VALIDATING AI IN CLASSIFYING CANCER IN REAL-TIME SURGERY

Project Information

CLASSICA

Grant agreement ID: 101057321

DOI

10.3030/101057321

EC signature date 19 May 2022

Start date 1 May 2022

End date 30 April 2026

Funded under

• Health

Total cost

€ 5 978 718,74

EU contribution

€ 5 978 716,00

Coordinated by

UNIVERSITY COLLEGE DUBLIN, NATIONAL UNIVERSITY OF IRELAND, DUBLIN
Ireland

CORDIS provides links to public deliverables and publications of HORIZON projects.

Links to deliverables and publications from FP7 projects, as well as links to some specific result types such as dataset and software, are dynamically retrieved from OpenAIRE .

Deliverables

Documents, reports (4)

Communication and Dissemination Plan
Website and Online Communications Setup Report
Training report (resources, photos from training, participant feedback)
Final Clinical Validation Protocol, Patient information document, Consent forms

Publications

Peer reviewed articles (28)

Privacy of Personal Data in the Generative AI Data Lifecycle

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

Artificial Intelligence and Medical Liability in Gastrointestinal Endoscopy

Author(s): Sami Elamin, Mindy Duffourc, Tyler M. Berzin, Mark E. Geissler, Sara Gerke
Published in: Clinical Gastroenterology and Hepatology, Issue 22, 2024, ISSN 1542-3565
Publisher: Elsevier
DOI: 10.1016/j.cgh.2024.03.011

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

Author(s): Cahill, Ronan; Duffourc, Mindy Nunez; Gerke, Sara
Published in: Annals of Surgery, 2024, ISSN 1528-1140
Publisher: Wolters Kluwer Health, Inc.
DOI: 10.1097/SLA.0000000000006336

Data sharing restrictions are hampering precision health in the European Union

Author(s): 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
Published in: Nature Medicine, Issue 31, 2025, ISSN 1078-8956
Publisher: Springer Science and Business Media LLC
DOI: 10.1038/S41591-024-03437-1

Validierung künstlicher Intelligenz für die Klassifizierung von Mastdarmkrebs während endoskopischer Chirurgie

Author(s): Felix Aigner, David Duller, Christoph Skias, Gabriele Moitzi, Martin Mitteregger
Published in: coloproctology, 2025, ISSN 0174-2442
Publisher: 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

Author(s): Cahill, Ronan A.; Duffourc, Mindy; Gerke, Sara
Published in: International Journal of Surgery, Issue 111, 2025, ISSN 1743-9159
Publisher: Elsevier, Wolters Kluwer
DOI: 10.1097/JS9.0000000000002309

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

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

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

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

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

Author(s): Porsdam Mann, Sebastian; Vazirani, Anuraag; Aboy, Mateo; Earp, Brian; Minssen, Timo; Cohen, Glenn; Savulescu, Julian
Published in: Nature Machine Intelligence, 2024, ISSN 2522-5839
Publisher: Springer Nature
DOI: 10.1038/s42256-024-00922-7

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

Author(s): Moynihan, A., Hardy, N., Dalli, J., Aigner, F., Arezzo, A., Knol, J., Tunyman, J., & Cahill, R.
Published in: Colorectal Disease: Special Issue:ESCP's 18th Scientific and Annual Conference, 2023, ISSN 1463-1318
Publisher: 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

Author(s): Gerke, Sara; Rezaeikhonakdar, Delaram
Published in: Cardozo Law Review, 2024, ISSN 2169-4893
Publisher: Cardozo Law Review
DOI: 10.5281/ZENODO.12922079

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

Author(s): Aigner, Felix
Published in: Journal Onkologie, Issue 25, 2025, ISSN 1618-7687
Publisher: MedTriX GmbH
DOI: 10.5281/ZENODO.17284979

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

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

New case law and liability risks for manufacturers of medical AI

Author(s): Sara Gerke, David A. Simon
Published in: Science, Issue 388, 2025, ISSN 0036-8075
Publisher: 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

Author(s): Duffourc, Mindy; Gerke, Sara
Published in: Stanford Technology Law Review, 2024, ISSN 1098-4267
Publisher: Stanford Technology Law Review
DOI: 10.5281/ZENODO.10078491

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

Author(s): Minssen, Timo; Vayena, Effy; Cohen, Glenn
Published in: JAMA, Issue 330, 2023, ISSN 1538-3598
Publisher: JAMA Network
DOI: 10.5281/zenodo.8269643

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

Author(s): Porsdam Mann, Sebastian; Cohen, I. Glenn; Minssen, Timo
Published in: NEJM AI, Issue 1 (11), 2024, ISSN 2836-9386
Publisher: NEJM Group
DOI: 10.1056/AIp2400449

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

Author(s): 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
Published in: Colorectal Disease, Issue 25 (12), 2023, ISSN 1463-1318
Publisher: Wiley
DOI: 10.1111/CODI.16769

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

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

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

Author(s): Mindy Nunez Duffourc, Sara Gerke
Published in: JAMA, Issue 331, 2024, ISSN 0098-7484
Publisher: 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

Author(s): Duffourc, Mindy Nunez; Gerke, Sara
Published in: JAMA, Issue 330, 2023, ISSN 1538-3598
Publisher: JAMA Network
DOI: 10.1001/jama.2023.9630

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

Author(s): Charlotte Tschider, Marcelo Corrales Compagnucci, Timo Minssen
Published in: Journal of Law and the Biosciences, Issue 11, 2024, ISSN 2053-9711
Publisher: Oxford University Press (OUP)
DOI: 10.1093/jlb/lsae022

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

Author(s): Duffourc, Mindy; Mllebk, Mathias; Druedahl, Louise; Minssen, Timo; Gerke, Sara
Published in: Annals of Surgery Open, 2025, ISSN 2691-3593
Publisher: Wolters Kluwer
DOI: 10.1097/AS9.0000000000000542

Chevron's Fall And Its Impact On Medical AI

Author(s): Gerke, Sara; Simon, David A.
Published in: Health Affairs Forefront, 2025, ISSN 1544-5208
Publisher: 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

Author(s): Emilia Niemiec, Timo Minssen, Patrick A. Boland, Philip D. McEntee, Ronan A. Cahill
Published in: Expert Review of Medical Devices, Issue 22, 2025, ISSN 1743-4440
Publisher: Informa UK Limited
DOI: 10.1080/17434440.2025.2531295

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

Author(s): Mateo Aboy, Timo Minssen, Effy Vayena
Published in: npj Digital Medicine, Issue 7, 2024, ISSN 2398-6352
Publisher: Springer Science and Business Media LLC
DOI: 10.1038/s41746-024-01232-3

Protocol for CLASSICA software as medical device trial

Author(s): 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
Published in: Minimally Invasive Therapy &amp; Allied Technologies, 2025, ISSN 1364-5706
Publisher: Informa UK Limited
DOI: 10.1080/13645706.2025.2540482

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

Author(s): Duffourc, Mindy Nunez; Gerke, Sara
Published in: npj Digital Medicine, Issue 6 (77), 2023, ISSN 2398-6352
Publisher: Springer Nature
DOI: 10.1038/s41746-023-00823-w

Book chapters (6)

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

Author(s): Minssen, Timo; Smith, Hannah Louise; Porsdam Mann, Sebastian
Published in: Inteligencia Artificial: Hacia una nueva era en la historia de la humanidad, 2025
Publisher: INADI
DOI: 10.5281/ZENODO.15608122

Patient Perspectives on Data Sharing

Author(s): Druedahl, Louise C.; Kälvemark Sporrong, Sofia
Published in: The Law and Ethics of Data Sharing in Health Sciences. Perspectives in Law, 2023
Publisher: Springer
DOI: 10.1007/978-981-99-6540-3_4

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

Author(s): Corrales Compagnucci, Marcelo; Fenwick, Mark; Aboy, Mateo; Minssen, Timo
Published in: The Law and Ethics of Data Sharing in Health Sciences, 2023
Publisher: Springer
DOI: 10.1007/978-981-99-6540-3_9

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

Author(s): Timo Minssen, Barry Solaiman, Lea Köttering, Jakob Wested, Abeer Malik
Published in: Research Handbook on Health, AI and the Law, 2024
Publisher: Edward Elgar Publishing
DOI: 10.4337/9781802205657.00027

Medical AI and tort liability

Author(s): Cohen, I. Glenn; Slottje, Andrew; Gerke, Sara
Published in: Artificial Intelligence in Medicine, 2024
Publisher: Elsevier
DOI: 10.1016/B978-0-323-95068-8.00007-8

Liability for use of artificial intelligence in medicine

Author(s): Price, Nicholson; Gerke, Sara; Cohen, Ivan
Published in: Research Handbook on Health, AI and the Law, 2024
Publisher: Edward Elgar Publishing
DOI: 10.4337/9781802205657.00016

Other (1)

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

Author(s): Corrales Compagnucci, Marcelo; Dahi, Alan; Alexander Earls Davis, Peter
Published in: European Health & Pharmaceutical Law Review, Issue 7 (3), 2023, ISSN 2751-3971
Publisher: Lexxion
DOI: 10.21552/ehpl/2023/3/5