Sara Gerke

University of Illinois College of Law

504 E Pennsylvania Ave

Champaign, IL 61820

United States

  • University of Illinois College of Law

SCHOLARLY PAPERS

30

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22

Scholarly Papers (30)

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1.

Ethical and Legal Challenges of Artificial Intelligence-Driven Healthcare

This article was published in Artificial Intelligence in Healthcare, 1st edition, Adam Bohr, Kaveh Memarzadeh (eds.), ISBN: 9780128184387, Copyright Elsevier, 2020
Number of pages: 42 Posted: 26 May 2020 Last Revised: 01 Mar 2021
Sara Gerke, Timo Minssen and I. Glenn Cohen
University of Illinois College of Law, University of Copenhagen - Centre for Advanced Studies in Biomedical Innovation Law (CeBIL) - Faculty of Law and Harvard Law School
Downloads 1,956 (18,191)
Citation 2

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Artificial Intelligence (AI), Ethical Challenges, U.S. and EU Law, Safety and Effectiveness, Data Protection and Privacy

2.

Liability for Use of Artificial Intelligence in Medicine

W. Nicholson Price II, Sara Gerke, & I. Glenn Cohen, Liability for Use of Artificial Intelligence in Medicine, Research Handbook on Health, AI and the Law, Barry Solaiman & I. Glenn Cohen, eds. Edward Elgar Publishing Ltd. (2023 Forthcoming), Harvard Public Law Working Paper No. 22-16, U of Michigan Public Law Research Paper No. 22-020, U of Michigan Law & Econ Research Paper No. 22-020
Number of pages: 22 Posted: 27 May 2022 Last Revised: 04 Oct 2022
W. Nicholson Price II, Sara Gerke and I. Glenn Cohen
University of Michigan Law School, University of Illinois College of Law and Harvard Law School
Downloads 1,000 (49,310)
Citation 3

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AI, liability, healthcare, malpractice, artificial intelligence

3.

Health AI for Good Rather Than Evil? The Need for a New Regulatory Framework for AI-Based Medical Devices

Yale Journal of Health Policy, Law, and Ethics, Vol. 20, Issue 2, 433 (2021)
Number of pages: 81 Posted: 29 Apr 2022
Sara Gerke
University of Illinois College of Law
Downloads 564 (104,952)
Citation 5

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Artificial intelligence, machine learning, medical devices, FDA law, safety and effectiveness, clinical decision support software, 510(k), Pre-Cert Program, black-box AI/ML models, clinical trials, adaptive algorithms, update problem, system view

4.

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

Cardozo Law Review, Vol. 45, No. 2, 2023 (published Feb. 2024)
Number of pages: 53 Posted: 07 Nov 2023 Last Revised: 27 Feb 2024
Sara Gerke and Delaram Rezaeikhonakdar
University of Illinois College of Law and Pennsylvania State University, Penn State Law
Downloads 434 (144,269)
Citation 2

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Privacy Shield 2.0, Adequacy Decision, Cross-Border Transfers of Personal Data, US Law, EU Law, US Executive Order on Enhancing Safeguards for United States Signals Intelligence Activities, General Data Protection Regulation, Privacy Law, Schrems I, Schrems II

5.

'Nutrition Facts Labels' for Artificial Intelligence/Machine Learning-Based Medical Devices—The Urgent Need for Labeling Standards

91 The George Washington Law Review 79 (2023).
Number of pages: 85 Posted: 18 Apr 2023 Last Revised: 28 Feb 2024
Sara Gerke
University of Illinois College of Law
Downloads 352 (182,636)
Citation 1

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AI, Machine Learning, Labeling, Medical Devices, FDA Law

6.

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

27 Stan. Tech. L. Rev. 1 (2024).
Number of pages: 70 Posted: 14 Sep 2023 Last Revised: 07 Jun 2024
Mindy Duffourc and Sara Gerke
Maastricht University and University of Illinois College of Law
Downloads 276 (236,724)
Citation 1

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Artificial Intelligence, Medical Liability, Product Liability, Black-Box AI, Comparative Law, US Law, EU Law, Law and Technology, AI Liability, Health Law, ChatGPT

7.

A User-Focused Transdisciplinary Research Agenda for AI-Enabled Health Tech Governance

Number of pages: 18 Posted: 31 May 2019
David Arney, Max Senges, Sara Gerke, Cansu Canca, Laura Haaber Ihle, Annabel Kupke, Ashveena Gajeelee, Stephen Lynch and Luis Meléndez-Cintrón
affiliation not provided to SSRN, Berlin University of the Arts, University of Illinois College of Law, AI Ethics Lab, Sant'Anna School of Advanced Studies, Boston University - School of Law, affiliation not provided to SSRN, affiliation not provided to SSRN and affiliation not provided to SSRN
Downloads 266 (245,783)
Citation 6

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AI, AI-Enabled Health Technology, AI Ethics, Health Data Governance and Security, AI Health Coaching

8.

Privacy of Personal Data in the Generative AI Data Lifecycle

Number of pages: 53 Posted: 24 Jul 2024
Mindy Duffourc, Sara Gerke and Konrad Kollnig
Maastricht University, University of Illinois College of Law and Law and Tech Lab, Faculty of Law, Maastricht University
Downloads 182 (353,770)

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9.

German Pharmaceutical Pricing: Lessons for the U.S.

International Journal of Health Services, 2021
Number of pages: 25 Posted: 06 Jan 2022
Marc A. Rodwin and Sara Gerke
Suffolk University Law School and University of Illinois College of Law
Downloads 122 (502,344)
Citation 1

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10.

The Need for 'Nutrition Facts Labels' and 'Front-Of-Package Nutrition Labeling' For Artificial Intelligence/Machine Learning-Based Medical Devices - Lessons Learned From Food Labeling

Forthcoming, Emory Law Journal (Vol. 74, 2025)
Number of pages: 78 Posted: 28 Jan 2025 Last Revised: 07 Feb 2025
Sara Gerke
University of Illinois College of Law
Downloads 97 (583,001)

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Artificial Intelligence, Machine Learning, Medical Devices, Labeling, Nutrition Facts Label, Front-of-Package

11.

Synthetic Health Data: Real Ethical Promise and Peril

Hastings Center Report, volume 54, issue 5, 2024[10.1002/hast.4911]
Number of pages: 6 Posted: 08 Jan 2025
Daniel Susser, Daniel Schiff, Sara Gerke, Laura Y. Cabrera, I. Glenn Cohen, Megan Doerr, Jordan Harrod, Kristin M. Kostick-Quenet, Jasmine E. McNealy, Michelle N. Meyer, W. Nicholson Price II and Jennifer K Wagner
Cornell University, Purdue University, University of Illinois College of Law, Michigan State University - Center for Ethics and Humanities in the Life Sciences, Harvard Law School, Sage Bionetworks, Harvard-MIT Health Sciences and Technology, Independent, University of Florida - College of Journalism & Communication, Geisinger Health System - Bioethics Research, University of Michigan Law School and Independent
Downloads 34 (992,494)
Citation 1

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synthetic data, privacy, health data, machine learning, privacy-enhancing technologies, PETs

12.

To Spur Growth in AI, We Need a New Approach to Legal Liability

HARVARD BUSINESS REVIEW (2021)
Posted: 13 Sep 2022
George Maliha, Sara Gerke, Ravi B. Parikh and I. Glenn Cohen
Independent, University of Illinois College of Law, Independent and Harvard Law School

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Artificial Intelligence, Liability

13.

Privacy Aspects of Direct-to-Consumer Artificial Intelligence/Machine Learning Health Apps

6 Intelligence-Based Medicine 100061 (2022)
Posted: 18 Aug 2022
Sara Gerke and Delaram Rezaeikhonakdar
University of Illinois College of Law and Pennsylvania State University, Penn State Law

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Privacy, Health, Apps, Direct-to-Consumer, Artificial intelligence, U.S. Law

14.

How Much Can Potential Jurors Tell Us About Liability for Medical Artificial Intelligence?

Journal of Nuclear Medicine January 2021, 62 (1) 15-16; DOI: https://doi.org/10.2967/jnumed.120.257196, U of Michigan Public Law Research Paper No. 21-023, U of Michigan Law & Econ Research Paper No. 21-023, Harvard Public Law Working Paper No. 21-46
Posted: 02 Aug 2021 Last Revised: 13 Dec 2021
W. Nicholson Price II, Sara Gerke and I. Glenn Cohen
University of Michigan Law School, University of Illinois College of Law and Harvard Law School

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Artificial Intelligence, Liability

15.

AI Surveillance during Pandemics: Ethical Implementation Imperatives

50 HASTINGS CENT. REP. 18 (2020). https://doi.org/10.1002/hast.1125
Posted: 30 Jul 2021
Carmel Shachar, Sara Gerke and Eli Y Adashi
Harvard Law School, University of Illinois College of Law and Brown University Medical School

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AI, surveillance, COVID-19, Ethics

16.

Applying the Proportionality Principle to COVID-19 Antibody Testing

Journal of Law and the Biosciences, Volume 7, Issue 1, January-June 2020, lsaa058, https://doi.org/10.1093/jlb/lsaa058
Posted: 09 Jul 2021
Hrefna D. Gunnarsdottir, Michael S. Sinha, Sara Gerke and Timo Minssen
University of Copenhagen - Centre for Advanced Studies in Biomedical Innovation Law (CeBIL), Saint Louis University - School of Law, University of Illinois College of Law and University of Copenhagen - Centre for Advanced Studies in Biomedical Innovation Law (CeBIL) - Faculty of Law

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Proportionality Principle, COVID-19, Antibody Testing

17.

Germany’s Digital Health Reforms in the COVID-19 Era: Lessons and Opportunities for Other Countries

npj Digit. Med. 3, 94 (2020). https://doi.org/10.1038/s41746-020-0306-7
Posted: 09 Jul 2021
Sara Gerke, Ariel Dora Stern and Timo Minssen
University of Illinois College of Law, University of Potsdam - Hasso Plattner Institute (HPI) and University of Copenhagen - Centre for Advanced Studies in Biomedical Innovation Law (CeBIL) - Faculty of Law

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Digital Health, Germany, Apps, Digital Healthcare Act

18.

COVID-19 Antibody Testing as a Precondition for Employment: Ethical and Legal Considerations

Journal of Law, Medicine & Ethics 2021, 49(2), 293-302. doi:10.1017/jme.2021.42, UC Hastings Research Paper Forthcoming
Posted: 09 Jul 2021
Sara Gerke, Gali Katznelson, Dorit Rubinstein Reiss and Carmel Shachar
University of Illinois College of Law, Independent, UC Law, San Francisco and Harvard Law School

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Antibody Testing, COVID-19, Employment, Ethics, Law, FDA, ADA

19.

When Machine Learning Goes Off the Rails

HARV. BUS. REV. (2021). https://hbr.org/2021/01/when-machine-learning-goes-off-the-rails. , Harvard Public Law Working Paper No. 21-32
Posted: 08 Jul 2021 Last Revised: 28 Oct 2021
Boris Babic, I. Glenn Cohen, Theodoros Evgeniou and Sara Gerke
Independent, Harvard Law School, INSEAD and University of Illinois College of Law

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Artificial Intelligence, Risk, Liability

20.

Direct-to-Consumer Medical Machine Learning and Artificial Intelligence Applications

Nat Mach Intell 3, 283–287 (2021). https://doi.org/10.1038/s42256-021-00331-0
Posted: 08 Jul 2021
Boris Babic, Sara Gerke, Theodoros Evgeniou and I. Glenn Cohen
Independent, University of Illinois College of Law, INSEAD and Harvard Law School

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Artificial Intelligence, Machine Learning, Direct-to-Consumer, Apps

21.

Ethical and Legal Aspects of Ambient Intelligence in Hospitals

JAMA. 2020;323(7):601-602. doi:10.1001/jama.2019.21699, Harvard Public Law Working Paper No. 21-26
Posted: 08 Jul 2021 Last Revised: 28 Oct 2021
Sara Gerke, Serena Yeung and I. Glenn Cohen
University of Illinois College of Law, Stanford University - Chan Zuckerberg Biohub and Harvard Law School

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Ambient Intelligence, Hospital, Ethical and Legal Issues

22.

Regulatory, Safety, and Privacy Concerns of Home Monitoring Technologies during COVID-19

Nat Med. 2020 Aug;26(8):1176-1182. doi: 10.1038/s41591-020-0994-1
Posted: 25 May 2021
Sara Gerke, Carmel Shachar, Peter R. Chai and I. Glenn Cohen
University of Illinois College of Law, Harvard Law School, Harvard University - Brigham and Women's Hospital and Harvard Law School

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Digital Health, Home Monitoring Technologies, Emergency Use Authorizations, Medical Devices, Safety, Privacy, Security

23.

Algorithms on Regulatory Lockdown in Medicine

Science. 2019 Dec 6;366(6470):1202-1204. doi: 10.1126/science.aay9547
Posted: 25 May 2021
Boris Babic, Sara Gerke, Theodoros Evgeniou and I. Glenn Cohen
Independent, University of Illinois College of Law, INSEAD and Harvard Law School

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artificial intelligence, FDA law, adaptive algorithms, risks

24.

Potential Liability for Physicians Using Artificial Intelligence

JAMA. 2019;322(18):1765-1766. doi:10.1001/jama.2019.15064
Posted: 25 May 2021
W. Nicholson Price II, Sara Gerke and I. Glenn Cohen
University of Michigan Law School, University of Illinois College of Law and Harvard Law School

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artificial intelligence; medical malpractice, liability

25.

The Need for a System View to Regulate Artificial Intelligence/Machine Learning-Based Software as Medical Device

NPJ Digit Med. 2020 Apr 7;3:53. doi: 10.1038/s41746-020-0262-2
Posted: 24 May 2021
Sara Gerke, Boris Babic, Theodoros Evgeniou and I. Glenn Cohen
University of Illinois College of Law, Independent, INSEAD and Harvard Law School

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Artificial Intelligence, Machine Learning, FDA law, Software as a Medical Device, System View

26.

The Ethics and Laws of Medical Big Data

in The Cambridge Handbook of Information Technology, Life Sciences and Human Rights (M. Ienca, O. Pollicino, L. Liguori, E. Stefanini & R. Andorno eds., Cambridge University Press, 2022)
Posted: 04 Mar 2021 Last Revised: 15 Aug 2022
Hrefna D. Gunnarsdottir, I. Glenn Cohen, Timo Minssen and Sara Gerke
University of Copenhagen - Centre for Advanced Studies in Biomedical Innovation Law (CeBIL), Harvard Law School, University of Copenhagen - Centre for Advanced Studies in Biomedical Innovation Law (CeBIL) - Faculty of Law and University of Illinois College of Law

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Big Data, Medicine, Ethics, Ownership, Informed Consent, Privacy, Data Sharing, COVID-19, EU Law, US Law

27.

Ethical and Legal Issues of Ingestible Electronic Sensors

Nat Electron 2, 329–334 (2019). https://doi.org/10.1038/s41928-019-0290-6
Posted: 18 Aug 2020 Last Revised: 07 Jul 2021
Sara Gerke, Timo Minssen, Helen Yu and I. Glenn Cohen
University of Illinois College of Law, University of Copenhagen - Centre for Advanced Studies in Biomedical Innovation Law (CeBIL) - Faculty of Law, University of Copenhagen - Center for Information and Innovation Law (CIIR) and Harvard Law School

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28.

How Does Emerging Patent Case Law in the US and Europe Affect Precision Medicine? How Will Today’s Patent Law Affect Tomorrow’s Innovation in the Areas of Biomarkers and Nature-Based Products; Diagnostics; and Algorithms, Big Data and AI?

Aboy, M., Liddell, K., Crespo, C. et al. How does emerging patent case law in the US and Europe affect precision medicine?. Nat Biotechnol 37, 1118–1125 (2019)
Posted: 18 Aug 2020
Mateo Aboy, I. Glenn Cohen, Kathleen Liddell, John Liddicoat, Cristina Crespo, Sara Gerke and Timo Minssen
LML, University of Cambridge, Harvard Law School, University of Cambridge - Faculty of Law, King’s College London, University of Cambridge, University of Illinois College of Law and University of Copenhagen - Centre for Advanced Studies in Biomedical Innovation Law (CeBIL) - Faculty of Law

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29.

The European Artificial Intelligence Strategy: Implications and Challenges for Digital Health

2 THE LANCET DIGITAL HEALTH E376 (2020). https://doi.org/10.1016/S2589-7500(20)30112-6
Posted: 14 Aug 2020 Last Revised: 07 Jul 2021
I. Glenn Cohen, Theodoros Evgeniou, Sara Gerke and Timo Minssen
Harvard Law School, INSEAD, University of Illinois College of Law and University of Copenhagen - Centre for Advanced Studies in Biomedical Innovation Law (CeBIL) - Faculty of Law

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Artificial Intelligence, European Commission, White Paper

30.

Regulatory Responses to Medical Machine Learning

Journal of Law and the Biosciences, Volume 7, Issue 1, January-June 2020, lsaa002, https://doi.org/10.1093/jlb/lsaa002
Posted: 14 Aug 2020 Last Revised: 07 Jul 2021
Timo Minssen, Sara Gerke, Mateo Aboy, W. Nicholson Price II and I. Glenn Cohen
University of Copenhagen - Centre for Advanced Studies in Biomedical Innovation Law (CeBIL) - Faculty of Law, University of Illinois College of Law, LML, University of Cambridge, University of Michigan Law School and Harvard Law School

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Medical Devices, Artificial Intelligence, Regulation

Other Papers (1)

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1.

A Comparative Legal Analysis of the Clinical Translation of hiPSCs in Germany and Austria (Eine rechtsvergleichende Analyse der klinischen Translation von hiPS-Zellen in Deutschland und Österreich)

in Die klinische Anwendung von humanen induzierten pluripotenten Stammzellen [The Clinical Application of Human Induced Pluripotent Stem Cells] 421 (Sara Gerke et al. eds., Springer 2020). https://doi.org/10.1007/978-3-662-59052-2_10
Posted: 17 Aug 2022
Sara Gerke, Christian Kopetzki, Verena Christine Blum, Danielle Noe and Claudia Steinböck
University of Illinois College of Law, affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN and affiliation not provided to SSRN

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German Law, Austrian Law, Stem Cells, Human Induced Pluripotent Stem Cells