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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.
The "Overview of the Privacy Act of 1974," prepared by the Department of Justice's Office of Privacy and Civil Liberties (OPCL), is a discussion of the Privacy Act's disclosure prohibition, its access and amendment provisions, and its agency recordkeeping requirements. Tracking the provisions of the Act itself, the Overview provides reference to, and legal analysis of, court decisions interpreting the Act's provisions.
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.
Federal government statistics provide critical information to the country and serve a key role in a democracy. For decades, sample surveys with instruments carefully designed for particular data needs have been one of the primary methods for collecting data for federal statistics. However, the costs of conducting such surveys have been increasing while response rates have been declining, and many surveys are not able to fulfill growing demands for more timely information and for more detailed information at state and local levels. Innovations in Federal Statistics examines the opportunities and risks of using government administrative and private sector data sources to foster a paradigm shift in federal statistical programs that would combine diverse data sources in a secure manner to enhance federal statistics. This first publication of a two-part series discusses the challenges faced by the federal statistical system and the foundational elements needed for a new paradigm.
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.
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.
The advent of computerized data systems, the growth of managed care, the AIDS epidemic, mandatory reporting requirements for child abuse, workplace drug testing, and various laws requiring that social workers maintain confidential communications in some situations yet disclose them in others have made confidentiality a vital, changing area of the law. Practitioners, administrators, and those studying for these professions need to know how to use these laws to protect their clients, themselves, and their agencies. Mental health practitioners need authoritative guidance in these areas when working with clients -- children as well as adults -- in both individual and group settings. Administrators must be aware of the laws that protect worker and client privacy, and those that permit legitimate access to information.
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.
Recent years have seen a growing tendency for social scientists to collect biological specimens such as blood, urine, and saliva as part of large-scale household surveys. By combining biological and social data, scientists are opening up new fields of inquiry and are able for the first time to address many new questions and connections. But including biospecimens in social surveys also adds a great deal of complexity and cost to the investigator's task. Along with the usual concerns about informed consent, privacy issues, and the best ways to collect, store, and share data, researchers now face a variety of issues that are much less familiar or that appear in a new light. In particular, collecting and storing human biological materials for use in social science research raises additional legal, ethical, and social issues, as well as practical issues related to the storage, retrieval, and sharing of data. For example, acquiring biological data and linking them to social science databases requires a more complex informed consent process, the development of a biorepository, the establishment of data sharing policies, and the creation of a process for deciding how the data are going to be shared and used for secondary analysis-all of which add cost to a survey and require additional time and attention from the investigators. These issues also are likely to be unfamiliar to social scientists who have not worked with biological specimens in the past. Adding to the attraction of collecting biospecimens but also to the complexity of sharing and protecting the data is the fact that this is an era of incredibly rapid gains in our understanding of complex biological and physiological phenomena. Thus the tradeoffs between the risks and opportunities of expanding access to research data are constantly changing. Conducting Biosocial Surveys offers findings and recommendations concerning the best approaches to the collection, storage, use, and sharing of biospecimens gathered in social science surveys and the digital representations of biological data derived therefrom. It is aimed at researchers interested in carrying out such surveys, their institutions, and their funding agencies.