The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics
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Concussion in sports is a topic that is receiving increasing amounts of publicity and attention. Increasing recognition of concussion as well as improving understanding of the short- and long-term physiologic effects of concussion have resulted in widespread legislation governing the recognition and treatment of sports concussion. The increasing amount of medical research in the field and oftentimes subjective symptoms of concussion leave many ethical questions to be answered.
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Under the Physician Payment Sunshine Act (PPSA), payments to physicians from pharmaceutical, biologics, and medical device manufacturers will be disclosed on a national, publicly available website. To inform the development of the federal website, we evaluated 21 existing state and industry disclosure websites. ⋯ These findings raise questions about the intended audience and aims of the PPSA disclosure database and expected outcomes of the law. Based on our evaluation, we offer recommendations for the national website and discuss implications of this policy for the health care system.
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Next generation sequencing raises new questions within the context of an existing and still evolving regulatory landscape for device manufacturers and clinical laboratories. FDA cleared the first NGS sequencing platform in November 2013, but it is unclear what lies ahead for this technology. NGS will require new types of training and expertise to interpret the vast quantities of genetic data so as to provide meaningful clinical information to physicians and patients. This paper will describe the current regulatory landscape for NGS technologies, identify the regulatory challenges they present, and consider whether new regulatory paradigms are needed to accommodate NGS technologies and services.
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This paper defends the right not to know personal health information, while it discards the right of research participants to receive individual research results. Disagreement regarding the right not to know stems from two different conceptions of autonomy, leading to opposing normative conclusions. Researchers occasionally have good reason to inform research participants about incidental findings in spite of the absence of a right to know such information. Such decisions have to be made by health care personnel and researchers on a case by case basis, although external support for the decisions may be available.
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The dialogue about the future of health care in the US has been impeded by flawed conceptions about medicine and business. The present paper re-examines some of the underlying assumptions about both medicine and business, and uses more nuanced readings of both terms to frame debates about the ACA and the emerging health care environment.