FDA Releases New Draft Guidance for the Use of Digital Health Technologies in Clinical Trials

In December 2021, FDA issued draft guidance document titled “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations.” The guidance discusses the proper use of digital health technology (DHT) for remote acquisition of clinical trial data. What is DHT?  It is hardware or software that collects data from clinical, physiological, behavioral, and functional studies. FDA does not regulate all DHT products. Rather, the product must meet the definition of a medical device to fall under the purview of FDA. In the early days of the pandemic, COVID-19 halted many clinical trials and created difficulties for others that were already underway. In some instances, clinical trials moved forward with the use of DHT, which enabled investigators to circumvent the traditional in-person methods of data collection, which potentially would have created dangerous exposures to COVID-19.

Clinical trials, generally speaking, have benefited from the new emphasis on DHT during the COVID-19 pandemic. The continuous feedback this technology provides can paint a more accurate picture of the use and functionality of a medical product in a study subject’s daily life. Additionally, DHT allows us to address issues often associated with the accessibility and diversity of centralized trials. Participation in traditional clinical trials is often not an option for patients with travel burdens, physical or cognitive limitations, and time constraints, but the use of DHT, and the remote monitoring it enables, has helped overcome some of these hurdles.

The draft guidance discusses recommendations for using DHTs during clinical trials for medical devices. It address: selection of suitable DHTs, verification and validation, the use of DHTs to collect data for trial endpoints, identifying risks associated with use, and risk management. [i] FDA makes several important recommendations, but one key recommendation is the importance of human factors engineering when using DHTs for clinical investigations. The misuse of digital health technology could easily result in faulty data, which will create products liability problems downstream. For this reason, it is important to understand the digital literacy of the user, accessibility concerns, the portability of the device, the power life, the environment in which the device will be used, and the privacy.

For more information, please see Medmarc’s webinar series on human factors engineering which is accessible here [video 1] and here [video 2]. Clinical trials will likely continue to make use of DHTs increasingly, however DHTs will create a whole new exposure that will require FDA regulation and oversight. To ensure your clinical trial is not halted or found to be noncompliant, continue to remain abreast of new FDA guidance documents, ensure timely submission of data to FDA, and consult with legal counsel regarding complex new requirements.

Interested parties, investigators, and other stakeholders may submit comments on the guidance by March 22, 2022.