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12/07/2018 - 10:59am

Nature editors write, "The claims from He Jiankui that he has used gene editing to produce twin girls demand action. A new registry of research is a good start"

12/07/2018 - 10:59am

A recent report for the patient safety and justice charity, AvMA (Action against Medical Accidents) identifies some short comings in the way the NHS statutory duty of candor is regulated. The report is not all doom and gloom, however. Some improvements are also noted.

The statutory duty of candor

The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: Regulation 20 is the relevant law here. The statutory duty of candor is designed to ensure that health providers are open and transparent with people who use services and other ‘relevant persons’ (people acting lawfully on their behalf) in general in relation to care and treatment. The NHS Health and Social Care regulator, the Care Quality Commission (CQC) regulates the statutory duty of candor.

The CQC describe the duty:

“Providers must promote a culture that encourages candor, openness and honesty at all levels. This should be an integral part of a culture of safety that supports organizational and personal learning. There should also be a commitment to being open and transparent at board level, or its equivalent such as a governing body.”(p8).

The CQC can prosecute for breach of Regulation 20 in accordance with their enforcement policy or can take other regulatory action.

Duty of candor reporting standards-2017 inspections

Whilst the CQC has improved in their inspection and reporting on compliance with the duty of candour, issues remain such as making recommendations to address candour issues.

Issues of implementation and non-compliance

Since 2015 NHS trusts (hospitals) have improved in how they implement the duty of candor provisions but there are still problems with compliance. The report makes several improvement recommendations.

Staff training

To properly implement the statutory duty of candor, NHS hospital staff must firstly be aware of the concept.

Categorization of incidents

CQC Inspectors found varied application of the duty of candor within hospitals. Triggering events for the duty of candor to come into effect can range from death to moderate harm or psychological harm. During inspections, CQC inspectors weren’t always assured that incidents were correctly categorized as triggering the duty.

Inspections and monitoring

The quality of inspections and the detail of the analysis in the CQC inspector’s reports were found to be varied highlighting the need for a standardized approach by CQC inspectors.

The CQC found that many hospitals lacked systems or where they had them, they were inadequate to monitor the application of the statutory duty of candor.

Active implementation of the duty of candor

Some good NHS hospital duty of candor implementation practices was found. Most hospitals have a duty of candor policy. Many use electronic reporting systems to record and monitor duty of candor compliance

CQC enforcement action

The report found that the CQC had used its statutory enforcement powers 108 times against providers who were not fully compliant with the duty of candor. The report notes that no examples were given at all for 2016.

The CQC according to the report, have no idea as to how many individual allegations about organizational breaches of the duty of candor it receives. Also, no system in place to ensure that allegations, indicating serious breaches are dealt with. The CQC are also weak on publicizing that it is taking breach of the duty of candor enforcement action.

The report makes several recommendations to the CQC on how it can improve its duty of candor regulation. It points to a significant improvement in the way the CQC regulates the statutory duty of candor. NHS hospitals can also be seen to be improving on the application of the duty. There are however problems identified in several key areas which must be addressed.


The post Regulating the Statutory Duty of Candor in the NHS appeared first on Bill of Health.

12/07/2018 - 10:46am

The case for and against CRISPR IVF clinics opening in the US. With comments from our Jeffrey Kahn

12/07/2018 - 9:49am

In early October, the Department of Homeland Security published a proposed redefinition of the Immigrant and Nationality Act’s “public charge” provision, stirring serious concern among health-care and immigrant advocacy groups.

The “public charge” provision of the INA currently allows immigration officers to deny green cards to legal immigrants who are likely to become “primarily dependent on the government for subsistence.”

DHS’s proposed rule would widen the scope of “public charge” to include any legal immigrant who uses cash or non-cash government benefits. In expanding the scope of the public charge inadmissibility determinations, DHS would empower immigration officers to consider immigrants’ current or prior use of programs like Medicaid and SNAP in evaluating applications.

(As a side-note, the public comment period for the proposed rule ends in a matter of days. Comments can be submitted through the federal register here.)

If enacted as a final rule, the redefinition of “public charge” would likely have a significant effect on immigrant health care utilization. News outlets have noted that the proposed rule, alone, has had a chilling effect on Medicaid participation among immigrants. Politico, for instance, reported that a number of agencies have seen drops of “up to 20 percent” in enrollment. Declines in participation are particularly troubling because Medicaid plays an important role in many immigrants’ access to care. Lawful immigrants are more likely to be low-income and less likely to receive health insurance through employers, and public insurance fills the gap.

It is also possible that the proposed rule could have expressive effects that deter health-care utilization among immigrants more broadly. In one of the courses I am taking at the Harvard School of Public Health, we learned about a study of health care utilization among Mexican-origin adolescent mothers before and after the Arizona legislature passed SB 1070. SB 1070, which empowered Arizona law enforcement to stop and question individuals under a “reasonable suspicion” that the individual was in the country illegally, was denounced by many as legalized racial profiling of immigrants.

The study showed that SB 1070 may have had reverberating social effects well beyond the sphere of law enforcement. Specifically, the authors found significant disparities in health care utilization among Mexican-origin adolescent mothers before and after the passage of SB 1070.

Strikingly, this effect was even stronger for study participants who were U.S. citizens. The authors suggest this finding shows that SB 1070 “is likely associated with heightened perceptions of fear and lack of community safety, even among Mexican-origin adolescent mothers who are US citizens.” They also point to the possibility that the U.S.-born mothers saw the law as a “moral violation” signaling a discriminatory social climate. Even though these study participants were not the intended subjects of the law, they changed their behavior in response to its message.

This study comports with theories of “expressive law.”

Scholars like Cass Sunstein have written about the messaging effects of laws on those subject to them. Laws and regulations like SB 1070 and DHS’s proposed public charge rule may send a broader statement to immigrants that they are not welcome to participate in the U.S. social system.

The expressive effects of the proposed public charge rule may thus change the health-seeking behavior even among those who would otherwise be unaffected by the substance of the rule.


Alexandra Slessarev is a 2018-2019 Petrie-Flom Center Student Fellow

The post Public Charge and the Expressive Effects of Immigration Law appeared first on Bill of Health.

12/07/2018 - 7:40am

The global scientific community has been unanimous in condemning Chinese scientist He Jiankui, who announced last week that he used the gene-editing technology called CRISPR to make permanent, heritable changes to the genes of two baby girls who were born this month in China. Criticism has focused on He’s violation of worldwide acknowledgement that CRISPR… Read more

The post CRISPR in China: Why Did the Parents Give Consent? appeared first on The Hastings Center.

12/07/2018 - 3:00am

Here are some of the challenges that have been articulated in meetings and in the hotel bars in Havana this week.

1. We must get more precise and accurate in how we determine death by neurological criteria. We are presently allowing false positives. T...

12/07/2018 - 3:00am

Here are some of the challenges that have been articulated in meetings and in the hotel bars in Havana this week.

2. We should ensure that the clinicians conducting the DDNC test are qualified. This can be done through institutional credentialing or through other vetting processes....

12/06/2018 - 10:44pm

By Jon Holmlund   This past Tuesday, the Presidential Symposium at the 2018 Annual Meeting of the American Society of Hematology (ASH) addressed human gene editing.  The speakers included NIH Director Dr. Francis Collins, who spoke about somatic gene editing.  That’s the attempt to edit disease-causing genes in existing, fully formed individuals who have the …

Continue reading "Human Embryos as Raw Materials"

12/06/2018 - 1:53pm

The University of North Carolina Chapel Hill proposed to relocate a statue known as “Silent Sam” to a new University History and Education Center. The statue was originally dedicated in 1913 to honor students who died fighting for the Confederacy and became a “lighting rod” for protests in the year following the Charlottesville riots. It […]

12/06/2018 - 11:11am

Researchers hope that by probing the immune system, they can determine why children are developing a polio-like disease