All times listed are in Eastern time.

Wednesday, November 30

4:00–4:40 PM
FDLI Welcome, Introductions, and Keynote Address
Christine Simmon
, President & CEO, Food and Drug Law Institute
Sonja Fulmer
, Acting Deputy Director, Digital Health Center of Excellence, FDA

4:45–5:45 PM
Digital Health and Privacy Roundtable
Aliza Fishbein Silver, Senior Health and Oversight Counsel, Senate Committee on HELP
Robert Jarrin, Strategic Advisor, Omega Concern LLC
René Quashie, Vice President, Digital Health at the Consumer Technology Association (CTA)
Moderated by Nathan A. Brown, Partner, Akin Gump Strauss Hauer & Feld

As the digital health market has grown, the challenges to fully leveraging digital health solutions have become clearer. Privacy and security of patient data have become a focus of legislative, regulatory, and interest group action. Coverage and reimbursement for digital health services and technologies have lagged behind their availability, and regulation of digital health remains in flux. Panelists will discuss these challenges and what barriers exist to progress at the federal and state level. Panelists will also address potential policy changes in these areas and look ahead to the next Congress for potential changes to law, including the Cures 2.0 Act and the PREVENT Pandemics Act.

Thursday, December 1

11:00 AM–12:00 PM
FDLI Welcome and Panel Discussion

FDLI Welcome
Laura Brown, Director of Educational Programs, FDLI

Regulatory and Enforcement Trends and Challenges in Digital Health
Gabriel Scannapieco, Assistant Director & Digital Assets Coordinator, US Department of Justice
Ariel Seeley, Associate Director, Regulatory Documents and Special Projects, Office of Policy, CDRH, FDA
Ronnie Solomon, Attorney, Division of Privacy and Identity Protection, FTC
Moderated by Kellie B. Combs, Partner, Ropes & Gray LLP

Digital healthcare companies are leading the revolution in consumer healthcare, which comes with challenges. Complying with federal, state, and local regulators, each with different mandates and priorities, can expose companies to increased risks. This panel will discuss current regulatory and enforcement trends, including the Federal Trade Commission’s (FTC’s) oversight over tracking data and the potential for exposure of patient visits and medical appointments, Department of Justice (DOJ) enforcement of health care fraud, including telehealth, and how the Food and Drug Law Administration (FDA) works with FTC and DOJ to enforce and regulate in this space. Panelists will also discuss available measures to safeguard data and prevent data breaches.

12:15–1:00 PM
Wearables: Developments and Legal Strategies
Wade Ackerman, Partner, Covington & Burling LLP
Marni Hall, VP & GM Regulatory Science & Strategy, IQVIA
Jonelle Saunders, Associate Product Counsel, Google Health
Moderated by Bethany Hills, Partner, DLA Piper LLP (US)

Technologies and innovations in the wearables sector, such as smartwatches performing medical-grade electrocardiograms, have positive implications for patient care but also consequences for regulation and the allocation of liability when the product fails to detect health risks that result in patient harm. This panel will provide an overview of wearables technologies and discuss challenges and risks that occur with wearables, such as safety hazard detection failure, personnel management, privacy, data concerns, and compliance. Panelists will also discuss legal implications associated with wearable technologies, such as the appropriate use of data, data control, and unique liability risks.

1:00–1:10 PM

1:10–2:05 PM
Artificial Intelligence and Machine Learning: Regulatory Considerations
Scott Danzis, Partner, Covington & Burling LLP
Matthew Diamond, Chief Medical Officer, Digital Health Center of Excellence, FDA
Cybil Roehrenbeck, Partner, Hogan Lovells US LLP
Cassie Scherer, Director of Regulatory Policy, U.S., Medtronic
Moderated by Allison Fulton, Partner, Sheppard Mullin Richter & Hampton LLP

Artificial Intelligence (AI) and Machine Learning (ML) technologies have transformed the healthcare industry by obtaining new and important insights from the extensive amount of data generated during everyday healthcare delivery. Panelists will address good machine learning practices (GMLP) and current developments in AI/ML and embedded AI. They will also discuss FDA’s product lifecycle-based regulatory framework for these technologies to ensure the safety and effectiveness of the software and provide an overview of FDA’s draft guidance, “Quality System (QS) Regulation/ Medical Device Good Manufacturing Practices” and its relevance for AI/ML products.

2:15–3:00 PM
Cybersecurity and Patient Safety: Hot Topics
David J. Bloch, Senior Principal Legal Counsel, Medtronic
Suzanne Schwartz, Associate Director for Science and Strategic Partnerships, CDRH, FDA
Jami Vibbert, Partner, Arnold & Porter LLP
Moderated by Sara Shanti, Partner, Sheppard Mullin Richter & Hampton LLP

Cybersecurity is critical to patient safety. Vulnerabilities can lead to security breaches that could impact device safety and effectiveness. Panelists will discuss FDA’s draft guidance, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” and the recommendations it provides to industry to strengthen cybersecurity; give an overview of FDA’s Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook, discuss challenges in this space, and what to expect in 2023.

3:15–4:00 PM
Risks and Unknowns of Clinical Decision Support (CDS) Software
Sonja Fulmer
, Acting Deputy Director, Digital Health Center of Excellence, FDA
M. Jason Brooke, Attorney & Manager Member, Brooke & Associates
Sonia W. Nath, Partner, Cooley LLP 
Moderated by Maura Martin Norden, Executive Vice President, Medical Products & Combination Products General Counsel, Greenleaf Health, Inc.

Clinical Decision Support (CDS) Software provide healthcare professionals with an innovative alternative to obtaining and storing patient-specific information. CDS software can provide opportunities for early and timely interventions that can improve patient outcomes and can enhance clinical performance for drug dosing, preventive care, and other aspects of medical care. This panel will discuss FDA’s guidance for industry and FDA staff “Clinical Decision Support Software” as well as some challenges and unknowns that healthcare providers face, such as the effect that CDS software has on the providers who use them, patient outcomes, costs, and risks, associated with clinical decision support software.

4:15–5:15 PM
Patient Engagement and Clinical Trials – How Digital Tools Can Further Patient Outcomes
Ryan Howells, Principal, Leavitt Partners, LLC
Deven McGraw , Lead, Data Stewardship & Data Sharing, Invitae
Anindita (Annie) Saha, Director, External Expertise and Partnerships, Digital Health Center of Excellence, CDRH, FDA
Moderated by Kalah Auchincloss, Executive Vice President, Greenleaf Health, Inc. 

The use of digital health tools can help increase diversity in clinical trials, particularly decentralized clinical trials, which often use remote technology and decentralization platforms, increasing the likelihood of patients participating and enrolling in clinical trials. This panel will discuss FDA’s expectations and what they have been doing in this space, and what to expect. Panelists will also discuss initiatives that give patients easier access to their data; and talk about real-world evidence (RWE) and real-world data (RWD) and whether some of these digital tools may be regulated as devices under the FDA.

5:15 PM
Closing Remarks and Adjournment