Digital Health Interventions (DHIs) continue to be classified and categorized in different ways by different organizations. This inconsistency leads to confusion and can inhibit assessments for regulatory, market access, and pricing and reimbursement (P&R) decision-making. This forum will give an update on the SIG’s special scoping review project, the aim of which is to collate and understand the numerous DHI categorization and definitions. This synthesis of available knowledge shall contribute to a better understanding of how to place digital health technologies in healthcare systems and also represents a valuable contribution to ongoing P&R developments for DHIs in different jurisdictions.

An overview of the P&R landscape for DHIs worldwide and an FDA regulatory update will be presented. Starting in 2020, Germany’s Digital Care Act (Digitale Versorgung-Gesetz, DVG) has introduced the statutory health insurance (SHI) reimbursement process for digital health applications (DiGA). We will discuss the implications of this law for manufacturers/operators of DHIs. Attendees will have opportunities to respond to specific questions and comments relating to DHI definitions and categorization, as well as answer general regulatory and P&R questions. During the closing Q&A, participants will have the chance to ask questions about the future projects of the SIG.
Dr. Kolasa will moderate and provide an overview of the P&R landscape; Dr. Odom, who will be speaking in an individual capacity and not as a representative of her company, will give updates on the ISPOR DH SIG key project manuscript; Dr. Mühlbacher will provide pricing and reimbursement updates and news from Germany, discussing the Digital Care Act and what it means for manufacturers and patients; Mr. Patel will provide FDA regulatory updates related to DH technologies; and Dr. Vinuesa will discuss member engagement work of the SIG.