DiMe-hih innovation in evidence generation

Accelerating innovation in evidence generation for digital health applications

The Digital Medicine Society (DiMe) and the health innovation hub (hih) of the German Federal Ministry of Health partnered to accelerate innovation in evidence generation related to digital health applications. Our shared goal is to speed the use of high-quality digital medicine products in routine care by addressing the maldistribution of innovative policy.

In late 2020 and early 2021, DiMe and hih held roundtable discussions with experienced international experts in evidence generation for digital medicine products. These products included tools driven by high-quality hardware and software that support the practice of medicine broadly – including treatment, recovery, disease prevention, and health promotion for individuals and across populations.

Photo: DiMe-hih Roundtable 3 featuring expert participants from Aetion, Anthem, BfArM, EIT Health, Evidation Health, FAU, U.S. FDA, Flatiron Health, Foundation Medicine, Google, Heidelberg University Hospital, IGES, IQWiG, NICE, Leibniz University, Synergus RWE, Taiwan FDA, UCSF, University of Greifswald, and ZEW.

Global priorities for innovation in real-world evidence generation for digital health

On Feb. 23, 2022, DiMe and hih released global priorities for digital health innovations in a The Lancet Digital Health article, “Advancing digital health applications: Priorities for innovation in real-world evidence (RWE) generation”.

The viewpoint identified key opportunities for better practices in evidence generation. It also highlighted methodological challenges and outstanding questions to inform future research. Advancing these topics and international agreement on definitions and best practices is vital to the safe and effective deployment of digital health applications in Germany. This model can also be adopted internationally in many ways.

Photo: Global priorities for innovation in digital health application in the Lancet Digital Health

Download the viewpoint

Virtual Journal Club discussion

Learn more from the co-authors of the Lancet Digital Health manuscript in an open discussion about the challenges and opportunities for the field of digital health application research.

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Panel “A look ahead for digital medicine: 2022-2025” at The Digital Medicine Week, 2021 with Jennifer Goldsack, Smit Patel, and Isabel Van De Keere; hosted by hih in partnership with DiMe.

EvidenceCon 2021
panel

Listen to DiMe’s presentation and panel discussion on this topic at the EvidenceCon following the opening remarks of Jens Spahn, Germany’s Federal Minister of Health. (2018-2021)

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European Council – Council of the European Union Press release

Council of
Europe
statement

So how will this new regulation work in practice? Read more about how these new health technology regulations will improve access to the digital healthcare.

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Overview: Digital health innovation in German healthcare

Learn more about digital health innovation for the German healthcare system and DiMe’s partnership for broad acceptance of digital health application.

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What’s next

Regulations don’t have to be daunting. DiMe’s Digital Health Regulatory Pathways project team is currently developing tools that will make it easier for you to know which pathways exist, if you need them, and how to pursue them so you can go to market faster. You can save time, money, and resources just by figuring out the right regulatory pathway for your products. Learn more about this effort.