Health Policy & Bioethics Consortia

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Telehealth use has rapidly increased over the last five years. It promises the potential to reduce health disparities in hard-to-reach populations and ease of access to care. However, telehealth also raises questions about patient confidentiality, informed consent, and clinicians’ scope of practice. This session will discuss the growth in telehealth use, opportunities to meet more health needs, and the policy and ethics questions that arise from this recent entrant into health care provision.

Presenters:

Ateev Mehrotra, MD, MPH, Professor of Health Care Policy, Department of Health Care Policy, Harvard Medical School; Associate Professor of Medicine and Hospitalist, Beth Israel Deaconess Medical Center

Smita Das, MD, PhD, MPH, Clinical Associate Professor, Psychiatry and Behavioral Sciences, Stanford University; Medical Director of Psychiatry, Lyra Health

Moderator:

Ameet Sarpatwari, PhD, JD, Assistant Professor of Medicine, Harvard Medical School; Associate Epidemiologist, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital; Assistant Director, PORTAL

The VA Pharmacy Benefits Management Services oversee the prescription drug benefit for the VA, which serves over 9 million veterans. A key component is a national formulary that determines which drugs are included in the benefit based on access and contracting to control VA spending. The national formulary promotes uniform benefits for all enrollees, appropriate prescribing, and reduced costs. This year, another federal health service, Medicare, will begin negotiating drug prices for the first time. In this session, experts on pharmaceutical markets and the VA formulary will discuss what can be learned from the VA program and how to ensure appropriate access to drugs while balancing cost concerns.

Presenters:

• Inmaculada (Inma) Hernandez, PharmD, PhD, Professor, Division of Clinical Pharmacy; Skaggs School of Pharmacy and Pharmaceutical Sciences, UC San Diego
• Chester (Bernie) B. Good, MD, MPH, Professor of Medicine and Pharmacy, University of Pittsburgh; Director, Center for Value-Based Pharmacy Initiatives; Senior Medical Director, UPMC Health Plan Insurance Division

Moderator:

• Leah Rand, DPhil, Research Scientist, PORTAL, Brigham and Women's Hospital; Lecturer, Harvard Medical School

Watch the recording on our YouTube channel.

The Indian Health Service (IHS) is the federal agency responsible for delivering health care services to American Indians and Alaskan Natives. Despite treaty obligations, the IHS has been chronically underfunded, even in comparison to other federal health programs, and health disparities persist. This session considered the complex laws governing Tribal and federal health programs, which were highlighted during COVID-19 public health actions, efforts to improve Tribal health care, and what can be done in the future for the federal government to meet its obligations.

Presenters:

Tom Sequist, MD, MPH, Chief Medical Officer, Mass General Brigham; Professor of Medicine and Professor of Health Care Policy, Harvard Medical School

Aila Hoss, JD, Associate Professor of Law, Indiana University Robert H. McKinney School of Law

Moderator:

Tony V. Pham, MD, Research Fellow in Indigenous Community Well-Being, Department of Global Health and Social Medicine, Harvard Medical School; Department of Psychiatry, Massachusetts General Hospital

Watch the recording on our YouTube channel.

Recently, numerous studies have revealed that commonly used medical devices, like pulse oximeters and spirometers, were designed to a "default" of light-skin tones or apply racial adjustments to outputs. This results in inferior diagnosis and care for Black and other minority patients. This session will explore how we got to this point where devices discriminate, how researchers identify racial bias in routine practice, and what changes would advance ethical, equitable medicine.

Panelists:

Thomas S. Valley, MD, MSc
Assistant Professor, Division of Pulmonary and Critical Care Medicine, University of Michigan

Amy Moran-Thomas, PhD
Associate Professor of Anthropology, Massachusetts Institute of Technology (MIT)

Moderator:

Frazer Tessema
PORTAL and Pritzker School of Medicine, University of Chicago

Watch the recording on our YouTube channel.

New prescription drugs and vaccines are protected by patents, which allow manufacturers to charge monopoly prices and prevent others from entering the market. In this session, experts in patents and vaccine development will identify and discuss challenges to making drug innovations open-access and opportunities for patent reform to improve access to new and important medicines.

Panelists:

Maria Elena Bottazzi, PhD
Associate Dean, National School of Tropical Medicine and Professor, Baylor College of Medicine
Co-Director, Texas Children's Hospital Center for Vaccine Development

Tahir Amin, LLB, Dip LP
Co-Founder and Co-Executive Director of the Initiative for Medicines, Access, and Knowledge (I-MAK)

Moderator:

Sean Tu, JD, PhD
Professor of Law, College of Law, West Virginia University

As one of the largest economic sectors globally, health care represents nearly 10% of GDP spending across O.E.C.D. countries. This significant activity produces an estimated 5-10% of global greenhouse gases, presenting opportunities to directly reduce this impact through changes to energy supply, waste, purchasing, and care models. Equally important, health care has a special interest in addressing climate change. Across the globe, human health is negatively impacted by the ramifications of climate change, such as heat, storms, flood, and fires. The health care sector must provide leadership on this critical issue to protect and improve the health of its patients.

What should the role of the health care sector be when it comes to climate change policies and advocacy? Dr. Aaron Bernstein and Anand Bhopal discussed the opportunities and challenges. This consortium was hosted by the Petrie-Flom Center. Please contact them at 617-496-4662 or petrie-flom@law.harvard.edu if you have questions.

Presenters:

Carmel Shachar
Executive Director, Petrie-Flom Center

Aaron Bernstein
Interim Director, The Center for Climate, Health, and the Global Environment, Harvard T.H. Chan School of Public Health (Harvard Chan C-CHANGE)
Assistant Professor of Pediatrics, Harvard Medical School
Pediatrician, Boston Children's Hospital

Anand Bhopal
Takemi Fellow, Takemi Program in International Health, Harvard T.H. Chan School of Public Health
PhD Candidate, University of Bergen

Moderator:

Alicia Ely Yamin
Lecturer on Law and Senior Fellow in Global Health & Rights, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School
Adjunct Senior Lecturer on Health Policy & Management, Harvard T.H. Chan School of Public Health

Watch the recording on our YouTube channel.

Many medical advances rely on Phase I trials that enroll healthy participants to test the safety of new therapies. These trials raise questions about what makes for a "good" trial and whether participants are compensated fairly for the risks and burdens of the research. This event brings together experts on clinical trial policy to discuss healthy participants' experiences and good trial governance.

Presenters:

Jill Fisher, PhD
Professor of Social Medicine, UNC School of Medicine

Holly Fernandez-Lynch, JD, MBE
Assistant Professor of Medical Ethics & Health Policy, Perelman School of Medicine, University of Pennsylvania

Moderator:

Benjamin Silverman, MD
Instructor for Medical Ethics & Professionalism, Harvard Medical School
IRB Chair, Mass General Brigham

The Model List of Essential Medicines of the World Health Organization (WHO) identifies priority drugs for low- and middle-income countries to include in health service coverage. The List influences formulary choices around the world and affects access to medications for millions of people. Thus, the list functions as both guidance and a political tool. Four international prescription drug experts will join us to discuss the List, challenges facing the selection of medicines, and how to promote fair access to important drugs.

Discussants:

Nicola Magrini, MD
Director General, AIFA—Italian Medicines Agency

Wilbert Bannenberg, MD
Partner, HERA and Chairperson, Pharmaceutical Accountability Foundation

Moderators:

Kerstin Vokinger, PhD, MD, JD
Professor for Law, Medicine, and Technology, University of Zurich

Thomas Hwang, MD
Clinical Fellow in Surgery, Brigham and Women’s Hospital and Harvard Medical School

Watch the recording on our YouTube channel.

Emergency medical situations need evidence-based interventions, but clinical trials in these contexts are challenging in part because patients cannot provide informed consent. Should we not conduct traditional trials in these circumstances? Is community-level consent an appropriate substitute? How can we handle variations in trust that different communities have in the medical system? This session will consider the ethical and legal challenges of emergency clinical research, policies related to waiving informed consent, and lessons learned from studies that have received waivers.

Discussants:

Neal W. Dickert, MD, PhD
Associate Professor, Emory School of Medicine, Division of Cardiology, EECRI and Emory University Rollins School of Public Health, Department of Epidemiology

Carrie Sims, MD, PhD
Director, Division of Trauma, Critical Care, and Burn
Ohio State University College of Medicine

Moderator:

William B. Feldman, MD, DPhil
Instructor in Medicine, Brigham and Women’s Hospital

Watch the recording on our YouTube channel.

Patients with psychiatric disease needing in-patient care have reportedly been waiting days, and sometimes even months, due to bed and staffing shortages. How did the US health care system reach this point? This session will consider the causes of the current crisis, policy and ethics challenges to providing the most appropriate care, and what solutions would promote better care and resource availability.

Discussants:

Dominic Sisti, PhD
Associate Professor of Medical Ethics and Health Policy and Director, Scattergood Program for Applied Ethics in Behavioral Health Care, University of Pennsylvania

Susan M. Szulewski, MD, MBA
Associate Chief Medical Officer and Medical Director, Clinical Evaluation Center, McLean Hospital

Jennifer Goetz, MD
Child & Adolescent Psychiatrist, McLean Hospital and Harvard Medical School

Moderator:

Benjamin Barsky, JD, MBE
PhD Candidate in Health Policy, Harvard University

Watch the recording on our YouTube channel.

Confronting pandemics and improving health in low-income countries requires ambitious public health plans. Global health responses to HIV/AIDS and multi-drug resistant tuberculosis can provide guidance on how to garner public support and gain financial and political commitments to implement large-scale public health interventions and systems. In this session experts will discuss what it takes to finance and operationalize major public health programs.

Discussants:

Jim Yong Kim, MD, PhD
Vice Chairman and Partner, Global Infrastructure Partners;
Former President (2012-2019), The World Bank Group

Teeb Al-Samarrai, MD
Director of Science and Policy, Office of the Surgeon General

Prashant Yadav, PhD, MBA
Lecturer on Global Health and Social Medicine, Harvard Medical School

Moderator:

Rebecca Weintraub, MD
Founder, Director, Global Health Delivery Project, Harvard University;
Assistant Professor of Global Health and Social Medicine, Harvard Medical School

Watch the recording on our YouTube channel.

Infertility diagnostics and assisted reproductive technologies are not required in insurance coverage. Although an increasing number of states have enacted mandates, access to them remains inconsistent across the country, raising ethical concerns about whose parenthood is supported. In this session, two experts will examine system and legal barriers and opportunities related to assisted reproductive technologies.

Discussants:

Judith Daar, JD
Ambassador Patricia L. Herbold Dean and Professor of Law
Chase College of Law, Northern Kentucky University

Eli Adashi, MD
Professor of Medical Science
Brown University

Moderator:

Bea Brown, MBE
Research Specialist, Program on Regulation, Therapeutics, And Law (PORTAL)

Technology is now part of our lives in ways that was not possible only ten to twenty years ago. Smart devices, like watches, phones, and speakers, can gather vast amounts of information about their users, often without the user's knowledge or consent. As technology continues to improve, many of these devices may also be leveraged to serve diagnostic functions. Technologies such as Amazon's Alexa and Google's Assistant can ambiently and continually monitor a variety of information about an individual's location, voice, and movement. As this technology merges with wearables, such as the Apple Watch or FitBit, it may become possible to diagnose a wide range of diseases, including Alzheimer's. But should it?

To help answer that question, Dr. Barbara Evans and Dr. Jason Karlawish will discuss the medical, legal, and ethical implications of using such technology to diagnose diseases, such as Alzheimer's.

Discussants:

Barbara J. Evans, JD, PhD
Stephen C. O'Connell Chair and Professor of Law, University of Florida Levin College of Law;
Professor of Engineering, University of Florida Wertheim College of Engineering

Jason Karlawish, MD
Professor of Medicine, Medical Ethics and Health Policy, and Neurology, University of Pennsylvania;
Co-Director, Penn Memory Center

Moderator:

David Simon, JD
Research Fellow, Digital Home Health, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School

Watch the recording on our YouTube channel.

Breakthroughs in genetic technologies make possible a new method of changing our environments using gene drives, the introduction of certain traits into wild populations. From reducing the impact of invasive species to wiping out disease-carrying mosquitoes, gene drives offer the possibilities to improve human health. But, they also raise concerns—once this Pandora’s box is opened, can it ever be closed and what will be the lasting effects on other species? We will examine the science making gene drives possible, their potential to eradicate some diseases, and the ethical implications of research in the wild that reshapes our environment.

Discussants:

Jason Delborne, PhD
Professor of Science, Policy, and Society University Faculty Scholar Genetic Engineering and Society Center Executive Committee Member North Carolina State University

Omar Akbari, PhD
Professor Division of Biological Sciences Cell and Developmental Biology Section
University of California, San Diego

Moderator:

Insoo Hyun, PhD
Director of Research Ethics, Center for Bioethics, Harvard Medical School; Professor of Bioethics, Case Western Reserve University School of Medicine

*Joint event with the Ethics in Research and Biotechnology Consortia

Watch the recording on our YouTube channel.

The COVID-19 pandemic and vaccine rollout has highlighted the broad reach and prevalence of health misinformation. From outright lies to fuzzy claims, what makes such misinformation convincing and why does it take hold? When misinformation threatens individuals’ or the public’s health, are its propagators protected by the First Amendment? We will examine the current state of health misinformation and what can be done to push back against its spread.

Discussants:

Wendy Parmet, JD
Matthews Distinguished University Professor of Law and Director, Center for Health Policy and Law, Northeastern University School of Law

Joseph Cappella, PhD
Gerlad R. Miller Professor Emeritus of Communication, Annenberg School for Communication, University of Pennsylvania

Moderator:

Michael Sinha, MD, JD, MPH
Research Fellow, Harvard-MIT Center for Regulatory Science;  Affiliated Researcher, Program On Regulation, Therapeutics, And Law (PORTAL)

Watch the recording on our YouTube channel.

Psychedelics have been classified as schedule I substances—illegal to possess—since 1973, but research has increasingly highlighted potentially beneficial clinical applications of psychedelic treatment. Ballot initiatives and local ordinances have decriminalized some psychedelic substances, ushering in public discussion about the uses and abuses of drugs and law enforcement. In this session, we’ll hear from experts at the forefront of psychedelic research and advocacy about the ethical and legal challenges of proving that psychedelics can be effective and safe medicines.

Speakers:

Sharmin Ghaznavi, MD, PhD
Associate Director and Director of Cognitive Neuroscience, Center for the Neuroscience of Psychedelics, Massachusetts General Hospital; Instructor in Psychiatry, Harvard Medical School

Rick Doblin, PhD
Founder and Executive Director, Multidisciplinary Association for Psychedelic Studies

Mason Marks, MD, JD
Senior Fellow, Petrie-Flom Center for Health Law, Policy, Biotechnology, and Bioethics at Harvard Law School; Assistant Professor of Law, University of New Hampshire Franklin Pierce School of Law

Watch the recording on our YouTube channel.

The spectacular clinical success of COVID-19 vaccines has been undermined by barriers to access to the vaccine, particularly in low- and middle-income settings around the world. Dissemination of the vaccine requires global coordination, which can be challenging in the face of patents and other barriers to sharing technological know-how. This session will explore how we have successfully distributed other essential medicines to patients around the world, what some of the novel issues are facing access to the COVID-19 vaccine, and the role of patents and patent waivers, donations, and other strategies in giving everyone a fair shot. 

Speakers:

Lisa Larrimore Ouellette, PhD, JD 
Professor of Law, Stanford Law School; Senior Fellow, Stanford Institute for Economic Policy and Research

Paul Farmer, MD, PhD
Kolokotrones University Professor Chair of the Department of Global Health and Social Medicine Harvard Medical School

Hussain Lalani, MD, MPH
Clinical Research Fellow

Caring for populations in prisons raises distinct medical ethics and policy challenges, including pressures on the traditional doctor-patient relationship. Years of litigation have improved conditions in prisons and access to health care services but problems remain. In this panel, experts will share their experiences promoting change through the courts and law, describe how the COVID19 pandemic has been handled, and consider how ethical imperatives to secure equitable health care treatment and conditions can be pursued in the future.

Discussants:

Robert Greifinger, MD  
Consultant
Correctional Health Care

David Fathi, JD
Director
National Prison Project
American Civil Liberties Union

Moderator:

Shannon Bell, MD
Assistant Professor
Obstetrics and Gynecology
Boston University School of Medicine

Watch the recording on our YouTube channel.

Since its passage over a decade ago, the Affordable Care Act (ACA) has expanded health care coverage for Americans but also faced constant litigation and uncertainty about its future, particularly in the last four years. With a new political administration now in place, the panelists will discuss the current state of ACA litigation and federal and state efforts that could improve the ACA and health care coverage in the U.S.

Discussants:

Jonathan Oberlander, PhD, MPhil, MA
Department Chair of Social Medicine
Professor of Health Policy & Management
University of North Carolina-Chapel Hill

Erin Fuse Brown, JD, MPH
Director
Cathy C. Henson Professor of Law
Associate Professor of Law
Center for Law, Health & Society
Georgia State College of Law

Moderator:

Michael Sinha, MD, JD, MPH
Research Fellow
Harvard-MIT Center for
Regulatory Science
Harvard Medical School

Minority racial and ethnic groups in the U.S. have long experienced disparities in health care access and have worse health outcomes, undermining broader social, political, and economic equity. Negative stereotypes in U.S. culture can affect how minority patients are perceived and treated.

This session will address the harms caused by the current medical discourse and how both health systems and legal changes can improve outcomes in the future.

Discussants:

Evelynn Hammonds, PhD, MS
Barbara Gutmann Rosenkrantz Professor of the History of Science,
Professor of African and African American Studies, and Chair
Department of the History of Science Harvard University
 
Craig Konnoth, JD, MPhil
Associate Professor of Law
Director, Health Law Certificate
University of Colorado Law School

Moderator:

Michelle Morse, MD, MPH
Harvard Medical School Assistant Professor of Medicine at Brigham and Women's Hospital
Robert Wood Johnson Foundation Health Policy Fellow
Founding Co-Director, Equal Health

Watch the recording on our YouTube channel.

In May 2018, the Right to Try Act was signed into law, creating a new pathway for patients with life-threatening conditions to access investigational drugs prior to FDA approval. Unlike its expanded access program, the FDA plays a limited role in right to try, which is negotiated between the patient and the drug developer. Prior to the federal law, more than half of states had passed their own versions of right to try. With two years of experiencing the law in action, two expert panelists will consider the effects of right-to-try. Early access to investigational drugs also raises numerous ethical questions, like whether individual patients should be able to bypass research, who bears liability for harms, whether informed consent is possible for an investigational drug, and if early access will delay research that could benefit all patients.  

Discussants:

Alison Bateman-House, MPH, PhD
Department of Population Health at NYU Grossman School of Medicine

George Daley, MD, PhD
Dean of the Faculty of Medicine
Harvard Medical School

Moderator:

Insoo Hyun, PhD
Professor, Department for Bioethics
Case Western University School of Medicine
Director of Research Ethics
Senior Lecturer on Global Health and Social Medicine, Part-time
Harvard Medical School

Potential links between contact sports and chronic traumatic encephalopathy or other long-lasting neurological effects have received renewed public interest with high-profile lawsuits and debate about the dangers of sport. There are challenges with the evidence for drawing firm conclusions, making these debates especially contentious. The concerns about sport and head injury, especially for young players, are not new. Despite recognition of the dangers inherent in contact sports, there is a history of avoiding addressing the problem head-on. American culture surrounding football, lauded for its rough style of play, also influences our understandings of risk, injury, and changes to the sport. 

Discussants:

Kathleen Bachynski, PhD, MPH
Assistant Professor, Muhlenberg College  

Grant Iverson, PhD
Professor, Department of Physical Medicine and Rehabilitation
Harvard Medical School 
Director, Sports Concussion Program
MassGeneral Hospital for Children 

Moderator:

Cynthia Stein, MD, MPH
Attending Physician, Sports Medicine Division
Department of Orthopedic Surgery
Director Medical Sports Medicine Fellowship Program