Tag: Privacy

Open Genomics and Privacy: New Case Law in South Africa Affirms a Key Principle

Donrich Thaldar Leave a comment

by Donrich Thaldar

As the era of genomic medicine dawns, large-scale genomics projects are becoming increasingly central to health care advancements. Projects like FinnGen in Finland, the UK Biobank, and the All of Us initiative in the United States are charting new frontiers in precision medicine, enabling researchers to unlock the genetic codes underlying a wide array of diseases. These initiatives collect genetic data from hundreds of thousands of individuals, providing an invaluable resource to identify disease markers and tailor medical treatments to individuals’ genetic makeup. Such projects are not only pushing the boundaries of medical knowledge but are also laying the foundation for a future where treatments are more effective and personalized.

However, in the Global South, large-scale genomics projects are far fewer. Qatar has taken strides with its own Qatar Genome Program, but examples are still limited across Africa and other regions, where genomics research is often constrained by funding, infrastructure, and representation issues. In Africa, where genetic diversity is high but research representation has historically been low, the need for such projects is critical. Without local genomics data, the benefits of precision medicine may largely bypass African populations, further exacerbating global health inequities.

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When AI Turns Miscarriage into Murder: The Alarming Criminalization of Pregnancy in the Digital Age

The Petrie-Flom Center Staff Leave a comment

by Abeer Malik

Imagine: Overjoyed at your pregnancy, you eagerly track every milestone, logging daily habits and symptoms into a pregnancy app. Then tragedy strikes—a miscarriage. Amidst your grief, authorities knock at your door. They’ve been monitoring your digital data and now question your behavior during pregnancy, possibly building a case against you using your own information as evidence.

This dystopian scenario edges closer to reality as artificial intelligence (AI) becomes more embedded in reproductive health care. In a post-Dobbs world where strict fetal personhood laws are gaining traction, AI’s predictive insight into miscarriage or stillbirth are at risk of becoming tools of surveillance, casting suspicion on women who suffer natural pregnancy losses.

The criminalization of pregnancy outcomes is not new, but AI introduces a high-tech dimension to an already chilling trend. At stake is the privacy and the fundamental right of women to make decisions about their own bodies without fearing criminal prosecution. Alarmingly, the law is woefully unprepared for this technological intrusion.

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Health Care, AI, and the Law: An Emerging Regulatory Landscape in California

The Petrie-Flom Center Staff Leave a comment

by Rebekah Ninan

This past month, California Governor Gavin Newsom signed a wave of artificial intelligence-related legislation into law. Much public debate has been focused on SB 1047, a proposal ultimately vetoed by Governor Newsom, which would have held AI companies liable for “catastrophic harms” from AI models. Comparatively little attention has been paid to three new laws aimed at health care-related AI and data privacy. Three laws are AB-3030, SB-1223, and SB-1120. AB 3030 requires that health care providers disclose when they have used generative AI to create communications with patients. SB 1223 amended the California Consumer Privacy Act of 2018 to include neural data as sensitive personal information, whose collection and use companies can be directed to limit. Finally, SB 1120 limits the degree to which health insurers can use AI to determine medical necessity for member health care services. This article seeks to summarize these developments in the law.

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Protecting Health Privacy is a Royal Pain

Bobby Stroup Leave a comment

Heightened Scrutiny of Your Royal Highness

On Sunday, March 10, tabloids were in quite a frenzy when the British royal family published a photoshopped picture of Catherine, princess of Wales. The hubbub was extra hubbubbly, because this was the first official photo after the princess had abdominal surgery this past January. The order of events caused some people to speculate the edits indicated there was something to hide about the princess’s health status.

Shortly after the public reaction, the princess issued an apology for the edits. Sadly, less than two weeks later, the rumors were confirmed to be true: Princess Catherine did have a health problem. She had been diagnosed with cancer and had commenced preventative chemotherapy. As part of this announcement, Princess Catherine bravely encouraged the public, “For everyone facing this disease in whatever form, please do not lose faith or hope. You are not alone.” Read More

Person hands keys into another person's outstretched hand.

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

Adithi Iyer Leave a comment

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

The Petrie-Flom Center Staff Leave a comment

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

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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DNA helix on colored background.

State Genetic Privacy Statutes: Good Intentions, Unintended Consequences?

The Petrie-Flom Center Staff Leave a comment

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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