CeBIL co-organizes 2020 Petrie-Flom Center Conference at Harvard Law School
Innovation and Protection: The Future of Medical Device Regulation
The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2020 annual conference: “Innovation and Protection: The Future of Medical Device Regulation.” This year’s conference is organized in collaboration with Timo Minssen, University of Copenhagen’s Center for Advanced Studies in Biomedical Innovation Law (CeBIL); Nicholson Price, University of Michigan School of Law; and Christopher Robertson, James E. Rogers College of Law of the University of Arizona. This year’s conference is organized in collaboration with the University of Copenhagen’s Center for Advanced Studies in Biomedical Innovation Law (CeBIL) and the University of Arizona Health Law Program.
Medical devices have historically been less regulated than their drug and biologic counterparts, both before and after coming to market. A benefit of this less demanding regulatory regime is facilitating innovation by making new devices available to consumers in a timely fashion. Nevertheless, there is increasing concern that this approach raises serious public health and safety issues.
Furthermore, there is increased awareness that the nature of medical devices is rapidly changing as the market shifts from hardware-only devices to increasing numbers of hybrids of hardware and software, or even software as a medical device (SaMD).
New regulations in the EU and the experiences of the FDA in the United States suggest that medical device regulation overall faces some global challenges, including the correct balance between patient protection and avoiding stifling business and innovation, the changing nature of medical devices to become increasingly software-based, and the difficulties of post-market surveillance. This conference will explore how these concerns can be expressed and successfully addressed in a variety of countries, each with a different medical device market.