FDA Creates Advisory Committee for Digital Health Technology

The United States Food and Drug Administration has created a Digital Health Advisory Committee to support the agency’s efforts to explore the scientific and technical issues related to using digital health technologies.

The use of digital health technologies has skyrocketed in recent years. According to a 2022 Rock Health survey, 80 percent of 8,014 US adults polled said they accessed care via telehealth at some point, and 46 percent reported owning a wearable device.

Another survey showed an increase in digital health adoption among healthcare providers. Conducted by the American Medical Association (AMA), the survey polled 1,300 US physicians. The survey revealed that the average number of tools used by a single physician grew from 2.2 in 2016 to 3.8 in 2022. Additionally, 93 percent of physicians said digital health tools offer significant advantages in patient care.

Amid this rise in popularity and use of digital health technology, the FDA aims to encourage innovation while ensuring that the technologies being developed are safe and effective. These technologies include remote patient monitoring, artificial intelligence/machine learning (AI/ML), augmented reality, virtual reality, digital therapeutics, and wearable devices.

“Many of these technologies are novel and tend to rapidly change; it’s our duty to seek as much knowledge on them as possible as we determine and implement appropriate regulation to encourage innovation while protecting public health,” said Troy Tazbaz, director of the FDA’s Digital Health Center of Excellence, in the press release.

The committee will comprise nine voting members, including a chair, with a wide array of technical and scientific expertise. The FDA will solicit views and advice from the committee to support the regulation of digital health technology in ways that enhance safety, efficacy, and health equity.

The committee aims to improve the FDA's understanding of the benefits, risks, and clinical outcomes associated with digital health technologies and help the agency identify risks, barriers, or unintended consequences of proposed or established FDA policies or regulations. This could include advice on using digital health technologies in clinical trials or post-market studies subject to FDA regulation.

“As one of our strategic priorities, our goal is to advance health equity in part through expanding access by bringing prevention, wellness and healthcare to all people where they live – at home, at work, in big cities and rural communities,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, in the press release. “Digital health technologies are critical for achieving this transformation in care delivery. As digital health technologies advance, the FDA must capitalize on knowledge from inside and outside of the agency to help ensure we appropriately apply our regulatory authority in a way that protects patient health while continuing to support innovation.”

Concerns around biases, data privacy, and information security related to digital health technology use have been growing.

A study published last year showed that AI models can accurately detect self-reported racial identity using medical images, but the mechanisms they use to do so are unclear to researchers, indicating that models already in use may accidentally exacerbate health disparities.

The researchers gathered images from public and private datasets to assess the models’ performance on varied imaging data. They found they could not identify any image-based variables or proxies for race that could explain the high performance of the models in detecting race across all image types and datasets, increasing the risk of bias.

Further, healthcare data breaches have proliferated, with breaches increasingly occurring within the digital health technology arena.

In 2021, more than 61 million fitness tracker records from Apple and Fitbit were exposed in a wearable device data breach. The breach stemmed from GetHealth, a New York-based health and wellness company that allows users to unify their wearable device, medical device, and app data. The exposed data belonged to wearable device users worldwide and contained names, birthdates, weight, height, gender, and geographical location.