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The Belmont Report

United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

Published: 1978

Total Pages: 614


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The Model Rules of Professional Conduct provides an up-to-date resource for information on legal ethics. Federal, state and local courts in all jurisdictions look to the Rules for guidance in solving lawyer malpractice cases, disciplinary actions, disqualification issues, sanctions questions and much more. In this volume, black-letter Rules of Professional Conduct are followed by numbered Comments that explain each Rule's purpose and provide suggestions for its practical application. The Rules will help you identify proper conduct in a variety of given situations, review those instances where discretionary action is possible, and define the nature of the relationship between you and your clients, colleagues and the courts.
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.
First multi-year cumulation covers six years: 1965-70.

For the Record

Committee on Maintaining Privacy and Security in Health Care Applications of the National Information Infrastructure

Published: 1997-06-23

Total Pages: 287


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When you visit the doctor, information about you may be recorded in an office computer. Your tests may be sent to a laboratory or consulting physician. Relevant information may be transmitted to your health insurer or pharmacy. Your data may be collected by the state government or by an organization that accredits health care or studies medical costs. By making information more readily available to those who need it, greater use of computerized health information can help improve the quality of health care and reduce its costs. Yet health care organizations must find ways to ensure that electronic health information is not improperly divulged. Patient privacy has been an issue since the oath of Hippocrates first called on physicians to "keep silence" on patient matters, and with highly sensitive data--genetic information, HIV test results, psychiatric records--entering patient records, concerns over privacy and security are growing. For the Record responds to the health care industry's need for greater guidance in protecting health information that increasingly flows through the national information infrastructure--from patient to provider, payer, analyst, employer, government agency, medical product manufacturer, and beyond. This book makes practical detailed recommendations for technical and organizational solutions and national-level initiatives. For the Record describes two major types of privacy and security concerns that stem from the availability of health information in electronic form: the increased potential for inappropriate release of information held by individual organizations (whether by those with access to computerized records or those who break into them) and systemic concerns derived from open and widespread sharing of data among various parties. The committee reports on the technological and organizational aspects of security management, including basic principles of security; the effectiveness of technologies for user authentication, access control, and encryption; obstacles and incentives in the adoption of new technologies; and mechanisms for training, monitoring, and enforcement. For the Record reviews the growing interest in electronic medical records; the increasing value of health information to providers, payers, researchers, and administrators; and the current legal and regulatory environment for protecting health data. This information is of immediate interest to policymakers, health policy researchers, patient advocates, professionals in health data management, and other stakeholders.
The escalation of security breaches involving personally identifiable information (PII) has contributed to the loss of millions of records over the past few years. Breaches involving PII are hazardous to both individuals and org. Individual harms may include identity theft, embarrassment, or blackmail. Organ. harms may include a loss of public trust, legal liability, or remediation costs. To protect the confidentiality of PII, org. should use a risk-based approach. This report provides guidelines for a risk-based approach to protecting the confidentiality of PII. The recommend. here are intended primarily for U.S. Fed. gov¿t. agencies and those who conduct business on behalf of the agencies, but other org. may find portions of the publication useful.