FDA's Digital Health Technologies Framework Addresses Important Challenges

By Chad Landmon & Gabriella McIntyre

Government agencies are in a constant race to keep up with the ever-quickening pace of innovation, particularly with respect to medical technologies and especially as industry increasingly utilizes nascent AI-based tools. In March 2023, CDER and CBER published a Framework for the Use of Digital Health Technologies (DHTs) in Drug and Biological Product Development (the “Framework”) to “guide the use of DHT-derived data in regulatory decision making for drugs and biological products.” This framework goes part of the way in satisfying the FDA’s commitments promised under the PDUFA VII and addresses a few important challenges associated with the use of DHTs in drug, device, and biologics product development. Here is what you need to know.

What Are DHTs?

According to the FDA, DHT is a general term that describes “a system that uses computing platforms, connectivity, software, and sensors for healthcare and related uses,” such as for general wellness, clinical trials, or medical device applications. DHTs include “technologies intended for use as a medical product, in a medical product, or as an adjunct to other medical products” and can be used “to develop or study medical products.” They can take the form of hardware or software, and those already in existence are capable of accurately monitoring continuous physiological or behavioral data. Examples of DHTs include continuous glucose monitoring devices and blood pressure readers that are compatible with and viewable on computing devices like mobile phones, tablets, and smart watches. DHTs can remotely obtain, store, and ultimately analyze clinically relevant information from their source subjects (particularly when AI-enabled). Thus, DHTs “provide opportunities for more efficient drug development” and review, particularly in the realm of clinical research and trials. But, as with all technology, DHTs are not without challenges.

Challenges Associated With DHT Regulation

Naturally, the very function of DHTs poses privacy risks to their users’ medically sensitive data. Additionally, questions about the efficacy of user-dependent data and misuse or misunderstanding by the end users may skew clinical results and affect data quality. As innovation in this area continues and more FDA submissions rely on data derived from DHTs, the agency will need to enhance its review protocols to evaluate these sorts of data, the appropriate application of AI technology to such data, and any crossover privacy compliance issues they present.

The Proposed Framework

The FDA proposes both internal and external programs to support DHT-related developments and address the challenges iterated above.

Internal Programs

The agency has established a steering committee to shepherd its DHT-related commitments and oversee policy developments to “ensure that DHT-based data are fit for the intended purpose.”  The committee is composed of senior staff from CDER, CBER, and CDRH (Center for Devices and Radiological Health) who will: (1) make recommendations and support the framework’s implementation through public meetings, guidance documents, demonstration projects, and training; (2) gather information about DHT developments and challenges; and (3) make policy recommendations. The committee also will oversee and coordinate the development of a consistent approach for reviewing drug submissions containing DHT-derived data across single studies or multiple studies based on the same DHT-derived measurements.

The FDA also commits to “build on its technical expertise and develop training within the human drugs and biological products programs to enhance internal knowledge regarding the DHTs in drug development.”  It will focus on verifying and validating — with assistance from domain-specific experts — the accuracy and reliability of DHT-derived data and the statistical considerations necessary to properly analyze such data. It also will focus on normalizing technical and performance specifications to ensure consistency, accuracy, and precision across household/personal DHT devices. In a more practical sense, the FDA also will consider the impact of software updates on ongoing clinical investigations.

DHTs have and will continue to generate vast amounts of clinical data. AI and machine learning can be employed to digest these data into important clinical insights. The FDA intends to build its expertise in “data science, informatics, statistics, and mathematics to help ensure the appropriate application of AI technology in the context of DHTs used for drug development.”  To that end, the agency commits to enhance its IT capabilities to receive and analyze large swaths of data used to support regulatory submissions.

Each of these internal objectives will require new staff hires capable of furthering the steering committee’s objectives.

External Programs

Externally, the FDA will engage stakeholders, such as sponsors, patient advocacy groups, DHT companies, clinical investigators, international regulatory bodies, and professional societies to help further implement its Framework. The agency has already published and alluded to additional draft guidances to clarify its thinking on several DHT topics. These guidances address the use of DHTs in clinical investigations, authenticity and confidentiality of electronic DHT-derived data, and acceptable labeling methods for use-related DHT software. The FDA will further its goals by engaging stakeholders at public meetings and demonstrations — the first of which will take place at the end of the second quarter of fiscal year 2023.

Although the Framework is not technically a guidance and is not binding on the agency, it certainly helps to clarify the FDA’s priorities with respect to integrating emerging technologies that will enhance clinical and patient experiences while also acknowledging the challenges associated with these technologies. The agency will consider comments on the Framework submitted through May 23, 2023, and the public and stakeholders are encouraged to weigh in on additional challenges or considerations associated with this approach to DHTs. As these technologies continue to develop and become more commonly used, it will be increasingly important for industry to engage with the FDA as it assesses and implements its policies.

About The Authors:

Chad Landmon is a partner at Axinn, Veltrop & Harkrider LLP, where he chairs the firm’s Intellectual Property and FDA Practice Groups and focuses his practice on IP and FDA issues faced by life sciences companies.

Gabriella McIntyre is an associate in Axinn’s Intellectual Property and FDA practice groups.