FDA Releases Framework for Digital Health Technology Standards

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September 1, 2023

Agency outlines stakeholder engagement and internal processes for evaluating the reliability of digital health technologies for drug development

The Food and Drug Administration has published a "Framework for the Use of Digital Health Technologies in Drug and Biological Product Development." The release of the framework is one of several stakeholder activities FDA is now carrying out to support the crucial role digital health technologies (DHTs) are playing in clinical drug development.

The 19-page document details the steps the agency is undertaking to address the many challenges that arise when incorporating DHTs and DHT-derived data into regulatory decision-making. These steps include providing training in the verification and validation of DHT measurements as well as hiring new staff and building domain expertise for artificial intelligence algorithms and DHT computing platforms.

Agency to update tech capabilities for handling DHT-based submissions

To better support submissions, the FDA framework also details how the agency will enhance specific abilities that are crucial for receiving and analyzing DHT data to support regulatory decisions. This includes upgrading internal systems, establishing secure cloud technologies, and developing data standards to handle large volumes of datasets from drug trials conducted using DHTs. 

In addition, the framework lists relevant guidance documents for DHTs such as the guidance FDA released earlier this year for conducting decentralized clinical trials (DCTs).

FDA to hold meetings with sponsors, stakeholders, and general public

To support drug development and review, the agency framework also states that engagement discussions between FDA and sponsors about the use of DHTs will take place across the different stages of drug development to address trial endpoints, verification, and the selection of DHTs for clinical investigations.  

On the public-facing side, the FDA framework also announces the agency's commitment to holding five public meetings or workshops throughout the remainder of 2023 with key stakeholders, including patients, biopharmaceutical companies, DHT companies, and academia, to gather feedback on the use of DHTs and their data-processing techniques, validation methods, and use of AI and machine learning algorithms. 

In March, FDA held the first of these public workshops focused on the potential of DHTs to increase clinical trial accessibility and diversity and to expand the type of data that can be captured in trials. 

In addition, the framework explains the role of the DHT Steering Committee in providing advice on the general feasibility of DHTs and the implementation of DCTs not associated with a specific drug development program. The collaborative makeup of the steering committee includes senior staff from the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health in Drug and Biological Product Development.

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