The Digital Health Measurement Collaborative Community (DATAcc), a collaborative effort hosted by the Digital Medicine Society (DiMe), announced a new set of open-access resources to guide inclusivity in the development and deployment of digital health measurement products.
In doing so, DATAcc’s 46 member organizations offer some tangible solutions for the industry to bridge the gap between recognizing the need for inclusivity with digital health measurements and making inclusivity a standard practice. A free, public launch event was held during which the experts from the DATAcc Steering Committee and project team detailed these two product suites.
“Collaborative communities like DATAcc are tackling important issues within the medical device ecosystem,” says Anindita Saha, assistant director of the Digital Health Center of Excellence in the U.S. Food and Drug Administration’s Center for Devices and Radiological Health. “The DATAcc community collectively agreed that their first priority project should focus on establishing inclusivity as a foundation of digital health measurement. The resources created by DATAcc provide product developers and clinical users with tools to help realize the promise of digital health measurement.”
The new resources sit within two sets of toolkits: one for developing digital health measurement products, and the second for deployment. The first toolkit features everything digital measurement product developers need to take an inclusive approach – providing the supporting tools and research that they need to take them from initial concept through the regulatory approval process.
- The Market Opportunity Calculator: This model provides tangible numbers quantifying the opportunity — clinically and financially — of taking an inclusive approach to digital measurement product development. It is an interactive tool, much like an online mortgage calculator, where users can look at major health conditions along different vectors of inclusivity (race, income, education, and age) and compare current state to future state.
- The Digital Measurement Product Development Process: Modeled after the FDA Device Development Process, this tool describes, for the first time, the inclusive approach to developing a digital measurement product. Decision points throughout the development process are layered with key steps and considerations to ensure that an inclusive approach is taken at each phase.
- The Library of Evidence: To support industry putting the inclusive development process into action, this “heat map” resource combines over 85 resources that demonstrate instances of quantified benefits, across vectors of inclusion, in areas both directly and indirectly related to digital health measurement products.
The second toolkit helps guide care and research teams, patients, community organizations, planning teams, and tech support teams on how to take an inclusive approach when deploying digital health measurement products in healthcare and research. The new Digital Measurement Product Deployment Toolkit includes a Quick Start Guide to Community Partnerships, Guidance on Inclusive Communications, End User Bill of Rights, Support Call Flowchart, and an annotated list of resources that includes organizations that specialize in inclusion and links to curated resources.
“DATAcc’s new resources will provide technology manufacturers with the powerful data they need to develop products and target communities that are in need of access,” says Rene Quashie, VP of Health at CTA. “Technology plays a critical role in improving our lives and DATAcc’s toolkit is a great step toward further inclusion and access to healthcare.”
The launch also marks the one-year anniversary of DATAcc. As it enters its second year, the community will consider the next most pressing issues to tackle in order to advance our shared vision of high-quality digital health measurement for all. Top topics under consideration include health data rights, data governance, and data standardization and harmonization.
“Our industry has a history of admiring the lack of inclusion in medical product development and healthcare, yet has been slow to act,” says Jennifer Goldsack, CEO of DiMe. “Digital health measurement offers the opportunity to redefine health and disease, inform an improved understanding of disease burden, and improve access to better healthcare. We are enormously proud of the DATAcc community for insisting that their inaugural resources support the industry in establishing new digital tools, measures, and their applications that address long-standing health disparities and inequity, helping move our industry from ‘should do’ to ‘how to.’”
DATAcc welcomes new members to its community annually through an open call period beginning in June 2022.