Bringing a sophisticated digital health product comprised of a combination of hardware and software to market can be tricky. Meena Datta and Deeona Gaskin advise on how to do so successfully by factoring in FDA marketing and reimbursement pathways, including insurers and employer-sponsored health plans.
The U.S. has issued final guidance on clinical decision support (CDS) software but, in the EU, the treatment is less nuanced and needs clarifying. Ioana Ratescu of Novartis and Eva von Mühlenen, Deeona Gaskin, and Zina Chatzidimitriadou of Sidley explain.
The European Parliament’s provisional agreement on the EU’s AI Act encompasses generative AI and imposes the requirements that are applicable to high-risk AI systems onto general purpose AI. As negotiations continue, Josefine Sommer, Eva von Mühlenen and Zina Chatzidimitriadou explain.
Sidley’s 2023 Global Life Sciences Trendspotting Report maps out seven key trends in the life sciences industry globally, and identifies some regional trends in the U.S., China, and Europe which are likely to have global ramifications during the coming year.
At our recent Digital Health App’ero, Zina Chatzidimitriadou led a discussion with key industry players Aleksandra Appelfeld of Philips and Megan Coder of the Digital Therapeutics Alliance on what changes the industry would like to see in order to make Europe more hospitable to digital health products. We set out the top five themes that emerged, and a space to watch for the next decade.
Sidley’s Eva von Mühlenen in Geneva and Josefine Sommer in Brussels talk to oncologist Wolfgang Hackl — the founder of a FemTech startup that guides doctors in the treatment of breast cancer — about regulation, research and development (R&D), and the vast potential of artificial intelligence in the field of health technology for women. (more…)
Elizabeth Curtin in Chicago and Jonathan Tomlin in London consider why any litigation arising over medtech that uses AI is likely to become complex. They consider how manufacturers of AI can support physicians’ medical judgments and help guard against the danger that they might themselves inadvertently become ‘insurers’ of medical outcomes.
On World Patient Safety Day, Torrey Cope in Washington, D.C., Chen Yang in Beijing, and Olivier Goarnisson in Geneva consider one big pharmacovigilance question raised by the increasingly patient-centric way in which life science companies are doing business today: How to treat the data collected by the apps provided with drugs and devices.