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

Summary: 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 di...

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Bibliographic Details
Main Authors: Ariel D Stern, PhD, Jan Brönneke, LLM, Jörg F Debatin, MD, Julia Hagen, MPA, Henrik Matthies, PhD, Smit Patel, PharmD, Ieuan Clay, PhD, Bjoern Eskofier, ProfPhD, Annika Herr, ProfPhD, Kurt Hoeller, PhD, Ashley Jaksa, MPH, Daniel B Kramer, MD, Mattias Kyhlstedt, Katherine T Lofgren, PhD, Nirosha Mahendraratnam, PhD, Holger Muehlan, PhD, Simon Reif, PhD, Lars Riedemann, MD, Jennifer C Goldsack, MA
Format: Article
Language:English
Published: Elsevier 2022-03-01
Series:The Lancet: Digital Health
Online Access:http://www.sciencedirect.com/science/article/pii/S2589750021002922

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