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2. Contributors

Author

Ackerman, Michael J., primary, Adedinsewo, Demilade A., additional, Akbilgic, Oguz, additional, Al-Falahi, Zaidon, additional, Alkhatib, Deya, additional, Alkhouli, Mohamad, additional, Awerbach, Jordan D., additional, Axelrod, David M., additional, Baker, G. Hamilton, additional, Bashir, Mohamad, additional, Bond, Raymond, additional, Bos, J. Martijn, additional, Brisk, Robert, additional, Brown, Sherry-Ann, additional, Butler, Liam, additional, C. Chang, Anthony, additional, Camara, Oscar, additional, Chou, Timothy, additional, Davis, Matthew, additional, Dearani, Joseph A., additional, Dorraki, Mohsen, additional, Doukky, Rami, additional, Druz, Regina, additional, Ehwerhemuepha, Louis, additional, Ernst, Zachary, additional, Feaster, William, additional, Feeny, Albert K., additional, Fernandez-Campos, Beatriz A., additional, Fisher, Michael, additional, Flores, Mona G., additional, Franklin, Wayne J., additional, Frederickson, Abby, additional, Gaffar, Sharib, additional, Gates, Darren, additional, Gearhart, Addison, additional, Gerke, Sara, additional, Gomez, Javier, additional, Goto, Shinichi, additional, Grutter, Giorgia, additional, Hall, E. Kevin, additional, Jacobs, Jeffrey P., additional, Jefferies, John L., additional, Jegatheeswaran, Anusha, additional, Jenkins, Kathy, additional, Jone, Pei-Ni, additional, Kouzehkonan, Vahid Ghodrati, additional, Kumar, S. Ram, additional, Lai, Wyman, additional, Laussen, Peter C., additional, Lei, Howard, additional, Leta, Ruben, additional, Liao, Zhibin, additional, Limon, Alfonso, additional, Lopez-Jimenez, Francisco, additional, Lopuszko, Aleksandra, additional, Maher, Kevin, additional, Marano, Rachel, additional, Mattia, Donald, additional, McEneaney, David, additional, McMahon, Colin J., additional, Mesana, Thierry, additional, Moras, Patrizio, additional, Moreno, Tatiana, additional, Moustafa, Abdel Hakim, additional, Nafee, Tarek, additional, Nag, Nitish, additional, Nahar, Jai, additional, Nguyen, Hoang H., additional, Olajide, Olufemi, additional, Overman, David M., additional, Paul Finn, J., additional, Ramirez, Jessily P., additional, Rayan, David, additional, Recto, Mitch, additional, Reddy, Charitha D., additional, Sengupta, Partho P., additional, Shamavu, Ketemwabi Y., additional, Silversides, Candice K., additional, Soliman, Elsayed Z., additional, St Louis, James D., additional, Sun, Louise Y., additional, Tan, Sven, additional, Tandon, Animesh, additional, Tcheng, James E., additional, Toscano, Alessandra, additional, Tozzi, Alberto Eugenio, additional, Tran, Tu Hao, additional, Trivedi, Bhavya, additional, Tsang, Wendy, additional, Tseng, Andrew S., additional, van den Hengel, Anton, additional, Verjans, Johan W., additional, and Young, Krista, additional

Published
2024
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10. “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

Author

Goodman, Georgia R., Kikut, Anna, Bustamante, Maria J., Mendez, Lizette, Mohamed, Yassir, Shachar, Carmel, Cohen, I. Glenn, Gerke, Sara, Boyer, Edward W., Rosen, Rochelle K., Mayer, Kenneth H., O’Cleirigh, Conall, and Chai, Peter R.

Published
2022
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13. Naturwissenschaftliche, ethische und rechtliche Empfehlungen zur klinischen Translation der Forschung mit humanen induzierten pluripotenten Stammzellen und davon abgeleiteten Produkten

Author

Gerke, Sara, Hansen, Solveig Lena, Blum, Verena Christine, Bur, Stephanie, Heyder, Clemens, Kopetzki, Christian, Meiser, Ina, Neubauer, Julia C., Noe, Danielle, Steinböck, Claudia, Wiesemann, Claudia, Zimmermann, Heiko, Taupitz, Jochen, Axer, Peter, Series Editor, Brand, Oliver, Series Editor, Dannecker, Gerhard, Series Editor, Müller-Terpitz, Ralf, Series Editor, Schuhr, Jan C., Series Editor, Taupitz, Jochen, Series Editor, Gerke, Sara, editor, Wiesemann, Claudia, editor, Kopetzki, Christian, editor, and Zimmermann, Heiko, editor

Published
2020
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14. Die klinische Translation von hiPS-Zellen in Deutschland

Author

Gerke, Sara, Axer, Peter, Series Editor, Brand, Oliver, Series Editor, Dannecker, Gerhard, Series Editor, Müller-Terpitz, Ralf, Series Editor, Schuhr, Jan C., Series Editor, Taupitz, Jochen, Series Editor, Gerke, Sara, editor, Wiesemann, Claudia, editor, Kopetzki, Christian, editor, and Zimmermann, Heiko, editor

Published
2020
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15. Eine rechtsvergleichende Analyse der klinischen Translation von hiPS-Zellen in Deutschland und Österreich

Author

Gerke, Sara, Kopetzki, Christian, Blum, Verena Christine, Noe, Danielle, Steinböck, Claudia, Axer, Peter, Series Editor, Brand, Oliver, Series Editor, Dannecker, Gerhard, Series Editor, Müller-Terpitz, Ralf, Series Editor, Schuhr, Jan C., Series Editor, Taupitz, Jochen, Series Editor, Gerke, Sara, editor, Wiesemann, Claudia, editor, Kopetzki, Christian, editor, and Zimmermann, Heiko, editor

Published
2020
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16. Die klinische Anwendung von hiPS-Zellen: ein Überblick

Author

Gerke, Sara, Hansen, Solveig Lena, Axer, Peter, Series Editor, Brand, Oliver, Series Editor, Dannecker, Gerhard, Series Editor, Müller-Terpitz, Ralf, Series Editor, Schuhr, Jan C., Series Editor, Taupitz, Jochen, Series Editor, Gerke, Sara, editor, Wiesemann, Claudia, editor, Kopetzki, Christian, editor, and Zimmermann, Heiko, editor

Published
2020
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17. PRESENTATION ON DATA PRIVACY QUESTIONS IN THE DIGITAL HEALTH WORLD

Author

Gerke, Sara

Subjects
Privacy, Right of -- Health aspects -- Laws, regulations and rules, Data security -- Health aspects -- Laws, regulations and rules, Medical records -- Access control -- Laws, regulations and rules -- Safety and security measures, Government regulation, Data security issue, Health, Law, Health Insurance Portability and Accountability Act of 1996
Abstract

The Journal of Law and Health's Digital Health & Technology Symposium CLEVELAND-MARSHALL COLLEGE OF LAW FRIDAY, APRIL 8, 2022 The following is a transcription from The Digital Health and Technology [...]

Published
2022

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

Author

Gerke, Sara, Shachar, Carmel, Chai, Peter R., and Cohen, I. Glenn

Subjects
Privacy, Right of -- Health aspects -- Laws, regulations and rules -- Usage -- Social aspects, Epidemics -- Social aspects -- Control, Telemedicine -- Social aspects -- Usage -- Laws, regulations and rules -- Health aspects, Patient monitoring equipment -- Usage -- Social aspects -- Laws, regulations and rules, Government regulation, Biological sciences, Health, Health Insurance Portability and Accountability Act of 1996, European Union -- Social policy
Abstract

There has been increasing interest in the use of home monitoring technologies during the COVID-19 pandemic to decrease interpersonal contacts and the resultant risks of exposure for people to the coronavirus SARS-CoV-2. This Perspective explores how the accelerated development of these technologies also raises major concerns pertaining to safety and privacy. We make recommendations for needed interventions to ensure safety and review best practices and US regulatory requirements for privacy and security. We discuss, among other topics, Emergency Use Authorizations for medical devices and privacy laws of the USA and Europe. Home monitoring technologies are being rushed to market during the COVID-19 pandemic; here, safety and privacy considerations are discussed., Author(s): Sara Gerke [sup.1] , Carmel Shachar [sup.1] , Peter R. Chai [sup.2] [sup.3] [sup.4] [sup.5] , I. Glenn Cohen [sup.6] Author Affiliations: (1) The Petrie-Flom Center for Health Law [...]

Published
2020
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31. PRIVACY OF PERSONAL DATA IN THE GENERATIVE AI DATA LIFECYCLE.

Author

Duffourc, Mindy Nunez, Gerke, Sara, and Kollnig, Konrad

Subjects
*STABLE Diffusion, *GENERAL Data Protection Regulation, 2016, *HEALTH Insurance Portability & Accountability Act, *INFORMATION theory, *PUBLIC records, *INFORMED consent (Medical law), FAMILY Educational Rights & Privacy Act of 1974 (U.S.)
Published
2024

32. Erratum zu: Die klinische Anwendung von humanen induzierten pluripotenten Stammzellen

Author

Gerke, Sara, Taupitz, Jochen, Wiesemann, Claudia, Kopetzki, Christian, Zimmermann, Heiko, Axer, Peter, Series Editor, Brand, Oliver, Series Editor, Dannecker, Gerhard, Series Editor, Müller-Terpitz, Ralf, Series Editor, Schuhr, Jan C., Series Editor, Taupitz, Jochen, Series Editor, Gerke, Sara, editor, Wiesemann, Claudia, editor, Kopetzki, Christian, editor, and Zimmermann, Heiko, editor

Published
2020
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33. List of contributors

Author

Aframian, Arash, primary, Bohr, Adam, additional, Bohr, Henrik, additional, Bøtker, Johan Peter, additional, Cobb, Justin, additional, Cohen, Glenn, additional, Colombo, Stefano, additional, Dutt, Rajeev, additional, Gerke, Sara, additional, Hlávka, Jakub P., additional, Iranpour, Farhad, additional, Jeddi, Zineb, additional, Memarzadeh, Kaveh, additional, Minssen, Timo, additional, Mirnezami, Reza, additional, Tran, Khanhvi, additional, Ward, Thomas, additional, and Witkowski, Elan, additional

Published
2020
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45. PRIVACY SHIELD 2.0--A NEW TRANS-ATLANTIC DATA PRIVACY FRAMEWORK BETWEEN THE EUROPEAN UNION AND THE UNITED STATES.

Author

Gerke, Sara and Rezaeikhonakdar, Delaram

Subjects
*ACTIONS & defenses (Law), *RIGHT of privacy, *DATA protection, *INFORMATION policy
Abstract

This Article is the first to thoroughly examine the new adequacy decision for the Trans-Atlantic Data Privacy Framework (also known as "Privacy Shield 2.0"), including the relevant events and milestones ultimately leading to its adoption. The European Commission adopted the new Privacy Shield on July 10, 2023, to restore transatlantic data flows and commercial exchanges between the European Union and the United States. This Article first explores the holdings of the Court of Justice of the European Union in the groundbreaking cases Schrems I and Schrems II and elaborates on the reasons for the invalidation of the Safe Harbor Decision and the Privacy Shield Decision, respectively. It then examines the practical implications of the invalidation of the Privacy Shield Decision in Schrems II, including the recent decision of the Irish Data Protection Commissioner regarding Meta Platforms Ireland Limited (formerly Facebook Ireland Limited). This Article subsequently discusses the efforts of the United States government and the European Commission toward the adoption of Privacy Shield 2.0. It analyzes recent events, from the announcement of a new Trans-Atlantic Data Privacy Framework to the release of the Executive Order on Enhancing Safeguards for United States Signals Intelligence Activities to the European Commission's draft adequacy decision, the launch of its adoption process, and ultimately its adoption. This Article argues that despite the excitement of a new Trans-Atlantic Data Privacy Framework, it is improbable that the validity of Privacy Shield 2.0 would be upheld by the Court of Justice of the European Union in a possible Schrems III case. Although Privacy Shield 2.0 is a considerable improvement compared to the previously invalidated Privacy Shield Decision, it is likely that the Court of Justice of the European Union would consider the newly introduced safeguards for United States signals intelligence activities insufficient to comply with the General Data Protection Regulation's requirements, read in the light of the Charter of Fundamental Rights of the European Union. This Article demonstrates the shortcomings of Privacy Shield 2.0 concerning the principles of necessity and proportionality as well as the right to effective judicial protection. It also argues for a comprehensive U.S. federal privacy law that ensures adequate protection of personal data for all data subjects in the United States. [ABSTRACT FROM AUTHOR]

Published
2023

46. Generative AI in Health Care and Liability Risks for Physicians and Safety Concerns for Patients

Author

Duffourc, Mindy Nunez and Gerke, Sara

Abstract

Generative artificial intelligence (AI) is a quickly emerging subfield of AI that can be trained with large data sets to create realistic images, videos, text, sound, 3-dimensional models, virtual environments, and even drug compounds. It has gained more attention recently as chatbots such as OpenAI’s ChatGPT or Google’s Bard display impressive performance in understanding and generating natural language text. Generative AI is being heralded in the medical field for its potential to ease the long-lamented burden of medical documentation by generating visit notes, treatment codes, and medical summaries. Physicians and patients might also turn to generative AI to answer medical questions about symptoms, treatment recommendations, or potential diagnoses. While these tools may improve patient care, the liability implications of using AI to generate health information are still in flux. To date, no court in the United States has considered the question of liability for medical injuries caused by relying on AI-generated information. &nbsp

Published
2023

47. Ethical perspectives on surgical video recording for patients, surgeons and society: systematic review

Author

Walsh, Ross, Kearns, Emma C, Moynihan, Alice, Gerke, Sara, Duffourc, Mindy, Compagnucci, Marcelo Corrales, Minssen, Timo, and Cahill, Ronan A

Abstract

Background Operating-room audiovisual recording is increasingly proposed, although its ethical implications need elucidation. The aim of this systematic review was to examine the published literature on ethical aspects regarding operating-room recording. Methods MEDLINE (via PubMed), Embase, and Cochrane databases were systematically searched for articles describing ethical aspects regarding surgical (both intracorporeal and operating room) recording from database inception to the present (the last search was undertaken in July 2022). Medical subject headings used in the search included ‘operating room’, ‘surgery’, ‘video recording’, ‘black box’, ‘ethics’, ‘consent’, ‘confidentiality’, ‘privacy’, and more. Title, abstract, and full-text screening determined relevance. The quality of studies was assessed using Centre for Evidence-Based Medicine grading and no formal assessment of risk of bias was attempted given the theoretical nature of the data collected. Results From 1048 citations, 22 publications met the inclusion criteria, with three more added from their references. There was evident geographical (21 were from North America/Europe) and recency (all published since 2010) bias and an exclusive patient/clinician perspective (25 of 25). The varied methodology (including ten descriptive reviews, seven opinion pieces, five surveys, two case reports, and one RCT) and evidence level (14 level V and 10 level III/IV) prevented meaningful systematic grading/meta-analysis. Publications were narratively analysed for ethical thematic content (mainly education, performance, privacy, consent, and ownership) that was then grouped by the four principles of biomedical ethics of Beauchamp and Childress, accounting for 63 distinct considerations concerning beneficence (22 of 63; 35 per cent), non-maleficence (17 of 63; 27 per cent), justice (14 of 63; 22 per cent), and autonomy (10 of 63; 16 per cent). From this, a set of proposed guidelines on the use of operative data is presented. Conclusion For a surgical video to be a truly valuable resource, its potential benefits must be more fully weighed against its potential disadvantages, so that any derived instruments have a solid ethical foundation. Universal, ethical, best-practice guidelines are needed to protect clinicians, patients, and society.

Published
2023

50. Artificial intelligence tools in clinical neuroradiology : essential medico-legal aspects.

Author

Hedderich, Dennis M, Weisstanner, Christian, Van Cauter, Sofie, Federau, Christian, Edjlali, Myriam, Radbruch, Alexander, Gerke, Sara, Haller, Sven, Hedderich, Dennis M, Weisstanner, Christian, Van Cauter, Sofie, Federau, Christian, Edjlali, Myriam, Radbruch, Alexander, Gerke, Sara, and Haller, Sven

Abstract

Commercial software based on artificial intelligence (AI) is entering clinical practice in neuroradiology. Consequently, medico-legal aspects of using Software as a Medical Device (SaMD) become increasingly important. These medico-legal issues warrant an interdisciplinary approach and may affect the way we work in daily practice. In this article, we seek to address three major topics: medical malpractice liability, regulation of AI-based medical devices, and privacy protection in shared medical imaging data, thereby focusing on the legal frameworks of the European Union and the USA. As many of the presented concepts are very complex and, in part, remain yet unsolved, this article is not meant to be comprehensive but rather thought-provoking. The goal is to engage clinical neuroradiologists in the debate and equip them to actively shape these topics in the future.

Published
2023
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