Hot Topics: Health Regulation & Law

Blog Posts (111)

October 16, 2018

Sunset on the RAC: When is it time to end special oversight of an emerging biotechnology?

by Jeffrey P. Kahn, Ph.D., M.P.H. and Anna C. Mastroianni, J.D., M.P.H.

National Institutes of Health Director (NIH) Francis S. Collins and Food and Drug Administration Commissioner Scott Gottlieb recently co-authoreda New England Journal of Medicinecommentary suggesting that special oversight of gene transfer research in humans was no longer necessary.…

October 9, 2018

A Little Dab Will Do Ya: Fact and Fiction of the Radiation Debate

by Craig Klugman, Ph.D.

My father tells the story of how when he was a child, shoe stores had boxes into which you could slide your feet, shod in potential new shoes.…

September 27, 2018

Investigative Genealogy: Guilty by Familial Association

by Craig Klugman, Ph.D.

This week I was on a panel discussing the topic of genealogical searchingrunning a DNA sample found at a crime scene against criminal, public and commercial DNA databases with the goal of not finding a suspect, but to find a relative of the suspect.…

September 7, 2018

RACeing to Deregulate: Can We Afford Less Oversight of Gene Transfer Research?

by Craig Klugman, Ph.D.

 “As gene therapy continues to change, so must the federal framework set up to oversee it.”-Francis Collins & Scott Gottlieb

In one of his first acts of office, Trump ordered executive agencies to reduce regulations.…

August 7, 2018

Popular Insurance Pre-Existing Conditions Ban Under Threat

by Craig Klugman, Ph.D.

Do you have pre-existing health conditions? Approximately 23 percent of Americans do.

According to the University of Pittsburgh Medical Center, a pre-existing condition is “a medical condition that occurred before a program of health benefits went into effect.

July 1, 2018

Confusion and Conscientious Objection in Arizona

by Steven H. Miles, MD and Arthur Caplan, Ph.D.

Nicole Mone Arteaga was trying to get pregnant. It had been difficult for her.…

May 31, 2018

Targeted Medicine: Advertising to the Medically Vulnerable

by Craig Klugman, Ph.D.

Imaging going to the doctor and suddenly finding ads popping up on your phone. Perhaps there’s a discount for receiving a specialized treatment.…

April 4, 2018

Rise of Neopaternalism

by Craig Klugman, Ph.D.

This week I was teaching autonomy and paternalism to my Introduction to Bioethics class. We talked about how one of the founding myths of bioethics is that we saved patients from paternalistic medicine by forcing a turn to autonomy: Instead of being objects on which doctors did medicine, we became subjects with whom doctors worked to heal.…

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.…

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Published Articles (38)

AJOB Neuroscience: Volume 18 Issue 3 - Sep 2018

Neurointerventions: Punishment, Mental Integrity, and Intentions Peter Vallentyne

American Journal of Bioethics: Volume 18 Issue 9 - Sep 2018

The Ethics of Smart Pills and Self-Acting Devices: Autonomy, Truth-Telling, and Trust at the Dawn of Digital Medicine Craig M. Klugman, Laura B. Dunn, Jack Schwartz & I. Glenn Cohen

American Journal of Bioethics: Volume 18 Issue 8 - Aug 2018

Ethical Considerations in the Manufacture, Sale, and Distribution of Genome Editing Technologies Jeremy Sugarman, Supriya Shivakumar, Martha Rook, Jeanne F. Loring, Christoph Rehmann-Sutter, Jochen Taupitz, Jutta Reinhard-Rupp & Steven Hildemann

American Journal of Bioethics: Volume 18 Issue 7 - Jul 2018

Provider Conscientious Refusal of Abortion, Obstetrical Emergencies, and Criminal Homicide Law Lawrence Nelson

American Journal of Bioethics: Volume 18 Issue 4 - Apr 2018

Building a Trustworthy Precision Health Research Enterprise David Magnus & Jason N. Batten

AJOB Neuroscience: Volume 9 Issue 1 - Mar 2018

Disorders of Consciousness, Agency, and Health Care Decision Making: Lessons From a Developmental Model Megan S. Wright, Claudia Kraft, Michael R. Ulrich & Joseph J. Fins

AJOB Primary Research: Volume 8 Issue 1 - Mar 2018

Same behavior, different provider: American medical students' attitudes toward reporting risky behaviors committed by doctors, nurses, and classmates Sahil Aggarwal & Aaron Kheriaty

American Journal of Bioethics: Volume 18 Issue 3 - Mar 2018

Ethical Dilemmas in Protecting Susceptible Subpopulations From Environmental Health Risks: Liberty, Utility, Fairness, and Accountability for Reasonableness David B. Resnik, D. Robert MacDougall & Elise M. Smith

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

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News (215)

October 20, 2018 9:00 am

The culprit’s name remains unknown. But he licked a stamp, and now his DNA stands indicted. (The Washington Post)

There was just enough spit on the back of the 9-cent stamp to piece together the identity of the person who licked it. Everything except for his name.

August 28, 2018 9:00 am

Officials remove special rules for gene therapy experiments (SF Gate)

U.S. health officials are eliminating special regulations for gene therapy experiments, saying that what was once exotic science is quickly becoming an established form of medical care with no extraordinary risks. A special National Institutes of Health oversight panel will no longer review all gene therapy applications and will instead take on a broader advisory role…

August 17, 2018 1:26 am

The Next Phase of Human Gene-Therapy Oversight (The New England Journal of Medicine)

The NIH envisions using the RAC as an advisory board on to- day’s emerging biotechnologies, such as gene editing, synthetic bi- ology, and neurotechnology, while harnessing the attributes that have long ensured its transparency. We at the NIH and the FDA look for- ward to working together with all our stakeholders to implement thesechanges.Wesharecommon goals: advancing science and hu- man health and accelerating the availability of safe and effective gene therapy, along with the many promising new products that fu- ture biotechnologies may bring.

August 2, 2018 6:31 am

What Is a Genetically Modified Crop? A European Ruling Sows Confusion (The New York Times)

Mushrooms that don’t brown. Wheat that fights off disease. Tomatoes with a longer growing season. All of these crops are made possible by a gene-editing technology called Crispr-cas9. But now its future has been clouded by the European Union’s top court. This week, the court ruled that gene-edited crops are genetically modified organisms, and therefore must comply with the tough regulations that apply to plants made with genes from other species. Many scientists responded to the decision with dismay, predicting that countries in the developing world would follow Europe’s lead, blocking useful gene-edited crops from reaching farms and marketplaces. The ruling may also curtail exports from the United States, which has taken a more lenient view of gene-edited foods.

July 30, 2018 3:00 am

European court ruling raises hurdles for CRISPR crops (Science)

Hopes for an easier regulatory road for genetic engineering in European agriculture were dashed today by the Court of Justice of the European Union. In a closely watched decision, the court ruled that plants created with new gene-editing techniques that don’t involve transferring genes between organisms—such as CRISPR—must go through the same lengthy approval process as traditional transgenic plants.

July 19, 2018 12:29 pm

Arizona law would give frozen embryos to spouse who wants baby after divorce (CBS News)

A controversial new Arizona law that took effect July 1 would give Torres access to the embryos. The law requires courts to give embryos to the spouse who plans to use them to have a baby when a couple decides to have a divorce. Supporters of the law say it will protect a partner’s right to his or her embryos. Opponents say it could force people to become parents against their will.

July 18, 2018 9:09 am

Are 'breakthrough' drugs as safe as other FDA-approved medicines? (CNN)

New research questions the quality of drugs given the “breakthrough therapy” designation by the US Food and Drug Administration. In late 2012, the FDA created this designation to speed the process for reviewing not-yet-approved experimental medicines intended to treat serious or life-threatening conditions.

May 14, 2018 9:00 am

As lab-grown meat advances, U.S. lawmakers call for regulation (Science)

Lab-grown chicken, beef, and duck products are edging toward the U.S. market—despite enduring confusion about how they’ll be regulated. But language buried in a draft spending bill released by a U.S. House of Representatives appropriations panel this week suggests some lawmakers are eager to get rules in place. A one-sentence proposal in the bill would put the U.S. Department of Agriculture (USDA) in charge of regulating products made from the cells of livestock or poultry, and instructs the agency to issue rules about how it will oversee their manufacture and labeling.

April 20, 2018 9:00 am

Why doctors don’t use alternatives to opioids (The New York Times)

As Congress deliberates how to respond to the surging opioid epidemic, a number of bills have been introduced to support the development and Food and Drug Administration approval of a non-opioid pain medication. But the problem in American medicine is not a lack of alternatives to opioids, but the minimal utilization of the many non-opioid treatments for pain that already exist.

April 3, 2018 6:46 pm

California Supreme Court lets stand controversial law allowing DNA collection upon arrest (The Los Angeles Times)

For years civil libertarians hoped to end California’s practice of taking DNA from people arrested on suspicion of a felony and storing that genetic information in an offender database — regardless of whether the suspects were later acquitted or had their charges dropped. That fight for more protective rules in the government’s DNA collection suffered a major setback Monday when the California Supreme Court let stand a provision of a 2004 voter initiative that said any adult arrested or charged with a felony must give up his or her DNA.

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