blue brain hovers over bright blue circle.

Is OI the New AI? Questions Surrounding “Brainoware”

By Adithi Iyer

The idea of artificial intelligence is just seeping into our collective consciousness, but as we watch new developments in the space, the true “new kid on the block” may be a new type of infused human-technology intelligence — one derived from a blob of cells no larger than a grain of rice. These new units of computational prowess are brain organoids, grown in-lab and capable of producing very basic, but real-time, neurological activity. Brain organoids are a specific, and arguably the most interesting, subset of organoid models that are just beginning to enter legal debates.

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Culturing cells in tissue culture plates.

R&D Mini-Me? New Legal Questions for Organoids

By Adithi Iyer

I have written previously about the not-so-distant possibility and promise of regenerative medicine, an area concerned with therapies that encourage the body to repair or heal itself. Cell-mediated and tissue-based technologies hold promise in inducing self-repair from within the body, and they’re making their way to market in traditional medicine. Much has been made of recently discussed CAR-T cell therapies for cancer, which have been around since 2017, and in-human sickle cell treatment Casgevy. Such applications of regenerative medicine and tissue engineering are wide-spanning and range across the bench-to-bedside pathway.

One application of regenerative medicine gaining some ground in the R&D space is the organoid. Organoids are lab-grown masses of cells and tissue that assemble to form miniature organs or organ systems in vitro. They come, too, in different forms and types, and while some organoid applications are heavily modified for specific functions, many are meant to recreate and model the naturally occurring organ systems we would find in our own bodies.

Organoids may sound especially futuristic, but are currently used regularly in labs for different research and therapeutic applications. A functional “organ” model not attached to a human body could offer the opportunity to model diseases and test treatments in real time without the need for an animal model (like the mice used today), especially in preclinical and early clinical trials for new drugs. Organoids generate information and data, and a single organoid model can even be hooked up to a “system” with other organoids to model systems and interrelated processes at once. The production of these models occurs in-lab, often involving stem cells that can divide and organize into tissues and organs on their own.

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Newspapers and Laptop.

AI, Copyright, and Open Science: Health Implications of the New York Times/OpenAI Lawsuit

By Adithi Iyer

The legal world is atwitter with the developing artificial intelligence (“AI”) copyright cage match between The New York Times and OpenAI. The Times filed its complaint in Manhattan Federal District Court on December 27 accusing OpenAI of unlawfully using its (copyrighted and paywalled) articles to train ChatGPT. OpenAI, in turn, published a sharply-worded response on January 8, claiming that its incorporation of the material for training purposes squarely constitutes fair use. This follows ongoing suits by authors against OpenAI on similar grounds, but the titanic scale of the Times-OpenAI dispute and its application of these issues to media in federal litigation makes it one to watch. While much of the buzz around the case has centered on its intellectual property and First Amendment implications, there may be implications for the health and biotech industries. Here’s a rundown of the major legal questions at play and the health-related stakes for a future decision.

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A surveillance camera on a white background.

Combatting Elder Abuse in Long-Term Care: Challenges and Opportunities of Electronic Monitoring

By Laura C. Hoffman

The aging population is growing at an extraordinary rate in the U.S. By 2040, it is anticipated that the U.S. aging population (defined as those ages 65 and older) will double, totaling 80 million.

Given this growth, preventing elder abuse must be at the forefront of policymaking. The U.S. Centers for Disease Control and Prevention (CDC) has recognized elder abuse as a “serious” problem that is commonly occurring, yet significantly underreported, in the U.S.

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3D illustration of a Renaissance marble statue of Zeus, king of the gods, who was also the god of the sky and thunder. Zeus in Greek mythology is known as Jupiter in Roman mythology.

Data Pseudonymization and POPIA

By Donrich Thaldar

Just as Zeus, the King of the Gods in Greek mythology, assumed various forms to conceal his true identity, so does modern data often undergo transformations to mask its origins. Zeus could become a swan, a bull, or even golden rain to achieve his purposes — all while maintaining his essence. Similarly, pseudonymization techniques aim to alter data enough to protect individual privacy without losing the core information necessary for research or analysis. This entails replacing data subjects’ identifying information in a dataset with unique codes, while keeping another dataset that links these data subjects’ identifying information with their allocated codes. Therefore, just as Zeus’ transformations were sometimes seen through by keen eyes, pseudonymized data can be re-identified by those having access to the linking dataset.

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Person hands keys into another person's outstretched hand.

We May Not ‘Own’ Our Bodies. Should We?

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

President Joe Biden at desk in Oval Office.

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

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

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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Doctor asking patient to fill out survey before medical treatment.

Key Considerations for Patient-Reported Outcome Measures

By Sharona Hoffman

Patient-reported outcome measures (PROMs) are questionnaires that patients fill out on tablets or other computers or devices. They ask patients to check boxes in answer to questions about their symptoms, treatment effects, and ability to function physically, emotionally, and socially. They thus may solicit very sensitive information about matters such as anxiety, depression, and sexual satisfaction. To illustrate, a query might be “in the past month, how often did you have a lot of trouble falling asleep,” and the patient is asked to check “never,” “rarely,” “sometimes,” “often,” or “always.”

PROM responses can be used for purposes of clinical care, research, quality improvement, Food and Drug Administration (FDA) approval of drugs and devices, and even insurance reimbursement. For example, insurers hypothetically could decide to decline coverage of particular treatments based on PROM responses indicating that many patients find them to be unhelpful.

I first became interested in patient-reported outcome measures because of an experience my husband had. Andy has Parkinson’s disease, and one of the neurologists he saw asked him to fill out a long questionnaire on a tablet computer before each appointment. This task was difficult for Andy because he had a hand tremor, and it was stressful because Andy worried that he would not have time to complete the survey before his appointment began. Moreover, Andy’s physician never referred to his responses and appeared never to look at them. Upon investigation, I found little to no analysis of PROMs in the legal literature, so Andy and I recently published a law review article about them.

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