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The Development, Implementation, and Oversight of Artificial Intelligence in Health Care: Legal and Ethical Issues
Jenna Becker, Sara Gerke, and I. Cohen
Artificial Intelligence (AI), especially of the machine learning (ML) variety, is used by health care organizations to assist with a number of tasks, including diagnosing patients and optimizing operational workflows. AI products already proliferate the health care market, with usage increasing as the technology matures. Although AI may potentially revolutionize health care, the use of AI in health settings also leads to risks ranging from violating patient privacy to implementing a biased algorithm. This chapter begins with a broad overview of health care AI and how it is currently used. We then adopt a “lifecycle” approach to discussing issues with health care AI. We start by discussing the legal and ethical issues pertaining to how data to build AI are gathered in health care settings, focusing on privacy. Next, we turn to issues in algorithm development, especially algorithmic bias. We then discuss AI deployment to treat patients, focusing on informed consent. Finally, we will discuss existing oversight mechanisms for health AI in the United States: liability and regulation.
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Ethical and Legal Issues in Artificial Intelligence-Based Cardiology
Sara Gerke
Intelligence-Based Cardiology and Cardiac Surgery: Artificial Intelligence and Human Cognition in Cardiovascular Medicine provides an especially timely multidisciplinary and comprehensive survey of artificial intelligence concepts and methodologies. It includes real-life applications in adult and pediatric cardiovascular medicine, spanning the life span from fetus to adult. Led by a senior cardiologist–data scientist and supported by renowned data scientists and cardiac clinicians with an ardent passion for artificial intelligence in cardiovascular medicine, the book provides a clinical interface between the medical and data science domains that is symmetric and realistic.The content consists of basic concepts and applications of artificial intelligence and human cognition in cardiology and cardiac surgery. This portfolio ranges from big data to machine and deep learning, as well as cognitive computing and natural language processing in cardiac disease states such as heart failure, hypertension, and pediatric cardiac care. Artificial intelligence tools are described from the intensive care unit setting to other venues, such as the outpatient clinic, catheterization laboratory, and operating room. Future applications in related areas, such as large language models, extended reality, and digital twins, are also discussed. The book encompasses more than 50 chapters written by cardiologists or cardiac surgeons. Each chapter provides sections on the current state of the art and future directions and concludes with major takeaways. A robust compendium of practical resources, such as a comprehensive glossary, best references, and other resources, is also included.The book narrows the knowledge and expertise chasm between data scientists, cardiologists, and cardiac surgeons, inspires these clinicians to embrace artificial intelligence methodologies, and educates data scientists about the cardiac ecosystem to create a transformational paradigm for cardiovascular healthcare that improves patient outcomes.
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Ethical and Legal Challenges of Digital Medicine in Pandemics
Timo Minssen and Sara Gerke
The Covid-19 pandemic and the resulting restrictions on mobility, contact bans, mobile phone surveillance apps, and other strategies for containment of infection chains have led to a clear increase in the use of digital applications in public and private healthcare in the past year. Improved data analysis in the research, development, and testing of new therapies, as well as the growing potential of artificial intelligence for rapidly developed diagnostic methods and vaccine candidates, has also resulted in increased demand and application of digital aids among doctors, patients, hospitals, researchers, and companies. However, the use of these technical innovations has been accompanied by socio-economic and political discussions as well as lively ethical and legal debates. Issues such as data protection, cyber security, consent, transparency, discrimination, ownership, and a fair distribution and access to digital opportunities play an important role here. This chapter discusses central ethical and legal issues using concrete examples and provides an in-depth discussion of selected issues that not only illustrate ethical and legal problem areas and risks, but also show possible solutions.
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Digital Home Health During the COVID-19 Pandemic Challenges to Safety, Liability, and Informed Consent, and the Way to Move Forward
Sara Gerke
In this chapter, I will first give an overview of the promise of digital home health. I will then discuss the regulation of digital home health before and during COVID-19 in the context of the US Federal Food, Drug, and Cosmetic Act (FDCA). This will be followed by a discussion of three digital home health challenges during the pandemic: 1) safety, 2) liability, and 3) informed consent. In this context, I will also make suggestions on how to move forward.
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The Ethics and Laws of Medical Big Data
Hrefna Gunnarsdottir, I. Cohen, Timo Minssen, and Sara Gerke
The COVID-19 pandemic has highlighted that leveraging medical big data can help to better predict and control outbreaks from the outset. However, there are still challenges to overcome in the 21st century to efficiently use medical big data, promote innovation and public health activities and adequately protect individuals’ privacy. The metaphor that property is a “bundle of sticks” applies equally to medical big data. Understanding medical big data in this way raises a number of questions, including: Who has the right to make money off its buying and selling, or is it inalienable? When does medical big data become sufficiently stripped of identifiers that the rights of an individual concerning the data disappear? How have different regimes such as the General Data Protection Regulation in Europe and the Health Insurance Portability and Accountability Act in the US answered these questions differently? In this chapter, we will discuss three topics: (1) privacy and data sharing, (2) informed consent, and (3) ownership.
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Ethische und rechtliche Herausforderungen digitaler Medizin in Pandemien
Timo Minssen and Sara Gerke
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Ethische und rechtliche Herausforderungen digitaler Medizin in Pandemien
Timo Minssen and Sara Gerke
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Naturwissenschaftliche, ethische und rechtliche Empfehlungen zur klinischen Translation der Forschung mit humanen induzierten pluripotenten Stammzellen und davon abgeleiteten Produkten
Sara Gerke, Solveig Hansen, Verena Blum, Stephanie Bur, Clemens Heyder, Christian Kopetzki, Ina Meiser, Julia Neubauer, Danielle Noe, Claudia Steinböck, Claudia Wiesemann, Heiko Zimmermann, and Jochen Taupitz
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Eine rechtsvergleichende Analyse der klinischen Translation von hiPS-Zellen in Deutschland und Österreich
Sara Gerke, Christian Kopetzki, Verena Blum, Danielle Noe, and Claudia Steinböck
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Ethical and Legal Challenges of Artificial Intelligence-Driven Healthcare
Sara Gerke, Timo Minssen, and I. Cohen
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Die klinische Anwendung von humanen induzierten pluripotenten Stammzellen
Sara Gerke, Jochen Taupitz, Claudia Wiesemann, Christian Kopetzki, and Heiko Zimmermann
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