Berlin, 17 November, 2020 – An international group of researchers and experts in the use of real-world data and real-world evidence joined the health innovation hub (hih) and Digital Medicine Society (DiMe) this week in the first of a series of expert discussions and in launching the organizations’ partnership. 

The goal of the partnership between the hih and DiMe is to accelerate innovation in evidence generation related to digital health applications and speed the use of high quality digital medicine products in routine care by addressing the maldistribution of innovative policy vis-a-vis expertise in novel approaches to health research and evaluation. 

“Digital Medicine must be an evidence-based practice.” said DiMe Executive Director Jennifer Goldsack. “As digital innovation outpaces traditional clinical research timelines, we must find new approaches that deliver better information, faster.” 

As part of Germany’s new Digital Healthcare Act (Digitale–Versorgung–Gesetz or DVG), the Fast-Track Process for Digital Health Applications (in German, Digitale Gesundheitsanwendungen, or DiGA, also known as “apps on prescription”) allows for digital technologies to be introduced into outpatient clinical practice and reimbursed by Germany’s statutory health insurers, with a concomitant goal of collecting real world performance data to accelerate high quality, digitally driven healthcare.

“Digital health applications (DiGA) finally have the opportunity to prove their effectiveness, supporting patients in managing and treating their diseases outside of the clinic, 24/7. These new digital solutions offer a plethora of novel capabilities and data sources, including direct insight into their use and usability in every-day life – the factors that matter most to patients. Yet we lack experience and research models to leverage the rich data that DiGA provide. I am grateful to DiMe and their vibrant community for sharing knowledge and supporting us in closing the gaps. In doing so, we become partners in building a better healthcare future” said Henrik Matthies, hih’s Managing Director. 

The innovative DVG legislation offers broad methodological flexibility to digital product manufacturers seeking to demonstrate the positive effects of their digital health applications. However, the scientists with the greatest experience in medical product development in Germany and Europe have, to date, focused almost exclusively on randomized controlled trials (RCTs) in the evidence generation process. Experience with novel study designs for high quality evidence generation is limited.

The research community in the United States has experience and expertise in using real-world data and novel study methodologies to generate high quality information. The international community has also developed approaches to challenges associated with the use of real-world data for regulatory and clinical decision-making such as lack of interoperability and non-representative data sets.

“The new DiGA-framework in Germany is another step towards a more digitalized healthcare system, but digital technologies also shed a light on a broader set of questions around the generation of evidence for healthcare outcomes: How do we address effectiveness in contrast to efficacy? Do we need a dynamic rather than a one-time assessment of (continuously refined) health technologies? And how do we develop and conduct such studies? By connecting the experience of the global health care research community with the innovative policy environment in Germany, we hope to stimulate innovative approaches to digital medical product evaluation” said Jan Brönneke, hih’s Director of Law and Economics Health Technologies

This month’s event identified a group of thought leaders and subject matter experts from within the German clinical research community as well as US-based experts with experience using real-world data and novel methodologies to generate high quality evidence of medical product performance. 

Over the coming months, the hih and DiMe will convene an additional expert event and will build out a selection of illustrative examples of novel approaches to health evaluation research that can be readily applied to the evaluation of DiGA in Germany and novel digital health applications more broadly. Further, the organizations will partner in hosting the English-language program of Digital Medicine Week on the 3. and 4. of February, 2021. 

“We are energized by the unique opportunity to build a trans-Atlantic collaborative community of researchers committed to the high quality evaluation of digital medicine products using real-world data sets and novel methodologies” said Julia Hagen, hih’s Director of Regulatory and Politics. 

Digital Medicine Week will feature a half-day long “Evidence Con” (evidence generation convention) and “Research-a-thon” (study design sprint) that will give aspiring medical entrepreneurs and researchers a chance to learn from international experts and gain hands-on experience in the design of novel, high quality evidence-generation studies for DiGA. For more information and to register for Digital Medicine Week, see https://dmw.hih-2025.de. 

About the health innovation hub

The health innovation hub (hih) serves as a think tank, sparring partner, and implementation supporter for the Federal Ministry of Health and its subordinate authorities, among others. The team was set up as a point of contact and bridge between all major stakeholders of the German health care system. For more information about the hih and our work, please visit https://hih-2025.de/en/about

About the Digital Medicine Society 

Founded in 2019, the Digital Medicine Society (DiMe) is the first professional organization for experts from all disciplines comprising the diverse field of digital medicine. Together, we drive scientific progress and broad acceptance of digital medicine to enhance public health. DiMe is a 501(c)(3) non-profit organization dedicated to advancing digital medicine to optimize human health. We do this by serving professionals at the intersection of the global healthcare and technology communities, supporting them in developing digital medicine through interdisciplinary collaboration, research, teaching, and the promotion of best practices. For more information about DiMe and to view our work please visit https://dimesociety.org