Person smoking cigarette.

Should Smokers be Prioritized for COVID Vaccine?

Cross-posted from Harvard Law Today, where it originally appeared on February 2, 2021. 

By Jeff Neal

Should smoking be among the pre-existing health risks that qualify people for priority access to the COVID-19 vaccine? In a Zoom interview with Harvard Law Today, public health expert Carmel Shachar J.D./M.P.H. ’10 says the answer is yes. 

CDC guidelines, which most states are following as they launch mass vaccination programs, say people with certain underlying medical conditions that put them at greater risk for hospitalization or death if they contract COVID-19 (also known as co-morbidities) should receive access to the vaccine before the general population. In Massachusetts, these individuals will be eligible to receive the vaccine in Group 4 of Phase 2 of the state’s vaccination rollout plan. But many have been surprised to see smoking listed among the qualifying conditions, alongside cancer and heart disease.

Shachar, the executive director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, says that smoking is often the result of structural and biological factors that make it more prevalent in historically marginalized communities, and that denying priority access for smokers would reinforce existing inequities. More practically, she says, “every time a person gets vaccinated, it’s good for the community.” 

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Medicine doctor and stethoscope in hand touching icon medical network connection with modern virtual screen interface, medical technology network concept

Data Talking to Machines: The Intersection of Deep Phenotyping and Artificial Intelligence

By Carmel Shachar

As digital phenotyping technology is developed and deployed, clinical teams will need to carefully consider when it is appropriate to leverage artificial intelligence or machine learning, versus when a more human touch is needed.

Digital phenotyping seeks to utilize the rivers of data we generate to better diagnose and treat medical conditions, especially mental health ones, such as bipolar disorder and schizophrenia. The amount of data potentially available, however, is at once both digital phenotyping’s greatest strength and a significant challenge.

For example, the average smartphone user spends 2.25 hours a day using the 60-90 apps that he or she has installed on their phone. Setting aside all other data streams, such as medical scans, how should clinicians sort through the data generated by smartphone use to arrive at something meaningful? When dealing with this quantity of data generated by each patient or research subject, how does the care team ensure that they do not miss important predictors of health?

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Person receiving vaccine.

What You Should Know About the COVID-19 Vaccine

Cross-posted from Harvard Law Today, where it originally appeared on December 3, 2020. 

By Jeff Neal

The race to approve and distribute a vaccine for COVID-19 got a huge shot in the arm this week.

On Tuesday, the United Kingdom approved a vaccine developed by pharmaceutical giant Pfizer. On the same day in the United States, a panel of experts advising the Centers for Disease Control and Prevention recommended a first-stage plan for distributing the vaccine to some of the most at-risk Americans. Separately, another advisory committee is set to meet twice in the coming weeks to evaluate for the U.S. Food and Drug Administration the safety and efficacy of both the Pfizer vaccine and a similar one produced by Moderna.

To better understand the impact of these developments, Harvard Law Today recently spoke with public health expert Carmel Shachar J.D./M.P.H. ’10, the executive director of the Petrie-Flom Center for Health Policy, Biotechnology, and Bioethics at Harvard Law School, about the vaccine, who is likely to get it first, and whether employers and states can require people to get vaccinated.

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Young male doctor in telehealth concept

Call for Abstracts: Looking Forward to a Post-Pandemic Landscape

By Carmel Shachar and Katie Kraschel

The COVID-19 pandemic has disrupted virtually every facet of day-to-day life.

This disruption has forced us to examine baseline choices and assumptions about how to deliver health care, participate in public discourse, provide access to education, and support the workforce. This “great revision” will continue in several iterative stages: an immediate response to the crisis, a modulation as the pandemic continues, and a resolution into a “new normal.”

The Petrie-Flom Center and the Solomon Center for Health Law Policy are interested in tracking when crisis settles into the new normal and articulating how public policy and law should respond to that evolution.

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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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Technical illustration of a respirator device

Why Medical Device Regulation?

By Carmel Shachar

The Petrie-Flom Center’s 2020 annual conference, Innovation and Protection: The Future of Medical Device Regulation, co-sponsored by the University of Copenhagen’s Center for Advanced Studies in Biomedical Innovation Law and the University of Arizona Health Law Program, was inspired by a growing sense that there is a need to reconsider our regulatory approach to medical devices as they become increasingly complex. Not only are medical devices becoming more mechanically complex, but they are also increasingly merging with digital technologies to expand capabilities.

Devices’ increasing complexity raises questions as to whether our regulatory pathways for medical devices are appropriate for ensuring safety and efficacy. The New York Times in a May 4, 2019 Editorial Opinion indicated that they believed the answer is no—that our current regulatory system, especially the 510(k) pathway and limited post-market surveillance, risk patient lives and health. The European Council is implementing new medical device regulations in May 2020 and 2022 to address similar concerns around safety and effectiveness in the EU. Both American and European regulators are struggling to find the best way to oversee the new hybrid medical devices that incorporate both hardware and software, as well as stand-alone algorithms.

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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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