 
August 5, 2024
Welcome to the summer edition of DHCoE’s Digital Health Newsletter. Learn about the latest digital health advancements to protect and promote public health.
Message from the DHCoE Director
It's no secret that artificial intelligence (AI) is changing the way we think about our health and health care. With more than 850 artificial intelligence-enabled devices authorized by FDA to date, it's clear that this technology is revolutionizing the medical products we use and how we regulate the medical device industry.
But how do we support the proper integration of AI across the health care ecosystem? How can we help AI reach its full potential in health care while reducing the risks and challenges presented by a new technology?
As AI continues to advance with more sophisticated algorithms and more data available than ever before, it's important that we consider ways to align on methodologies, best practices, and quality assurance standards to help all people living in the United States truly benefit from AI's tremendous capability in health care settings.
I explore these concepts and potential approaches for addressing these questions, in my latest blogs.
Troy Tazbaz
Director, Digital Health Center of Excellence
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Developer Highlight
New Educational Materials for FDA's Digital Health Technology Guidance
The FDA is offering new educational materials to accompany the Digital Health Technologies for Remote Data Acquisition in Clinical Investigations guidance document.
- CDER’s Guidance Snapshot highlights key points in the guidance document, using visuals and plain language.
- A Guidance Recap Podcast episode includes an interview with Elizabeth Kunkoski (Office of Medical Policy, CDER) and Anindita Saha (DHCoE, CDRH), who discuss the background, intent, and other key recommendations of the guidance document.
These educational materials are designed to increase public awareness of and engagement with the guidance document recommendations. These materials are not substitutes for the guidance document.
Patient Highlight
FDA Releases Spanish Versions of Augmented Reality and Virtual Reality Resources for Patients, Caregivers, and Health Care Professionals
Health equity is important. That's why the FDA released Spanish translations of two previously available infographics on augmented reality and virtual reality. These translations support Spanish-speaking patients, caregivers, and health care professionals to make informed decisions about medical extended reality in their health care or practice.
View the Spanish infographics.
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DHCoE Activities
Update on the FDA's Digital Health Advisory Committee
The FDA is announcing the roster of the Digital Health Advisory Committee. The Digital Health Advisory Committee will advise the FDA on issues related to digital health technologies (DHTs), providing relevant expertise and perspective to enhance the agency’s understanding of the benefits, risks, and clinical outcomes associated with the use of DHTs.
Save the date: On November 20-21, 2024, the FDA plans to hold the inaugural Digital Health Advisory Committee meeting in person in Gaithersburg, MD, with simultaneous webcast. Topics planned to be addressed include how the use of Generative AI may impact safety and effectiveness of medical devices enabled with this technology. In upcoming weeks, further details about this meeting will be announced in the Federal Register in accordance with the FDA’s policies and procedures for Advisory Committee Meetings. Read more.
New AI Paper Outlines FDA's Agency-Wide Approach to Protect Public Health and Promote Ethical Innovation
In March 2024, the FDA released “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This Paper outlines how FDA’s medical product centers are working together to protect public health while fostering responsible and ethical innovation through AI.
The paper is a joint collaboration between FDA's Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), and Office of Combination Products (OCP).
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New Guiding Principles Promote Transparency Throughout the Lifecycle of Machine Learning-enabled Devices
The FDA, Health Canada, and the U.K.’s Medicines and Health care products Regulatory Agency (MHRA) jointly published “Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles."
Integrating these guiding principles across the entirety of the product lifecycle helps improve transparency to the intended user of the device by sharing information about the device that is relevant to them. This information can influence the trust of health care professionals and patients towards a medical device and inform decisions regarding its use.
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The International Medical Device Regulators Forum (IMDRF) Seeks Feedback on Proposed Document by August 30
IMDRF's Artificial Intelligence / Machine Learning-enabled Working Group, which FDA co-chairs, is seeking feedback on the proposed document "Good Machine Learning Practice for Medical Device Development - Guiding Principles." Learn more.
The Digitally-Derived Endpoints for Freezing-of-Gait Detection (DEFoGD) Challenge is Underway!
The FDA's Digitally-Derived Endpoints for Freezing-of-Gait Detection (DEFoGD) Challenge seeks AI models to identify and predict freezing of gait (FoG) events related to Parkinson’s disease. These endpoints can foster digital health innovation and may speed up the development of new and effective approaches to helping people with this disease.
Submissions will be accepted through August 2, 2024. The top performing AI models from Phase 1 will advance and be evaluated against validated FoG data in Phase 2.
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FDA Announces Five Winners of the Veterans Cardiac Health and AI Model Predictions (V-CHAMPS) Challenge
A team of data scientists and clinicians from the FDA, Veterans Health Administration, and National Institute of Standards and Technology did dual-anonymous judging of the entries to select the winners based on performance of model predictions when tested with real-world data. See the winners.
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Recent Journal Publication
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Transparency of artificial intelligence/machine learning-enabled medical devices. This article discusses the views expressed at a virtual public workshop in October 2021 by participants including patients, health care providers, researchers, industry members, regulators, and payors on ways to achieve transparency in AI-enabled medical devices.
FDA co-authors include Aubrey A. Shick, Christina M. Webber, Nooshin Kiarashi, Jessica P. Weinberg, Aneesh Deoras, Nicholas Petrick, Anindita Saha & Matthew C. Diamond
Contact Us
We value your feedback. Check out our Digital Health Frequently Asked Questions (FAQs). If you have additional questions, please e-mail us at DigitalHealth@fda.hhs.gov.
DHCoE is leading the advancement of digital health to protect and promote public health. Visit our pages on FDA.gov to learn more about digital health products and regulatory policies.
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