VALIDATING AI IN CLASSIFYING CANCER IN REAL-TIME SURGERY

Informations projet

CLASSICA

N° de convention de subvention: 101057321

DOI

10.3030/101057321

Date de signature de la CE 19 Mai 2022

Date de début 1 Mai 2022

Date de fin 30 Avril 2026

Financé au titre de

• Health

Coût total

€ 5 978 718,74

Contribution de l’UE

€ 5 978 716,00

Coordonné par

UNIVERSITY COLLEGE DUBLIN, NATIONAL UNIVERSITY OF IRELAND, DUBLIN
Ireland

CORDIS fournit des liens vers les livrables publics et les publications des projets HORIZON.

Les liens vers les livrables et les publications des projets du 7e PC, ainsi que les liens vers certains types de résultats spécifiques tels que les jeux de données et les logiciels, sont récupérés dynamiquement sur OpenAIRE .

Livrables

Documents, reports (9)

Communication and Dissemination Plan
Liability Landscape
Report on potential obstacles and solutions
Bias
Regulatory Landscape
Website and Online Communications Setup Report
Training report (resources, photos from training, participant feedback)
Final Clinical Validation Protocol, Patient information document, Consent forms
Midterm Recruitment Report (Study 1)

Publications

Peer reviewed articles (39)

Privacy of Personal Data in the Generative AI Data Lifecycle

Auteurs: Duffourc, Mindy; Gerke, Sara; Kollnig, Konrad
Publié dans: Journal of intellectual property and entertainment law, Numéro 13(2), 2024, ISSN 2324-6286
Éditeur: NYU Journal of Intellectual Property & Entertainment Law
DOI: 10.2139/ssrn.4899219

Artificial Intelligence and Medical Liability in Gastrointestinal Endoscopy

Auteurs: Sami Elamin, Mindy Duffourc, Tyler M. Berzin, Mark E. Geissler, Sara Gerke
Publié dans: Clinical Gastroenterology and Hepatology, Numéro 22, 2024, ISSN 1542-3565
Éditeur: Elsevier
DOI: 10.1016/j.cgh.2024.03.011

"Surgical Video Data - ""In,"" ""Out,"" or ""Shake It All About"" the Medical Record"

Auteurs: Cahill, Ronan; Duffourc, Mindy Nunez; Gerke, Sara
Publié dans: Annals of Surgery, 2024, ISSN 1528-1140
Éditeur: Wolters Kluwer Health, Inc.
DOI: 10.1097/SLA.0000000000006336

Stepwise organ-preserving management of incidental pT1 rectal adenocarcinoma: outcomes after completion transanal endoscopic microsurgery (TEM)

Auteurs: Alberto Arezzo, Carlo Alberto Ammirati, Giovanni Distefano, Michele Barbiero, Simone Arolfo, Roberto Passera, Mario Morino
Publié dans: Surgical Endoscopy, 2025, ISSN 0930-2794
Éditeur: Springer Science and Business Media LLC
DOI: 10.1007/S00464-025-12313-Z

Data sharing restrictions are hampering precision health in the European Union

Auteurs: Cristina Legido-Quigley, Nicolai J. Wewer Albrechtsen, Martin Bæk Blond, Marcelo Corrales Compagnucci, Madeleine Ernst, Markus J. Herrgård, Timo Minssen, Filip Ottosson, Flemming Pociot, Peter Rossing, Karolina Sulek
Publié dans: Nature Medicine, Numéro 31, 2025, ISSN 1078-8956
Éditeur: Springer Science and Business Media LLC
DOI: 10.1038/S41591-024-03437-1

Validierung künstlicher Intelligenz für die Klassifizierung von Mastdarmkrebs während endoskopischer Chirurgie

Auteurs: Felix Aigner, David Duller, Christoph Skias, Gabriele Moitzi, Martin Mitteregger
Publié dans: coloproctology, 2025, ISSN 0174-2442
Éditeur: Springer Science and Business Media LLC
DOI: 10.1007/S00053-025-00900-6

The AI-enhanced surgeon – integrating black-box artificial intelligence in the operating room

Auteurs: Cahill, Ronan A.; Duffourc, Mindy; Gerke, Sara
Publié dans: International Journal of Surgery, Numéro 111, 2025, ISSN 1743-9159
Éditeur: Elsevier, Wolters Kluwer
DOI: 10.1097/JS9.0000000000002309

Data Portability Revisited: Toward the Human-Centric, AI-Driven Data Ecosystems of Tomorrow

Auteurs: Fenwick, Mark; Fertik, Michael; Jurcys, Paulius; Minssen, Timo
Publié dans: The Vanderbilt Journal of Entertainment and Technology Law, Numéro 27 (3), 2025, ISSN 1942-678X
Éditeur: Vanderbilt University Law School
DOI: 10.2139/SSRN.4475106

Ethical perspectives on surgical video recording for patients, surgeons and society: systematic review

Auteurs: Walsh, Ross; Kearns, Emma C; Moynihan, Alice; Gerke, Sara; Duffourc, Mindy; Compagnucci, Marcelo Corrales; Minssen, Timo; Cahill, Ronan A
Publié dans: BJS Open, Numéro 7 (3), 2023, ISSN 2474-9842
Éditeur: Oxford University Press
DOI: 10.1093/bjsopen/zrad063

Legal implications of AI standard of care integration on patients’ informed consent: lessons from surgery

Auteurs: Mindy N. Duffourc, Ronan A. Cahill
Publié dans: npj Digital Medicine, Numéro 9, 2026, ISSN 2398-6352
Éditeur: Springer Science and Business Media LLC
DOI: 10.1038/S41746-025-02157-1

Guidelines for ethical use and acknowledgement of large language models in academic writing

Auteurs: Porsdam Mann, Sebastian; Vazirani, Anuraag; Aboy, Mateo; Earp, Brian; Minssen, Timo; Cohen, Glenn; Savulescu, Julian
Publié dans: Nature Machine Intelligence, 2024, ISSN 2522-5839
Éditeur: Springer Nature
DOI: 10.1038/s42256-024-00922-7

Classica: Validating AI in classifying cancer in real time during surgery

Auteurs: Moynihan, A., Hardy, N., Dalli, J., Aigner, F., Arezzo, A., Knol, J., Tunyman, J., & Cahill, R.
Publié dans: Colorectal Disease: Special Numéro:ESCP's 18th Scientific and Annual Conference, 2023, ISSN 1463-1318
Éditeur: Colorectal Disease
DOI: 10.5281/zenodo.10075241

Privacy Shield 2.0—A New Trans-Atlantic Data Privacy Framework Between the European Union and the United States

Auteurs: Gerke, Sara; Rezaeikhonakdar, Delaram
Publié dans: Cardozo Law Review, 2024, ISSN 2169-4893
Éditeur: Cardozo Law Review
DOI: 10.5281/ZENODO.12922079

Minimal-invasive Chirurgie bei kolorektalen Tumoren: Aktuelle Evidenz und klinische Perspektiven

Auteurs: Aigner, Felix
Publié dans: Journal Onkologie, Numéro 25, 2025, ISSN 1618-7687
Éditeur: MedTriX GmbH
DOI: 10.5281/ZENODO.17284979

Liability Risks of Ambient Clinical Workflows With Artificial Intelligence for Clinicians, Hospitals, and Manufacturers

Auteurs: Sara Gerke, David A. Simon, Benjamin R. Roman
Publié dans: JCO Oncology Practice, 2025, ISSN 2688-1527
Éditeur: American Society of Clinical Oncology (ASCO)
DOI: 10.1200/OP-24-01060

Technical and functional design considerations for a real-world interpretable AI solution for NIR perfusion analysis (including cancer)

Auteurs: Moynihan, Alice; Boland, Patrick; Cucek, Jernej; Eržen, Samo; Hardy, Niall; McEntee, Phil; Rojc, Jan; Cahill, Ronan
Publié dans: European Journal of Surgical Oncology, Numéro 50 (12), 2024, ISSN 1532-2157
Éditeur: Elsevier
DOI: 10.1016/J.EJSO.2024.108273

New case law and liability risks for manufacturers of medical AI

Auteurs: Sara Gerke, David A. Simon
Publié dans: Science, Numéro 388, 2025, ISSN 0036-8075
Éditeur: American Association for the Advancement of Science (AAAS)
DOI: 10.1126/SCIENCE.ADU4932

Decoding US Tort Liability in Healthcare's Black-Box Era: Lessons From the EU

Auteurs: Duffourc, Mindy; Gerke, Sara
Publié dans: Stanford Technology Law Review, 2024, ISSN 1098-4267
Éditeur: Stanford Technology Law Review
DOI: 10.5281/ZENODO.10078491

The Challenges for Regulating Medical Use of ChatGPT and Other Large Language Models

Auteurs: Minssen, Timo; Vayena, Effy; Cohen, Glenn
Publié dans: JAMA, Numéro 330, 2023, ISSN 1538-3598
Éditeur: JAMA Network
DOI: 10.5281/zenodo.8269643

The EU AI Act: Implications for U.S. Health Care

Auteurs: Porsdam Mann, Sebastian; Cohen, I. Glenn; Minssen, Timo
Publié dans: NEJM AI, Numéro 1 (11), 2024, ISSN 2836-9386
Éditeur: NEJM Group
DOI: 10.1056/AIp2400449

CLASSICA: Validating artificial intelligence in classifying cancer in real time during surgery

Auteurs: Moynihan, Alice; Hardy, Niall; Dalli, Jeffery; Aigner, Felix; Arezzo, Alberto; Hompes, Roel; Knol, Joep; Tuynman, Jurriaan; Cucek, Jernej; Rojc, Jan; Rodríguez-Luna, María Rita; Cahill, Ronan
Publié dans: Colorectal Disease, Numéro 25 (12), 2023, ISSN 1463-1318
Éditeur: Wiley
DOI: 10.1111/CODI.16769

Patient-centric federated learning: automating meaningful consent to health data sharing with smart contracts

Auteurs: Kostick-Quenet, Kristin M.; Corrales Compagnucci, Marcelo; Aboy, Mateo; Minssen, Timo
Publié dans: Journal of Law and the Biosciences, Numéro 12 (1), 2025, ISSN 2053-9711
Éditeur: Oxford University Press
DOI: 10.1093/JLB/LSAF003

How Should We Think About Ambient Listening and Transcription Technologies’ Influences on EHR Documentation and Patient-Clinician Conversations?

Publié dans: AMA Journal of Ethics, Numéro 27, 2025, ISSN 2376-6980
Éditeur: American Medical Association (AMA)
DOI: 10.1001/AMAJETHICS.2025.787

Health Care AI and Patient Privacy—<i>Dinerstein v Google</i>

Auteurs: Mindy Nunez Duffourc, Sara Gerke
Publié dans: JAMA, Numéro 331, 2024, ISSN 0098-7484
Éditeur: American Medical Association (AMA)
DOI: 10.1001/jama.2024.1110

Generative AI in Health Care and Liability Risks for Physicians and Safety Concerns for Patients

Auteurs: Duffourc, Mindy Nunez; Gerke, Sara
Publié dans: JAMA, Numéro 330, 2023, ISSN 1538-3598
Éditeur: JAMA Network
DOI: 10.1001/jama.2023.9630

The new EU–US data protection framework’s implications for healthcare

Auteurs: Charlotte Tschider, Marcelo Corrales Compagnucci, Timo Minssen
Publié dans: Journal of Law and the Biosciences, Numéro 11, 2024, ISSN 2053-9711
Éditeur: Oxford University Press (OUP)
DOI: 10.1093/jlb/lsae022

Intraoperative near infrared functional imaging of rectal cancer using artificial intelligence methods - now and near future state of the art

Auteurs: Patrick A. Boland, N. P. Hardy, A. Moynihan, P. D. McEntee, C. Loo, H. Fenlon, R. A. Cahill
Publié dans: European Journal of Nuclear Medicine and Molecular Imaging, Numéro 51, 2024, ISSN 1619-7070
Éditeur: Springer Science and Business Media LLC
DOI: 10.1007/S00259-024-06731-9

Surgeons' Perspectives on Liability for the Use of Artificial Intelligence Technologies in the United States and European Union: Results From a Focus Group Study

Auteurs: Duffourc, Mindy; Mllebk, Mathias; Druedahl, Louise; Minssen, Timo; Gerke, Sara
Publié dans: Annals of Surgery Open, 2025, ISSN 2691-3593
Éditeur: Wolters Kluwer
DOI: 10.1097/AS9.0000000000000542

Chevron's Fall And Its Impact On Medical AI

Auteurs: Gerke, Sara; Simon, David A.
Publié dans: Health Affairs Forefront, 2025, ISSN 1544-5208
Éditeur: Project HOPE: The People-to-People Health Foundation, Inc.
DOI: 10.1377/forefront.20250101.818091

Legal and regulatory challenges in multi-country data-driven projects developing and validating medical AI systems in the EU

Auteurs: Emilia Niemiec, Timo Minssen, Patrick A. Boland, Philip D. McEntee, Ronan A. Cahill
Publié dans: Expert Review of Medical Devices, Numéro 22, 2025, ISSN 1743-4440
Éditeur: Informa UK Limited
DOI: 10.1080/17434440.2025.2531295

Navigating the EU AI Act: implications for regulated digital medical products

Auteurs: Mateo Aboy, Timo Minssen, Effy Vayena
Publié dans: npj Digital Medicine, Numéro 7, 2024, ISSN 2398-6352
Éditeur: Springer Science and Business Media LLC
DOI: 10.1038/s41746-024-01232-3

Digital endoscopic characterisation of significant rectal neoplasia: A video vignette

Auteurs: P. A. Boland, E. Murphy, P. D. McEntee, S. Erzen, T. Petropoulou, J. Knol, A. Arezzo, F. Aigner, R. Hompes, J. Tuynman, J. P. Burke, R. A. Cahill
Publié dans: Colorectal Disease, Numéro 27, 2025, ISSN 1462-8910
Éditeur: Wiley
DOI: 10.1111/CODI.70260

Protocol for CLASSICA software as medical device trial

Auteurs: Boland PA, McEntee PD, Cucek J, Erzen S, Niemiec E, Galligan M, Petropoulou T, Burke JB, Knol J, Hompes R, Tuynman J, Aigner F, Arezzo A, Cahill RA
Publié dans: Minimally Invasive Therapy &amp; Allied Technologies, 2025, ISSN 1364-5706
Éditeur: Informa UK Limited
DOI: 10.1080/13645706.2025.2540482

The proposed EU Directives for AI liability leave worrying gaps likely to impact medical AI

Auteurs: Duffourc, Mindy Nunez; Gerke, Sara
Publié dans: npj Digital Medicine, Numéro 6 (77), 2023, ISSN 2398-6352
Éditeur: Springer Nature
DOI: 10.1038/s41746-023-00823-w

Oncologic and survival outcomes of pT2N0 rectal adenocarcinoma treated by transanal local excision: a retrospective cohort study

Auteurs: Alberto Arezzo, Carlo Alberto Ammirati, Giovanni Distefano, Michele Barbiero, Roberto Passera, Mario Morino
Publié dans: Surgical Endoscopy, 2025, ISSN 0930-2794
Éditeur: Springer Science and Business Media LLC
DOI: 10.1007/S00464-025-12239-6

From precision to strength: computer vision for suture quality assessment—an ex vivo pilot study

Auteurs: Roberto Spagnulo, Francesco Marzola, Federica Corso, Giovanni Distefano, Matteo Pescio, Kengo Hayashi, Federica Barontini, Giulio Dagnino, Kaspar Althoefer, Bruno Siciliano, Sebastien Ourselin, Albert
Publié dans: Surgical Endoscopy, 2025, ISSN 0930-2794
Éditeur: Springer Nature
DOI: 10.1007/S00464-025-12441-6

Hybrid laparo-endoscopic techniques for challenging colorectal lesions: a systematic review

Auteurs: Giovanni Distefano, Carlo Alberto Ammirati, Michele Barbiero, Roberto Passera, Alberto Arezzo
Publié dans: Surgical Endoscopy, Numéro 39, 2025, ISSN 0930-2794
Éditeur: Springer Nature
DOI: 10.1007/S00464-025-12243-W

Quantum cryptography and data protection for medical devices before and after they meet Q-Day

Auteurs: Oscar Freyer, Max Ostermann, Timo Minssen, Stephen Gilbert
Publié dans: npj Digital Medicine, Numéro 8, 2025, ISSN 2398-6352
Éditeur: Springer Science and Business Media LLC
DOI: 10.1038/S41746-025-02082-3

Enabling secure and self determined health data sharing and consent management

Auteurs: Cindy Welzel, Max Ostermann, Hannah Louise Smith, Timo Minssen, Toralf Kirsten, Stephen Gilbert
Publié dans: npj Digital Medicine, Numéro 8, 2025, ISSN 2398-6352
Éditeur: Springer Nature
DOI: 10.1038/S41746-025-01945-Z

Book chapters (6)

The European AI Act- Promises, Perils & Trade-Offs in a Complex Regulatory Ecosystem

Auteurs: Minssen, Timo; Smith, Hannah Louise; Porsdam Mann, Sebastian
Publié dans: Inteligencia Artificial: Hacia una nueva era en la historia de la humanidad, 2025
Éditeur: INADI
DOI: 10.5281/ZENODO.15608122

Patient Perspectives on Data Sharing

Auteurs: Druedahl, Louise C.; Kälvemark Sporrong, Sofia
Publié dans: The Law and Ethics of Data Sharing in Health Sciences. Perspectives in Law, 2023
Éditeur: Springer
DOI: 10.1007/978-981-99-6540-3_4

Supplementary Measures and Appropriate Safeguards for International Transfers of Health Data After Schrems II

Auteurs: Corrales Compagnucci, Marcelo; Fenwick, Mark; Aboy, Mateo; Minssen, Timo
Publié dans: The Law and Ethics of Data Sharing in Health Sciences, 2023
Éditeur: Springer
DOI: 10.1007/978-981-99-6540-3_9

Governing AI in the European Union: emerging infrastructures and regulatory ecosystems in health

Auteurs: Timo Minssen, Barry Solaiman, Lea Köttering, Jakob Wested, Abeer Malik
Publié dans: Research Handbook on Health, AI and the Law, 2024
Éditeur: Edward Elgar Publishing
DOI: 10.4337/9781802205657.00027

Medical AI and tort liability

Auteurs: Cohen, I. Glenn; Slottje, Andrew; Gerke, Sara
Publié dans: Artificial Intelligence in Medicine, 2024
Éditeur: Elsevier
DOI: 10.1016/B978-0-323-95068-8.00007-8

Liability for use of artificial intelligence in medicine

Auteurs: Price, Nicholson; Gerke, Sara; Cohen, Ivan
Publié dans: Research Handbook on Health, AI and the Law, 2024
Éditeur: Edward Elgar Publishing
DOI: 10.4337/9781802205657.00016

Other (1)

Conducting a Data Protection Impact Assessment in Health Science: A Comprehensive Guide

Auteurs: Corrales Compagnucci, Marcelo; Dahi, Alan; Alexander Earls Davis, Peter
Publié dans: European Health & Pharmaceutical Law Review, Numéro 7 (3), 2023, ISSN 2751-3971
Éditeur: Lexxion
DOI: 10.21552/ehpl/2023/3/5

Conference proceedings (1)

Fluorescence guided surgery: lessons to learn from 15 years of clinical perfusion evaluation

Auteurs: Ronan Cahill
Publié dans: Molecular-Guided Surgery: Molecules, Devices, and Applications X, 2024
Éditeur: SPIE
DOI: 10.1117/12.3011288