REGISTER NOW: Aligning Policy and People:
Why the Time is Right to Transform Advanced Care

Tuesday, June 21, 2016 9:00 AM - 1:00 PM
Wasserstein Hall, Milstein East ABC
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA


Please join us for the inaugural event of the Project on Advanced Care and Health Poli...

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2016 Annual Conference:
Big Data, Health Law, and Bioethics

Friday, May 06, 2016
Wasserstein Hall, Milstein East ABC
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Registration for this event is now closed. If you would like to be added to the wait list, please c...

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‘Unacceptable’ that families ‘not told of resuscitation plans’

BBC News, May 2, 2016

Medical staff have placed "do not resuscitate" orders on thousands of patients in England without t...

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Quaker Oats’ 100% Natural Claim Questioned in Lawsuit

New York Times, May 1, 2016
by Stephanie Strom

A lawsuit seeking to be certified as a classaction has been filed on behalf of consumers...

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Antismoking Coalition Gives Big Tobacco a Fight in Indonesia

New York Times, April 30, 2016
by John Emont

[...] Over the last decade, it has become a last Eden for tobacco companies facing declining s...

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Feds Act To Help More Ex-Inmates Get Medicaid

NPR, April 29, 2016
by Jay Hancock

Administration officials moved Thursday to improve low Medicaid enrollment for emerging prisoners,...

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There’s a new sheriff in town in Silicon Valley — the FDA

Washington Post, April 28, 2016
by Ariana Eunjung Cha

[...] As a tidal wave of new health-related gadgets, apps and tests hits the market, governmen...

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Drug Companies To Pour $100M Into Battle Against California’s Price Control Ballot Initiative

Kaiser Health News, April 25, 2016

KHN Morning Briefing: Summaries of health policy coverage from major news organizations

The i...

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Kaiser Health News, April 25, 2016
by Jay Hancock

[...] Thousands of people leave incarceration every year without access to the coverage and ca...

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Abortion doctors would lose medical licenses under new Oklahoma bill

Washington Post, April 23, 2016
by Niraj Chokshi

Oklahoma is just a signature away from revoking the licenses of most doctors who perform abortions.



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More Exchange Plans Offer Patients Easier Access To Some Expensive Drugs:

Kaiser Health News, April 22, 2016
by Michelle Andrews

Some people with cancer, HIV and multiple sclerosis have better access to high-cost speci...

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Obese patients denied surgery in a third of areas in England

BBC News, April 22, 2016

Surgeons are worried overweight patients and smokers in England and Wales are being denied surgery...

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Israel’s Health Minister To McDonald’s:

NPR, April 22, 2016
by Daniel Estrin

[...] In its newspaper ad campaign, McDonald's challenged the Israeli health minister to set a...

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What’s next for opioid legislation?

Politico Pulse, April 22, 2016
by Dan Diamond, referencing Rachel E. Sachs (Academic Fellow)

Excerpt from article:

[...] HEALTH WONK RECAP — PULSE flagged a few interesting st...

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Cities Begin To Count The Scars Of Childhood, And Try To Prevent New Damage

Kaiser Health News, April 21, 2016
by Sarah Varney

LOS ANGELES — Kimberly Cervantes has spent much of her young life learning to outwit the peri...

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Vancouver Prescriptions for Addicts Gain Attention as Heroin and Opioid Use Rises

New York Times, April 21, 2016
by Dan Levin

VANCOUVER, British Columbia — Dave Napio started doing heroin over four decades ago, at 11 ye...

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Hearing Aid Prices Under Pressure From Consumer Electronics

New York Times, April 20, 2016
by Andrew Pollack

[...] The consumer electronics industry is encroaching on the hearing aid business, offering p...

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Forbes, April 20, 2016
by Judy Stone

Alarming warnings to delay pregnancy for women in at-risk regions have been issued by the CDC, as w...

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Prizing Insurance: Prescription Drug Insurance as Innovation Incentive,

Harvard Journal of Law and Technology, Vol. 30, No. 1 (forthcoming)
by Rachel E. Sachs


A problem perennially facing scholars of both intellectual property and health law...

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NIH Halts Some Research Amid Concerns Over Contamination And Safety

NPR, April 19, 2016
by Nell Greenfieldboyce

The National Institutes of Health has suspended work in two facilities that manufacture products gi...

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La. Governor Announces Medicaid Expansion Will Begin June 1, Save State $677M Over 5 Years

Kaiser Health News, April 19, 2016

KHN Morning Briefing
Summaries of health policy coverage from major news organizations

About 375,0...

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Justice Department, SEC Launch Probes Into Theranos’ Practices And Technology

Kaiser Health News, April 19, 2016

KHN Morning Briefing: Summaries of health policy coverage from major news organizations

The i...

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Promoting Healthcare Innovation on the Demand Side,

U of Michigan Law & Econ Research Paper No. 16-008; U of Michigan Public Law Research Paper No. 503
by Rebecca Eisenberg and W. Nicholson Price II (Academic Fellow Alumnus)


Innovation policy often focuses on the incentives of firms that sell new products. But o...

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More People Seek Genetic Testing, But There Aren’t Enough Counselors

NPR, April 18, 2016
by Todd Bookman

[...] Genetic testing can help diagnose a disease and estimate your future risks, based on DNA. It...

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New Polio Vaccine Rolled Out In Massive Synchronized Worldwide Switch

NPR, April 17, 2016
by Merrit Kennedy

Starting today, 155 countries and territories will start switching to a different polio vaccine.


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Sperm Donor’s Profile Hid Mental Illness and Crime, Lawsuits Say

New York Times, April 17, 2016
by Christine Hauser

[...] Ms. Collins and Ms. Hanson, who live in Port Hope, Ontario, about 70 miles east of Toronto, w...

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Political Gridlock Blocks Missouri Database For Fighting Drug Abuse

Kaiser Health News, April 14, 2016
by Bram Sable-Smith

[...] In the battle against America’s surging opioid drug addiction, 49 states, the...

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Aid Groups Aim to Put Mental Health on World Agenda

New York Times, April 12, 2016
by Benedict Carey

Good mental health care is scarce in many parts of the United States, but it is nonexiste...

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Critics Say Medicare Cancer Drug Plan A ‘Dreadful Mistake,’

Kaiser Health News, April 11, 2016

KHN Morning Briefing: Summaries of health policy coverage from major news organizations

The O...

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The Female Viagra, Undone by a Drug Maker’s Dysfunction

New York Times, April 9, 2016
by Katie Thomas and Gretchen Morgenson

Last August, Sprout Pharmaceuticals had a new pill on its hands that quickly captured the nation&rs...

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When The Cost Of Care Triggers A Medical Deportation

NPR, April 9, 2016
by John Henning Schumann

[...] The best estimates suggest dozens or maybe a few hundred cases occur each year. I called seve...

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Abortion Providers In Utah Adapt To New Anesthesia Requirement

NPR, April 7, 2016
by Andrea Smardon

In Utah, a doctor performing an abortion will soon have to administer anesthesia after 20 weeks of...

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White House Warns More Money Needed On Zika: ‘We Should Not Play With Fire Here’

Kaiser Health News, April 7, 2016

KHN Morning Briefing: Summaries of health policy coverage from major news organizations

The O...

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Pfizer And IBM Launch Ambitious ‘Internet Of Things’ For Parkinson’s Research

Forbes, April 7, 2016
by Emily Mullin

Pfizer is betting big on the Internet of Things, or IoT, in medicine–that is, the connectivit...

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Book Review: FDA in the Twenty-First Century:The Challenges of Regulating Drugs and New Technologies

Journal of Law and the Biosciences, Vol. 3, Issue 1 (April 1, 2016)
by Ryan Abbot, reviewing book edited by Holly Fernandez Lynch (Executive Director) and I. Glenn Cohen (Faculty Director)

From the review: 

FDA in the 21st Century is an excellent edited volume based on th...

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Signing Up Organ Donors in China Can Be an Uphill Battle

New York Times, April 6, 2016
by Didi Kirsten Tatlow

[...] About 300,000 Chinese people need transplants each year. In the face of this enormous ne...

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A Big Week For Parents:

NPR, April 6, 2016
by Camila Domonoske

Two record-setting parental-leave laws were passed this week, on opposite sides of the U.S.

In New...

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Pfizer, Allergan Call Off Their $150 Billion Merger

NPR, April 6, 2016
by Camila Domonoske

Pfizer and Allergan won't be merging after all, the companies announced Wednesday.

U.S. d...

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Scientists Say It’s Time To End ‘Parachute Research’

NPR, April 2, 2016
by Nurith Aizenman

Critics call them "parachute researchers": Scientists from wealthy nations who swoop in when a puzz...

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CRISPR, Are We Ready to Rewrite the Human Genome?

ECUSA Boston, March 24, 2016
by Speaker: Rachel Sachs (Academic Fellow)

Rachel Sachs (Academic Fellow) was a speaker at the ECUSA Boston event "CRISPR, Are We Ready to Rew...

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Faith charities eye Justice Kennedy in Obamacare birth control fight

The Washington Times, March 21, 2016
by Tom Howell Jr., quoting Holly Fernandez Lynch (Executive Director)

Excerpt from article:

[...] The Justice Department argues that a victory for the nonprofits w...

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Feeling Better: What is the FDA doing, and how is it doing it?

The Weekly Standard, March 21, 2016
by by Devorah Goldman, reviewing FDA in the 21st Century by Holly F. Lynch (Executive Director) and I. Glenn Cohen (Faculty Director)

Excerpt from the article:

[...] In his last State of the Union address, Barack Obama asked, &...

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Call for Papers: The Animal Welfare Act


Call for Papers: The Animal Welfare Act
Harvard Law School

Deadline: April 5, 2016

The Animal Law & Policy Program at Harvard Law School is pleased to announce The Animal Welfare...

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FDA - Food

U.S. Food and Drug Administration

Website for the U.S. Food and Drug Administration, one of the agencies responsible for regulating t...

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Genetically Modified Crops

Foundation of American Scientists

An introduction to genetically modified crops, including key ecological concerns. 

... Read More

Title 21: Food and Drugs

Code of Federal Regulations

In Chapter I, Subchapter B, Parts 100-190, the regulations applicable to FDA’s oversight of f...

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Food, Genetically Modified

World Health Organization

Educational page providing general and technical information on genetically modified foods. 

... Read More

FDA - Guidance and Regulation

U.S. Food and Drug Administration

Section of the FDA website containing FDA guidance and regulatory information applicable to food, i...

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Genetically Engineered Crops in the United States

United States Department of Agriculture, February 2014

Report by the USDA Economic Research Service on recent trends in adoption of genetically engineered...

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Food Code

U.S. Food and Drug Administration

The FDA’s Food Code is a model that assists food control jurisdictions at all levels of gover...

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Food from Genetically Engineered Plants

Food and Drug Administration

This FDA site includes consumer information about food from genetically engineered plants, as well...

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Consensus Statement on Electronic Health Predictive Analytics: A Guiding Framework

eGEMs (Generating Evidence & Methods to improve patient outcomes), 2016, Vol. 4, Issue 1
by I. Glenn Cohen (Faculty Director) et al.


Context: The recent explosion in available electronic health record (EHR) data is mo...

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USDA - Food Safety

U.S. Department of Agriculture, Food Safety and Inspection Service

Website for FSIS, an agency of the USDA responsible for ensuring food safety for meat, poultry, and...

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Genetically Engineered Crops: Past Experience and Future Prospects

National Academy of Science

Website announcing NAS study on the benefits and risks of GE crops. 

... Read More

What is a biobank? Differing definitions among biobank stakeholders

Clinical Genetics, March 2014
by Shaw et al.

An article discussing areas of agreement and difference in determining what constitutes a biob...

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Specimen Science: Ethics and Policy Implications

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics

Many important advances in human health depend on the effective collection, storage, use, and shari...

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Foodborne Outbreaks

Centers for Disease Control

This site outlines the CDC’s role in investigation, surveillance, and prevention of food safe...

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Bioengineered (Genetically Engineered) Crops and Foods

American Medical Association

AMA statement on genetically engineered crops and foods. 

... Read More

Biorepositories and Biospecimen Research Branch

National Cancer Institute

Website for the BBRB, which provides leadership, tools, resources, and policies in biobanking...

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Food Safety

Describes provisions of the Food Safety Modernization Act of 2011 and their role in strengthening t...

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GMOs, Herbicides, and Public Health

New England Journal of Medicine, Aug. 20, 2015
by Philip J. Landrigan and Charles Benbrook

Describes the impact of two recent changes in the GMO landscape, and considers their larger implica...

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NIH Data Sharing Policy

National Institutes of Health

This site includes the NIH Statement on Sharing Research Data (2003), Data Sharing Regulations...

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Characterizing biobank organizations in the U.S.

Genome Medicine, Jan. 2013
by Henderson et al.

Results from a national survey of U.S. biobanks, including information on location, reason for...

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Codex Alimentarius

World Health Organization

The Codex, administered by WHO and the U.N. Food and Agriculture Organization, establishes internat...

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Principles for Responsible Clinical Trial Data Sharing

PhRMA, EFPIA, Jul. 2013

A joint agreement produced by pharmaceutical trade groups PhRMA and EFPIA, affirming the indus...

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Biobank resources for future patient care: developments, principles and concepts

Journal of Clinical Bioinformation, Sept. 2011
by Ákos Végvári et al

An overview of global biobank development, outlining the critical research role of biobanks an...

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Food Labeling Litigation

by Nicole E. Negowetti

Report on food labeling class action lawsuits and FDA regulatory authority. 

... Read More

Clinical Trial Data Portal Gateway


This site offers a published list of major pharmaceutical companies’ online portals aimed&nbs...

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WMA Declaration on Ethical Considerations Regarding Health Databases and   Biobanks

World Medical Association, March 2015

A supplemental declaration to the Declaration of Helskini, which provides additional principle...

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Food and Drug Law Institute

Non-profit site providing a space for discussion of food and drug law, including conferences and pu...

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Sharing of Clinical Trials Data: Benefits, Risks, and Uniform Principles

Annals of Internal Medicine, 2015
by Michael Rosenblatt et al.

This commentary discusses the benefits and risks of data sharing from the perspective of perso...

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Research Repositories, Databases, and the HIPAA Privacy Rule

NIH, January 2004

Discusses the impact of the HIPAA privacy rule on the creation of research databases and repos...

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Harvard Food Law and Policy Clinic

The Harvard Law School clinic focused on seeking to increase access to healthy foods, reduce food w...

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Sharing and Reporting the Results of Clinical Trials

JAMA, Jan. 2015
by Kathy L. Hudson and Francis S. Collins

This article advocates for sharing the results of clinical trials as an important means for ad...

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Global Directory of Biobanks, Tissue Banks, and Biorepositories

Specimen Central

An extensive listing of biobanks, tissue banks, and biorepositories, with links to all institu...

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Fecal Transplants to Treat C. difficile: FDA Seeks Comment on What IND Requirements to Waive

Regulatory Affairs, February 29, 2016
by Zachary Brennan, citing Rachel E. Sachs (Academic Fellow)

From the article: 

[...] The draft guidance comes as over the past few years, FMT, which basi...

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Food Safety News

Website providing coverage on food safety issues, including contributions from the FDA.

... Read More

Preparing for Responsible Sharing of Clinical Trial Data

New England Journal of Medicine, Oct. 2013
by Michelle M. Mello et al.

As more patient data from clinical trials is shared by sponsors and investigators, this articl...

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Going Germline: Mitochondrial Replacement as a Guide to Genome Editing

Cell, February 25, 2016, Vol. 164, Issue 5
by By Eli Y. Adashi & I. Glenn Cohen (Faculty Director)

Mitochondrial replacement (MR) serves as a crucial test case and learning guide for the scientific,...

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New Journal of Law & Biosciences featuring Harvard student work

Journal of Law and the Biosciences (JLB), Vol. 3, Issue 1

The Journal of Law and the Biosciences, the open-access journal launched in 2014 by the P...

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Food and Drug Law

Peter Hutt et al., 2013

Introductory casebook on administrative and other key issues in food and drug law. 

... Read More

Technical and Policy Approaches to Balancing Patient Privacy and Data Sharing

Journal of Investigative Medicine, Jan. 2010
by Bradley Malin et al.

This paper reviews several aspects of the privacy-related problems associated with data sharin...

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Yale University Open Data Access Project

Yale School of Medicine

The YODA project has iteratively developed a model to make data available to researchers in a...

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Global Tobacco Control as a Public Health and Human Rights Imperative

Monday, February 08, 2016 5:00 - 6:30 PM
Lectures and Panels
Hauser 102
Harvard Law School, Cambridge, MA

Please join us for a talk by Professors Howard Kyongju Koh and Harold Hongju Koh regarding the batt...

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Data Sharing and Transparency Initiative

Multi-Regional Clinical Trials Center

A data sharing and transparency initiative aimed at facilitating broad stakeholder clinical tr...

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Expert Committee: FDA Should Allow Mitochondrial Replacement Trials Under Certain Conditions

Regulatory Affairs, February 3, 2016
by Zachary Brennan, quoting I. Glenn Cohen (Faculty Director)

From the article:

Glenn Cohen, faculty director of the Petrie-Flom Center for Health Law Policy, B...

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NAM Releases Report on Mitochondrial Replacement Therapy

Bill of Health Blog, February 3, 2016
by I. Glenn Cohen (Faculty Director)

From the Part II post: 
My last post was a summary of the NAM’s Reco...
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Health Law Workshop: Michelle M. Mello

Monday, February 01, 2016 5:00 - 7:00 PM
Health Law Workshops
Hauser Hall 105
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Presentation Title: "Reforming the Medical Liability System in New York: Outcomes of the New York S...

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Fourth Annual Health Law Year in P/Review

Friday, January 29, 2016 8:00 AM - 5:00 PM
Wasserstein Hall, Milstein West AB
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Couldn't attend in person? Learn more about the event:

  • Learn more about the presentations...

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Does it break the law to charge a lot for a cure?

The Incidental Economist Blog, January 28, 2016
by Nicolas Bagley, quoting Rachel E. Sachs (Academic Fellow)

From the article:

[...] Talk about sending the wrong signals about what sorts of drugs we value mo...

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