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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