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Aslanishvili K: Healthcare Law and
Medical Malpractice

Healthcare Law and Medical Malpractice

A Comprehensive Resource Guide

This book provides a timely and much-needed critical legal review of children's participation in healthcare that goes beyond merely documenting the extent and scope of participation, and explores the importance, definition of, and barriers to their meaningful participation. Addressing a gap in the literature, the book uses a combination of empirical data, childhood and participatory theory, and legal analysis to study the participation of children and young people in the medical context from a child's rights perspective. Centring the unheard and underrepresented lived experiences of recent and past child patients, and doctors, the book uses Interpretative Phenomenological Analysis, a methodology traditionally used in psychology, to provide a refreshing and unique exploration of children's participation in their healthcare. The book explores to what extent national law and international non-binding conventions have created a 'right' to participation, studies the application of national law in clinical practice asking whether the law facilitates meaningful participation, and analyses the interaction between law and quasi-legal regulations. The book will be useful for academics, children's activists, and legal and clinical practitioners.

Medical Decision-Making with Children and Young People

Brill

How safe is medicine when decisions are made by artificial intelligence? What happens when a misdiagnosis comes from an algorithm rather than a doctor? Intelligent Medicine explores these urgent questions. The book shows how AI transforms patient safety, redefines the medical standard of care and shifts legal responsibility when things go wrong. It provides a clear EU-based perspective while drawing on law, ethics, medicine, and technology. Taking a practical approach, theory meets real-life dilemmas, and the combination offers concrete guidance for professionals, policymakers, and scholars facing the challenges of AI in healthcare.

Intelligent Medicine

What happens in the brain of someone who prays? What does quantum physics have to say about the nature of reality? Why do people in cardiac arrest report vivid and verifiable experiences? And why, despite all scientific advancement, does humanity continue to believe? In Improbable Miracles, Irrefutable Faith, legal researcher and Master in Human Rights André Kologeski leads the reader on a fascinating journey through the frontier between science and spirituality. With the analytical rigor of someone who has spent decades investigating facts and evidence, and the openness of someone who recognizes the limits of what can be measured, Kologeski explores the latest discoveries in neuroscience, quantum physics, and psychology to illuminate one of humanity's oldest questions: is there something beyond what we can see, measure, and calculate? This book does not take sides. It is not a defense of religion nor an attack on faith. It is an invitation to thought-rigorous, honest, and open-about what makes us human: our capacity to believe in the improbable and to live as if the irrefutable were true.

The frontier between belief and evidence in the 21st century Author: André Kologeski

IMPROBABLE MIRACLES, IRREFUTABLE FAITH

Hiding Behind the White Coat

Doctors and Their Crimes

When the cost of medicines place them beyond reach for the patients who need them, rationing or priority-setting is often treated as the only way forward. But is this assumption always justified? This book looks closely at Health Technology Assessment (HTA), a quiet multidisciplinary decision-making engine of healthcare systems, and asks whether the international right to health can do more than simply legitimise scarcity through a fair procedure. Drawing on international law, original doctrinal analysis, and a detailed case study, it shows how HTA resource allocation is inseparable from resource mobilisation. This book argues that States are legally obliged not only to prioritise fairly through an accountable process, but also to intervene in prices and market dynamics, and that integrating pricing and regulatory measures can transform HTA into a tool for substantive equality, market accountability, and genuine efforts for access to health.

Mobilising and Distributing Resources in Priority-Setting

Health Technology Assessments and the Right to Health

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 regulation of ART and reproductive genetic innovation. Contrasting the prevailing viewpoint that ART is "minimally regulated," Lewis uncovers how ART techniques that combine IVF with genetic modification or substitution face hidden regulations from federal agencies that curtail access to reproductive genetic innovation. Though the jurisdictional basis of these agency actions has never been clearly articulated, agency employees continue to use agency-issued letters and advisories to deter practitioners of reproductive genetic innovation. In doing so, these actions limit access to life-altering reproductive technologies in the United States and further disparities in access to assisted reproduction. Exposing the extent of over-regulation assisted reproduction in the US, Regulating Conception urges the minimal regulation of assisted reproduction and reproductive genetic innovation in place of clandestine regulation, to increase transparency and safeguard reproductive rights.

Science, Politics, and Reproductive Genetic Innovation

Regulating Conception

Representing a compromise in the pharmaceutical industry in balancing patent exclusivity against market competition, the effect of the Drug Price Competition and Patent Term Restoration Act (commonly known as the Hatch-Waxman Act) on controlling the pharmaceutical market remains unsettled. Amendments to the original act included provisions for an abbreviated process for FDA approval of generic versions of patented pharmaceuticals through the filing of an Abbreviated New Drug Application (ANDA) and the right to initiate patent litigation against an applicant. This law has resulted in ANDA litigation cases and a constant struggle to shape the landscape of the patent and regulatory regime governing FDA approved patented and generic drugs. The Hatch-Waxman Act with it amendments is a hybrid of two already complex areas of the law -- U.S. patent law and FDA regulatory law--which makes patent litigation in this area especially complicated and hotly contested.Now updated and expanded, this Fourth Edition of ANDA Litigation: Strategies and Tactics for Pharmaceutical Patent Litigators is a comprehensive guide examining the intersection between the statutory and regulatory scheme governing approval of generic pharmaceuticals and U.S. patent law in the context of Paragraph IV ANDA litigation. In 23 detailed chapters, this single-source reference focuses both on the current and developing law as well as the strategies and tactics employed by the litigants.ANDA Litigation provides both a ready roadmap for novice litigators in the field as well as more detailed material and strategy to assist the more experienced ANDA litigator. The first part details the Hatch-Waxman Act and how it was implemented. Practical tools in these chapters include: an overview of the drug approval process, including required notice and pre-litigation considerations, and issues related to the timeline of litigation. Following this, the authors explore even deeper into the actual litigation under the act, with topics covering: responses to the complaint, discovery, the work of experts, and patent claim construction and summary judgment.Further chapters are practice-focused, covering issues including preparing the case for trial, the work of trial, managing the litigation process, and post-trial issues, including appeals to the U.S. Court for the Federal Circuit. Finally, the authors discuss remedies, settlement, and antitrust implications, and the book also includes chapters on regulation and litigation of pharmaceuticals outside the U.S.

Strategies and Tactics for Pharmaceutical Patent Litigators, Fourth Edition

Anda Litigation

Debating Law

Who is best placed in medical decision-making, to decide: the patient or the doctor? In this important new volume in the Debating Law series, Imogen Goold argues that the law should strongly support individual choice and autonomy. Medical decisions, she argues, are deeply personal, with life-changing consequences, and it must be for the patient to make them. Even in the event of those decisions ultimately harming the patient, fully informed, autonomous decisions by the patient must be supported by the law. 
 Jonathan Herring counters, arguing that placing the an overriding emphasis on personal autonomy does not always achieve the best outcome for the patient. He argues instead that in certain circumstances, best interest considerations must take precedence over autonomous decision-making. He suggests that the law does not support autonomy as is commonly claimed, but instead takes a much more nuanced approach, balancing the principle of autonomy against other principles and considerations. This is a fascinating addition to this compelling series which grapples with the most pressing issues facing lawyers today.

Debating Autonomy

Cambridge Bioethics and Law

Despite increasing global respect for disability rights since the 2008 entry into force of the UN Convention on the Rights of Persons with Disabilities (CRPD), the equal right to live in the world for disabled people continues to be undermined. This undermining stems from a range of factors, not least the selective prevention and termination of disabled lives, along with long-standing barriers to life-sustaining care, including restricted access to controlled substances and experimental treatment. Investigating the problem of disability discrimination at the margins of life and death, Tony Bogdanoski draws on a range of materials, including international human rights law, reports of UN treaty monitoring bodies and special rapporteurs, and laws largely from the US, UK, and Canada to explore how selective reproduction, assisted dying, and drug control impact struggles for disability equality. His insights are broad in consequence, spanning the fields of disability studies, human rights, law, and bioethics.

Confronting Ableism at Life's Margins

After Disability Rights

Schriften zum Gesundheitsrecht

'Conformity Assessment of AI-based Medical Devices': Since the entry into force of the AI Act, AI-specific requirements supplement the MDR. These must be assessed within a joint conformity assessment, requiring a coherent interplay. This concerns the certifiability of dynamic systems and substantive requirements. Under the MDR, certifying dynamic systems is possible de lege lata if consistent processes are encompassed. The requirements of the AI Act ensure safety despite the dynamic nature of the systems.

Konformitätsbewertung künstlich intelligenter Medizinprodukte

Pharmaceutical and medical device manufacturers face relentless and costly waves of product liability claims across U.S. federal and state courts, spanning individual suits, consolidated multidistrict litigation and coordinated proceedings, multi-plaintiff actions, and class actions. As this complex area of litigation continues to expand-often into more treacherous and plaintiff-friendly venues-the stakes for getting strategy right, early and often, have never been higher. The third edition of Drug and Device Product Liability Litigation Strategy equips litigators with clear, practical guidance from pre-litigation investigations through trial. Reflecting significant developments since the prior edition, it distills the current and evolving legal landscape impacting drug and device lawyers, and offers actionable analysis on the issues that are most likely to influence outcomes: pre-litigation investigation and risk assessment, document preservation and fact discovery, coordination in MDLs and state proceedings, class action challenges, developments in preemption and personal jurisdiction case law, admissibility of expert testimony, dispositive and pre-trial motion practice, jury selection, and trial strategy. This edition highlights strategic inflection points and delivers practice-oriented insights to streamline case management and sharpen advocacy. With its emphasis on strategy and results, it is an indispensable resource for lawyers navigating high-profile drug and device litigation in a continually shifting environment.

Drug and Device Product Liability Litigation Strategy

Healthcare Law and Medical Malpractice

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