Understanding the FDA's views on use of digital health technologies in clinical trials

In December 2021, The U.S. Food and Drug Administration released draft guidance for industry and investigators about best practices for acquiring data from digital health technologies (DHTs) during clinical investigations.

Reviewing criteria listed in the document — which is open for public comment until March 23, 2022 — can help journalists better understand the agency’s views on this topic and provide them with key points to consider when reporting on studies about DHTs.

“Importantly, the guidance zeroes in on the need to clearly outline how data collected from participants will be analyzed and used, and to make sure participants understand the privacy risks,” wrote the co-authors of STAT’s Health Tech electronic newsletter. “It also lays out details that should be addressed in obtaining informed consent, such as an explanation of who will have access to data collected during and after the trial.”

In the guidance, the FDA defines DHT as a system that uses computing platforms, connectivity, software and/or sensors for health care and related uses. DHTs allow for the continuous or intermittent recording of physiological data such as blood pressure, physical activity or glucose levels. The category also includes software applications such as those used to collect patient-reported outcomes. Data captured by DHTs can often be transmitted directly to investigators or other authorized parties remotely.

DHTs are playing a growing role in health care and provide opportunities to record data directly from trial participants wherever they may be, the guidance noted. They also may facilitate the collection of information from participants who can’t report their experiences, such as infants or those with cognitive impairments.

Compared to intermittent trial visits, the authors wrote, the use of DHTs to remotely collect data from trial participants may allow for continuous or more frequent data collection, which “may provide a broader picture of how participants feel or function in their daily lives.”

In choosing an appropriate DHT, the FDA suggested study sponsors consider the clinical event or characteristic of the disease or condition to be studied and the proposed trial population and characteristics of the DHT that may influence participant use. They also should consider whether DHTs already owned by participants, such as smartphones or watches, may be appropriate.

Some of the recommendations in the guidance are:

Physical features of the DHT should be evaluated for risk of injury. If applicable, instructions for cleaning a DHT before and after use should be provided to study participants to prevent infection or other adverse events.
Sponsors should consider cybersecurity risks that could impact the functionality of a DHT and/or compromise patient privacy. They also should address the risk of potential disclosure of identifiable information about patients and ensure security safeguards are in place to secure data to prevent access by malicious parties.
Investigators must describe any “reasonably foreseeable risks or discomforts” to study participants during the informed consent process. The informed consent process also should explain the type of information that will be collected by the DHT and how that information will be used and monitored. Study participants should be informed of what actions to take in case of any concerning sign or symptom detected by a DHT.
Relevant data captured from DHTs should be securely transferred to and retained in an electronic repository as part of the record of the clinical investigation.
To help ensure the quality and the integrity of the data as well as adequate protection of trial participants, study sponsors should ensure proper training of trial participants and study personnel on using DHTs, develop a plan for technical assistance and develop a risk management plan to address potential problems such as loss or damage of a DHT. They also should develop a safety monitoring plan that addresses how abnormal measurements related to participants’ safety measured by DHTs will be reviewed and managed.

The document does not have the force and effect of law and is not meant to bind the public in any way, authors wrote. It is intended only to provide clarity to the public and should be viewed as guidance. Still, journalists could use these points as a springboard for questions to ask principal investigators in their studies of digital health technologies.

Even if the guidance is never finalized, “as often happens with FDA guidance documents, [it] offers important insights into how the FDA thinks its existing regulations apply to digital health technologies used in clinical investigations,” according to a summary of the document’s key points published by law firm Bass, Berry and Sims.

It’s not the only release from the FDA in this arena. In October 2021, the agency released a list of “guiding principles” to help promote the safe, effective development of high-quality medical devices that use artificial intelligence and machine learning. Among their 10 points are that clinical study participants and data sets are representative of the intended target patient population and that testing demonstrates the device’s performance during clinically relevant conditions.

The FDA has weighed in on the development and oversight of artificial intelligence and machine learning-driven health tools several times over the past few years, according to an article in Healthcare IT News, especially where bias is concerned. This includes an AI/ML-Based Software as a Medical Device Action Plan, released in January 2021, which outlined several actions the FDA plans to take.

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