Friday: FDA Chief Counsel Stacy Cline Amin and more at 7th Annual Health Law in P/Review

This year brought with it a wave of interesting issues in the health law arena—be it questions of limiting health care access to immigrants, the ongoing challenges of the opioid epidemic, or the ever-changing landscape of drug pricing.

Join us as we unpack the major health law developments of 2019 and discuss what to watch for in the year to come. Over the course of the day, leading experts will consider hot topic issues such as, health policy under the current administration, pharmaceutical policy, and global health. Featured panel discussions include “Challenges Facing Health Care General Counsels” and “AI in Health Care.”

In addition to panel discussions and speaker presentations, the conference will feature a special Fireside Chat between Glenn Cohen and Stacy Cline Amin, who serves as Chief Counsel of the Food and Drug Administration and Deputy General Counsel of the Department of Health and Human Services. She previously served as Special Assistant to the President and Senior Associate Counsel to the President, serving as the senior legal advisor on matters relating to the Department of Health and Human Services. Stacy will offer a window into what 2019 holds for the FDA.

 

This event is free and open to the public, but seating is limited and registration is required. Register now!

The Seventh Annual Health Law Year in P/Review is sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund at Harvard University.

Anya Prince on Gene Therapy and Exacerbating Health Care Inequalities

Anya Prince, a legal scholar and thought leader in the field of genetic discrimination, will present a new paper at Monday’s Health Law Workshop that interrogates whether gene therapies will exacerbate inequalities in health care, as more treatments enter the market. “Gene Therapy’s Field of Dreams: If You Build It, Will We Pay?” focuses on some of the many issues raised by the prices of gene therapies.
Read More

digital health at harvard logo

Can Computer Simulations Enhance Vaccine Trials?

Infectious disease emergencies are opportunities to test the efficacy of newly developed interventions—for example, drugs, vaccines, and treatment regimens. Yet they raise many intertwined challenges around politics, logistics, ethics, and study design.

It is essential to advance the discussion of how such products can and should be tested while remaining consistent with the efforts of CEPI, WHO, and others who encourage development and testing of candidate vaccines in advance of emergencies. Read More

Join Us For A Special Evening with Author John Carreyrou

 

Please join us for a conversation with John Carreyrou, Investigative reporter for the Wall Street Journal and author of the New York Times bestseller “Bad Blood: Secrets and Lies in a Silicon Valley Startup.”

Carreyrou will discuss his book about the rise and fall of Silicon Valley darling, the blood testing company Theranos, and its charismatic, Stanford drop-out CEO, Elizabeth Holmes.

In recent weeks, news has emerged that the company will in fact cease operations, despite a short-lived attempt to survive after removing Holmes.

Read More

‘Big Data, Health Law, and Bioethics’ Examines the Intersection of Major Issues in Health Care

When data from all aspects of our lives can be relevant to our health – from our habits at the grocery store and our Google searches to our FitBit data and our medical records – can we really differentiate between big data and health big data? Will health big data be used for good, such as to improve drug safety, or ill, as in insurance discrimination? Will it disrupt health care (and the health care system) as we know it? Will it be possible to protect our health privacy? What barriers will there be to collecting and utilizing health big data? What role should law play, and what ethical concerns may arise? A new timely, groundbreaking volume explores these questions and more from a variety of perspectives, examining how law promotes or discourages the use of big data in the health care sphere, and also what we can learn from other sectors.

Read More

Govind persad

When All You Have is a DALY, Everything Looks Like Disease

Recently the Petrie-Flom Center’s annual conference brought together medical experts, bioethics scholars, and disability advocates to rethink how medical systems and public health policies can engage with disability.

During the many fascinating panels at “Beyond Disadvantage: Disability, Law, and Bioethics” one idea that sparked some debate was whether we should use quality/disability adjusted life years (QALY/DALY) to set priorities for who gets access to healthcare resources. Prof. Govind Persad, a bioethicist at Johns Hopkins and blogger for Bill of Health, suggested in his presentation that we should dramatically reduce the role of such utilitarian calculations in priority setting, instead focusing on the genesis of the disadvantage.

Read More

Putting Patients at the Center of Research: Opportunities and Challenges for Ethical and Regulatory Oversight

Efforts to place the patient at the center of medical research, spurred by the Affordable Care Act’s founding of the Patient Centered Outcomes Research Institute, have begun to change the way clinical research is conceptualized and conducted.

Such efforts hold great promise, but also raise potential challenges for ethical oversight.

How should oversight bodies approach the presence of patients in potentially unfamiliar research roles, such as investigator? What forms of patient involvement in research, if any, warrant increased scrutiny from oversight bodies? How do we keep the patient voice from being ‘captured’ by special interest groups?

This symposium will bring together a diverse group of patients and community members, policymakers, bioethicists, and regulatory officials to address these and other issues.

Read More

2018 Petrie-Flom Center Annual Conference: Beyond Disadvantage: Disability, Law, and Bioethics

2018 Petrie-Flom Center Annual Conference: Beyond Disadvantage: Disability, Law, and Bioethics
June 1, 2018 8:00 AM – 5:00 PM
Wasserstein Hall, Milstein East ABC (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

“Congress acknowledged that society’s accumulated myths and fears about disability and disease are as handicapping as are the physical limitations that flow from actual impairment.” Justice William J. Brennan, Jr., School Bd. of Nassau, Fl. v. Arline, 480 U.S. 273 (1987).

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2018 annual conference, entitled: “Beyond Disadvantage: Disability, Law, and Bioethics.” This year’s conference is organized in collaboration with the Harvard Law School Project on Disability.

Conference Description

Historically and across societies people with disabilities have been stigmatized and excluded from social opportunities on a variety of culturally specific grounds. These justifications include assertions that people with disabilities are biologically defective, less than capable, costly, suffering, or fundamentally inappropriate for social inclusion. Rethinking the idea of disability so as to detach being disabled from inescapable disadvantage has been considered a key to twenty-first century reconstruction of how disablement is best understood.

Read More

2018 Petrie-Flom Center Annual Conference: Beyond Disadvantage: Disability, Law, and Bioethics

2018 Petrie-Flom Center Annual Conference: Beyond Disadvantage: Disability, Law, and Bioethics
June 1, 2018 8:00 AM – 5:00 PM
Wasserstein Hall, Milstein East ABC (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

“Congress acknowledged that society’s accumulated myths and fears about disability and disease are as handicapping as are the physical limitations that flow from actual impairment.” Justice William J. Brennan, Jr., School Bd. of Nassau, Fl. v. Arline, 480 U.S. 273 (1987).

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2018 annual conference, entitled: “Beyond Disadvantage: Disability, Law, and Bioethics.” This year’s conference is organized in collaboration with the Harvard Law School Project on Disability.

Conference Description

Historically and across societies people with disabilities have been stigmatized and excluded from social opportunities on a variety of culturally specific grounds. These justifications include assertions that people with disabilities are biologically defective, less than capable, costly, suffering, or fundamentally inappropriate for social inclusion. Rethinking the idea of disability so as to detach being disabled from inescapable disadvantage has been considered a key to twenty-first century reconstruction of how disablement is best understood.

Read More