263 results match your criteria: "Petrie-Flom Center for Health Law Policy[Affiliation]"

Preimplantation sex selection via in vitro fertilization: time for a reappraisal.

F S Rep

September 2023

Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard University, Cambridge, Massachusetts.

In recent years, there has been rapid increase in the availability of elective sex selection via genetic testing of preimplantation embryos created through in vitro fertilization. We explore the standing of this ethically controversial practice in the context of a changing legal landscape after the Dobbs v Jackson Women's Health decision by the US Supreme Court.

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While the literature on putting a "human in the loop" in artificial intelligence (AI) and machine learning (ML) has grown significantly, limited attention has been paid to how human expertise ought to be combined with AI/ML judgments. This design question arises because of the ubiquity and quantity of algorithmic decisions being made today in the face of widespread public reluctance to forgo human expert judgment. To resolve this conflict, we propose that human expert judges be included via appeals processes for review of algorithmic decisions.

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Maternal Mortality Crisis and Extension of Medicaid Postpartum Coverage.

JAMA

September 2023

Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School, Harvard University, Cambridge, Massachusetts.

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The FDA Declares Levonorgestrel a Nonabortifacient-A 50-Year Saga Takes a Decisive Turn.

JAMA Health Forum

August 2023

Harvard Law School, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard University, Cambridge, Massachusetts.

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This article revisits the debate on the regulation of human genomic research, with a focus on Africa. The article comprehensively examines the concept of genomic sovereignty, which was invoked mainly in the global South as a conceptual framework for state regulation of human genomic research. It demonstrates that genomic sovereignty has no utility value in human genomic research as it violates the rights of individuals and researchers.

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What Should ChatGPT Mean for Bioethics?

Am J Bioeth

October 2023

Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics, Harvard Law School.

In the last several months, several major disciplines have started their initial reckoning with what ChatGPT and other Large Language Models (LLMs) mean for them - law, medicine, business among other professions. With a heavy dose of humility, given how fast the technology is moving and how uncertain its social implications are, this article attempts to give some early tentative thoughts on what ChatGPT might mean for bioethics. I will first argue that many bioethics issues raised by ChatGPT are similar to those raised by current medical AI - built into devices, decision support tools, data analytics, etc.

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The Challenges for Regulating Medical Use of ChatGPT and Other Large Language Models.

JAMA

July 2023

Harvard Law School, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard University, Cambridge, Massachusetts.

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Assisted reproduction post-: the prospect of legislative protection.

F S Rep

June 2023

Harvard Law School, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard University, Cambridge, Massachusetts.

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After considerable progress in recent decades, maternal mortality and morbidity (MMM) either stagnated or worsened in most regions of the globe between 2016 and 2020. The world should be outraged given that we have known the key interventions necessary for preventing MMM for over three-quarters of a century. Since the 1990s, human rights advocacy on MMM has gained crucial ground, demonstrating that entitlements related to maternal health are judicially enforceable and delineating rights-based approaches to health in the context of MMM.

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Despite advocacy in favour of benefit sharing with research participants in genomics research that is conducted in South Africa, there has been little critical legal engagement with this concept. That is what this article provides by posing the hitherto unexplored-but foundational-question: Is benefit sharing with research participants lawful in South Africa? The answer is clearly 'no'. South African law provides that it is unlawful to provide any financial or other reward to research participants for donating biospecimens-except for reimbursement of reasonable costs incurred.

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Towards a data transfer agreement for the South African research community: The empowerment approach.

S Afr J Bioeth Law

April 2023

School of Law, College of Law and Management Studies, University of KwaZulu-Natal, Durban, South Africa.

The idea of a data transfer agreement (DTA) template for the South African (SA) research community is receiving increasing attention. While developing such a DTA template is certainly a worthwhile project, questions regarding the project's practical execution should be addressed, including how to best operationalise the envisioned DTA template, and the content of the envisioned DTA template. It is proposed that an empowerment approach be followed in operationalising the envisioned DTA template, which is contrasted with the regulatory approach followed with the material transfer agreement that the Minister of Health promulgated in 2018.

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Hospital at Home Receives a New Lease on Life: A Promising if Uncertain Future.

Am J Med

October 2023

Harvard, Law School, Harvard University, Cambridge, Mass; Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard University, Cambridge, Mass.

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Patient-Assistance Programs, Kickbacks, and the Courts.

N Engl J Med

June 2023

From the Center for Health and Pharmaceutical Law, Seton Hall University School of Law, Newark, NJ (J.T.E.); the Department of Medical Science, Brown University, Providence, RI (E.Y.A.); and Harvard Law School and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard University - both in Cambridge, MA (I.G.C.).

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Novel forms of assisted gestation-uterus transplantation and artificial placentas-are highly anticipated in the ethico-legal literature for their capacity to enhance reproductive autonomy. There are also, however, significant challenges anticipated in the development of novel forms of assisted gestation. While there is a normative exploration of these challenges in the literature, there has not yet, to my knowledge, been empirical research undertaken to explore what reproductive rights organisations and advocates identify as potential benefits and challenges.

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In 2021, the WHO Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing (the 'Committee') published its policy recommendations. It proposes, inter alia, a set of nine values and principles to inform the governance of human genome editing (HGE) and makes recommendations regarding how HGE can be regulated. While these proposals contain valuable contributions to the discourse on the global governance of HGE, they also contain elements that call for heightened attention to the risks of the technology, and a countervailing focus on the potential benefits of the technology is missing.

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Genomics research holds the potential to improve healthcare. Yet, a very low percentage of the genomic data used in genomics research internationally relates to persons of African origin. Establishing a large-scale, open access genomics database of South Africans may contribute to solving this problem.

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Time plays a fundamental role in abortion regulation. In this article, we compare the regulatory frameworks in England and Wales and the Netherlands as examples of the centrality accorded to viability in the determination of the parameters of non-criminal abortion, demonstrating that the use of viability as a threshold renders the law uncertain. We assess the role played by the concept of viability, analysing its impact upon the continued criminalization of abortion and categorization of abortion as a medical matter, rather than a reproductive choice.

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