At last week’s America’s Physician Groups Spring conference in San Diego, California, we listened as physicians and health system leaders described the ways in which they are responding to short and long term challenges to the sustainability of America’s healthcare system in its current form. It now stands at a critical juncture, facing challenges such
This digest covers key virtual and digital health regulatory and public policy developments during April and early May 2024.
You will note that France has set out new pricing rates for innovative digital therapeutic medical devices under the accelerated market access pathway, known as PECAN. While the pathway was set out in February 2023, the
Colorado became the first state to adopt a comprehensive AI framework when Gov. Jared Polis signed Senate Bill 205. The law, unlike the EU AI Act, does not ban certain uses of AI. Instead, Colorado focused on accountability; the law adds guardrails designed to prevent discrimination from certain high-risk AI uses and imposes transparency
America’s Seed Fund provides innovation funding for startups and small businesses across technology areas and markets. To discuss U.S. federal funding opportunities and eligibility, contact us at fedtrade@rothwellfigg.com
America’s Seed Fund is a startup innovation funding program of the U.S. National Science Foundation. Its purpose is to provide financial support to technology startups during the
This week in New York, many leading health systems came together for the long-running Not-For-Profit Health Care Investors Conference, now sponsored by Barclays, HFMA and the American Hospital Association. The conference allowed investors and industry observers to take the pulse of the nation’s non-profit health systems and to note some interesting trends.
On 21 May 2024, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published a statement of policy intent (the Statement) setting out its proposals for international recognition of regulatory “approvals” of medical devices. Under the proposed scheme, medical devices will be subject to limited pre-market requirements where they are already “approved” in a trusted
Colorado recently passed a law creating consumer protections for interactions with artificial intelligence systems. The law specifically identifies high-risk systems, including in those that impact health care. The law requires risk mitigation, documentation and robust governance.
Monique N. Bhargava has written an in-depth article on the law and what it means for AI regulation in
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published its strategic approach to artificial intelligence (AI). The publication is in response to the request from the Secretaries of State of DSIT and DHSC dated 1 February 2024, in which the MHRA was asked to provide details about what steps it is taking
In our blog post on 22 February 2024 we reported on the Medicines and Healthcare products Regulatory Agency (MHRA) announcement that it intended to launch a regulatory sandbox for software and AI medical devices called the “AI-Airlock”. The pilot project went live on 9 May 2024, and government sources are citing it as a
Medical technology is evolving every day. What trends are investment banks seeing, and what are some of the capital trends in the medical technology space?
In this episode of The Corner Series, McGuireWoods’ Geoff Cockrell chats with Brian Scullion, senior director, medical technology at William Blair, a boutique multinational investment bank