Hot Topics: Health Regulation & Law

Blog Posts (116)

December 12, 2018

Hospitals Selling Patient Records To Data Brokers: A Violation of Patient Trust and Autonomy

by Craig Klugman, Ph.D.

I recently received an email from a community organization which asked the following question: “Are there any ethical issues with our community health plan selling its medical records to a private company?” This is not an example of a new occurrence.…

December 4, 2018

Deregulating Anti-Kickback: More Than A Kick in Patients’ Wallets.

by Craig Klugman, Ph.D.

Federal kickback rules state that a pharmaceutical manufacturer or medical device producer cannot pay providers or patients to recommend or prescribe their products.…

November 27, 2018

Open Letter to Trump, Whitaker and Nielsen: Give safe passage to legal asylum seekers

“A group of ethicists, public health and health policy experts, healthcare providers, and lawyers has composed an open letter to President Donald J.
November 27, 2018

Birth of Twins from Embryo Editing Raise Ethical, Legal, and Social Issues

Updated November 28 at 8:30am EST

by Craig Klugman, Ph.D.

The film GATTACA turned 20 years old this year. The premise of that film is a society where DNA is viewed as predictive of everything: Your intelligence, physical abilities, your health, even how long you will live.…

November 15, 2018

#InMyLane: Gun Violence and an Ethical Health Care Response

by Craig Klugman, Ph.D.

Since January 1, 2018 through November 15, the United States has seen 311 mass shootings that have killed 339 people and injured 1,249.…

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.

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Published Articles (41)

American Journal of Bioethics: Volume 18 Issue 11 - Nov 2018

Just Policy? An Ethical Analysis of Early Intervention Policy Guidance Ibrahim Garba, Leila Barraza & Elizabeth Hall-Lipsy

AJOB Primary Research: Volume 9 Issue 3 - Nov 2018

Reliance agreements and single IRB review of multisite research: Concerns of IRB members and staff Charles W. Lidz, Ekaterina Pivovarova, Paul Appelbaum, Deborah F. Stiles, Alexandra Murray & Robert L. Klitzman

AJOB Primary Research: Volume 9 Issue 3 - Nov 2018

Data and tissue research without patient consent: A qualitative study of the views of research ethics committees in New Zealand Angela Ballantyne & Andrew Moore

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

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News (240)

December 14, 2018 11:43 am

Gene editing: who should decide? (Nature)

Last month’s announcement claiming the birth of the world’s first genome-edited babies has sparked a furore over how to regulate this cutting-edge technology (see Nature 563, 607–608; 2018, and Nature564, 5; 2018). In our view, piling up scientist-led conferences modelled on Asilomar in 1975 (see Nature 526, 293–294; 2015) without any clear consensus is futile.

December 13, 2018 9:15 am

Trump administration halts study that would use fetal tissue ‘to discover a cure for HIV’ (The Washington Post)

The shutdown of the HIV research at the federal lab in Montana, first reported in Science, was never disclosed publicly by government officials, who have forbidden affected researchers from discussing what happened. But colleagues say they are incensed by the action, which has fanned a controversy that pits the biomedical research community against antiabortion activists and other social conservatives pressing the administration to stop the flow of federal grants and contracts for work involving fetal tissue. Such tissue comes from elective abortions.

December 11, 2018 9:15 am

The CRISPR Baby Scandal Gets Worse by the Day (The Atlantic)

Before last week, few people had heard the name He Jiankui. But on November 25, the young Chinese researcher became the center of a global firestorm when it emerged that he had allegedly made the first crispr-edited babies, twin girls named Lulu and Nana. Antonio Regalado broke the story for MIT Technology Review, and He himself described the experiment at an international gene-editing summit in Hong Kong. After his talk, He revealed that another early pregnancy is under way.

It is still unclear if He did what he claims to have done. Nonetheless, the reaction was swift and negative. The crispr pioneer Jennifer Doudna says she was “horrified,” NIH Director Francis Collins said the experiment was “profoundly disturbing,” and even Julian Savulescu, an ethicist who has described gene-editing research as “a moral necessity,” described He’s work as “monstrous.”

December 9, 2018 12:47 pm

Why Are Scientists So Upset About the First Crispr Babies? (The New York Times)

A Chinese scientist recently claimed he had produced the world’s first gene-edited babies, setting off a global firestorm. If true — the scientist has not yet published data that would confirm it — his actions would be a sensational breach of international scientific conventions. Although gene editing holds promise to potentially correct dangerous disease-causing mutations and treat some medical conditions, there are many safety and ethical concerns about editing human embryos.

Here are answers to some of the numerous questions swirling around this development.

December 8, 2018 10:15 am

Microsoft calls for laws to prevent facial recognition AI from hurting consumers (The LA Times)

Microsoft Corp. called for new legislation to govern artificial intelligence software for recognizing faces, advocating for human review and oversight of the technology in crucial cases.

“This includes where decisions may create a risk of bodily or emotional harm to a consumer, where there may be implications on human or fundamental rights, or where a consumer’s personal freedom or privacy may be impinged,” Microsoft’s president and chief legal officer, Brad Smith, wrote in a blog post published Thursday in conjunction with a speech on the topic at the Brookings Institution think tank.

December 5, 2018 9:15 am

Genetically Modified People Are Walking Among Us (The New York Times)

It felt as if humanity had crossed an important line: In China, a scientist named He Jiankui announced on Monday that twins had been born in November with a gene that he had edited when they were embryos.

But in some ways this news is not new at all. A few genetically modified people already walk among us.

December 2, 2018 9:00 am

Battle Against Ebola in Congo Pits Medical Hope Against Local Chaos (The New York Times)

A vaccine and new treatments are on hand, but the outbreak is in an area rife with unpredictable gunfire, bandits and suspicion of outsiders.

November 30, 2018 11:59 am

China Halts Work by Scientist Who Says He Edited Babies’ Genes (New York Times)

BEIJING — China said on Thursday that it had suspended the work of a scientist who claims to have created the world’s first genetically edited babies, saying his conduct appeared to be unethical and in violation of Chinese law.

The scientist, He Jiankui, announced on Monday that he had used the gene-editing technique Crispr to alter embryos, which he implanted in the womb of a woman who gave birth to twin girls this month. At an international conference on Wednesday, he asserted that he was proud of what he had done.

November 28, 2018 9:15 am

Outbreak Culture: The Ebola Crisis and the Next Epidemic (The Washington Post)

When Ebola broke out in West Africa in 2014, it spread with dizzying speed — and outwitted responders. By the time the epidemic ended in 2016, more than 28,000 people had been infected and 11,325 had died. It didn’t have to be that way, write Pardis Sabeti and Lara Salahi. In “Outbreak Culture: The Ebola Crisis and the Next Epidemic,” they uncover the chaos behind the world’s response to the 2014-2016 Ebola outbreak, and posit how it could have been avoided.

November 27, 2018 9:15 am

Task Force Calls for Offering PrEP to All at High Risk for H.I.V. (The New York Times)

An influential government task force has drafted a recommendationthat would for the first time urge doctors to offer a daily prophylactic pill to patients who are at risk for contracting H.I.V. The recommendation would include all men and women whose sexual behavior, sex partners or drug use place them at high risk of contracting the virus that causes AIDS.

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