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

被引：89

作者：

Stern, Ariel D. ^{[1
,2
,3
]}

Broenneke, Jan ^{[2
]}

Debatin, Jorg F. ^{[2
]}

Hagen, Julia ^{[2
]}

Matthies, Henrik ^{[2
]}

Patel, Smit ^{[4
]}

Clay, Ieuan ^{[4
,5
]}

Eskofier, Bjoern ^{[6
]}

Herr, Annika ^{[7
]}

Hoeller, Kurt ^{[8
]}

Jaksa, Ashley ^{[9
]}

Kramer, Daniel B. ^{[10
]}

Kyhlstedt, Mattias ^{[11
]}

Lofgren, Katherine T. ^{[12
]}

Mahendraratnam, Nirosha ^{[13
]}

Muehlan, Holger ^{[14
]}

Reif, Simon ^{[15
]}

Riedemann, Lars ^{[16
]}

Goldsack, Jennifer C. ^{[4
]}

机构：

[1] Harvard Sch Business, Technol & Operat Management Unit, Boston, MA 02163 USA

[2] Hlth Innovat Hub, Berlin, Germany

[3] Hasso Plattner Inst, Digital Hlth Ctr, Potsdam, Germany

[4] Digital Med Soc DiMe, Boston, MA USA

[5] Evidat Hlth, San Mateo, CA USA

[6] Friedrich Alexander Univ Erlangen Nurnberg, Dept Artificial Intelligence Biomed Engn, Erlangen, Germany

[7] Leibniz Univ Hannover, Inst Hlth Econ, Dept Econ, Hannover, Germany

[8] EIT Hlth, Erlangen, Germany

[9] Aetion, Boston, MA USA

[10] Beth Israel Deaconess Med Ctr, Richard A & Susan F Smith Ctr Outcomes Res, Boston, MA 02215 USA

[11] Synergus RWE, Stockholm, Sweden

[12] Fdn Med, Cambridge, MA USA

[13] Aetion, New York, NY USA

[14] Univ Greifswald, Psychol Inst, Dept Hlth & Prevent, Greifswald, Germany

[15] ZEW Leibniz Ctr European Econ Res, Hlth Care Markets & Policy Grp, Mannheim, Germany

[16] Heidelberg Univ Hosp, Dept Neurol, Heidelberg, Germany

来源：

LANCET DIGITAL HEALTH | 2022年 / 4卷 / 03期

基金：

美国国家卫生研究院;

关键词：

D O I：

10.1016/S2589-7500(21)00292-2

中图分类号：

R-058 [];

学科分类号：

摘要：

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.

引用

页码：E200 / E206

页数：7

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