VALIDATING AI IN CLASSIFYING CANCER IN REAL-TIME SURGERY

Información del proyecto

CLASSICA

Identificador del acuerdo de subvención: 101057321

DOI

10.3030/101057321

Fecha de la firma de la CE 19 Mayo 2022

Fecha de inicio 1 Mayo 2022

Fecha de finalización 30 Abril 2026

Financiado con arreglo a

• Health

Coste total

€ 5 978 718,74

Aportación de la UE

€ 5 978 716,00

Coordinado por

UNIVERSITY COLLEGE DUBLIN, NATIONAL UNIVERSITY OF IRELAND, DUBLIN
Ireland

CORDIS proporciona enlaces a los documentos públicos y las publicaciones de los proyectos de los programas marco HORIZONTE.

Los enlaces a los documentos y las publicaciones de los proyectos del Séptimo Programa Marco, así como los enlaces a algunos tipos de resultados específicos, como conjuntos de datos y «software», se obtienen dinámicamente de OpenAIRE .

Resultado final

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)

Publicaciones

Peer reviewed articles (42)

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

Autores: Gerke, Sara; Simon, David A.
Publicado en: 27, Edición 11, 2025, ISSN 2376-6980
Editor: American Medical Association
DOI: 10.1001/AMAJETHICS.2025.787

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

Autores: Matteo Pescio, Francesco Marzola, Giovanni Distefano, Pietro Leoncini, Carlo Alberto Ammirati, Federica Barontini, Giulio Dagnino, Alberto Arezzo
Publicado en: Journal of Personalized Medicine, Edición 16, 2026, ISSN 2075-4426
Editor: MDPI AG
DOI: 10.3390/JPM16020071

Privacy of Personal Data in the Generative AI Data Lifecycle

Autores: Duffourc, Mindy; Gerke, Sara; Kollnig, Konrad
Publicado en: Journal of intellectual property and entertainment law, Edición 13(2), 2024, ISSN 2324-6286
Editor: NYU Journal of Intellectual Property & Entertainment Law
DOI: 10.2139/ssrn.4899219

Artificial Intelligence and Medical Liability in Gastrointestinal Endoscopy

Autores: Sami Elamin, Mindy Duffourc, Tyler M. Berzin, Mark E. Geissler, Sara Gerke
Publicado en: Clinical Gastroenterology and Hepatology, Edición 22, 2024, ISSN 1542-3565
Editor: Elsevier
DOI: 10.1016/j.cgh.2024.03.011

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

Autores: Cahill, Ronan; Duffourc, Mindy Nunez; Gerke, Sara
Publicado en: Annals of Surgery, 2024, ISSN 1528-1140
Editor: 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)

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

Data sharing restrictions are hampering precision health in the European Union

Autores: 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
Publicado en: Nature Medicine, Edición 31, 2025, ISSN 1078-8956
Editor: Springer Science and Business Media LLC
DOI: 10.1038/S41591-024-03437-1

Validierung künstlicher Intelligenz für die Klassifizierung von Mastdarmkrebs während endoskopischer Chirurgie

Autores: Felix Aigner, David Duller, Christoph Skias, Gabriele Moitzi, Martin Mitteregger
Publicado en: coloproctology, 2025, ISSN 0174-2442
Editor: 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

Autores: Cahill, Ronan A.; Duffourc, Mindy; Gerke, Sara
Publicado en: International Journal of Surgery, Edición 111, 2025, ISSN 1743-9159
Editor: Elsevier, Wolters Kluwer
DOI: 10.1097/JS9.0000000000002309

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

Autores: Fenwick, Mark; Fertik, Michael; Jurcys, Paulius; Minssen, Timo
Publicado en: The Vanderbilt Journal of Entertainment and Technology Law, Edición 27 (3), 2025, ISSN 1942-678X
Editor: Vanderbilt University Law School
DOI: 10.2139/SSRN.4475106

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

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

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

Autores: Mindy N. Duffourc, Ronan A. Cahill
Publicado en: npj Digital Medicine, Edición 9, 2026, ISSN 2398-6352
Editor: 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

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

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

Autores: Moynihan, A., Hardy, N., Dalli, J., Aigner, F., Arezzo, A., Knol, J., Tunyman, J., & Cahill, R.
Publicado en: Colorectal Disease: Special Edición:ESCP's 18th Scientific and Annual Conference, 2023, ISSN 1463-1318
Editor: 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

Autores: Gerke, Sara; Rezaeikhonakdar, Delaram
Publicado en: Cardozo Law Review, 2024, ISSN 2169-4893
Editor: Cardozo Law Review
DOI: 10.5281/ZENODO.12922079

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

Autores: Aigner, Felix
Publicado en: Journal Onkologie, Edición 25, 2025, ISSN 1618-7687
Editor: MedTriX GmbH
DOI: 10.5281/ZENODO.17284979

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

Autores: Sara Gerke, David A. Simon, Benjamin R. Roman
Publicado en: JCO Oncology Practice, 2025, ISSN 2688-1527
Editor: 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)

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

New case law and liability risks for manufacturers of medical AI

Autores: Sara Gerke, David A. Simon
Publicado en: Science, Edición 388, 2025, ISSN 0036-8075
Editor: 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

Autores: Duffourc, Mindy; Gerke, Sara
Publicado en: Stanford Technology Law Review, 2024, ISSN 1098-4267
Editor: Stanford Technology Law Review
DOI: 10.5281/ZENODO.10078491

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

Autores: Minssen, Timo; Vayena, Effy; Cohen, Glenn
Publicado en: JAMA, Edición 330, 2023, ISSN 1538-3598
Editor: JAMA Network
DOI: 10.5281/zenodo.8269643

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

Autores: Porsdam Mann, Sebastian; Cohen, I. Glenn; Minssen, Timo
Publicado en: NEJM AI, Edición 1 (11), 2024, ISSN 2836-9386
Editor: NEJM Group
DOI: 10.1056/AIp2400449

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

Autores: 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
Publicado en: Colorectal Disease, Edición 25 (12), 2023, ISSN 1463-1318
Editor: Wiley
DOI: 10.1111/CODI.16769

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

Autores: Kostick-Quenet, Kristin M.; Corrales Compagnucci, Marcelo; Aboy, Mateo; Minssen, Timo
Publicado en: Journal of Law and the Biosciences, Edición 12 (1), 2025, ISSN 2053-9711
Editor: Oxford University Press
DOI: 10.1093/JLB/LSAF003

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

Autores: Mindy Nunez Duffourc, Sara Gerke
Publicado en: JAMA, Edición 331, 2024, ISSN 0098-7484
Editor: 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

Autores: Duffourc, Mindy Nunez; Gerke, Sara
Publicado en: JAMA, Edición 330, 2023, ISSN 1538-3598
Editor: JAMA Network
DOI: 10.1001/jama.2023.9630

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

Autores: Charlotte Tschider, Marcelo Corrales Compagnucci, Timo Minssen
Publicado en: Journal of Law and the Biosciences, Edición 11, 2024, ISSN 2053-9711
Editor: Oxford University Press (OUP)
DOI: 10.1093/jlb/lsae022

Artificial intelligence classification of rectal neoplasia by endoscopic fluorescence perfusion analysis

Autores: 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
Publicado en: Scientific Reports, Edición 16, 2026, ISSN 2045-2322
Editor: 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

Autores: Patrick A. Boland, N. P. Hardy, A. Moynihan, P. D. McEntee, C. Loo, H. Fenlon, R. A. Cahill
Publicado en: European Journal of Nuclear Medicine and Molecular Imaging, Edición 51, 2024, ISSN 1619-7070
Editor: 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

Autores: Duffourc, Mindy; Mllebk, Mathias; Druedahl, Louise; Minssen, Timo; Gerke, Sara
Publicado en: Annals of Surgery Open, 2025, ISSN 2691-3593
Editor: Wolters Kluwer
DOI: 10.1097/AS9.0000000000000542

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

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

Chevron's Fall And Its Impact On Medical AI

Autores: Gerke, Sara; Simon, David A.
Publicado en: Health Affairs Forefront, 2025, ISSN 1544-5208
Editor: 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

Autores: Emilia Niemiec, Timo Minssen, Patrick A. Boland, Philip D. McEntee, Ronan A. Cahill
Publicado en: Expert Review of Medical Devices, Edición 22, 2025, ISSN 1743-4440
Editor: Informa UK Limited
DOI: 10.1080/17434440.2025.2531295

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

Autores: Mateo Aboy, Timo Minssen, Effy Vayena
Publicado en: npj Digital Medicine, Edición 7, 2024, ISSN 2398-6352
Editor: Springer Science and Business Media LLC
DOI: 10.1038/s41746-024-01232-3

Digital endoscopic characterisation of significant rectal neoplasia: A video vignette

Autores: 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
Publicado en: Colorectal Disease, Edición 27, 2025, ISSN 1462-8910
Editor: Wiley
DOI: 10.1111/CODI.70260

Protocol for CLASSICA software as medical device trial

Autores: 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
Publicado en: Minimally Invasive Therapy &amp; Allied Technologies, 2025, ISSN 1364-5706
Editor: Informa UK Limited
DOI: 10.1080/13645706.2025.2540482

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

Autores: Duffourc, Mindy Nunez; Gerke, Sara
Publicado en: npj Digital Medicine, Edición 6 (77), 2023, ISSN 2398-6352
Editor: 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

Autores: Alberto Arezzo, Carlo Alberto Ammirati, Giovanni Distefano, Michele Barbiero, Roberto Passera, Mario Morino
Publicado en: Surgical Endoscopy, 2025, ISSN 0930-2794
Editor: 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

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

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

Autores: Giovanni Distefano, Carlo Alberto Ammirati, Michele Barbiero, Roberto Passera, Alberto Arezzo
Publicado en: Surgical Endoscopy, Edición 39, 2025, ISSN 0930-2794
Editor: Springer Nature
DOI: 10.1007/S00464-025-12243-W

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

Autores: Oscar Freyer, Max Ostermann, Timo Minssen, Stephen Gilbert
Publicado en: npj Digital Medicine, Edición 8, 2025, ISSN 2398-6352
Editor: Springer Science and Business Media LLC
DOI: 10.1038/S41746-025-02082-3

Enabling secure and self determined health data sharing and consent management

Autores: Cindy Welzel, Max Ostermann, Hannah Louise Smith, Timo Minssen, Toralf Kirsten, Stephen Gilbert
Publicado en: npj Digital Medicine, Edición 8, 2025, ISSN 2398-6352
Editor: 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

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

Patient Perspectives on Data Sharing

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

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

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

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

Autores: Timo Minssen, Barry Solaiman, Lea Köttering, Jakob Wested, Abeer Malik
Publicado en: Research Handbook on Health, AI and the Law, 2024
Editor: Edward Elgar Publishing
DOI: 10.4337/9781802205657.00027

Medical AI and tort liability

Autores: Cohen, I. Glenn; Slottje, Andrew; Gerke, Sara
Publicado en: Artificial Intelligence in Medicine, 2024
Editor: Elsevier
DOI: 10.1016/B978-0-323-95068-8.00007-8

Liability for use of artificial intelligence in medicine

Autores: Price, Nicholson; Gerke, Sara; Cohen, Ivan
Publicado en: Research Handbook on Health, AI and the Law, 2024
Editor: Edward Elgar Publishing
DOI: 10.4337/9781802205657.00016

Other (1)

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

Autores: Corrales Compagnucci, Marcelo; Dahi, Alan; Alexander Earls Davis, Peter
Publicado en: European Health & Pharmaceutical Law Review, Edición 7 (3), 2023, ISSN 2751-3971
Editor: Lexxion
DOI: 10.21552/ehpl/2023/3/5

Conference proceedings (1)

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

Autores: Ronan Cahill
Publicado en: Molecular-Guided Surgery: Molecules, Devices, and Applications X, 2024
Editor: SPIE
DOI: 10.1117/12.3011288