VALIDATING AI IN CLASSIFYING CANCER IN REAL-TIME SURGERY

Informazioni relative al progetto

CLASSICA

ID dell’accordo di sovvenzione: 101057321

DOI

10.3030/101057321

Data della firma CE 19 Maggio 2022

Data di avvio 1 Maggio 2022

Data di completamento 30 Aprile 2026

Finanziato da

• Health

Costo totale

€ 5 978 718,74

Contributo UE

€ 5 978 716,00

Coordinato da

UNIVERSITY COLLEGE DUBLIN, NATIONAL UNIVERSITY OF IRELAND, DUBLIN
Ireland

CORDIS fornisce collegamenti ai risultati finali pubblici e alle pubblicazioni dei progetti ORIZZONTE.

I link ai risultati e alle pubblicazioni dei progetti del 7° PQ, così come i link ad alcuni tipi di risultati specifici come dataset e software, sono recuperati dinamicamente da .OpenAIRE .

Risultati finali

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)

Pubblicazioni

Peer reviewed articles (42)

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

Autori: Gerke, Sara; Simon, David A.
Pubblicato in: 27, Numero 11, 2025, ISSN 2376-6980
Editore: American Medical Association
DOI: 10.1001/AMAJETHICS.2025.787

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

Autori: Matteo Pescio, Francesco Marzola, Giovanni Distefano, Pietro Leoncini, Carlo Alberto Ammirati, Federica Barontini, Giulio Dagnino, Alberto Arezzo
Pubblicato in: Journal of Personalized Medicine, Numero 16, 2026, ISSN 2075-4426
Editore: MDPI AG
DOI: 10.3390/JPM16020071

Privacy of Personal Data in the Generative AI Data Lifecycle

Autori: Duffourc, Mindy; Gerke, Sara; Kollnig, Konrad
Pubblicato in: Journal of intellectual property and entertainment law, Numero 13(2), 2024, ISSN 2324-6286
Editore: NYU Journal of Intellectual Property & Entertainment Law
DOI: 10.2139/ssrn.4899219

Artificial Intelligence and Medical Liability in Gastrointestinal Endoscopy

Autori: Sami Elamin, Mindy Duffourc, Tyler M. Berzin, Mark E. Geissler, Sara Gerke
Pubblicato in: Clinical Gastroenterology and Hepatology, Numero 22, 2024, ISSN 1542-3565
Editore: Elsevier
DOI: 10.1016/j.cgh.2024.03.011

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

Autori: Cahill, Ronan; Duffourc, Mindy Nunez; Gerke, Sara
Pubblicato in: Annals of Surgery, 2024, ISSN 1528-1140
Editore: 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)

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

Data sharing restrictions are hampering precision health in the European Union

Autori: 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
Pubblicato in: Nature Medicine, Numero 31, 2025, ISSN 1078-8956
Editore: Springer Science and Business Media LLC
DOI: 10.1038/S41591-024-03437-1

Validierung künstlicher Intelligenz für die Klassifizierung von Mastdarmkrebs während endoskopischer Chirurgie

Autori: Felix Aigner, David Duller, Christoph Skias, Gabriele Moitzi, Martin Mitteregger
Pubblicato in: coloproctology, 2025, ISSN 0174-2442
Editore: 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

Autori: Cahill, Ronan A.; Duffourc, Mindy; Gerke, Sara
Pubblicato in: International Journal of Surgery, Numero 111, 2025, ISSN 1743-9159
Editore: Elsevier, Wolters Kluwer
DOI: 10.1097/JS9.0000000000002309

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

Autori: Fenwick, Mark; Fertik, Michael; Jurcys, Paulius; Minssen, Timo
Pubblicato in: The Vanderbilt Journal of Entertainment and Technology Law, Numero 27 (3), 2025, ISSN 1942-678X
Editore: Vanderbilt University Law School
DOI: 10.2139/SSRN.4475106

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

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

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

Autori: Mindy N. Duffourc, Ronan A. Cahill
Pubblicato in: npj Digital Medicine, Numero 9, 2026, ISSN 2398-6352
Editore: 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

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

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

Autori: Moynihan, A., Hardy, N., Dalli, J., Aigner, F., Arezzo, A., Knol, J., Tunyman, J., & Cahill, R.
Pubblicato in: Colorectal Disease: Special Numero:ESCP's 18th Scientific and Annual Conference, 2023, ISSN 1463-1318
Editore: 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

Autori: Gerke, Sara; Rezaeikhonakdar, Delaram
Pubblicato in: Cardozo Law Review, 2024, ISSN 2169-4893
Editore: Cardozo Law Review
DOI: 10.5281/ZENODO.12922079

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

Autori: Aigner, Felix
Pubblicato in: Journal Onkologie, Numero 25, 2025, ISSN 1618-7687
Editore: MedTriX GmbH
DOI: 10.5281/ZENODO.17284979

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

Autori: Sara Gerke, David A. Simon, Benjamin R. Roman
Pubblicato in: JCO Oncology Practice, 2025, ISSN 2688-1527
Editore: 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)

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

New case law and liability risks for manufacturers of medical AI

Autori: Sara Gerke, David A. Simon
Pubblicato in: Science, Numero 388, 2025, ISSN 0036-8075
Editore: 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

Autori: Duffourc, Mindy; Gerke, Sara
Pubblicato in: Stanford Technology Law Review, 2024, ISSN 1098-4267
Editore: Stanford Technology Law Review
DOI: 10.5281/ZENODO.10078491

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

Autori: Minssen, Timo; Vayena, Effy; Cohen, Glenn
Pubblicato in: JAMA, Numero 330, 2023, ISSN 1538-3598
Editore: JAMA Network
DOI: 10.5281/zenodo.8269643

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

Autori: Porsdam Mann, Sebastian; Cohen, I. Glenn; Minssen, Timo
Pubblicato in: NEJM AI, Numero 1 (11), 2024, ISSN 2836-9386
Editore: NEJM Group
DOI: 10.1056/AIp2400449

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

Autori: 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
Pubblicato in: Colorectal Disease, Numero 25 (12), 2023, ISSN 1463-1318
Editore: Wiley
DOI: 10.1111/CODI.16769

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

Autori: Kostick-Quenet, Kristin M.; Corrales Compagnucci, Marcelo; Aboy, Mateo; Minssen, Timo
Pubblicato in: Journal of Law and the Biosciences, Numero 12 (1), 2025, ISSN 2053-9711
Editore: Oxford University Press
DOI: 10.1093/JLB/LSAF003

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

Autori: Mindy Nunez Duffourc, Sara Gerke
Pubblicato in: JAMA, Numero 331, 2024, ISSN 0098-7484
Editore: 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

Autori: Duffourc, Mindy Nunez; Gerke, Sara
Pubblicato in: JAMA, Numero 330, 2023, ISSN 1538-3598
Editore: JAMA Network
DOI: 10.1001/jama.2023.9630

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

Autori: Charlotte Tschider, Marcelo Corrales Compagnucci, Timo Minssen
Pubblicato in: Journal of Law and the Biosciences, Numero 11, 2024, ISSN 2053-9711
Editore: Oxford University Press (OUP)
DOI: 10.1093/jlb/lsae022

Artificial intelligence classification of rectal neoplasia by endoscopic fluorescence perfusion analysis

Autori: 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
Pubblicato in: Scientific Reports, Numero 16, 2026, ISSN 2045-2322
Editore: 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

Autori: Patrick A. Boland, N. P. Hardy, A. Moynihan, P. D. McEntee, C. Loo, H. Fenlon, R. A. Cahill
Pubblicato in: European Journal of Nuclear Medicine and Molecular Imaging, Numero 51, 2024, ISSN 1619-7070
Editore: 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

Autori: Duffourc, Mindy; Mllebk, Mathias; Druedahl, Louise; Minssen, Timo; Gerke, Sara
Pubblicato in: Annals of Surgery Open, 2025, ISSN 2691-3593
Editore: Wolters Kluwer
DOI: 10.1097/AS9.0000000000000542

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

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

Chevron's Fall And Its Impact On Medical AI

Autori: Gerke, Sara; Simon, David A.
Pubblicato in: Health Affairs Forefront, 2025, ISSN 1544-5208
Editore: 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

Autori: Emilia Niemiec, Timo Minssen, Patrick A. Boland, Philip D. McEntee, Ronan A. Cahill
Pubblicato in: Expert Review of Medical Devices, Numero 22, 2025, ISSN 1743-4440
Editore: Informa UK Limited
DOI: 10.1080/17434440.2025.2531295

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

Autori: Mateo Aboy, Timo Minssen, Effy Vayena
Pubblicato in: npj Digital Medicine, Numero 7, 2024, ISSN 2398-6352
Editore: Springer Science and Business Media LLC
DOI: 10.1038/s41746-024-01232-3

Digital endoscopic characterisation of significant rectal neoplasia: A video vignette

Autori: 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
Pubblicato in: Colorectal Disease, Numero 27, 2025, ISSN 1462-8910
Editore: Wiley
DOI: 10.1111/CODI.70260

Protocol for CLASSICA software as medical device trial

Autori: 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
Pubblicato in: Minimally Invasive Therapy &amp; Allied Technologies, 2025, ISSN 1364-5706
Editore: Informa UK Limited
DOI: 10.1080/13645706.2025.2540482

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

Autori: Duffourc, Mindy Nunez; Gerke, Sara
Pubblicato in: npj Digital Medicine, Numero 6 (77), 2023, ISSN 2398-6352
Editore: 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

Autori: Alberto Arezzo, Carlo Alberto Ammirati, Giovanni Distefano, Michele Barbiero, Roberto Passera, Mario Morino
Pubblicato in: Surgical Endoscopy, 2025, ISSN 0930-2794
Editore: 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

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

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

Autori: Giovanni Distefano, Carlo Alberto Ammirati, Michele Barbiero, Roberto Passera, Alberto Arezzo
Pubblicato in: Surgical Endoscopy, Numero 39, 2025, ISSN 0930-2794
Editore: Springer Nature
DOI: 10.1007/S00464-025-12243-W

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

Autori: Oscar Freyer, Max Ostermann, Timo Minssen, Stephen Gilbert
Pubblicato in: npj Digital Medicine, Numero 8, 2025, ISSN 2398-6352
Editore: Springer Science and Business Media LLC
DOI: 10.1038/S41746-025-02082-3

Enabling secure and self determined health data sharing and consent management

Autori: Cindy Welzel, Max Ostermann, Hannah Louise Smith, Timo Minssen, Toralf Kirsten, Stephen Gilbert
Pubblicato in: npj Digital Medicine, Numero 8, 2025, ISSN 2398-6352
Editore: 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

Autori: Minssen, Timo; Smith, Hannah Louise; Porsdam Mann, Sebastian
Pubblicato in: Inteligencia Artificial: Hacia una nueva era en la historia de la humanidad, 2025
Editore: INADI
DOI: 10.5281/ZENODO.15608122

Patient Perspectives on Data Sharing

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

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

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

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

Autori: Timo Minssen, Barry Solaiman, Lea Köttering, Jakob Wested, Abeer Malik
Pubblicato in: Research Handbook on Health, AI and the Law, 2024
Editore: Edward Elgar Publishing
DOI: 10.4337/9781802205657.00027

Medical AI and tort liability

Autori: Cohen, I. Glenn; Slottje, Andrew; Gerke, Sara
Pubblicato in: Artificial Intelligence in Medicine, 2024
Editore: Elsevier
DOI: 10.1016/B978-0-323-95068-8.00007-8

Liability for use of artificial intelligence in medicine

Autori: Price, Nicholson; Gerke, Sara; Cohen, Ivan
Pubblicato in: Research Handbook on Health, AI and the Law, 2024
Editore: Edward Elgar Publishing
DOI: 10.4337/9781802205657.00016

Other (1)

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

Autori: Corrales Compagnucci, Marcelo; Dahi, Alan; Alexander Earls Davis, Peter
Pubblicato in: European Health & Pharmaceutical Law Review, Numero 7 (3), 2023, ISSN 2751-3971
Editore: Lexxion
DOI: 10.21552/ehpl/2023/3/5

Conference proceedings (1)

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

Autori: Ronan Cahill
Pubblicato in: Molecular-Guided Surgery: Molecules, Devices, and Applications X, 2024
Editore: SPIE
DOI: 10.1117/12.3011288