Hot Topics: Health Regulation & Law

Blog Posts (89)

April 17, 2017

A Bioethics View of Executions in Arkansas

by Craig Klugman, Ph.D.

This week the state of Arkansas had planned to execute 8 death-row inmates in 4, back-to-back killings using lethal injection over 10 days.…

April 5, 2017

Internet Privacy and Health Portals: Why I Won’t Be Contacting My Doctor Online

by Craig Klugman, Ph.D.

Part of the Affordable Care Act was an effort to increase efficiency in sharing and storing health data through electronic health records.…

March 22, 2017

Texas Considers Letting Doctors Lie to Patients

by Craig Klugman, Ph.D.

The Texas Senate just passed a new bill (SB 25) that would shield doctors from a lawsuit if a baby is born with a disability even if the doctor knew of the concern and chose not to tell the parents.…

March 7, 2017

The Ethics of the New GOP Health Plan – Violating Justice & Solidarity

by Craig Klugman, Ph.D.

Whatever one may think of the Affordable Care Act (ACA), it began with noble intentions. The ACA was built on a philosophy of providing more people not only with access to health insurance but also with assistance to pay for it.…

February 15, 2017

The National Academy of Sciences Expands its Approval for Gene Editing

by Keisha Ray, Ph.D.

This week the National Academy of Sciences (NAS) released a report giving their support for altering heritable genes when previously the NAS only supported altering uninheritable genes.…

February 13, 2017

The Death of Aid-in-Dying in DC

by Craig Klugman, Ph.D.

I recently gave a talk to a local chapter of a national physicians’ health care group where I was talking about what end of life could look like under a single payer health care system.…

January 30, 2017

Bioethics and the Problem of Silent Neutrality in the age of Trump

by Craig Klugman, Ph.D.

One of the most contentious of all issues in bioethics has been whether as a profession, we should take a stand against issues.…

January 24, 2017

Can Science Survive in a Communications Blackout: Restricting Speech Violates Scientific Ethics

by Craig Klugman, Ph.D.

That good ethics begins with good facts is an oft-heard mantra and was my first lesson when I began conducting clinical ethics consults 20 years ago.…

January 17, 2017

The Future of Health Insurance May Look A Lot Like Our Past

by Craig Klugman, Ph.D.

This week marks the transition of power from President Obama to President-elect Trump. One issue that has been high on Trump’s list of policy changes is a repeal and replace of the Affordable Care Act (a.k.a.…

January 10, 2017

Be Wary What You Research: You Might Get Sued

by Craig M. Klugman, Ph.D.

Peter Cohen, Clayton Bloszies, Caleb Yee and Roy Gerona published an article in the journal Drug Testing and Analysis in April 2015 explaining the results of their testing of supplements.…

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Published Articles (16)

American Journal of Bioethics: Volume 17 Issue 4 - Apr 2017

Psychiatric Genomics and Mental Health Treatment: Setting the Ethical Agenda Camillia Kong, Michael Dunn & Michael Parker

American Journal of Bioethics: Volume 17 Issue 3 - Mar 2017

The Precautionary Principle and the Tolerability of Blood Transfusion Risks Koen Kramer, Hans L. Zaaijer & Marcel F. Verweij

AJOB Primary Research: Volume 8 Issue 1 - Feb 2017

Morals or markets? Regulating assisted reproductive technologies as morality or economic policies in the states Erin Heidt-Forsythe

AJOB Primary Research: Volume 8 Issue 1 - Feb 2017

Problematic protocols: An overview of medical research protocols not approved by the LUMC medical ethics review committee Derek Gideon Tersmette & Dirk Peter Engberts

American Journal of Bioethics: Volume 16 Issue 12 - Dec 2016

Does Lack of “Genetic-Relative Family Health History” Represent a Potentially Avoidable Health Disparity for Adoptees? Thomas May, Kimberly A. Strong, Kaija L. Zusevics, Jessica Jeruzal, Michael H. Farrell, Alison LaPean Kirschner, Arthur R. Derse, James P. Evans & Harold D. Grotevant

American Journal of Bioethics: Volume 16 Issue 11 - Nov 2016

The Ethics of Organ Donor Registration Policies: Nudges and Respect for Autonomy Douglas MacKay & Alexandra Robinson

American Journal of Bioethics: Volume 16 Issue 11 - Nov 2016

Autonomy by Default Cass R. Sunstein

AJOB Primary Research: Volume 7 Issue 3 - Jul 2016

Ethical challenges in designing and implementing health systems research: Experiences from the field Adnan Hyder & Carleigh Krubiner

American Journal of Bioethics: Volume 16 Issue 2 - Feb 2016

Fetal Risks, Relative Risks, and Relatives' Risks Howard Minkoff & Mary Faith Marshall

American Journal of Bioethics: Volume 16 Issue 2 - Feb 2016

Restricting Choices of Childbearing Women Bela Fishbeyn

News (189)

April 20, 2017 9:00 am

Medical robotics—Regulatory, ethical, and legal considerations for increasing levels of autonomy (Science)

The regulatory, ethical, and legal barriers imposed on medical robots necessitate careful consideration of different levels of autonomy, as well as the context for use.

April 13, 2017 9:00 am

US regulators test organs-on-chips for food safety monitoring (Nature)

The US Food and Drug Administration (FDA) has started testing whether livers-on-a-chip — miniature ‘organs’ engineered to mimic biological functions — can reliably model human reactions to food and foodborne illnesses. The experiments will help the agency to determine whether companies can substitute chip data for animal data when applying for approval of a new compound, such as a food additive, that could prove toxic. It is the first time a regulatory agency anywhere in the world has pursued organs-on-chips as an alternative to animal testing.

April 11, 2017 9:00 am

Congress and FDA nominee heap love on ‘adaptive trials’ (Science)

This week, as President Donald Trump’s nominee to head FDA, Gottlieb sat before Republican lawmakers hungry for promises of “shorter time frames” for drug and device approvals, and again expressed his zeal—repeatedly—for adaptive trial designs. If confirmed to be FDA’s head, as expected, Gottlieb suggested he’d promote wider use of the approach.

April 3, 2017 9:00 am

Donald Trump believes the solution to the opioid crisis is talk (Vox)

President Donald Trump will soon sign an executive order to tackle what he’s called the “total epidemic” of opioid abuse and addiction. The main objective of the order is to create a commission that’s tasked with publishing a report on what to do about America’s deadliest drug crisis ever.

March 31, 2017 9:00 am

Europe says University of California deserves broad patent for CRISPR (Science)

The European Patent Office (EPO) announced on 23 March its “intention to grant a patent” to the University of California (UC) for its broad-based claims about the genome-editing tool popularly known as CRISPR. UC, on behalf of several parties, has been in a pitched battle with the Broad Institute of Cambridge, Massachusetts, over CRISPR patents, and the new decision marks a sharp departure from the position of the U.S. Patent and Trademark Office (USPTO).

March 21, 2017 9:00 am

Federal advisory panels agree Opana's risks outweigh benefits (USA Today)

The new extended-release version of Endo Pharmaceuticals’ Opana may even be more dangerous than the version it replaced, according to critics including the advocacy group Public Citizen. Two Food and Drug Administration advisory panels seemed to agree, voting 18 to 8 that it presents more risks than benefits to society. Next it’s up to the FDA to decide whether to act on the panels’ advice, which it generally does. Possible actions include changes to labels, restriction of prescriptions and an outright ban.

March 13, 2017 9:00 am

Employees who decline genetic testing could face penalties under proposed bill (Washington Post)

Employers could impose hefty penalties on employees who decline to participate in genetic testing as part of workplace wellness programs if a bill approved by a U.S. House committee this week becomes law.

February 16, 2017 9:00 am

Speedy drug approvals are risky, but drug companies have another idea that's just terrible (Los Angeles Times)

As with Trump’s proposed elimination of consumer safeguards, environmental-protection measures and financial reforms, the reality is that if his administration proceeds with a wholesale deregulation of the drug industry, the public will be largely undefended against the aggressive and potentially dangerous predations of multibillion-dollar conglomerates.

February 6, 2017 9:00 am

Will the Trump presidency mean the end of FDA drug regulation? (Los Angeles Times)

Donald Trump will be coming into office waving the banner of deregulation. While most of the speculation about his plans has focused on the financial industry and the possibility of eviscerating Dodd-Frank reforms, keep your eyes on the Food and Drug Administration. In a Trump administration the agency, figuratively speaking, will have a big bull’s-eye on its back.

January 25, 2017 9:00 am

We spoke with the man who could lead the world's top health organization (Business Insider)

The WHO lost a lot of trust in the aftermath of the 2014 Ebola outbreak in West Africa. Nabarro said his hope is to make sure that doesn’t happen again.

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