10/30/2024 Updates Meeting
Steering Committee Series
Watch the recording from the meeting.
Legislative Updates
Verifying Accurate Leading-edge IVCT Development Act of 2024 (download .pdf)
Association for Molecular Pathology Files Lawsuit Against FDA to Challenge Final Rule on Regulation for Laboratory Developed Testing Procedures (download .pdf)
FDA’S Laboratory Developed Test Proposed Rule (download .pdf)
Cybersecurity Updates
Privacy-preserving large language models for structured medical information retrieval (download .pdf)
DEI Updates
Bias Assessment in Case–Control and Cohort Studies for Hazard Identification (download .pdf)
FDA Updates
Labeling Requirements for In Vitro Diagnostic Products (IVD), Including LDTs, Under 21 CFR 809.10(b) (download .pdf)
Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations Questions and Answers Guidance for Industry (download .pdf)
Europe and Beyond Updates
Recommendations for Further Actions when Implementing the European Health Data Space in Germany (download .pdf)
Guidance on qualification of in vitro diagnostic medical devices(download .pdf)
MDIC
Predetermined Change
Control Plans (PCCPs) for
Artificial Intelligence (AI) and
Machine Learning (ML)-enabled
Medical Devices (download .pdf)
Publications and Resources
Is It Time to Expand Our Definition of “Clinical Utility”? (download .pdf)
Evaluating Use of Generative Artificial Intelligence in Clinical Pathology Practice (download .pdf)
Addition is all you need for Energy-Efficient Language Models (download .pdf)
Clinical applications of generative artificial intelligence in radiology: image translation, synthesis, and text generation (download .pdf)
Consent in Crisis: The Rapid Decline of the AI Data Commons (download .pdf)
Navigating the horizon of opportunity: a comprehensive review of artificial intelligence applications in cancer care—insights from the 2024 landscape, a narrative review (download .pdf)
Oncology Accelerated Approval Confirmatory Trials: When a Failed Trial Is Not a Failed Drug (download .pdf)
AI accurately predicts breast cancer years before diagnosis (download .pdf)
FDA’s Final Rule on Laboratory-Developed Tests: What Is the Impact on Clinical Pharmacogenomics in the United States? (download .pdf)
Ethical and Regulatory Perspectives on Generative Artificial Intelligence in Pathology (download .pdf)
Clinical and economic outcomes of a pharmacogenomics- enriched comprehensive medication management program in a self-insured employee population (download .pdf)
The value of anticancer drugs — a regulatory view (download .pdf)
The high costs of anticancer therapies in the USA: challenges, opportunities and progress (download .pdf)
Amplifying mutational profiling of extracellular vesicle mRNA with SCOPE (download .pdf)
Targeted therapy guided by circulating tumor DNA analysis in advanced gastrointestinal tumors (download .pdf)
A toolbox for surfacing health equity harms and biases in large language models(download .pdf)
Comparative analysis of GPT-4-based ChatGPT’s diagnostic performance with radiologists using real-world radiology
reports of brain tumors (download .pdf)
Expanding drug targets for 112 chronic diseases using a machine learning-assisted genetic priority score (download .pdf)
Cancer therapy with antibodies (download .pdf)
A standing platform for cancer drug development using ctDNA-based evidence of recurrence (download .pdf)
Open e-commerce 1.0, five years of crowdsourced U.S. Amazon purchase histories with user demographics (download .pdf)
Developmental mosaicism underlying EGFR-mutant lung cancer presenting with multiple primary tumors (download .pdf)
A call to action to scale up research and clinical genomic data sharing (download .pdf)
How Companies Use Generative AI to Execute with Speed (download .pdf)
FDA-NIH Terminology for Clinical Research (download .pdf)
5 of 7 Medicare Administrative Contractors approve payment for imaging AI software (download .pdf)
WHO
The selection and use of essential in vitro diagnostics (download .pdf)