FDA Addresses the Role of Digital Health Technology in Clinical Trials

11 January 2022 Health Care Law Today Blog
Author(s): Jessa Boubker Kyle Y. Faget

The U.S. Food & Drug Administration (FDA) recently issued draft guidance regarding the use of digital health technology (DHT) for the remote acquisition of clinical trial data.

DHT can take the form of hardware and software, and is capable of collecting a wide range of clinical, physiological, psychological, behavioral, and functional data. A single clinical investigation can use multiple DHTs to collect such data. Instead of waiting for each study subject brick-and-mortar office visit, a study subject participant can provide real time DHT data to clinical trial investigators. Continuous feedback can paint a more accurate picture of the use and functionality of a medical product in a study subjects’ daily life. Remote monitoring and data collection can help address significant issues associated with the accessibility and diversity of centralized trials, which often restrict opportunities for patients to participate in clinical trials due to issues such as travel burdens, physical or cognitive limitations, and time constraints.

DHT software often runs on everyday computing platforms, such as mobile phones, tablets, or smart watches. DHT software can transform an everyday device into a medical device. A DHT product may use sensor hardware for continuous or intermittent monitoring, such as blood pressure or glucose levels, and use algorithms to translate the results. The FDA, however, does not regulate all DHT products because the products do not always meet the definition of a medical device, e.g., a general wellness device.

FDA Draft Guidance Recommendations

The draft guidance outlines recommendations for using DHTs in clinical investigations for the evaluation of medical products. The draft guidance addresses: (1) selection of suitable DHTs; (2) verification and validation of DHTs; (3) use of DHTs to collect data for trial endpoints; (4) identifying risks associated with using DHTs; and (5) managing those risks.

FDA recommends sponsors ensure a DHT is “fit-for-purpose” through verification and validation. Verification means that the DHT measures the physical parameters accurately and precisely. Validation means that the DHT appropriately assesses the clinical event or characteristic in the proposed population. Sponsors should explain why a DHT is “fit-for-purpose” in its clinical investigation submission. The sponsor should consider the clinical investigation population (e.g., digital literacy and accessibility concerns), the design and operation of the DHT (e.g., portability, power life, storage capacity, environment, privacy/security, etc.), and the pros and cons of using the study subjects’ own computing platform.

Sponsors should clarify how they collect and use data and actively monitor and evaluate risks. The applicable informed consent should clearly identify the data being collected and how that data will be used. Sponsors should discuss data collection in a statistical analysis plan, and consider any other risks associated with the use of DHTs for data collection, such as clinical risks and privacy-related risks. Moreover, the sponsor should appropriately protect and retain electronic records.  Investigators should train participants and personnel on how to appropriately use the DHT.

DHT has the power to transform certain forms of clinical research and provide new opportunities to obtain real-world data. DHT is only valuable, however, if it is accurately assessing and evaluating the appropriate target data within the unique context of the target patient population.

The FDA encourages stakeholders to submit comments under docket number FDA-2021-D-1128. The last day to submit comments is March 22, 2022.

Foley is here to help you address the short- and long-term impacts in the wake of regulatory changes. We have the resources to help you navigate these and other important legal considerations related to business operations and industry-specific issues. Please reach out to the authors, your Foley relationship partner, or to our Health Care Practice Group with any questions.

This blog is made available by Foley & Lardner LLP (“Foley” or “the Firm”) for informational purposes only. It is not meant to convey the Firm’s legal position on behalf of any client, nor is it intended to convey specific legal advice. Any opinions expressed in this article do not necessarily reflect the views of Foley & Lardner LLP, its partners, or its clients. Accordingly, do not act upon this information without seeking counsel from a licensed attorney. This blog is not intended to create, and receipt of it does not constitute, an attorney-client relationship. Communicating with Foley through this website by email, blog post, or otherwise, does not create an attorney-client relationship for any legal matter. Therefore, any communication or material you transmit to Foley through this blog, whether by email, blog post or any other manner, will not be treated as confidential or proprietary. The information on this blog is published “AS IS” and is not guaranteed to be complete, accurate, and or up-to-date. Foley makes no representations or warranties of any kind, express or implied, as to the operation or content of the site. Foley expressly disclaims all other guarantees, warranties, conditions and representations of any kind, either express or implied, whether arising under any statute, law, commercial use or otherwise, including implied warranties of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Foley or any of its partners, officers, employees, agents or affiliates be liable, directly or indirectly, under any theory of law (contract, tort, negligence or otherwise), to you or anyone else, for any claims, losses or damages, direct, indirect special, incidental, punitive or consequential, resulting from or occasioned by the creation, use of or reliance on this site (including information and other content) or any third party websites or the information, resources or material accessed through any such websites. In some jurisdictions, the contents of this blog may be considered Attorney Advertising. If applicable, please note that prior results do not guarantee a similar outcome. Photographs are for dramatization purposes only and may include models. Likenesses do not necessarily imply current client, partnership or employee status.