Hot Topics: Health Regulation & Law

Blog Posts (103)

January 30, 2018

The Fine Line Between Living and Dead

by Craig Klugman, Ph.D.

Traditionally, a determination of death can only be made by a physician or by a health care provider (including first responder) if there is evidence of brain matter leakage or the head is severed from the body.…

January 20, 2018

45 Administration Provides New HCP Protections|Permits HCPs to Discriminate

by Lori Bruce, MA

News broke this week that the U.S. Department of Health and Human Services is creating a new “Conscience and Religious Freedom Division” (CRFD) in the Office for Civil Rights.…

January 9, 2018

Blindness Cure Is Out of Sight

by Craig Klugman, Ph.D.

The FDA has approved the world’s first gene therapy: Luxturna (voretigene neparvovec; AAV2-hRPE65v2) is a one-time intervention that can treat an inherited retinal disease (RPE65-mediated inherited retinal dystrophy).…

December 12, 2017

Tax Acts of 2017: Big Changes to Health Care and Education May Be Coming

by Craig Klugman, Ph.D.

As you may be aware, the U.S. House and U.S. Senate are in conference over a major tax bill.…

October 12, 2017

The Rescinding of DACA: What Should Healthcare Professionals and Academics Do? (And Why?)

by Mark G. Kuczewski, Ph.D. Danish Zaidi, MTS, MBE

Imagine that the 14th Amendment is repealed. Suddenly, birthright citizenship is no longer the accepted law of the United States.…

October 6, 2017

BioethicsTV (October 2-6, 2017): Communication Issues and Assisting Suicide

by Craig Klugman, Ph.D.

The Good Doctor (Season 1; Episode 2); Communication (lying, stealing credit; keeping silent)

This week’s episode of this new drama was about communication, specifically on the topic of lying.…

September 22, 2017

Another (Un)Health Care Bill Forced onto Us

tby Craig Klugman, Ph.D.

Americans still tend to think of human rights violations as abridgments of free speech and religion, and extreme crimes against humanity, such as slavery, torture, and arbitrary detention.

September 8, 2017

Harvey and Irma: Bioethics in Natural Disasters

by Craig Klugman, Ph.D.

This is a time of disaster. Last week Hurricane Harvey devastated Southeast Texas, a place where I did my doctoral studies.…

August 29, 2017

Taking Patient Autonomy Out of the DNR

by Craig Klugman, Ph.D.

The Texas government has passed SB 11 an act “relating to general procedures and requirements for certain do-not-resuscitate orders; creating a criminal offense.” As of April 1, 2018, one can be jailed for offenses involving DNR orders.  …

August 4, 2017

The Age of Designed Babies Arrives

by Craig Klugman, Ph.D.

In the film Gattaca, a couple desiring to have a child visits their neighborhood geneticist:

Geneticist: You have specified hazel eyes, dark hair and fair skin.

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Published Articles (30)

AJOB Primary Research: Volume 8 Issue 4 - Dec 2017

Ethical and regulatory challenges of research using pervasive sensing and other emerging technologies: IRB perspectives Camille Nebeker, John Harlow, Rebeca Espinoza Giacinto, Rubi Orozco-Linares, Cinnamon S. Bloss & Nadir Weibel

AJOB Neuroscience: Volume 8 Issue 1 - Mar 2017

tDCS Research in a World With FDA Regulation Patricia J. Zettler

AJOB Primary Research: Volume 8 Issue 3 - Sep 2017

Physician understanding and application of surrogate decision-making laws in clinical practice Amber Rose Comer, Margaret Gaffney, Cynthia L. Stone & Alexia Torke

American Journal of Bioethics: Volume 17 Issue 9 - Sep 2017

Now is the Time for a Postracial Medicine: Biomedical Research, the National Institutes of Health, and the Perpetuation of Scientific Racism Javier Perez-Rodriguez & Alejandro de la Fuente

American Journal of Bioethics: Volume 17 Issue 7 - Jul 2017

The Final Rule: When the Rubber Meets the Road P. Pearl O'Rourke

American Journal of Bioethics: Volume 17 Issue 7 - Jul 2017

Examining Provisions Related to Consent in the Revised Common Rule Jeremy Sugarman

American Journal of Bioethics: Volume 17 Issue 7 - Jul 2017

Rethinking the Belmont Report? Phoebe Friesen, Lisa Kearns, Barbara Redman & Arthur L. Caplan

American Journal of Bioethics: Volume 17 Issue 7 - Jul 2017

A Proposed Process for Reliably Updating the Common Rule Benjamin E. Berkman, David Wendler, Haley K. Sullivan & Christine Grady

American Journal of Bioethics: Volume 17 Issue 7 - Jul 2017

At Last! Aye, and There's the Rub Alexander M. Capron

American Journal of Bioethics: Volume 17 Issue 7 - Jul 2017

Modernizing Research Regulations Is Not Enough: It's Time to Think Outside the Regulatory Box Suzanne M. Rivera, Kyle B. Brothers, R. Jean Cadigan, Heather L. Harrell, Mark A. Rothstein, Richard R. Sharp & Aaron J. Goldenberg

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News (205)

December 22, 2017 9:00 am

Ohio bill would prohibit abortions in Down syndrome cases (CNN)

The bill prohibits abortions after tests reveal Down syndrome in a fetus or if there’s “any other reason to believe” the fetus has the genetic condition. A person performing an abortion in such a case could face a fourth-degree felony charge, and physicians could lose their licenses. The woman seeking the abortion would not be held accountable, according to the bill.

December 12, 2017 9:00 am

Regulations Amending the Food and Drug Regulations (Public Release of Clinical Information) (Government of Canada)

Without access to detailed clinical data, health professionals and researchers are unable to perform independent analyses of the evidence underlying published research findings and Health Canada’s regulatory reviews. This approach limits transparency and misses opportunities to promote greater confidence in the oversight of drugs and medical devices. It is also out of step with Health Canada’s key regulatory partners, including the European Medicines Agency (EMA) and the U.S. Food and Drug Administration, which have increased clinical data transparency over the past 10 years.

November 9, 2017 9:00 am

Infusions of young blood tested in patients with dementia (Nature)

The first controlled, but controversial and small, clinical trial of giving young blood to people with dementia has reported that the procedure appears safe. It has also hinted that it may even produce modest improvements in the daily lives of people who have Alzheimer’s disease.

October 30, 2017 9:00 am

Special Report: U.S. company makes a fortune selling bodies donated to science (Reuters)

McDonald’s and Kroc got rich selling hamburgers. Science Care and Rogers have made millions from human body parts. From 2012 through 2014, Rogers and his co-owner, wife Josie, parlayed the donated dead into at least $12.5 million in earnings, according to Internal Revenue Service audits and court documents reviewed by Reuters.

October 11, 2017 9:00 am

Is it easier to buy guns than Sudafed? (CNN)

“It is harder in America to buy two packs of Sudafed than 10 assault rifles,” comedian D.L. Hughley said on his radio show Monday, the day after a gunman opened fire on a concert crowd in Las Vegas.

September 7, 2017 9:00 am

Massive Ebola data site planned to combat outbreaks (Nature)

More than 11,000 people died when Ebola tore through West Africa between 2014 and 2016, and yet clinicians still lack data that would enable them to reliably identify the disease when a person first walks into a clinic. To fill that gap and others before the next outbreak hits, researchers are developing a platform to organize and share Ebola data that have so far been scattered beyond reach.

August 16, 2017 9:00 am

Commit to talks on patient data and public health (Nature)

Of course it was going to happen — and now it has. Last week, an international team reported the use of CRISPR–Cas9 gene-editing techniques to correct a heart-wrenching mutation in human embryos. These attempts worked several times more efficiently than previous ones had, and avoided introducing new genetic errors. Although the embryos were never destined to be used for pregnancies (and have now been destroyed), the work — carried out mainly in the United States — makes it easy to foresee practical applications to genetically alter human embryos.

August 11, 2017 9:00 am

CRISPR fixes disease gene in viable human embryos (Nature)

An international team of researchers has used CRISPR–Cas9 gene editing — a technique that allows scientists to make precise changes to genomes with relative ease — to correct a disease-causing mutation in dozens of viable human embryos. The study represents a significant improvement in efficiency and accuracy over previous efforts.

July 19, 2017 9:00 am

British baby Charlie Gard to be evaluated by US doctor (CNN Health)

Baby Charlie Gard, the 11-month-old with a rare, terminal medical condition who has been the center of an ongoing legal battle, will be evaluated by a doctor from the United States. Charlie will be examined early this week, in London, by Dr. Michio Hirano, a neurologist at New York’s Columbia University Medical Center.

July 10, 2017 9:00 am

How Canadian researchers reconstituted an extinct poxvirus for $100,000 using mail-order DNA (Science)

A group led by virologist David Evans of the University of Alberta in Edmonton, Canada, says it has synthesized the horsepox virus, a relative of smallpox, from genetic pieces ordered in the mail. Horsepox is not known to harm humans—and like smallpox, researchers believe it no longer exists in nature; nor is it seen as a major agricultural threat. But the technique Evans used could be used to recreate smallpox, a horrific disease that was declared eradicated in 1980.

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