Episode 4: Summary of the FDA Guidance on Digital Health Technologies in Clinical Investigations

In December 2023 the FDA issued a guidance document on Digital Health Technologies for Remote Data Acquisition in Clinical Investigations.

The guidance provides recommendations for sponsors, investigators, and stakeholders on using digital health technologies (DHTs) for remote data acquisition from participants in clinical trials evaluating medical products. DHTs can include hardware and software for functions like measuring biomarkers or administering clinical outcome assessments remotely.

There are some Regulatory Considerations:

Some DHTs may meet the definition of a medical device under the FDA regulation. Depending on the risk level, an investigational device exemption (IDE) may or may not be required for using a DHT in a clinical trial. Sponsors should engage early with the relevant CDRH Digital Health Center of Excellence to discuss using specific DHTs.

When selecting and describing DHTs sponsors should consider the trial population, technical specifications, design or operation, and whether participants can use their own DHTs when selecting a device. Submissions should describe the DHT, its intended functions, verification or validation of data, and data flow or management plans.

In regards to the verification of DHTs it should confirm that the DHT measures the intended parameter accurately. The validation should confirm that the DHT appropriately measures the clinical events or characteristics in the study population. And the usability studies should assess if participants can properly use the DHT as intended.

If DHTs are being used for endpoints sponsors should precisely define endpoints using DHT data and justify novel endpoints which could not be easily measured previously. Factors like measuring in-home versus within the clinic, continuous data, and endpoint acceptability should be considered.

For statistical considerations endpoints should be defined, as well as the handling of missing data. Data quality should be ensured and  technology changes should be accounted for in the statistical analysis plan.

Also, potential clinical risks (e.g. erroneous measurements) and privacy risks (e.g. data breaches)should be considered and mitigated. Participants should be informed of risks and data sharing through the informed consent process.

DHT data should be securely transferred to a durable electronic repository considered as the source data. The data should be retained per applicable regulations and available for FDA inspection. 

Sponsors should develop plans for training, technical support, risk management, safety monitoring, and handling software updates or DHT errors.

Investigators should train and monitor participants, ensure informed consent, and review safety data.

The guidance covers key issues for ensuring DHTs are fit-for-purpose and can support high-quality remote data acquisition in clinical trials while protecting participants.