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Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309316324 Category : Medical Languages : en Pages : 304
Book Description
Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research--from funders, to researchers, to journals, to physicians, and ultimately, to patients.
Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309316324 Category : Medical Languages : en Pages : 304
Book Description
Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research--from funders, to researchers, to journals, to physicians, and ultimately, to patients.
Author: Carolyn Adams Publisher: Cambridge University Press ISBN: 1108619916 Category : Law Languages : en Pages : 279
Book Description
Health research around the world relies on access to data, and much of the most valuable, reliable, and comprehensive data collections are held by governments. These collections, which contain data on whole populations, are a powerful tool in the hands of researchers, especially when they are linked and analyzed, and can help to address “wicked problems” in health and emerging global threats such as COVID-19. At the same time, these data collections contain sensitive information that must only be used in ways that respect the values, interests, and rights of individuals and their communities. Sharing Linked Data for Health Research provides a template for allowing research access to government data collections in a regulatory environment designed to build social license while supporting the research enterprise.
Author: Sen, Devjani Publisher: IGI Global ISBN: 1799834891 Category : Computers Languages : en Pages : 335
Book Description
Health and fitness apps collect various personal information including name, email address, age, height, weight, and in some cases, detailed health information. When using these apps, many users trustfully log everything from diet to sleep patterns. However, by sharing such personal information, end-users may make themselves targets to misuse of this information by unknown third parties, such as insurance companies. Despite the important role of informed consent in the creation of health and fitness applications, the intersection of ethics and information sharing is understudied and is an often-ignored topic during the creation of mobile applications. Privacy Concerns Surrounding Personal Information Sharing on Health and Fitness Mobile Apps is a key reference source that provides research on the dangers of sharing personal information on health and wellness apps, as well as how such information can be used by employers, insurance companies, advertisers, and other third parties. While highlighting topics such as data ethics, privacy management, and information sharing, this publication explores the intersection of ethics and privacy using various quantitative, qualitative, and critical analytic approaches. It is ideally designed for policymakers, software developers, mobile app designers, legal specialists, privacy analysts, data scientists, researchers, academicians, and upper-level students.
Author: Agency for Healthcare Research and Quality/AHRQ Publisher: Government Printing Office ISBN: 1587634333 Category : Medical Languages : en Pages : 396
Book Description
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.
Author: Institute of Medicine Publisher: ISBN: 9780309303606 Category : Medical Languages : en Pages : 0
Book Description
Many of the elements of the Affordable Care Act (ACA) went into effect in 2014, and with the establishment of many new rules and regulations, there will continue to be significant changes to the United States health care system. It is not clear what impact these changes will have on medical and public health preparedness programs around the country. Although there has been tremendous progress since 2005 and Hurricane Katrina, there is still a long way to go to ensure the health security of the Country. There is a commonly held notion that preparedness is separate and distinct from everyday operations, and that it only affects emergency departments. But time and time again, catastrophic events challenge the entire health care system, from acute care and emergency medical services down to the public health and community clinic level, and the lack of preparedness of one part of the system places preventable stress on other components. The implementation of the ACA provides the opportunity to consider how to incorporate preparedness into all aspects of the health care system. The Impacts of the Affordable Care Act on Preparedness Resources and Programs is the summary of a workshop convened by the Institute of Medicine's Forum on Medical and Public Health Preparedness for Catastrophic Events in November 2013 to discuss how changes to the health system as a result of the ACA might impact medical and public health preparedness programs across the nation. This report discusses challenges and benefits of the Affordable Care Act to disaster preparedness and response efforts around the country and considers how changes to payment and reimbursement models will present opportunities and challenges to strengthen disaster preparedness and response capacities.
Author: Marius Fieschi Publisher: Elsevier ISBN: 0081027583 Category : Science Languages : en Pages : 340
Book Description
Health Data Processing: Systemic Approaches focuses on the design of health information systems and touches on the main themes of medical informatics and public health. The book is written for health professionals in practice or training, and is especially useful for decision-makers or future decision-makers in the field of health information systems. Users will find sections on the question of reusing data for other purposes, protection of individual liberties that this data and technologies make more acute, and the irruption of large masses of genetic data and its related problems. This book develops the methodological and conceptual aspects related to these issues. Proposes a methodology for the development of health information systems for the better use of digital technologies Illustrates a systemic, transversal, conceptual vision that supports the complex reality of the healthcare world, where the interoperability of agents (professionals and software) is central Discusses the reuse of resources of data for knowledge improvement, health security and public health
Author: Khaled El Emam Publisher: Trafford Publishing ISBN: 1466980494 Category : Law Languages : en Pages : 253
Book Description
Due to the digitization of medical records, more and more health data is readily available. This dynamic has created many opportunities to unlock this information and use it to improve medical practice, and through research and surveillance understand the effectiveness and side effects of drugs and medical devices to ultimately improve the public’s health. This data can also be used for commercial purposes such as sales and marketing. However, this newfound utility raises some profound questions about how this data ought to be used and how it will impact personal privacy. Unless we are able to address these privacy issues in a convincing and defensible way, there will be increased breaches of personal privacy. This will provoke regulators to impose new rules limiting the use and disclosure of health data for secondary purposes, patients increasingly to adopt privacy protective behaviours because they no longer trust how their health information is being managed, or healthcare providers to be reluctant to share their patients’ data. By adopting responsible data sharing practices, researchers, companies and the general public can gain the benefits and the promise of big data analytics without sacrificing personal privacy or infringing upon law or regulation. Risky Business – Sharing Health Data While Protecting Privacy illustrates how this goal can be achieved. Bringing articles from a diverse collection of health data experts to inform the reader on contemporary policy, legal and technical issues surrounding health information privacy and data sharing. It is a uniquely practical work to inform the reader on how best – and how not to – share health data in the US and Canada.
Author: National Research Council Publisher: National Academies Press ISBN: 0309056977 Category : Medical Languages : en Pages : 287
Book Description
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 dataâ€"genetic information, HIV test results, psychiatric recordsâ€"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 infrastructureâ€"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.
Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309136849 Category : Computers Languages : en Pages : 178
Book Description
As digital technologies are expanding the power and reach of research, they are also raising complex issues. These include complications in ensuring the validity of research data; standards that do not keep pace with the high rate of innovation; restrictions on data sharing that reduce the ability of researchers to verify results and build on previous research; and huge increases in the amount of data being generated, creating severe challenges in preserving that data for long-term use. Ensuring the Integrity, Accessibility, and Stewardship of Research Data in the Digital Age examines the consequences of the changes affecting research data with respect to three issues - integrity, accessibility, and stewardship-and finds a need for a new approach to the design and the management of research projects. The report recommends that all researchers receive appropriate training in the management of research data, and calls on researchers to make all research data, methods, and other information underlying results publicly accessible in a timely manner. The book also sees the stewardship of research data as a critical long-term task for the research enterprise and its stakeholders. Individual researchers, research institutions, research sponsors, professional societies, and journals involved in scientific, engineering, and medical research will find this book an essential guide to the principles affecting research data in the digital age.
Author: National Academies of Sciences, Engineering, and Medicine Publisher: National Academies Press ISBN: 0309378125 Category : Science Languages : en Pages : 102
Book Description
Sharing research data on public health issues can promote expanded scientific inquiry and has the potential to advance improvements in public health. Although sharing data is the norm in some research fields, sharing of data in public health is not as firmly established. In March 2015, the National Research Council organized an international conference in Stellenbosch, South Africa, to explore the benefits of and barriers to sharing research data within the African context. The workshop brought together public health researchers and epidemiologists primarily from the African continent, along with selected international experts, to talk about the benefits and challenges of sharing data to improve public health, and to discuss potential actions to guide future work related to public health research data sharing. Sharing Research Data to Improve Public Health in Africa summarizes the presentations and discussions from this workshop.
Author: Institute of Medicine
Author: Institute of Medicine
Author: Carolyn Adams
Author: Sen, Devjani
Author: Agency for Healthcare Research and Quality/AHRQ
Author: Institute of Medicine
Author: Marius Fieschi
Author: Khaled El Emam
Author: National Research Council
Author: Institute of Medicine
Author: National Academies of Sciences, Engineering, and Medicine