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2023 Petrie-Flom Center Annual Conference: Health Law as Private Law

June 23, 2023
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Conference Description The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2023 annual conference: “Health Law as Private…

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Videos now available! 2022 Petrie-Flom Center Annual Conference: Diagnosing in the Home: The Ethical, Legal, and Regulatory Challenges and Opportunities of Digital Diagnostics and Therapeutics Outside of Traditional Clinical Settings

June 15, 2022
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Even prior to the COVID-19 pandemic, health care delivery was already shifting away from the clinic and into the home, utilizing telehealth, wearable sensors, ambient surveillance, and other products. The…

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Automating the Administrative State: 52nd Annual Administrative Law Symposium

February 12, 2022

Agenda 11:00 - 11:05 ET/8:00 - 8:05 PT, Welcome 11:05 - 11:35 ET/8:05 – 8:35 PT, Introductory Keynote Cass R. Sunstein Robert Walmsley University Professor, Harvard Law School Symposium Article: Governing by Algorithm? No Noise and …

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Data and COVID-19

June 2, 2020

Event Description John Snow famously used data to trace the source of a cholera outbreak, helping found the field of epidemiology. Data will play just as crucial a role in…

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Podcasts now available! 2020 Petrie-Flom Center Annual Conference: Innovation and Protection: The Future of Medical Device Regulation

May 8, 2020

Notice of Revision In light of developments with COVID-19, we converted our annual conference into a series of podcasts interviewing our contributors.Check out the episodes on This Week in…

The need for a system view to regulate artificial intelligence/machine learning-based software as medical device image

The need for a system view to regulate artificial intelligence/machine learning-based software as medical device

Sara Gerke (Research Fellow), Boris Babic, Theodoros Evgeniou, I. Glenn Cohen (Faculty Director)
nature: npj Digital Medicine

Abstract Artificial intelligence (AI) and Machine learning (ML) systems in medicine are poised to significantly improve health care, for example, by offering earlier diagnoses of diseases or recommending optimally individualized…

Telehealth can help fight the novel coronavirus, but U.S. challenges could limit its potential

Erin Brodwin
STAT

As the world braces for the spread of disease caused by the new coronavirus, public health officials are calling on clinicians and health systems to embrace a set of tools…

Philadelphia hepatitis data exposure posed ‘no risk to confidentiality’ because of Inquirer notification, city says image

Philadelphia hepatitis data exposure posed ‘no risk to confidentiality’ because of Inquirer notification, city says

Nathaniel Lash, quoting I. Glenn Cohen (Faculty Director)
Philadelphia Inquirer

From the article: The records in question were specific and intimate. One of the first few positive tests listed in the data set linked a woman’s name, race…

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Eighth Annual Health Law Year in P/Review

December 6, 2019
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At the Petrie-Flom Center's eighth annual Health Law Year in P/Review, leading experts discussed major developments in health law and policy during 2019 and what to watch out for…

Call for Participation: Contested Data: What Happens When the Givens Aren’t Taken, Data & Society, New York, NY

Deadline: November 25, 2019

From the call: DEADLINE FOR APPLICATIONS: NOVEMBER 25, 2019 APPLY HERE: HTTP://DATASOCIETY.NET/CONTESTED-DATA-APPLICATION FOR QUESTIONS, EMAIL EVENTS@DATASOCIETY.NET On March 6, 2020, Data & Society will host a workshop…

Apple’s Reach Reshapes Medical Research: The company’s tools enable researchers to track huge numbers of people. But doctors do not yet know if it will significantly improve health outcomes.

Natasha Singer
New York Times

[...] The new ingredients allowing the huge scale: Apple’s iPhones, apps and money. Harvard’s new study is just one of three new large research efforts that Apple…

With ‘Project Nightingale,’ Google Amassing Health Care Data On Millions Of Patients Without Their Knowledge

Kaiser Health News

KHN Morning Briefing: Summaries of health policy coverage from major news organizations Google launched the initiative with St. Louis-based Ascension, a Catholic chain of 2,600 hospitals, doctors’ offices and other…

Google to acquire Fitbit for $2.1 billion in major health tech deal

Megan Theilking and Rebecca Robbins
STAT

SAN FRANCISCO — Google parent company Alphabet announced on Friday it will buy Fitbit for $2.1 billion — a massive deal that will pit Google squarely against Apple (AAPL) in the…

Book Launch: Transparency in Health and Health Care in the United States

September 16, 2019
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Description In June 2019, Cambridge University Press published Transparency in Health and Health Care in the United States. This volume, edited by Holly Fernandez Lynch, I. Glenn Cohen, Carmel Shachar, and…

Digital Health Innovation (DHI) Executive Director, Partners HealthCare (PHS)

Deadline: Open until filled.
>Read the full job posting.

From the job posting: General Summary/Overview Enterprise Data and Digital Health (EDDH) program is an exciting new undertaking by Partners HealthCare and its affiliated hospitals that aims to transform…

Big Data, Big Tech, and Protecting Patient Privacy

By I. Glenn Cohen, JD (Faculty Director); Michelle M. Mello, JD, PhD
JAMA Viewpoint

From the article: The market for patient data has never been more active. Technology companies, from startups to giants, are eager to access electronic health record (EHR) data to build…

The Risks of Pregnancy-Tracking Apps

By Adam Jacobsen, quoting Carmel Shachar (Executive Director)
Risk Management

From the article: App companies should address potential user privacy concerns by engineering their products to be more secure by design, re-examining what data they provide to whom, and by…

Park DuValle Clinic Faces Blowback After Ransomware Attack

By Lisa Gillespie, quoting I. Glenn Cohen (Faculty Director)
WFPL

From the article: Glenn Cohen, a professor and expert on bioethics and biotechnology at Harvard, said he understands why a health provider might not want to broadcast that they are…

Digital Health Coalition Newsletter - July 2019

By Digital Health Coalition, quoting Sara Gerke (Research Fellow, Medicine, Artificial Intelligence, and Law)
Digital Health Coalition Newsletter

From the newsletter: Sara Gerke... …Research Fellow, Medicine, Artificial Intelligence, and Law, Harvard on why “Big Data” is the AI term on which marketers must have a…

What Should Happen to Our Medical Records When We Die?: Digital Health @ Harvard

April 3, 2019

Couldn't join us at the event? Check out our presenter's slides! Description Digital innovation is transforming health care, and the amount of digital health care data being generated…

Social Media and Pediatric Research Recruitment

Luke Gelinas (Former Senior Researcher) and Jennifer Kesselheim
In Ethics and Research with Children: A Case Based Approach, edited by Eric Kodish and Robert M. Nelson

From the chapter: "Social media use has increased exponentially across all demographics. With social media’s widespread popularity comes an increased potential for research sponsors and investigators to use…

Health Law Workshop: Natalie Ram

October 22, 2018

Presentation Topic: "Rebuilding Privacy Practices after Carpenter" This paper is not available for download. To request a copy in preparation for the workshop, please contact Jennifer Minnich at jminnich@law…

Digital Health @ Harvard Series: Medicaid Work Requirements: Limitations in Digitally Identifying Individuals for Exemption Due to Disability

October 16, 2018
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Description This year, several states applied for and received permission from the federal government to implement work requirements in their Medicaid programs. Policy designs vary by state, but all states…

Smart pills can transmit data to your doctors, but what about privacy?

I. Glenn Cohen (Faculty Director) and Alex Pearlman (Communications Manager)
New Scientist

From the article: Abilify MyCite, a pill-app combination that can be used to track the ingestion of drugs for bipolar disorder and schizophrenia, was the first such product approved by…

Book Launch: Big Data, Health Law, and Bioethics

September 12, 2018
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Couldn't join us for the event? Check out coverage from HLS Today and view some of the panelists' slide presentations below! Description In March 2018, Cambridge University Press published Big…

HIPAA and Protecting Health Information in the 21st Century

I. Glenn Cohen (Faculty Director) and Michelle M. Mello
JAMA

Faculty Director I. Glenn Cohen has co-authored a new opinion piece in JAMA that addresses the adequacy of HIPAA in protecting electronic health data in light of the launch of…

2018 Fulbright Visiting Research Chair in Health Law, Policy and Ethics, Center for Health Law, Policy and Ethics, University of Ottawa

Deadline: August 01, 2018

>Read full call

General Description:  Breakthroughs in health sciences offer tremendous hope to patients and the public, but with progress emerge new legal and ethical challenges. This position allows a scholar to…

Big Data, Health Law, and Bioethics

I. Glenn Cohen (Faculty Director), Holly Fernandez Lynch (former Executive Director), Urs Gasser, and Effy Vayena
Cambridge University Press

Now available - order it online! From the book: When data from all aspects of our lives can be relevant to our health - from our habits at the grocery…

Doctoral Scholarship: Digital Technologies and Protecting Privacy, The University of Melbourne

Deadline: September 30, 2018

>Read full call

Call for applications: Applications are invited from suitably qualified scholars for a PhD scholarship and to join Professor Jane Kaye’s team in Melbourne Law School (MLS), which specialises…

Risk and Resilience in Health Data Infrastructure

W. Nicholson Price II (Academic Fellow Alumnus)
Colorado Technology Law Journal

From the journal article: Today’s health system runs on data. However, for a system that generates and requires so much data, the health care system is surprisingly bad…

Digital Health @ Harvard Series: Health Care Costs and Transparency

February 6, 2018
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Description Health spending continues outpace wages and GDP, while some new insurance designs transfer greater shares of that to patients’ own out of pocket costs. In this talk, Dr.…

Can Healthcare Avoid “Black Box” Artificial Intelligence Tools?

Jennifer Bresnick, quoting I. Glenn Cohen (Faculty Director) and W. Nicholson Price II (Academic Fellow Alumnus)
Health IT Analytics

From the article: Artificial intelligence is taking the healthcare industry by storm as researchers share breakthrough after breakthrough and vendors quickly commercialize advanced algorithms offering clinical decision support or financial…

Big Data, Health Law, and Bioethics

Edited by I. Glenn Cohen (Faculty Director), Holly Fernandez Lynch (former Executive Director), Urs Gasser, and Effy Vayena
Cambridge University Press

This edited volume stems from the Petrie-Flom Center’s 2016 annual conference, which brought together leading experts to identify the various ways in which law and ethics intersect with the…

First Digital Pill Approved to Worries About Biomedical ‘Big Brother’

Pam Belluck, featuring I. Glenn Cohen (Faculty Director)
New York Times

For the first time, the Food and Drug Administration has approved a digital pill — a medication embedded with a sensor that can tell doctors whether, and when, patients take…

Book Launch: Specimen Science: Ethics and Policy Implications

November 9, 2017

In September 2017, MIT Press will publish Specimen Science: Ethics and Policy Implications, co-edited by Holly Fernandez Lynch (outgoing Petrie-Flom Executive Director), Barbara Bierer, I. Glenn Cohen (Faculty Director), and Suzanne…

Health Law Workshop: I. Glenn Cohen

October 16, 2017

Presentation Topic: "Cops, Docs, and Code: A Dialogue Between Big Data in Health Care and Predictive Policing" This paper is not available for download. To request a copy in preparation…

Your Money or Your Patient’s Life? Ransomware and Electronic Health Records

By I. Glenn Cohen (Faculty Director), Sharona Hoffman, and Eli Y. Adashi
Annals of Internal Medicine

The mugger's demand “Your money or your life” is a familiar one. However, in an era of vast hospital computer networks and electronic health records, a novel…

Health Law Workshop: Jody L. Madeira

September 18, 2017

Presentation Download the Presentation: "Terminating the Paper Trail: Evaluating the Efficacy of a Multimedia Informed Consent Application in Reproductive Medicine" For context, please also read: "Is Informed Consent in Reproductive…

Ideation Challenge: Good Questions Meet Big Data, Harvard Catalyst and the Crowd Innovation Laboratory, Harvard Business School

Deadline: July 13, 2017

>Read the Full Call

Ideation Challenge: Good Questions Meet Big Data - Up to $10,000 in Prizes DEADLINE: 11:59pm on July 13, 2017 Challenge: Can you identify a human health problem that might be resolved with…

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

Deadline: June 15, 2017
Christina Socci, Conference Coordinator

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…

2017 Petrie-Flom Center Annual Conference: Transparency in Health and Health Care: Legal and Ethical Possibilities and Limits

April 28, 2017
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Couldn't attend in person? You can still check out the conversation on Twitter: @PetrieFlom #transparencyinhealth! And check out many of the speakers' slide presentations below! Description Transparency is a…

Digital Health @ Harvard Brown Bag Lunch Series: Holding Hospitals Hostage: From HIPAA to Ransomware

April 27, 2017

The Digital Health @ Harvard brown bag lunch series features speakers from Harvard as well as collaborators and colleagues from other institutions who research the intersection between health and digital technology.…

Crowdfunding Medical Care: Identifying Ethical Implications

April 5, 2017
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Crowdfunding for medical care—seeking financial contributions from a large number of donors, often via social networks, to pay medical expenses—is growing in popularity in both the…

Digital Health @ Harvard Brown Bag Lunch Series: Using Mobile Phone Data to Map Migration and Disease: Politics, Privacy, and Public Health

March 30, 2017

The Digital Health @ Harvard brown bag lunch series features speakers from Harvard as well as collaborators and colleagues from other institutions who research the intersection between health and digital technology.…

Digital Health @ Harvard Brown Bag Lunch Series: Public Health Echo Chambers in a Time of Mistrust and Misinformation

February 23, 2017

The Digital Health @ Harvard brown bag lunch series features speakers from Harvard as well as collaborators and colleagues from other institutions who research the intersection between health and digital technology.…

Yuval Noah Harari in conversation with Michael Sandel: A discussion of Harari's new book Homo Deus: A Brief History of Tomorrow

February 22, 2017

Harvard Book Store and welcomes the bestselling author of Sapiens Yuval Noah Harari for a discussion of his latest book, Homo Deus: A Brief History of Tomorrow. Harari will be…

Digital Health @ Harvard Brown Bag Lunch Series: Free Independent Health Records, featuring Adrian Gropper, MD

January 26, 2017

The Digital Health @ Harvard brown bag lunch series features speakers from Harvard as well as collaborators and colleagues from other institutions who research the intersection between health and digital technology.…

Review of Human Subjects Research Regulation: Perspectives on the Future: edited by I. Glenn Cohen (Faculty Director) and Holly Fernandez Lynch (Executive Director)

Erin Phinney Johnson
American Journal of Bioethics

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…

Social Media Use in Research Recruitment: A New Guidance Document from Petrie-Flom and Harvard Catalyst

Luke Gelinas (Petrie-Flom/Harvard Catalyst Fellow in Clinical Research Ethics)
Petrie-Flom Center / Harvard Catalyst

Cross-posted at the Petrie-Flom Center's blog Bill of Health. Imagine this scenario: you are a researcher conducting a clinical trial on a promising treatment for a rare but serious…

Professor offers basics of bioethics and the law in 90 minutes: Harvard expert breaks down complex topic for Ed Portal and online audience

Deborah Blackwell, reviewing lecture by I. Glenn Cohen (Faculty Director)
Harvard Gazette

On September 13, 2016, Petrie-Flom Faculty Director I. Glenn Cohen delivered a lecture at the Harvard Ed Portal as part of his online EdX course "Bioethics: The Law, Medicine, and Ethics of…

PFC Spotlight: Student Fellow Alumnus Neel Shah

Petrie-Flom Center

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…

Big Data Neglects Populations Most in Need of Medical and Public Health Research and Interventions

Sarah E. Malanga, Jonathan D. Loe, Christopher T. Robertson (Academic Fellow alumnus), and Kenneth S. Ramos
Arizona Legal Studies Discussion Paper

Originally presented as a paper at the 2016 Petrie-Flom Center Annual Conference: Big Data, Health Law, and Bioethics. Check out the event website to watch video of this and other presentations! …

Correlations and Research Results: Do They Match Up?

Andy Oram
EMR & EHR

Andy Oram, an editor specializing in open source, software engineering, and health IT, attended the Petrie-Flom Center's 2016 annual conference, "Big Data, Health Law, and Bioethics," on May 6, 2016. From his…

When Big Data Isn’t Big Enough

Elise Davis
Ampersand

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…

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

May 6, 2016
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Couldn't join us in person? Check out the conversation on Twitter @PetrieFlom and #BigDataandHealthLaw! The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School 2016 annual…

Health Law Workshop: Robert Cook-Deegan

April 18, 2016

About the Presenter Robert Cook-Deegan is a research professor in the Sanford School of Public Policy at Duke University, with secondary appointments in Internal Medicine (School of Medicine), and Biology …

Health Law Workshop: Nathan Cortez

April 11, 2016

Presentation Download the Presentation: "Regulation by Database" About the Presenter Nathan Cortez is Associate Dean for Research and Associate Professor in Dedman School of Law at Southern Methodist University. He…

Health Law Workshop: Nicolas P. Terry

April 4, 2016

Presentation Download the Presentation: "Regulatory Disruption and Arbitrage in Healthcare Data Protection" About the Presenter Nicolas P. Terry is the Hall Render Professor of Law at the Indiana University Robert…

Consensus Statement on Electronic Health Predictive Analytics: A Guiding Framework

I. Glenn Cohen (Faculty Director) et al.
eGEMs (Generating Evidence & Methods to improve patient outcomes)

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 as the use of…

Symposium on “Ethical Risk Assessment in Biomedical Big Data”

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

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…

Specimen Science: Ethics and Policy Implications

November 16, 2015
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An edited volume based on this conference is due out from MIT Press in September 2017. Check it out! Learn more about the presentations - check out some of our speakers'…

Big Data, Patents, and the Future of Medicine

W. Nicholson Price II (Academic Fellow Alumnus)
Cardozo Law Review, Forthcoming

Abstract: Big data has tremendous potential to improve health care. Unfortunately, intellectual property law isn’t ready to support that leap. In the next wave of data-driven medicine, black-box…

Black Box Medicine

W. Nicholson Price II (Academic Fellow alumnus)
Harvard Journal of Law & Technology

Petrie-Flom Academic Fellow alumnus Nicholson Price, now an Assistant Professor at the University of New Hampshire School of Law, has recently published an article in the Harvard Journal of Law …

Review of Human subjects research regulation: perspectives on the future: by I. Glenn Cohen (Faculty Director) & Holly F. Lynch (Executive Director) (eds.):

Lydia Stewart Ferreira (Visiting Scholar)
Theoretical Medicine and Bioethics

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 of I. Glenn Cohen …

Predicting the sick through personal trails of health data

Todd Bookman, quoting I. Glenn Cohen (Faculty Director)
News Works

[...] "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…

NOW ONLINE: I. Glenn Cohen Discusses Modern Fertility Technologies and Benefits

Shayna Seymour, interviewing I. Glenn Cohen (Faculty Director)
Chronicle (WCVB/ABC Boston)

Show Abstract: The birds and the bees are still important – but today's couples eager to start a family can also rely on Big Data to get them to…

ReSourcing Big Data: A Symposium and Collaboration Opportunity

Harvard Catalyst

March 23: Symposium 9:00am-5:00pm Joseph B. Martin Conference Center Harvard Medical School Extant data is an inexhaustible resource that is not yet very well understood and is underutilized. The focus…

Emerging Issues and New Frontiers for FDA Regulation

October 20, 2014

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Food and Drug Law Institute were pleased to announce this collaborative academic symposium. Agenda: …

Legal and Ethical Issues in Healthcare Start-Ups: (followed by Petrie-Flom's 2014 Open House)

October 6, 2014
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New healthcare start-ups face a range of legal and ethical challenges as they develop new products and services and solicit financial support from investors. Building on the success of the…

FDA Regulation of Mobile Health Technologies

Nathan G. Cortez, J.D., I. Glenn Cohen, J.D., and Aaron S. Kesselheim, M.D., J.D., M.P.H.
NEJM

Petrie-Flom Faculty Director I. Glenn Cohen has published a new co-authored article in the New England Journal of Medicine on FDA regulation of new mobile health technologies. From the article: …

Hated the Facebook experiment? You’ll hate what’s next for health care.

Adriana McIntyre interviewing I. Glenn Cohen (Faculty Director)
Vox

From the article: Facebook isn't the only company that wants to capitalize on information collected from millions of people do do research. Health care systems want to use the…

Using Big Data To Transform Care: A Briefing on the July 2014 Special Issue of Health Affairs

Featuring I. Glenn Cohen (Faculty Director)
Health Affairs

The application of big data to transform health care delivery, health research, and health policy is underway, and its potential is limitless. The July 2014 issue of Health Affairs, "Using Big…

Electronic Health Records and Medical Liability

October 27, 2009

The American Recovery and Reinvestment Act of 2009 promises to trigger an explosion in the use of electronic health records through direct payments to health providers. While the privacy concerns related…