hospital equipment

The Import of the UNCRPD and Disability Justice for Pandemic Preparedness and Response

By Joel Michael Reynolds and Rosemarie Garland-Thomson

During the COVID-19 crisis, many nation-states did not consult or substantively take into consideration treaties protecting the rights of people with disabilities when developing their pandemic responses.

For example, the United Nations’ 2008 Convention on the Rights of Persons with Disabilities (UNCRPD) is an international human rights treaty intended to protect the rights and dignity of all persons with disabilities. It articulates principles of non-discrimination (see especially Articles 2, 3, and 5) and broader obligations upon specific parties, such as states parties, which are obligated to protect the rights and freedoms of people with disabilities (see Article 4, et al.).

The failures to uphold these principles and obligations during the COVID-19 pandemic were met with a swift response. The Office of the United Nations High Commissioner for Human Rights (OHCHR) produced guidelines on COVID-19 and the rights of persons with disabilities in April of 2020, as well as a policy brief in May of that year.

This commentary outlines three of the more important considerations for international pandemic lawmaking — both for specific instruments and wider deliberation — with respect to people with disabilities in general and the United Nations’ 2008 Convention on the Rights of Persons with Disabilities (UNCRPD) in particular.

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Los Angeles, California, United States. June 23, 2021: #FreeBritney rally at LA Downtown Grand Park during a conservatorship hearing for Britney Spears.

How Adult Guardianship Law Fails to Protect Contraceptive Decision-Making Rights

By Kaitlynn Milvert

After Britney Spears testified this past summer about her struggle to have her intrauterine device (IUD) removed while under conservatorship, many commentators posed a simple, but critical question: Can conservators (or guardians) make contraceptive decisions for those under their care?

Attempting to answer that question reveals an area of state guardianship law where guardians’ authority is particularly murky and ill-defined. Reform is needed to address the restrictions on reproductive decision-making rights that adults under guardianship currently face.

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Child with bandaid on arm.

Should Vaccinating Children Off-Label Against COVID-19 Be Universally Prohibited?

By Govind PersadPatricia J. Zettler, and Holly Fernandez Lynch

As children are experiencing the highest rates of COVID-19 in many states, can efforts to universally preclude vaccination of those under 12 until the U.S. Food and Drug Administration (FDA) specifically authorizes use in that age group be justified?

In a case commentary published today in Pediatrics, we argue that the answer is no.

This view diverges from the positions of the American Association of Pediatrics, FDA, and the U.S. Centers for Disease Control and Prevention (CDC). In fact, the CDC, which controls the nation’s supply of COVID-19 vaccines, has taken steps to currently ban the practice of vaccinating youth under the age of 12.

We acknowledge that recommendations to widely vaccinate 5-11 year olds should await FDA and CDC guidance (which is expected soon, given upcoming advisory committee meetings). But, especially at the lower dose offered in pediatric clinical trials, we think that off-label pediatric administration of approved COVID-19 vaccines, like Pfizer’s Comirnaty mRNA vaccine, should be treated like other off-label uses and left to the individual risk-benefit judgments of doctors and patients (or here, parents).

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UN United Nations general assembly building with world flags flying in front - First Avenue, New York City, NY, USA

Legal Capacity and Persons with Disabilities’ Struggle to Reclaim Control over Their Lives

The Health Law, Policy, Bioethics, and Biotechnology Workshop provides a forum for discussion of new scholarship in these fields from the world’s leading experts. Though the Workshop is typically open to the public, it is not currently, due to the COVID-19 pandemic. However, many of our presenters will contribute blog posts summarizing their work, which we are happy to share here on Bill of Health.

By Matthew S. Smith & Michael Ashley Stein

Persons with disabilities face an ongoing struggle to reclaim power and control over their lives.

The United Nations Convention on the Rights of Persons with Disabilities (CRPD) is an important tool in this struggle.

In mental health care settings, the CRPD has challenged states and practitioners to reject coercive forms of care orchestrated by substitute decision-makers — be they clinicians, family members, or court appointees — in favor of modalities that preserve and privilege individuals’ direct control over their care.

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Hand holding smartphone with colorful app icons concept.

Who Owns the Data Collected by Direct-to-Consumer Health Apps?

By Sara Gerke and Chloe Reichel

Who owns the data that are collected via direct-to-consumer (DTC) health apps? Who should own that data?

We asked our respondents to answer these questions in the third installment of our In Focus Series on Direct-to-Consumer Health Apps. Learn about the respondents and their views on data privacy concerns in the first installment of this series, and read their thoughts on consumer access to DTC health app data in the second installment.

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Society or population, social diversity. Flat cartoon vector illustration.

Engendering Equity in Biomedical Research by Meeting Communities Where They Are

By Rachele Hendricks-Sturrup

To address the root of both health disparities and community underrepresentation in biomedical research, it is mission-critical to teach early-stage career researchers how to empower underrepresented communities as partners in research while respecting and appreciating local history, context, and values.

As a researcher, I often encounter empirical studies in the literature that explore and experiment with institutionally– (versus community-) derived interventions that are meant to help boost underrepresented community engagement in biomedical research.

What if researchers took more time to intentionally harness their power and training to elevate, empower, and mobilize the voices of the communities they study to help design more impactful engagement interventions?

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Illustration of multicolored profiles. An overlay of strings of ones and zeroes is visible

Should Users Have Access to Data Collected by Direct-to-Consumer Health Apps?

By Sara Gerke and Chloe Reichel

Should consumers have access to the data (including the raw data) that are collected via direct-to-consumer (DTC) health apps? What real-world challenges might access to this data introduce, and how might they be addressed?

In this second installment of our In Focus Series on Direct-to-Consumer Health Apps, that’s what we asked our respondents. Learn about the respondents and their views on data privacy concerns in the first installment of this series. Read on for their thoughts on whether and how consumers should gain access to the data that direct-to-consumer health apps collect.

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hands hold phone with app heart and activity on screen over table in office

Perspectives on Data Privacy for Direct-to-Consumer Health Apps

By Sara Gerke and Chloe Reichel

Direct-to-consumer (DTC) health apps, such as apps that manage our diet, fitness, and sleep, are becoming ubiquitous in our digital world.

These apps provide a window into some of the key issues in the world of digital health — including data privacy, data access, data ownership, bias, and the regulation of health technology.

To better understand these issues, and ways forward, we contacted key stakeholders representing a range of perspectives in the field of digital health for their brief answers to five questions about DTC health apps.

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Traditional countryside scene in the Netherlands with windbreak lane of poplar trees in the wind under summer sky. Ens, Flevoland Province, the Netherlands.

Q&A with Mason Marks on New Psychedelics Law and Regulation Initiative

By Chloe Reichel

On June 30th, the Petrie-Flom Center announced the launch of a three-year research initiative, the Project on Psychedelics Law and Regulation (POPLAR), which is supported by a generous grant from the Saisei Foundation.

The Project on Psychedelics Law and Regulation at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School will advance evidence-based psychedelics law and policy.

In 2017, the FDA designated MDMA a breakthrough therapy for post-traumatic stress disorder, and in 2018 the agency recognized psilocybin as a breakthrough therapy for treatment-resistant depression. These designations indicate that psychedelics may represent substantial improvements over existing treatments for mental health conditions. Many other psychedelics, including ibogaine, ketamine, and dimethyltryptamine, are the focus of ongoing psychiatric research and commercialization efforts.

Despite the proliferation of clinical research centers and increasing private investment in psychedelic drug development, there is a relative lack of research on the ethical, legal, and social implications of psychedelics research, commerce, and therapeutics.

In the following interview, which has been edited and condensed, Senior Fellow and POPLAR Project Lead Mason Marks explains how POPLAR will fill this gap, and previews some of the initiative’s topics of inquiry.

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Home innovation technology concept illustration.

Call for Abstracts — 2022 Petrie-Flom Center Annual Conference: Diagnosing in the Home

Contribute to the 2022 Petrie-Flom Center Annual Conference and subsequent book project!

Through October 14, 2021, the Petrie-Flom Center is accepting abstracts for its annual conference. The 2022 annual conference will focus on ethical, legal, and regulatory challenges and opportunities around at home digital health technology.

This conference will engage with the vision for a 21st century health care system that embraces the potential of at home digital products to support diagnoses, improve care, encourage caregivers, maximize pandemic resilience, and allow individuals to stay within the home when preferable. The goals of this conference and subsequent book project are to consider the ethical, sociological, regulatory, and legal challenges and opportunities presented by the implementation of digital products that support clinical diagnosis and/or treatment in patients’ homes over the next decade.

Interested in submitting an abstract, but want to know more about what we’re looking for? Read through the following frequently asked questions.

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