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Atlantic Salmon in Maine - Committee On Atlantic Salmon In Maine - Bog - National Academies Press - Plusbog.dk

Perspectives on Essential Health Benefits - Institute Of Medicine - Bog - National Academies Press - Plusbog.dk

Perspectives on Essential Health Benefits - Institute Of Medicine - Bog - National Academies Press - Plusbog.dk

The Patient Protection and Affordable Care Act (herein known as the Affordable Care Act [ACA]) was signed into law on March 23, 2010. Several provisions of the law went into effect in 2010 (including requirements to cover children up to age 26 and to prohibit insurance companies from denying coverage based on preexisting conditions for children). Other provisions will go into effect during 2014, including the requirement for all individuals to purchase health insurance. In 2014, insurance purchasers will be allowed, but not obliged, to buy their coverage through newly established health insurance exchanges (HIEs)--marketplaces designed to make it easier for customers to comparison shop among plans and for low and moderate income individuals to obtain public subsidies to purchase private health insurance. The exchanges will offer a choice of private health plans, and all plans must include a standard core set of covered benefits, called essential health benefits (EHBs). The Department of Health and Human Services requested that the Institute of Medicine (IOM) recommend criteria and methods for determining and updating the EHBs. In response, the IOM convened two workshops in 2011 where experts from federal and state government, as well as employers, insurers, providers, consumers, and health care researchers were asked to identify current methods for determining medical necessity, and share decision-making approaches to determining which benefits would be covered and other benefit design practices. Essential Health Benefits summarizes the presentations in this workshop. The committee's recommendations will be released in a subsequent report.

DKK 292.00
1

Understanding the Benefits and Risks of Pharmaceuticals - Board On Health Sciences Policy - Bog - National Academies Press - Plusbog.dk

Understanding the Benefits and Risks of Pharmaceuticals - Board On Health Sciences Policy - Bog - National Academies Press - Plusbog.dk

All pharmaceutical products have inherent risks, and their use involves trade-offs between their therapeutic benefits and their risks. However, the public has a limited understanding of the benefits and risks of drugs, and many individuals believe that drugs approved by the U.S. Food and Drug Administration (FDA) carry no risks. The FDA is responsible for evaluating and balancing the potential risks of drugs with their potential benefits. Assessing, managing, and communicating the benefit-risk profile of a pharmaceutical product is a complex and nuanced scientific, political, and sociological challenge. Once the assessment is made, the FDA is then responsible for managing how to communicate these risks and make healthcare decisions based on them. To explore these issues, the Forum on Drug Discovery, Development, and Translation conducted a public workshop entitled Understanding the Benefits and Risks of Pharmaceuticals, with the broad goals of gaining a better understanding of the current system used to evaluate benefit and risk, and to identify opportunities for improvement. This workshop was held in Washington, D.C., on May 30-31, 2006. The benefit-risk profiles of pharmaceuticals are constantly evolving as new data are collected throughout the life cycle of a drug. Discussions during the workshop focused on the following: (1) premarket assessment, during which clinical trial data are used to assess benefit and risk; (2) communication of that information to prescribing physicians and their patients; (3) healthcare decisions made by prescribing physicians and their patients; and (4) the accumulation of benefit-risk information from postmarketing experience, which feeds back into the other phases. Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary explains in detail the discussions during this workshop.

DKK 208.00
1

Genetic Status of Atlantic Salmon in Maine - Ocean Studies Board - Bog - National Academies Press - Plusbog.dk

Assessing Equity in the Distribution of Fisheries Management Benefits - Committee On Assessing Equity In The Distribution Of Fisheries Management

Essential Health Benefits - Board On Health Care Services - Bog - National Academies Press - Plusbog.dk

Essential Health Benefits - Board On Health Care Services - Bog - National Academies Press - Plusbog.dk

In 2010, an estimated 50 million people were uninsured in the United States. A portion of the uninsured reflects unemployment rates; however, this rate is primarily a reflection of the fact that when most health plans meet an individual's needs, most times, those health plans are not affordable. Research shows that people without health insurance are more likely to experience financial burdens associated with the utilization of health care services. But even among the insured, underinsurance has emerged as a barrier to care. The Patient Protection and Affordable Care Act (ACA) has made the most comprehensive changes to the provision of health insurance since the development of Medicare and Medicaid by requiring all Americans to have health insurance by 2016. An estimated 30 million individuals who would otherwise be uninsured are expected to obtain insurance through the private health insurance market or state expansion of Medicaid programs. The success of the ACA depends on the design of the essential health benefits (EHB) package and its affordability. Essential Health Benefits recommends a process for defining, monitoring, and updating the EHB package. The book is of value to Assistant Secretary for Planning and Evaluation (ASPE) and other U.S. Department of Health and Human Services agencies, state insurance agencies, Congress, state governors, health care providers, and consumer advocates.

DKK 344.00
1

Evaluating Testing, Costs, and Benefits of Advanced Spectroscopic Portals - National Research Council - Bog - National Academies Press - Plusbog.dk

Evaluating Testing, Costs, and Benefits of Advanced Spectroscopic Portals - National Research Council - Bog - National Academies Press - Plusbog.dk

This letter is the abbreviated version of an update of the interim report on testing, evaluation, costs, and benefits of advanced spectroscopic portals (ASPs), issued by the National Academies' Committee on Advanced Spectroscopic Portals in June 2009 (NRC 2009). This letter incorporates findings of the committee since that report was written, and it sharpens and clarifies the messages of the interim report based on subsequent committee investigations of more recent work by the Domestic Nuclear Detection Office (DNDO). The key messages in this letter, which is the final report from the committee, are stated briefly in the synopsis on the next page and described more fully in the sections that follow. The committee provides the context for this letter, and then gives advice on: testing, evaluation, assessing costs and benefits, and deployment of advanced spectroscopic portals. The letter closes with a reiteration of the key points. The letter is abbreviated in that a small amount of information that may not be released publicly for security or law-enforcement reasons has been redacted from the version delivered to you in October 2010, but the findings and recommendations remain intact. Table of ContentsFront MatterLetter ReportReferencesAttachment 1 The Joint Explanatory Statement and the Statement of TaskAttachment 2 Evaluating Testing, Costs, and Benefits of Advanced Spectroscopic Portals for Screening Cargo at Ports of Entry INTERIM REPORTAttachment 3 Committee on Advanced Spectroscopic Portals Roster and Brief BiographiesAttachment 4 Nuclear and Radiation Studies BoardAttachment 5 Reviewers

DKK 72.00
1

Potential Risks and Benefits of Gain-of-Function Research - National Research Council - Bog - National Academies Press - Plusbog.dk

Potential Risks and Benefits of Gain-of-Function Research - National Research Council - Bog - National Academies Press - Plusbog.dk

On October 17, 2014, spurred by incidents at U.S. government laboratories that raised serious biosafety concerns, the United States government launched a one-year deliberative process to address the continuing controversy surrounding so-called "gain-of-function" (GOF) research on respiratory pathogens with pandemic potential. The gain of function controversy began in late 2011 with the question of whether to publish the results of two experiments involving H5N1 avian influenza and continued to focus on certain research with highly pathogenic avian influenza over the next three years. The heart of the U.S. process is an evaluation of the potential risks and benefits of certain types of GOF experiments with influenza, SARS, and MERS viruses that would inform the development and adoption of a new U.S. Government policy governing the funding and conduct of GOF research. Potential Risks and Benefits of Gain-of-Function Research is the summary of a two-day public symposia on GOF research. Convened in December 2014 by the Institute of Medicine and the National Research Council, the main focus of this event was to discuss principles important for, and key considerations in, the design of risk and benefit assessments of GOF research. Participants examined the underlying scientific and technical questions that are the source of current discussion and debate over GOF research involving pathogens with pandemic potential. This report is a record of the presentations and discussion of the meeting. Table of ContentsFront Matter1 Introduction2 Assessing Risks and Benefits3 Gain-of-Function Research: Background and Alternatives4 Potential Benefits of Gain-of-Function Research5 Potential Risks: Biosafety and Biosecurity6 Policy ImplicationsReferencesAppendix A: Key Issues for Risk/Benefit Assessment for Gain-of-Function ResearchAppendix B: Committee BiographiesAppendix C: AgendaAppendix D: Speaker BiographiesAppendix E: List of AttendeesAppendix F: Acronym List

DKK 292.00
1

Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products - Institute Of Medicine - Bog -

Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products - Institute Of Medicine - Bog -

Despite the extensive body of evidence that informs regulatory decisions on pharmaceutical products, significant uncertainties persist, including the underlying variability in human biology, factors associated with the chemistry of a drug, and limitations in the research and clinical trial process itself that might limit the generalizability of results. As a result, regulatory reviewers are consistently required to draw conclusions about a drug's safety and efficacy from imperfect data. Efforts are underway within the drug development community to enhance the evaluation and communication of the benefits and risks associated with pharmaceutical products, aimed at increasing the predictability, transparency, and efficiency of pharmaceutical regulatory decision making. Effectively communicating regulatory decisions necessarily includes explanation of the impact of uncertainty on decision making. On February 12 and May 12, 2014, the Institute of Medicine's Forum on Drug Discovery, Development, and Translation held public workshops to advance the development of more systematic and structured approaches to characterize and communicate the sources of uncertainty in the assessment of benefits and risks, and to consider their implications for pharmaceutical regulatory decisions. Workshop presentations and discussions on February 12 were convened to explore the science of identifying and characterizing uncertainty in scientific evidence and approaches to translate uncertainties into decisions that reflect the values of stakeholders. The May 12 workshop presentations and discussions explored tools and approaches to communicating about scientific uncertainties to a range of stakeholders in the drug development process. Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products summarizes the presentation and discussion of both events. This report explores potential analytical and communication approaches and identifies keyconsiderations on their development, evaluation, and incorporation into pharmaceutical benefit-risk assessment throughout the entire drug development lifecycle. Table of ContentsFront Matter1 Introduction2 Identifying and Characterizing Uncertainty3 The Regulators' Challenge4 Basic Methodologies and Applications for Understanding and Evaluating Uncertainty5 Communicating Uncertainty6 Final Reflections on Ways to Characterize and Communicate UncertaintyReferencesAppendix A: Workshop AgendaAppendix B: FDA Case StudiesAppendix C: BibliographyAppendix D: Participant Biographies

DKK 305.00
1

The Power of Video Technology in International Comparative Research in Education - Division Of Behavioral And Social Sciences And Education - Bog -

Informing Social Security's Process for Financial Capability Determination - Board On The Health Of Select Populations - Bog - National Academies

Informing Social Security's Process for Financial Capability Determination - Board On The Health Of Select Populations - Bog - National Academies

The U.S. Social Security Administration (SSA) provides benefits to disabled adults and children, offering vital financial support to more than 19 million disabled Americans. Of that group, approximately 5.5 million have been deemed – by virtue of youth or mental or physical impairment – incapable of managing or directing the management of their benefits. Hence, a representative payee has been appointed to receive and disburse SSA payments for these beneficiaries to ensure that their basic needs for shelter, food, and clothing are met. Periodically, however, concerns have been expressed about the accuracy of the process by which SSA determines whether beneficiaries are capable of managing their benefits, with some evidence suggesting that underdetection of incapable recipients may be a particular problem. The importance of creating as accurate a process as possible for incapability determinations is underscored by the consequences of incorrectly identifying recipients either as incapable when they can manage their benefits or as capable when they cannot. Failure to identify beneficiaries who are incapable of managing their funds means abandoning a vulnerable population to potential homelessness, hunger, and disease. Informing Social Security's Process for Financial Capability Determination considers capability determination processes used by other similar benefit programs, abilities required to manage, and direct the management of, benefits, and effective methods and measures for assessing capability. This report evaluates SSA's capability determination process for adult beneficiaries and provides recommendations for improving the accuracy and efficiency of the agency's policy and procedures for making these determinations. Table of ContentsFront MatterSummary1 Introduction2 Review of the Social Security Administration and Other Selected Capability Determination Processes3 Effects of Appointment of Representative Payees on Beneficiaries4 Abilities Required to Manage and Direct the Management of Benefits5 Methods and Measures for Assessing Financial Competence and Performance6 Conclusions and RecommendationsAppendix A: Public Session AgendasAppendix B: GlossaryAppendix C: Selected FormsAppendix D: Biographical Sketches of Committee Members

DKK 331.00
1