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.
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.
As our nation enters a new era of medical science that offers the real prospect of personalized health care, we will be confronted by an increasingly complex array of health care options and decisions. The Learning Healthcare System considers how health care is structured to develop and to apply evidence-from health profession training and infrastructure development to advances in research methodology, patient engagement, payment schemes, and measurement-and highlights opportunities for the creation of a sustainable learning health care system that gets the right care to people when they need it and then captures the results for improvement. This book will be of primary interest to hospital and insurance industry administrators, health care providers, those who train and educate health workers, researchers, and policymakers. The Learning Healthcare System is the first in a series that will focus on issues important to improving the development and application of evidence in health care decision making. The Roundtable on Evidence-Based Medicine serves as a neutral venue for cooperative work among key stakeholders on several dimensions: to help transform the availability and use of the best evidence for the collaborative health care choices of each patient and provider; to drive the process of discovery as a natural outgrowth of patient care; and, ultimately, to ensure innovation, quality, safety, and value in health care.
