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The genetic testing of minors within the direct-to-consumer (DTC) genetic testing (GT) context has been given relatively little attention. The issue of testing healthy children for diseases that would only develop in adulthood raises many important ethical, legal and social issues. As genetic testing is now available outside of the traditional health care system, often without even the intermediate of a health care professional, we surveyed 37 DTC GT companies regarding their policies for testing in children. Although the response rate is relatively low (35%, 13/37), our findings reveal that a clear majority of companies do perform genetic testing in minors. As such, companies testing for adult onset diseases are acting in contradiction of established professional guidelines, which state, among others, that, for predictive genetic testing, the availability of therapeutic or preventive measures is necessary for testing to be performed in asymptomatic minors. The community of stakeholders in children's health care and genetic testing should, therefore, decide which standards need to be upheld by DTC GT companies and ensure that these are met.

Context: There is a widespread belief that the US health care system needs to move \"from volume to value.\" This transformation to value (eg, quality divided by cost) is conceptualized as a two-fold movement: (1) from fee-for-service to alternative payment models; and (2) from solo practice and freestanding hospitals to medical homes, accountable care organizations, large hospital systems, and organized clinics like Kaiser Permanente. Methods: We evaluate whether this transformation is happening quickly, shifting risk to providers, lowering costs, and improving quality. We draw on recent evidence on provider payment and organization and their effects on cost and quality. Findings: Data suggest a low prevalence of provider risk payment models and slow movement toward new payment and organizational models. Evidence suggests the impact of both on cost and quality is weak. Conclusions: We need to be patient in expecting system improvements from ongoing changes in provider payment and organization. We also may need to look for improvements in other areas of the economy or to accept and accommodate prospects of modest improvements over time.

There has been a dramatic spread of market relationships in many low- and middle-income countries. This spread has been much faster than the development of the institutional arrangements to influence the performance of health service providers. In many countries poor people obtain a large proportion of their outpatient medical care and drugs from informal providers working outside a regulatory framework, with deleterious consequences in terms of the safety and efficacy of treatment and its cost. Interventions that focus only on improving the knowledge of these providers have had limited impact. There is a considerable amount of experience in other sectors with interventions for improving the performance of markets that poor people use. This paper applies lessons from this experience to the issue of informal providers, drawing on the findings of studies in Bangladesh and Nigeria. These studies analyse the markets for informal health care services in terms of the sources of health-related knowledge for the providers, the livelihood strategies of these providers and the institutional arrangements within which they build and maintain their reputation. The paper concludes that there is a need to build a systematic understanding of these markets to support collaboration between key actors in building institutional arrangements that provide incentives for better performance.

For more than three decades the field of biotechnology has had an extraordinary impact on science, health care, law, the regulatory environment, and business. During this time more than 260 novel biotechnology products were approved for over 230 indications. Global sales of these products exceeded $175 billion in 2013 and have helped sustain a vibrant life sciences sector that includes more than 4,600 biotech companies worldwide. In this article we examine the evolution of biotechnology during the past three decades and the profound impact that it has had on health care through four interrelated and interdependent tracks: innovations in science, government activity, business development, and patient care. The future impact of biotechnology is promising, as long as the public and private sectors continue to foster policies and provide funds that lead to scientific breakthroughs; governments continue to offer incentives for private-sector biotech innovation; industry develops business models for cost-effective research and development; and all stakeholders establish policies to ensure that the therapeutic advances that mitigate or cure medical conditions that currently have inadequate or no available therapies are accessible to the public at a reasonable cost.

Somatic gene editing (SGE) holds great promise for making genetic therapy possible for many monogenic conditions very soon. Is our current system of European market authorization and reimbursement ready for the expected tsunami of gene therapies? At a recent workshop of the Netherlands ZonMw consortium on ethical, legal, and social implications of personalized medicine, we discussed the current possibilities for bringing new gene therapies to the clinic. In Europe, it is not yet clear whether the route via the European medicines agency as an advanced therapy medicinal product is the most appropriate for evaluation of highly personalized SGE applications, although this may optimally guarantee safety and effectiveness. Compassionate use may ensure faster access than the centralized procedure but does not stimulate the commercial development of products. Prescription to named patients may only provide adequate access for single patients. Temporary authorization of use may allow access to medication half a year before formal market authorization has been granted, but may also have large budget impacts. Magistral compounding under a hospital exemption may be an attractive solution for rare, tailor-made applications at an acceptable price. To approve local experimental use of a therapy on a case-by-case basis may be fast, but does not guarantee optimal safety, effectiveness, and broad implementation. We argue that alternative routes should be considered for products developed for a market of large groups of patients versus unique personalized treatments. A balance between scientific evidence for safety and effectiveness, affordability, and fast access may demand a range of alternative solutions.

To assess whether organisations that develop health care guidelines have conflict of interest (COI) policies and to review the content of the available COI policies. Survey and content analysis of COI policies available in English, French, Spanish, and Italian conducted between September 2014 and June 2015. A 24-item data abstraction instrument was created on the basis of guideline development standards. The survey identified 29 organisations from 19 countries that met the inclusion criteria. From these organisations, 19 policies were eligible for inclusion in the content analysis. Over one-third of the policies (7/19, 37%) did not report or did not clearly report whether disclosure was a prerequisite for membership of the guideline panel. Strategies for the prevention of COI such as divestment were mentioned by only two organisations. Only 21% of policies (4/19) used criteria to determine whether an interest constitutes a COI and to assess the severity of the risk imposed. The finding that some organisations, in contradiction of widely available standards, still do not have COI policies publicly available is concerning. Also troubling were the findings that some policies did not clearly report critical steps in obtaining, managing and communicating disclosure of relationships of interest. This in addition to the variability encountered in content and accessibility of COI policies may cause confusion and distrust among guideline users. It is in the interest of guideline users and developers to design an agreed-upon, comprehensive, clear, and accessible COI policy.

The One Big Beautiful Bill Act (OBBBA) contains$1.3 trillion cuts in funding to federal healthcare programs—including $ 1 trillion cuts to Medicaid and $300 billion cuts to the Supplemental Nutrition Assistance Program (SNAP)—mandating a significant response from the US healthcare system. Important responses to this sweeping legislation include an update of strategic and capital planning, optimization of revenue cycle management, labor and the supply chain, and development of new sources of nonoperating revenue to support the organization’s mission. The OBBBA represents a movement toward a market-based healthcare system in which healthcare organizations must become less dependent on third-party reimbursement and more reliant on disposable spending, nonoperating revenue, and market-based demand.

In 2016, the Office of the State Coroner of New South Wales released its report into the death of an Australian woman, Sheila Drysdale, who had died from complications of an autologous stem cell procedure at a Sydney clinic. In this report, we argue that Mrs Drysdale's death was avoidable, and it was the result of a pernicious global problem of an industry exploiting regulatory systems to sell unproven and unjustified interventions with stem cells.

Communication-and-resolution programs (CRPs) in health care organizations seek to identify medical injuries promptly; ensure that they are disclosed to patients compassionately; pursue timely resolution through patient engagement, explanation, and, where appropriate, apology and compensation; and use lessons learned to improve patient safety. CRPs have existed for years, but they are being tested in new settings and primed for broad implementation through grants from the Agency for Healthcare Research and Quality. These projects do not require changing laws. However, grantees' experiences suggest that the path to successful dissemination of CRPs would be smoother if the legal environment supported them. State and federal policy makers should try to allay potential defendants' fears of litigation (for example, by protecting apologies from use in court), facilitate patient participation (for example, by ensuring access to legal representation), and address the reputational and economic concerns of health care providers (for example, by clarifying practices governing National Practitioner Data Bank reporting and payers' financial recourse following medical error). [PUBLICATION ABSTRACT]

US health care is in ferment. Private entities are merging, aligning, and coordinating in a wide array of configurations. At the same time, there is a great deal of policy change. This includes the federal government's Affordable Care Act, as well as actions by Medicare, state legislatures, and state agencies. The health system is built upon markets, which determine how (and how well) goods and services are delivered to consumers, so it is critical that these markets work as well as possible. As the primary federal antitrust enforcement agencies, the Federal Trade Commission and the Department of Justice are charged with ensuring that health care markets operate well, but they are not alone. The functioning of health care markets is also profoundly affected by other parts of the federal government (notably the Centers for Medicare and Medicaid Services) and by state legislation and regulation. In this current period of such dynamic change, it is particularly important for the antitrust agencies to continue and enhance their communication and coordination with other government agencies as well as to maintain vigilant antitrust enforcement and consumer protection in health care markets.US health care is in ferment. Private entities are merging, aligning, and coordinating in a wide array of configurations. At the same time, there is a great deal of policy change. This includes the federal government's Affordable Care Act, as well as actions by Medicare, state legislatures, and state agencies. The health system is built upon markets, which determine how (and how well) goods and services are delivered to consumers, so it is critical that these markets work as well as possible. As the primary federal antitrust enforcement agencies, the Federal Trade Commission and the Department of Justice are charged with ensuring that health care markets operate well, but they are not alone. The functioning of health care markets is also profoundly affected by other parts of the federal government (notably the Centers for Medicare and Medicaid Services) and by state legislation and regulation. In this current period of such dynamic change, it is particularly important for the antitrust agencies to continue and enhance their communication and coordination with other government agencies as well as to maintain vigilant antitrust enforcement and consumer protection in health care markets.