Sara Gerke

Search results

• 2025

  Surgical Video Data – “In,” “Out,” or “Shake It All About” the Medical Record

  Cahill, R. A., Duffourc, M. & Gerke, S., Mar 1 2025, In: Annals of Surgery. 281, 3, p. 382-384 3 p.

  Research output: Contribution to journal › Article › peer-review

  Open Access
• 2024

  AI And Health Insurance Prior Authorization: Regulators Need To Step Up Oversight

  Shachar, C., Killelea, A. & Gerke, S., Jul 8 2024, Health Affairs Forefront.

  Research output: Contribution to specialist publication › Article

• Artificial Intelligence and Medical Liability in Gastrointestinal Endoscopy

  Elamin, S., Duffourc, M., Berzin, T. M., Geissler, M. E. & Gerke, S., Jun 2024, In: Clinical Gastroenterology and Hepatology. 22, 6, p. 1165-1169.e1

  Research output: Contribution to journal › Article › peer-review

  Open Access

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

  Duffourc, M. & Gerke, S., Feb 6 2024, In: Stanford Technology Law Review. 27, 1

  Research output: Contribution to journal › Article › peer-review

  • Artificial Intelligence 100%
  • Black Box 100%
  • Injury 100%
  • Consumer 20%
  • Combination Therapy 20%

• Privacy of Personal Data in the Generative AI Data Lifecycle

  Duffourc, M., Gerke, S. & Kollnig, K., 2024, In: New York University Journal of Intellectual Property & Entertainment Law. 13, 2, p. 219-268

  Research output: Contribution to journal › Article › peer-review

  Open Access

  • Personal Data 100%
  • Data Lifecycle 100%
  • Generative Artificial Intelligence 100%
  • AI Data 100%
  • Data Privacy 28%

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

  Gerke, S. & Rezaeikhonakdar, D., Feb 2024, In: Cardozo Law Review. 45, 2

  Research output: Contribution to journal › Article › peer-review

  • Data Protection 100%
  • European Community 100%
  • Privacy Shield 100%
  • Cell Excitability 100%
  • Facebook 100%

• Synthetic data and ELSI-focused computational checklists—A survey of biomedical professionals’ views

  Wagner, J. K., Cabrera, L. Y., Gerke, S. & Susser, D., Nov 20 2024, In: PLOS Digital Health. 3, 11, e0000666.

  Research output: Contribution to journal › Article › peer-review

  Open Access

  • Synthetic Data 100%
  • Professional Perspectives 100%
  • Artificial Intelligence Machine Learning 100%
  • Social Implication 100%
  • Ethical Implication 100%

• Video Endoscopy as Big Data: Balancing Privacy and Progress in Gastroenterology

  Uche-Anya, E. N., Gerke, S. & Berzin, T. M., Apr 2024, In: American Journal of Gastroenterology. 119, 4, p. 600-605 6 p.

  Research output: Contribution to journal › Article › peer-review

  Open Access
• 2023

  How AI can learn from the law: putting humans in the loop only on appeal

  Cohen, I. G., Babic, B., Gerke, S., Xia, Q., Evgeniou, T. & Wertenbroch, K., Dec 2023, In: npj Digital Medicine. 6, 1, 160.

  Research output: Contribution to journal › Article › peer-review

  Open Access

  • Decision-Making 100%
  • Decision-Making Process 100%
  • Artificial Intelligence 100%
  • Machine Learning 100%
  • Machine Learning in Medicine 20%

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

  Duffourc, M. N. & Gerke, S., Dec 2023, In: npj Digital Medicine. 6, 1, 77.

  Research output: Contribution to journal › Article › peer-review

  Open Access

  • AI Liability 100%
  • EU Directives 100%
  • Medical AI 100%
  • Artificial Intelligence 100%
  • Black Box 33%

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

  Gerke, S., Feb 2023, In: George Washington Law Review. 91, 1, p. 79-163 85 p.

  Research output: Contribution to journal › Article › peer-review

  • Machine Learning Based 100%
  • Isotope Internal Standard 100%
  • Nutrition Facts Label 100%
  • Artificial Intelligence Machine Learning 100%
  • Artificial Intelligence 100%
• 2022

  AI in the hands of imperfect users

  Kostick-Quenet, K. M. & Gerke, S., Dec 2022, In: npj Digital Medicine. 5, 1, 197.

  Research output: Contribution to journal › Article › peer-review

  Open Access

  • Artificial Intelligence Learning 100%
  • Artificial Intelligence 100%
  • Machine Learning 66%
  • Interface Design 33%
  • Healthcare 33%

• Ethical Considerations Related to Using Machine Learning-Based Prediction of Mortality in the Pediatric Intensive Care Unit

  Michelson, K. N., Klugman, C. M., Kho, A. N. & Gerke, S., Aug 2022, In: Journal of Pediatrics. 247, p. 125-128 4 p.

  Research output: Contribution to journal › Article › peer-review

  Open Access

• German Pharmaceutical Pricing: Lessons for the United States

  Rodwin, M. A. & Gerke, S., Jan 2022, In: International Journal of Health Services. 52, 1, p. 146-158 13 p.

  Research output: Contribution to journal › Article › peer-review

  Open Access

  • Pharmaceutical Pricing 100%
  • Pricing 100%
  • Epileptic Absence 100%
  • Pharmaceutical Market 100%
  • Health Insurance 50%

• Mitigating Racial Bias in Machine Learning

  Kostick-Quenet, K. M., Cohen, I. G., Gerke, S., Lo, B., Antaki, J., Movahedi, F., Njah, H., Schoen, L., Estep, J. E. & Blumenthal-Barby, J. S., 2022, In: Journal of Law, Medicine and Ethics. 50, 1, p. 92-100 9 p.

  Research output: Contribution to journal › Article › peer-review

  • Safety Concerns 100%
  • Disadvantaged Groups 100%
  • Racial Bias 100%
  • Legal Concerns 100%
  • AI-based Applications 100%

• Privacy aspects of direct-to-consumer artificial intelligence/machine learning health apps

  Gerke, S. & Rezaeikhonakdar, D., Jan 2022, In: Intelligence-Based Medicine. 6, 100061.

  Research output: Contribution to journal › Article › peer-review

  Open Access

  • Health Insurance 100%
  • Machine Learning 100%
  • Federal Trade Commission 50%
  • General Data Protection Regulation 28%
  • California Consumer Privacy Act 14%

• To explain or not to explain?—Artificial intelligence explainability in clinical decision support systems

  Amann, J., Vetter, D., Blomberg, S. N., Christensen, H. C., Coffee, M., Gerke, S., Gilbert, T. K., Hagendorff, T., Holm, S., Livne, M., Spezzatti, A., Strümke, I., Zicari, R. V., Madai, V. I. & Z-Inspection initiative, Feb 1 2022, In: PLOS Digital Health. 1, 2, p. e0000016 e0000016.

  Research output: Contribution to journal › Article › peer-review

  Open Access

  • Artificial Intelligence 100%
  • Clinical Decision Support System 100%
  • Artificial Intelligence Explainability 100%
  • Decision-Making 40%
  • Use Case 40%

• Transcript: Presentation on Data Privacy Questions in the Digital Health World

  Gerke, S., Sep 2022, In: Journal of law and health. 35, 3, p. 449-453 5 p.

  Research output: Contribution to journal › Article

  • Digital Health 100%
  • Data Privacy 100%
  • Data Protection 100%
  • Health Insurance 100%
  • Law 66%

• When Is a Change Significant? The Update Problem of Apps in Medical and Behavioral Research

  Shachar, C., Gerke, S., Morrell, W., Kirby, A., Cohen, I. G. & Bierer, B. E., May 1 2022, In: Ethics and Human Research. 44, 3, p. 2-11 10 p.

  Research output: Contribution to journal › Article › peer-review

  Open Access

  • Behavioral Research 100%
  • Institutional Review 100%
  • Research Participant 50%
  • Participant Protection 33%

• “I’d feel like someone was watchin’ me… watching for a good reason”: perceptions of data privacy, access, and sharing in the context of real-time PrEP adherence monitoring among HIV-negative MSM with substance use

  Goodman, G. R., Kikut, A., Bustamante, M. J., Mendez, L., Mohamed, Y., Shachar, C., Cohen, I. G., Gerke, S., Boyer, E. W., Rosen, R. K., Mayer, K. H., O’Cleirigh, C. & Chai, P. R., Sep 2022, In: AIDS and Behavior. 26, 9, p. 2981-2993 13 p.

  Research output: Contribution to journal › Article › peer-review

  • Data Sharing 100%
  • Data Privacy 100%
  • Substance Abuse 100%
  • Pre-Exposure Prophylaxis 100%
  • Id 100%
• 2021

  Artificial Intelligence and Liability in Medicine: Balancing Safety and Innovation

  Maliha, G., Gerke, S., Cohen, I. G. & Parikh, R. B., Sep 2021, In: Milbank Quarterly. 99, 3, p. 629-647 19 p.

  Research output: Contribution to journal › Article › peer-review

  Open Access

  • Medicine 100%
  • Injury 50%
  • Clinician 50%
  • Current Liabilities 33%

• Beware explanations from AI in health care

  Babic, B., Gerke, S., Evgeniou, T. & Glenn Cohen, I., Jul 16 2021, In: Science. 373, 6552, p. 284-286 3 p.

  Research output: Contribution to journal › Article › peer-review

  • Health Care 100%
  • Artificial Intelligence 100%
  • Health Service 100%
  • Healthcare 100%
  • Machine Learning 100%

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

  Gerke, S., Katznelson, G., Reiss, D. & Shachar, C., 2021, In: Journal of Law, Medicine and Ethics. 49, 2, p. 293-302 10 p.

  Research output: Contribution to journal › Article › peer-review

  Open Access

  • Antibody Test 100%
  • Ethical Considerations 100%
  • Legal Considerations 100%
  • COVID-19 Testing 100%
  • Feeding 100%

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

  Gerke, S., 2021, In: Yale journal of health policy, law, and ethics. 20, 2

  Research output: Contribution to journal › Article › peer-review

  • Framework 100%
  • Medical 100%
  • Artificial Intelligence 100%
  • Evil 100%
  • Regulatory Framework 100%

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

  Zicari, R. V., Brusseau, J., Blomberg, S. N., Christensen, H. C., Coffee, M., Ganapini, M. B., Gerke, S., Gilbert, T. K., Hickman, E., Hildt, E., Holm, S., Kühne, U., Madai, V. I., Osika, W., Spezzatti, A., Schnebel, E., Tithi, J. J., Vetter, D., Westerlund, M. & Wurth, R. & 20 others, Amann, J., Antun, V., Beretta, V., Bruneault, F., Campano, E., Düdder, B., Gallucci, A., Goffi, E., Haase, C. B., Hagendorff, T., Kringen, P., Möslein, F., Ottenheimer, D., Ozols, M., Palazzani, L., Petrin, M., Tafur, K., Tørresen, J., Volland, H. & Kararigas, G., 2021, In: Frontiers in Human Dynamics. 3, 673104.

  Research output: Contribution to journal › Article › peer-review

  Open Access

  • Heart Arrest 100%
  • Artificial Intelligence 100%
  • Machine Learning 100%
  • Emergency Calls 100%
  • Ethical Trade-offs 20%

• The need for health AI ethics in medical school education

  Katznelson, G. & Gerke, S., Oct 2021, In: Advances in Health Sciences Education. 26, 4, p. 1447-1458 12 p.

  Research output: Contribution to journal › Article › peer-review

  • School Education 100%
  • Artificial Intelligence 100%
  • Health Care 100%
  • Ethical Issue 60%
  • Informed Consent 50%

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

  Maliha, G., Gerke, S., Parikh, R. B. & Cohen, I. G., 2021, In: Harvard Business Review.

  Research output: Contribution to journal › Article › peer-review

  • United States 100%
  • Spur 100%
  • Standard of Care 100%
  • Cant 100%
  • Insurance 100%

• When machine learning goes off the rails: a guide to managing the risks

  Babic, B., Cohen, I. G., Evgeniou, T. & Gerke, S., Jan 1 2021, In: Harvard Business Review. 2021, January-February, p. 1-10 10 p.

  Research output: Contribution to journal › Article › peer-review
• 2020

  Applying the proportionality principle to COVID-19 antibody testing

  Gunnarsdóttir, H. D., Sinha, M. S., Gerke, S. & Minssen, T., 2020, In: Journal of Law and the Biosciences. 7, 1

  Research output: Contribution to journal › Article › peer-review

  Open Access

  • Vaccination Policy 100%
  • Vaccine Efficacy 100%
  • Pandemic 100%
  • Immunoassay 100%
  • Proportionality 100%

• Can AI Fairly Decide Who Gets an Organ Transplant?

  Babic, B., Cohen, I. G., Evgeniou, T., Gerke, S. & Trichakis, N., 2020, Harvard Business Review Digital Articles, p. 2-5 4 p.

  Research output: Contribution to specialist publication › Article

  • AI-driven Analytics 100%
  • Artificial Intelligence 100%

• Ethical and Legal Implications of Remote Monitoring of Medical Devices

  Cohen, I. G., Gerke, S. & Kramer, D. B., Dec 2020, In: Milbank Quarterly. 98, 4, p. 1257-1289 33 p.

  Research output: Contribution to journal › Article › peer-review

  Open Access

  • Collected Data 100%
  • Remote Monitoring 100%
  • Digital Health Data 100%
  • General Data Protection Regulation 66%
  • Smartphone Application 50%

• Regulatory, safety, and privacy concerns of home monitoring technologies during COVID-19

  Gerke, S., Shachar, C., Chai, P. R. & Cohen, I. G., Aug 1 2020, In: Nature Medicine. 26, 8, p. 1176-1182 7 p.

  Research output: Contribution to journal › Article › peer-review

  Open Access

  • COVID-19 100%
  • Home Monitoring 100%
  • Home Monitoring Technology 100%
  • Regulatory Requirement 100%
  • Interpersonal Contact 100%

• Regulatory responses to medical machine learning

  Minssen, T., Gerke, S., Aboy, M., Price, N. & Cohen, G., Jan 1 2020, In: Journal of Law and the Biosciences. 7, 1, lsaa002.

  Research output: Contribution to journal › Article › peer-review

  Open Access

  • Machine Learning 100%
  • Medical Machine 100%
  • Medical Device 100%
  • Artificial Intelligence 28%
  • Healthcare Provider 14%

• The need for a system view to regulate artificial intelligence/machine learning-based software as medical device

  Gerke, S., Babic, B., Evgeniou, T. & Cohen, I. G., Dec 1 2020, In: npj Digital Medicine. 3, 1, 53.

  Research output: Contribution to journal › Article › peer-review

  Open Access

  • Machine Learning Based 100%
  • Systems View 100%
  • Software as a Medical Device (SaMD) 100%
  • Artificial Intelligence Machine Learning 100%
  • Medical Device 100%
• 2019

  Algorithms on regulatory lockdown in medicine

  Babic, B., Gerke, S., Evgeniou, T. & Glenn Cohen, I., Dec 6 2019, In: Science. 366, 6470, p. 1202-1204 3 p.

  Research output: Contribution to journal › Article › peer-review

  Open Access

• How does emerging patent case law in the US and Europe affect precision medicine?

  Aboy, M., Liddell, K., Crespo, C., Cohen, I. G., Liddicoat, J., Gerke, S. & Minssen, T., Oct 1 2019, In: Nature Biotechnology. 37, 10, p. 1118-1125 8 p.

  Research output: Contribution to journal › Article › peer-review

  Open Access
• 2015

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

  Taupitz, J., Geisthövel, F., Coester-Waltjen, D., Frister, H., Frommel, M., Gerke, S., Hermes, B., Hufen, F., Ochsner, A., Beier, H. & Thaler, C., 2015, In: Journal für Reproduktionsmedizin und Endokrinologie-Journal of Reproductive Medicine and Endocrinology. 12, 2, p. 42-56 15 p.

  Research output: Contribution to journal › Article › peer-review

  Open Access