Current Developments in Digital Health Technology and Regulation Conference
January 31–February 1, 2024 | Virtual Event
Agenda
Agenda Subject to Change
All Times Listed in Eastern Time
Wednesday, January 31
Christine Simmon, President & CEO, Food and Drug Law Institute
Sonja Fulmer, Deputy Director, Digital Health Center of Excellence, FDA
Increased use of artificial intelligence (AI) and machine learning (ML) in digital health nationally and internationally has created new challenges in the global marketplace. Panelists will discuss what the FDA and the European Medicines Agency (EMA) are doing in the AI/ML medical device, drug development, and manufacturing space and address how both, FDA and EMA are providing a framework that balances innovation and patient safety. This session will also overview the challenges in AI/ML such as transparency, accountability, reliability, and data quality and what is being done to address these challenges.
Anindita (Annie) Saha, Assistant Director, Digital Health Center of Excellence, FDA
Keo Shaw, Of Counsel, DLA Piper (US)
Madison Green, Director, Technical Operations, Emma International
Moderated by Charlotte Walker-Osborne, Partner, Morrison & Foerster LLP
As companies increasingly enhance drug therapy via digital companions, FDA recently issued a draft guidance on Prescription Drug-Use Related Software (PDURS). This guidance outlines the regulatory approach to prescription drug use-related software and serves as the framework for branded pharma companion apps. This panel will review the guidance and delve into FDA’s discussion papers on drug development and drug manufacturing and how they relate to companion apps used with pharmaceutical products and AI being used in several manufacturing operations.
Brendan Carroll, Partner, Alston & Bird LLP
Jessica Greenbaum, Partner, King & Spalding
Bradley Thompson, Partner, Epstein Becker & Green, PC
1:45–2:30 PM | Break
As cyber hackers increasingly target medical devices, the 2023 Omnibus Bill included provisions increasing FDA’s authority to require medical devices meet certain minimum cybersecurity standards. This panel will cover recent FDA activity, including its guidance entitled Cybersecurity in Medical Devices: Quality System Considerations and Content Premarket Submissions. Panelists will also explore potential FCA liability for cybersecurity failures, recent healthcare industry cybersecurity breaches, and best practices for prevention.
Teal Bjoraker, Sr. Manager Regulatory Affairs, Intelligent Data Solutions, Cranial & Spinal Technologies, Medtronic
Nidhi Gani, Archimedes Medical Device Security Fellow, Archimedes Center for Medical Device Security, Northeastern University
Monroe Molesky, Cybersecurity Specialist, FDA
Moderated by William Garvin, Shareholder, Buchanan Ingersoll & Rooney PC
There has been a significant increase in compliance oversight by FTC and FDA in the digital health space. Panelists will discuss inter-agency collaboration on data security, recent web tracking litigation, and how both interplay with privacy and safeguarding data. This session will also cover updated state and federal security requirements for telehealth.
Heather Deixler, Partner, Latham & Watkins
Sara Shanti, Partner, Sheppard Mullin Richter & Hampton LLP
Moderated by Nancy Perkins, Counsel, Arnold & Porter LLP
Thursday, February 1
FDLI Welcome
Bianca Cardona Melendez, Assistant Director, Educational Programs, FDLI
Panel Discussion: The New Era of Clinical Decision Support Software: Risks and Unknowns
Clinical Decision Support Software(CDSS) offers healthcare professionals an innovative solution for acquiring and managing patient-specific data, however, it also creates compliance risks and challenges for industry. Panelists will review FDA’s Clinical Decision Support Software, guidance for industry and FDA personnel on discuss FDA’s approach to CDSS enforcement, and discuss other practical challenges that industry faces. This session will also include case studies (such as Abiomed) and what enforcement will look like moving forward they might reveal about future enforcement.
Sonja Fulmer, Deputy Director, Digital Health Center of Excellence, FDA
Greg Levine, Partner, Ropes & Gray LLP
Sonia W. Nath, Partner, Cooley LLP
Moderated by M. Jason Brooke, Attorney & Managing Member, Brooke & Associates
Remote patient data collection and the integration of artificial intelligence have been reshaping traditional healthcare procedures and decision-making in clinical trials. This panel will examine FDA’s draft guidance on decentralized clinical trials (DCT), covering FDA’s efforts and recommendations regarding the implementation of DCTs to advance medical product development and research. Panelists will also discuss cutting-edge digital health tools and their role in enhancing the efficacy of clinical trials, and challenges such as oversight and ensuring participant safety when face-to-face contact is limited.
Kalah Auchincloss, Executive Vice President, Regulatory Compliance and Deputy General Counsel, Greenleaf Health, Inc.
Elizabeth Richards, Partner, Latham & Watkins
Blake E. Wilson, Partner, Hogan Lovells US LLP
Moderated by Shelby Buettner, Assistant General Counsel, Regulatory Law and Compliance Officer, Becton Dickinson (BD)
1:15–2:00 PM | Break
At the forefront of the consumer healthcare revolution, digital healthcare companies face significant compliance challenges, with a particularly complex federal regulatory landscape. This panel will discuss ongoing regulatory and enforcement trends, including FTC’s supervision of tracking data and the risk of exposing patient visits and medical appointments, DOJ’s enforcement of healthcare fraud (including telehealth), and examine collaboration between FDA, FTC, and DOJ to regulate and enforce in this space.
Mahnu V. Davar, Partner, Arnold & Porter LLP
Gabriel Scannapieco, Assistant Director, Consumer Protection Branch, US Department of Justice
Moderated by Christina Kuhn, Special Counsel, Covington & Burling LLP
Lab Developed Tests (LDTs) have recently become a hot topic in the digital health space, raising questions about how LDTs and software interact, especially CDSS. This panel will cover the history of LDTs regulation, including FDA’s past guidances, the 21st Century Cures Act, and FDA’s most recent proposed rule that increases the oversight over LDTs. Panelists will also offer their predictions and expectations for the future of LDT oversight.
Lisa M. Dwyer, Partner, King & Spalding LLP
Jeremiah J. Kelly, Partner, Venable LLP
Joshua M. Oyster, Partner, Ropes & Gray LLP
Moderated by Bethany Hills, Vice Chair, FDA Regulatory Practice, DLA Piper (US)
4:15 PM | Closing Remarks and Adjournment
