Sara Gerke

Pennsylvania State University, Dickinson Law

150 S College St

Carlisle, PA 17013

United States

SCHOLARLY PAPERS

24

DOWNLOADS

1,633

SSRN CITATIONS

2

CROSSREF CITATIONS

2

Scholarly Papers (24)

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
Pennsylvania State University, Dickinson Law, University of Copenhagen - Centre for Advanced Studies in Biomedical Innovation Law (CeBIL) - Faculty of Law and Harvard Law School
Downloads 948 (36,318)
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
University of Michigan Law School, Pennsylvania State University, Dickinson Law and Harvard Law School
Downloads 268 (167,660)

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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
Pennsylvania State University, Dickinson Law
Downloads 198 (222,660)

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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.

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

Number of pages: 18 Posted: 31 May 2019
affiliation not provided to SSRN, 42 Wolfsburg / Berlin, Pennsylvania State University, Dickinson Law, AI Ethics Lab, Sant'Anna School of Advanced Studies, affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN and affiliation not provided to SSRN
Downloads 162 (264,605)
Citation 5

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

5.

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 Pennsylvania State University, Dickinson Law
Downloads 57 (517,159)

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6.

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

HARVARD BUSINESS REVIEW (2021)
Posted: 13 Sep 2022
Independent, Pennsylvania State University, Dickinson Law, Independent and Harvard Law School

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Artificial Intelligence, Liability

7.

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
Pennsylvania State University, Dickinson Law and affiliation not provided to SSRN

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

8.

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
University of Michigan Law School, Pennsylvania State University, Dickinson Law and Harvard Law School

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Artificial Intelligence, Liability

9.

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, Pennsylvania State University, Dickinson Law and Brown University Medical School

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AI, surveillance, COVID-19, Ethics

10.

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
University of Copenhagen - Centre for Advanced Studies in Biomedical Innovation Law (CeBIL), Saint Louis University - School of Law, Pennsylvania State University, Dickinson 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

11.

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
Pennsylvania State University, Dickinson Law, Harvard Business School 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

12.

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
Pennsylvania State University, Dickinson Law, Independent, UC Hastings Law and Harvard Law School

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

13.

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
Independent, Harvard Law School, INSEAD and Pennsylvania State University, Dickinson Law

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Artificial Intelligence, Risk, Liability

14.

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
Independent, Pennsylvania State University, Dickinson Law, INSEAD and Harvard Law School

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

15.

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
Pennsylvania State University, Dickinson Law, affiliation not provided to SSRN and Harvard Law School

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Ambient Intelligence, Hospital, Ethical and Legal Issues

16.

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
Pennsylvania State University, Dickinson 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

17.

Algorithms on Regulatory Lockdown in Medicine

Science. 2019 Dec 6;366(6470):1202-1204. doi: 10.1126/science.aay9547
Posted: 25 May 2021
Independent, Pennsylvania State University, Dickinson Law, INSEAD and Harvard Law School

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artificial intelligence, FDA law, adaptive algorithms, risks

18.

Potential Liability for Physicians Using Artificial Intelligence

JAMA. 2019;322(18):1765-1766. doi:10.1001/jama.2019.15064
Posted: 25 May 2021
University of Michigan Law School, Pennsylvania State University, Dickinson Law and Harvard Law School

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artificial intelligence; medical malpractice, liability

19.

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
Pennsylvania State University, Dickinson Law, Independent, INSEAD and Harvard Law School

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

20.

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
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 Pennsylvania State University, Dickinson Law

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

21.

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
Pennsylvania State University, Dickinson 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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22.

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
LML, University of Cambridge, Harvard Law School, University of Cambridge - Faculty of Law, King's College London, University of Cambridge, Pennsylvania State University, Dickinson Law and University of Copenhagen - Centre for Advanced Studies in Biomedical Innovation Law (CeBIL) - Faculty of Law

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23.

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
Harvard Law School, INSEAD, Pennsylvania State University, Dickinson 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

24.

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
University of Copenhagen - Centre for Advanced Studies in Biomedical Innovation Law (CeBIL) - Faculty of Law, Pennsylvania State University, Dickinson 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)

Total Downloads: 0
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
Pennsylvania State University, Dickinson 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