Earlier this year, the American Academy of Pediatrics (AAP) and
the American College of Medical Genetics and Genomics
(ACMG) issued recommendations and proposed best practices for
genetic testing and screening of infants and children. In Ethical
and Policy Issues in Genetic Testing and Screening of Children, the
AAP and ACMG reviewed the scenarios in which genetic testing or
screening of minors may occur and recommended best practices
for such testing (See post of
March 4, 2013 for a review of the report). The University
of California, South Francisco (UCSF) and UC Berkeley recently announced a pilot project that will study and
address several issues raised but by the AAP and ACMG, and in
particular, whether large-scale gene sequencing to detect disorders
and conditions should be performed routinely for newborns. The
study is one of four projects supported by the National Institutes
of Health (NIH) to evaluate the accuracy and feasibility of
conducting genetic sequencing along side current newborn screening
that relies on biochemical analysis. The study will also evaluate
what additional information would be useful to have at birth and
the ethics and public interest in conducting newborn genetic
The UCSF and Berkeley study will focus on the sequencing the
exome (the portion of the genome that encode proteins) and its
potential to identify disorders that California currently includes
in newborn screening. The study also will evaluate what additional
disorders should be included in newborn screening, for
example the disorders for which early intervention would
be beneficial. In addition to prospective studies, the group in
partnership with the California Department of Public Health, will
conduct genetic analysis of blood collected from 1,400 children who
received conventional newborn screening. The results will be
compared to determine if genetic analysis of the samples is more
accurate than conventional biochemical analysis.
In addition to collecting and analyzing the data, the group also
will develop a participant protection framework for conducting
genomic sequencing during infancy and will explore legal issues
related to using genome analysis in newborn screening programs.
Similar NIH-supported studies are being conducted by Brigham and
Women's Hospital in Boston, Children's Mercy Hospital in
Kansas City, and the University of North Carolina at Chapel
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
To print this article, all you need is to be registered on Mondaq.com.
Click to Login as an existing user or Register so you can print this article.
Remember how Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), dismissed the §510k "substantially equivalence" medical device clearance as non-preemptive because it was supposedly "focused on equivalence, not safety"? Id. at 493.
The US Food and Drug Administration (FDA) related portions of the 21st Century Cares Act, found in title III, establish a streamlined process for the exemption of certain Class I and II devices from the premarket notification requirement and allow for the establishment of revised regulatory standards for accessories to high-risk devices.
Hospitals are commonly named as defendants in medical malpractice lawsuits for claims arising from alleged injuries within their walls, but what is their exposure to liability for claims that arise from alleged sexual assaults by staff on their premises?
Eric Fader was quoted in a November 9 article, "Incoming Trump Administration May Mean Less Funding for HIPAA Audits," in Bloomberg BNA's Health Care Fraud Report. Eric said that the incoming Trump administration may eventually be forced to reduce funding for some healthcare initiatives to pay for other priorities, such as large tax cuts and increased spending on the military.
Title III of the 21st Century Cures Act includes portions of the FDA Device Accountability Act of 2015, Promoting Biomedical Research and Public Health for Patients Act, and FDA and NIH Workforce Authorities Modernization Act.
A February 2 article in Bloomberg BNA's Privacy Law Watch and other publications, "Hospital Hit With $3.2M Penalty for Ongoing Health Data Security Lapses," reported that Children's Medical Center of Dallas received a $3.2 million civil money penalty after years of noncompliance with HIPAA rules and after failing to request a hearing on the penalty.
The 21st Century Cures Act includes portions of the Helping Families in Mental Health Crisis Reform Act of 2016, which was approved by the US House of Representatives in July 2016, but not advanced by the Senate.
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).