Healthcare leaders are working together to demystify regulatory avenues and strategies for digital healthcare products

Leading digital healthcare innovators come together to oversee regulations to change the attitude and outlook of the industry

BOSTON, June 14, 2022 / PRNewswire / – Today, Digital Medicine Association (DiMe) launched a collaborative project, Ways to Regulate Digital Health, 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 the product and regulatory strategy for digital healthcare providers. . Considering the broad spectrum of digital health solutions (including clinical decision support systems, digital diagnostics and therapies, augmented reality and remote monitoring technologies), the planned resources will support innovators seeking to optimize their regulatory strategy to promote high quality and reliable digital development. health products that best meet their commercial goals and the needs of patients.

Digital health solutions offer high hopes for meeting the most serious and enduring health challenges. However, end users are confused as to how to differentiate between the 300,000 health apps available for download and the much more sophisticated evidence-based digital healthcare solutions. Digital health innovators are equally mixed. In a recent survey of the digital medical community, DiMe found that 25% of developers did not know whether their digital healthcare product should be regulated. Among those surveyed who knew that their product should be regulated, 75% said they did not know the most appropriate regulatory route.

“We need to turn the script around and make the regulatory strategy distinctive for digital healthcare solution providers. As we anticipate tightening funding for digital innovators, the importance of choosing the best rules for individual products and product portfolios is critical to market access, trust and adoption.” he said Jennifer Goldsack, CEO of DiMe. “We are proud to work with industry leaders and our regulatory partners to provide innovators with the clarity and structure they need to follow the regulatory guidelines to make their products have the greatest impact on healthcare performance and patient life.”

In the coming months, DiMe and its partners will develop an open access, interactive, and regulatory support tool based on existing FDA and other agency guidance documents. Digital solution providers can use this as they evaluate the following questions: What is the right regulatory strategy for our product? What are the pros and cons of following a regulatory path? What are the milestones and evidence needed for success?

“We believe that digital health solutions have the potential to unlock more accessible and equitable care for all, driven by new technologies and in areas such as artificial intelligence and machine learning,” he said. Linda Peters, Vice President of Quality, Regulation and Safety and Health at Google. “We are delighted that this DiMe team is working together to develop and expand tools to support the wider ecosystem so that we can all help accelerate the translation of new technologies from ideas to everyday use.”

The development of this publicly available tool and resource, which will be publicly available in early 2023, is only part of DiMe. implementation work in favor of broad acceptance digital health tools and optimization of regulatory strategy. DiMe has a strong track record in this area, among other things Worked with the German Ministry of Healththe regulatory authorities take over the previous work and the existing cooperation with the FDA (DiMe takes over Collaborative Community for Digital Health Measurement (DATAAcc) and is part of the FDA “Network of Experts “.

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

Those interested in receiving information about this project can register here.

About the Digital Medicine Association: Tell me it is the professional headquarters of all members of the global nonprofit and digital medicine community. Together, we address the toughest challenges of digital medicine, develop quality clinical resources on the timeline of technology, and deliver these viable resources to the field through open source channels and educational programs. Join us to advance the ethical, effective, fair and safe use of digital medicine, redefine health care and improve life.

Media contact: English carla, [email protected]

SOURCE Digital Medicine Society (DiMe)


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