DiMe, FDA, Amazon Eye Best Practices for Sensors in mHealth Devices

The Digital Medicine Society (DiMe) is collaborating with the US Food and Drug Administration and some heavy hitters in the technology market to develop best practices for integrating mHealth sensors – such as those used in remote patient monitoring – into clinical research and patient care.

“In order to expand the use of digital sensor products and fulfill the promise of digital health measurement to redefine healthcare, stakeholders including clinicians, researchers, patients, regulators and payers must be able to leverage sensor data that is trustworthy, relevant, and accessible,” Ieuan Clay, chief scientific officer for the two-year-old Boston-based organization, said in a press release. “We have identified this as the biggest limitation to scaling digital health measurement and have gathered a best in class project team with regulators, cloud and analytics platforms, healthcare systems, pharmaceutical and standards organizations to help us design the solutions.”

DiME has reportedly seen a 665 percent increase in the number of unique digital endpoints used in clinical programs over the past two years, pointing to a surge of interest in mHealth devices, including wearables, that can collect biometric data outside the healthcare setting. The development of those types of tools is especially important to the remote patient monitoring industry, which has seen programs increase from 10 percent to 20 percent and promises to continue growing.

“If we want to keep our current momentum, our industry will require a set of guidelines that address the considerations involved with integrating these data into platforms that manage study data or help clinicians guide patient care,” DiMe CEO Jennifer Goldsack said in the press release.

Along with DiMe, participants in the project include the FDA’s Center for Drug Evaluation and Research and its Center for Devices and Radiological Health, the Veterans Health Administration, Amazon Web Services, Evidation, Takeda, Oracle, the Moffitt Cancer Center and the IEEE Standards Association.

It’s not the first group launched to tackle the sensor market.

In September 2019, Nextbridge Health, Shimmer Research and Dr. Vincent van Hees unveiled the Open Wearables Initiative (OWEAR), which aims to create a common workplace for healthcare providers and researchers using mHealth sensors in wearables and other devices.

“Wearables, ingestible sensors and in-home monitoring technologies offer the opportunity to assess an individual's health continuously, objectively and in real time,” the group said in a press release. “As a result, they hold the potential to revolutionize health, healthcare, and health research. However, the lack of accepted endpoints is proving to be a major impediment to the adoption of these digital measures in clinical trials. OWEAR will leverage the work of thousands of researchers from academia, pharma, and other organizations during the past decade to facilitate the development of those requisite endpoints.”

DiMe has been busy lately. Earlier this month the group unveiled the Payer V1C Contracting Toolkit, designed to help virtual-first care programs negotiate payer coverage. In July it launched the Digital Health Measurement Collaborative Community (DATAcc), aimed at addressing “the challenge of diversity, equity and inclusion in digital health measurement.” And in January the organization joined forces with the American Telemedicine Association to launch the IMPACT (vIrtual-first Medical PrActice CollaboraTion) initiative, aimed at supporting virtual-first care providers.