Photograph of a doctor holding a headset sitting in front of a laptop

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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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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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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Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari, Charlie Lee, Frazer Tessema, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of July. The selections feature topics ranging from the price increases of protected-class drugs in Medicare Part D, to the impact of price regulation on the availability of new drugs in Germany, to the association between FDA advisory committee recommendations and agency actions. A full posting of abstracts/summaries of these articles may be found on our website.

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Fazal Khan on ‘The Week in Health Law’ Podcast

By Nicolas Terry

This episode was recorded at the annual meeting of the Southeastern Association of Law Schools during a panel reviewing the year in healthcare financing. This episode features a talk by Professor Fazal Khan who teaches Health Law & Policy, Bioethics, Public Health Law and International Products Liability at the University of Georgia School of Law. His current research focuses on several major themes: reform of the American health care system, the effect of globalization on health care, and the challenge of regulating emerging biotechnologies. His talk was on the financing of telemedicine and the slow alignment of the technologies with health care value and other models.

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, Spotify, Tunein or Podbean.

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!

Illustration of a pill with a sensor embedded

Ethical and legal issues of ingestible electronic sensors

This post originally appeared in Device and Materials Engineering. You can read it here.

By Sara Gerke & I. Glenn Cohen

In our new paper, we discuss the ethical challenges of ingestible electronics sensors (IESs; also called “smart pills”) and examine the legal regulation of such sensors in the United States and Europe.

IESs are increasingly being developed for improving health outcomes. One such use could facilitate monitoring and promoting medication adherence. Once swallowed, an IES connects with a wearable sensor that can detect and record valuable data, including behavioral and physiological metrics or the time of drug intake. The wearable sensor subsequently sends the collected data to a computing device (e.g., a smartphone) that processes and displays the information. There is also the option to link the display function with a cloud database for data sharing with the patient’s doctor or family.

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Professor: The Law Has No Straight Answer for Our High-Tech Baby Boom

This is an excerpt of an article by Alaina Lancaster that originally appeared on Law.com. Read the full interview here. 

After thousands of dollars of in vitro fertilization treatments and nine months of pregnancy, a New York couple was forced to give up the twins they birthed. It turns out CHA Fertility Center, the Los Angeles clinic where the couple sought IVF treatment, mixed up the embryos of three patients, resulting in two of the couples having to give up children to their genetic parents. Now, those parents are suing.

Dov Fox, professor of law at the University of San Diego and the director of the school’s Center for Health Law Policy & Bioethics, said the law has not caught up with reproductive technology and victims of this type of medical malpractice aren’t left with many legal options. Yet, legal frameworks are out there, Fox said. Judges and lawmakers just might need to look outside the U.S.

Read the full interview here.

The World is About to Change—Again

Dr. Susan Hockfield, the first female President of the Massachusetts Institute of Technology, has written a beautiful and powerful book, “The Age of Living Machines,” articulating her vision of the merging of engineering and biology. This merger, she argues, has potential to lead to a scientific revolution that she believes will create the future. The ability to distill complicated concepts into concise, understandable prose, is a skill with limitless value, regardless of the subject matter. Dr. Hockfield is clearly a master in this art, and why should we be surprised that the past Provost of Yale and President of MIT would possess such skill and aplomb.

In her book, Dr. Hockfield, an accomplished biologist who was recruited early in her distinguished career by Nobel Laureate James Watson to the iconic Cold Spring Harbor Laboratory, lays out the case for Convergence 2.0. This is, of course, the sequel to Convergence 1.0, the confluence of physics and engineering, which produced the electron and the information technology revolution, leading to breathtaking innovation that has altered virtually every aspect of human life. Read More

How Might we Approach Discussions on the Implications of Using Genetic Data from a Human Rights or Social Justice Perspective?

By Alicia Ely Yamin and Jonathan Chernoguz

To complement the Petrie-Flom Center’s annual conference this year, Consuming Genetics, the Global Health and Rights Project at Petrie-Flom (GHRP) convened a small meeting of feminists, students, and other activists. On May 16, Harvard University’s Global Health Education and Learning Incubator , which co-sponsors GHRP, hosted the forum in conjunction with Marcy Darnovsky and Katie Hasson of Center for Genetics and Society (CGS).

Focusing on “Gene Editing, Ethics, Rights and Health Equity Issues,” and in particular the irrevocability of germline gene editing, the meeting began with Marcy Darnovsky, Executive Director of CGS asking, “How might we begin the discussion from [the perspective of] human rights, feminism, equity, and social justice, rather than from the science and biotechnology?”

This question echoed some of those posed during the Consuming Genetics conference, for example, by Jonathan Kahn in interrogating the equivocation of social diversity and empirical diversity in genomic research.  Read More