The U.S. Food & Drug Administration (FDA) recently issued draft guidance regarding the use of digital health technology (DHT) for the remote acquisition of clinical trial data.

DHT can take the form of hardware and software, and is capable of collecting a wide range of clinical, physiological, psychological, behavioral, and functional data. A single clinical investigation can use multiple DHTs to collect such data. Instead of waiting for each study subject brick-and-mortar office visit, a study subject participant can provide real time DHT data to clinical trial investigators. Continuous feedback can paint a more accurate picture of the use and functionality of a medical product in a study subjects’ daily life. Remote monitoring and data collection can help address significant issues associated with the accessibility and diversity of centralized trials, which often restrict opportunities for patients to participate in clinical trials due to issues such as travel burdens, physical or cognitive limitations, and time constraints.

DHT software often runs on everyday computing platforms, such as mobile phones, tablets, or smart watches. DHT software can transform an everyday device into a medical device. A DHT product may use sensor hardware for continuous or intermittent monitoring, such as blood pressure or glucose levels, and use algorithms to translate the results. The FDA, however, does not regulate all DHT products because the products do not always meet the definition of a medical device, e.g., a general wellness device.

FDA Draft Guidance Recommendations

The draft guidance outlines recommendations for using DHTs in clinical investigations for the evaluation of medical products. The draft guidance addresses: (1) selection of suitable DHTs; (2) verification and validation of DHTs; (3) use of DHTs to collect data for trial endpoints; (4) identifying risks associated with using DHTs; and (5) managing those risks.

FDA recommends sponsors ensure a DHT is “fit-for-purpose” through verification and validation. Verification means that the DHT measures the physical parameters accurately and precisely. Validation means that the DHT appropriately assesses the clinical event or characteristic in the proposed population. Sponsors should explain why a DHT is “fit-for-purpose” in its clinical investigation submission. The sponsor should consider the clinical investigation population (e.g., digital literacy and accessibility concerns), the design and operation of the DHT (e.g., portability, power life, storage capacity, environment, privacy/security, etc.), and the pros and cons of using the study subjects’ own computing platform.

Sponsors should clarify how they collect and use data and actively monitor and evaluate risks. The applicable informed consent should clearly identify the data being collected and how that data will be used. Sponsors should discuss data collection in a statistical analysis plan, and consider any other risks associated with the use of DHTs for data collection, such as clinical risks and privacy-related risks. Moreover, the sponsor should appropriately protect and retain electronic records.  Investigators should train participants and personnel on how to appropriately use the DHT.

DHT has the power to transform certain forms of clinical research and provide new opportunities to obtain real-world data. DHT is only valuable, however, if it is accurately assessing and evaluating the appropriate target data within the unique context of the target patient population.

The FDA encourages stakeholders to submit comments under docket number FDA-2021-D-1128. The last day to submit comments is March 22, 2022.