3/27/2024 Updates Meeting
Steering Committee Series
Watch the recording from the meeting.
FDA
The FDA’s Proposed Rule on Laboratory-Developed Tests: Impacts on Clinical Laboratory Testing and Patient Care (download .pdf)
Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together (download .pdf)
Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products Guidance for Industry (download .pdf)
MDIC
Join us at #ModSim2024
Click here to register
Join us at #MXR2024 (link)
EU
Foresight: Use and impact of Artificial Intelligence in the scientific process (download .pdf)
Resources & Publications
A Systematic Pan-Cancer Study on Deep Learning-Based Prediction of Multi-Omic Biomarkers from Routine Pathology Images (download .pdf)
Artificial Intelligence-Assisted Double Reading of Chest Radiographs to Detect Clinically Relevant Missed Findings: A Two-Centre Evaluation (download .pdf)
Utility of Artificial Intelligence in a Binary Classification of Soft Tissue Tumors (download .pdf)
Next-Generation Sequencing Trends Among Adult Patients with Select Advanced Tumor Types: A Real-World Evidence Evaluation (download .pdf)
Strategies to Address the Clinical Practice Gaps Affecting the Implementation of Personalized Medicine in Cancer Care (download .pdf)
The Molecular Basis of Cell Memory in Mammals: The Epigenetic Cycle (download .pdf)
Clinical Value of Timely Targeted Therapy for Patients With Advanced Non–Small Cell Lung Cancer With Actionable Driver Oncogenes (download .pdf)
Genome Diagnostics in the Fast Lane (download .pdf)
Prediction of Effectiveness and Toxicities of Immune Checkpoint Inhibitors Using Real-World Patient Data (download .pdf)
The Lucent yet Opaque Challenge of Regulating Artificial Intelligence in Radiology (download .pdf)
Economics of Artificial Intelligence in Healthcare: Diagnosis vs. Treatment (download .pdf)
Smart Healthcare in the Age of AI: Recent Advances, Challenges, and Future Prospects (download .pdf)
Heterogeneity and Predictors of the Effects of AI Assistance on Radiologists (download .pdf)
An Immunophenotype-Coupled Transcriptomic Atlas of Human Hematopoietic Progenitors (download .pdf)
Evolutionary Trajectories of Small Cell Lung Cancer Under Therapy (download .pdf)
Tertiary Lymphoid Structures and B cells Determine Clinically Relevant T cell Phenotypes in Ovarian Cancer (download .pdf)
Allele-Specific Transcriptional Effects of Subclonal Copy Number Alterations Enable Genotype-Phenotype Mapping in Cancer Cells (download.pdf)
The Impact of Prior Single-Gene Testing on Comprehensive Genomic Profiling Results for Patients with Non-Small Cell Lung Cancer (download .pdf)
Explanatory Memorandum on the Updated OECD Definition of an AI System (download .pdf)
The Technologist (download .pdf)
Summary Witness Statements (download .pdf)
Summary Testimony of Susan Van Meter, President, American Clinical Laboratory Association before the Health Subcommittee of the House Energy & Commerce Committee (download .pdf)
Written Testimony of Zach Rothstein Executive Director, AdvaMedDx: House Energy & Commerce Committee, Subcommittee on Health Hearing on “Evaluating Approaches to Diagnostic Test Regulation and the Impact of FDA’s Proposed Rule (download .pdf)
Master Announcement Instructions for Advanced Research Projects: Agency for Health ARPA-H-MAI-24-01 (download .pdf)
Module Announcement for Advanced Research Projects Agency for Health Advanced Analysis for Precision Cancer Therapy (ADAPT) ARPA-H-MAI-24-01-03 (download .pdf)
DEI
Self-Care Interventions for Women’s Health and Well-Being (download .pdf)
Women, power, and cancer: a Lancet Commission (download .pdf)
Demographic Bias of Expert-Level Vision-Language Foundation Models in Medical Imaging (download .pdf)
Non-White Scientists Appear on Fewer Editorial Boards, Spend More Time Under Review, and Receive Fewer Citations (download .pdf)
Events
Applied Economics in Digital Health (download .pdf)