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.

This book focuses on the development and use of interoperability standards related to healthcare information technology (HIT) and provides in-depth discussion of the associated essential aspects. The book explains the principles of conformance, examining how to improve the content of healthcare data exchange standards (including HL7 v2.x, V3/CDA, FHIR, CTS2, DICOM, EDIFACT, and ebXML), the rigor of conformance testing, and the interoperability capabilities of healthcare applications for the benefit of healthcare professionals who use HIT, developers of HIT applications, and healthcare consumers who aspire to be recipients of safe and effective health services facilitated through meaningful use of well-designed HIT. Readers will understand the common terms interoperability, conformance, compliance and compatibility, and be prepared to design and implement their own complex interoperable healthcare information system. Chapters address the practical aspects of the subject matter to enable application of previously theoretical concepts. The book provides real-world, concrete examples to explain how to apply the information, and includes many diagrams to illustrate relationships of entities and concepts described in the text. Designed for professionals and practitioners, this book is appropriate for implementers and developers of HIT, technical staff of information technology vendors participating in the development of standards and profiling initiatives, informatics professionals who design conformance testing tools, staff of information technology departments in healthcare institutions, and experts involved in standards development. Healthcare providers and leadership of provider organizations seeking a better understanding of conformance, interoperability, and IT certification processes will benefit from this book, as will students studying healthcare information technology.

Received document entitled: APPENDIX TO PETITION FOR WRIT