Category: Professional Regulation

Double exposure of abstract digital world map on laptop background.

Harmonizing Africa’s Data Governance: Challenges and Solutions

Donrich Thaldar Leave a comment

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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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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U.S. Supreme Court

Context Matters: Affirmative Action, Public Health, and the Use of Population-Level Data

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By Wendy E. Parmet, Elaine Marshall & Alisa K. Lincoln

Last June, in Students for Fair Admissions (SFFA), the Supreme Court ruled that universities could not consider race in admitting students. In support of that decision, the Court dismissed the relevance of data about the varied experiences of racial groups, insisting that admissions decisions must be based solely on the experiences and merits of individual applicants. The Court’s rejection of group-level data evinces a critical misunderstanding about the uses and limits of such data that, if applied more broadly, portends troubling implications for health equity and health policy.

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Hundred dollar bills rolled up in a pill bottle

Reasonable Pricing Clauses: A First Step Toward Ensuring Taxpayers a Fair Return on their Public R&D Investment

The Petrie-Flom Center Staff Leave a comment

By Nikhil Chaudhry and Reshma Ramachandran

Earlier this month, the Department of Health and Human Services announced that it had successfully included a reasonable pricing provision in a $326M investment contract with Regeneron for development of a next generation monoclonal antibody therapy for COVID-19. This was the first time the Biden Administration had included such a provision as part of its research funding agreements with the private sector, demonstrating that it is indeed possible for the federal government to negotiate deals with pharmaceutical companies that ensure that products developed with public dollars are priced comparably to the global market.

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

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

James Jolin 1 Comment

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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Empty nurses station in a hospital.

The NHS Patient Safety Information Tidal Wave

John Tingle Leave a comment

By John Tingle

The English National Health Service (NHS) was 75 years of age on 5th July 2023 and there was a lot to celebrate. We are proud of our universal health care system which provides free care at the point of delivery. The NHS is an intrinsic part of our national heritage and culture.

The King’s Fund provide some facts and figures on the NHS. It has one of the world’s largest workforces with around 1.26 million full-time equivalent staff in England, as of November 2022. In terms of patient care and treatment, the King’s Fund states that on an average day in the NHS, more than 1.2 million people attend a general practitioner (GP) appointment, and around 260,000 an outpatient appointment. The NHS faces high demand for finite health care resources. We have a growing elderly population in England presenting often with comorbidities. Staffing levels are also a problem, which is being addressed in the NHS long term workforce plan.

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Austin, TX, USA - Oct. 2, 2021: Participants at the Women's March rally at the Capitol protest SB 8, Texas' abortion law that effectively bans abortions after six weeks of pregnancy.

Why Must Abortion Providers Needlessly Travel to Texas?

Carmel Shachar Leave a comment

By Carmel Shachar

This year, the American Board of Obstetrics and Gynecology (ABOG) — the organization that runs the exam doctors must take to become certified in obstetrics and gynecology (OB-GYN) — is requiring all candidates to attend in-person examinations in Dallas, Texas. By doing so, ABOG is failing its duties to its membership by asking the practitioners who are most likely to provide abortion services to travel to a state with a legal regimen that is particularly hostile to them.

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