BOSTON, Feb. 23, 2022 /PRNewswire/ — Today, The Digital Medicine Society (DiMe) and the Health Innovation Hub (hih) of the German Federal Ministry of Health published a viewpoint on how to advance digital health applications and priorities for innovation in real-world evidence generation. The collaborative work, published in The Lancet Digital Healthhighlights global best practices and a roadmap for the continued methodological advancements necessary for the acceleration of digital medical innovation.
In 2019, Germany passed regulation which, among other things, created a regulatory and reimbursement pathway for digital health applications in the German market. The innovative “Fast-Track” pathway set the legal framework for doctors to prescribe certain categories of digital health applications (known by their German acronym, DiGA), while evidence demonstrating a positive healthcare effect is still being collected.
“Authorities across Europe are beginning to emulate Germany’s innovative policies advancing digital health innovation,” says Jennifer Goldsack, CEO of DiMe. “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.”
Coupling real-world evidence with new scientific approaches provides a powerful opportunity for the agile, patient-oriented evaluation of digital health applications in practice. While Germany’s “Fast-Track” pathway unequivocally sanctions these types of approaches to evidence generation and other authorities are fast followers, scientific best practice supporting these novel approaches remains siloed by discipline and geography. In order to deliver on the promise of digital innovation, the international community must come together to advance and harmonize the science, supporting optimized regulatory and reimbursement pathways for digital innovation.
Last year, DiMe and hih agreed leading scientists, digital innovators, healthcare providers, and regulators from around the world to connect the international community of experts experienced with real-world evidence and novel trial methodologies with the innovative policy environment in Germany. The viewpoint published today reports the findings from these discussions.
“The methodological challenges that informed priorities for future research spanned a number of dimensions – from missing data and equity to multimodal intervention and generalizability,” says Ariel Dora Sternan Associate Professor at Harvard University and a Visiting Scholar at Germany’s Hasso Plattner Institute’s Digital Health Center. “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.”
To read the Lancet DigitalHealth paper, please click here. Organizations looking to get involved can now join DiMe’s upcoming initiative focused on the development of a regulatory pathway decision tool for digital health products. The initiative aims to increase the efficiency and impact of digital health product development and deployment by supporting developers to identify and pursue optimal regulatory pathways that support their product strategy and the patients our field exists to serve. To share your interest in getting involved through participation and sponsorship of this important work, click here.
About the Digital Medicine Society: The Digital Medicine Society (DiMe) is the professional society serving the digital medicine community, driving scientific progress and broad acceptance of digital medicine to enhance public health. At DiMe, our commitment to fully integrating experts from all of the disciplines comprising digital medicine is unwavering. From regulators to white-hat hackers, ethicists to engineers, and clinicians to citizen scientists, we are proud to welcome all experts committed to ensuring that digital medicine realizes its full potential to improve human health. join us!
Media Contact: Jamie Gray, [email protected]310.699.3163
SOURCE Digital Medicine Society (DiMe)