Digital Health Technologies are increasingly used in the development, manufacturing, investigation, marketing, and maintenance of medicines, medical devices, and combination products. This focused session will cover a range of digital health topics that are relevant to development, quality, regulatory, and patient safety functions that support medical products.

Workshop Introduction
10 minutes
In recent years, global health authorities have shared more about the classification and evidence required to support use of digital health technologies and medical device software in clinical studies and marketing applications. The introduction will provide a preview of the planned workshop sessions and allow attendees to share their own experience with digital technologies at their tables.

Session 1: Digital Health Technologies for Remote Data Acquisition
50 minutes
The US FDA has recently outline expectations for development and use of digital health technologies (DHT) for remote data acquisition in investigational studies These expectations include the verification, validation, and security of DHTs as well as the level of detail the Agency expects to be submitted within investigational applications. This session will cover these details as well as industry perspectives for how to comply to the new Agency expectations.

Overview of DHT for Remote Data Acquisition Guidance
Elizabeth Kunkoski​, Health Science Policy Analyst, Center for Drug Evaluation and Research (CDER), FDA

Design Control Applicability under Guidance
John Schalago

Verification and Validation on DHTs
Peter Petrochenko​, Associate Director in Regulatory Strategy, Regeneron Pharmaceuticals

Unapproved Medical Devices under IND submission
Andrew Yeatts​, Combination Product Policy Analyst, Center for Devices and Radiological Health (CDRH), FDA

Session 2: Artificial Intelligence and Machine Learning (AI/ML)
50 minutes
Artificial Intelligence and Machine Learning technologies have advanced nearly all facets of medical product development. Health Authorities have begun to form conceptions around use of these technologies and how to validate and maintain these systems. This session will review current health authority guidance for AI/ML systems, basics of good machine learning practices, and post approval change control plans. This session will also discuss industry best practices, case studies, and lifecycle management considerations for leveraging AI/ML technologies in combination product development.

AI/ML Lifecycle Considerations and Best Practices
Eric Staib, Vice President, Corporate Quality, Syneos Health

GxP and Risk Control Framework for AI/ML
Brandi Stockton, Managing Partner, Triality Group

Predetermined Change Control Plans and AI/ML Case Study
Erez Kaminski, CEO & Founder Ketryx

Session 3: Regulatory Considerations for Medical Device Software
50 minutes
Since 21st century cures FDA has been releasing multiple guidances to enable innovation in the mobile medical device applications space by taking a multiple function approach and exercising enforcement discretion for low-risk software functions. In 2023, FDA took a step further by providing additional guidance for Prescription Drug Use-Related Software. This document formalizes thinking on software as a promotional and labeling artifact when it is used with medicines. This session will introduce the FDA guidance documents, case studies, and implications of the Agency’s policies on reporting software as promotional and regulated labeling.

Multiple Function Device Products: Policy and Considerations – FDA Guidance
Katie Chowdhury​ Director, Global Regulatory Affair, Emerging Technologies, Digital Medical Devices, & Combination Products, AbbVie

Regulatory Considerations for Prescription Drug Use-Related Software
Bonnie Odom​, Partner in the Healthcare and Life Sciences Practice, Epistein, Becker and Green

Case-study: Q&A
Anchal Choudhuri​, Senior Consultant, Biologics Consulting