VALIDATING AI IN CLASSIFYING CANCER IN REAL-TIME SURGERY

Informacje na temat projektu

CLASSICA

Identyfikator umowy o grant: 101057321

DOI

10.3030/101057321

Data podpisania przez KE 19 Maja 2022

Data rozpoczęcia 1 Maja 2022

Data zakończenia 30 Kwietnia 2026

Finansowanie w ramach

• Health

Koszt całkowity

€ 5 978 718,74

Wkład UE

€ 5 978 716,00

Koordynowany przez

UNIVERSITY COLLEGE DUBLIN, NATIONAL UNIVERSITY OF IRELAND, DUBLIN
Ireland

CORDIS oferuje możliwość skorzystania z odnośników do publicznie dostępnych publikacji i rezultatów projektów realizowanych w ramach programów ramowych HORYZONT.

Odnośniki do rezultatów i publikacji związanych z poszczególnymi projektami 7PR, a także odnośniki do niektórych konkretnych kategorii wyników, takich jak zbiory danych i oprogramowanie, są dynamicznie pobierane z systemu OpenAIRE .

Rezultaty

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)

Publikacje

Peer reviewed articles (42)

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

Autorzy: Gerke, Sara; Simon, David A.
Opublikowane w: 27, Numer 11, 2025, ISSN 2376-6980
Wydawca: American Medical Association
DOI: 10.1001/AMAJETHICS.2025.787

Artificial Intelligence in Minimally Invasive and Robotic Gastrointestinal Surgery: Major Applications and Recent Advances

Autorzy: Matteo Pescio, Francesco Marzola, Giovanni Distefano, Pietro Leoncini, Carlo Alberto Ammirati, Federica Barontini, Giulio Dagnino, Alberto Arezzo
Opublikowane w: Journal of Personalized Medicine, Numer 16, 2026, ISSN 2075-4426
Wydawca: MDPI AG
DOI: 10.3390/JPM16020071

Privacy of Personal Data in the Generative AI Data Lifecycle

Autorzy: Duffourc, Mindy; Gerke, Sara; Kollnig, Konrad
Opublikowane w: Journal of intellectual property and entertainment law, Numer 13(2), 2024, ISSN 2324-6286
Wydawca: NYU Journal of Intellectual Property & Entertainment Law
DOI: 10.2139/ssrn.4899219

Artificial Intelligence and Medical Liability in Gastrointestinal Endoscopy

Autorzy: Sami Elamin, Mindy Duffourc, Tyler M. Berzin, Mark E. Geissler, Sara Gerke
Opublikowane w: Clinical Gastroenterology and Hepatology, Numer 22, 2024, ISSN 1542-3565
Wydawca: Elsevier
DOI: 10.1016/j.cgh.2024.03.011

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

Autorzy: Cahill, Ronan; Duffourc, Mindy Nunez; Gerke, Sara
Opublikowane w: Annals of Surgery, 2024, ISSN 1528-1140
Wydawca: 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)

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

Data sharing restrictions are hampering precision health in the European Union

Autorzy: 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
Opublikowane w: Nature Medicine, Numer 31, 2025, ISSN 1078-8956
Wydawca: Springer Science and Business Media LLC
DOI: 10.1038/S41591-024-03437-1

Validierung künstlicher Intelligenz für die Klassifizierung von Mastdarmkrebs während endoskopischer Chirurgie

Autorzy: Felix Aigner, David Duller, Christoph Skias, Gabriele Moitzi, Martin Mitteregger
Opublikowane w: coloproctology, 2025, ISSN 0174-2442
Wydawca: 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

Autorzy: Cahill, Ronan A.; Duffourc, Mindy; Gerke, Sara
Opublikowane w: International Journal of Surgery, Numer 111, 2025, ISSN 1743-9159
Wydawca: Elsevier, Wolters Kluwer
DOI: 10.1097/JS9.0000000000002309

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

Autorzy: Fenwick, Mark; Fertik, Michael; Jurcys, Paulius; Minssen, Timo
Opublikowane w: The Vanderbilt Journal of Entertainment and Technology Law, Numer 27 (3), 2025, ISSN 1942-678X
Wydawca: Vanderbilt University Law School
DOI: 10.2139/SSRN.4475106

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

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

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

Autorzy: Mindy N. Duffourc, Ronan A. Cahill
Opublikowane w: npj Digital Medicine, Numer 9, 2026, ISSN 2398-6352
Wydawca: 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

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

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

Autorzy: Moynihan, A., Hardy, N., Dalli, J., Aigner, F., Arezzo, A., Knol, J., Tunyman, J., & Cahill, R.
Opublikowane w: Colorectal Disease: Special Numer:ESCP's 18th Scientific and Annual Conference, 2023, ISSN 1463-1318
Wydawca: 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

Autorzy: Gerke, Sara; Rezaeikhonakdar, Delaram
Opublikowane w: Cardozo Law Review, 2024, ISSN 2169-4893
Wydawca: Cardozo Law Review
DOI: 10.5281/ZENODO.12922079

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

Autorzy: Aigner, Felix
Opublikowane w: Journal Onkologie, Numer 25, 2025, ISSN 1618-7687
Wydawca: MedTriX GmbH
DOI: 10.5281/ZENODO.17284979

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

Autorzy: Sara Gerke, David A. Simon, Benjamin R. Roman
Opublikowane w: JCO Oncology Practice, 2025, ISSN 2688-1527
Wydawca: 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)

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

New case law and liability risks for manufacturers of medical AI

Autorzy: Sara Gerke, David A. Simon
Opublikowane w: Science, Numer 388, 2025, ISSN 0036-8075
Wydawca: 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

Autorzy: Duffourc, Mindy; Gerke, Sara
Opublikowane w: Stanford Technology Law Review, 2024, ISSN 1098-4267
Wydawca: Stanford Technology Law Review
DOI: 10.5281/ZENODO.10078491

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

Autorzy: Minssen, Timo; Vayena, Effy; Cohen, Glenn
Opublikowane w: JAMA, Numer 330, 2023, ISSN 1538-3598
Wydawca: JAMA Network
DOI: 10.5281/zenodo.8269643

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

Autorzy: Porsdam Mann, Sebastian; Cohen, I. Glenn; Minssen, Timo
Opublikowane w: NEJM AI, Numer 1 (11), 2024, ISSN 2836-9386
Wydawca: NEJM Group
DOI: 10.1056/AIp2400449

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

Autorzy: 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
Opublikowane w: Colorectal Disease, Numer 25 (12), 2023, ISSN 1463-1318
Wydawca: Wiley
DOI: 10.1111/CODI.16769

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

Autorzy: Kostick-Quenet, Kristin M.; Corrales Compagnucci, Marcelo; Aboy, Mateo; Minssen, Timo
Opublikowane w: Journal of Law and the Biosciences, Numer 12 (1), 2025, ISSN 2053-9711
Wydawca: Oxford University Press
DOI: 10.1093/JLB/LSAF003

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

Autorzy: Mindy Nunez Duffourc, Sara Gerke
Opublikowane w: JAMA, Numer 331, 2024, ISSN 0098-7484
Wydawca: 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

Autorzy: Duffourc, Mindy Nunez; Gerke, Sara
Opublikowane w: JAMA, Numer 330, 2023, ISSN 1538-3598
Wydawca: JAMA Network
DOI: 10.1001/jama.2023.9630

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

Autorzy: Charlotte Tschider, Marcelo Corrales Compagnucci, Timo Minssen
Opublikowane w: Journal of Law and the Biosciences, Numer 11, 2024, ISSN 2053-9711
Wydawca: Oxford University Press (OUP)
DOI: 10.1093/jlb/lsae022

Artificial intelligence classification of rectal neoplasia by endoscopic fluorescence perfusion analysis

Autorzy: Patrick A. Boland, Pol MacAonghusa, Ashokkumar Singaravelu, Philip D. McEntee, Jernej Cucek, Samo Erzen, Felix Aigner, Alberto Arezzo, John P. Burke, Roel Hompes, Jurriaan B. Tuynman, Peter M. Neary, Ronan A. Cahill
Opublikowane w: Scientific Reports, Numer 16, 2026, ISSN 2045-2322
Wydawca: Springer Science and Business Media LLC
DOI: 10.1038/S41598-026-35233-X

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

Autorzy: Patrick A. Boland, N. P. Hardy, A. Moynihan, P. D. McEntee, C. Loo, H. Fenlon, R. A. Cahill
Opublikowane w: European Journal of Nuclear Medicine and Molecular Imaging, Numer 51, 2024, ISSN 1619-7070
Wydawca: 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

Autorzy: Duffourc, Mindy; Mllebk, Mathias; Druedahl, Louise; Minssen, Timo; Gerke, Sara
Opublikowane w: Annals of Surgery Open, 2025, ISSN 2691-3593
Wydawca: Wolters Kluwer
DOI: 10.1097/AS9.0000000000000542

Peritoneal opening during transanal endoscopic microsurgery: can preoperative positioning assessment improve intraoperative management?

Autorzy: Alberto Arezzo, Carlo Alberto Ammirati, Giovanni Distefano, Michele Barbiero, Simone Arolfo, Mario Morino
Opublikowane w: Surgical Endoscopy, 2026, ISSN 0930-2794
Wydawca: Springer Science and Business Media LLC
DOI: 10.1007/S00464-026-12625-8

Chevron's Fall And Its Impact On Medical AI

Autorzy: Gerke, Sara; Simon, David A.
Opublikowane w: Health Affairs Forefront, 2025, ISSN 1544-5208
Wydawca: 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

Autorzy: Emilia Niemiec, Timo Minssen, Patrick A. Boland, Philip D. McEntee, Ronan A. Cahill
Opublikowane w: Expert Review of Medical Devices, Numer 22, 2025, ISSN 1743-4440
Wydawca: Informa UK Limited
DOI: 10.1080/17434440.2025.2531295

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

Autorzy: Mateo Aboy, Timo Minssen, Effy Vayena
Opublikowane w: npj Digital Medicine, Numer 7, 2024, ISSN 2398-6352
Wydawca: Springer Science and Business Media LLC
DOI: 10.1038/s41746-024-01232-3

Digital endoscopic characterisation of significant rectal neoplasia: A video vignette

Autorzy: 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
Opublikowane w: Colorectal Disease, Numer 27, 2025, ISSN 1462-8910
Wydawca: Wiley
DOI: 10.1111/CODI.70260

Protocol for CLASSICA software as medical device trial

Autorzy: 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
Opublikowane w: Minimally Invasive Therapy &amp; Allied Technologies, 2025, ISSN 1364-5706
Wydawca: Informa UK Limited
DOI: 10.1080/13645706.2025.2540482

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

Autorzy: Duffourc, Mindy Nunez; Gerke, Sara
Opublikowane w: npj Digital Medicine, Numer 6 (77), 2023, ISSN 2398-6352
Wydawca: 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

Autorzy: Alberto Arezzo, Carlo Alberto Ammirati, Giovanni Distefano, Michele Barbiero, Roberto Passera, Mario Morino
Opublikowane w: Surgical Endoscopy, 2025, ISSN 0930-2794
Wydawca: 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

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

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

Autorzy: Giovanni Distefano, Carlo Alberto Ammirati, Michele Barbiero, Roberto Passera, Alberto Arezzo
Opublikowane w: Surgical Endoscopy, Numer 39, 2025, ISSN 0930-2794
Wydawca: Springer Nature
DOI: 10.1007/S00464-025-12243-W

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

Autorzy: Oscar Freyer, Max Ostermann, Timo Minssen, Stephen Gilbert
Opublikowane w: npj Digital Medicine, Numer 8, 2025, ISSN 2398-6352
Wydawca: Springer Science and Business Media LLC
DOI: 10.1038/S41746-025-02082-3

Enabling secure and self determined health data sharing and consent management

Autorzy: Cindy Welzel, Max Ostermann, Hannah Louise Smith, Timo Minssen, Toralf Kirsten, Stephen Gilbert
Opublikowane w: npj Digital Medicine, Numer 8, 2025, ISSN 2398-6352
Wydawca: 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

Autorzy: Minssen, Timo; Smith, Hannah Louise; Porsdam Mann, Sebastian
Opublikowane w: Inteligencia Artificial: Hacia una nueva era en la historia de la humanidad, 2025
Wydawca: INADI
DOI: 10.5281/ZENODO.15608122

Patient Perspectives on Data Sharing

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

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

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

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

Autorzy: Timo Minssen, Barry Solaiman, Lea Köttering, Jakob Wested, Abeer Malik
Opublikowane w: Research Handbook on Health, AI and the Law, 2024
Wydawca: Edward Elgar Publishing
DOI: 10.4337/9781802205657.00027

Medical AI and tort liability

Autorzy: Cohen, I. Glenn; Slottje, Andrew; Gerke, Sara
Opublikowane w: Artificial Intelligence in Medicine, 2024
Wydawca: Elsevier
DOI: 10.1016/B978-0-323-95068-8.00007-8

Liability for use of artificial intelligence in medicine

Autorzy: Price, Nicholson; Gerke, Sara; Cohen, Ivan
Opublikowane w: Research Handbook on Health, AI and the Law, 2024
Wydawca: Edward Elgar Publishing
DOI: 10.4337/9781802205657.00016

Other (1)

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

Autorzy: Corrales Compagnucci, Marcelo; Dahi, Alan; Alexander Earls Davis, Peter
Opublikowane w: European Health & Pharmaceutical Law Review, Numer 7 (3), 2023, ISSN 2751-3971
Wydawca: Lexxion
DOI: 10.21552/ehpl/2023/3/5

Conference proceedings (1)

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

Autorzy: Ronan Cahill
Opublikowane w: Molecular-Guided Surgery: Molecules, Devices, and Applications X, 2024
Wydawca: SPIE
DOI: 10.1117/12.3011288