This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.

The need for quality improvement and for cost saving are driving both individual choices and health system dynamics. The health services research that we need to support informed choices depends on access to data, but at the same time, individual privacy and patient-health care provider confidentiality must be protected.

In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.

In "Patient Privacy: When It Matters", Dr. Mazer chronicles the history of privacy within the cultural norms of the time and then moves to the current narratives from patients who share their own stories. The question of when patient privacy matters is answered through the lens of the lived experience. "Whatever I see or hear in the lives of my patients... I will keep secret, as considering all such things to be private." (From the Hippocratic Oath, 4th century, B.C.) Patient privacy was first declared in writing by Hippocrates in the 5th century and is often considered the first document to define ethical standards of patient care. Today, while patient privacy remains a mandate for every healthcare professional, it has become enveloped in exceptions many of which are defined in the Health Insurance Portability and Accountability Act of 1996. The analysis identifies both direct and indirect implications for the patient experience.

Secure and protect sensitive personal patient healthcare information Written by a healthcare information security and privacy expert, this definitive resource fully addresses security and privacy controls for patient healthcare information. Healthcare Information Security and Privacy introduces you to the realm of healthcare and patient health records with a complete overview of healthcare organization, technology, data, occupations, roles, and third parties. Learn best practices for healthcare information security and privacy with coverage of information governance, risk assessment and management, and incident response. Written for a global audience, this comprehensive guide covers U.S. laws and regulations as well as those within the European Union, Switzerland, and Canada. Healthcare Information and Security and Privacy covers: Healthcare industry Regulatory environment Privacy and security in healthcare Information governance Risk assessment and management

Determinants of health - like physical activity levels and living conditions - have traditionally been the concern of public health and have not been linked closely to clinical practice. However, if standardized social and behavioral data can be incorporated into patient electronic health records (EHRs), those data can provide crucial information about factors that influence health and the effectiveness of treatment. Such information is useful for diagnosis, treatment choices, policy, health care system design, and innovations to improve health outcomes and reduce health care costs. Capturing Social and Behavioral Domains and Measures in Electronic Health Records: Phase 2 identifies domains and measures that capture the social determinants of health to inform the development of recommendations for the meaningful use of EHRs. This report is the second part of a two-part study. The Phase 1 report identified 17 domains for inclusion in EHRs. This report pinpoints 12 measures related to 11 of the initial domains and considers the implications of incorporating them into all EHRs. This book includes three chapters from the Phase 1 report in addition to the new Phase 2 material. Standardized use of EHRs that include social and behavioral domains could provide better patient care, improve population health, and enable more informative research. The recommendations of Capturing Social and Behavioral Domains and Measures in Electronic Health Records: Phase 2 will provide valuable information on which to base problem identification, clinical diagnoses, patient treatment, outcomes assessment, and population health measurement.

v. 1. Research findings -- v. 2. Concepts and methodology -- v. 3. Implementation issues -- v. 4. Programs, tools and products.