Advancing digital health applications: priorities for innovation in real-world evidence generation.

In 2019, Germany passed the Digital Healthcare Act, which, among other things, created a "Fast-Track" regulatory and reimbursement pathway for digital health applications in the German market. The pathway explicitly provides for flexibility in how researchers can present evidence for new digital products, including the use of real-world data and real-world evidence. Against this backdrop, the Digital Medicine Society and the Health Innovation Hub of the German Federal Ministry of Health convened a set of roundtable discussions to bring together international experts in evidence generation for digital medicine products. This Viewpoint highlights findings from these discussions with the aims of (1) accelerating and stimulating innovative approaches to digital medical product evaluation, and (2) promoting international harmonisation of best evidentiary practices. Advancing these topics and fostering international agreement on evaluation approaches will be vital to the safe, effective, and evidence-based deployment and acceptance of digital health applications globally.
Competing Interests: Declaration of interests ADS declares that she serves as a member of the Scientific Advisory Board of HumanFirst. SP declares that he serves on the Advisory Board of the Brown-Lifespan Center of Digital Health and Clinicom. IC declares honoraria from University of Basel, ETH Zurich, and FHNW, and holds stock options in Evidation Health. BE declares funding from the DFG (German Research Foundation) Heisenberg Funding (ES434/11), DFG SFB 1483 EmpkinS; consulting fees from Adidas AG, Siemens Healthineers, Portabiles HealthCare Technologies, and Sivantos; honoraria from AbbVie Deutschland and AGAPLESION; and a patent application EP 16174268.9 (Gait Assessment), with Portabiles HealthCare Technologies. KH declares grant income from the European Innovation Council, patent WO2010105946 (A1) (Endoscope and Imaging Device), also published as DE102009013761 (A1), ES2384949 (T3), EP2323541 (A1), EP2323541 (B1), AT550982 (T); stock or stock options in Siemens Healthineers, Siemens, and BioNTech; and other financial interests in EIT Health. AJ declares honoraria from ISPOR and stock or stock options in Aetion and CVS Health. DBK declares research grants from the National Institutes of Health and the Moore Foundation and consulting income from Firefly Health. MK declares financial interests as the owner of Synergus RWE, a market access consulting company. KTL is an employee of Foundation Medicine, a wholly owned subsidiary of Roche, and declares equity interest in Roche. NM is an employee of Aetion. HMu declares research grants from the German Federal Ministry of Education and Research (GBA Research Grant [01VSF16027] 2017–2021) and the German Research Foundation (MIMI [Evaluation Study] 2018–2019). SR declares funding from the Ministry of Science, Research and Arts, State of Baden-Württemberg, Germany, and the Digital Medical Application Center. The other authors declare no competing interests.
(Copyright © 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)