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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open door to the sky.

Open Science and Its Enemies: Policy Initiatives in South Africa 

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

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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Hand with a red napkin washes the chalk board.

A European Cancer Survivors’ Right to be Forgotten?

By Hannah van Kolfschooten and Mirko Faccioli

There are currently over 12 million cancer survivors in Europe. Due to improving cancer screening methods and medical treatment, this number is expected to grow every year. Former cancer patients often face multiple forms of discrimination throughout their lives. Many commercial companies make long-term cancer survivors “pay twice” – while having similar life expectancies as their peers, they are denied access to key services because of their former cancer status.

To combat this unfair practice, some European countries are establishing a “cancer survivors’ right to be forgotten,” also referred to as the “oncological right to be forgotten.” Italy’s parliament just passed a law to establish the right. Patients’ rights organizations and EU institutions are pushing for a “European cancer survivors’ right to be forgotten.” This post outlines the purpose of such a right and flags potential challenges in its adoption.

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Three blister packs of birth control pills on a pink background.

Opill’s FDA Approval: Implications for Pharmaceutical Regulation and Access to Care

By James René Jolin and Susannah Baruch

On July 13, 2023, the United States Food and Drug Administration (FDA) approved Opill (norgestrel) as the first daily oral contraceptive available for non-prescription use in the U.S. While the timeline for availability and price of Opill will ultimately be set by its manufacturer, Perrigo, this recent move represents a significant step forward in improving access to contraceptive health care. Indeed, shortly after Opill’s approval, the American College of Obstetricians and Gynecologists described the FDA’s decision as “a critically important advancement in the accessibility of reproductive health care.”

In response to this development, Petrie-Flom Center intern James René Jolin and Executive Director Susannah Baruch sat down to discuss its legal, regulatory, and public health implications. This interview has been edited for brevity and clarity.

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Woman injecting hormones into her abdomen to stimulate follicles for IVF.

Parental Leave Has Proven It Works — It Is Time to Talk About Assisted Reproduction Leave

By Dafni Lima

A series of legal rules are designed to ensure that, when welcoming a child, parents are given the protection and support they need in relation to work. The same cannot be said for those dealing with challenges unique to assisted reproduction. This post argues that the protective rationale of parental leave should be extended to address the needs for those undergoing fertility treatment in the form of a new “assisted reproduction leave.”

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A Professional In Vitro Fertilisation Microscope with A Monitor in Background

Introduction to the Symposium: Reproductive Technologies and Workplace Equality

By Victoria Hooton and Elizabeth Chloe Romanis

Decisions about whether and how to reproduce are some of the most intimate and personal choices individuals and/or couples can make. For people struggling with involuntary childlessness, attempting to become a parent can involve some particularly complex decision making about technological assistance. Inevitably, these decisions touch upon all aspects of a person’s life. Their employment is no exception. People’s working status and working conditions, set against the broader context of their social circumstances, can have a huge influence on what decisions they feel able to make. This is particularly relevant for people who, for biological, social, or psychosocial reasons, need to use assisted reproductive technologies (ARTs) to reproduce.

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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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