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SARA GERKE sgerke@law.harvard.edu

857-200-9352 ♦ 23 Everett Street, Cambridge, MA 02138

PROFESSIONAL EXPERIENCE

Aug. 2018–present The Petrie-Flom Center for Health Law Policy, Biotechnology, and

Bioethics at Harvard Law School, Cambridge, MA, USA

Research Fellow, Medicine, Artificial Intelligence, and Law

The Project on Precision Medicine, Artificial Intelligence, and the Law

(PMAIL); collaborators at the Center for Advanced Studies in

Biomedical Innovation Law (CeBIL) at the University of Copenhagen;

this research is supported by a Novo Nordisk Foundation-grant for a

scientifically independent collaborative research program (grant

agreement number NNF17SA0027784)

Apr. 2018–June 2018 The Petrie-Flom Center for Health Law Policy, Biotechnology, and

Bioethics at Harvard Law School, Cambridge, MA, USA

Visiting Researcher

The ethics and law of in vitro gametogenesis (IVG) in the U.S. and

Europe, reproductive and regenerative medicine, U.S. patent and Food

and Drug Administration (FDA) law

Oct. 2016–Mar. 2018 Institute for German, European and International Medical Law,

Public Health Law and Bioethics of the Universities of Heidelberg

and Mannheim, Germany

General Manager

External presentation of the Institute, contact person for inquiries,

supervision of 24 student assistants, organization of conferences (e.g.,

Ethics Symposium), acquiring third-party funded projects, annual and

financial reports

Apr. 2016–Mar. 2018 Institute for German, European and International Medical Law,

Public Health Law and Bioethics of the Universities of Heidelberg

and Mannheim, Germany

Co-Investigator

Project: ClinhiPS – A Scientific, Ethical and Comparative Legal

Analysis of the Clinical Application of Human Induced Pluripotent

Stem Cells in Germany and Austria; sponsored by the German Federal

Ministry of Education and Research (BMBF); funds: 657,678.00 EUR

Jan. 2014–June 2015 Institute for German, European and International Medical Law,

Public Health Law and Bioethics of the Universities of Heidelberg

and Mannheim, Germany

Research Assistant

Various projects in the areas of medical law, public health law and

bioethics; teaching of law students at the University of Mannheim,

Germany; correction of/assessor in examinations

Sept. 2012 Dr. iur. Bianka S. Dörr Bühlmann, LL.M., Attorney-at-Law,

University of Zurich, Switzerland

Research Assistant

Medical Law, Human Rights

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Aug. 2012–Sept. 2012 Law firm Bender & Philipp, Munich, Germany

Research Assistant

Assistance with the commentary on sections 1–19, 28–45b SGB XI;

Kreikebohm, R., Spellbrink, W. and Waltermann, R. (eds.) (2013)

Kommentar zum Sozialrecht [Commentary on Social Law]. 3rd ed.

Munich: C. H. Beck

Dec. 2009–Sept. 2010 University of Augsburg, Germany

Student Assistant

Medical Law, Health Sciences and Civil Law

PUBLICATIONS

(* Equal contribution; # corresponding author)

EDITED BOOK

Apr. 2020 Gerke, S., Taupitz, J., Wiesemann, C., Kopetzki, C. and Zimmermann,

H. (eds.) Die klinische Anwendung von humanen induzierten

pluripotenten Stammzellen - Ein Stakeholder-Sammelband [The

Clinical Application of Human Induced Pluripotent Stem Cells – A

Stakeholder Anthology]. Berlin, Heidelberg: Springer.

CHAPTER IN BOOK

June 2020 Gerke, S.#, Minssen, T. and Cohen, I. G. (2020) Ethical and Legal

Challenges of Artificial Intelligence-Driven Health Care, in: Bohr, A.

and Memarzadeh, K. (eds.) Artificial Intelligence in Healthcare.

Elsevier Inc, pp.295-336. Draft published on SSRN.

Apr. 2020 Gerke, S. (2020) Die klinische Translation von hiPS-Zellen in

Deutschland [The Clinical Translation of hiPSCs in Germany], in:

Gerke, S., Taupitz, J., Wiesemann, C., Kopetzki, C. and Zimmermann,

H. (eds.) Die klinische Anwendung von humanen induzierten

pluripotenten Stammzellen - Ein Stakeholder-Sammelband [The

Clinical Application of Human Induced Pluripotent Stem Cells – A

Stakeholder Anthology]. Berlin, Heidelberg: Springer, pp.243-327.

Apr. 2020 Gerke, S.# and Hansen, S. (2020) Die klinische Anwendung von hiPS-

Zellen: ein Überblick [The Clinical Application of hiPSCs: An

Overview], in: Gerke, S., Taupitz, J., Wiesemann, C., Kopetzki, C. and

Zimmermann, H. (eds.) Die klinische Anwendung von humanen

induzierten pluripotenten Stammzellen - Ein Stakeholder-Sammelband

[The Clinical Application of Human Induced Pluripotent Stem Cells –

A Stakeholder Anthology]. Berlin, Heidelberg: Springer, pp.1-16.

Apr. 2020 Gerke, S.#, Hansen, S., Blum, V., Bur, S., Heyder, C., Kopetzki, C.,

Meiser, I., Neubauer, J., Noe, D., Steinböck, C., Wiesemann, C.,

Zimmermann, H. and Taupitz, J. (2020) Naturwissenschaftliche,

ethische und rechtliche Empfehlungen zur klinischen Translation der

Forschung mit humanen induzierten pluripotenten Stammzellen und

davon abgeleiteten Produkten [Scientific, Ethical, and Legal

Recommendations for the Clinical Translation of Research Using

Human Induced Pluripotent Stem Cells and Derived Products], in:

Gerke, S., Taupitz, J., Wiesemann, C., Kopetzki, C. and Zimmermann,

H. (eds.) Die klinische Anwendung von humanen induzierten

pluripotenten Stammzellen - Ein Stakeholder-Sammelband [The

Clinical Application of Human Induced Pluripotent Stem Cells – A

Stakeholder Anthology]. Berlin, Heidelberg: Springer, pp.459-485.

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Apr. 2020

Jan. 2018

JOURNAL ARTICLE

July 2020

July 2020

June 2020

Apr. 2020

Apr. 2020

Jan. 2020

Jan. 2020

Dec. 2019

Oct. 2019

Gerke, S.#, Kopetzki, C., Blum, V., Noe, D. and Steinböck, C. (2020)

Eine rechtsvergleichende Analyse der klinischen Translation von hiPS-

Zellen in Deutschland und Österreich [A Comparative Legal Analysis

of the Clinical Translation of hiPSCs in Germany and Austria], in:

Gerke, S., Taupitz, J., Wiesemann, C., Kopetzki, C. and Zimmermann,

H. (eds.) Die klinische Anwendung von humanen induzierten pluripotenten Stammzellen - Ein Stakeholder-Sammelband [The Clinical Application of Human Induced Pluripotent Stem Cells – A Stakeholder Anthology]. Berlin, Heidelberg: Springer, pp.421-455.

Gerke, S. and Taupitz, J. (2018) 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)

[Legal Aspects of Stem Cell Research in Germany: Limits and

Possibilities of Research Using Human Embryonic Stem Cells (hESCs)

and Human Induced Pluripotent Stem Cells (hiPSCs)], in: Zenke, M.,

Marx-Stölting, L. and Schickl, H. (eds.) Stammzellforschung: Aktuelle

wissenschaftliche und gesellschaftliche Entwicklungen [Stem Cell

Research: Current Scientific and Social Developments]. Baden-Baden:

Nomos, pp.209-235.

Gerke, S., Stern A. D. and Minssen, T. (2020) Germany’s Digital

Health Reforms in the COVID-19 Era: Lessons and Opportunities for

Other Countries, npj Digital Medicine, 3, Article number: 94.

Cohen, I. G., Evgeniou, T., Gerke, S.* and Minssen, T. (2020) The

European Artificial Intelligence Strategy: Implications and Challenges

for Digital Health, The Lancet Digital Health, 2(7), E376-E379.

Shachar, C., Gerke, S. and Adashi, E. Y. (2020) AI Surveillance during

Pandemics: Ethical Implementation Imperatives, Hastings Center

Report, pp.18-21.

Gerke, S.*, Babic, B., Evgeniou, T. and Cohen, I. G. (2020) The Need

for a System View to Regulate Artificial Intelligence/Machine

Learning-Based Software as Medical Device, npj Digital Medicine, 3,

Article number: 53.

Minssen, T., Gerke, S., Aboy, M., Price, N. and Cohen, I. G. (2020)

Regulatory Responses to Medical Machine Learning, Journal of Law

and the Biosciences, lsaa002, pp.1-18.

Gerke, S., Yeung, S., and Cohen, I. G. (2020) Ethical and Legal

Aspects of Ambient Intelligence in Hospitals, JAMA, 323(7), pp.601-

602.

Cohen, I. G., Adashi, E. Y., Gerke, S.*, Palacios-González, C.,

Ravitsky, V. (2020) The Regulation of Mitochondrial Replacement

Techniques Around the World, Annual Reviews of Genomics and

Human Genetics, 21, pp.3.1-3.22.

Babic, B., Gerke, S.*, Evgeniou, T. and Cohen, I. G. (2019) Algorithms

on Regulatory Lockdown in Medicine: Prioritize Risk Monitoring to

Address the “Update Problem”, Science, 366(6470), pp.1202-1204.

Price II, W. N., Gerke, S. and Cohen, I. G. (2019) Potential Liability

for Physicians Using Artificial Intelligence, JAMA, 322(18), pp.1765-

1766.

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Oct. 2019 Aboy, M., Liddell, K., Crespo, C., Cohen, I. G., Liddicoat, J., Gerke,

S. and Minssen, T. (2019) How Does Emerging Patent Case Law in the

US and Europe Affect Precision Medicine?, Nature Biotechnology, 37,

pp.1118-1125.

Aug. 2019 Gerke, S.#, Minssen, T., Yu, H. and Cohen, I. G. (2019) Ethical and

Legal Issues of Ingestible Electronic Sensors, Nature Electronics, 2,

pp.329-334.

Jan. 2017 Gerke, S. and Pattinson, S. (2017) EU Marketing Authorisation of

Orphan Medicinal Products and Its Impact on Related Research,

European Journal of Health Law, 24(5), pp.541-564.

Apr. 2015 Taupitz, J., Geisthövel, F., Coester-Waltjen, D., Frister, H., Frommel,

M., Gerke, S., Hermes, B., Hufen, F., Ochsner, A., Beier, H. and

Thaler, C. (2015) V. Mannheimer Workshop zur

Fortpflanzungsmedizin: Ein juristischer Diskurs zur

Präimplantationsdiagnostik und Embryonenspende auf der Basis

neuerer reproduktionsbiologischer Prämissen [5th Mannheim

Workshop on Reproductive Medicine: A Legal Discourse on

Preimplantation Diagnosis and Embryo Donation Based on Recent

Reproductive Biological Premises], Journal für Reproduktionsmedizin

und Endokrinologie [Journal of Reproductive Medicine and

Endocrinology], 12(2), pp.42-56.

MAGAZINE ARTICLE

May 2019 Gerke, S., Kramer, D. and Cohen, I. G. (2019). Ethical and Legal

Challenges of Artificial Intelligence in Cardiology, AIMed Magazine,

2, pp.12–17.

May 2018 Gerke, S. and Cantz, T. (2018) ELSA: Eine neue Fachgruppe des

GSCN, ELSA: A New Working Group of the GSCN, Zukunft der

Stammzellforschung: Jahresmagazin des German Stem Cell Network

(GSCN) 2017/18, Future of Stem Cell Research: Annual Magazine of

the German Stem Cell Network (GSCN) 2017/18, pp.47-51.

GUIDELINE

May 2018 Informed Consent Sample Text for the Donation of Somatic Cells for

Human Induced Pluripotent Stem Cell (hiPSC) Research, German Stem

Cell Network (GSCN) together with the ELSA working group and the

Pluripotent Stem Cell Core Network (PluriCore Network).

BLOG

May 2020 Gerke, S. (2020) Germany’s Response to the COVID-19 Pandemic,

Bill of Health.

Aug. 2019 Gerke, S. and Cohen, I. G. (2019) Ethical and Legal Issues of Ingestible

Electronic Sensors: Behind the Paper, Nature Research Device &

Materials Engineering. Reposted on Bill of Health.

July 2019 Minssen, T., Gerke, S. and Shachar, C. (2019) Is Data Sharing Caring

Enough About Patient Privacy? Part II: Potential Impact on US Data

Sharing Regulations, Bill of Health.

July 2019 Minssen, T., Gerke, S. and Shachar, C. (2019) Is Data Sharing Caring

Enough About Patient Privacy? Part I: The Background, Bill of Health.

Nov. 2018 Gerke, S. and Feldman J. (2018) The Tricky Task of Defining AI in the

Law, Bill of Health.

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June 2018 Gerke, S. (2018) The German Stem Cell Network Has Compiled a

Sample Text for Informed Consent, Bill of Health.

May 2018 Gerke, S. (2018) The EU’s GDPR in the Health Care Context, Bill of

Health.

WORKING PAPER

Jan. 2019 Arney, D., Senges, M., Gerke, S., Canca, C., Haaber Ihle, L., Kaiser,

N., Karkarmath, S., Kupke, A., Gajeelee, A., Lynch, S. and Melendez,

L. (2019) A User-Focused Transdisciplinary Research Agenda for AI-

Enabled Health Tech Governance.

SHORT MOVIE

Dec. 2018 Stakeholder-Conference: The Clinical Translation of Human Induced

Pluripotent Stem Cells, ClinhiPS, Department for Medical Ethics and

History of Medicine, University Medical Center Göttingen, Germany.

MEDIA (FEATURING WORK BY GERKE, S.) (SEL./MOST RECENT)

June 2020 Interview Podcast, Lancet Digital Health.

Apr. 2020 Taylor, N. P., Harvard, INSEAD Authors Pitch Systemic Regulatory

Approach to AI/ML Devices, Healthcaredive.com.

Mar. 2020 Chernoguz, J., Protecting Rights in a Global Crisis, Harvard Law

Review.

Febr. 2020 Flynn, L., When AI is Watching Patient Care: Ethics to Consider,

Medical Health News.

Dec. 2019 Slabodkin, G., Researchers Call on Regulators to Reduce Risks of AI

in Medicine, Health Data Management.

Dec. 2019 Park, A. Harvard Law School Researchers Call for More Regulation in

Medical AI, Becker's Hospital Review.

Sept. 2019 Fernandez, E., That Pill Is Watching You – Privacy and Hackability of

Ingestible Electronic Sensors, Forbes.

July 2019 Digital Health Coalition Newsletter

Spring 2019 German Stem Cell Network (GSCN) Annual Magazine

Oct. 2018 Diamond, M., Rise of AI in Healthcare Raises Important Questions

About Safety, Liability and Privacy, Harvard Global Health Institute.

SCHOLARSHIPS

Aug. 2018–present Research Fellowship, Medicine, Artificial Intelligence, and Law;

The Petrie-Flom Center for Health Law Policy, Biotechnology, and

Bioethics at Harvard Law School; Cambridge, MA, USA

July 2015–Nov. 2015 Scholarship for Doctoral Students sponsored by the DAAD (German

Academic Exchange Service)

Oct. 2009–present E-fellows.net Scholarship

GRANT WRITING

Nov. 2019 Post-Grant-Fund, Open Access Publication, German Federal Ministry

of Education and Research (BMBF); funds: 1,650.00 EUR; role: first

and corresponding author

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June 2019 Post-Grant-Fund, Open Access Publication, German Federal Ministry

of Education and Research (BMBF); funds: 2,427.60 EUR; role: first

and corresponding author

Apr. 2019 Open Medical Student Education Research Grant (MSERG); funds:

$5,000; role: Co-Investigator

Apr. 2016 Research Project: ClinhiPS – A Scientific, Ethical and Comparative

Legal Analysis of the Clinical Application of Human Induced

Pluripotent Stem Cells in Germany and Austria; sponsored by the

German Federal Ministry of Education and Research (BMBF); funds:

657,678.00 EUR; term: Apr. 2016–Mar. 2018; role: Co-Investigator

PRESENTATIONS (SEL.)

May 2020 Ethical and Legal Issues of Health AI and COVID-19, TECHNIS

webinar

Mar. 2020 Artificial Intelligence in Health Care – Safety, Effectiveness, and

Liability, Symposium Machine Learning, Santa Clara University

School of Law, Santa Clara, CA, USA

Jan. 2020 Data Rights in the Age of Machine Learning, AIMed, webinar

Dec. 2019 (Coming) Developments in Health IT, 8th Annual Health Law Year in

P/Review, Harvard Law School, Cambridge, MA, USA

Oct. 2019 AI in Health, Harvard Technology Review, Cambridge, MA, USA

June 2019 Ethical and Legal Challenges of AI in Cardiology, AIMed Cardiology,

Chicago, Illinois, IL, USA

June 2019 Open Forum: AI in Medicine for Cardiology – Current State of the Art

and How to Get Started and Future, AIMed Cardiology, Chicago, IL,

USA

June 2019 Ethical and Legal Challenges of AI-Driven Health Care in the U.S. and

Europe, U.S. Department of Health & Human Services, webinar

June 2019 Ethical and Legal Issues of Stem Cell-Based Gametes for Reproductive

Purposes, RIPS Symposium, University of Copenhagen, Denmark

May 2019 AI and Big Data – Data Protection and Privacy in the US and the EU,

Governing Health 4.0: Legal and Ethical Considerations – US-

European Perspectives, University of Copenhagen, Denmark

May 2019 Health Care and Life Sciences: Digital Health & Connected Devices,

Boston Bar Privacy & Cybersecurity Conference: Managing Digital

Risk, Boston Bar Association, Boston, MA, USA

May 2019 A Smart Pill to Swallow: Legal and Ethical Issues of Ingestible

Electronic Sensors (together with Minssen, T., University of

Copenhagen), The 2019 Digital Medicine Symposium, Harvard

Business School and the Harvard MIT Center for Regulatory Sciences,

Boston, MA, USA

May 2019 Ethics in Digital Health: The Patient/Consumer Experience, Digital

Health Coalition Northeast Summit, AMAG Pharmaceuticals,

Waltham, MA, USA

May 2019 The Customer Experience Paradigm, Digital Health Coalition

Northeast Summit, AMAG Pharmaceuticals, Waltham, MA, USA

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Apr. 2019 Precision Medicine: Future Trends & Challenges, Promises and Perils

of Emerging Health Innovations, 2019 Annual Health Law Conference,

Center for Health Policy and Law, Northeastern University, School of

Law, Boston, MA, USA

Apr. 2019 Experience the Future of AI in Radiology, AIMed, Boston, MA, USA

Mar. 2019 Ingestible Electronic Sensors: Cutting Edge Medicine, and Their

Ethical & Legal Issues (together with Minssen, T., University of

Copenhagen), BioLawLapalooza, Center for Law and the Biosciences,

Stanford Law School, CA, USA

Nov. 2018 How Will AI Transform Healthcare? CELLS (Center for Ethics and

Law in the Life Sciences) 10 Year Anniversary Celebration, Leibniz

University Hannover, Germany

Oct. 2018 AI in Drug Discovery and Clinical Trials, Panel IV: Innovations in

Drug Discovery and Policy, Drug Pricing Policies in the United States

and Globally: From Development to Delivery, Harvard Law School,

Cambridge, MA, USA

Oct. 2018 Artificial Intelligence and the Explosion of Health Data: Global Ethical

& Legal Issues (together with Cohen, I. G., Harvard Law School),

Technology & Health Seminar Series, Harvard Global Health Institute,

Cambridge, MA, USA

Sept. 2018 Precision Medicine, Artificial Intelligence, and the Law (together with

Cohen, I. G., Harvard Law School), CeBIL Annual Symposium 2018,

University of Cambridge, England

Oct. 2017 The Clinical Translation of Human Induced Pluripotent Stem Cells:

Legal Challenges and Hurdles? The Clinical Translation of Human

Induced Pluripotent Stem Cells: A Stakeholder Conference on the

Evaluation of Innovative Risk Research, Göttingen, Germany

Sept. 2017 ELSA – Proposal of a New Strategic Working Group (together with

Cantz, T., Hannover Medical School), 5th Annual GSCN (German

Stem Cell Network) Conference, Jena, Germany

June 2017 Poster Presentation of the “ClinhiPS” Project, ISSCR (International

Society for Stem Cell Research) 2017 Annual Meeting, Boston, MA,

USA

Jan. 2017 Research in Europe: An Experience Report, Information Seminar on

National and European Research Grants, University of Mannheim,

Germany

Apr. 2016 CRISPR/Cas9 – Genome Editing: The Ethical and Legal Situation in

the United Kingdom, Federal Association of the German Centers for

Reproductive Medicine (BRZ), Berlin, Germany

Mar. 2016 Regulatory Hurdles for Bringing Limbal Stem Cell Research to Clinical

Application in Germany and the UK, Durham CELLS (Center for Ethics

and Law in the Life Sciences), Durham, United Kingdom

ORGANIZATION & MODERATION OF CONFERENCES, WORKSHOPS, ETC. (SEL.)

Mar. 2020 Steering Core Committee (together with Cohen, I.G. and Shachar, C.,

Petrie-Flom Center, Harvard Law School; Stein, M. A., Harvard Law

School Project on Disability; Danielle Allen, Harvard Edmond J. Safra

Center for Ethics; Mendonca, E. A., Regenstrief Institute; Israni, S. T.,

Presence, Stanford Medicine, Stanford University) of the virtual event:

Artificial Intelligence and Disability/Dependency: Equity, Access, and

Interdependence, Harvard University, Cambridge, MA, USA

8/12

Sept. 2019 Organization and moderation (together with Cantz, T., Hannover

Medical School) of the Symposium: ELSA – Ethical, Legal and Social

Aspects of Stem Cell Research, including the workshop:

Ethical Aspects of Human-Animal Chimera Research;

as part of the 7th German Stem Cell Network (GSCN) Annual

Conference; Max Delbrück Center (MDC), Berlin, Germany

Feb. 2019 Organization (together with the Petrie-Flom Center’s team, Harvard

Law School; Harvard Medical School Center for Bioethics; and the

Program on Regulation, Therapeutics, and Law (PORTAL) at Brigham

and Women’s Hospital) of the event: Black-Box Medicine: Legal and

Ethical Issues, A Health Policy and Bioethics Consortium, Harvard

Law School, Cambridge, MA, USA

Dec. 2018 Moderation of the Panel Discussion: AI in Health Care, Seventh Annual

Health Law Year in P/Review, Harvard Law School, Cambridge, MA,

USA

Sept. 2018 Organization and moderation (together with Cantz, T., Hannover

Medical School) of the Symposium: ELSA – Ethical, Legal and Social

Aspects of Stem Cell Research, including three workshops:

Workshop 1: Cell Therapy and Genome Editing;

Workshop 2: Organoids;

Workshop 3: Gametes (moderator);

as part of the 6th German Stem Cell Network (GSCN) Annual

Conference; German Cancer Research Center (DKFZ), Heidelberg,

Germany

June 2018–Aug. 2018 Organization and moderation of the Working Sessions: Nudging and AI

Governance, as part of the AI-Health Working Group, Berkman Klein

Center for Internet & Society at Harvard University and Petrie-Flom

Center, Harvard Law School, Cambridge, MA, USA

Oct. 2017 Organization and moderation (together with Hansen, S. L., University

Medical Center Göttingen) of the Workshop: Requirements for

Securing Donor Rights, The Clinical Translation of Human Induced

Pluripotent Stem Cells: A Stakeholder Conference on the Evaluation of

Innovative Risk Research, Göttingen, Germany

ROUNDTABLES/SUMMITS (INVITATION ONLY)

June 2020 Data and COVID-19: Roundtable with the Berkman Klein Center for

Internet & Society and the Petrie-Flom Center, Harvard University,

virtual event

July 2019 Roundtable on Balancing Privacy with Health Data Access, U.S.

Department of Health and Human Services, Washington, D.C., USA

Apr. 2019 Roundtable: Mitochondrial Replacement Therapy: Considering the

Future of U.S. Policy “Three-Parent IVF”, Harvard Law School,

Cambridge, MA, USA

Apr. 2019 Roundtable on Sharing and Utilizing Health Data for AI Applications,

U.S. Department of Health and Human Services, Washington, D.C.,

USA

Feb. 2019 Harvard AI for Global Health Summit, Hype vs. Reality: The Role of

Artificial Intelligence in Global Health, Harvard Global Health

Institute, Cambridge, MA, USA

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MENTORING GRADUATE STUDENTS (SEL./MOST RECENT)

Summer 2019 Gali Katznelson

M.D. Program, Schulich School of Medicine and Dentistry, Western

University, London, Canada; project sponsored by MSERG

Meetings: once a week, Petrie-Flom Center, Harvard Law School,

Cambridge, MA, USA

Spring 2019 Neil O’Dougherty

J.D. Program, Harvard Law School, Cambridge, MA, USA

Meetings: every two weeks (together with Mason Kortz, Clinical

Instructor at the Harvard Law School Cyberlaw Clinic, part of the

Berkman Klein Center for Internet & Society, Cambridge, MA, USA)

Winter 2018 Alexander Erwig

J.D. Program, Harvard Law School, Cambridge, MA, USA

Meetings: every two weeks (together with Mason Kortz, Clinical

Instructor at the Harvard Law School Cyberlaw Clinic, part of the

Berkman Klein Center for Internet & Society, Cambridge, MA, USA)

TEACHING EXPERIENCE (SEL.)

June 2020 Lecture/Podcast Interview: Legal, Ethical, and Governance Issues

Associated with AI in Health Care, Guest Speaker of the Course Social

Issues of AI, Matthew Jordan, McMaster University, Ontario, Canada

May 2020 Lecture/Webinar: Artificial Intelligence in Health, Ethics, Data

Security, Privacy, Bias. Guest Speaker of the Course AI in Health,

Deborah DiSanzo, Harvard T.H. Chan School of Public Health, Boston,

MA, USA

Sept. 2016 Introduction of the Major Subject “Medical and Health Law”, School

of Law and Economics, University Mannheim, Germany

Mar. 2015 Assessor, Oral Exam “Medical and Health Law”, Prof. Dr. Jochen

Taupitz, School of Law and Economics, University of Mannheim,

Germany

Jan. 2015 Teaching, Crash Course in Civil Law, undergraduate students,

Integrated LL.B. and State Examination Program in Law, School of

Law and Economics, University of Mannheim, Germany, including the

correction of 34 mock exams

Jan. 2015 Creation of the PowerPoint slides (266 slides), Lecture “Medical Law”,

Prof. Dr. Jochen Taupitz, School of Law and Economics, University of

Mannheim, Germany

Sept.–Dec. 2014 Teaching, Tutorial Civil Law 1.2, undergraduate students, Integrated

LL.B. and State Examination Program in Law, School of Law and

Economics, University of Mannheim, Germany, including the

correction of 17 mock exams

Sept.–Dec. 2014 Teaching, Tutorial Civil Law 1.1, undergraduate students, Integrated

LL.B. and State Examination Program in Law, School of Law and

Economics, University of Mannheim, Germany, including the

correction of 18 mock exams

Apr. 2014 Correction of 10 Orientation Exams in Civil Law, Prof. Dr. Jochen

Taupitz, School of Law and Economics, University of Mannheim,

Germany

10/12

Mar. 2014 Assistance in the drafting of the case and solution to the case for the

Exam in Civil Law, Prof. Dr. Jochen Taupitz, School of Law and

Economics, University of Mannheim, Germany

Jan. 2014 Revision of the Script “Medical Law” (163 pages), Lecture “Medical

Law”, Prof. Dr. Jochen Taupitz, School of Law and Economics,

University of Mannheim, Germany

EDUCATION

Present University of Mannheim, Germany

Doctor iuris (Dr. iur.)

Topic: Stem Cell Research – From Laboratory to Clinic in Europe

Supervisor: Prof. Dr. Jochen Taupitz

Dec. 2013 King’s College London, United Kingdom

M.A. in Medical Ethics and Law

Modules:

Dissertation:

A Market in Human Organs from the Living or an Opt-Out System?

A Legal and Ethical Analysis to Identify a Way to Address the Organ

Shortage in the United Kingdom

Apr. 2009–July 2012 University of Augsburg, Germany

Dipl.-Jur. Univ.

Major field of study:

Biolaw, Health Law and Medical Law

Final paper:

The Transplantation of Organs – What are the Rights of Organ Donors

and Organ Recipients?

Oct. 2006–Mar. 2009 University of Passau, Germany

Law Studies

Oct. 1998–May 2006 Gymnasium Landschulheim Schloss Heessen, Hamm, Germany

Allgemeine Hochschulreife (general higher education entrance

qualification)

Aug. 1997–Oct. 1998 Gymnasium St. Christophorus, Werne, Germany

FURTHER EDUCATION (SEL.)

Fall 2019 Health Law, Policy, Bioethics, and Biotechnology Workshop, led by

Prof. I. Glenn Cohen, Cambridge, MA, USA

Fall 2019 Torts, taught by Daniel Hemel, Visiting Professor of Law, Harvard Law

School, Cambridge, MA, USA

Jan. 2019 Food and Drug Law, taught by Peter Barton Hutt, Lecturer on Law,

Harvard Law School, Cambridge, MA, USA

Medical Law I: Consent, Refusal

and Request

Law at the End of Life

Law and Reproduction

Moral Theory and

Medical Ethics

Ethics at the End of Life

Topics in Medical Ethics

11/12

Fall 2018 Health Law, Policy, Bioethics, and Biotechnology Workshop, led by

Prof. I. Glenn Cohen, Cambridge, MA, USA

Nov. 2017 The New European Data Protection Law – Recommendations for

Companies in the Health Sector, Seminar BBLife, Potsdam, Germany

Nov. 2017 The Product is the Process – Is it? Quality Aspects of the Manufacture

of Advanced Therapy Medicinal Products, Seminar BBLife, Berlin,

Germany

Sept. 2016–Nov. 2016 HLS4X: Bioethics: The Law, Medicine, and Ethics of Reproductive

Technologies and Genetics; e-learning course taught by I. Glenn Cohen,

Professor of Law, Harvard Law School; Cambridge, MA, USA (final

grade: 100 %, A+)

VOLUNTARY WORK / MEMBERSHIPS (SEL.)

Sept. 2017–present Initiator of the Strategic Working Group ELSA (Ethical, Legal, and

Social Aspects of the Modern Life Sciences), GSCN (German Stem

Cell Network), Germany

Aug. 2015–present Member of Durham CELLS (Center for Ethics and Law in the Life

Sciences), United Kingdom

Feb. 2015–present Member of the ISSCR (International Society for Stem Cell Research),

Skokie, IL, USA

Nov. 2014 Jury member of the Negotiation Competition 2014, ELSA (European

Law Students’ Association) Mannheim e.V., Germany

July 2014–Oct. 2016 Probation officer of “Neustart”, non-profit private limited company,

Mannheim, Germany

Mar. 2014–present Member of the Association for the Promotion of German, European and

International Medical Law, Health Law and Bioethics in Mannheim and

Heidelberg, Germany

REVIEWER

Journals: Journal of Law and the Biosciences, Oxford University Press; Science

Book: Gerke, S., Taupitz, J., Wiesemann, C., Kopetzki, C. and Zimmermann, H. (eds.) Die

klinische Anwendung von humanen induzierten pluripotenten Stammzellen - Ein

Stakeholder-Sammelband [The Clinical Application of Human Induced Pluripotent Stem Cells – A

Stakeholder Anthology]. Berlin, Heidelberg: Springer (2020).

RESEARCH STAYS

May 2019–June 2019 Center for Advanced Studies in Biomedical Innovation Law

(CeBIL), University of Copenhagen, Denmark

Visiting Researcher

Projects on ethical and legal issues with AI and medicine, including

working on comparative approaches, cardiac devices as well as data

protection and privacy

12/12

Apr. 2018–June 2018 The Petrie-Flom Center for Health Law Policy, Biotechnology, and

Bioethics at Harvard Law School, Cambridge, MA, USA

Visiting Researcher

The ethics and law of in vitro gametogenesis (IVG) in the U.S. and

Europe, reproductive and regenerative medicine, U.S. patent and Food

and Drug Administration (FDA) law

July 2015–Mar. 2016 Durham University, United Kingdom

Visiting Researcher

Field of study: Legal framework for bringing stem cell research to

clinical application in the EU, Germany and the UK

Supervisor: Prof. Shaun D. Pattinson

IT SKILLS

Microsoft Office (Word, Excel, PowerPoint, Outlook); Citavi

Operating systems: Windows, Mac OS X

Website maintenance: www.ClinhiPS.de (Apr. 2016–Mar. 2018; German and English)

LANGUAGES

German Native language

English Business fluent

French Good knowledge

Spanish Basic knowledge