The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics
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Oocyte donation raises conflicts of interest and commitment for physicians but little attention has been paid to how to reduce these conflicts in practice. Yet the growing popularity of assisted reproduction has increased the stakes of maintaining an adequate oocyte supply and (where appropriate) minimizing conflicts. A growing body of professional guidelines, legal challenges to professional self-regulation, and empirical research on the practice of oocyte donation all call for renewed attention to the issue. ⋯ We then describe studies on conflicts at four phases of oocyte donation: recruitment, screening, stimulation, and post-stimulation monitoring. Next we consider three models for conflict reduction in medicine generally: improved professional self-regulation, outright restriction like Stark anti-referral laws, or the use of conflict mediators, like in living organ donation. We ultimately conclude that improved professional self-regulation is a reasonable starting place for oocyte donation.
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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.