12/18/2024 Updates Meeting

Written By PIcc Alliance

Steering Committee Series

Watch the recording from the meeting.

Download the slides from the meeting here

Legislative Updates

  • Further Continuing Appropriations and Disaster Relief Supplemental Appropriations Act, 2025 (download .pdf)

FDA Updates

  • The AI Lifecycle expanded to illustrate per-phase considerations (download .pdf)

  • Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions (download .pdf)

Europe and Beyond Updates

  • Artificial Intelligence in Medical Devices (download .pdf)

  • Joint paper of Croatia, Finland, France, Germany, Ireland, Luxembourg, Romania, Malta and Slovenia on necessary reforms in MDR and IVDR: priorities / main points (download .pdf)

  • Regulation (EU) 2024/… of the European Parliament and of the Council of… on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (download .pdf)

  • Artificial Intelligence in European Medicines Regulation: From Vision to Action. Harnessing the Capabilities of Artificial Intelligence for the Benefit of Public and Animal Health (download .pdf)

Legal Updates

  • Brief of the College of American Pathologists as Amicus Curiae in Support of Plaintiffs’ Motion for Summary Judgment (download .pdf)

Publications and Resources

  • Matching patients to clinical trials with large language models (download .pdf)

  • Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial (download .pdf)

  • Review of: “Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial (download .pdf)

  • Introduction to Generative Artificial Intelligence Contextualizing the Future (download .pdf)

  • Artificial intelligence-aided data mining of medical records for cancer detection and screening (download .pdf)

  • Are the Latent Representations of Foundation Models for Pathology Invariant to Rotation? (download .pdf)

  • Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI extension (download .pdf)

  • Artificial Intelligence and Radiologist Burnout (download .pdf)

  • Method of the Year 2024: spatial proteomics (download .pdf)

  • Eleven clinical trials that will shape medicine in 2025 (download .pdf)

  • Artificial Intelligence awarded two Nobel Prizes for innovations that will shape the future of medicine (download .pdf)

  • Metrics Reloaded toolkit report (download .pdf)

  • Finding FDA-authorized devices with Predetermined Change Control Plans (Access Here)

  • ARPA-H ImagiNg Data EXchange (INDEX) (Access Here)

  • INDEX: Imaging Data Exchange (Access Here)

  • MIC-MET Tree: Decision Tree for Medical Imaging AI/ML Classification Metrics - Catalog of Regulatory Science Tools to Help Assess New Medical Devices  (Access Here)

  • An interactive Decision Support Tool for Evaluating Machine Learning Algorithm Performance in Medical Image Analysis (Access Here)

  • MIC-MET Tree: Decision Tree for Medical Imaging AI/ML Classification Metrics (Access Here)

  • Metrics Reloaded (Access Here)

College of American Pathologists

  • Practical Tips to Assist Implementation of Whole Slide Imaging (download .pdf)

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December 2024 PIcc Meeting

PIcc Alliance
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11/27/2024 Updates Meeting