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Regulating Conception
Uncovers the hidden federal regulation of assisted reproductive technology and reproductive genetic innovation The use of assisted reproductive technology (ART) has become increasingly prevalent in society, with approximately 42% of American adults reporting in 2023 that they or someone they know has undergone fertility treatment. Yet, while traditional ART techniques like artificial insemination or in vitro fertilization (IVF) have led to the birth of millions of children worldwide, their use and research has remained contested within the American regulatory sphere. In Regulating Conception, Myrisha S. Lewis assesses the moral, political and social issues that influence the federal regulati...
Ethics in Pharmacy Practice: A Practical Guide
This textbook offers a unique and accessible approach to ethical decision-making for practicing pharmacists and student pharmacists. Unlike other texts, it gives clear guidance based on the fundamental principles of moral philosophy, explaining them in simple language and illustrating them with abundant clinical examples and case studies. The strength of this text is in its emphasis on normative ethics and critical thinking, and that there is truly a best answer in the vast majority of cases, no matter how complex. The authors place high trust in a pharmacist’s moral judgment. This teaches the reader how to think, based on ethical principles, not necessarily what to think. This means navig...
The EU Artificial Intelligence (AI) Act
The EU Artificial Intelligence (AI) Act: A Commentary Edited by Ceyhun Necati Pehlivan, Nikolaus Forgó & Peggy Valcke As artificial intelligence (AI) systems increasingly permeate various facets of our lives, there are growing concerns about their disruptive effects on society and the risks they pose to human rights, democracy, and the rule of law. Accordingly, the AI phenomenon has given rise to numerous governance frameworks at all levels of jurisdiction. In this context, it cannot be denied that the European Union’s AI Act is the first legislation of its kind with global impact, establishing horizontal rules for the development, market placement, and use of AI systems. However, graspin...
The Law and Ethics of Data Sharing in Health Sciences
Data sharing – broadly defined as the exchange of health-related data among multiple controllers and processors – has gained increased relevance in the health sciences over recent years as the need and demand for collaboration has increased. This includes data obtained through healthcare provisions, clinical trials, observational studies, public health surveillance programs, and other data collection methods. The practice of data sharing presents several notable challenges, however. Compliance with a complex and dynamic regulatory framework is essential, with the General Data Protection Regulation being a prominent example in a European context. Recent regulatory developments related to ...
Digital Health Care Outside of Traditional Clinical Settings
Examines the ethical, legal, and regulatory impacts of digital diagnostics and other products on health care outside of clinical settings.
Personal Genome Medicine
In the years following FDA approval of direct-to-consumer, genetic-health-risk testing, millions of people in the United States have sent their DNA to companies to receive personal genetic health risk information without physician or other learned medical professional involvement. In Personal Genome Medicine, Michael J. Malinowski examines the ethical, legal, and social implications of this development. Drawing from the past and present of medicine in the U.S., Malinowski applies law, policy, public and private sector practices, and governing norms to analyze the commercial personal genome sequencing and testing sectors and to assess their impact on the future of U.S. medicine. Written in relatable and accessible language, the book also proposes regulatory reforms for government and medical professionals that will enable technological advancements while maintaining personal and public health standards.
Own Your Fertility
A ticking biological clock shouldn't feel like a time bomb! Learn what you need to know about modern fertility to help take control of your reproductive future—from egg and embryo freezing to IVF, surrogacy, and beyond. Women are born with all the eggs they will ever have, and 90 percent of them are gone by age 30. The eggs that remain will decline in both quantity and quality, making it increasingly difficult to become pregnant around the same time that many women are focused on finding a life partner, building their career, or both. But Jaime Knopman, MD, wants you to know that science has advanced, the world has transformed, and the choices available to us have changed too. For years, D...
Innovation and Protection
A detailed analysis of the ethical, legal, and regulatory landscape of medical devices in the US and EU.
