subject to change
All times are in Eastern Time

Tuesday, November 9

4:00 – 4:40 PM
FDLI Welcome, Introductions, and Keynote Address
Amy Comstock Rick, President & CEO, FDLI
Andi Lipstein Fristedt, Deputy Commissioner for Policy, Legislation, and International Affairs, FDA

4:45–5:45 PM
Congressional Perspectives in Digital Health
Remy L. Brim, Principal, BGR Government Affairs, LLC
Santiago Gonzalez, Senior Policy Advisor, Office of U.S. Senator Michael Bennet
Aliza Fishbein Silver, Senior Health and Oversight Counsel, Senate Committee on HELP
Grace Stuntz Graham, Chief Health Counsel, House Energy & Commerce Health Subcommittee, U.S. House of Representatives
Moderated by Stacy Cline Amin, Partner, Morrison & Foerster LLP

Under the 21st Century Cures legislation, there are five categories of software excluded from the definition of a “device”. What was the intent of these provisions, where is FDA on implementing these carveouts, and is FDA taking actions intended under the legislation? If not, what can or should FDA be doing differently? During this session, speakers will discuss these topics, whether FDA has the authority needed to properly regulate new technologies, their perspectives on recent and upcoming legislation, and more.

Wednesday, November 10

11:00 AM – 12:00 PM
FDLI Welcome
Laura Brown, Director of Educational Programs, FDLI

FDA’s Digital Health Center of Excellence: Working with the FDA on Digital Health
Zac Henderson, Head of Legal, Levels Health
Diane Johnson, Senior Director, Strategic Regulatory, Medical Devices & Diagnostics, Johnson & Johnson
Bakul Patel, Director, Digital Health Center of Excellence, CDRH, FDA
Moderated by Shelby Buettner, Principal Legal Counsel, Medtronic

A year into its inception, what activities have been undertaken by FDA’s Digital Health Center of Excellence? Speakers will discuss the Center’s goals and priorities, whether they changed over the past year, and areas of frustration or challenge for FDA or stakeholders. Speakers will also discuss perspectives on how industry can work with FDA to facilitate goals and address challenges.

12:15–1:00 PM
Artificial Intelligence and Machine Learning: Product Development, Regulation and FDA’s Action Plan
Matthew Diamond, Chief Medical Officer, Digital Health Center of Excellence, CDRH, FDA
Sally Howard, Vice President, Regulatory, External Affairs, & Quality, Adaptive Biotechnologies Corp.
Cassie Scherer, Director or Regulatory Policy, U.S., Medtronic
Moderated by
Nathan A. Brown, Partner, Akin Gump Strauss Hauer & Feld LLP

1:00–1:20 PM

1:20–2:05 PM
Clinical Investigations: Utilizing Software and Digital Health Tools
Nicholas Benetatos,  Senior Managing Consultant, Exponent, Inc.
Rasika Kalamegham, Head, US Regulatory Policy, Genentech, Inc.
Anindita (Annie) Saha, Assistant Director, Digital Health Center of Excellence, CDRH, FDA

This panel will address remote monitoring in clinical investigations, different forms of monitoring, increased use of digital platforms in clinical investigations, including how the technology is regulated, and whether the use of digital tools can facilitate more representative clinical populations. This session will also include a discussion of novel outcome assessments as well as the associated challenges with their use.

2:15–3:00 PM
Telehealth 2021: Regulatory and Reimbursement Developments
Bethany Hills, Partner, Co-lead FDA Regulatory and Compliance Practice Morrison and Foerster, LLP
Lidia Niecko-Najjum, Counsel, Crowell & Moring LLP
Moderated by Kyle Thomson, Senior Legislative Counsel, American Medical Association

COVID-19 greatly accelerated the use of telehealth and related digital tools. While industry is likely to continue to build on the inroads made during COVID-19, and virtual healthcare is likely to continue to accelerate there are many challenges to navigate in the post-pandemic landscape. This panel will discuss allowances under current legal and regulatory flexibilities for coverage and reimbursement during the COVID-19 public health emergency, what is likely to change as the public health emergency is lifted, and risks and best practices for industry moving forward.

3:15–4:15 PM
Cybersecurity vs. Interoperability:  Understanding How They Interrelate and Managing Risk
Jodi G. Daniel
, Partner, Crowell & Moring LLP
Aftin Ross, Senior Special Advisor for Emerging Initiatives, Office of Strategic Partnerships and Technology Innovation, CDRH, FDA
Moderated by Charlene Cho, Senior Counsel, Medical Devices, Global Regulatory Legal Team, Johnson & Johnson

While seemingly conflicting, the dual goals of cybersecurity and interoperability can both be achieved. This panel will address the unique aspects of each goal, and how they can be thought of as extensions of each other as information is safely and securely exchanged and utilized to increase efficiency in patient care. Best practices and areas of risk will also be discussed, including potential cybersecurity vulnerabilities in data sharing, data flow, and remote monitoring; who is responsible for managing risk through the total product lifecycle; and recordkeeping responsibilities.

4:30–5:30 PM
Enforcement Trends and Risks for Digital Health Products
Michele L. Buenafe, Partner, Morgan, Lewis & Bockius LLP
John Claud, Assistant Director, Consumer Protection Branch, DOJ
Fred Medick, Senior Corporate Counsel, Healthcare Law Group, Genentech, Inc.
Moderated by Wade Ackerman, Partner, Covington & Burling LLP

This panel will address areas of enforcement risk for companies in the digital health space – regardless of whether they are currently regulated by the FDA. Speakers will discuss recent FDA actions, including “it has come to our attention” letters and Warning Letters, FTC activities in the software space, and recent DOJ cases and settlements. Topics such as safeguarding data, falsification of data or improper validation during the clinical trial phase, and potential risks associated with clinical decision support software will also be discussed.

5:30 PM
Closing Remarks and Adjournment