Digital Health Technologies Use in Clinical Trials: Support from MAHA and Defined Expectations from FDA’s Final Guidance

Digital health technologies (DHT) are a key aspect of U.S. Health & Human Services (HHS) Secretary Robert F. Kennedy Jr.’s Make America Healthy Again (MAHA) agenda. DHTs are health care focused technology systems using computing platforms, connectivity, software, and/or sensors, to perform one or more functions. These include wearable devices like smartwatches, fitness trackers, blood pressure or blood glucose monitors and more. In fact, earlier this year, Secretary Kennedy told House of Representatives Committee members that his goal is to have all Americans using DHT within the next four years. This is part of a larger push to increase quality of care by incorporating more telemedicine and artificial intelligence into the health care space.

As DHTs have become more common in the personal health care space, they have also gained popularity in clinical trials. One of the many benefits of DHTs in the context of clinical trials is the ability to remotely capture data from trial participants wherever they are, which allows for more frequent or continuous data collection, offering a broader picture about the patient.

In line with HHS’s push towards increased use of DHTs, the U.S. Food & Drug Administration (FDA) released its final guidance on DHT for Remote Data Acquisition in Clinical Investigations in July 2024 (Final Guidance). This comprehensive guidance provides recommendations on the use of DHTs to acquire data remotely from participants in clinical trials that evaluate medical products. The Final Guidance provides recommendations for ensuring that a DHT is fit-for-purpose (i.e., that the level of validation associated with the DHT is sufficient to support the use), including the interpretability of its data in the clinical investigation. This analysis involves considerations of both the DHT’s form (i.e., design) and function (i.e., distinct purpose(s) within the investigation). Utilizing DHTs to capture and transmit data remotely increases opportunities for individuals to participate in decentralized clinical trials and provides for the inclusion of diverse and underrepresented populations.

In the Final Guidance, the FDA puts forth considerations for using DHTs in clinical trials to ensure the DHT is fit-for-purpose and how to choose suitable DHTs for clinical trials. The Final Guidance also describes regulatory submission to FDA that include DHTs, verification and validation requirements and use of DHTs in a clinical trial setting, and record protection and retention of data when using DHTs.

An overview of the Final Guidance is provided below:

Selection of a DHT and Rationale for Use in a Clinical Investigation

The Final Guidance outlines how to choose suitable DHTs for clinical trials and includes a glossary, as well as examples illustrating various types of DHTs. Key considerations include the clinical event or characteristic of the disease or condition of interest, the clinical trial population, minimum DHT technical and performance specifications, design and operation of DHTs and other technologies, and the use of a participant’s own DHTs and/or other technologies (such as continuous glucose monitors and smartphones or tablets). The Final Guidance prioritizes choosing DHTs that enhance the trial’s effectiveness while ensuring participant safety and data integrity.

DHT Description in a Submission

In clinical trial submissions involving DHTs, sponsors should detail how the DHT is appropriate for the study. This includes describing the DHT’s design, technological aspects, data output, and how the DHT measures relevant clinical events or characteristics. Additionally, the sponsor should outline the data flow from the DHT to the data repository and discuss usability aspects like the user interface and device maintenance. Finally, privacy and data management processes, including collection, storage, transmission, and archiving, must be detailed to demonstrate data integrity and confidentiality.

Evaluations of DHTs

DHTs must be verified and validated for clinical investigations. Verification involves ensuring DHTs accurately measure parameters like acceleration or temperature, while validation confirms the DHT appropriately assesses clinical events or characteristics in the target population (e.g., step count or heart rate). The process includes testing DHTs under various conditions, evaluating calibration processes, and ensuring consistent measurements across different DHTs. Usability evaluations are also vital to ensure the DHT can be efficiently used by trial participants in remote settings while maintaining accuracy and participant engagement. This comprehensive process ensures the suitability and reliability of DHTs for clinical trials.

Evaluation of Endpoints Involving Data Collected Using DHTs

The FDA emphasizes the need for clearly defining reliable endpoints in clinical trials using data from DHTs. The Final Guidance discusses general principles for justifying various types of endpoints (i.e., primary, secondary, and exploratory) and the importance of obtaining input from interested parties (e.g., patients, caregivers, and engineers) to ensure clinical relevance and adequate data capture by DHTs. Established endpoints using DHTs may not require new justifications, but verification and validation are still necessary. Novel endpoints offer insights into patient functions or performance over time and in various settings. Justifying use of novel endpoints involves considering the endpoint’s relevance to patient experiences and its relationship to similar, established endpoints.

Statistical Analysis and Trial Design Considerations

The FDA evaluates DHT data based on factors like endpoints, medical products, and patient populations. Data analyses should be part of a statistical analysis plan, ensuring consistent data collection methods across study arms. Non-inferiority trial designs, trials that aim to demonstrate that a new treatment is not worse than an existing treatment by a pre-specified margin, may be unsuitable when effect sizes have not been established using similar DHT measurements. Endpoints and source data must be prespecified in the plan. Late-phase trials should use the estimand framework for treatment effect description (e.g., describing the treatment effect associated with the clinical trial objective). The plan should account for events affecting data collection or endpoint interpretation, address missing data, and define strategies for handling technology changes and compliance issues.

Risk Considerations When Using DHTs

Sponsors, investigators, and institutional review boards should consider the risks associated with using DHTs in clinical trials. The Final Guidance categorizes risks into clinical and privacy-related concerns, emphasizing the importance of evaluating these risks, communicating them in informed consent documents, and addressing them in submissions. Key points include assessing physical risks of DHTs, potential for erroneous measurements affecting treatment, cybersecurity threats, privacy breaches, and informed consent requirements. The informed consent process must detail foreseeable risks, data usage, participant action in case of abnormal events, data access, privacy measures, additional costs, and implications of end-user license agreements or terms of service.

Record Protection and Retention of Data When Using DHTs

When using DHTs, data and metadata should be securely transferred and stored in a durable electronic data repository. The FDA’s regulations require specific record retention for clinical investigators and sponsors, which includes the inspection of records. The FDA’s guidance on electronic systems in clinical investigations addresses remote data capture via DHTs, including issues of access control and audit trails. Sponsors should discuss with the FDA the type of DHT data to be submitted. Data, including associated metadata, should be maintained according to the FDA’s record retention requirements and be in a human-readable format. Source data from DHTs should be available for inspection, and clinical investigators are responsible for reviewing and retaining these data.

The FDA’s guidance on DHTs for remote data acquisition significantly impact decentralized clinical trials. Decentralized trials rely on technologies to collect data remotely, reducing the need for physical site visits. By providing a framework for selecting, validating, and using DHTs, these guidance documents help ensure the reliability and regulatory compliance of data collected in such trials. This can lead to more efficient, accessible, and patient-centric clinical research, as DHTs enable broader participation and real-time data collection, vital for the success of decentralized trials.

These changes are consistent with larger White House initiatives to increase the use of advanced technology and particularly AI and wearable technologies in the health care space. For example, on July 30, 2025, President Trump and several key health advisors including HHS Secretary Robert F. Kennedy, Jr. and Centers for Medicare & Medicaid Services Administrator Dr. Mehmet Oz, held a “Make Health Tech Great Again” event. The event called on key industry leaders from technology firms, such as Amazon, Anthropic, Apple, Google, and OpenAI, to “begin laying the foundation for a next-generation digital health ecosystem that will improve patient outcomes, reduce provider burden, and drive value.”

Conclusion

The FDA’s guidance on DHTs in clinical investigations and the Make Health Tech Great Again event signal the current administration’s interest in pursuing advanced technologies in the health care space. To this end, technology firms and other key stakeholders will want to pay close attention to trends and regulatory changes in the digital health technology space. Entities sponsoring clinical trials may also see opportunities in this renewed area of focus. Foley continues to monitor digital health technology trends and developments across the country.

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