Fay A. Rozovsky – författare

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.

What Do I Say? Communicating Intended or Unanticipated Outcomes in Obstetrics will help physicians and other health care professionals improve their communication skills with patients and their family members. Written by James R. Woods, a perinatologist, and Fay A. Rozovsky, an attorney, risk management consultant, and authority on informed consent, What Do I Say? explores how to explain risk to patients, how to obtain patient consent, and how to talk with patients when adverse events occur. What Do I Say? is a comprehensive book that Explains consent as a foundation of the caregiver-patient relationshipExplains the legal context for disclosing bad newsOutlines the practical issues associated with OB consentIn addition to the information, research, and practical advice contained in this helpful volume, What Do I Say? is filled with useful case examples that can prepare physicians and other health care professionals for handling communications in potentially high-risk situations.

Written for virtually every professional and leader in the health care field, as well as students who are preparing for careers in health services delivery, this book presents a framework for developing a patient safety program, shows how best to examine events that do occur, and reveals how to ensure that appropriate corrective and preventative actions are reviewed for effectiveness. The book covers a comprehensive selection of topics including The link between patient safety and legal and regulatory compliance The role of accreditation and standard-setting organizations in patient safety Failure modes and effect analysis Voluntary and regulatory oversight of medical error Evidence-based outcomes and standards of care Creation and preservation of reports, data, and device evidence in medical error situations Claims management when dealing with patient safety events Full disclosure Patient safety in human research Managing confidentiality in the face of litigation Managing patient safety compliance through accountability-based credentialing for health care professionals Planning for the future

Written for virtually every professional and leader in the health care field, as well as students who are preparing for careers in health services delivery, this book presents a framework for developing a patient safety program, shows how best to examine events that do occur, and reveals how to ensure that appropriate corrective and preventative actions are reviewed for effectiveness. The book covers a comprehensive selection of topics including The link between patient safety and legal and regulatory complianceThe role of accreditation and standard-setting organizations in patient safetyFailure modes and effect analysisVoluntary and regulatory oversight of medical errorEvidence-based outcomes and standards of careCreation and preservation of reports, data, and device evidence in medical error situationsClaims management when dealing with patient safety eventsFull disclosurePatient safety in human researchManaging confidentiality in the face of litigationManaging patient safety compliance through accountability-based credentialing for health care professionalsPlanning for the future