A collaborative effort hosted by the Digital Medicine Society (DiMe), the Digital Health Measurement Collaborative Community (DATAcc) strives to encourage communication among industry leaders to modernize how health is measured and defined through the use of digital solutions. The DATAcc has now come out with a new set of open-access resources that are intended to help increase inclusivity in the development and deployment of digital health measurement products.
“Collaborative communities like DATAcc are tackling important issues within the medical device ecosystem,” said Anindita Saha, assistant director of the Digital Health Center of Excellence in the US Food and Drug Administration (FDA) 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.”
These resources are contained within two toolkits. The first features tools needed to take a more inclusive approach to their work, and the second is designed to help 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.
To find out more about the toolkits and the importance of improving inclusivity along the digital health pipeline, Outsourcing-Pharma spoke with Jennifer Goldsack, DiMe CEO.
OSP: As you point out, the clinical research field has (especially in recent years) been aware of the lack of inclusivity but has not sufficiently acted to remedy the situation. Could you please share your perspective on some of the reasons why that might be?
JG: “Inclusivity” is a broad concept, with many elements that need specific consideration and deliberate actions required to drive success. Ownership of inclusivity also falls under many individuals and departments, so it can become easy for people to push this off on the next person.
These challenges leave clinical researchers unclear on where to start to promote inclusive approaches. The new toolkits and resources released today by DATAcc fill this gap with very specific instructions on where and how to start.
OSP: Then, please tell us why equity and inclusion are part of the DATAcc and DiMe’s mission.
JG: DiMe exists to advance the safe, effective, ethical and equitable use of digital technologies to optimize health. DATAcc is committed to realizing the benefits of digital health measurement, for all. Equity and inclusion are at the core of our mission to ensure that every individual benefits from the digitization of healthcare. The pandemic showed the world the grave consequences of inequitable and non-inclusive practices, which have reverberated in all aspects of our lives, not only healthcare.
As we bring digital tools to bear in the service of better health, we must be intentional about how they are developed and deployed to drive a future state of healthcare that better cares for all people. We are very proud of our DATAcc community for selecting inclusion as their first area of focus. They recognized that taking an inclusive approach to digital health measurement must be foundational to the field and backed that up through the pursuit of ambitious projects and the action-oriented resources released today.
With the promises of digital health technologies to transform care, a strong foundation in inclusivity will accelerate advancements throughout the healthcare continuum. We cannot wait until we are five or 10 years into digital medicine to then realize we have left large segments of the population behind.
OSP: Could you please tell us how the components of this toolkit will work (together, individually) to help increase inclusivity?
JG: The two toolkits can be used separately or in combination to meet the specific needs of the community. Together, they will guide inclusivity across the entire spectrum of the development and deployment of digital health measurement products.
The first toolkit features everything digital measurement product developers need to take an inclusive approach to take them from the initial concept through the regulatory approval process. For instance, developers can use the Market Opportunity Calculator to generate tangible numbers quantifying the opportunity – clinically and financially – of taking an inclusive approach to digital measurement product development.
The second toolkit provides guidance on how to take an inclusive approach when deploying digital health measurement products in healthcare and research. The toolkit includes resources for getting to know patients, participants, and the communities they live in, and for educating and assisting these groups with the use of digital health products.
OSP: Do you have anything to add?
JG: These tools are free and publicly available. We encourage the community to visit the website and explore the toolkits.
Also, we invite interested stakeholders to consider joining the community to advance these values and help us address the next set of challenges facing digital health measure development.