Nutraceutical and Functional Food Regulations in the United States and Around the World, Third Edition addresses the latest regulatory requirements designed to ensure the safe production and delivery of these valuable classes of foods. The book is well recognized, showing how food and nutrition play a critical role in enhancing human performance, and in overall health. The book discusses the scope, importance and continuing growth opportunities in the nutraceutical and functional food industries, exploring the acceptance and demand for these products, regulatory hurdles, the intricate aspects of manufacturing procedures, quality control, global regulatory norms and guidelines.

This tool kit for the health sector aims to improve understanding of the legal framework, technology, and unique health identifiers or patient registries involved in ensuring the continuity and quality of care. Unique health identifiers help improve quality and continuum of care, strengthen surveillance of communicable diseases, eradicate diseases, and optimize provider and payer transactions in health financing schemes. They are important enablers for achieving Universal Health Coverage. Through this tool kit, governments and experts will learn how to assess the existing legal, policy, and institutional framework; information and communication technology infrastructure; and current use of identifiers relevant for the health sector, to inform policy decisions on advancing unique identification in the health sector.

The U.S. Coast Guard is the nations principal law enforcement authority on U.S. waters. Its missions include maritime safety and security, marine environmental protection, search and rescue, drug and migrant interdiction, fisheries enforcement, and defense readiness. The Coast Guards responsibilities are specified in legislation establishing the agency as well as authorization bills typically passed by Congress every one to two years and in Department of Homeland Security appropriations acts.

This book contributes towards EU studies and the growing discourse on law and public health. It uses the EU's governance of public health as a lens through which to explore questions of legal competence and its development through policy and concrete techniques, processes and practices, risk and security, human rights and bioethics, accountability and legitimacy, democracy and citizenship, and the nature, essence and 'future trajectory' of the European integration project. These issues are explored first by situating the EU's public health strategy within the overarching architecture of governance and subsequently by examining its operationalisation in relation to the key public health problems of cancer, HIV/AIDS and pandemic planning. The book argues that the centrality and valorisation of scientific and technical knowledge and expertise in the EU's risk-based governance means that citizen participation in decision-making is largely marginalised and underdeveloped - and that this must change if public health and the quality, accountability and legitimacy of EU governance and its regulation are to be improved. Subsequently the book goes on to argue that the legitimating discourses of ethics and human rights, and the developing notion of EU (supra-)stewardship responsibility, can help to highlight the normative dimensions of governance and its interventions in public health. These discourses and dimensions provide openings and possibilities for citizens to power 'technologies of participation' and contribute important supplementary knowledge to decision-making.

In caring for a pregnant women, physicians consider the health of two biologically linked, yet individually viable patients. Viewed as an organic whole, the combined maternal-fetal benefit of proposed interventions is weighed against the combined burdens. The complexity of maternal-fetal conflicts (MFC) places the medical profession in a position where the provider's determination in doing what is believed to be the best is seen as a denial of women's autonomy or pro-fetus jurisprudence. In the common-law, the concept of MFC often becomes an indirect evidence or inter alia, an ever-resolving puzzle comprised of elements of crime or tort. The account set in this book is not to resonate, but to simplify our concerns or duties in resolving MFC. Stemmed of 650 references and packed in 35 chapters, this 480-page compilation briefs and analyzes 120 cases held in the United States, Canada, and the United Kingdom, as well as MFC scenarios--stratifying them into the clusters to present an obstetrical problem. Each chapter starts with a concise review of the medical-legal repository, followed by the case briefs inclusive for the I.R.A.C. (issue, rule, analysis, conclusion), precedents, dicta, concurring/dissent, dispositions or verdicts, remedies, reliefs, and reasoning pursuant to the Constitutional or statute enactments in British Commonwealth, the United States and District of Columbia, Canadian provinces and territories. All published cases are located via LexisNexis, BlueBook and WestLaw, and are free for the public visit under the U.S. Health Insurance Portability & Accountability Act (HIPAA), the Brady Rule, the Patient Safety & Quality Improvement Act of 2005 (PSQIA), 17 U.S.C. 512, Digital Millennium Copyright Act (DMCA); Canadian Personal Information Protection & Electronic Documents Act (PIPEDA), Confidentiality Guidance 2009 of the General Medical Council of British Commonwealth, and other codes, acts or dicta. Bound for both medical and legal practitioners, this book may lessen the fees on the legal counsel, prof-liability insurances, and forensic testimony.

The HIPAA Roadmap for Ambulatory Care is a step-by-step guide to HIPAA/HITECH compliance for health care providers, with emphasis on changes to policies, procedures and forms required under HITECH and the Omnibus Final Rule. HIPAA covered entities will need to comply with the new rules prior to September 23, 2013. The HIPAA Roadmap for Ambulatory Care is designed to provide physician practices, ambulatory surgery centers, therapy providers, and other outpatient providers make the necessary changes to their HIPAA policies and forms in a thorough and efficient manner. The HIPAA Roadmap for Ambulatory Care includes sample policies to implement the new patient rights established under HITECH and the changes relating to marketing, sale of PHI, fundraising and release of immunization records. The Roadmap also includes a sample Notice of Privacy Practices incorporating the changes required under HITECH, sample breach policy complying with the Omnibus Final Rule, and sample Business Associate Agreement and amendment. While the Roadmap focuses on the changes to HIPAA resulting from HITECH and the Omnibus Final Rule, the Roadmap also includes resources for new providers that are setting up their HIPAA policies. Documents of particular interest to new providers include job descriptions for the HIPAA Privacy Official and Security Official, and a sample training presentation for employees on information security practices. Also included are tools for performing a security risk analysis as required under the HIPAA Security Rule, and information security policies covering administrative, physical and technical safeguards required under the Security Rule standards and implementation specifications.

There is an understandable tendency or desire to attribute blame when patients are harmed by their own healthcare. However, many cases of iatrogenic harm involve little or no moral culpability. Even when blame is justified, an undue focus on one individual often deflects attention from other important factors within the inherent complexity of modern healthcare. This revised second edition advocates a rethinking of accountability in healthcare based on science, the principles of a just culture, and novel therapeutic legal processes. Updated to include many recent relevant events, including the Keystone Project in the USA and the Mid Staffordshire scandal in the UK, this book considers how the concepts of a just culture have been successfully implemented so far, and makes recommendations for best practice. This book will be of interest to anyone concerned with patient safety, medical law and the regulation of healthcare.

Law is neither panacea nor justice. An element of calculation, it answers to the "how" question, whereas justice answers to the "why" question. Law is anything but simple. It is a piecemeal doctrinal construction, each part more readily explained by the circumstances of its addition than by its relation to a coherent whole. An up to date analysis of the court-visited 36 cases, this monograph depicts the challenges, and outcomes of surgical negligence claims in the States, by covering a range of malpractice determinants: plaintiff's reasonableness, surgeon's state of mind, res ipsa loquitur, inter alia, strict liability, qualifications of the witness-expert, plain-error doctrine, but-for rule and proximate causation, patent law and infringement, defamation, concert of actions, conspiracy, fraud, taxation of the awards, and the dicta.