By Hannah Rahim
The regulation of medical assistance in dying (MAID) is drastically different between the U.S. and Canada. Comparing the hasty liberalization of MAID in Canada with the more wary approach of the U.S. can yield important learnings for both countries.
By Neşe Devenot
Since the 2022 publication of “Preparing for the Bursting of the Psychedelic Hype Bubble,” a JAMA Psychiatry Viewpoint by David Yaden and colleagues, a wave of scholarship and commentaries has emphasized the ethical importance of nuanced science communication about the still-nascent field of psychedelic medicine.
By Adithi Iyer
As the provision of human tissue leaves the research realm and becomes a bona fide consumer transaction, our legal responses to these developments will be most effective when we know what we want to protect, and how.
Perhaps the most famous discussion around tissue “donation” comes from the story of Henrietta Lacks and her family. Ms. Lacks is the namesake and unknowing donor of HeLa cells, and subject of the Rebecca Skloot bestseller, The Immortal Life of Henrietta Lacks. In a settlement obtained just this past summer with manufacturing giant ThermoFisher, the Lacks estate (Ms. Lacks herself died of an aggressive cervical cancer in 1951) obtained a confidential payment for the unconsented taking of her cells for research. The settled case was built on an unjust enrichment claim, and while this wasn’t decided on the merits, it raises the question of whether a provision of tissue is a transfer of value. If so, what are our ownership stakes in that value? Read More
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.
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?
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.
By Christi Guerrini, David Gurney, Steve Kramer, CeCe Moore, Margaret Press, and Amy McGuire
State legislators have enacted a flurry of genetic privacy bills that will strengthen the privacy and security practices of direct-to-consumer genetic testing companies and give customers more control over their data. What they might not realize is that these bills could be interpreted in ways that limit law enforcement’s ability to use a new technique that helps identify violent criminals and human remains and exonerate the wrongfully convicted.
By Jennifer S. Bard
Until more is known about how to mitigate the threat of AI-fueled persuasion in human subject research, a ban on its use is the only reasonable way to keep the promise that we, as a country, made to those harmed while participating in research.
By Zainab Ahmed
Psychiatric care in the Emergency Department is all-or-nothing and never enough. Often, legal holds are the only intervention available, and they rarely are therapeutic. Upon discharge, our patients are, once again, on their own.
The ED acts as a safety-net for a failing health system, one that places little value on mental health services, either preventative or follow-up. The demand for acute psychiatric care is high; however, EDs have little physical capacity for psychiatric patients.
By Enrique Santamaría
Together with the Data Governance Act (DGA) and the General Data Protection Regulation (GDPR), the proposal for a Regulation on the European Health Data Space (EHDS) will most likely form the new regulatory and governance framework for the use of health data in the European Union. Although well intentioned and thoroughly needed, there are aspects of the EHDS that require further debate, reconsiderations, and amendments. Clarity about what constitutes scientific research is particularly needed.