Undermining Genetic Privacy? Employee Wellness Programs and the Law

NEJM, 24 May 2017
Authors: Kathy L. Hudson, Karen Pollitz
“Genetic information is becoming ubiquitous in research and medicine. The cost of genetic analysis continues to fall, and its medical and personal value continues to grow. Anticipating this age of genetic medicine, policymakers passed laws and regulations years ago to protect Americans’ privacy and prevent misuse of their health-related information. But a bill moving through the House of Representatives, called the Preserving Employee Wellness Programs Act (H.R. 1313), would preempt key protections. Because the bill, which was sent to the full House by the Education and the Workforce Committee in March, would substantially change legal protections related to the collection and treatment of personal health and genetic information by workplace wellness programs, it should be on the radar screens of physicians, researchers, and the public.”
Find article here.

State Sepsis Mandates — A New Era for Regulation of Hospital Quality

NEJM, 21 May 2017
Authors: Tina B. Hershey, Jeremy M. Kahn
“Sepsis is a major cause of illness and death in the United States, affecting more than 1.5 million Americans each year at an annual cost of over $20 billion. To improve outcomes of sepsis, policymakers are increasingly using regulatory mechanisms intended to provide incentives to clinicians and hospitals to improve the quality of sepsis care. One such initiative is an unprecedented set of New York State regulations implemented in 2013 and collectively known as “Rory’s Regulations.” Named after Rory Staunton, who died at 12 years of age from sepsis resulting from a soft-tissue infection, Rory’s Regulations mandate that all hospitals in the state use evidence-based protocols for sepsis identification and management and that they report to the state government data on their sepsis-protocol adherence and clinical outcomes.”
Find article here.

Responsible advertising of health services: Practitioners reminded about their legal obligations on advertising

AHPRA, 21 April 2017
“The National Boards and the Australian Health Practitioner Regulation Agency (AHPRA) published a strategy for the National Scheme today to help keep health service consumers safe from misleading advertising. The Advertising compliance and enforcement strategy for the National Scheme explains how National Boards and AHPRA will manage advertising complaints and compliance, including the regulatory powers available to deal with breaches of the National Law.”
Find media release and strategy here.

California Has A Deadly Problem With Regulating Naturopathic Doctors

Forbes, 24 April 2017
Author: Britt Marie Hermes
“Since there is no “naturopathic standard of care,” a point that the committee acknowledged in 2009 and that critics of the regulation of naturopathy have noticed too, naturopathic expert reviewers must make ad hoc determinations that are likely to deviate from the medical consensus and fail to establish lasting precedent. For some influential naturopathic doctors, the standard of care includes anything taught in naturopathic school or done by two or more practitioners.”
Find article here.

Revamping the US Federal Common Rule: Modernizing Human Participant Research Regulations

JAMA. 2017;317(15):1521-1522
Authors: James G. Hodge Jr; Lawrence O. Gostin
“On January 19, 2017, the Office for Human Research Protections (OHRP), Department of Health and Human Services, and 15 federal agencies published a final rule to modernize the Federal Policy for the Protection of Human Subjects (known as the “Common Rule”). Initially introduced more than a quarter century ago, the Common Rule predated modern scientific methods and findings, notably human genome research.”
Find article here.

More than 800 women sue NHS and manufacturers over vaginal mesh implants

The Guardian, 19 April 2017
Author: Hannah Devlin
“Some women reported that implants had cut into their vaginas, with one woman saying she was left in so much pain that she considered suicide. Others have been left unable to walk or have sex, according to the BBC. However, the medical regulator said that the best current evidence supports the continued use of mesh implants to resolve health conditions that could themselves cause serious distress to patients.”
Find article here.

A critique of the regulation of data science in healthcare research in the European Union

BMC Medical Ethics 2017 18:27
Authors: John M. M. Rumbold, Barbara K. Pierscionek
“The EU offers a suitable milieu for the comparison and harmonisation of healthcare across different languages, cultures, and jurisdictions (albeit with a supranational legal framework), which could provide improvements in healthcare standards across the bloc. There are specific ethico-legal issues with the use of data in healthcare research that mandate a different approach from other forms of research. The use of healthcare data over a long period of time is similar to the use of tissue in biobanks. There is a low risk to subjects but it is impossible to gain specific informed consent given the future possibilities for research. Large amounts of data on a subject present a finite risk of re-identification.”
Find article here.

Medical devices face tougher premarket testing under new EU laws

BMJ 2017; 357: j1870
Author: Deborah Cohen
“The European Parliament has passed new legislation to tighten regulation of medical devices that will require high risk devices, such as hip implants, to undergo more premarket testing and assessment. European device regulation has come in for criticism after a series of high profile failures—including hip replacements, breast implants, and pelvic meshes—that have resulted in harm to patients.”
Find article here.

The Deadly Business of an Unregulated Global Stem Cell Market

BMJ Blog, 30 March 2017
Authors: Tereza Hendl, Tamra Lysaght
“In our paper, we report on the case of a 75-year old Australian woman who died in December 2013 from complications of an autologous stem cell procedure. This case was tragic and worth reporting to the medical ethics community because her death was entirely avoidable and the result of a pernicious global problem – doctors exploiting regulatory systems in order to sell unproven and unjustified stem cell interventions.”
Find article here.

NG v Chinese Medicine Board of Australia [2017] NSWCATOD 36

Decision date: 15 March 2017
“PROFESSIONS AND TRADES – Where health practitioner has appealed against conditions placed on her registration – where the Chinese Medical Board concedes an error in imposing conditions and has caused removal of conditions from the Register maintained by the Australian Health Practitioner Regulation Agency –
Whether appeal is frivolous or vexatious or misconceived or lacking in substance – Consideration of objects of Civil and Administrative Tribunal Act 2013 (NSW) and of the Health Practitioner Regulation National Law – whether dismissal of appeal would deny appellant procedural fairness. Where continuation of appeal will not result in a practical outcome.”
Find case here.