A collaborative work published recently highlights a viewpoint on how to advance digital health applications in real-world evidence generation.
The Digital Medicine Society (DiME) and the Health Innovation Hub (HIH) of the German Federal Ministry of Health published their view on advancing digital health and priorities for innovation in The Lancet Digital Health, with a focus on global best practices and a roadmap for methodological advancements needed to accelerate innovation in the space.
Germany’s “fast-track” pathway, a regulation passed in 2019 that created a pathway for regulatory and reimbursement for digital health applications in the German market, allows for doctors to prescribe certain categories of digital health applications while evidence demonstrating a positive healthcare effect is still being collected, according to a news release.
“Authorities across Europe are beginning to emulate Germany’s innovative policies advancing digital health innovation,” DiME CEO Jennifer Goldsack said in the release. “The DiGA program is thriving in Germany, France is preparing to institute a similar policy, and Europe is harmonizing approaches to evidence required for regulating digital products. Now is the time to support the high-quality science underpinning these policies and decisions, which will prove useful to regulators, payers, digital innovators, and the patients these digital applications are intended to serve.”
Germany’s fast-track pathway allows for the coupling of real-world evidence with new scientific approaches, but DiME and HIH say scientific best practice that supports novel approaches remains “siloed” by discipline and geography. They called for the international community to come together to “advance and harmonize” the science that supports optimized regulatory and reimbursement pathways for digital innovation.
DiME and HIH said that last year they convened leading scientists, digital innovators, healthcare providers and regulators from across the globe in an effort to connect the community of experts in the area of real-world evidence and novel trial methodologies.
“The methodological challenges that informed priorities for future research spanned a number of dimensions – from missing data and equity to multimodal intervention and generalizability,” Ariel Dora Stern, an associate professor at Harvard University and a visiting scholar at Germany’s Hasso Plattner Institute’s Digital Health Center, said. “By advancing these topics and fostering international agreement on definitions and best practices, Germany can serve as a model for international adoption of evidence-based digital health applications.”