Digital Medicine Society and BMG publish global priorities for digital health innovations
23.02.2022 15:49
The Digital Medicine Society (DiMe) and the Health Innovation Hub (hih) of the German Federal Ministry of Health have published a position paper on how to advance digital health applications and innovation priorities in generating real-world insights. The collaborative work, published in The Lancet Digital Health, identifies global best practices and a roadmap for the continuous methodological advancements needed to accelerate digital medical innovation.
In 2019, Germany passed a regulation that, among other things, establishes a regulatory and reimbursement pathway for digital health applications on the German market. This innovative "fast-track" pathway creates the legal framework that allows physicians to prescribe certain categories of digital health applications (DiGA) while evidence of their positive health effects is still being gathered.
„Governments across Europe are beginning to emulate Germany’s innovative policies to promote digital health innovation,“ says Jennifer Goldsack, CEO of DiMe. „The DiGA program is already thriving in Germany, France is preparing a similar policy, and Europe is harmonizing the approaches to the evidence required for regulating digital products. Now is the time to support the high-quality science that underpins these strategies and decisions and will prove beneficial to regulators, payers, digital innovators, and the patients these digital applications are intended to serve.“
Linking practical insights with new scientific approaches offers a powerful opportunity for the agile, patient-centered evaluation of digital health applications in practice. While the German "fast-track" pathway unequivocally sanctions these kinds of knowledge-gathering approaches, and other authorities are quickly following suit, the scientific best practices supporting these novel approaches remain disciplinarily and geographically isolated. To deliver on the promise of digital innovation, the international community must collaborate to advance and harmonize the science that supports optimized regulatory and reimbursement pathways for digital innovations.
Last year, DiMe and hih brought together leading scientists, digital innovators, healthcare providers, and regulatory authorities from around the world to connect the international community of experts with experience in real-world evidence and novel study methods with the innovative policy environment in Germany. This newly published position paper reports on the results of these discussions.
„The methodological challenges that shaped the priorities for future research encompassed a range of dimensions—from data shortages and equity to multimodal interventions and generalizability,“ says Ariel Dora Stern, Associate Professor at Harvard University and Visiting Researcher at the Hasso Plattner Institute’s Digital Health Center in Germany. „By advancing these issues and fostering international consensus on definitions and best practices, Germany can serve as a model for the international adoption of evidence-based digital health applications.“
To read "The Lancet Digital Health", please click here. here. Organizations wishing to get involved can now participate in the upcoming DiMe initiative, which focuses on developing a decision-making tool for the regulatory pathway of digital health products. According to the initiators, the initiative aims to increase the efficiency and impact of developing and deploying digital health products by helping developers identify and pursue optimal regulatory pathways that support their product strategy and the patients this field is meant to serve. If you are interested in participating in this work, Please click here.
Background:
The Digital Medicine Society (DiMe) The German Association for Digital Medicine (DiMe) is a professional society dedicated to digital medicine, promoting scientific progress and widespread acceptance of digital medicine to improve public health. DiMe strives to integrate experts from all areas of digital medicine, from regulatory authorities to white-hat hackers, from ethicists to engineers, and from clinicians to citizen scientists.