Washington, USA- January13, 2020: FDA Sign outside their headquarters in Washington. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.

A New Step for the FDA in Regulating Digital Health Products

By Vrushab Gowda

On September 22, the U.S. Food and Drug Administration (FDA) announced the establishment of a new initiative to regulate digital health products – the Digital Health Center of Excellence (DHCoE).

In some ways, the announcement does not come as a surprise; FDA Commissioner Stephen Hahn’s predecessor, Scott Gottlieb, outlined the DHCoE in a press release two years ago. What does remain to be seen is whether DHCoE represents a true paradigm shift in FDA’s approach to regulating digital health products.

According to Hahn, the DHCoE aims to (1) build partnerships, (2) share knowledge across FDA and with stakeholders, and (3) innovate regulatory approaches. It will be led by the current Director of CDRH’s Division of Digital Health, Bakul Patel.

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a stethoscope tied around a dollar bill, with a bottle of pills nearby

Can We Expect Legislation on Surprise Medical Billing? I’d Be Surprised

By Abe Sutton

Surprise medical billing has emerged as a top political priority amid a torrent of complaints about expensive balance billing.

Despite leaders such as President Trump, former Vice President Biden, and members of the 116th Congress pledging to address surprise medical billing, federal legislation is unlikely, due to powerful health associations’ divergent interests. To shake legislation loose, the President would need to publicly take a side and expend political capital on a creative solution.

In this piece, I walk through why federal legislative action has been stymied to date, and what it would take to get surprise medical billing legislation over the line.

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Petrie-Flom Center student fellows 2020-2021.

Petrie-Flom Welcomes 2020-2021 Student Fellows

(Clockwise from top left: Jenna Becker, Sravya Chary, Vrushab Gowda, Abe Sutton, Sunnie Ning, Laura Karas)

We are so excited to welcome a new group of Student Fellows to the Petrie-Flom Center family. These six students are a fantastic cohort of health law policy, biotechnology, and bioethics scholars who join us from Harvard Law School and the HMS Center for Bioethics. While we cannot physically welcome our fellows this year, we are excited to provide them with a robust virtual fellowship.

They each will undertake a year-long research project with mentorship from Center faculty and affiliates, and also will blog here at Bill of Health regularly. Keep an eye out for their bylines!

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Madison, Wisconsin / USA - April 24th, 2020: Nurses at Reopen Wisconsin Protesting against the protesters protesting safer at home order rally holding signs telling people to go home.

Safer at Home? Yes, but Not According to the Wisconsin Supreme Court

By Beatrice Brown, Jane Cooper, and Danielle Pacia

Due to the Bill of Health production schedule, this piece is being published two weeks after it was written, on May 20th, 2020. The authors would like to affirm the importance of protests against anti-Black racism in America.

Stay-at-home orders—the primary means of managing the COVID-19 pandemic in the U.S.—face increasing opposition as protestors against these public health measures clamor for a “return to normal.” In Wisconsin, pushback against stay-at-home orders culminated in the state Supreme Court’s decision on May 13 to reverse the state’s “Safer at Home” policy.

Republican leaders of the state legislature filed suit against state Department of Health Services Secretary-designee Andrea Palm and other health officials, resulting in the case Wisconsin Legislature v. Palm. In a 4-3 ruling, the Wisconsin Supreme Court held that the “Safer at Home” order was “unlawful” and “unenforceable.”  Read More

WASHINGTON MAY 21: Pro-choice activists rally to stop states’ abortion bans in front of the Supreme Court in Washington, DC on May 21, 2019.

The Harms of Abortion Restrictions During the COVID-19 Pandemic

By Beatrice Brown

Several states, including Texas, Ohio, and Alabama, have dangerously and incorrectly deemed abortions a non-essential or elective procedure during the COVID-19 pandemic. The stated reason for these orders is to conserve personal protective equipment (PPE), a scarce, important resource for protecting health care workers treating COVID-19 patients.

However, these policies restricting abortion are unlikely to conserve PPE, and more importantly, they mischaracterize the nature and importance of abortions.

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person typing at computer

Social Workers and Chaplains at the Front Lines During COVID-19

By Adriana Krasniansky

Like doctors and nurses, chaplains and social workers are critical members of hospital care teams who are adapting their workflow and adopting telehealth platforms during the COVID-19 pandemic. 

However, much of their work requires navigating difficult and vulnerable conversions not well-suited for a video screen. This article investigates the unique approaches chaplains and social workers are taking to serve patients digitally in their times of need. Read More

mask, gloves, goggles.

Are Clinicians Without PPE Morally Obligated to Care for COVID-19 Patients?

By Beatrice Brown

There is currently a dire shortage of personal protective equipment (PPE) at hospitals across the United States, especially in areas that have been hit the hardest by COVID-19.

PPE is essential to protecting those on the front lines of the pandemic – the President of the American Medical Association (AMA) has said that without adequate PPE, we may face a shortage of clinicians to treat COVID-19 patients, in addition to other shortages of critical resources.

Without adequate PPE, are clinicians morally obligated to provide care to patients who are either presumed positive for COVID-19 or who definitely have the virus?

Here, I argue that to treat patients without adequate PPE is supererogatory but not obligatory. In other words, this is a noble and praiseworthy act, but clinicians should not be obligated to perform these heroic acts, nor should we blame them, morally, for their decision to refuse to provide care.

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woman doing yoga

Staying Sane and Hopeful During the COVID-19 Pandemic

By Sarah Alawi

March was a month full of stress and anxiety around the uncertainties of the COVID-19 pandemic and the disruption of normal life.

Following Harvard Law School’s decision to evacuate campus in early March, most students – myself included – had to hurriedly pack our lives into suitcases and return home in the space of days.

For some of us, getting home (for me, New Zealand) meant having to travel internationally  through airports and transit hubs amid a global pandemic. We landed on the other side to a new normal as the rest of the world caught on; we now live in quarantine “bubbles” while continuing to learn, meet and even socialize via Zoom. Our days are shadowed by restraint and a desperate hope to return to normalcy.

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hospital equipment, including heart rate monitor and oxygen monitor functioning at bedside.

The Ethical Allocation of Scarce Resources in the US During the COVID-19 Pandemic: The Role of Bioethics

By Beatrice Brown

Critical resources for handling the COVID-19 pandemic, including ventilators and ICU beds, are quickly becoming scarce in the US as the number and density of infections continue to rise. Leading bioethicists have crafted guidelines for the ethical rationing of these scarce resources during the pandemic. On March 16, The Hastings Center published “Ethical Framework for Health Care Institutions and Guidelines for Institutional Ethics Services Responding to the Novel Coronavirus Pandemic,” detailing three ethical duties for health care leaders: 1) duty to plan; 2) duty to safeguard; and 3) duty to guide. The report also contains a compilation of materials on resource and ventilator allocation.

More recently, on March 23, two insightful pieces were published in the New England Journal of Medicine: “The Toughest Triage — Allocating Ventilators in a Pandemic” by Truog, Mitchell, and Daley, and “Fair Allocation of Scarce Medical Resources in the Time of Covid-19” by Emanuel et al. These two pieces complement each other well and lay a crucial foundation for the inevitable resource allocation that clinicians and hospitals will be forced to practice in the coming weeks. As such, here, I summarize the central takeaways from these two articles while understanding their recommendations in tandem, as well as reflect on the importance of bioethics during these times of medical crisis and how the work of this field must adapt to changing circumstances. Read More

Vials of medications with syringe and needle.

Is “Implied Consent” Ethically Permissible in WHO’s Malaria Vaccine Pilot Introduction?

By Beatrice Brown

A recent BMJ article has exposed ethical concerns with the informed consent process in the World Health Organization’s (WHO) large, randomized cluster trial of the world’s first licensed malaria vaccine, RTS,S, known as Mosquirix. The study is being conducted in Malawi, Ghana, and Kenya, and 720,000 children will receive the vaccine. The vaccine is currently limited to pilot implementation because of residual safety concerns from previous clinical trials, including: a tenfold rate of meningitis in those who received the vaccine versus those who did not, “increased cerebral malaria cases, and a doubling in the risk of death in girls.” Rather than engaging in the traditional informed consent process, the WHO is utilizing an implied consent process, leading several bioethicists, including Charles Weijer, Christine Stabell Benn, and Jonathan Kimmelman, to voice concern.

The WHO has defended their use of implied consent to BMJ on the grounds that “the study is a ‘pilot introduction’ and not a ‘research activity.'” A WHO spokesperson explained that in an implied consent process, “parents are informed of imminent vaccination through social mobilisation and communication, sometimes including letters directly addressed to parents. Subsequently, the physical presence of the child or adolescent, with or without an accompanying parent at the vaccination session, is considered to imply consent.” However, as Weijer rightly points out, this is not truly consent, as “We have no assurance that parents, in fact, received information about the study let alone that they understood it.” After the publication of the original article criticizing the WHO for going against international ethical standards for research involving human participants, the WHO released a response in BMJ and on their own website, contending that this implied consent process is “used for all vaccines provided through the Expanded Programme on Immunization” and that the study is in accordance with international ethical standards. Here, I further explore whether this implied consent process is ethically permissible in this specific trial by exploring the guidelines set out by two organizations.

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