Foley Special Counsel Kyle Faget, member of the firm’s Health Care, Digital Health, and Telemedicine Industry Team, will be presenting during the Food Drug Law Institute’s “Digital Health Technology and Regulation During COVID-19 and Beyond” virtual event on September 10th. Her panel is titled “Regulation of Digital Health During and After COVID-19,” and will take place at 12:05 p.m. ET. She will be joined by Michele Buenafe (Partner, Morgan, Lewis & Bockius LLP), Megan Coder (Executive Director, Digital Therapeutics Alliance), and Kellie Combs (Partner, Ropes & Gray LLP).
The session will discuss and compare the traditional approval pathways available for software-as-medical device products, as well as significant enforcement discretion policies and exemptions, both pre-and post-COVID-19. The panel will examine how FDA’s enforcement trends during COVID-19 have expanded beyond previously delineated requirements for products such as digital health therapeutic devices for psychiatric conditions, and whether those trends are likely to continue beyond the COVID-19 pandemic. The impact of increased funding for telehealth and remote patient monitoring tools under the CARES Act will also be discussed.
To find out more, or register for the webinar, click here.
09 April 2024 Events
Lunch and Learn: Preparing for Your Future Business Transition
Foley & Lardner LLP and Journey Consulting are partnering to offer an exclusive, small intimate group Lunch & Learn interactive roundtable discussion on April 9, 2024.
21 May 2024 Events
Strategies for Working with and Discharging Homeless Populations
On May 21, Foley partners Anil Shankar, Adam Hepworth, and Claire Marblestone are speaking in one of Hospital Association of Southern California’s 2024 Annual Meeting Breakout Sessions. Their presentation is titled “Strategies for Working with and Discharging Homeless Populations.”
21 February 2024 Legal News: Employee Benefits Insights
Diving Into SECURE 2.0: IRS Issues Guidance to Expand Access to 401(k) Savings for Long-Term Part-Time Employees
In this article, we discuss the proposed regulations that were recently published, covering SECURE 2.0’s expanded access to 401(k) plan savings for certain long-term part-time employees.