I. Glenn Cohen

James A. Attwood and Leslie Williams Professor of Law

Deputy Dean

Faculty Director, Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics

Biography

Prof. Cohen is one of the world's leading experts on the intersection of bioethics (sometimes also called "medical ethics") and the law, as well as health law. He also teaches civil procedure. From Seoul to Krakow to Vancouver, Professor Cohen has spoken at legal, medical, and industry conferences around the world and his work has appeared in or been covered on PBS, NPR, ABC, CNN, MSNBC, Mother Jones, the New York Times, the New Republic, the Boston Globe, and several other media venues.

He was the youngest professor on the faculty at Harvard Law School (tenured or untenured) both when he joined the faculty in 2008 (at age 29) and when he was tenured as a full professor in 2013 (at age 34), though not the youngest in history.

Prof. Cohen's current projects relate to big data, medical AI, health information technologies, mobile health, reproduction/reproductive technology, research ethics, organ transplantation, rationing in law and medicine, health policy, FDA law, COVID-19, translational medicine, and to medical tourism – the travel of patients who are residents of one country, the "home country," to another country, the "destination country," for medical treatment.

He is the author of more than 200 articles and chapters and his award-winning work has appeared in leading legal (including the Stanford, Cornell, and Southern California Law Reviews), medical (including the New England Journal of Medicine, JAMA), bioethics (including the American Journal of Bioethics, the Hastings Center Report), scientific (Science, Cell, Nature Reviews Genetics) and public health (the American Journal of Public Health) journals, as well as Op-Eds in the New York Times, Washington Post, New Republic, Time Magazine, and other venues.

Cohen is the author, co-author, editor, or co-editor of more than 18 books. They include: Consumer Genetic Technologies: Ethical and Legal Considerations (Cambridge University Press, 2021); Reproductive Technologies and the Law (Caroline Academic Press, 2021); Readings in Comparative Health Law and Bioethics (Carolina Academic Press, 2020); Disability, Health, Law, and Bioethics (Cambridge University Press, 2020); Transparency in Health and Health Care in the United States (Cambridge University Press, 2019); Health Care Law and Ethics (Aspen, 2018); Big Data, Health Law, and Bioethics (Cambridge University Press, 2018); Law, Religion, and Health in the United States (Cambridge University Press, 2017); Specimen Science (MIT Press, 2017); Nudging Health: Health Law and Behavioral Economics (John Hopkins University Press, 2016) The Oxford Handbook of U.S. Health Care Law (Oxford University Press, 2016); FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies (Columbia University Press, 2015); Identified Versus Statistical Lives: An Interdisciplinary Perspective (Oxford University Press, 2015); Patients with Passports: Medical Tourism, Law, and Ethics (Oxford University Press, 2014); Human Subjects Research Regulation: Perspectives on the Future (MIT Press, 2014); The Globalization of Health Care: Legal and Ethical Issues (Oxford University Press, 2013).

For his law school teaching he was awarded the HLS Student Government Teaching and Advising Award in 2017. He also sometimes teaches courses at Harvard College and Harvard Medical School. For the public he created the free online Harvard X class Bioethics: The Law, Medicine, and Ethics of Reproductive Technologies and Genetics, which was nominated by Harvard for the Japan Prize. More than 97,000 students have taken the course so far. You can also watch his Tedx talk, Are There Non-Human Persons? Are There Non-Person Humans? He is also the faculty lead on Zero-L, an online course to help law students transition to law school that is now being used by more than half of all U.S. law schools.

Prior to becoming a professor he served as a law clerk to Judge Michael Boudin of the U.S. Court of Appeals for the First Circuit and as a lawyer for U.S. Department of Justice, Civil Division, Appellate Staff, where he handled litigation in the Courts of Appeals and (in conjunction with the Solicitor General’s Office) in the U.S. Supreme Court. In his spare time (where he can find any!) he still litigates, having authored an amicus brief in the U.S. Supreme Court for leading gene scientist Eric Lander in Association of Molecular Pathology v. Myriad, concerning whether human genes are patent eligible subject matter, a brief that was extensively discussed by the Justices at oral argument. Most recently he submitted an amicus brief to the U.S. Supreme Court in Whole Women's Health v. Hellerstedt (the Texas abortion case, on behalf of himself, Melissa Murray, and B. Jessie Hill).

Cohen was selected as a Radcliffe Institute Fellow for the 2012-2013 year and by the Greenwall Foundation to receive a Faculty Scholar Award in Bioethics. He is also a Fellow at the Hastings Center, the leading bioethics think tank in the United States as well as being a fellow of the Pierre Elliot Trudeau Foundation.  He leads the Project on Precision Medicine, Artificial Intelligence, and the Law (PMAIL), which is part of the larger Centre for Advanced Studies in Biomedical Innovation Law (CeBIL). He co-leads the Regulatory Foundations, Ethics, and Law Program of Harvard Catalyst | The Harvard Clinical and Translational Science Center program. He is also the lead on the Project on Psychedelics Law and Regulation (POPLAR). He previously served as one of the key co-investigators on the multi-million dollar Football Players Health Study at Harvard which is committed to improving the health of NFL players (for more on this work click here). He is also one of three editors-in-chief of the Journal of Law and the Biosciences, a peer-reviewed journal published by Oxford University Press and serves on the editorial board for the American Journal of Bioethics. He served on the Steering Committee for Ethics for the Canadian Institutes of Health Research (CIHR), the Canadian counterpart to the NIH, and the Ethics Committee for the American College of Obstetricians and Gynecologists (ACOG). He currently serves on the Ethics Committee of the U.S. Organ Procurement and Transplantation Network (OPTN).

You can freely download his work here, and follow him on twitter @CohenProf.

Areas of Interest

FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies (Holly Fernandez Lynch & I. Glenn Cohen eds., Columbia Univ. Press 2015).
Categories:
Health Care
,
Government & Politics
,
Constitutional Law
Sub-Categories:
First Amendment
,
Administrative Law & Agencies
,
Congress & Legislation
,
Bioethics
,
Food & Drug Law
,
Health Law & Policy
Type: Book
Abstract
In its decades-long effort to assure the safety, efficacy, and security of medicines and other products, the Food and Drug Administration has struggled with issues of funding, proper associations with industry, and the balance between consumer choice and consumer protection. Today, these challenges are compounded by the pressures of globalization, the introduction of novel technologies, and fast-evolving threats to public health. With essays by leading scholars and government and private industry experts, FDA in the Twenty-First Century addresses perennial and new problems and the improvements the agency can make to better serve the public good.The collection features essays on effective regulation in an era of globalization, consumer empowerment, and comparative effectiveness, as well as questions of data transparency, conflicts of interest, industry responsibility, and innovation policy, all with an emphasis on pharmaceuticals. The book also intervenes in the debate over off-label drug marketing and the proper role of the FDA before and after a drug goes on the market. Dealing honestly and thoroughly with the FDA's successes and failures, contributors rethink the structure, function, and future of the agency and the effect policy innovations may have on regulatory institutions in other countries.
I. Glenn Cohen, Patients with Passports: Medical Tourism, Law, and Ethics (Oxford Univ. Press 2015).
Categories:
Health Care
Sub-Categories:
Bioethics
,
Health Law & Policy
Type: Book
Abstract
Can your employer require you to travel to India for a hip replacement as a condition of insurance coverage? If injury results, can you sue the doctor, hospital or insurer for medical malpractice in the country where you live? Can a country prohibit its citizens from helping a relative travel to Switzerland for assisted suicide? What about travel for abortion? In Patients with Passports, I. Glenn Cohen tackles these important questions, and provides the first comprehensive legal and ethical analysis of medical tourism. Medical tourism is a growing multi-billion dollar industry involving millions of patients who travel abroad each year to get health care. Some seek legitimate services like hip replacements and travel to avoid queues, save money, or because their insurer has given them an incentive to do so. Others seek to circumvent prohibitions on accessing services at home and go abroad to receive abortions, assisted suicide, commercial surrogacy, or experimental stem cell treatments. In this book, author I. Glenn Cohen focuses on patients traveling for cardiac bypass and other legal services to places like India, Thailand, and Mexico, and analyzes issues of quality of care, disease transmission, liability, private and public health insurance, and the effects of this trade on foreign health care systems. He goes on to examine medical tourism for services illegal in the patient's home country, such as organ purchase, abortion, assisted suicide, fertility services, and experimental stem cell treatments. Here, Cohen examines issues such as extraterritorial criminalization, exploitation, immigration, and the protection of children. Through compelling narratives, expert data, and industry explanations Patients with Passports enables the reader to connect with the most prevalent legal and ethical issues facing medical tourism today.
Human Subjects Research Regulation: Perspectives on the Future (I. Glenn Cohen & Holly Fernandez Lynch, eds., MIT Press 2014).
Categories:
Health Care
Sub-Categories:
Bioethics
,
Health Law & Policy
Type: Book
Abstract
The ANPRM requested public comment on how the current regulations for protecting human research subjects might be modernized and revised to improve efficiency and enhance protections. The ANPRM represents the first potential revision ...
Mason Marks & I. Glenn Cohen, Patents on Psychedelics: The Next Legal Battlefront of Drug Development, 135 Harv. L. Rev. F. (forthcoming 2022).
Categories:
Health Care
,
Property Law
Sub-Categories:
Food & Drug Law
,
Intellectual Property - Patent & Trademark
Type: Article
Abstract
In the past few decades, pioneering research has rekindled interest in the therapeutic use of psychedelic substances such as psilocybin, ibogaine, and dimethyltryptamine (DMT). Indigenous communities have used them for centuries, and researchers studied them in the 1950s and 60s. However, most psychedelics were banned in the 70s, when President Nixon launched the U.S. war on drugs. Fifty years later, rising rates of mental illness, substance use, and suicide are prompting researchers to revisit psychedelics, and some have gained permission to study them in limited quantities. Clinical trials are producing promising results, creating enthusiasm for commercializing and patenting psychedelics. This Essay analyzes the ethical, legal, and social implications of patenting these controversial substances. Patents on psychedelics raise unique concerns associated with their unusual qualities, history, and regulation. Because they were criminalized for decades, the Patent Office lacks personnel with expertise in the field, increasing the likelihood of granting meritless psychedelic patents. Moreover, because Indigenous communities pioneered many aspects of modern psychedelic therapies, their patenting by Western corporations may promote biopiracy, the exploitation of Indigenous knowledge without compensation. Importantly, control of psychedelics by a small number of companies may stifle innovation and reduce access to these therapies. The Essay presents proposals to reduce the risk of biopiracy and the issuance of meritless psychedelic patents. Potential solutions include the implementation of psychedelic patent pledges, the creation of psychedelic prior art repositories, and the tightening of patentability requirements for novel drug therapies. The Essay concludes that ultimately, due to their importance to the advancement of science and public health, psychedelics are appropriately viewed as research tools, eligible only for limited patent protection.
Eli Y. Adashi et al., Mitochondrial Disease: Replace or Edit?, 373 Science 1200 (2021).
Categories:
Health Care
Sub-Categories:
Genetics & Reproduction
Type: Article
Consumer Genetic Technologies: Ethical and Legal Considerations (I. Glenn Cohen, Nita A. Farahany, Henry T. Greely & Carmel Shachar eds., forthcoming September 2021).
Categories:
Consumer Finance
,
Health Care
Sub-Categories:
Consumer Protection Law
,
Genetics & Reproduction
Type: Book
Abstract
For the average person, genetic testing has two very different faces. The rise of genetic testing is often promoted as the democratization of genetics by enabling individuals to gain insights into their unique makeup. At the same time, many have raised concerns that genetic testing and sequencing reveal intensely personal and private information. As these technologies become increasingly available as consumer products, the ethical, legal, and regulatory challenges presented by genomics are ever looming. Assembling multidisciplinary experts, this volume evaluates the different models used to deliver consumer genetics and considers a number of key questions: How should we mediate privacy and other ethical concerns around genetic databases? Does aggregating data from genetic testing turn people into products by commercializing their data? How might this data reduce or exacerbate existing healthcare disparities? Contributing authors also provide guidance on protecting consumer privacy and safety while promoting innovation.
I. Glenn Cohen & Christopher T. Robertson, Cruise ship vaccine mandates are great. The latest ruling for them wasn’t., Wash. Post., Aug. 11, 2021.
Categories:
Health Care
,
Constitutional Law
Sub-Categories:
First Amendment
,
Health Law & Policy
Type: News
Abstract
A judge’s framing of the controversy as a free-speech issue fits a troubling pattern.
I. Glenn Cohen, Can Your Employer Require That You Get Vaccinated? It Depends Where You Live, Time, Aug. 2, 2021.
Categories:
Labor & Employment
,
Health Care
Sub-Categories:
Health Law & Policy
,
Labor Law
Type: Article
Boris Babic, Sara Gerke, Theodoros Evgeniou & I. Glenn Cohen, The Hidden Hazards of Smart Device Medical Advice, INSEAD Knowledge (July 12, 2021).
Categories:
Technology & Law
,
Consumer Finance
Sub-Categories:
Consumer Protection Law
,
Medical Technology
Type: Other
Abstract
Diagnostic mobile medical apps call for increased regulatory intervention, even if they do not dispense advice or treatment.
George Maliha, Sara Gerke, Ravi B. Parikh & I. Glenn Cohen, To Spur Growth in AI, We Need a New Approach to Legal Liability, Harv. Bus. Rev., July 2021.
Categories:
Civil Practice & Procedure
,
Technology & Law
Sub-Categories:
Torts - Product Liability
Type: Article
Abstract
The existing liability system in the United States and other countries can’t handle the risks relation to AI. That’s a problem because it will slow AI innovation and adoption. The answer is to revamp the system, which involves revising standards of care, changing who compensates parties when inevitable accidents occur via insurance and indemnity; changing default liability options; creating new adjudicators; and revamping regulations to prevent mistakes and exempt certain kinds of liability.
Eli Y. Adashi & I. Glenn Cohen, Industry-Sponsored Speaker Programs—End of the Line?, JAMA (Apr. 12, 2021).
Categories:
Health Care
Sub-Categories:
Bioethics
Type: Article
Lawrence O. Gostin, I. Glenn Cohen & Jana Shaw, Digital Health Passes in the Age of COVID-19: Are “Vaccine Passports” Lawful and Ethical?, JAMA (April 7, 2021).
Categories:
Health Care
Sub-Categories:
Bioethics
Type: Article
George Maliha, Sara Gerke, I. Glenn Cohen & Ravi B. Parikh, Artificial Intelligence and Liability in Medicine: Balancing Safety and Innovation, The Milbank Q. (Apr. 6, 2021).
Categories:
Health Care
,
Technology & Law
Sub-Categories:
Bioethics
,
Medical Technology
Type: Article
Eli Y. Adashi, I. Glenn Cohen & Winston L. McCormick, The Interstate Medical Licensure Compact Attending to the Underserved, JAMA (Mar. 26, 2021).
Categories:
Health Care
Sub-Categories:
Bioethics
Type: Article
Hrefna D. Gunnarsdottir, I. Glenn Cohen, Timo Minssen & Sara Gerke, The Ethics and Laws of Medical Big Data, in Cambridge Handbook of Information Technology, Life Sciences and Human Rights, (Marcello Ienca, O. Pollicino, L. Liguori, R. Andorno & E. Stefanini, eds., forthcoming 2021).
Categories:
Health Care
,
Technology & Law
,
Legal Profession
,
Property Law
Sub-Categories:
Bioethics
,
Legal Ethics
,
Information Privacy & Security
,
Medical Technology
Type: Other
Abstract
The COVID-19 pandemic has highlighted that leveraging medical big data can help to better predict and control outbreaks from the outset. However, there are still challenges to overcome in the 21st century to efficiently use medical big data, promote innovation and public health activities and, at the same time, adequately protect individuals’ privacy. The metaphor that property is a “bundle of sticks”, each representing a different right, applies equally to medical big data. Understanding medical big data in this way raises a number of questions, including: Who has the right to make money off its buying and selling, or is it inalienable? When does medical big data become sufficiently stripped of identifiers that the rights of an individual concerning the data disappear? How have different regimes such as the General Data Protection Regulation in Europe and the Health Insurance Portability and Accountability Act in the US answered these questions differently? In this chapter, we will discuss three topics: (1) privacy and data sharing, (2) informed consent, and (3) ownership. We will identify and examine ethical and legal challenges and make suggestions on how to address them. In our discussion of each of the topics, we will also give examples related to the use of medical big data during the COVID-19 pandemic, though the issues we raise extend far beyond it.
I. Glenn Cohen & Harry Graver, What Big Data in Health Care Can Teach Us About Predictive Policing, in Predictive Policing and Artificial Intelligence (John L.M. McDaniel & Ken G. Pease eds., 2021).
Categories:
Criminal Law & Procedure
,
Health Care
,
Technology & Law
Sub-Categories:
Criminal Justice & Law Enforcement
,
Health Law & Policy
,
Networked Society
,
Medical Technology
,
Information Privacy & Security
Type: Book
Abstract
We take two professions — police officers and doctors — and place their experiences with big data in dialogue. Policing and medicine, while naturally different in some obvious respects, actually both need to grapple with a lot of the same moral, social, and legal questions that come with adopting big data programs. This because, as we discuss below, both professions generally possess a monopoly over an acute societal vulnerability, be it safety or health, and have accordingly developed a set of settled internal norms to shape individual discretion in service of each respective function. We place the professions side-by-side and try to distill certain insights from the perspective of three key stakeholders — practitioners, policymakers, and the polity.
Eli Y. Adashi & I. Glenn Cohen, An Overdue Executive Order: Reinstating the National Bioethics Commission, 134 Am. J. Med. 1199 (2021).
Categories:
Government & Politics
,
Health Care
Sub-Categories:
Administrative Law & Agencies
,
Bioethics
Type: Article
Eli Y. Adashi & I. Glenn Cohen, Antiviral Therapeutics: Key to Curbing the COVID-19 Pandemic, Am. J. Med. (2021).
Categories:
Health Care
Sub-Categories:
Health Law & Policy
Type: Article
Eli Y. Adashi & I. Glenn Cohen, CRISPR Immunity: a Case Study for Justified Somatic Genetic Modification?, J. Med. Ethics, Online First (Mar. 3, 2021).
Categories:
Health Care
Sub-Categories:
Bioethics
Type: Article
Abstract
The current SARS-CoV-2 pandemic has killed thousands across the world. SARS-CoV-2 is the latest but surely not the last such global pandemic we will face. The biomedical response to such pandemics includes treatment, vaccination, and so on. In this paper, though, we argue that it is time to consider an additional strategy: the somatic (non-heritable) enhancement of human immunity. We argue for this approach and consider bioethics objections we believe can be overcome.
Boris Babic, Sara Gerke, Theodoros Evgenious & I. Glenn Cohen, Direct-to-consumer Medical Machine Learning and Artificial Intelligence Applications, 3 Nature Mach. Intel. 283 (2021).
Categories:
Consumer Finance
,
Technology & Law
Sub-Categories:
Consumer Protection Law
,
Medical Technology
Type: Article
Abstract
Direct-to-consumer medical artificial intelligence/machine learning applications are increasingly used for a variety of diagnostic assessments, and the emphasis on telemedicine and home healthcare during the COVID-19 pandemic may further stimulate their adoption. In this Perspective, we argue that the artificial intelligence/machine learning regulatory landscape should operate differently when a system is designed for clinicians/doctors as opposed to when it is designed for personal use. Direct-to-consumer applications raise unique concerns due to the nature of consumer users, who tend to be limited in their statistical and medical literacy and risk averse about their health outcomes. This creates an environment where false alarms can proliferate and burden public healthcare systems and medical insurers. While similar situations exist elsewhere in medicine, the ease and frequency with which artificial intelligence/machine learning apps can be used, and their increasing prevalence in the consumer market, calls for careful reflection on how to effectively regulate them. We suggest regulators should strive to better understand how consumers interact with direct-to-consumer medical artificial intelligence/machine learning apps, particularly diagnostic ones, and this requires more than a focus on the system’s technical specifications. We further argue that the best regulatory review would also consider such technologies’ social costs under widespread use.
Eli Y. Adashi & I. Glenn Cohen, Enforcement of the Physician Payments Sunshine Act Trust and Verify, 326 JAMA 807 (2021).
Categories:
Health Care
,
Technology & Law
Sub-Categories:
Health Law & Policy
,
Medical Technology
Type: Article
Kerry Lynn Macintosh, I. Glenn Cohen, Jacob. S. Sherkow & Eli Y. Adashi, Gene Editing Sperm and Eggs for Use in Clinical Trials - The Authors Respond, 49 J. L. Med. & Ethics 156 (2021).
Categories:
Health Care
Sub-Categories:
Food & Drug Law
,
Genetics & Reproduction
Type: Article
Jacob S. Sherkow, Eli Y. Adashi & I. Glenn Cohen, Governing Human Germline Editing Through Patent Law, 326 JAMA 1149 (2021).
Categories:
International, Foreign & Comparative Law
,
Health Care
Sub-Categories:
Genetics & Reproduction
,
Health Law & Policy
,
International Law
Type: Article
I. Glenn Cohen & Eli Y. Adashi, Legal and Ethical Issues in the Report Heritable Human Genome Editing, 51 Hastings Ctr. Rep. 8 (2021).
Categories:
Health Care
Sub-Categories:
Genetics & Reproduction
Type: Article
Abstract
This essay discusses the new report, Heritable Human Genome Editing, by the National Academy of Medicine, the National Academy of Sciences, and the Royal Society. After summarizing the report, we argue that the report takes four quite bold steps away from prior reports, namely (1) rejecting an omnibus approach to heritable human genome editing (HHGE) in favor of a case-by-case analysis of possible uses of HHGE, accepting that HHGE is acceptable in some cases; (2) recognizing that the interest in having children who are genetically related to both would-be rearing parents is one that the regulation of HHGE should honor; (3) patterning a regulatory model for HHGE on the United Kingdom's approach to regulating mitochondrial replacement techniques; and (4) conveying skepticism that international regulation is possible while showing a strong preference for a default into national regulatory regimes for HHGE.
Jack L. Turban, Katherine L. Kraschel & I. Glenn Cohen, Legislation to Criminalize Gender-Affirming Medical Care for Transgender Youth, 325 JAMA 2251 (2021).
Categories:
Health Care
,
Discrimination & Civil Rights
Sub-Categories:
LGBTQ Rights Law
,
Gender & Sexuality
,
Health Law & Policy
Type: Article
Tyler Giannini, Pharmaceutical Companies, Human Rights, and the Alien Tort Statute, 49 J. Law Med Ethics 500 (2021)
Categories:
Health Care
,
International, Foreign & Comparative Law
Sub-Categories:
Health Law & Policy
,
Human Rights Law
Type: Article
Abstract
On January 3, 2019, U.S. District Judge Theodore D. Chuang of the U.S. District Court of the District of Maryland took a crucial first step in redressing one of the worst human subjects research ethics violations in U.S. history.
Mason Marks & I. Glenn Cohen, Psychedelic Therapy: A Roadmap for Wider Acceptance and Utilization, 27 Nat. Med. 1669 (2021).
Categories:
Health Care
Sub-Categories:
Food & Drug Law
Type: Article
Abstract
Psychedelics have shown great promise in treating mental-health conditions, but their use is severely limited by legal obstacles, which could be overcome.
Eli Y. Adashi, Daniel P. O'Mahony & I. Glenn Cohen, The Affordable Care Act: Resurrected Curtailing the Ranks of the Uninsured, 326 JAMA 1797 (2021).
Categories:
Government & Politics
,
Health Care
Sub-Categories:
Supreme Court of the United States
,
Health Law & Policy
Type: Article
Eli Y. Adashi & I. Glenn Cohen, The American Rescue Plan Act of 2021: A Historic if Transitory Expansion of the ACA, 326 JAMA 27 (2021).
Categories:
Health Care
Sub-Categories:
Health Law & Policy
Type: Article
Eli Y. Adashi & I. Glenn Cohen, The Biden Administration’s Proposal for an Advanced Research Projects Agency for Health, 2 JAMA Health F. e212972 (2021).
Categories:
Government & Politics
,
Health Care
Sub-Categories:
Administrative Law & Agencies
,
Health Law & Policy
Type: Article
I. Glenn Cohen, Eli Y. Adashi & Lawrence O. Gostin, The Supreme Court, the Texas Abortion Law (SB8), and the Beginning of the End of Roe v Wade?, 326 JAMA 1473 (2021).
Categories:
Government & Politics
,
Health Care
,
Discrimination & Civil Rights
Sub-Categories:
Gender & Sexuality
,
Supreme Court of the United States
,
Bioethics
,
Health Law & Policy
,
Genetics & Reproduction
Type: Article
Eli Y. Adashi & I. Glenn Cohen, When Failure Is Not an Option: The Independent Panel Pandemic Report, Am. J. Med. (2021).
Categories:
International, Foreign & Comparative Law
,
Health Care
Sub-Categories:
Health Law & Policy
,
Food & Drug Law
,
International Law
,
Nonprofit & Nongovernmental Organizations
Type: Article
Boris Babic, I. Glenn Cohen, Theodoros Evgeniou & Sara Gerke, When Machine Learning Goes Off the Rails, Harv. Bus. Rev. Jan.-Feb. 2021, at 76.
Categories:
Technology & Law
Sub-Categories:
Medical Technology
,
Science & Technology
Type: Article
Boris Babic, I. Glenn Cohen, Theodoros Evgeniou, Sara Gerke & Nikos Trichakis, Can AI Fairly Decide Who Gets an Organ Transplant?, Harv. Bus. Rev., Dec. 1, 2020.
Categories:
Technology & Law
,
Health Care
Sub-Categories:
Bioethics
,
Medical Technology
Type: Article
Abstract
To tackle the challenge of how to distribute organs, vaccines, and other kinds of health care, organizations are relying on AI and analytics. But many of them treat ethical considerations as an afterthought. This is a mistake. Such factors should be taken into the account at the outset of the effort to create the AI algorithm or analytics model.
Eli Y. Adashi, Michael M. Burgess, Simon Burall, I. Glenn Cohen, Leonard M. Flect, John Harris, Soren Holm, Cristina Lafont, Jonathan D. Moreno, Michael A. Neblo, Simon J. Niemeyer, Eugene J. Rowe, Dietram A. Scheufele, Paul F. Tetsa, Effy Vayena, Richard P. Watermeyer & Archon Fung, Heritable Human Genome Editing: The Public Engagement Imperative, 3 CRISPR J. 434 (2020).
Categories:
Health Care
Sub-Categories:
Bioethics
,
Genetics & Reproduction
Type: Article
Abstract
In the view of many, heritable human genome editing (HHGE) harbors the remedial potential of ridding the world of deadly genetic diseases. A Hippocratic obligation, if there ever was one, HHGE is widely viewed as a life-sustaining proposition. The national go/no-go decision regarding the implementation of HHGE, however, must not, in the collective view of the authors, proceed absent thorough public engagement. A comparable call for an “extensive societal dialogue” was recently issued by the International Commission on the Clinical Use of Human Germline Genome Editing. In this communication, the authors lay out the foundational principles undergirding the formation, modification, and evaluation of public opinion. It is against this backdrop that the societal decision to warrant or enjoin the clinical conduct of HHGE will doubtlessly transpire.
W. Nicholson Price, Sara Gerke & I. Glenn Cohen, Invited Perspective: How Much Can Potential Jurors Tell Us about Liability for Medical AI?, J. Nuclear Med. (Nov. 6, 2020).
Categories:
Health Care
,
Civil Practice & Procedure
,
Technology & Law
Sub-Categories:
Litigation & Settlement
,
Torts - Negligence
,
Medical Jurisprudence
,
Networked Society
,
Medical Technology
Type: Article
I. Glenn Cohen, Sara Gerke & Daniel R. Kramer, Ethical and Legal Implications of Remote Monitoring of Medical Devices, Milbank Q. (Oct. 20, 2020).
Categories:
Health Care
,
Technology & Law
Sub-Categories:
Health Law & Policy
,
Bioethics
,
Information Privacy & Security
,
Networked Society
,
Medical Technology
Type: Article
Eli Y. Adashi & I. Glenn Cohen, Assisted Same-Sex Reproduction: The Promise of Haploid Stem Cells?, Stem Cells & Dev. (Oct. 19, 2020).
Categories:
Discrimination & Civil Rights
,
Health Care
,
Family Law
Sub-Categories:
LGBTQ Rights Law
,
Reproduction
,
Genetics & Reproduction
,
Health Law & Policy
Type: Article
Abstract
Same-sex couples, not unlike their heterosexual counterparts, would prefer having a genetically related child.However, assisted same-sex human reproduction has heretofore been deemed infeasible absent haploid cellularanalogs of human gametes. Recent developments, however, may have overcome this limitation through thederivation of haploid embryonic stem cells (hapESCs). Undifferentiated, pluripotent, self-renewing, and stablyhaploid, hESCs have also displayed germline competence. It is in this capacity that murine hESCs, doubling upas de facto gametes, gave rise to bimaternal and bipaternal progeny. Herein we argue that assisted same-sexhuman reproduction, although potentially attainable at this time, is still years away from the clinic. In support ofthis perspective, we note the significant technical, regulatory, statutory, and societal hurdles that stand in theway of near-term implementation.
Eli Y. Adashi & I. Glenn Cohen, Heritable Human Genome Editing: The International Commission Report, JAMA (Oct. 8, 2020).
Categories:
Health Care
Sub-Categories:
Bioethics
,
Genetics & Reproduction
Type: Article
Eli Y. Adashi & I. Glenn Cohen, Disruptive Synergy: Melding of Human Genetics and Clinical Assisted Reproduction, 1 Cell Rep. Med. 10093 (2020).
Categories:
Health Care
Sub-Categories:
Bioethics
,
Genetics & Reproduction
,
Health Law & Policy
Type: Article
Abstract
The melding of human genetics with clinical assisted reproduction, now all but self-evident, gave flight to diagnostic and therapeutic approaches previously deemed infeasible. Preimplantation genetic diagnosis, mitochondrial replacement techniques, and remedial germline editing are particularly noteworthy. Here we explore the relevant disruption brought forth by coalescence of these mutually enabling disciplines with the regulatory and legal implications thereof.
Dov Fox, I. Glenn Cohen & Eli Y. Adashi, June Medical Services v. Russo: The Future of Abortion Access in the U.S., JAMA Health F. (Sept. 14, 2020).
Categories:
Health Care
,
Government & Politics
Sub-Categories:
Supreme Court of the United States
,
Bioethics
,
Genetics & Reproduction
,
Health Law & Policy
Type: Article
Abstract
June Medical Services v. Russo is the U.S.Supreme Court’s first abortion case since President Donald Trump appointed two new conservative justices—leading many to predict the end of Roe v. Wade. Yet Chief Justice John Roberts joined his four more liberal colleagues to strike down the restriction by a 5-4 majority. But the distinct reasoning of his separate opinion could give shelter to a wide range of abortion laws. Chief Justice Roberts may be playing the long game. His vote ensures that a woman's basic constitutional right to decide the fate of her pregnancy will live to fight another day. But his opinion should leave advocates wary of counting on the judiciary alone to protect against state restrictions on abortion access and providers. This article analyzes the Supreme Court's case and its multiple opinions, the significance of the Roberts concurrence for future abortion challenges, and next steps for both lower court judges and lawmakers at the state and federal level.
I. Glenn Cohen, Jacob S. Sherkow & Eli Y. Adashi, Gene Editing Sperm and Eggs (not Embryos): Does it Make a Legal or Ethical Difference?, 48 J.L. Med. & Ethics 619 (2020).
Categories:
Health Care
Sub-Categories:
Bioethics
,
Genetics & Reproduction
,
Health Law & Policy
Type: Article
I. Glenn Cohen, Eli Y. Adashi, Sara Gerke, César Palacios-González & Vardit Ravitsky, The Regulation of Mitochondrial Replacement Techniques Around the World, 21 Ann. Rev. Genomics & Hum. Genetics 565 (2020).
Categories:
Health Care
Sub-Categories:
Bioethics
,
Health Law & Policy
,
Genetics & Reproduction
Type: Article
Abstract
Mitochondrial replacement techniques (MRTs, also referred to as mitochondrial replacement therapies) have given hope to many women who wish to have genetically related children but have mitochondrial DNA mutations in their eggs. MRTs have also spurred deep ethical disagreemensts and led to different regulatory approaches worldwide. In this review, we discuss the current regulation of MRTs across several countries. After discussing the basics of the science, we describe the current law and policy directions in seven countries: the United Kingdom, the United States, Canada, Australia, Germany, Israel, and Singapore. We also discuss the emerging phenomenon of medical tourism (also called medical travel) for MRTs to places like Greece, Spain, Mexico, and Ukraine. We then pull out some key findings regarding similarities and differences in regulatory approaches around the world.
Lawrence O. Gostin, I. Glenn Cohen & Jeffrey P. Koplan, Universal Masking in the United States: The Role of Mandates, Health Education, and the CDC, 324 JAMA 837 (2020).
Categories:
Health Care
,
Government & Politics
Sub-Categories:
Administrative Law & Agencies
,
Congress & Legislation
,
State & Local Government
,
Supreme Court of the United States
,
Health Law & Policy
Type: Article
Sara Gerke, Carmel Shachar, Peter R. Chai & I. Glenn Cohen, Regulatory, Safety, and Privacy Concerns of Home Monitoring Technologies During COVID-19, 26 Nature Med. 1176 (2020).
Categories:
Health Care
,
Technology & Law
,
International, Foreign & Comparative Law
,
Government & Politics
Sub-Categories:
Administrative Law & Agencies
,
Food & Drug Law
,
Health Law & Policy
,
Comparative Law
,
European Law
,
Medical Technology
,
Information Privacy & Security
,
Networked Society
Type: Article
Abstract
There has been increasing interest in the use of home monitoring technologies during the COVID-19 pandemic to decrease interpersonal contacts and the resultant risks of exposure for people to the coronavirus SARS-CoV-2. This Perspective explores how the accelerated development of these technologies also raises major concerns pertaining to safety and privacy. We make recommendations for needed interventions to ensure safety and review best practices and US regulatory requirements for privacy and security. We discuss, among other topics, Emergency Use Authorizations for medical devices and privacy laws of the USA and Europe.
I. Glenn Cohen, Theodoros Evgeniou, Sara Gerke & Timo Minssen, The European Artificial Intelligence Strategy: Implications and Challenges for Digital Health, 2 Lancet Digital Health 376 (2020).
Categories:
Technology & Law
,
Health Care
Sub-Categories:
Health Law & Policy
,
Digital Property
,
Information Privacy & Security
,
Medical Technology
,
Networked Society
,
Intellectual Property Law
Type: Article
Abstract
In February, 2020, the European Commission published a white paper on artificial intelligence (AI) as well as an accompanying communication and report. The paper sets out policy options to facilitate a secure and trustworthy development of AI and considers health to be one of its most important areas of application. We illustrate that the European Commission's approach, as applied to medical AI, presents some challenges that can be detrimental if not addressed. In particular, we discuss the issues of European values and European data, the update problem of AI systems, and the challenges of new trade-offs such as privacy, cyber-security, accuracy, and intellectual property rights. We also outline what we view as the most important next steps in the Commission's iterative process. Although the European Commission has done good work in setting out a European approach for AI, we conclude that this approach will be more difficult to implement in health care. It will require careful balancing of core values, detailed consideration of nuances of health and AI technologies, and a keen eye on the political winds and global competition.
Sara Gerke, Timo Minssen & I. Glenn Cohen, Ethical and Legal Challenges of Artificial Intelligence-Driven Health Care, in Artificial Intelligence in Healthcare (Adam Bohr & Kaveh Memarzade eds., 2020).
Categories:
Government & Politics
,
Health Care
,
International, Foreign & Comparative Law
,
Technology & Law
Sub-Categories:
Administrative Law & Agencies
,
Congress & Legislation
,
Executive Office
,
Bioethics
,
Food & Drug Law
,
Health Law & Policy
,
Comparative Law
,
European Law
,
Cyberlaw
,
Information Privacy & Security
,
Intellectual Property Law
,
Medical Technology
,
Networked Society
Type: Book
Abstract
This chapter will map the ethical and legal challenges posed by artificial intelligence (AI) in health care and suggest directions for resolving them. Section 1 will briefly clarify what AI is and Section 2 will give an idea of the trends and strategies in the United States (U.S.) and Europe, thereby tailoring the discussion to the ethical and legal debate of AI-driven health care. This will be followed in Section 3 by a discussion of four primary ethical challenges, namely (1) informed consent to use, (2) safety and transparency, (3) algorithmic fairness and biases, and (4) data privacy. Section 4 will then analyze five legal challenges in the U.S. and Europe: (1) safety and effectiveness, (2) liability, (3) data protection and privacy, (4) cybersecurity, and (5) intellectual property law. Finally, Section 5 will summarize the major conclusions and especially emphasize the importance of building an AI-driven health care system that is successful and promotes trust and the motto “Health AIs for All of Us”.
I. Glenn Cohen, Lawrence O. Gostin & Daniel J. Weitzner, Digital Smartphone Tracking for COVID-19: Public Health and Civil Liberties in Tension, 323 JAMA 2371 (2020).
Categories:
Health Care
,
Technology & Law
,
International, Foreign & Comparative Law
Sub-Categories:
Health Law & Policy
,
Comparative Law
,
Medical Technology
,
Networked Society
,
Information Privacy & Security
Type: Article
Abstract
Contact investigations have been a vital public health strategy, most recently in controlling tuberculosis and sexually transmitted infections including HIV. Yet, the sheer scale of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections poses major challenges to contact investigations. Strategies in China, Singapore, South Korea, and Taiwan have supplemented traditional manual approaches with digital surveillance through smartphone applications. The US has not used digital surveillance as a tool, but Google, Apple, the Massachusetts Institute of Technology (MIT), as well as 2 pan-European consortia and a variety of independent efforts are developing Bluetooth smartphone technology to enable rapid notification of users that they have had a close exposure to individuals diagnosed with medically verified coronavirus disease 2019 (COVID-19). How does digital tracking differ from manual tracing? Although digital surveillance has the distinct advantages of scale and speed, does it confer sufficient public health benefit to justify adoption given privacy concerns? How do the design choices of digital contact tracing systems affect public health and privacy?
I. Glenn Cohen, Book Review, 54 ♠Law & Soc’y Rev. 524 (2020) (reviewing Tina Stevens & Stuart Newman, ♠Biotech Juggernaut: Hope, Hype, and Hidden Agendas of Entrepreneurial BioScience (2019)).
Categories:
Health Care
,
Technology & Law
Sub-Categories:
Bioethics
,
Medical Technology
Type: Article
I. Glenn Cohen, Nikolas Bowie, Megan Jones & Eli Y. Adashi, Preventing Female Genital Mutilation in the United States: The Legal Threat to Effective Action, 110 Am. J. Pub. Health 813 (2020).
Categories:
Criminal Law & Procedure
,
Discrimination & Civil Rights
,
Health Care
,
Government & Politics
,
International, Foreign & Comparative Law
Sub-Categories:
Criminal Prosecution
,
Civil Rights
,
Discrimination
,
Gender & Sexuality
,
Congress & Legislation
,
State & Local Government
,
Health Law & Policy
,
Human Rights Law
,
Treaties & International Agreements
Type: Article
Abstract
FGM can cause short-term complications such as severe pain, hemorrhage, tetanus infection, and urine retention.2 Long-term consequences include recurrent urinary tract infections, cyst formation, sexual difficulties, and increased risk of childbirth complications and newborn deaths.2 While some claim religious or ethnographic reasons for the practice, others view it as sustained by myths of femininity and virginity, and intended to cure vaginal "uncleanliness," prevent "deviant" premarital sexual activity, preserve "purity," and hinder sexual pleasure.2 FGM is a globally recognized human rights violation rendered unlawful under several international treaties. THE COURT'S DECISION On November 20, 2018, Judge Bernard A. Friedman of the US District Court for the Eastern District of Michigan found in Nagarwala that the statute exceeded the federal government's enumerated powers and thus declared the statute unconstitutional.3 The federal government, the court made clear, has no authority to police local or state criminal activity; such authority should be left to the states.3 The Department of Justice declined to prosecute its appeal and the US Sixth Circuit Court of Appeals refused a request by the House of Representatives to intervene, making Judge Friedman's opinion the final word.4,5 Most criminal laws are passed and enforced by states, as Congress has the power to pass legislation only in areas in which the Constitution grants it authority. "4(p31) It also accords with the interpretation of Congress, which passed the FGM ban after finding that no "single State or local jurisdiction [could] control [FGM]" or protect against the physical, psychological, and civil injury it causes.5 Second, the district court mischaracterized FGM as a noncommercial "form of physical assault" rather than as a paid-for health care service within the national market of licensed medical providers. 3(p22) As federal prosecutors argued, "FGM is usually performed by trained practitioners," and the statute "contemplates criminalizing FGM undertaken by medical practitioners in a commercial healthcare setting, which is in and of itself economic activity.
Eli Y. Adashi & I. Glenn Cohen, Reproduction Reimagined, 1 F&S Reports 7 (2020).
Categories:
Health Care
Sub-Categories:
Bioethics
,
Genetics & Reproduction
Type: Article
I. Glenn Cohen, Andrew M. Crespo & Douglas B. White, Potential Legal Liability for Withdrawing or Withholding Ventilators During COVID-19: Assessing the Risks and Identifying Needed Reforms, 323 JAMA 1901 (2020).
Categories:
Criminal Law & Procedure
,
Civil Practice & Procedure
,
Health Care
,
Government & Politics
Sub-Categories:
Torts - Negligence
,
State & Local Government
,
Bioethics
,
Medical Jurisprudence
Type: Article
Abstract
With an anticipated shortage of ventilators for patients with coronavirus disease 2019 (COVID-19), hospitals, physicians, and nurses may have to make an unprecedented decision: should they withdraw or withhold ventilators from some patients and use them for other patients who have a better chance of survival? It is not uncommon for care teams to decide against initiating or continuing mechanical ventilation when such treatment would not achieve a patient’s goals or directives. COVID-19 presents a different case: patients who do not receive a ventilator could benefit, perhaps living for many additional years, if they receive short-term mechanical ventilation. Denying patients such treatment, against their wishes, most likely will result in their death, but it will also make this scarce resource available to other patients who are more likely to survive if they receive ventilator support. Recently developed protocols expressly call for the rationing and reallocation of ventilators, in a manner that aims to save the greatest number of lives.1 These protocols are broadly accepted by medical ethicists.1,2 But ethics aside, there are potential legal ramifications of either withholding or withdrawing a ventilator from a patient who would ordinarily receive such aid in the absence of a public health emergency. In this Viewpoint, we assess the legal risks that physicians, other health care workers, and hospital systems confront in such scenarios and recommend that states explicitly and immediately adopt legal protections for health care workers, modeled on provisions in place in Maryland.
Eli Y. Adashi & I. Glenn Cohen, The Case for Remedial Germline Editing-The Long-term View, 323 JAMA 1762 (2020).
Categories:
Technology & Law
,
Health Care
Sub-Categories:
Bioethics
,
Genetics & Reproduction
,
Health Law & Policy
,
Medical Technology
Type: Article
I. Glenn Cohen, Informed Consent and Medical Artificial Intelligence: What to Tell the Patient?, 108 Geo. L.J. 1425 (2020).
Categories:
Health Care
,
Technology & Law
Sub-Categories:
Bioethics
,
Health Law & Policy
,
Medical Technology
,
Networked Society
Type: Article
Abstract
Imagine you are a patient who has been diagnosed with prostate cancer. The two main approaches to treating it in the United States are active surveillance versus the surgical option of radical prostatectomy. Your physician recommends the surgical option, and spends considerable time explaining the steps in the surgery, the benefits of (among other things) eliminating the tumor and the risks of (among other things) erectile dysfunction and urinary incontinence after the surgery. What your physician does not tell you is that she has arrived at her recommendation of prostatectomy over active surveillance based on the analysis of an Artificial Intelligence (AI)/Machine Learning (ML) system, which recommended this treatment plan based on analysis of your age, tumor size, and other personal characteristics found in your electronic health record. Has the doctor secured informed consent from a legal perspective? From an ethical perspective? If the doctor actually chose to “overrule” the AI system, and the doctor fails to tell you that, has she violated your legal or ethical right to informed consent? If you were to find out that the AI/ML system was used to make recommendations on your care and no one told you, how would you feel? Well, come to think of it, do you know whether an AI/ML system was used the last time you saw a physician? This Article, part of a Symposium in the Georgetown Law Journal, is the first to examine in depth how medical AI/ML interfaces with our concept of informed consent. Part I provides a brief primer on medical Artificial Intelligence and Machine Learning. Part II sets out the core and penumbra of U.S. informed consent law and then seeks to determine to what extent AI/ML involvement in a patient’s health should be disclosed under the current doctrine. Part III examines whether the current doctrine “has it right,” examining more openly empirical and normative approaches to the question. To forefront my conclusions: while there is some play in the joints, my best reading of the existing legal doctrine is that in general, liability will not lie for failing to inform patients about the use of medical AI/ML to help formulate treatment recommendations. There are a few situations where the doctrine may be more capacious, which I try to draw out (such as when patients inquire, when the medical AI/ML is more opaque, when it is given an outsized role in the final decision-making, or when the AI/ML is used to reduce costs rather than improve patient health), though extending it even here is not certain. I also offer some thoughts on the question: if there is room in the doctrine (either via common law or legislative action), what would it be desirable for the doctrine to look like when it comes to medical AI/ML? I also briefly touch on the question of how the doctrine of informed consent should interact with concerns about biased training data for AI/ML.
Eli Y. Adashi & I. Glenn Cohen, Therapeutic Germline Editing: Sense and Sensibility, 36 Trends in Genetics 315 (2020).
Categories:
Health Care
Sub-Categories:
Bioethics
,
Genetics & Reproduction
,
Health Law & Policy
Type: Article
Abstract
Safe and effective heritable editing of the human genome is years away from the clinic because of formidable technical, statutory, regulatory, and societal challenges. In particular, we note the fledgling state of the science, the imperatives of editing efficiency, specificity, and uniformity, and the extant legal roadblock.
Timo Minssen, Sara Gerke, Mateo Aboy, Nicholson Price & I. Glenn Cohen, Regulatory Responses to Medical Machine Learning, 7 J.L. & Biosciences lsaa002 (2020).
Categories:
Government & Politics
,
International, Foreign & Comparative Law
,
Health Care
,
Technology & Law
Sub-Categories:
Administrative Law & Agencies
,
Health Law & Policy
,
Bioethics
,
Comparative Law
,
European Law
,
Digital Property
,
Information Privacy & Security
,
Intellectual Property Law
,
Networked Society
,
Medical Technology
Type: Article
Abstract
Companies and healthcare providers are developing and implementing new applications of medical artificial intelligence, including the artificial intelligence sub-type of medical machine learning (MML). MML is based on the application of machine learning (ML) algorithms to automatically identify patterns and act on medical data to guide clinical decisions. MML poses challenges and raises important questions, including (1) How will regulators evaluate MML-based medical devices to ensure their safety and effectiveness? and (2) What additional MML considerations should be taken into account in the international context? To address these questions, we analyze the current regulatory approaches to MML in the USA and Europe. We then examine international perspectives and broader implications, discussing considerations such as data privacy, exportation, explanation, training set bias, contextual bias, and trade secrecy.
Sara Gerke, Boris Babic, Theodoros Evgeniou & I. Glenn Cohen, The Need For a System View to Regulate Artificial Intelligence/Machine Learning-Based Software as Medical Device, npj Digital Med., art. no. 53, Apr. 7, 2020.
Categories:
Health Care
,
Technology & Law
,
Government & Politics
Sub-Categories:
Administrative Law & Agencies
,
Bioethics
,
Food & Drug Law
,
Medical Technology
Type: Article
Abstract
Artificial intelligence (AI) and Machine learning (ML) systems in medicine are poised to significantly improve health care, for example, by offering earlier diagnoses of diseases or recommending optimally individualized treatment plans. However, the emergence of AI/ML in medicine also creates challenges, which regulators must pay attention to. Which medical AI/ML-based products should be reviewed by regulators? What evidence should be required to permit marketing for AI/ML-based software as a medical device (SaMD)? How can we ensure the safety and effectiveness of AI/ML-based SaMD that may change over time as they are applied to new data? The U.S. Food and Drug Administration (FDA), for example, has recently proposed a discussion paper to address some of these issues. But it misses an important point: we argue that regulators like the FDA need to widen their scope from evaluating medical AI/ML-based products to assessing systems. This shift in perspective—from a product view to a system view—is central to maximizing the safety and efficacy of AI/ML in health care, but it also poses significant challenges for agencies like the FDA who are used to regulating products, not systems. We offer several suggestions for regulators to make this challenging but important transition.
Andrew Crespo, I. Glenn Cohen & Douglas B. White, Protect the Doctors and Nurses Who Are Protecting Us, N.Y. Times, Apr. 1, 2020.
Categories:
Health Care
,
Government & Politics
Sub-Categories:
State & Local Government
,
Health Law & Policy
Type: News
Disability, Health, Law, and Bioethics (I. Glenn Cohen, Carmel Shachar, Anita Silvers & Michael Ashley Stein eds., 2020).
Categories:
Health Care
,
Discrimination & Civil Rights
Sub-Categories:
Disability Rights
,
Bioethics
,
Disability Law
,
Health Law & Policy
Type: Book
Eli Y. Adashi & I. Glenn Cohen, What Would Responsible Remedial Human Germline Editing Look Like?, 38 Nature Biotech. 398 (2020).
Categories:
Health Care
Sub-Categories:
Bioethics
,
Genetics & Reproduction
Type: Article
Danielle Allen, Lucas Stanczyk, I. Glenn Cohen, Carmel Shachar, Rajiv Sethi, Glen Weyl & Rosa Brooks, Securing Justice, Health, and Democracy against the COVID-19 Threat (Edmond J. Safra Center for Ethics, Mar. 24, 2020).
Categories:
Government & Politics
,
Health Care
Sub-Categories:
Administrative Law & Agencies
,
Congress & Legislation
,
Elections & Voting
,
Government Transparency
,
State & Local Government
,
Government Benefits
,
Health Law & Policy
Type: Other
Holly Fernandez Lynch, D. James Greiner & I. Glenn Cohen, Overcoming Obstacles to Experiments in Legal Practice, 367 Science 1078 (2020).
Categories:
Disciplinary Perspectives & Law
,
Legal Profession
,
Health Care
,
Technology & Law
Sub-Categories:
Empirical Legal Studies
,
Bioethics
,
Legal Ethics
,
Legal Reform
,
Legal Services
,
Science & Technology
Type: Article
Abstract
The importance of evidence-based policy rooted in experimental methods is increasingly recognized, from the Oregon Medicaid experiment to the efforts to address global poverty that were awarded a 2019 Nobel Prize. Over the past several decades, there have been attempts to extend this scientific approach to legal systems and practice. Yet, despite progress in empirical legal studies and experimental social policy research, judges, lawyers, and legal services providers often fail to subject their own practices to empirical study or to be guided by empirical data, with a particular aversion to randomized controlled trials (RCTs) (1). This is troubling, as many questions fundamental to legal practice and those it affects, such as allocation of attorney services, bail decisions, and use of mandatory mediation, could and should be informed by a rigorous evidentiary foundation. Although there are practical obstacles to undertaking legal practice RCTs, they have also been stymied by cultural barriers...
I. Glenn Cohen & Michelle M. Mello, HIPAA in the Era of Data Sharing—Reply, 323 JAMA 477 (2020).
Categories:
Health Care
,
Technology & Law
Sub-Categories:
Bioethics
,
Health Law & Policy
,
Information Privacy & Security
,
Medical Technology
Type: Article
I. Glenn Cohen, Commentary on Gestation, Equality and Freedom: Ectogenesis as a Political Perspective, 46 J. Med. Ethics 87 (2020).
Categories:
Discrimination & Civil Rights
,
Health Care
,
Family Law
Sub-Categories:
Gender & Sexuality
,
Reproduction
,
Bioethics
,
Genetics & Reproduction
Type: Article
Readings in Comparative Health Law and Bioethics (Nathan Cortez, I. Glenn Cohen & Timothy Stoltzfus Jost eds., 3rd ed. 2020).
Categories:
Health Care
,
International, Foreign & Comparative Law
Sub-Categories:
Bioethics
,
Health Law & Policy
,
Comparative Law
Type: Book
Abstract
Readings in Comparative Health Law and Bioethics examines how different countries around the world approach the same challenges in health care law and ethics: how to finance care for as many people as possible; how to ensure quality care; how to best secure patients' rights; how to regulate abortion, end of life decision-making, and assisted reproduction; and how to manage infectious diseases, tobacco use, and human subject research. The new edition considers a broader array of countries, particularly from Asia, Latin America, Africa, and the Middle East.
Sara Gerke, Serena Young & I. Glenn Cohen, Ethical and Legal Aspects of Ambient Intelligence in Hospitals, JAMA (Jan. 24, 2020).
Categories:
Health Care
,
Technology & Law
Sub-Categories:
Bioethics
,
Health Law & Policy
,
Medical Technology
,
Information Privacy & Security
Type: Article
I. Glenn Cohen, The Right(s) to Procreate and Assisted Reproductive Technologies in the United States, in The Oxford Handbook of Comparative Health Law (Tamara K. Hervey & David Orentlicher eds., 2020).
Categories:
Family Law
,
Health Care
Sub-Categories:
Reproduction
,
Genetics & Reproduction
,
Bioethics
,
Health Law & Policy
Type: Book
Abstract
This chapter focuses on the right (or rights) to procreate in the United States, with a focus on reproductive technology use. The United States has been too often described as the “wild west” of reproductive technology use. When measured against many of its comparators — Canada, Australia, the UK, Germany, etc. — it is undoubtedly true that more forms of reproductive technology use are permitted in the United States than elsewhere. It is for this reason that the United States has been a frequent destination for “circumvention tourism” or “fertility tourism.” At the same time, it would be wrong to think that reproductive medicine is unregulated in the United States. The chapter argues that it is just that the regulation is more fragmented, both in terms of the locus of control (federal vs. state authority, governmental vs. professional self-regulation, etc.) and also of the legal sources involved (more of a focus on tort law and family law than direct regulation at the statutory or constitutional level).
Boris Babic, Sara Gerke, Theodoros Evgeniou & I. Glenn Cohen, Algorithms on Regulatory Lockdown in Medicine, 366 Science 1202 (2019).
Categories:
Health Care
,
Technology & Law
,
Government & Politics
Sub-Categories:
Administrative Law & Agencies
,
Health Law & Policy
,
Bioethics
,
Science & Technology
,
Medical Technology
Type: Article
John H. Rex, Holly Fernandez Lynch, I. Glenn Cohen, Jonathan J. Darrow & Kevin Outterson, Designing Development Programs for Non-Traditional Antibacterial Agents, 10 Nature Comm. no. 3416 (2019).
Categories:
Government & Politics
,
Health Care
Sub-Categories:
Administrative Law & Agencies
,
Bioethics
,
Food & Drug Law
Type: Article
Abstract
In the face of rising rates of antibacterial resistance, many responses are being pursued in parallel, including ‘non-traditional’ antibacterial agents (agents that are not small-molecule drugs and/or do not act by directly targeting bacterial components necessary for bacterial growth). In this Perspective, we argue that the distinction between traditional and non-traditional agents has only limited relevance for regulatory purposes. Rather, most agents in both categories can and should be developed using standard measures of clinical efficacy demonstrated with non-inferiority or superiority trial designs according to existing regulatory frameworks. There may, however, be products with non-traditional goals focused on population-level benefits that would benefit from extension of current paradigms. Discussion of such potential paradigms should be undertaken by the development community.
Sarah McGraw, Chris Deubert, Holly Fernandez Lynch, Alixandra Nozzolillo & I. Glenn Cohen, NFL or 'Not For Long'? Transitioning Out of the NFL, 42 J. Sport Behav. 461 (2019).
Categories:
Health Care
,
Disciplinary Perspectives & Law
Sub-Categories:
Gaming & Sports Law
,
Health Law & Policy
Type: Article
Abstract
Like many other elite athletes, National Football League (“NFL”) players typically have a short playing career, often leaving the league due to injury or lack of interest from teams before they have been able to prepare sufficiently for life after the league. This qualitative study examines the experiences of NFL players related to preparing for the transition out of professional sports. We completed interviews with a total of 25 players including both current and former players, as well as 27 family members of former and current players. Factors that affected their career preparation included features of the NFL work environment which necessitated an emphasis on football over other interests, identity foreclosure that made it difficult to consider other career options, limited exposure to other professions, and challenges with financial planning. Social contacts had both positive and negative effects on players’ preparation but family, particularly wives, provided important support. Our findings point to policies that might guide players in their preparation for life as former players including instituting mandatory training and counseling concerning these issues, beginning in a player’s rookie year, and continuing throughout players’ tenures in the league.
Eli Adashi & I. Glenn Cohen, Heritable Genome Editing—Edited Eggs and Sperm to the Rescue?, 322 JAMA 1754 (2019).
Categories:
Health Care
Sub-Categories:
Genetics & Reproduction
,
Bioethics
Type: Article
W. Nicholson Price, Sara Gerke & I. Glenn Cohen, Potential Liability for Physicians Using Artificial Intelligence, 322 JAMA 1765 (2019).
Categories:
Health Care
,
Technology & Law
,
Civil Practice & Procedure
Sub-Categories:
Torts
,
Bioethics
,
Health Law & Policy
,
Medical Technology
Type: Article
Dov Fox, I. Glenn Cohen & Eli Y. Adashi, Fertility Fraud, Legal Firsts, and Medical Ethics, 134 Obstetrics & Gynecology 918 (2019).
Categories:
Health Care
,
Family Law
Sub-Categories:
Reproduction
,
Bioethics
,
Genetics & Reproduction
Type: Article
Abstract
On May 5, 2019, Indiana became the first state to legislate against a doctor’s failure to obtain his fertility patient’s consent before inseminating her using his own sperm. Less than a month later, Texas passed an even stricter law against fertility fraud, as the practice is called. The explosion of at-home DNA testing has recently uncovered dozens of doctors who conceived scores of offspring using their own sperm instead of the samples provided by a spouse, an unknown donor, or a donor that the patients had selected. This revelation has upended families, revealed webs of biological half-siblings, and confounded the legal system. Fertility fraud is a pressing case study about the demands of informed consent and modern struggles between patient wellbeing and autonomy in the clinical practice of obstetric and fertility medicine. The answers to these hard questions are also giving rise to new criminal and civil penalties that are codifying those developments in medical ethics into law.
Jeremy Snyder & I. Glenn Cohen, Medical Crowdfunding for Unproven Medical Treatments: Should GoFundMe Become a Gatekeeper?, 49 Hastings Ctr. Rep. 32 (2019).
Categories:
Health Care
,
Technology & Law
Sub-Categories:
Bioethics
,
Health Law & Policy
,
Information Privacy & Security
,
Networked Society
Type: Article
Abstract
Medical crowdfunding has raised many ethical concerns, among them that it may undermine privacy, widen health inequities, and commodify health care. One motivation for medical crowdfunding has received particular attention among ethicists. Recent studies have shown that many individuals are using crowdfunding to finance access to scientifically unsupported medical treatments. Recently, GoFundMe prohibited campaigns for antivaccination groups on the grounds that they “promote misinformation about vaccines” and for treatment at a German clinic offering unproven cancer treatments due to “the need to make sure people are equipped to make well-informed decisions.” GoFundMe has not taken any additional actions to regulate the much larger presence of campaigns seeking to fund unproven medical interventions on the platform. In this article, we make the ethical case for intervention by GoFundMe and other crowdfunding platforms.
Dov Fox, I. Glenn Cohen & Eli Y. Adashi, The Law and Ethics of Fetal Burial Requirements for Reproductive Health Care, 322 JAMA 1347 (2019).
Categories:
Health Care
Sub-Categories:
Genetics & Reproduction
,
Bioethics
Type: Article
Mateo Aboy, Kathleen Liddell, Cristina Crespo, I. Glenn Cohen, Johnathon Liddicoat, Sara Gerke & Timo Minssen, How Does Emerging Patent Case Law in the US and Europe Affect Precision Medicine?, 37 Nature Biotechnology 1118 (2019).
Categories:
International, Foreign & Comparative Law
,
Technology & Law
,
Health Care
,
Property Law
Sub-Categories:
Health Law & Policy
,
Bioethics
,
European Law
,
Comparative Law
,
Intellectual Property - Patent & Trademark
,
Intellectual Property Law
,
Medical Technology
Type: Article
I. Glenn Cohen, Organ Donor Intervention Trials and Risk to Bystanders: An Ethical Analysis, 16 Clinical Trials 463 (2019).
Categories:
Health Care
Sub-Categories:
Bioethics
Type: Article
Abstract
There are two distinct problems about bystander effects raised by organ donor intervention research. The first is the problem of “bystander organs”—sometimes called “non-target organs”—which Kimmelman discusses in his case presentation. How do we treat the recipients of organs that are not the subject of the intervention research but nonetheless might be directly affected by the research? The second problem is not about altering the organ but the pattern of distribution of organs. Each of these cases shows bystander effects that matter for real people. This article examines how research ethics should approach each of these cases.
I. Glenn Cohen & Michelle M. Mello, Big Data, Big Tech, and Protecting Patient Privacy, 322 JAMA 1141(2019).
Categories:
Health Care
,
Technology & Law
Sub-Categories:
Health Law & Policy
,
Information Privacy & Security
,
Networked Society
Type: Article
Abstract
The market for patient data has never been more active. Technology companies, from startups to giants, are eager to access electronic health record (EHR) data to build the next generation of health-focused products. Medical artificial intelligence (AI) is particularly data-hungry; large, representative data sets hold promise for advancing not only AI companies’ growth, but also the health of patients. Companies’ overtures to major hospitals about data sharing have highlighted legal and ethical uncertainties as to whether and how to undertake these relationships. One such partnership is now being challenged in court. In June 2019, a patient sued the University of Chicago Medical Center and Google for alleged misuse of patient EHR data. This Viewpoint discusses the case and what it signals about the need for thoughtful governance of data sharing between health care organizations and technology companies.
I. Glenn Cohen, Changing Conception, 365 Science 872 (2019)(reviewing Margaret S. Marsh & Wanda Ronner, The Pursuit of Parenthood (2019)).
Categories:
Health Care
Sub-Categories:
Bioethics
,
Genetics & Reproduction
Type: Article
Jean-Christophe Bélisle-Pipon, Effy Vayena, Robert C. Green & I. Glenn Cohen, Genetic Testing, Insurance Discrimination and Medical Research: What the United States Can Learn From Peer Countries, 25 Nature Med. 1198 (2019).
Categories:
Health Care
,
International, Foreign & Comparative Law
Sub-Categories:
Genetics & Reproduction
,
Health Law & Policy
,
Comparative Law
Type: Article
Abstract
While genetic testing may be the gateway to the future of medicine, it also poses challenges for individuals, especially in terms of differentiated treatments on the basis of their genetic characteristics. The fear of unwanted disclosure to insurers and the possibility of genetic discrimination can hamper the recruitment of individuals for clinical research that involves genetic testing. Precision medicine initiatives, such as All of Us, are proliferating in the United States. In order to succeed, however, they must ensure that the millions of Americans recruited to share their genetic data are not penalized with regard to life, disability and long-term insurance coverage. In this Perspective, we discuss several initiatives adopted by countries around the world, such as the United Kingdom and France, that better balance the interests of insurers and research subjects, and explain how the United States might learn from them. We call for regulatory and industry leadership to come together to establish a voluntary moratorium on insurance pricing with the aim of protecting research participants.
Sara Gerke, Timo Minssen, Helen Yu & I. Glenn Cohen, Ethical and Legal Issues of Ingestible Electronic Sensors, 2 Nature Electronics 329 (2019).
Categories:
Health Care
,
Technology & Law
Sub-Categories:
Bioethics
,
Food & Drug Law
,
Health Law & Policy
,
Medical Technology
Type: Article
Abstract
Ingestible electronic sensors are a promising technology for improving health outcomes that may, for example, be useful in monitoring and promoting the taking of medication. However, these sensors also raise ethical and legal challenges that need to be considered by all stakeholders—notably, the creators of such products—at the earliest stages of the development process. Here, we examine selected ethical and legal issues related to ingestible electronic sensors. We first briefly describe sensors that are already available on the US and European markets as well as potential future sensor combinations. We then focus on ethical aspects, discussing patient, provider, and social issues. Finally, we provide a comparative analysis of legal regulation of ingestible electronic sensors in the US and Europe.
Ross Zafonte, Alvaro Pascual‐Leone, Aaron Baggish, Marc G. Weisskopf, Herman A. Taylor, Ann Connor, Jillian Baker, Sarah Cohan, Chelsea Valdivia, Theodore K. Courtney, I. Glenn Cohen, Frank E. Speizer & Lee M. Nadler, The Football Players' Health Study at Harvard University: Design and Objectives, 62 Am. J. Indus. Med. 643 (2019).
Categories:
Health Care
Sub-Categories:
Health Law & Policy
Type: Article
Abstract
The Football Players Health Study at Harvard University (FPHS) is a unique transdisciplinary, strategic initiative addressing the challenges of former players’ health after having participated in American style football (ASF). The whole player focused FPHS is designed to deepen understanding of the benefits and risks of participation in ASF, identify risks that are potentially reversible or preventable, and develop interventions or approaches to improve the health and wellbeing of former players. We are recruiting and following a cohort of former professional ASF players who played since 1960 (current n = 3785). At baseline, participants complete a self‐administered standardized questionnaire, including initial reporting of exposure history and physician‐diagnosed health conditions. Additional arms of the initiative are addressing targeted studies, including promising primary, secondary, and tertiary interventions; extensive in‐person clinical phenotyping, and legal and ethical concerns of the play. This paper describes the components of the FPHS studies undertaken and completed thus far, as well as those studies currently underway or planned for the near future. We present our initiatives herein as a potential paradigm of one way to proceed (acknowledging that it is not the only way). We share what we have learned so that it may be useful to others, particularly in regard to trying to make professional sports meet the needs of multiple stakeholders ranging from players to owners, to fans, and possibly even to parents making decisions for their children.
Eli Y. Adashi & I. Glenn Cohen, Heritable Genome Editing: Is a Moratorium Needed?, 322 JAMA 104 (2019).
Categories:
Health Care
Sub-Categories:
Bioethics
,
Genetics & Reproduction
Type: Article
Eli Y. Adashi, Arthur L. Caplan, Alexander Capron, Audrey R. Chapman, Mildred Cho, Ellen Wright Clayton, I. Glenn Cohen, Robert Cook-Deegan, Ruth R. Faden, Theodore Friedmann, Lawrence O. Gostin, Henry T. Greely, Josephine Johnston, Eric Juengst, Patricia A. King, Lori P. Knowles, Anne Drapkin Lyerly, Amy L. McGuire, Jonathan D. Moreno, Karen Rothenberg, Robert D. Truog & LeRoy Walters, In Support of Mitochondrial Replacement Therapy, 25 Nature Med. 870 (2019).
Categories:
Health Care
Sub-Categories:
Bioethics
,
Genetics & Reproduction
Type: Article
Carmel Shachar, I. Glenn Cohen, Holly Fernandez Lynch & Barbara J. Evans, Introduction and Front Matter, in Transparency in Health and Health Care in the United States: Law and Ethics 1 (Holly Fernandez Lynch, I. Glenn Cohen, Carmel Shachar & Barbara J. Evans, eds., 2019).
Categories:
Health Care
Sub-Categories:
Health Law & Policy
Type: Book
Abstract
This Introduction summarizes the contributions of the chapters and introduces the main themes of the edited volume Transparency in Health and Health Care in the United States: Law and Ethics (Holly Fernandez Lynch, I. Glenn Cohen, Carmel Shachar, Barbara J. Evans, eds., Cambridge University Press 2019). It also provides the front matter for the volume, including its table of contents.
Dov Fox, Eli Y. Adashi & I. Glenn Cohen, A Troubling Court Decision for Reproductive Rights, 322 JAMA 23 (2019).
Categories:
Health Care
Sub-Categories:
Genetics & Reproduction
,
Health Law & Policy
Type: Article
Abstract
Abortion remains one of the most divisive controversies in the United States, and few states restrict the practice more than Alabama. In 2018, Alabama voters passed an amendment to the state’s constitution that “recognize[s] and support[s] the sanctity of unborn life and the rights of unborn children.” Kansas, Missouri, and Louisiana have enacted similar language into their constitutions. These clauses variously classify fertilized eggs, zygotes, embryos, and fetuses as “persons” entitled to unspecified legal protections from the moment of conception. They have the potential for sweeping consequences. It is unclear whether and how these measures would lead to criminal penalties against pregnant women for activities like drug use that risk harming the fetus, as well as prohibitions on in vitro fertilization (IVF), stem cell research, or other practices that involve the destruction of human embryos
I. Glenn Cohen, Eli Y. Adashi & Vardit Ravitsky, How Bans on Germline Editing Deprive Patients with Mitochondrial Disease, 37 Nature Biotechnology 589 (2019).
Categories:
Health Care
Sub-Categories:
Bioethics
,
Genetics & Reproduction
,
Health Law & Policy
Type: Article
Eli Y. Adashi, Rohit S. Rajan & I. Glenn Cohen, When Science and Politics Collide: Enhancing the FDA, 364 Science 628 (2019).
Categories:
Government & Politics
,
Health Care
Sub-Categories:
Administrative Law & Agencies
,
Politics & Political Theory
,
Food & Drug Law
Type: Article
Eli Y. Adashi & I. Glenn Cohen, Germline Editing: Could Ban Encourage Medical Tourism?, 569 Nature, May 2019, at 40.
Categories:
Health Care
Sub-Categories:
Bioethics
,
Genetics & Reproduction
,
Health Law & Policy
Type: Article
Transparency in Health and Health Care in the United States: Law and Ethics (Holly Fernandez Lynch, I. Glenn Cohen, Carmel Shachar & Barbara J. Evans eds., 2019).
Categories:
Health Care
Sub-Categories:
Health Law & Policy
,
Bioethics
Type: Book
Abstract
Transparency is a concept that is becoming increasingly lauded as a solution to a host of problems in the American health care system. Transparency initiatives show great promise, including empowering patients and other stakeholders to make more efficient decisions, improve resource allocation, and better regulate the health care industry. Nevertheless, transparency is not a cure-all for the problems facing the modern health care system. The authors of this volume present a nuanced view of transparency, exploring ways in which transparency has succeeded and ways in which transparency initiatives have room for improvement. Working at the intersection of law, medicine, ethics, and business, the book goes beyond the buzzwords to the heart of transparency's transformative potential, while interrogating its obstacles and downsides. It should be read by anyone looking for a better understanding of transparency in the health care context.
I. Glenn Cohen, On Repugnance, Distribution, and the Global Kidney Exchange: Comment, 175 J. Inst. & Theoretical Econ. 20 (2019).
Categories:
Health Care
,
Disciplinary Perspectives & Law
Sub-Categories:
Law & Economics
,
Bioethics
,
Health Law & Policy
Type: Article
Eli Y. Adashi, I. Glenn Cohen, Jacob H. Hanna, Azim M. Surani & Katsuhiko Hayashi, Stem Cell-Derived Human Gametes: The Public Engagement Imperative, 25 Trends Molecular Med. 165 (2019).
Categories:
Health Care
Sub-Categories:
Genetics & Reproduction
,
Health Law & Policy
,
Bioethics
Type: Article
Abstract
The implications of scientific breakthroughs are rarely faced up to in advance of their realization. Stem cell-derived human gametes, a disruptive technology in waiting, are likely to recapitulate this historic pattern absent active intervention. Herein we call for the conduct of thoughtful ante hoc deliberations on the prospect of stem cell-derived human gametes with an eye toward minimizing potential untoward post hoc regulatory or statutory impositions.
William M. Sage, I. Glenn Cohen & Allison K. Hoffman, Health Law and Ethics, in Health Systems Science (Susan Skochelak ed., 2d ed. 2019).
Categories:
Health Care
,
Government & Politics
,
Corporate Law & Securities
Sub-Categories:
Antitrust & Competition Law
,
Fiduciaries
,
Insurance Law
,
Administrative Law & Agencies
,
Health Law & Policy
,
Bioethics
Type: Book
Abstract
Law and ethics are both essential attributes of a high-functioning health care system and powerful explainers of why the existing system is so difficult to improve. U.S. health law is not seamless; rather, it derives from multiple sources and is based on various theories that may be in tension with one another. There are state laws and federal laws, laws setting standards and laws providing funding, laws reinforcing professional prerogatives, laws furthering social goals, and laws promoting market competition. Complying with law is important, but health professionals also should understand that the legal and ethical constraints under which health systems operate must themselves adapt if health systems science is to advance.
W. Nicholson Price II & I. Glenn Cohen, Privacy in the Age of Medical Big Data, 25 Nature Med. 37 (2019).
Categories:
Health Care
,
Technology & Law
Sub-Categories:
Health Law & Policy
,
Bioethics
,
Information Privacy & Security
,
Networked Society
,
Medical Technology
Type: Article
I. Glenn Cohen & Nichlas Bagley, Private Rights and the Public Interest in Drug and Medical Device Litigation, 180 JAMA Internal Med. 299 (2019).
Categories:
Civil Practice & Procedure
,
Government & Politics
,
Health Care
Sub-Categories:
Litigation & Settlement
,
Private Law
,
Administrative Law & Agencies
,
Courts
,
Public Law
,
Food & Drug Law
,
Health Law & Policy
Type: Article
I. Glenn Cohen, The Regulation of Reproduction and Best Interests Analysis, in The Oxford Handbook of Children and the Law (James G. Dwyer ed., 2019).
Categories:
Family Law
,
Discrimination & Civil Rights
,
Health Care
,
Government & Politics
Sub-Categories:
Gender & Sexuality
,
Reproduction
,
State & Local Government
,
Genetics & Reproduction
Type: Book
Abstract
In its 1972 decision in Eisenstadt v. Baird, the US Supreme Court announced that: “it is the right of the individual, married or single, to be free from unwarranted governmental intrusion into matters so fundamentally affecting a person as the decision whether to bear or beget a child.” But, in fact, both within and outside the United States, this firm-sounding principle has often been honored in the breach. Both as to coital and assisted reproduction, but particularly the latter, the state has asserted significant control over reproductive decision-making. This chapter details various forms of reproductive regulation prevalent today in a variety of areas including: Sterilization, abstinence education, surrogacy, sperm and egg “donor” anonymity and paternity, insurance funding, cloning, and mitochondrial replacement therapy. More conceptually, it divides state regulation of reproduction along the axes of attempts to influence whether, when, with whom, and how we reproduce and the means by which the state intervenes. Finally, it examines variations on child welfare justifications the state has or might offer for such reproductive regulation, and raises some questions about those justifications.
Eli Y. Adashi & Glenn Cohen, The Ethics of Heritable Genome Editing: New Considerations in a Controversial Area, 320 JAMA 2531 (2018).
Categories:
Health Care
Sub-Categories:
Genetics & Reproduction
,
Bioethics
,
Health Law & Policy
Type: Article
I. Glenn Cohen, Dov Fox & Eli Y. Adashi, Losing Embryos, Finding Justice: Life, Liberty, and the Pursuit of Personhood, 169 Annals Internal Med. 800 (2018).
Categories:
Health Care
,
Property Law
,
Consumer Finance
,
Civil Practice & Procedure
Sub-Categories:
Consumer Contracts
,
Torts - Negligence
,
Genetics & Reproduction
,
Health Law & Policy
,
Bioethics
,
Personal Property
Type: Article
Eli Y. Adashi & Glenn Cohen, The Lumbering Crawl Toward Human Germline Editing, 46 J.L. Med. & Ethics 1010 (2018).
Categories:
Health Care
Sub-Categories:
Genetics & Reproduction
,
Bioethics
,
Health Law & Policy
Type: Article
Abstract
A review of the article "Untangling the Promise of Human Genome Editing" by Professor K. Drabiak, which appears in the same issue of the journal, is presented, and it mentions germline gene editing, Mitochondrial Replacement Therapy, and an appropriations-related U.S. Congressional Rider.
Mary Anne Bobinsky, David Orentlicher, I. Glenn Cohen & Mark A. Hall, Bioethics and Public Health Law (4th ed. 2018).
Categories:
Health Care
Sub-Categories:
Bioethics
,
Health Law & Policy
Type: Book
Abstract
The updated Fourth Edition includes recent cases and developments in biotechnology, including stem cell research and gene patents, and updates to HIPPA coverage, DNA research, and bio-banks.

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