Examining Federal Regulation of Mobile Medical Apps and Other Health Software

Examining Federal Regulation of Mobile Medical Apps and Other Health Software PDF Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Publisher:
ISBN:
Category : Application software
Languages : en
Pages : 128

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Examining Federal Regulation of Mobile Medical Apps and Other Health Software

Examining Federal Regulation of Mobile Medical Apps and Other Health Software PDF Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Publisher:
ISBN:
Category : Application software
Languages : en
Pages : 128

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Book Description


Activity Report of the Committee on Energy and Commerce of the U.S. House of Representatives ... Together with Dissenting Views

Activity Report of the Committee on Energy and Commerce of the U.S. House of Representatives ... Together with Dissenting Views PDF Author: United States. Congress. House. Committee on Energy and Commerce
Publisher:
ISBN:
Category : Energy policy
Languages : en
Pages : 136

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Legislative Calendar

Legislative Calendar PDF Author: United States. Congress. Senate. Committee on Homeland Security and Governmental Affairs
Publisher:
ISBN:
Category :
Languages : en
Pages : 492

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FDA in the Twenty-First Century

FDA in the Twenty-First Century PDF Author: Holly Fernandez Lynch
Publisher: Columbia University Press
ISBN: 0231540078
Category : Business & Economics
Languages : en
Pages : 499

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Book Description
In its decades-long effort to assure the safety, efficacy, and security of medicines and other products, the Food and Drug Administration has struggled with issues of funding, proper associations with industry, and the balance between consumer choice and consumer protection. Today, these challenges are compounded by the pressures of globalization, the introduction of novel technologies, and fast-evolving threats to public health. With essays by leading scholars and government and private-industry experts, FDA in the Twenty-First Century addresses perennial and new problems and the improvements the agency can make to better serve the public good. The collection features essays on effective regulation in an era of globalization, consumer empowerment, and comparative effectiveness, as well as questions of data transparency, conflicts of interest, industry responsibility, and innovation policy, all with an emphasis on pharmaceuticals. The book also intervenes in the debate over off-label drug marketing and the proper role of the FDA before and after a drug goes on the market. Dealing honestly and thoroughly with the FDA's successes and failures, these essays rethink the structure, function, and future of the agency and the effect policy innovations may have on regulatory institutions abroad.

Congressional Record

Congressional Record PDF Author: United States. Congress
Publisher:
ISBN:
Category : Law
Languages : en
Pages : 1538

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Book Description
The Congressional Record is the official record of the proceedings and debates of the United States Congress. It is published daily when Congress is in session. The Congressional Record began publication in 1873. Debates for sessions prior to 1873 are recorded in The Debates and Proceedings in the Congress of the United States (1789-1824), the Register of Debates in Congress (1824-1837), and the Congressional Globe (1833-1873)

Congressional Record, Daily Digest of the 113th Congress, First Session Volume 159 - Part 15

Congressional Record, Daily Digest of the 113th Congress, First Session Volume 159 - Part 15 PDF Author:
Publisher:
ISBN:
Category :
Languages : en
Pages : 606

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Digital Health Care Outside of Traditional Clinical Settings

Digital Health Care Outside of Traditional Clinical Settings PDF Author: I. Glenn Cohen
Publisher: Cambridge University Press
ISBN: 1009373242
Category : Law
Languages : en
Pages : 229

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Book Description
Examines the ethical, legal, and regulatory impacts of digital diagnostics and other products on health care outside of clinical settings.

Registries for Evaluating Patient Outcomes

Registries for Evaluating Patient Outcomes PDF Author: Agency for Healthcare Research and Quality/AHRQ
Publisher: Government Printing Office
ISBN: 1587634333
Category : Medical
Languages : en
Pages : 385

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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.

An Examination of Emerging Bioethical Issues in Biomedical Research

An Examination of Emerging Bioethical Issues in Biomedical Research PDF Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309676630
Category : Medical
Languages : en
Pages : 133

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Book Description
On February 26, 2020, the Board on Health Sciences Policy of the National Academies of Sciences, Engineering, and Medicine hosted a 1-day public workshop in Washington, DC, to examine current and emerging bioethical issues that might arise in the context of biomedical research and to consider research topics in bioethics that could benefit from further attention. The scope of bioethical issues in research is broad, but this workshop focused on issues related to the development and use of digital technologies, artificial intelligence, and machine learning in research and clinical practice; issues emerging as nontraditional approaches to health research become more widespread; the role of bioethics in addressing racial and structural inequalities in health; and enhancing the capacity and diversity of the bioethics workforce. This publication summarizes the presentations and discussions from the workshop.

Hearing Health Care for Adults

Hearing Health Care for Adults PDF Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309439264
Category : Medical
Languages : en
Pages : 325

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Book Description
The loss of hearing - be it gradual or acute, mild or severe, present since birth or acquired in older age - can have significant effects on one's communication abilities, quality of life, social participation, and health. Despite this, many people with hearing loss do not seek or receive hearing health care. The reasons are numerous, complex, and often interconnected. For some, hearing health care is not affordable. For others, the appropriate services are difficult to access, or individuals do not know how or where to access them. Others may not want to deal with the stigma that they and society may associate with needing hearing health care and obtaining that care. Still others do not recognize they need hearing health care, as hearing loss is an invisible health condition that often worsens gradually over time. In the United States, an estimated 30 million individuals (12.7 percent of Americans ages 12 years or older) have hearing loss. Globally, hearing loss has been identified as the fifth leading cause of years lived with disability. Successful hearing health care enables individuals with hearing loss to have the freedom to communicate in their environments in ways that are culturally appropriate and that preserve their dignity and function. Hearing Health Care for Adults focuses on improving the accessibility and affordability of hearing health care for adults of all ages. This study examines the hearing health care system, with a focus on non-surgical technologies and services, and offers recommendations for improving access to, the affordability of, and the quality of hearing health care for adults of all ages.