New Non-Profit Aims to Develop Digital Medicine Research, Standards

A newly formed non-profit in the mHealth and telehealth ecosystem aims to support “the development of digital medicine through interdisciplinary collaboration, research, teaching, and the promotion of best practices.”

The Boston-based Digital Medicine Society (DiMe) announced itself earlier this month with a call for new members and the unveiling of three research projects. The group includes a strategic advisory board that features executives from Amazon, the Department of Veterans Affairs, the Digital Therapeutics Alliance, Evidation Health, Novartis, Takeda and the University of North Carolina and a scientific leadership board featuring US Food and Drug Administration executives and representatives of the Icahn School of Medicine at Mount Sinai, the Michael J Fox Foundation, Pfizer and the Duke Clinical Research Institute.

The group aims to create a new forum to draw collaboration from a wide range of connected health enthusiasts.

“Cross-discipline cooperative networks are needed to unlock the full potential of digital medicine to improve human health,” Jennifer Goldsack, DiMe’s interim Executive Director, said in a press release. “DiMe provides the only professional home for individuals across digital medicine - from regulators to white-hat hackers, ethicists to engineers, and clinicians to citizen scientists. We look forward to welcoming a diverse membership to DiMe and, together, driving scientific progress and broad acceptance of digital medicine to enhance public health.”

“DiMe is championing digital medicine as an evidence-based field,” added Edmondo Robinson, the Christiana Care Health System’s chief transformation officer. “By convening experts and providing the infrastructure for evidence development, it will help clinical decision-makers and end users better identify digital tools that are safe and effective for patients.”

The new group also announced three research projects:

  1. Ethical Considerations in Digital Medicine, aimed at “developing recommendations for the ethical use of mobile technology in research and clinical settings” and “rais(ing) awareness amongst investigators and regulators regarding potential ethical pitfalls in the field of digital medicine, alongside suggested strategies to address those pitfalls.”

  2. Verification and Validation of Digital Medicine Tools, focused on “creating guidance and recommendations regarding the principles of verification and validation, with reference to concepts covered by the US Food and Drug Administration guidance for software validation which has been widely adopted by the medical device industry, as well as concepts of fit-for-purpose biomarker validation explored via the BEST initiative.

  3. Measuring Adherence in Studies Utilizing Digital Medicine, which aims to “explore the various factors that enable optimal adherence in successful trials, as well as factors that may have negatively impacted adherence and how these may be addressed in future studies.”

In a Q&A with the Regulatory Affairs Professional Society, Goldsack – formerly of Christiana Care’s Value Institute and the Clinical Trials Transformation Initiative (CTTI) and a former Olympic rower – said the group wants to “get everyone to the table” to define digital medicine and create a set of standards that promote the adoption of mobile health technology.

“There are tens of thousands of digital apps that are intended for health and wellbeing,” she said. “But many of them are not evidence-based. We define digital medicine as being evidence-based, which is one of our metrics. Tools must also be intended to support the practice of medicine. From digital therapeutics and diagnostics to tools for population health management, preventative care or for tracking an individual during a clinical trial or a patient after joint replacement surgery, anything that supports the practice of medicine, is evidence-based and contains high-quality software falls into our digital medicine definition.”

Originally published in mHealth Intelligence by Eric Wicklund on May 22, 2019