Artificial intelligence continues to be one of the most talked about business trends. Many of the AI technologies that health care and life sciences companies are adopting are largely untested from a legal perspective, creating gray areas that regulatory agencies are grappling with. AI innovations also offer opportunities for competitive advantage through the strategic management of intellectual property rights.
Telemedicine companies are preparing for heightened regulatory scrutiny of advertising on social media platforms while seeing an overall shift from direct-to-consumer to third-party reimbursement models. On the provider front, established health care systems are increasingly entering into joint ventures with technology-enabled health care platform startups to evolve and innovate.
Pharmaceutical companies are bracing for what could be a sea change in the “deference, supremacy, preemption” paradigm while cosmetics manufacturers are facing increased FDA regulatory requirements under the Modernization of Cosmetics Regulation Act of 2022. The FDA also continues to demonstrate a commitment to expanding diversity in clinical trials with a focus on the recruitment of diverse clinical trial participants.
Download Full Report
Lea Gulotta James, Claire Marblestone, James W. Matthews, Alexandra B. Maulden, Elizabeth P. Nevle, Catilin N. Otis, Susan E. Pravda, David L. Rosen. Anil Shankar, Jordan H. Smiley, Morgan J. Tilleman, and Adria Warren contributed to this article.