Healthcare leaders unite to demystify regulatory pathways and strategy for digital healthcare products

Leading innovators in digital healthcare are coming together to change the industry mindset and approach to regulatory oversight

BOSTON, June 14, 2022 /PRNewswire/ — Today, the Digital Medicine Society (DiMe) launched a collaborative project, Digital Health Regulatory Pathways, with partners including Abbott, the Consumer Technology Association (CTA), the US Food and Drug Administration (FDA), Google and the Harvard MIT Center for Regulatory Science to develop tools to help transform product and regulatory strategies for digital health solution providers. The planned resources will consider a broad spectrum of digital health solutions — including clinical decision support systems, digital diagnostics and therapy, augmented reality and remote monitoring technologies — and will support innovators looking to optimize their regulatory strategy to drive the development of high-quality, trusted digital health products that meet their commercial goals and best meet patient needs.

Digital health solutions show promise to address some of the most pressing and persistent healthcare challenges. However, end-users are confused trying to distinguish between the 300,000+ health apps available for download and much more sophisticated, evidence-based digital health solutions. Digital health innovators are confused as well. In a recent survey of the digital medicine community, DiMe found that 25% of developers didn’t know if their digital health product should be regulated. Of those respondents who knew their product should be regulated, 75% said they did not know the best way to regulate.

“We need to flip the script and see regulatory strategy become a differentiator for digital health solution providers. As we expect funding for digital innovators to tighten, selecting optimal regulatory pathways for individual products and product portfolios becomes critical to ensure market access, trust and adoption,” he said Jennifer GoldsackCEO of DiMe. “We’re proud to work with industry leaders and our regulatory peers to provide the clarity and structure innovators need to navigate regulatory pathways that position their products to have the greatest impact on healthcare and the lives of people have patients.”

Over the next few months, DiMe and its partners will create an open-access, interactive tool to support regulatory science based on existing guidance from the FDA and other agencies. It can be used by digital solution providers when assessing the following questions: What is the right regulatory strategy for our product? What are the pros and cons of a regulatory route? What are the key milestones and evidence required for success?

“We believe that digital health solutions have the potential to enable more accessible and equitable care for all, based on new technologies and advances in areas such as artificial intelligence and machine learning,” he said Linda PetersVice President of Quality, Regulatory & Safety, Health at Google. “We’re excited that DiMe is bringing this group together to develop and expand tools that can support the broader ecosystem, so we can all help accelerate the adoption of new technologies from idea to everyday use.”

The development of this tool and accompanying resources, which will be publicly available in early 2023, is just part of DiMe’s implementation work to support the widespread adoption of digital health tools and streamlining the regulatory strategy. DiMe has a solid track record in this area, including working with the German Ministry of Health, inheriting previous work from regulators, and existing partnerships with the FDA (DiMe hosts the Digital Health Measurement Collaborative Community (DATAcc) and is part of the “Network of Experts” of the FDA.

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

Those interested in receiving updates on this project can subscribe here.

About the Digital Medicine Society: DiMe is a global non-profit organization and professional home for all members of the digital medicine community. Together, we’re tackling the toughest digital medicine challenges, developing clinical-quality resources on a technology timeline, and delivering these actionable resources to practitioners through open-source channels and educational programs. Join us to advance the ethical, effective, equitable and safe use of digital medicine to redefine healthcare and improve lives.

Media contact: Charles English, [email protected]

SOURCE Digital Medicine Society (DiMe)

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