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

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

Protecting Consumer Privacy in DTC Tissue Testing

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

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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DNA helix on colored background.

State Genetic Privacy Statutes: Good Intentions, Unintended Consequences?

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.

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File folders containing medical records.

How Dobbs Threatens Health Privacy

By Wendy A. Bach and Nicolas Terry

Post-Dobbs, the fear is visceral. What was once personal, private, and one hoped, protected within the presumptively confidential space of the doctor-patient relationship, feels exposed. In response to all this fear, the Internet exploded – delete your period tracker; use encrypted apps; don’t take a pregnancy test. The Biden administration too, chimed in, just days after the Supreme Court’s decision, issuing guidance seeking to reassure both doctors and patients that the federal Health Privacy Rule (HIPAA) was robust and that reproductive health information would remain private. Given the history of women being prosecuted for their reproductive choices and the enormous holes in HIPAA that have long allowed prosecutors to rely on healthcare information as the basis for criminal charges, these assurances rang hollow (as detailed at length in our forthcoming article, HIPAA v. Dobbs). From a health care policy perspective, what is different now is not what might happen. All of this has been happening for decades. The only difference today is the sheer number of people affected and paying attention.

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Medicine doctor and stethoscope in hand touching icon medical network connection with modern virtual screen interface, medical technology network concept

AI in Digital Health: Autonomy, Governance, and Privacy

The following post is adapted from the edited volume AI in eHealth: Human Autonomy, Data Governance and Privacy in Healthcare.

By Marcelo Corrales Compagnucci and Mark Fenwick

The emergence of digital platforms and related technologies are transforming healthcare and creating new opportunities and challenges for all stakeholders in the medical space. Many of these developments are predicated on data and AI algorithms to prevent, diagnose, treat, and monitor sources of epidemic diseases, such as the ongoing pandemic and other pathogenic outbreaks. However, these opportunities and challenges often have a complex character involving multiple dimensions, and any mapping of this emerging ecosystem requires a greater degree of inter-disciplinary dialogue and more nuanced appreciation of the normative and cognitive complexity of these issues.

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Hand holding smartphone with colorful app icons concept.

The Fourth Amendment and the Post-Roe Future of Privacy

By Katie Gu

An April 2021 data privacy bill sponsored by Senator Ron Wyden (D-OR) has taken on new urgency in the post-Roe Digital Age.

The bipartisan bill, The Fourth Amendment Is Not For Sale Act, would close the current legal loophole through which the FBI, Department of Homeland Security, Department of Defense, Customs and Border Protection, Immigration and Customs Enforcement, and the Internal Revenue Service, have repeatedly purchased Americans’ personal and consumer information from data brokers.

In the wake of the recent Dobbs v. Jackson Women’s Health Organization decision, this bill may play an important role in protecting reproductive health data against government overreach and new forms of surveillance technologies.

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Washington, DC, USA, May 5, 2022: people protest the leaked draft Supreme Court opinion overturning Roe v. Wade and the right to abortion

Stemming Supreme Court Rights Reversals

By James G. Hodge, Jr.

Based on the May 2022 leak of an initial draft, most believe the Supreme Court will carry through some rescission of abortion rights later this month through its final opinion in Dobbs v. Jackson Women’s Health Organization.

Already, concerns have arisen over other freedoms the Court may seriously reconsider down the road, including rights to gay marriage, intimacy, contraception, and informational privacy.

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