Clinical Trials and Human Research

Clinical Trials and Human Research

Author: Fay A. Rozovsky

Publisher: Jossey-Bass

Published: 2003-06-10

Total Pages: 0

ISBN-13: 9780787965709

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This easy-to-read reference book provides a practical approach for dealing with the legal and regulatory compliance issues involved in human research. Covering a broad range of topics, such as consent, confidentiality, subject recruitment and selection, the role of the investigator and Institutional Review Board, it offers timely and useful strategies for achieving regulatory compliance while reducing liability. In addition, insurance, quality management, accreditation, and risk management are topics examined in the book. The practical insights found in this volume are not found in other books on the subject. Clinical Trials and Human Research is a practical tool to help anyone involved in clinical research.


The Healthcare Compliance Professional's Guide to Clinical Trials

The Healthcare Compliance Professional's Guide to Clinical Trials

Author: F. Lisa Murtha

Publisher: Hcpro, a Division of Simplify Compliance

Published: 2008

Total Pages: 0

ISBN-13: 9781601462244

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Billing for clinical trials is a focal point of government scrutiny, with several new CMS directives that mandate compliance with regulations for hospitals and university research facilities. The Healthcare Compliance Professional's Guide to Clinical Trials helps you sort through the various rules and establish policies and procedures that ensure Medicare-covered research is reimbursed appropriately. Professional's Guide to Clinical Trials Written by the Huron Consulting Group, a team of clinical research compliance experts, The Healthcare Compliance Professional's Guide to Clinical Trials will help ensure that your facility minimizes its compliance risk in the important research that it conducts. With this book, you can: *Customize forms to conduct a Medicare Coverage Analysis *Develop your own review plan based on proven sample auditing and monitoring templates *Analyze recent changes to the National Coverage Determination *Apply concepts from real-life clinical trial situations to your compliance program *Coordinate research and revenue teams The sample materials in this guide can be used right away. Download them from the companion CD-ROM and customize each document to fit your specific needs. It's that easy to develop a plan to ensure that your clinical trial research conforms to CMS regulations and that you receive the proper reimbursement.


Risk Management Handbook for Health Care Organizations

Risk Management Handbook for Health Care Organizations

Author: American Society for Healthcare Risk Management (ASHRM)

Publisher: John Wiley & Sons

Published: 2009-03-27

Total Pages: 672

ISBN-13: 0470443715

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Risk Management Handbook for Health Care Organizations, Student Edition This comprehensive textbook provides a complete introduction to risk management in health care. Risk Management Handbook, Student Edition, covers general risk management techniques; standards of health care risk management administration; federal, state and local laws; and methods for integrating patient safety and enterprise risk management into a comprehensive risk management program. The Student Edition is applicable to all health care settings including acute care hospital to hospice, and long term care. Written for students and those new to the topic, each chapter highlights key points and learning objectives, lists key terms, and offers questions for discussion. An instructor's supplement with cases and other material is also available. American Society for Healthcare Risk Management (ASHRM) is a personal membership group of the American Hospital Association with more than 5,000 members representing health care, insurance, law, and other related professions. ASHRM promotes effective and innovative risk management strategies and professional leadership through education, recognition, advocacy, publications, networking, and interactions with leading health care organizations and government agencies. ASHRM initiatives focus on developing and implementing safe and effective patient care practices, preserving financial resources, and maintaining safe working environments.


The Health Care Compliance Professional's Manual

The Health Care Compliance Professional's Manual

Author: Hcca

Publisher: Aspen Publishers

Published: 2007

Total Pages: 1080

ISBN-13: 9780735570382

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The Health Care Compliance Professional's Manual gives you all the tools you need to plan and execute a customized compliance program that meets federal standards. It walks you through the entire process, start to finish, showing you how to draft compliance policies, build a strong compliance infrastructure in your organization, document your efforts, apply self-assessment techniques, create an effective education program, pinpoint areas of risk, conduct internal probes and much more. The Health Care Compliance Professional's Manual is used by the Health Care Compliance Association (HCCA) as the basic text for its Compliance Academy - the program that prepares compliance professionals for the CHC (Certificate in Healthcare Compliance) certification exam. The Health Care Compliance Professional's Manual will help you to: Use OIG publications and Federal Sentencing Guidelines to help plan and execute a customized compliance strategy that meets tough federal standards Perform risk assessment to pinpoint areas within your company that pose compliance and operational risks Draft compliance policies that form the foundation for a strong compliance program Build a strong infrastructure for compliance to work, including hiring the right personnel Create an effective education and training program that instills in employees the value of legal compliance Conduct internal probes that uncover legal violations before the federal government does - and mitigate possible penalties Stay up-to-date on all the latest legal and regulatory requirements affecting your facility, including HIPAA, EMTALA, fraud and abuse reimbursement, privacy, security, patient safety and much more! Packed with tools to make your job easier, The Health Care Compliance Professional's Manual will provide: Practical coverage of federal and state laws governing your facility Document efforts and apply self assessment techniques Insight into helpful federal standards on effective compliance programs Step-by-step guidance on implementing a sound compliance program Time-saving sample compliance policies, forms, checklists, and chart The Health Care Compliance Professional's Manual will protect your company if violations do occur: Learn how to apply auditing, monitoring, and self-assessment techniques Discover how to successfully follow the OIG's voluntary disclosure program to resolve overpayment problems and avoid exclusion from Medicare Find out how to enter into a corporate integrity agreement to settle with the federal government and mitigate FCA-related penalties Document your compliance efforts so you leave a protective paper trail that shields you from liability And much more


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

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

Author: OECD

Publisher: OECD Publishing

Published: 2019-10-17

Total Pages: 447

ISBN-13: 9264805907

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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.


AHLA Health Care Compliance Legal Issues Manual (Non-members)

AHLA Health Care Compliance Legal Issues Manual (Non-members)

Author: American Health Lawyers Association

Publisher:

Published: 2019

Total Pages:

ISBN-13: 9781522173441

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Authored by experts with years of health care compliance experience, this new edition integrates changes in regulation, trends in enforcement, and the reasoning of the courts to help you navigate emerging and unsettled areas of compliance risk, such as self-disclosure obligations, risks associated with opioid use, and the impact of statistical sampling.Highlights of this edition include:All new glossary of health care compliance terms, including key statutes, acronyms, governing agencies, and moreExpanded civil monetary penalty and exclusion authorities under 2017 final rulesDiscussion of core elements of compliance programs for Medicare Advantage Plans and Part D Plans as established by federal regulationsExpanded whistleblower protections under federal and state law, false claims based on lack of medical necessity, materiality after Escobar, and recent enforcement activityExpanded discussion of determinations of medical necessity, CMS review of medical necessity terminations, consequences, and appeals processesRecent health information privacy and security developments, including new guidance, risks associated with innovative technologies, and trends in Health Insurance Portability and Accountability Act (HIPAA) enforcement activityNew chapters:Chapter 1, Glossary of Key TermsChapter 10, The Relationship between Enforcement and ComplianceChapter 17, Health Care Civil Rights and Nondiscrimination Under Section 1557 of the Affordable Care ActChapter 19, Behavioral Health