The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics
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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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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.
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Public health emergencies implicate difficult decisions among medical and emergency first responders about how to allocate essential resources. While various actors have proffered approaches on how to make these tough choices, meaningful guidance on shifting standards of care in major emergencies remained lacking. In March 2012, the Institute of Medicine (IOM) released additional guidance to assist facilities and practitioners to address scarce resource allocation through the development of "crisis standards of care" in catastrophes. As discussed in the article, identifying and resolving of complex practical, ethical, and legal challenges underlying real-time implementation of these standards are indispensable to protecting the public's health.
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Today, opiate-based prescription painkillers account for significant morbidity and mortality in the U. S. According to the Centers for Disease Control and Prevention, prescription painkiller overdose has reached epidemic proportions over the past decade. ⋯ Since 2007, states have increasingly used their authority to address inappropriate prescribing. State strategies to address this complex problem have included: establishing and strengthening prescription drug monitoring programs, regulating pain management facilities, and establishing dosage thresholds above which a consult with a pain specialist is required. With chronic pain affecting at least 116 million adults in the United States, it will also be important to evaluate the impact these policies are having on legitimate access to pain care.
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Opioid overdose is the leading cause of accidental injury death in the United States, taking the lives of over 16,000 Americans every year. Many of those deaths are preventable through the timely provision of naloxone, a drug that reliably and effectively reverses opioid overdose. ⋯ Preliminary evidence suggests that amending those laws to encourage the prescription and use of naloxone will reduce opioid overdose deaths, and a number of states have done so in the past several years. Since legal amendments designed to facilitate naloxone access have no documented negative effects, can be implemented at little or no cost, and have the potential to save both lives and resources, states that have not passed them may benefit from doing so.