Centers for Disease Control and Prevention. Georgia, Atlanta USA March 6, 2020.

For Whom Does the CDC Think it Works?

By Jennifer S. Bard

As weekly deaths from COVID in the U.S. soar into thousands, monkeypox continues to spread, and New York reports the country’s first case of paralytic polio since 1979, it is fair to question the U.S. Centers for Disease Control and Prevention (CDC)’s effectiveness and ability to achieve its mission to “to protect America from health, safety and security threats” and its pledge to “base all public health decisions on the highest quality scientific data that is derived openly and objectively” and “place the benefits to society above the benefits to our institution.”

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A half face dust mask and HEPA filter over white background.

Being an Adult in the Face of Omicron

By Jennifer S. Bard

To those who believe that the federal government is a benign force doing the best they can to fight the COVID-19 pandemic and keep us all safe, I have two words of advice: Grow up.

Neither the U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), or Dr. Fauci should be anthropomorphized into a benevolent but perhaps out-of-touch parental figure. They are not.

As a matter of law, the government, in contrast to your parents, or school, or perhaps even your employer, does not have a fiduciary duty to protect your (or any individual’s) health and safety. As the Supreme Court said in Deshaney v. Winnebago Country Dept of Social Services, 489 U.S. 189 (1980) and again in Castlerock v. Gonzales, 545 U.S. 748 (2005), individuals do not have an enforceable right to government protection unless the state itself creates the danger. Their duty, if it exists, is to the public in general, which can encompass many factors beyond any one person’s health.

Just knowing that the government, duly elected or not, has no obligation to protect you or your family should be enough to look at its pandemic guidance as minimum, rather than maximum, standards. It should also encourage you to be proactive in taking precautions beyond those “recommended,” rather than seeing these minimal standards as unwarranted restrictions that can be negotiated down.

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Money.

Conflicts of Interest in the Hospital Sector: A Q&A with Rina K. Spence

By Chloe Reichel

Brigham and Women’s Hospital recently made headlines when the Boston Globe reported that the hospital’s president, Dr. Elizabeth Nabel, held a seat on the board of Moderna, a Cambridge biotech company that is working to develop an mRNA COVID-19 vaccine. The hospital has a major role in a national study of the vaccine.

The hospital maintained that safeguards were put in place to protect against conflicts of interest during the collaboration. Nevertheless, amid public outcry, Nabel stepped down from the board.

But this story is just one high-profile case of what is commonplace in the hospital sector. A 2014 research letter published in the Journal of the American Medical Association found that 40 percent of pharmaceutical company boards of directors had at least one member who also held, at the same time, a leadership role at an academic medical center.

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Doctors hold blood sample wearing ppe suit and face mask in hospital.

New Stark Law Waiver Opens Opportunity for Creative Physician Compensation and Benefits

By Carmel Shachar

On March 30, 2020 the Department of Health and Human Services (HHS) announced a partial waiver of some key elements of the Stark Law, a health care fraud and abuse law. The purpose of this waiver is to relax some of the fraud and abuse requirements around physician compensation during the COVID-19 pandemic to allow hospitals and physician groups to think creatively about meeting the needs of an overworked and stressed workforce. It also provides us an opportunity to consider the post-pandemic future of the Stark Law, long thought to be an impediment to innovative payment and delivery models.

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Close up of a computer screen displaying code

What Google Isn’t Saying About Your Health Records

By Adrian Gropper

Google’s semi-secret deal with Ascension is testing the limits of HIPAA as society grapples with the future impact of machine learning and artificial intelligence.

I. Glenn Cohen points out that HIPAA may not be keeping up with our methods of consent by patients and society on the ways personal data is used. Is prior consent, particularly consent from vulnerable patients seeking care, a good way to regulate secret commercial deals with their caregivers? The answer to a question is strongly influenced by how you ask the questions.

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Couple sitting on a couch, leaning forward to have a serious conversation with a doctor or counselor

Genetic Testing: Is There a “Duty to Warn” At-Risk Family Members?

By Shelly Simana

Genetic information is quite distinguishable from much medical information due its familial nature and its unique ability to predict future health. The fact that genetic testing supplies comprehensive information about the genetic make-up of patients and their family members underlies the ethical and legal challenges faced by physicians and patients when deciding whether to disclose genetic information to family members. Failure to disclose information may “lead to harm, particularly when knowledge could result in avoidance, treatment, or prevention of a genetic condition or in significant changes to reproductive choices or lifestyle.” Due to the potential harm, one may ask herself if there is a legal “duty to warn” family members about the presence of defective genes, and if so, upon whom should it be imposed.

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Photograph of Purdue Pharma headquarters

The Role of Attorneys General in the Opioid Litigation

By Daniel Aaron

People following the opioid lawsuits might have noticed some strange headlines as of late. Virtually every state’s attorney general (AG) is suing Purdue Pharmaceuticals, maker of the blockbuster drug OxyContin. Purdue filed for bankruptcy and is hoping to settle for “$10 billion.” However, the deal only includes $4.4 billion in cash, which is less than the Sackler family, owners of Purdue, transferred to personal accounts over the past decade. In other words, the amount of money the Sacklers made from the opioid epidemic is more than what they will pay more than forty states to help abate the crisis. Is anyone supporting this deal?

Yes, in fact, and this is where the plot thickens. With several exceptions, support for the deal falls along party lines: Republican AGs support the deal, and Democratic AGs oppose it. Why does a decision about settling with an opioid company appear to be political? What is the role of an attorney general? And are they supposed to defend public health?

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Picture of doctor neck down using an ipad with digital health graphics superimposed

Is Data Sharing Caring Enough About Patient Privacy? Part II: Potential Impact on US Data Sharing Regulations

A recent US lawsuit highlights crucial challenges at the interface of data utility, patient privacy & data misuse

By Timo Minssen (CeBIL, UCPH), Sara Gerke & Carmel Shachar

Earlier, we discussed the new suit filed against Google, the University of Chicago (UC), and UChicago Medicine, focusing on the disclosure of patient data from UC to Google. This piece goes beyond the background to consider the potential impact of this lawsuit, in the U.S., as well as placing the lawsuit in the context of other trends in data privacy and security.

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Image of binary and dna

Is Data Sharing Caring Enough About Patient Privacy? Part I: The Background

By Timo Minssen (CeBIL, UCPH), Sara Gerke & Carmel Shachar

A recent US lawsuit highlights crucial challenges at the interface of data utility, patient privacy & data misuse

The huge prospects of artificial intelligence and machine learning (ML), as well as the increasing trend toward public-private partnerships in biomedical innovation, stress the importance of an effective governance and regulation of data sharing in the health and life sciences. Cutting-edge biomedical research strongly demands high-quality data to ensure safe and effective health products. It is often argued that greater access to individual patient data collections stored in hospitals’ medical records systems may considerably advance medical science and improve patient care. However, as public and private actors attempt to gain access to such high-quality data to train their advanced algorithms, a number of sensitive ethical and legal aspects also need to be carefully considered. Besides giving rise to safety, antitrust, trade secrets, and intellectual property issues, such practices have resulted in serious concerns with regard to patient privacy, confidentiality, and the commitments made to patients via appropriate informed consent processes.

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