Photograph of protestor holding a hot pink sign that reads "I Stand with Planned Parenthood"

Trump’s Title X Gag Rule: An Ethical Conundrum for Planned Parenthood

By Beatrice Brown

On August 19, Planned Parenthood announced that they would be leaving the Title X family planning program due to the Trump Administration’s new prohibition that restricts those who receive Title X funds from providing or referring patients for abortion. This restriction on Title X funding has unsurprisingly been met with a lot of criticism, namely, that it interferes with a woman’s constitutional right to abortion. This can be seen as a partial victory for those who have been attempting to defund Planned Parenthood for years, an organization that, despite others’ characterizations, is fundamentally committed to providing all women access to quality health care and is not solely an abortion provider.

As a result of this gag rule, Planned Parenthood has faced a huge ethical dilemma: Do they continue to accept Title X funding to assist low-income women with everyday health care, such as yearly routine wellness visits, or do they reject this funding and both 1) take a stand on a woman’s constitutional right to abortion and 2) continue to provide a service (or retain the right to refer patients to a service) that is crucial to women’s health? Planned Parenthood has chosen the latter, and I think that Planned Parenthood’s difficult choice is justified.

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FDA’s Warning Letter to Juul & the First Amendment

By Daniel Aaron

On September 10, 2019, the Food and Drug Administration (FDA) issued a warning letter to Juul asserting that the vaping manufacturer had violated federal law by illegally marketing its e-cigarettes as safer than other products. Citing evidence uncovered at a July 2019 House Subcommittee hearing as well as industry documents, FDA claims that Juul marketed its products as modified-risk tobacco products (MRTPs) without an FDA order allowing the product to be marketed as such. Therefore, FDA concluded, Juul’s products are adulterated.

At first blush, this seems like a heavy-hitting letter. FDA warning letters are an effective enforcement tool because they intimidate regulated entities and carry the threat of further enforcement. FDA likely hopes Juul will bring itself into compliance with federal law by ceasing to market its products as lower-risk.

However, enforcement letters carry no legal weight in and of themselves. Should Juul continue to market its products as lower-risk, there may be a long legal battle implicating the First Amendment.

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The Care Quality Commission (CQC) in England: Annual Review of Progress

By John Tingle

The Care Quality Commission (CQC) occupies a pivotal role in the National Health Service (NHS) and social care sector in securing health quality and patient safety. Its inspection activities through its reports and publications form the backbone of quality and safety in these sectors. As the independent regulator of health and social care in England it faces a mammoth task. The CQC has recently published its annual report and accounts, which provide useful insights into its work. The report provides a window on how England regulates health, social care quality, and patient safety. There is detailed reflection in the report about how the organisation can better perform its functions and the challenges and opportunities currently facing it.

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Navigating Sensitive Hospital Conversations in the Age of Telemedicine

By Adriana Krasniansky

On March 5, 2019, a terminally ill patient from Fremont, California, learned that he was expected to die within several days. The doctor who delivered the news did so via a robotic video teleconferencing device. 

Ernest Quintana, a 79-year-old patient with a previously-diagnosed terminal lung condition, was taken to the Kaiser Permanente Fremont Medical Center emergency room after reporting shortness of breath. His 16-year-old granddaughter, Annalisia Wilharm, was with him when a nurse stopped by and said that a doctor would visit shortly to deliver Mr. Quintana’s results. 

The video below, recorded by Ms. Wilharm, shows Mr. Quintana’s consultation with a critical care doctor through an Ava Robotics telepresence device—in which the doctor explains Mr. Quintana’s rapidly worsening condition and suggests transitioning to comfort care. Ms. Wilharm and her family chose to share the video with local media and on Facebook, inciting a debate around the legal and ethical challenges of using telemedicine in critical care conversations. 

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Exploring the Future of Meat: Academy of Food Law & Policy 2nd Annual Conference at Georgia State University, Dec. 10, 2019

By Nicole Negowetti

Sustainably feeding a growing population with healthy diets is a pressing global challenge. The role of meat in such diets is a deeply contentious issue that has public health, animal welfare, food systems, farming, and environmental experts and advocates weighing in on the issue. As we learn more about the impacts of meat production and consumption on human and environmental health and animal welfare, meat consumption is changing. In North America, eaters are heeding recommendations to reduce, replace, or eliminate meat in their diets; however, global meat production and consumption continues to rise.

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What happens when assisted reproductive technology agreements break down?

By Sarah Alawi

My name is Sarah Alawi; I’m an LLM Student at Harvard Law School, from New Zealand. I am excited to contribute to the Petrie-Flom Blog as a Petrie-Flom Student Fellow. My area of interest is assisted reproductive technology (ART), although I intend to use this forum to write on a broad range of medico-legal issues in the bioethics sphere. This post introduces my specific research interest in ART disputes, and concludes with a recommendation for anyone considering ART.

ART is a growth industry and yet, despite the sophistication of new birth technologies, its use depends on functioning human relationships. Commonly, parties try to define these relationships using pre-conception ART agreements. During my fellowship at the Petrie-Flom Center, I intend to write a thesis on what should happen, in terms of the parties’ rights at law, when three common forms of ART agreements break down:

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Legislating Genetic Non-Discrimination: What Is GINA and Why Does It Matter?

By John Novembre, Mason Kortz, Kaitlyn Dowling

In a new, year-long series on Bill of Health, we’ll be exploring the legal scholarship on genetic non-discrimination. We’ll talk more about GINA and state laws protecting citizens from genetic discrimination. We hope these posts help shed light on this complex and ever-more-relevant area for legal scholars, policymakers, and the public at large.

What if the hidden code underwriting your humanity could be used to prevent you from getting approved for a mortgage? Or siphoned you into a different classroom from your peers? What if the specter of an illness — possibly years away from manifesting — kept you from getting a job? The Genetic Information Non-Discrimination Act is a law passed in 2008 aimed at protecting Americans from discrimination based on information gleaned from genetic testing. With increasing access to genetic counseling in a traditional clinical setting, as well as the growth in popularity of direct-to-consumer genetic testing (like 23andMe), GINA is more relevant now than ever.

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Rachel Rebouché and Scott Burris on “The Week in Health Law” Podcast

By Nicolas Terry

Two great guests this week, Rachel Rebouché and Scott Burris, both from Temple Law School in Philadelphia. We’re here not only to tease Temple Law’s 2019 Law Review Symposium: Looking Back and Looking Ahead, 10 Years of Public Health Law Research, Friday, September 13, 2019, but also to discuss some cutting edge issues in public health responses to the opioids overdose crisis and the erosion of reproductive rights. Scott, of course, is a Professor of Law at the law school, where he directs the Center for Public Health Law Research. He is also a Professor in Temple’s School of Public Health.  Rachel is a Professor of Law at Temple and also serves as Associate Dean for Research. She teaches Family Law, Health Care Law, and Contracts and is currently a co-investigator on two grant-funded research projects related to reproductive health.

The Week in Health Law Podcast from Nicolas Terry is a commuting-length discussion about some of the more thorny issues in health law and policy. Subscribe at Apple Podcasts or Google Play, listen at Stitcher Radio, SpotifyTunein or Podbean, or search for The Week in Health Law in your favorite podcast app. Recent episodes are also available on YouTube.

Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find me on Twitter @nicolasterry and @WeekInHealthLaw.

Subscribe to TWIHL here!

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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New York’s Strict Vaccine Mandate Goes to Court

By Dorit Reiss

On June 13, 2019 New York repealed the religious exemption from its school immunization mandates. While the actual repeal went fast – the bill passed the Assembly health committee, the Assembly floor, the Senate floor and the Governor’s office on the same day – the bill has been in the process since January, and activists on both sides were active in the lead up to the vote. The bill was a response to a large measles outbreak in New York that sickened hundreds of people and hospitalized over a hundred, sending tens to the ICU.

Not surprisingly, opponents filed lawsuits against the new law. Two of these lawsuits were led by the Children’s Health Defense organization, an anti-vaccine group led by Robert F. Kennedy, Jr., though with two different lead lawyers. Eight additional ones were recently filed by two unassociated lawyers in eight different counties.

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