Sara Gerke

Pennsylvania State University, Dickinson Law

150 S College St

Carlisle, PA 17013

United States

SCHOLARLY PAPERS

28

DOWNLOADS

624

SSRN CITATIONS

2

CROSSREF CITATIONS

2

Scholarly Papers (28)

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 522 (65,942)
Citation 2

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

2.

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, Stanford University - Center on Democracy, Development and the Rule of Law, 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 102 (317,698)
Citation 5

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

3.

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), Harvard-MIT Center for Regulatory Science, 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

4.

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

5.

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
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

6.

When Machine Learning Goes Off the Rails

HARV. BUS. REV. (2021). https://hbr.org/2021/01/when-machine-learning-goes-off-the-rails.
Posted: 08 Jul 2021
Independent, Harvard Law School, INSEAD and Pennsylvania State University, Dickinson Law

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Artificial Intelligence, Risk, Liability

7.

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

8.

Ethical and Legal Aspects of Ambient Intelligence in Hospitals

JAMA. 2020;323(7):601-602. doi:10.1001/jama.2019.21699
Posted: 08 Jul 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

9.

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

10.

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

11.

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

12.

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

13.

The Ethics and Laws of Medical Big Data

Cambridge Handbook of Information Technology, Life Sciences and Human Rights, Marcello Ienca, O. Pollicino, L. Liguori, R. Andorno & E. Stefanini (eds.) (Forthcoming)
Posted: 04 Mar 2021
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

14.

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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15.

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, University of Cambridge - Faculty of Law, 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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16.

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

17.

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

18.

Die klinische Translation von hiPS-Zellen in Deutschland

in Die klinische Anwendung von humanen induzierten pluripotenten Stammzellen [The Clinical Application of Human Induced Pluripotent Stem Cells] 243 (Sara Gerke et al. eds., Springer 2020). https://doi.org/10.1007/978-3-662-59052-2_8
Sara Gerke
Pennsylvania State University, Dickinson Law

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German Law, Stem Cells, Human Induced Pluripotent Stem Cells

19.

EU Marketing Authorisation of Orphan Medicinal Products and Its Impact on Related Research

24 EUR. J. HEALTH L. 541 (2017).
Sara Gerke and Shaun D. Pattinson
Pennsylvania State University, Dickinson Law and affiliation not provided to SSRN

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Orphan Medicinal Products, EU Marketing Authorisation, Market Exclusivity

20.

AI Surveillance during Pandemics: Ethical Implementation Imperatives

50 HASTINGS CENT. REP. 18 (2020). https://doi.org/10.1002/hast.1125
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

21.

The Regulation of Mitochondrial Replacement Techniques Around the World

Annu Rev Genomics Hum Genet. 2020 Aug 31;21:565-586. https://doi.org/10.1146/annurev-genom-111119-101815
Harvard Law School, Brown University Medical School, Pennsylvania State University, Dickinson Law, King's College London - Centre of Medical Law and Ethics (CMLE) and University of Montreal, Dept of Social and Preventive Medicine

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mitochondrial replacement, mitochondrial transfer, law, ethics, gene editing

22.

V. Mannheimer Workshop zur Fortpflanzungsmedizin: Ein juristischer Diskurs zur Präimplantationsdiagnostik und Embryonenspende auf der Basis neuerer reproduktionsbiologischer Prämissen

12 JOURNAL OF REPROD. MED. AND ENDOCRINOL. 42 (2015).
affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN, Pennsylvania State University, Dickinson Law, affiliation not provided to SSRN, 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 Embryo Protection Act, Reproductive Medicine, Preimplantation Diagnosis, Embryo Donation

23.

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

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Artificial Intelligence, Liability

24.

Die klinische Anwendung von hiPS-Zellen: ein Überblick

in Die klinische Anwendung von humanen induzierten pluripotenten Stammzellen [The Clinical Application of Human Induced Pluripotent Stem Cells] 1 (Sara Gerke et al. eds., Springer 2020). https://doi.org/10.1007/978-3-662-59052-2_1
Sara Gerke and Solveig Lena Hansen
Pennsylvania State University, Dickinson Law and affiliation not provided to SSRN

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Stem Cells, Human Induced Pluripotent Stem Cells

25.

Naturwissenschaftliche, ethische und rechtliche Empfehlungen zur klinischen Translation der Forschung mit humanen induzierten pluripotenten Stammzellen und davon abgeleiteten Produkten

in Die klinische Anwendung von humanen induzierten pluripotenten Stammzellen [The Clinical Application of Human Induced Pluripotent Stem Cells] 459 (Sara Gerke et al. eds., Springer 2020). https://doi.org/10.1007/978-3-662-59052-2_11
Pennsylvania State University, Dickinson Law, affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN, 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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Science, Ethics, Law, Stem Cell Research, Human Induced Pluripotent Stem Cells

26.

Rechtliche Aspekte der Stammzellforschung in Deutschland: Grenzen und Möglichkeiten der Forschung mit humanen embryonalen Stammzellen (hES)-Zellen und mit humanen induzierten pluripotenten Stammzellen (hiPS)-Zellen

in Stammzellforschung: Aktuelle wissenschaftliche und gesellschaftliche Entwicklungen 209 (Martin Zenke, Lilian Marx-Stölting & Hannah Schickl eds., Nomos 2018).
Sara Gerke and Jochen Taupitz
Pennsylvania State University, Dickinson Law and affiliation not provided to SSRN

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

27.

On Assessing Trustworthy AI in Healthcare. Machine Learning as a Supportive Tool to Recognize Cardiac Arrest in Emergency Calls

Front. Hum. Dyn., 08 July 2021 | https://doi.org/10.3389/fhumd.2021.673104
affiliation not provided to SSRN, Pace University - Dyson College of Arts and Sciences, affiliation not provided to SSRN, affiliation not provided to SSRN, New York University (NYU) - Division of Infectious Diseases and Immunology, affiliation not provided to SSRN, Pennsylvania State University, Dickinson Law, affiliation not provided to SSRN, University of Cambridge - Faculty of Law, University of Tubingen, University of Copenhagen - Department of Media, Cognition and Communication, affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN, Goethe University, Department of Economy, affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN, University of Copenhagen - Faculty of Science, affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN, University of Tuebingen, affiliation not provided to SSRN, Universität Marburg (Institut für Handels- und Wirtschaftsrecht), affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN, University College London - Faculty of Laws, 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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Artificial Intelligence, Ethics, Trustworthy AI, Healthcare, AI HLEG

28.

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
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