As technology advances, the use of Digital Health Technologies (DHTs) in clinical research is becoming more widespread.2023 In December 2023, the U.S. Food and Drug Administration (FDA) released a guidance for industry, researchers, and other stakeholders aimed at providing information on the use of DHTs for remote data collection as a recommended practice.
DHTs are systems that utilize computing platforms, connectivity, software, and/or sensors for healthcare and related purposes. These technologies have a wide range of applications, from general health monitoring to use as part of a medical device.FDA’s guidance emphasizes the applicability of DHTs in clinical research, including their potential use in evaluating medical products. For example, DHTs can be used to measure biomarkers, administer Clinical Outcome Assessments (COAs), and provide for more frequent or continuous data collection, which can lead to a more complete understanding of how participants feel and function in their daily lives.
The FDA’s guidance discusses in detail regulatory considerations when using DHTs, communication with the agency, considerations when selecting and using DHTs, and how to validate, verify, and assess the usability of DHTs. In addition, the guidance addresses risk considerations when using DHTs for data collection, record protection and retention, and other considerations for using DHTs in clinical research.
A key point addressed in the guidance is that the use of DHTs should ensure that they are fit for purpose, i.e., the level of validation of DHTs should be sufficient to support their use in clinical studies, including the interpretability of the data.FDA encourages sponsors to collaborate with the DHT manufacturer or other interested parties to utilize available information to support the suitability of the DHTs for use in specific clinical studies. At the same time, sponsors should ensure that DHTs remain fit for purpose throughout their use in clinical studies.
In addition, the FDA guidance emphasizes the importance of considering participant privacy and data security when using DHTs in clinical research. This includes ensuring that data are secure during transmission and storage, as well as addressing events and issues that may affect data collection, quality, and analysis.
Overall, this FDA guidance provides a comprehensive framework and recommendations for the use of DHTs in clinical research aimed at ensuring the effectiveness, safety, and compliance of these technologies. As DHTs continue to advance and be used in healthcare, this guidance will have a significant impact on industry practices and help modernize medical product development and regulatory decision-making.