262 results match your criteria: "Petrie-Flom Center for Health Law Policy[Affiliation]"
Who would own the HeLa cell line if the Henrietta Lacks case happened in present-day South Africa?
J Law Biosci
May 2023
School of Law, University of KwaZulu-Natal, Durban, South Africa.
The HeLa cell line was created in 1951 without consent from Henrietta Lacks, the person whose tissue sample was used. In 2021, the descendants of Henrietta Lacks sued a well-known biotechnology company for the profits it made from the HeLa cell line. In this article, ownership of the cell lines is investigated from a South African legal perspective by considering three possible contemporary scenarios bearing points of similarity to the Henrietta Lacks case.
View Article and Find Full Text PDFAbortion Miscoding-Legal Risks for Clinicians and Hospital Systems.
JAMA
June 2023
The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School, Cambridge, Massachusetts.
Pressing regulatory challenges for psychedelic medicine.
Science
April 2023
Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School, Cambridge, MA, USA.
Policy must support generation of evidence on safety and effectiveness.
View Article and Find Full Text PDFDrug Importation from Canada: The Wrong Prescription.
R I Med J (2013)
May 2023
Deputy Dean and James A. Attwood and Leslie Williams Professor of Law, Harvard Law School; Faculty Director, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard University, Cambridge, MA.
The FDA Modernization Act 2.0: Drug Testing in Animals is Rendered Optional.
Am J Med
September 2023
Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School, Harvard University, Cambridge, Mass.
The Inflation Reduction Act: Recasting the Medicare Prescription Drug Plans.
Am J Prev Med
June 2023
Harvard Law School, Harvard University, Cambridge, Massachusetts; Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, Harvard University, Cambridge, Massachusetts.
Workplace Violence in Health Care: Protective Federal Legislation Must Not Be Delayed.
Am J Med
July 2023
Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School, Harvard University, Cambridge, Mass.
- s Collateral Consequences for Pharmaceutical Regulation.
N Engl J Med
March 2023
From the Moritz College of Law, the Drug Enforcement and Policy Center, and the James Comprehensive Cancer Center, Ohio State University, Columbus (P.J.Z.); the Department of Medical Science, Warren Alpert Medical School, 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, Cambridge, MA (I.G.C.).
The FDA Initiative to Assure Racial and Ethnic Diversity in Clinical Trials.
J Am Board Fam Med
April 2023
From the Professor of Medical Science, Former Dean of Medicine and Biological Sciences, Brown University, Providence, RI (EYA); Attwood and Leslie Williams Professor of Law, Harvard Law School, Faculty Director, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard University, Cambridge, MA (IGC).
On April 13, 2022, the Food & Drug Administration (FDA) issued a new draft guidance for industry for "developing plans to enroll more participants from underrepresented racial and ethnic populations in the U.S. into clinical trials .
View Article and Find Full Text PDFDrug scheduling limits access to essential medicines and should be reformed.
Nat Med
February 2023
Project on Psychedelics Law and Regulation (POPLAR) at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, Cambridge, MA, USA.
Early telemedical abortion, safeguarding, and under 18s: a qualitative study with care providers in England and Wales.
BMJ Sex Reprod Health
October 2023
Keele Law School, Keele University, Keele, Staffordshire, UK.
Background: Telemedical early medical abortion (TEMA) was introduced in England and Wales as a temporary measure in 2020 and was made permanent in 2022. While there are considerable data showing the safety, efficacy, and acceptability of TEMA for patients, there have been objections raised to TEMA based on safeguarding-particularly for people under 18 years of age. Little is known about abortion care providers' views and experiences of carrying out their safeguarding duties with people aged under 18 in the shift to TEMA.
View Article and Find Full Text PDFThe Reply.
Am J Med
February 2023
Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard University, Cambridge, Mass.
Abortion Access and the Benefits and Limitations of Abortion- Legal Frameworks: Lessons from the United Kingdom.
Camb Q Healthc Ethics
July 2023
Centre for Ethics and Law in the Life Sciences, Durham Law School, Durham University, Durham, UK.
This paper argues that abortion access is an important subject for bioethics scholarship and reflects on the relationship between legal frameworks and access to care. The author uses the example of the United Kingdom to examine the benefits and limitations of abortion- legal frameworks in terms of access. These are legal frameworks that enable the provision of abortion but subject to restrictions.
View Article and Find Full Text PDFAssessing-and Extending-California's Insulin Manufacturing Initiative.
JAMA
February 2023
Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School, Cambridge, Massachusetts.
EMTALA After : Emergency Reproductive Health Care in the Balance.
Ann Intern Med
February 2023
Harvard Law School, and Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard University, Cambridge, Massachusetts (I.G.C.).
Should the Administration for Strategic Preparedness and Response Lead the National Response to a Public Health Emergency?
JAMA Health Forum
January 2023
Harvard Law School, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard University, Cambridge, Massachusetts.
Prevention of Bias and Discrimination in Clinical Practice Algorithms.
JAMA
January 2023
Penn State Dickinson Law, Carlisle, Pennsylvania.
The varieties of psychedelic law.
Neuropharmacology
March 2023
Project on Psychedelics Law and Regulation (POPLAR) at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, 23 Everett St, 3rd Floor, Cambridge, MA, 02138, USA; Florida State University College of Law, 301 S Martin Luther King Jr Blvd, Tallahassee, FL, 32301, USA. Electronic address:
After decades of prohibition, psychedelics are generating intense public and private interest. Scientists are researching the therapeutic properties of these substances, and mounting evidence supports their ability to treat a variety of mental health conditions. Meanwhile, dozens of cities and states are proposing or enacting psychedelics legislation to promote research, increase therapeutic and non-therapeutic access, and decrease criminal penalties associated with producing, possessing, or consuming psychedelics.
View Article and Find Full Text PDFThe FDA Struggle to Withdraw Makena: Problems With the Accelerated Approval Process.
JAMA
December 2022
Department of Medical Science, Brown University, Providence, Rhode Island.
Ethical, Translational, and Legal Issues Surrounding the Novel Adoption of Ectogestative Technologies.
Risk Manag Healthc Policy
November 2022
Edmond & Lily Safra Center for Ethics and Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics, Harvard University, Cambridge, MA, USA.
Increasing numbers of research teams are investigating the feasibility of developing artificial amnion and placenta technology (AAPT), commonly referred to as "artificial womb technology". This technology, aimed at supporting ex vivo gestation, has not yet been tested in humans, but it has been stated that we are closer to clinical application than ever before as breakthroughs in animal studies demonstrate good proof of principle. With these proof-of-concept models, further dissemination of AAPT as a research modality is expected.
View Article and Find Full Text PDFPersistent Inpatient Harm: the Unremitting Challenge of Patient Safety.
J Gen Intern Med
May 2023
Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School, Harvard University, Cambridge, MA, USA.
The sobering realization that little has changed in the scope of inpatient harm makes it plain that efforts intent on improving patient safety must be redoubled if the status quo is to be reversed. Living up to the recommendations of the iconic Institute of Medicine (IOM) Report (To Err Is Human: Building a Safer Health System) must remain top of mind. Much can and must be done to assure to the degree possible the safety of the inpatient population.
View Article and Find Full Text PDFTraveling Across States for Prohibited Treatments: Medical Aid in Dying and Looming Battles Over Abortion.
J Gen Intern Med
February 2023
Mitchell Hamline School of Law, Saint Paul, MN, USA.
This JGIM Perspective discusses new and emerging challenges with accessing controversial medical therapies like medical aid in dying and abortion. While some states permit these therapies for only their residents, other states prohibit these therapies for their own residents. We summarize recent developments and growing challenges for clinicians treating "medical tourism" patients from other jurisdictions.
View Article and Find Full Text PDFCapping Prescription Drug Costs: State Initiatives to the Rescue?
R I Med J (2013)
November 2022
Deputy Dean and James A. Attwood and Leslie Williams Professor of Law, Harvard Law School; Faculty Director, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard University, Cambridge, MA.