FDA

Researchers Call for Outcome-Centric Approach to Health AI Regulation

February 7, 2024 - In a recent viewpoint published in the Journal of the American Medical Association (JAMA), researchers from the University of California San Diego (UCSD) argued that the White House Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence (AI) does not sufficiently address the role that patient outcomes...


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Discrepancies in Marketing, Clearance of AI-Enabled Medical Devices Found

by Shania Kennedy

In a recent study published in JAMA Network Open, researchers found discrepancies between the marketing and 510(k) clearance of artificial intelligence (AI)- or machine learning (ML)-enabled medical...

FDA Releases AI/ML-Enabled Medical Device Modification Guidance

by Shania Kennedy

The Food and Drug Administration (FDA) released new draft guidance last week proposing an approach to ensure that artificial intelligence (AI) and machine learning (ML)-enabled devices can be safely...

Researchers Suggest Changes to FDA Oversight of AI Breast Cancer Screening

by Shania Kennedy

In a special communication published this week in JAMA Internal Medicine, Yale researchers explore the current regulatory processes for artificial intelligence (AI)-based breast cancer screening tools,...

FDA Releases Guidance on AI-Driven Clinical Decision Support Tools

by Shania Kennedy

The Food and Drug Administration (FDA) has released new guidance stating that some artificial intelligence (AI) tools should be regulated as medical devices as part of the agency’s oversight of...

Researchers Call for ‘Reimbursement Framework’ for Healthcare AI

by Shania Kennedy

A paper published in npj Digital Medicine earlier this month outlines a potential “reimbursement framework” for the adoption of healthcare artificial intelligence (AI), which researchers...

Researchers Call for ‘Distributed Approach’ to Clinical AI Regulation

by Shania Kennedy

Researchers argue that the national, centralized regulation of clinical artificial intelligence (AI) is not sufficient and instead propose a hybrid model of centralized and decentralized...

FDA Evaluations of Medical AI Devices Show Limitations

by Jessica Kent

To ensure medical AI devices are effective, reliable, and safe, FDA evaluations should include prospective studies and assessments in multiple clinical sites, according to a review published in...

FDA Approves Machine Learning Tool for COVID-19 Screening

by Jessica Kent

The FDA has issued an emergency use authorization (EUA) for the first machine learning-based non-diagnostic screening tool to prevent the spread of COVID-19.   The Tiger Tech COVID Plus Monitor...

FDA Data Dashboard Shows Adverse Events Related to COVID-19 Products

by Jessica Kent

The FDA has launched the FDA Adverse Event Reporting System (FAERS), a public data dashboard showing human adverse event reports for drugs and therapeutic products used under emergency use...

FDA Releases Action Plan for AI, Machine Learning Medical Software

by Jessica Kent

The FDA has released its first artificial intelligence and machine learning action plan, a multi-step approach designed to advance the agency’s management of advanced medical software. The...

Patient Safety, Data Privacy Key for Use of AI-Powered Chatbots

by Jessica Kent

Patient safety, data privacy, and health equity are key considerations for the use of chatbots powered by artificial intelligence in healthcare, according to a viewpoint piece published in JAMA. With...

ACR, RSNA Caution FDA Against Autonomous AI in Medical Imaging

by Jessica Kent

Despite the promise of artificial intelligence in medical imaging, the FDA currently cannot ensure the safety and efficacy of automated AI in the imaging field, according to comments from the American...

FDA Leverages Real-World Data to Enhance COVID-19 Response

by Jessica Kent

The Food and Drug Administration (FDA) is leveraging real-world data to better understand COVID-19 risk factors, tailor public health interventions to specific communities, and mitigate the spread of...

ONC Project Aims to Facilitate Real-World Data Access, Exchange

by Jessica Kent

ONC recently released results from its Coordinated Registry Network for Women’s Health Technology project, a joint effort with the FDA and NIH to facilitate real-world data access and...

Artificial Intelligence Accelerates Search for COVID-19 Treatments

by Jessica Kent

A team from Northwestern University has developed an artificial intelligence platform that can quickly identify research that has the most potential to produce COVID-19 treatments and solutions. For...

Deep Learning Can Identify Newborns at High Risk of Eye Disease

by Jessica Kent

A deep learning device could help identify newborns at risk for aggressive posterior retinopathy of prematurity (AP-ROP), a condition that is difficult to diagnose and can lead to vision loss if left...

FDA Approvals Advance Precision Medicine, Genomics Treatments

by Jessica Kent

The FDA approved or cleared 12 personalized medicines and seven diagnostics in 2019, helping providers address the root causes of disease and further integrating precision medicine with clinical...

New Gene Therapies Institute Aims to Address Regulatory Barriers

by Jessica Kent

The Institute for Gene Therapies (IGT), a new advocacy foundation focused on policy issues surrounding gene therapies, recently launched with the goal of modernizing US regulatory and reimbursement...

FDA Launches Public Database Providing Information on HIV Treatments

by Jessica Kent

The Food and Drug Administration (FDA) has launched a public, interactive database that will offer critical information about antiretrovirals (ARVs) to treat HIV. “This launch is an important...