Human rights violations in organ procurement practice in China

BMC Medical Ethics 2017 18:11
Authors: Norbert W. Paul, Arthur Caplan, Michael E. Shapiro, Charl Els, Kirk C. Allison, Huige Li
“Over 90% of the organs transplanted in China before 2010 were procured from prisoners. Although Chinese officials announced in December 2014 that the country would completely cease using organs harvested from prisoners, no regulatory adjustments or changes in China’s organ donation laws followed. As a result, the use of prisoner organs remains legal in China if consent is obtained.”
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Weak Reporting System Let Risky Surgical Device Stay in Use

NYT Health, 8 February 2017
Author: Denise Grady
“Doctors and hospitals failed to tell the Food and Drug Administration about cases in which cancer was spread around inside women’s bodies by a surgical tool used to operate on the uterus, according to a report issued on Wednesday by the Government Accountability Office.”
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A New Day For Oversight Of Human Subjects Research

Health Affairs Blog, 6 February 2017
Author: Holly Fernandez Lynch
“On January 19, 2017—President Obama’s last day in office—the Federal Register published a Final Rule to amend the Federal Policy for the Protection of Human Subjects, the set of regulations applicable to most human subjects research conducted or supported with federal funds, and more typically referred to as the “Common Rule.” This rule change had been a long time coming, with an Advance Notice of Proposed Rule Making (ANPRM) published in July 2011 and a Notice of Proposed Rule Making (NPRM) published in September 2015. The seriousness of its impact on the research community, patients, and the public is evidenced by the more than 3,300 public comments submitted during the rulemaking process. So what changed?”
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Remote monitoring of medical devices in Australia

Med J Aust 2017; 206 (2): 62-63
Authors: Bradley Wilsmore, James Leitch
“The collection, storage and distribution of remote monitoring information by industry are not clearly regulated. Regulation is complex, given all current industry providers have offshore servers and local distribution of data. While some companies have adopted a worldwide information security management system standard (ISO 27001), regulation has been company dependent and the current system is largely self-regulated by industry at the local level. This raises further issues and may exacerbate the potential for a conflict of interest regarding industry involvement.”
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Inspectors’ ethical challenges in health care regulation: a pilot study

Med Health Care and Philos (2017). doi:10.1007/s11019-016-9736-z p1-20
Authors: Seekles, W., Widdershoven, G., Robben, P. et al.
“There is an increasing body of research on what kind of ethical challenges health care professionals experience regarding the quality of care. In the Netherlands the Dutch Health Care Inspectorate is responsible for monitoring and regulating the quality of health care. No research exists on what kind of ethical challenges inspectors experience during the regulation process itself. In a pilot study we used moral case deliberation as method in order to reflect upon inspectors’ ethical challenges. The objective of this paper is to give an overview of the ethical challenges which health care inspectors encounter in their daily work.”
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Exclusive: Canada seeks warnings on prescription painkillers amid rising deaths

Reuters, 23 January 2017
Author: Anna Mehler Paperny
“As deaths from powerful painkillers continue to rise, Canada is pursuing unprecedented measures to curb their use, including requiring cigarette-style warning stickers on every prescription, Health Minister Jane Philpott told Reuters.”
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Directing Discipline: State Medical Board Responsiveness to State Legislatures

Journal of Health Politics, Policy and Law 2017 Volume 42, Number 1: 123-165
Authors: Denise F. Lillvis, Robert J. McGrath
“State medical boards are increasingly responsible for regulating medical and osteopathic licensure and professional conduct in the United States. Yet, there is great variation in the extent to which such boards take disciplinary action against physicians, indicating that some boards are more zealous regulators than others. We look to the political roots of such variation and seek to answer a simple, yet important, question: are nominally apolitical state medical boards responsive to political preferences?”
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Mitochondrial Donation — Clearing the Final Regulatory Hurdle in the United Kingdom

NEJM, 28 December 2016
Authors: Mary Herbert, Doug Turnbull
“No other IVF-based technique has undergone the intense scrutiny that has been applied to mitochondrial donation. This is, in part, because of the ethical and regulatory issues that are unique to this technique. In the United Kingdom, mitochondrial donation — which is both critical and central to this IVF-based technique — required a change in the law. Scientific progress in this area has also been a focus of the U.S. National Academy of Medicine at the request of the Food and Drug Administration.”
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Drugmakers await FDA guidance on ‘off-label’ uses of medicines

The Hill, 19 December 2016
Author: Sarah Chacko
“Doctors commonly prescribe drugs to treat conditions the medications weren’t designed for, but for drugmakers, discussing such “off-label” uses can lead to trouble. As a result, drugmakers have been pushing both the Food and Drug Administration and lawmakers to draw clearer lines around communicating about unapproved uses of their products, particularly since it affects what companies can tell insurers. Such information is used to negotiate prices for covered medical products and their place in certain payment models.”
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