This timely book emphasizes the importance of regulation in enabling and channelling innovation at a time when technology is increasingly embedded in healthcare. It considers the adequacy of current regulatory approaches, identifying apparent gaps, risks and liabilities, and discusses how these might be collectively addressed. The authors present possible solutions that balance the protection and promotion of public trust in healthcare against enabling technological progress and disruptive innovation. Offering both a theoretical and practical approach to challenges at the intersection of healthcare, law and technology, this thought-provoking book explores broad questions of regulation and innovation before analysing contextual applications of these topics. It moves from a wide-ranging consideration of the polycentric and changing nature of health regulation through to a more specific examination of topics including patient consent, the role of device representatives, privacy, artificial intelligence and big data. Providing an international perspective, Technology, Innovation and Healthcare will be a valuable resource for scholars and students of health law, innovation, technology law, law and development and law and society. It will also be of benefit to lawyers, healthcare professionals, technology developers and policy makers, seeking to better integrate technology with healthcare.

Respect for autonomy has become a fundamental principle in human research ethics. Nonetheless, this principle and the associated process of obtaining informed consent do have limitations. This can lead to some groups, many of them vulnerable, being left understudied. This book considers these limitations and contributes through legal and philosophical analyses to the search for viable approaches to human research ethics. It explores the limitations of respect for autonomy and informed consent both in law and through the examination of cases where autonomy is lacking (infants), diminished (addicts), and compromised (low socio-economic status). It examines alternative and complementary concepts to overcome the limits of respect for autonomy, including beneficence, dignity, virtue, solidarity, non-exploitation, vulnerability and self-ownership. It takes seriously the importance of human relationality and community in qualifying, tempering and complementing autonomy to achieve the ultimate end of human research - the good of humankind.