Category: Privacy

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

Donrich Thaldar Leave a comment

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?

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

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

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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

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

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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 

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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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Siri, Apple's voice-activated digital assistant, tells iPhone user, "Go ahead, I'm listening," which also displays as text on the screen.

On Siri and Recognitive Violence

The Petrie-Flom Center Staff Leave a comment

By Joshua A. Halstead

As a disabled person who relies on speech recognition software to complete a range of daily writing tasks (from emails to book chapters), I am no stranger to the universe of voice assistants, having cut my teeth on Dragon Dictate in the ’90s.

Though I’m used to the software knowing my voice, that it now knows my location is uncanny. This discovery occurred on a morning stroll when Siri spelled “Urth Caffé” correctly, rather than, as was expected, scribing “earth café.” This is when I realized that my assistant had turned into a stalker.

In this short article, I argue that Apple’s decision to integrate user location data into Siri’s speech recognition system created a product that contributes to gentrification and could further marginalize disabled people.

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