Managing Legal Compliance in the Health Care Industry


Book Description

Managing Legal Compliance in the Health Care Industry is a comprehensive text that prepares students for this increasingly critical field in health care administration. In three sections, this unique title first examines all the key laws and regulations that health care organizations must comply with. In section two, it explores in detail the seven essential ingredients for a good compliance program. In the final section, the book explains how the compliance program must be adapted to the special needs of different types of health care organizations. Designed for graduate level students in programs of public health, health administration, and law, the text is filled with highly practical information about the ways that legal violations occur and how good compliance programs function. Key Features: - Examines in detail the current laws and regulations with which all types of health care organizations must comply - Explore the seven essential ingredients for a good compliance program - Looks at compliance programs within twelve different types of health care organizations - References real world cases of fraud and abuse - Includes Study Questions and Learning Experiences in each chapter that are designed to encourage critical thinking




Improving Healthcare Quality in Europe Characteristics, Effectiveness and Implementation of Different Strategies


Book Description

This volume, developed by the Observatory together with OECD, provides an overall conceptual framework for understanding and applying strategies aimed at improving quality of care. Crucially, it summarizes available evidence on different quality strategies and provides recommendations for their implementation. This book is intended to help policy-makers to understand concepts of quality and to support them to evaluate single strategies and combinations of strategies.




Ethical Conduct of Clinical Research Involving Children


Book Description

In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.




Improving the Quality of Long-Term Care


Book Description

Among the issues confronting America is long-term care for frail, older persons and others with chronic conditions and functional limitations that limit their ability to care for themselves. Improving the Quality of Long-Term Care takes a comprehensive look at the quality of care and quality of life in long-term care, including nursing homes, home health agencies, residential care facilities, family members and a variety of others. This book describes the current state of long-term care, identifying problem areas and offering recommendations for federal and state policymakers. Who uses long-term care? How have the characteristics of this population changed over time? What paths do people follow in long term care? The committee provides the latest information on these and other key questions. This book explores strengths and limitations of available data and research literature especially for settings other than nursing homes, on methods to measure, oversee, and improve the quality of long-term care. The committee makes recommendations on setting and enforcing standards of care, strengthening the caregiving workforce, reimbursement issues, and expanding the knowledge base to guide organizational and individual caregivers in improving the quality of care.




Health Care Regulation in America


Book Description

Regulation shapes all aspects of America's fragmented health care industry. While the health and lives of patients as well as almost one-sixth of the national economy depend on its effectiveness, health care regulation in America is bewilderingly complex. 'Health Care Regulation in America' is a guide to this regulatory maze.




Guidelines Manual


Book Description




The Future of Drug Safety


Book Description

In the wake of publicity and congressional attention to drug safety issues, the Food and Drug Administration (FDA) requested the Institute of Medicine assess the drug safety system. The committee reported that a lack of clear regulatory authority, chronic underfunding, organizational problems, and a scarcity of post-approval data about drugs' risks and benefits have hampered the FDA's ability to evaluate and address the safety of prescription drugs after they have reached the market. Noting that resources and therefore efforts to monitor medications' riskâ€"benefit profiles taper off after approval, The Future of Drug Safety offers a broad set of recommendations to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used.




Medical Device Regulations


Book Description

The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.




Medical Regulatory Affairs


Book Description

This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Experts from influential international regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book. Government bodies, the medical device industry, academics, students, and general readers will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.




Healthcare Information Privacy and Security


Book Description

Healthcare IT is the growth industry right now, and the need for guidance in regard to privacy and security is huge. Why? With new federal incentives and penalties tied to the HITECH Act, HIPAA, and the implementation of Electronic Health Record (EHR) systems, medical practices and healthcare systems are implementing new software at breakneck speed. Yet privacy and security considerations are often an afterthought, putting healthcare organizations at risk of fines and damage to their reputations. Healthcare Information Privacy and Security: Regulatory Compliance and Data Security in the Age of Electronic Health Records outlines the new regulatory regime, and it also provides IT professionals with the processes and protocols, standards, and governance tools they need to maintain a secure and legal environment for data and records. It’s a concrete resource that will help you understand the issues affecting the law and regulatory compliance, privacy, and security in the enterprise. As healthcare IT security expert Bernard Peter Robichau II shows, the success of a privacy and security initiative lies not just in proper planning but also in identifying who will own the implementation and maintain technologies and processes. From executive sponsors to system analysts and administrators, a properly designed security program requires that that the right people are assigned to the right tasks and have the tools they need. Robichau explains how to design and implement that program with an eye toward long-term success. Putting processes and systems in place is, of course, only the start. Robichau also shows how to manage your security program and maintain operational support including ongoing maintenance and policy updates. (Because regulations never sleep!) This book will help you devise solutions that include: Identity and access management systems Proper application design Physical and environmental safeguards Systemwide and client-based security configurations Safeguards for patient data Training and auditing procedures Governance and policy administration Healthcare Information Privacy and Security is the definitive guide to help you through the process of maintaining privacy and security in the healthcare industry. It will help you keep health information safe, and it will help keep your organization—whether local clinic or major hospital system—on the right side of the law.