FDA Publishes Digital Health and Artificial Intelligence Glossary

October 11, 2024

Reading Time : 2 min

On September 26, 2024, FDA published a compilation of commonly used terms in the digital health, artificial intelligence (AI), and machine learning space and their definitions, available here.1   FDA intends the glossary to be used for general education purposes. The definitions are either directly from, or adapted from, various public sources, including consensus standard organizations and published literature, and FDA includes references to those sources in the glossary.

FDA publishes this glossary amid growing discussion of a need for a set of national standards applicable to AI.  The agency has already made notable progress in adapting its regulatory framework for AI’s novel attributes. As part of the glossary, the agency defines one of issues that continues to concern FDA: data drift. FDA defines “data drift” as “the change in the input data distribution a deployed model receives over time, which can cause the model’s performance to degrade. This occurs when the properties of the underlying data change. Data drift can affect the accuracy and reliability of predictive models.”  FDA explains that AI-enabled medical products can experience data drift due to statistical differences between the data used for model development and data used in clinical operation due to variations between medical practices or context of use between training and clinical use, and changes in patient demographics, disease trends and data collection methods over time. 

One way to avoid data drift is to conduct what FDA terms “AI performance monitoring.” FDA defines AI performance monitoring as the process of regularly collecting and analyzing data on the use of a deployed AI system to evaluate its performance in accomplishing its intended tasks in real-world settings.” Although this concept of AI performance monitoring is already incorporated into the total lifecycle management for AI-enabled medical devices, FDA has indicated that the agency needs expanded authority to adequately regulate the use of AI, in particular for AI-enabled medical devices.2

FDA plans routine updates to the glossary. FDA welcomes stakeholders to submit feedback by emailing digitalhealth@fda.hhs.gov.


1 FDA, Digital Health and Artificial Intelligence Glossary – Educational Resource (Sept. 26, 2024), https://www.fda.gov/science-research/artificial-intelligence-and-medical-products/fda-digital-health-and-artificial-intelligence-glossary-educational-resource.

2 Government Accountability Office (GAO), Federal Regulation: Selected Emerging Technologies Highlight the Need for Legislative Analysis and Enhanced Coordination, GAO-24-106122 (Jan. 25, 2024), https://www.gao.gov/products/gao-24-106122.

Share This Insight

Previous Entries

Eye on FDA

January 17, 2025

On January 6, 2025, the FDA released final guidance for industry entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers.” The guidance outlines FDA’s enforcement policy concerning certain firm-initiated communications of scientific information on unapproved uses (SIUU) of the firm’s approved or cleared medical products to health care providers involved in prescribing or administering those products to individual patients. It finalizes the October 2023 draft guidance, which itself revised draft guidance from 2014 and 2009. The latest guidance is not for current implementation and is pending the Office of Management and Budget’s (OMB) approval of the guidance’s information collection provisions.

...

Read More

Eye on FDA

January 16, 2025

On January 15, 2025, FDA announced an order revoking the listings providing for the use of the color additive FD&C Red No. 3 in both foods (including dietary supplements) and ingested drugs. The order is in response to a 2022 petition filed by the Center for Science in the Public Interest, among other food safety and health advocates, which asserted that the additive induces cancer in male rats and urged the agency to revoke authorization. 

...

Read More

Eye on FDA

January 14, 2025

On January 7, the FDA made available draft guidance on the development of drugs and biological products for weight reduction within the Center for Drug Evaluation and Research intended for reduction and long-term maintenance of body weight in patients with obesity or who are overweight. Notably, this draft guidance includes recommendations with respect to the clinical assessment of weight reduction drugs in both adults and pediatric patients, revising and replacing the draft guidance for industry “Developing Products for Weight Management” issued in February 2007. 

...

Read More

Eye on FDA

January 7, 2025

On January 6, the FDA announced the availability of draft guidance on accelerated approval for drugs and biological products, and consideration for determining whether a confirmatory trial is underway. Under the Consolidated Appropriations Act, 2023, Congress gave the FDA the authority to require that a confirmatory trial be underway prior to the granting of accelerated approval or within a specific time period after the date of accelerated approval. This latest guidance comes on the heels of the accelerated approval guidance issued by the agency just last month (see prior analysis here), in which the agency stated its intent to address the 2023 authority in a separate guidance.

...

Read More

Eye on FDA

January 7, 2025

On January 6 and 7, 2025, the FDA announced, by our count, 31 draft or final guidances, on a wide range of topics. Historically, an incoming administration will impose a temporary freeze on the issuance of guidances and rules, and might ultimately have different policy priorities and goals than the previous administration. Thus, the release of these numerous new guidances reflects topics that the FDA likely views as particularly important to address.

...

Read More

Eye on FDA

January 2, 2025

On December 30, 2024, FDA unveiled an Idea Lab as part of its Home as a Health Care Hub initiative to reimagine how new and existing medical devices can be incorporated in a home environment.

...

Read More

Eye on FDA

December 16, 2024

On December 12, 2024, FDA’s Center for Drug Evaluation and Research (CDER) announced a new CDER Center for Real-World Evidence Innovation (CCRI). The CCRI is intended to serve as the focal point to promote more efficient and consistent communications across CDER offices regarding real-world data (RWD) and real-world evidence (RWE).

...

Read More

Eye on FDA

December 6, 2024

On December 5, 2024, FDA unveiled the draft guidance for industry regarding accelerated approval for drugs and biologics. This guidance provides additional information regarding the development of drugs and biologics to treat serious conditions for which there is an unmet need, and for which the sponsor is seeking accelerated approval. In particular, the guidance details the conditions for confirmatory study or studies that sponsors are required to conduct under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Consolidated Appropriations Act, 2023. This guidance also elaborates on the process for the expedited withdrawal of an accelerated approval. In announcing the availability of the draft guidance, the agency has requested comments be submitted by February 4, 2025.

...

Read More

© 2025 Akin Gump Strauss Hauer & Feld LLP. All rights reserved. Attorney advertising. This document is distributed for informational use only; it does not constitute legal advice and should not be used as such. Prior results do not guarantee a similar outcome. Akin is the practicing name of Akin Gump LLP, a New York limited liability partnership authorized and regulated by the Solicitors Regulation Authority under number 267321. A list of the partners is available for inspection at Eighth Floor, Ten Bishops Square, London E1 6EG. For more information about Akin Gump LLP, Akin Gump Strauss Hauer & Feld LLP and other associated entities under which the Akin Gump network operates worldwide, please see our Legal Notices page.