A newly minted collaborative of industry, government, and patient groups is seeking to develop a set of best practices that will help make digital health measurement technologies work for all users, regardless of gender, race, ethnicity, and other factors.
The Digital Health Measurement Collaborative Community (DATAcc), launched in May 2021, is hosted by the nonprofit Digital Medicine Society (DiMe) and brings together more than 30 organizations, including the US Food and Drug Administration’s Center for Devices and Radiological Health. In July 2021, DATAcc announced its inaugural moves to promote health equity in the digital health technology arena.
In its first initiative, DATAcc aims to ensure that technology developers get input from a diverse group of potential users – across race, ethnicity, age, disability status, gender, geography, socioeconomic status, education level, health status and sexual orientation – at each stage in the product lifecycle. The second effort will focus on standardizing the evaluation of inclusivity in the development process, as well as product deployment and commercialization.
The goal is to create a roadmap of the best practices for inclusion throughout the lifecycle of a digital health measurement product and then hold everyone in the process accountable for adhering to those principles, Jennifer Goldsack, CEO of DiMe, told Focus. “There’s a moment in time where we can be intentional, and we can build the field of digital health to be inclusive from the start.”
Within the field of digital health measurement there are new concerns related to trust, digital literacy, and access, Goldsack said. “We don’t have a deep understanding of those yet because this is an early field.”
Goldsack described DATAcc’s timeline for these initial projects as “aggressive” with some output expected in the first half of 2022.
She said that without a focus on inclusion, these technologies will only be able to serve an “average” user, falling short of their full potential impact in health care.
The issue of potential racial and gender bias is not new in the medical device field. A recent perspective in the journal Science raised the issue of physical, computational, and interpretation bias in medical devices such as pulse oximeters (RELATED: How to reduce bias, improve fairness in medical devices, Regulatory Focus 07 April 2021).
Developers are also grappling with standards for artificial intelligence algorithms being used in clinical trials, including issues of ensuring diversity within training and validation datasets and potential biases that may be “baked in” to the algorithms themselves (RELATED: CONSORT-AI sets standards for reporting on artificial intelligence in trials, Regulatory Focus 25 September 2020).
The DATAcc effort won’t be starting entirely from scratch, Goldsack said. She pointed to the successful efforts of regulators to address cybersecurity risks in the medical device field as a starting point. But she added that the efforts around digital inclusion should not be limited to regulated medical devices. “I think that we need to think more about global best practice when it comes to digital tools, regulated or otherwise, and recognize that if we take that approach, it can further augment the power of medical devices and assorted regulated products,” she said.
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