Digital Medicine Society Reports Healthcare Leaders Unite to Demystify Regulatory Pathways and Strategies for Digital Health Products

Digital Medicine Society has launched a collaborative project, Digital Health Regulatory Pathways, with partners including Abbott, the Consumer Technology Association (CTA), the U.S. Food and Drug Administration (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.

Contemplating a broad spectrum of digital health 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, end users 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 of Digital Medicine Society. “We are proud to work alongside industry leaders and our regulatory colleagues to provide the clarity and structure needed for innovators to pursue regulatory pathways that position their products to have the greatest impact on healthcare delivery and patients’ lives.”

Over the next few months, Digital Medicine Society and its partners will create an open access, interactive, regulatory science support tool that is based on existing FDA and other agency guidance documents. It 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? 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, Vice President of Quality, Regulatory & Safety, Health at Google. “We’re delighted that DiMe is convening this group to develop and extend tools that can support the wider ecosystem, so that we can all help accelerate the translation of new technologies from ideas to daily use.”

The development of this tool and companion resources, which will be publicly available in early 2023, is 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 the FDA (DiMe hosts the Digital Health Measurement Collaborative Community (DATAcc) and is part of FDA’s “Network of Experts”.

Community partners on this project are Abbott, Aetion, Amgen, the Consumer Technology Association (CTA), the Digital Therapeutic Alliance (DTA), the U.S. Food and Drug Administration (FDA), Genentech – a member of the Roche Group, Google, the Harvard-MIT Center for Regulatory Science, Janssen, Otsuka Pharmaceuticals, Rock Health, Sidekick Health, and Tidepool.

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