Category: Biotechnology

President Joe Biden at desk in Oval Office.

What’s on the Horizon for Health and Biotech with the AI Executive Order

Adithi Iyer Leave a comment

By Adithi Iyer

Last month, President Biden signed an Executive Order mobilizing an all-hands-on-deck approach to the cross-sector regulation of artificial intelligence (AI). One such sector (mentioned, from my search, 33 times) is health/care. This is perhaps unsurprising— the health sector touches almost every other aspect of American life, and of course continues to intersect heavily with technological developments. AI is particularly paradigm-shifting here: the technology already advances existing capabilities in analytics, diagnostics, and treatment development exponentially. This Executive Order is, therefore, as important a development for health care practitioners and researchers as it is for legal experts. Here are some intriguing takeaways:  Read More

Double exposure of abstract digital world map on laptop background.

Harmonizing Africa’s Data Governance: Challenges and Solutions

Donrich Thaldar Leave a comment

By Donrich Thaldar

The establishment of a single data market across African nations promises significant socio-economic advantages, facilitating unrestricted and fluid data exchange. This concept has captured the attention of political leaders and has been prominently featured in the African Union’s (AU) Digital Transformation Strategy for Africa, as well as the AU’s Data Policy Framework. Further, entities like Smart Africa are actively championing the cause of creating an African single data market.

To transform the vision of an African single data market into reality, and to unlock its potential benefits for the continent’s populace, establishing regulatory alignment is paramount. This necessitates the integration of markets, the implementation of uniform online payment systems, the standardization of taxation and duties, and cross-border trade facilitation. This article delves into two critical legal dimensions of cross-border trade facilitation: data privacy and data ownership.

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Operating room Doctor or Surgeon anatomy on Advanced robotic surgery machine.

Protecting Consumer Privacy in DTC Tissue Testing

Adithi Iyer Leave a comment

By Adithi Iyer

In my last piece, I discussed the hypothetical successor of 23andme — a tissue-based direct-to-consumer testing service I’ve called yourtissueandyou — and the promise and perils that it might bring in consumer health information and privacy. Now, as promised, a closer look at the “who” and “how” of protecting the consumer at the heart of direct-to-consumer precision medicine. While several potential consumer interests are at stake with these services, at top of mind is data privacy — especially when the data is medically relevant and incredibly difficult to truly de-anonymize.

As we’ve established, the data collected by a tissue-based service will be vaster and more varied than we’ve seen before, magnifying existing issues with traditional data privacy. Consumer protections for this type of information are, in a word, complicated. A singular “authority” for data privacy does not exist in the United States, instead being spread among individual state data privacy statutes and regulatory backstops (with overlapping sections of some federal statutes in the background). In the context of health, let alone highly sophisticated cell signaling and microenvironment data, the web gets even more tangled.

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sample tube in female hands with pipette.

Why We Should Care About the Move from Saliva to Living Cells in Precision Medicine

Adithi Iyer Leave a comment

By Adithi Iyer

The cultural, informational, and medical phenomenon that is 23andMe has placed a spotlight on precision medicine, which seeks to personalize medical care to each patient’s unique makeup. Thus far, advances in direct-to-consumer genetic testing have made saliva-sample sequencing services all the rage in this space, but regenerative medicine, which relies on cells and tissues, rather than saliva, now brings us to a new, increasingly complex inflection point.

While collecting and isolating DNA samples from saliva may offer a wealth of information regarding heredity, disease risk, and other outflows of the “instruction manual” for patients, analyzing cells captures the minutiae of patients that goes “beyond the book” and most closely informs pathology. Disease isn’t always “written in the stars” for patients. Epigenetic changes from environmental exposures, cell-to-cell signaling behaviors, and the mutations present in diseased cells all profoundly inform how cells behave in whether and how they code the instructions that DNA offers. These factors are critical to understanding how disease materializes, progresses, and ultimately responds to treatment. This information is highly personal to each patient, and reflects behavioral factors as well as genetics.

Regenerative medical technologies use cell- and tissue-based methods to recapitulate, bioengineer, and reprogram human tissue, making a whole suite of sci-fi-sounding technologies an ever-closer reality. With cell-based and other regenerative therapies entering the market (making up an entire FDA subgroup), it well worth considering how cell-based medicine can advance the world of personalized consumer testing. In other words, could a corporate, direct-to-consumer cell-based testing service be the next 23andMe? And what would that mean for patients?

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open door to the sky.

Open Science and Its Enemies: Policy Initiatives in South Africa 

Donrich Thaldar Leave a comment

By Donrich Thaldar

Within South Africa’s science policy landscape, two recent proposals, the Draft National Open Science Policy and the Draft National Policy on Data and Cloud, highlight an ideological struggle between individual freedom and central control by the state.

This article discusses both of these proposals, the strengths and weaknesses of their approaches, and their concordance with broader social and political goals in South Africa.

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line drawing of computers, tablets, and televisions.

Autistic Screen Time: Swipe Left on Stigma

The Petrie-Flom Center Staff Leave a comment

By Maxfield Sparrow

I am an autistic person who has been using the internet as a social prosthetic device since 1983. I was born in 1967 and began therapy in 1972, so the iPad didn’t exist and the only screen time parents worried about was the five channels of broadcast television available twenty hours a day. TV was fine, but my real passion was books. I was hyperlexic and from a very early age I had an unquenchable thirst for written language. My obsession with reading was considered pathological, and adults took my books away to try to force me to socialize with other children instead.

It didn’t work. But it is sadly common that those of us with developmental disabilities are held to higher standards than everyone else. As children, once we are identified, everything about us is scrutinized. Well-meaning adults, fearing for our future, hold us to higher standards of everything from politeness to academic discipline to the age-appropriateness of our interests to the ways we move through the world. We’re not allowed to “get away with” the things non-disabled kids do every day.

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Cover image of Ashley Shew's book, Against Technoableism.

Symposium Introduction: Addressing Technoableism: Reforming Infrastructure and Disability Representation

The Petrie-Flom Center Staff Leave a comment

By Ashley Shew

Far too often, when people write and talk about technology and disability, stories are deeply shaped by ableism. Often when devices are painted as “solving the problem of disability” or “empowering disabled people,” they suggest that being disabled is itself a problem, and that people should try to be as nondisabled as possible. But pretending to be nondisabled is not a great way to live — to be in hiding or denial, to not give your body and mind the rest they deserve, to hurt yourself trying to live up to expectations and infrastructure sometimes literally designed to keep you out. Technology itself gets painted as heroic and important — and, please, investors, throw more money at the tech industry — when any disability is mentioned. Disability is often appealed to as a justification for technological development, and as a moral imperative toward investment in technological research. This is technoableism as I describe it in my book, Against Technoableism: Rethinking Who Needs Improvement. 

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View of runners crossing Verrazano Bridge at the start of NY City Marathon

What the New York City Marathon Can Teach Us About Equitable Access to Vaccines

The Petrie-Flom Center Staff Leave a comment

By Ana Santos Rutschman

What can the New York City Marathon experience teach those reflecting on ways to increase equity in the transnational allocation of scarce vaccine doses?

Quite a lot, it turns out. I explore this analogy in a recently published article in the Journal of Law, Medicine and Ethics (JLME), Increasing Equity in the Transnational Allocation of Vaccines Against Emerging Pathogens: A Multi-Modal Approach.

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Close up of surgery team operating.

Access to Uterus Transplantation and the Workplace

The Petrie-Flom Center Staff Leave a comment

By Natasha Hammond-Browning

Uterus transplantation first hit the headlines in 2014, with the birth of the first baby born following a uterus transplant. This first birth in Sweden has led to trials worldwide. Most recently, in August 2023, the United Kingdom saw its first uterus transplant. In the United States, the University of Alabama (UAB) Medicine uterus transplant program is the first program to offer uterus transplantation outside of a clinical trial, and the first birth in that program was in May 2023.

While recent estimates of future uterus transplants are relatively small — for instance, Womb Transplant UK estimates that between 20-30 uterus transplants could be performed annually — the increasing number of uterus transplant recipients should not be ignored. In particular, questions of access and the workplace rights of those undergoing this surgery are important to consider. This post will briefly lay out some of the issues that may arise for potential recipients and their partners in the workplace.

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Scales with the center depicted as an egg being fertilized through ivf.

Surrogacy and Employment Rights in the UK    

The Petrie-Flom Center Staff Leave a comment

By Zaina Mahmoud and Kirsty Horsey

At the end of March 2023, the Law Commission of England and Wales and the Scottish Law Commission published their joint Report, Building Families Through Surrogacy: A New Law, outlining recommendations for a new regulatory regime governing surrogacy in the UK, including a new route to (legal) parenthood for intended parents (IPs), referred to as “the new pathway” (para 1.10). Chapter 15 of the Report provides an overview of the consequential impact of surrogacy on other areas of law — most relevantly here, employment law.

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