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.
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.