Pre-order now and get 30% off! Specimen Science

MIT Press, September 2017
by Edited by Holly Fernandez Lynch (Executive Director), Barbara E. Bierer, I. Glenn Cohen (Faculty Director), and Suzanne M. Rivera

Pre-order through MIT Press and receive 30% off using discount code MSPECIMEN30: Order now! This edited volume stems from a conference in 2015 that brought together leading experts to address key… Read More

NHS patients to be asked about sexuality

BBC News, October 15, 2017

Health professionals in England are to be told to ask patients aged 16 or over about their sexual orientation, under new NHS guidelines. NHS England said no-one would be forced to answer the question but… Read More

PFC Spotlight: Academic Fellow Alumnus Jeffrey Skopek

Petrie-Flom Center, June 15, 2017
by Petrie-Flom Center

Jeffrey Skopek was an Academic Fellow for the 2011-2014 academic years, during which he wrote extensively on anonymity, differentiating it from privacy in articles that reveal its importance… Read More

Legal Roundtable: Discussing abortion restrictions, health care, Supreme Court developments and more

St. Louis Public Radio, May 30, 2017
by Kelly Moffitt, featuring Rachel Sachs (Academic Fellow Alumna)

From the radio episode: On Tuesday’s St. Louis on the Air, Legal Roundtable panel returned to discuss pressing issues of the law. They discussed a number of topics, starting with national issues… Read More

Call for Papers: Data-driven Health Care Conference
Ewha Institute for Biomedical Law & Ethics, South Korea

Deadline: June 15, 2017

1.   Conference Description The Ewha Institute for Biomedical Law & Ethics (EIBLE) is seeking submissions for its annual conference to be held on September 23, 2017 in Seoul. This year’s… Read More

Using Social Media as a Research Recruitment Tool: Ethical Issues and Recommendations

The American Journal of Bioethics, Volume 17, 2017 - Issue 3
by Luke Gelinas, Robin Pierce, Sabune Winkler, I. Glenn Cohen, Holly Fernandez Lynch, and Barbara Bierer

Part of the Petrie-Flom Center's collaboration with the Regulatory Foundations, Ethics, and Law Program of Harvard Catalyst | The Harvard Clinical and Translational Science… Read More

Mid-Atlantic Health Law Works-in-Progress Retreat
Seton Hall Law School

Deadline: February 03, 2017

Seton Hall Law School’s Center for Health & Pharmaceutical Law & Policy is pleased to announce the inaugural Mid-Atlantic Health Law Works-in-Progress Retreat, which will be held on February… Read More

Regulating Secrecy

Washington Law Review, 2016, Vol. 91, Nr. 4
by W. Nicholson Price II (Academic Fellow Alumnus)

Abstract: Inventors face a stark choice between two intellectual property systems of protecting innovative ideas: patents and trade secrecy. But accounts of this choice underexplore the role of the… Read More

Review of Human Subjects Research Regulation: Perspectives on the Future

American Journal of Bioethics, Vol. 16, Issue 12 (2016)
by Erin Phinney Johnson

From the review: Overall, the editors present an intriguing look at the concerns currently facing human subjects research regulation and provide a number of suggestions for how to go about solving some… Read More

“Sperm Donor Anonymity and Compensation: An Experiment with American Sperm Donors”

Journal of Law and the Biosciences (JLB), November 23, 2016
by Glenn Cohen (Faculty Director), Travis Coan, Michelle Ottey, and Christina Boyd

Prohibiting Sperm Donor Anonymity Could Reduce the Number of Donors: A new study published in the Journal of Law and the Biosciences (JLB) suggests that prohibiting anonymous sperm donation would result… Read More

PFC Spotlight: Student Fellow Alumnus Neel Shah

Petrie-Flom Center, September 8, 2016

Dr. Neel Shah was a Student Fellow for the 2007-2008 academic year, while in his third year at Harvard Medical School. Then Academic Fellow and now Faculty Director I. Glenn Cohen served as his… Read More

CALL FOR ABSTRACTS: 2017 Petrie-Flom Center Annual Conference
Harvard Law School

Deadline: Due no later than December 2, 2016

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2017 annual conference, entitled: “Transparency in Health and… Read More

When Big Data Isn’t Big Enough

Ampersand, May 20, 2016
by Elise Davis

Elise Davis of PRIM&R attended the Petrie-Flom Center's 2016 Annual Conference on "Big Data, Health Law, and Bioethics" on May 6, 2016. From her review at PRIM&R's blog Ampersand: … Read More

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)

Abstract: Innovation policy often focuses on the incentives of firms that sell new products. But optimal use of healthcare products also requires good information about the likely effects of products in… Read More

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 Rewrite the Human Genome?" on March 24, 2016. The gene editing tool CRISPR has revolutionized… Read More

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.

Abstract Context: The recent explosion in available electronic health record (EHR) data is motivating a rapid expansion of electronic health care predictive analytic (e-HPA) applications, defined… Read More

Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk

Institute of Medicine, 2015

A report commissioned by NIH and other sponsors on promoting responsible access to participant level data. Read More

Sharing Clinical Trial Data — A Proposal from the International Committee of Medical Journal Editor

International Committee of Medical Journal Editors, Jan. 2016

A proposal from the editors of major medical journals across the world to make publication in their journals contingent on sharing de-identified, individual-level participant data from clinical… Read More

NIH Data Sharing Policy

National Institutes of Health

This site includes the NIH Statement on Sharing Research Data (2003), Data Sharing Regulations for NIH Awards, and other information on the NIH data sharing policy. Read More

Principles for Responsible Clinical Trial Data Sharing

PhRMA, EFPIA, Jul. 2013

A joint agreement produced by pharmaceutical trade groups PhRMA and EFPIA, affirming the industry’s commitment to responsible data sharing. Read More

Clinical Trial Data Portal Gateway

EFPIA

This site offers a published list of major pharmaceutical companies’ online portals aimed at advancing responsible clinical trial data sharing. Read More

Health Insurance Portability and Accountability Act of 1996

104th Congress

Full text of the Health Insurance Portability and Accountability Act (HIPAA), the key federal law governing data privacy and security of medical information. Read More

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 persons with experience in academic medicine, government, and medical publishing, as well as the pharmaceutical… Read More

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 repositories, and research that uses identifiable health information in repositories and databases. Read More

Health Information Privacy

Department of Health and Human Services

HHS site providing comprehensive information about HIPAA, for individuals and professionals, with details on both the privacy and security rules. Read More

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 advancing medical knowledge and promoting health. Read More

HIPAA: Health Insurance Portability and Accountability Act

American Medical Association

This site describes HIPAA and relevant Affordable Care Act provisions, as well as a  variety of HIPAA-related resources. 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 article provides a suggested framework for broad sharing of participant-level data from clinical trials… Read More

HIPAA Privacy Rule and Its Impacts on Research

National Institutes of Health

Educational materials concerning HIPAA’s role in clinical research, authorizations, and other aspects of the research process. Read More

HIPAA Privacy Rule and Public Health

Centers for Disease Control and HHS

Guidance from the CDC and Department of Health and Human Services on HIPAA and public health. Read More

Privacy Legislation and Regulations

Centers for Disease Control

CDC page on privacy legislation and regulations, including HIPAA. 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 sharing for clinical research from technical and policy perspectives. Read More

Portability of Health Coverage (HIPAA)

Department of Labor

Department of Labor site describes HIPAA rights and protections for participants and beneficiaries in group health plans. Read More

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 sustainable way; the project currently has 123 trials available to request. Read More

HIPAA: Impacts and Actions by States

National Conference of State Legislatures

Site featuring a variety of information relating to state enactment of HIPAA. Read More

Data Sharing and Transparency Initiative

Multi-Regional Clinical Trials Center

A data sharing and transparency initiative aimed at facilitating broad stakeholder clinical trials data sharing. Read More

Learning the wrong lesson on privacy from Henrietta Lacks

Washington Post, January 8, 2016
by Christopher Robertson (Student Fellow Alumnus) and Jonathan D. Loe

From the article: In her acclaimed 2010 book, “The Immortal Life of Henrietta Lacks,” Rebecca Skloot tells the story of a poor black woman with cervical cancer who checked into Johns Hopkins… Read More

Symposium on “Ethical Risk Assessment in Biomedical Big Data”

Organised by the Oxford Internet Institute, University of Oxford, in association with the Brocher Foundation., March 14-15, 2016
by Featuring I. Glenn Cohen (Faculty Director)

Please register via the event website. Description In biomedical research, the analysis of large datasets (Big Data) has become a major driver of innovation and success. ‘Biomedical Big Data’… Read More

Health Law, Policy, and Bioethics: Cross-Registration Opportunity for Harvard Students
Harvard Medical School

Deadline: January 15, 2016

Cross-registration is available for "Health Law, Policy, and Bioethics," a new course being offered as part of the HMS Master’s program in bioethics. A course description is provided below. Interested… Read More

Call for Abstracts: 2016 Petrie-Flom Annual Conference: Big Data, Health Law, and Bioethics
Petrie-Flom Center, Harvard Law School

Deadline: December 01, 2015

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2016 annual conference, entitled: “Big Data, Health Law, and… Read More

Call For Papers: Beyond IRBs - Designing Ethical Review Processes for Big Data Research
Future of Privacy Forum

Deadline: October 25, 2015

The Future of Privacy Forum is hosting an academic workshop supported by the National Science Foundation to discuss ethical, legal, and technical guidance for organizations conducting research… Read More

Review of Human subjects research regulation: perspectives on the future

Theoretical Medicine and Bioethics, Vol. 36, Issue 2, April 2015
by Lydia Stewart Ferreira (Visiting Scholar)

Petrie-Flom Visiting Scholar Lydia Stewart Ferreira, currently Adjunct Professor at the University of Toronto Faculty of Law and Osgoode Hall Law School, recently published a review… Read More

Predicting the sick through personal trails of health data

News Works, April 14, 2015
by Todd Bookman, quoting I. Glenn Cohen (Faculty Director)

[...] "I think there is a lot of interest in the area right now, and it is a great coming together of the healthcare world and the computer science world, as well as the patient experience world," says… Read More

The Future of Personalized Medicine

Hosted by The Future Society at the Harvard Kennedy School, January 28, 2015
by Rachel E. Sachs

On January 28, 2015, Academic Fellow Rachel E. Sachs spoke to the Future Society at the Harvard Kennedy School of Government on "The Future of Personalized Medicine." The talk addressed a range of… Read More

Academic Fellow Jeffrey Skopek to Join Faculty of Law at the University of Cambridge

Petrie-Flom Center, August 11, 2014

We are pleased to announce that Petrie-Flom Academic Fellow Jeffrey Skopek will be joining the law faculty of the University of Cambridge in the fall.  At Cambridge, Jeff will continue his… Read More

US big-data health network launches aspirin study

Nature, August 6, 2014
by Sara Reardon, quoting I. Glenn Cohen (Faculty Director)

From the article: One of the largest big-data experiments in health care has set its first research target. The leaders of the Patient-Centered Outcomes Research Institute (PCORI) in Washington DC voted… Read More

Human Subjects Research Regulation

MIT Press, August 2014
by I. Glenn Cohen (Faculty Director) and Holly Fernandez Lynch (Executive Director), eds.

Human Subjects Research Regulation: Perspectives on the Future (MIT Press 2014), co-edited by Petrie-Flom Center Faculty Director, I. Glenn Cohen, and Executive Director, Holly Fernandez Lynch, stems from… Read More

Petrie-Flom Seeks Research Assistant
Petrie-Flom Center, Harvard Law School

Deadline: August 15, 2014

The Petrie-Flom Center for Health Law and Policy, Biotechnology and Bioethics, seeks a part-time research assistant for project collaboration with Harvard Catalyst (Harvard Clinical and Translational Science… Read More

Inquisitive Nashville teen finds her egg donor mom

USA Today, June 5, 2014
by Heidi Hall, featuring I. Glenn Cohen (Faculty Director)

Originally published as "Nashville teen finds her egg donor mom," The Tennesseean (June 5, 2014). [...] The identity of U.S. sperm and egg donors is protected by default. In the United Kingdom,… Read More

Health Law Counsel
Aetna Inc.

Deadline: May 21, 2014

Position Summary This position will support Lead Privacy and Behavioral Health Counsel in providing legal advice and recommendations for action regarding matters of complexity as well as more routine privacy… Read More

Will your clothing spy on you?

Fortune, February 13, 2014
by David Whitford, on I. Glenn Cohen (Petrie-Flom Faculty Co-Director)

[...] Like it or not, we have entered the era of assumed ubiquitous snooping, and we have not begun to parse the implications. That was my takeaway from Cohen's lecture, "The Ethicist's and the… Read More

Can You Buy Sperm Donor Identification?

Journal of Empirical Legal Studies, October 23, 2013
by I. Glenn Cohen and Travis G. Coan

In the United States, most sperm donations are anonymous. By contrast, many developed nations require sperm donors to be identified, typically requiring new sperm (and egg) donors to put identifying information… Read More

Health Insurance Portability and Accountability Act of 1996 Privacy Rule

The Department of Health and Human Services

Issued on August 14, 2002, the HIPAA Privacy Rule regulates the use and disclosure of Protected Health Information (PHI) held by institutions such as health insurance companies, health care clearinghouses,… Read More