The Digital Medicine Society (DiMe) https://dime.society.org has launched a collaborative project with Abbott, Consumer Technology Association (CTA), FDA, Google, and the Harvard-MIT Center for Regulatory Science to develop tools to help transform product and regulatory strategy for digital health solution providers.
The plan is to contemplate a broad spectrum of digital solutions—including clinical decision support systems, digital diagnostics and therapeutics, extended reality, and remote monitoring technologies.
The planned resources will support innovators seeking to optimize their regulatory strategy to drive the development of high quality, trustworthy digital health products that best meet their commercial goals and the needs of patients.
Digital health solutions offer enormous promise to address some of the most pressing and persistent challenges in healthcare. However, consumers are confused as they seek to differentiate between the 300K+health apps available for download and much more sophisticated, evidence-based digital health solutions.
Digital health innovators are equally confused. In a recent survey of the digital medicine community, DiMe found that 25% of developers didn’t know whether their digital health product should be regulated. Of those surveyed who knew their product should be regulated, 75% reported not knowing the optimal regulatory pathway.
“We need to flip the script and see regulatory strategy become a differentiator for digital health solution providers. As we anticipate a tightening of funding for digital innovators, the importance of selecting optimal regulatory pathways for individual products and product portfolios, becomes critically important to ensure market access, trust, and adoption,” said Jennifer Goldsack, CEO, DiMe.
Over the next few months, DiMe and partners will create an evidence-based, open access, and interactive decision support tool, which can be used by digital solutions providers as they evaluate the following questions:
- What is the right regulatory strategy for our product?
- What are the pros and cons of pursuing a regulatory pathway?
- Which pathways should we consider?
- What are the key milestones and evidence needed to be successful?
“We believe digital health solutions have the potential to unlock more accessible and equitable care for everyone, powered by new technologies and advances in areas like artificial intelligence and machine learning,” said Linda Peters, VP, Quality, Regulatory & Safety, Health at Google.
The development of this tool and companion resources will be publicly available in early 2023, as just one part of DiMe’s implementation work to support broad acceptance of digital health tools and optimization of regulatory strategy.
DiMe has a robust history of success in this area, including work with the German Ministry of Health, the adoption of previous work by regulatory authorities, and existing partnerships with FDA. DiME hosts the Digital Health Measurement Collaborative Community (DATAcc) and part of FDA’s Network of Experts.
Community partners on this project are Abbott, Aetion, Amgen, Consumer Technology Association (CTA), Digital Therapeutic Alliance (DTA, FDA, Genentech-a member of the Roche Group, Google, Harvard-MIT Center for Regulatory Science, Janssen, Otsuka Pharmaceuticals, Rock Health, sidekick Health, and Tidepool.