On December 22, 2023, FDA issued final guidance–Digital Health Technologies for Remote Data Acquisition in Clinical Investigations. This final guidance is aimed at sponsors and others who may be involved in remote data acquisition for clinical trials to evaluate medical products. As digital health technologies (DHTs) used for remote data acquisition are playing a growing role in health care and offer important opportunities in clinical research the FDA is providing guidance for ensuring that technologies used are safe, appropriate, and store and transmit data appropriately. Highlights of the guidance are below.
Most DHTs used in clinical trials will be used to measure performance of daily activities, sleep, vital signs, and other monitoring. These are generally going to be considered either low risk devices or be exempt from the definition of a device. The DHT itself, used as a tool in a clinical trial, may need an Investigational Device Exemption (IDE).
The guidance considers the use of DHTs that are not cleared or approved. If the DHT is a device and poses a nonsignificant risk, an IDE application is not likely required. If a device does pose significant risk, but the information is disclosed in the NDA for a drug approval, an IDE may not be necessary.
Devices that are cleared or approved by FDA will not need an IDE submission if they are being used for the indications for use.
The selection of DHTs, and the outcomes they measure, should be considered carefully. FDA includes aspects like the clinical characteristics of the disease or condition, the trial population, and the user interface of the DHT.
Determining the signs to be measured may involve discussion with the review team, and developers of DHTs can pursue qualification of DHTs as a Drug Development Tool – including a Clinical Outcome Assessment Qualification — or Medical Device Development Tool. FDA reminds sponsors that the submission should include a description of the endpoints and a justification for selecting them.
When selecting the DHT, the performance characteristics of the tool should meet the sponsor’s minimum technical and performance specifications. New models or technologies may be released during the trial; in those cases, the sponsor may want to consider adding or amending the DHT to ensure it is fit for purpose.
FDA suggests that sponsors verify and validate the DHT. Verification is confirmation that the DHT accurately measures the parameter and validation is confirmation that the DHT appropriate assesses the clinical event or characteristic. For example, in a study that is measuring activity, verification would confirm that that DHT can accurately measure acceleration and distance, while validation would ensure that the DHT can measure gait and step count.
Considerations may also include the design of the tool, the ability for users to see their data, the power needs and the alerts of the tool.
In some cases, trial participants may already have a device that measures some or all of the fields needed. Sponsors should carefully consider the pros and cons of use of a patient’s own tool; regardless, sponsor-provided DHTs should be available to all participants.
Appropriate Data Policies
Part of selecting the right tool is to ensure that the data are appropriately stored and protected. Network availability, for example, may affect the ability of the DHT to transmit data.
FDA already considers cybersecurity in device applications. The guidance reminds sponsors that they should take measures to manage cybersecurity risks, prevent unauthorized access to data and ensure privacy and security.
The flow of data necessitates that the connect systems can exchange information. FDA recommends the use of public data exchange standards.
When FDA reviews the data, it may need only the master file. However, the submission should include information about the flow of data from the DHT to the durable electronic repository. FDA will also want information about data management, including collection, storage, transmission and archiving. FDA discusses record retention policies.
Sponsors that want to use DHTs for clinical investigations should review the guidance to ensure they are considering and addressing issues identified by the FDA, and should engage early with the appropriate Center responsible for the medical product under investigation to discuss use of DHTs in a specific clinical investigation.