Advancing digital health applications: priorities for innovation in real-world evidence generation
Stern AD, Brönneke J, Debatin JF, Hagen J, Matthies H, Patel S, Clay I, Eskofier B, Herr A, Hoeller K, Jaksa A, Kramer DB, Kyhlstedt M, Lofgren KT, Mahendraratnam N, Muehlan H, Reif S, Riedemann L, Goldsack JC (2022)
Publication Type: Journal article, Review article
Publication year: 2022
Journal
Book Volume: 4
Pages Range: e200-e206
Journal Issue: 3
DOI: 10.1016/S2589-7500(21)00292-2
Abstract
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.
Authors with CRIS profile
Additional Organisation(s)
Involved external institutions
Universität Greifswald
Germany (DE)
Foundation Medicine Inc
United States (USA) (US)
Digital Medicine Society (DiMe)
United States (USA) (US)
Universitätsklinikum Heidelberg
Germany (DE)
Zentrum für Europäische Wirtschaftsforschung (ZEW)
Germany (DE)
Aetion Inc.
United States (USA) (US)
Synergus RWE
Sweden (SE)
Beth Israel Deaconess Medical Center (BIDMC)
United States (USA) (US)
EIT Health InnoStars e. V.
Germany (DE)
Hochschule Hannover (HsH) / University of Applied Sciences Hannover
Germany (DE)
Bundesministerium für Gesundheit
Germany (DE)
Harvard Business School
United States (USA) (US)
Germany (DE)
Foundation Medicine Inc
United States (USA) (US)
Digital Medicine Society (DiMe)
United States (USA) (US)
Universitätsklinikum Heidelberg
Germany (DE)
Zentrum für Europäische Wirtschaftsforschung (ZEW)
Germany (DE)
Aetion Inc.
United States (USA) (US)
Synergus RWE
Sweden (SE)
Beth Israel Deaconess Medical Center (BIDMC)
United States (USA) (US)
EIT Health InnoStars e. V.
Germany (DE)
Hochschule Hannover (HsH) / University of Applied Sciences Hannover
Germany (DE)
Bundesministerium für Gesundheit
Germany (DE)
Harvard Business School
United States (USA) (US)
How to cite
APA:
Stern, A.D., Brönneke, J., Debatin, J.F., Hagen, J., Matthies, H., Patel, S.,... Goldsack, J.C. (2022). Advancing digital health applications: priorities for innovation in real-world evidence generation. The Lancet Digital Health, 4(3), e200-e206. https://dx.doi.org/10.1016/S2589-7500(21)00292-2
MLA:
Stern, Ariel D., et al. "Advancing digital health applications: priorities for innovation in real-world evidence generation." The Lancet Digital Health 4.3 (2022): e200-e206.
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