decision that appeared to add to a circuit split about how lower courts are to determine whether common issues predominate under Federal Rule of Civil Procedure 23(b)(3).
The case, Visa Inc. v. Nat’l ATM Council, Inc.,
On April 17, 2024, the EPA released a final rule designating two perfluorinated chemicals—Perfluorooctanoic Acid (PFOA) and Perfluorooctanesulfonic Acid (PFOS)—as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). EPA also released enforcement guidance explaining how it intends to apply the new listing with respect to certain types of potentially responsible parties.
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
Senate Commerce Committee Chair Maria Cantwell (D-WA) and Senators Todd Young (R-IN), John Hickenlooper (D-CO), and Marsha Blackburn (R-TN) recently introduced the Future of AI Innovation Act, a legislative package that addresses key bipartisan priorities to promote AI safety, standardization, and access. The bill would also advance U.S. leadership in AI by facilitating R&D
A court in the Southern District of New York recently dismissed a lawsuit alleging that an “All Natural” representation on the front label of defendant’s beverage products was false and misleading because the products contained synthetic citric acid and used vegetable and fruit juice concentrates for color. Valencia v. Snapple Beverage Corp., 2024 WL 1158476
On April 16, 2024, the IRS issued fact sheet FS-2024-13 providing answers to frequently asked questions about the tax treatment of work-life referral services provided to employees under an employer’s work-life referral program. The FAQs clarify that, under certain circumstances, the value received from work-life referral services provided to employees through a work-life referral program
Environmental, social, and corporate governance (ESG) initiatives have become increasingly important in today’s business setting. Increased awareness and heightened scrutiny of ESG-related issues, combined with third-party litigation funding, has led to a surge in ESG-related litigation and enforcement actions as consumers, regulators, and investors seek to hold companies accountable for claims about their environmental