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  • Lancet Digital Health

Advancing Digital Health Applications: Priorities for Innovation in Real-World Evidence Generation

By: Ariel Dora Stern, Jan Brönneke, Jörg F Debatin, Julia Hagen, Henrik Matthies, Smit Patel, Ieuan Clay, Bjoern Eskofier, Annika Herr, Kurt Hoeller, Ashley Jaksa, Daniel B Kramer, Mattias Kyhlstedt, Katherine T Lofgren, Nirosha Mahendraratnam, Holger Muehlan, Simon Reif, Lars Riedemann and Jennifer C Goldsack
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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.

Keywords

Digital Health; Health Care and Treatment; Technological Innovation

Citation

Stern, Ariel Dora, Jan Brönneke, Jörg F Debatin, Julia Hagen, Henrik Matthies, Smit Patel, Ieuan Clay, Bjoern Eskofier, Annika Herr, Kurt Hoeller, Ashley Jaksa, Daniel B Kramer, Mattias Kyhlstedt, Katherine T Lofgren, Nirosha Mahendraratnam, Holger Muehlan, Simon Reif, Lars Riedemann, and Jennifer C Goldsack. "Advancing Digital Health Applications: Priorities for Innovation in Real-World Evidence Generation." Lancet Digital Health 4, no. 3 (March 2022): e200–e206.
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About The Author

Ariel D. Stern

Technology and Operations Management
→More Publications

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More from the Authors
  • Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance By: Alexander O. Everhart, Soumya Sen, Ariel D. Stern, Yi Zhu and Pinar Karaca-Mandic
  • Post-market Surveillance of Software Medical Devices: Evidence from Regulatory Data By: Alexander O. Everhart and Ariel D. Stern
  • The Regulation of Medical AI: Policy Approaches, Data, and Innovation Incentives By: Ariel Dora Stern
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