‘The Week in Health Law’ Podcast

By Nicolas Terry

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This week we are joined by Mark Rothstein, the Herbert F. Boehl Chair of Law and Medicine and the Founding Director of the Institute for Bioethics, Health Policy and Law at the University of Louisville School of Medicine. One of Mark’s recent papers concerns Ethical Issues in Big Data Health Research. We discuss that as well as Apple’s ResearchKit  (See Nic’s blog post at Bill of Rights) and the Administration’s proposed Privacy Bill of Rights (See Nic’s blog post at Health Affairs).

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy.

Subscribe at iTunes, listen at Stitcher Radio and Podbean, or search for The Week in Health Law in your favorite podcast app.

Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

TOMORROW at 12PM: Moral Decisions in the Law: What’s the Brain Got to Do with It?

Moral Decisions in the Law: What’s the Brain Got to Do with It?

brainscan_colored_slide_270_174_85April 8, 2015 12:00 PM

Harvard Law School
Wasserstein Hall, Room 3019
1585 Massachusetts Ave.
Cambridge, MA [Map]

Law – particularly criminal law – is infused with moral judgment and calls upon prosecutors, judges, and jurors to make morally-informed decisions. But where does morality come from? How do we “do” moral decision-making? Come join experimental philosopher and neuroscientist Fiery Cushman for a fascinating and provocative discussion of the current state of neuroscience research on morality. Dr. Cushman will present his computational models of learning and moral decision-making to describe how we learn what morality is within our own cultures, how we internalize moral rules, and how we make moral judgments about others. Amanda Pustilnik, Senior Fellow in Law and Applied Neuroscience at the Petrie-Flom Center and the Center for Law, Brain, and Behavior at Massachusetts General Hospital, will respond.

This event is free and open to the public. Lunch will be provided.

 Part of the Project on Law and Applied Neuroscience.

TWO Upcoming Events (5/7-5/9): “After Hobby Lobby: What Is Caesar’s, What Is God’s?” & “Law, Religion, and Health in America”

Pre-Conference Session

Hobby_Lobby_slide_270_174_85“After Hobby Lobby: What Is Caesar’s, What Is God’s?”
May 7, 2015, 4:00 – 6:00 PM
Wasserstein Hall, Milstein East BC
Harvard Law School,
1585 Massachusetts Ave.,
Cambridge, MA [Map]

As prelude to the 2015 Petrie-Flom Center Annual Conference, “Law, Religion, and Health in America,” please join us for a pre-conference session examining the role of religion in the American public sphere. Our expert panel will discuss the nature of conscience and conscientious objection, religious freedom, and religious accommodation from philosophical, theological, historical, legal, and political perspectives.

Panelists:

  • J. Dionne, Jr., Columnist, The Washington Post; Senior Fellow, The Brookings Institution
  • Diane L. Moore, Senior Lecturer on Religious Studies and Education and Senior Fellow at the Center for the Study of World Religions, Harvard Divinity School
  • Charles Fried, Beneficial Professor of Law, Harvard Law School
  • Frank Wolf, Representative, Virginia’s 10th Congressional District, U.S. House of Representatives, 1981-2015 (retired)
  • Moderator: Daniel Carpenter, Freed Professor of Government, Harvard University and Director, Center for American Political Studies at Harvard University
  • Moderator:  Glenn Cohen, Professor of Law, Harvard Law School and Faculty Director, Petrie-Flom Center

The panel will be followed by a light reception.

This event is free and open to the public, but seating is limitedRegister online!

 Full Conference:
stethoscope_bible_slide“Law, Religion, and Health in America”
May 8-9, 2015
Wasserstein Hall
Milstein East ABC

Harvard Law School
1585 Massachusetts Ave.,
Cambridge, MA [Map]

Religion and medicine have historically gone hand in hand, but increasingly have come into conflict in the U.S. as health care has become both more secular and more heavily regulated.  Law has a dual role here, simultaneously generating conflict between religion and health care, for example through new coverage mandates or legally permissible medical interventions that violate religious norms, while also acting as a tool for religious accommodation and protection of conscience. 

This conference will identify the various ways in which law intersects with religion and health care in the United States, understand the role of law in creating or mediating conflict between religion and health care, and explore potential legal solutions to allow religion and health care to simultaneously flourish in a culturally diverse nation.

Highlights:

Keynote Lecture: Religious Liberty, Health Care, and the Culture Wars

 Plenary Session: The Contraceptives Coverage Mandate Litigation

The conference is free and open to the public, but seating is limited. View the full agenda and register online!

The pre-conference session is co-sponsored by the Petrie-Flom Center and the Ambassador John L. Loeb, Jr. Initiative on Religious Freedom and Its Implications at the Center for American Political Studies at Harvard University.

The 2015 Petrie-Flom Center Annual Conference, Law, Religion, and Health in America, is supported by the Oswald DeN. Cammann Fund.

Monday 4/6: HLS Health Law Workshop with Thomas Greaney

HLS Health Law Workshop: Thomas Greaney

April 6, 2015 5:00 PM
Griswold Hall, Room 110 (Harvard Law School)
1525 Massachusetts Ave., Cambridge, MA [Map here.]

Download the paper: “Medicare Advantage, Accountable Care Organizations, and Traditional Medicare: Synchronization or Collision?”

Thomas L. Greaney is Chester A. Myers Professor of Law and Co-Director of the Center for Health Law Studies at St. Louis University School of Law. Greaney joined the faculty at SLU LAW in 1987 after completing two fellowships and a visiting professorship at Yale Law School. He became Chester A. Myers Professor of Law in 2004 and was named Health Law Teacher of the Year by the American Society of Law, Medicine and Ethics in 2007. His academic writing has been recognized six times by the Thompson Coburn Award for SLU Faculty scholarship.

Greaney’s extensive body of scholarly writing on health care and antitrust laws encompasses articles published in some of the country’s most prestigious legal and health policy journals. He has authored or co-authored several books, including the leading health care casebook, Health Law. A frequent speaker in academia and the media, Greaney has also offered expert testimony at hearings sponsored by the Federal Trade Commission on the issues of applying competition law and policy to health care, and submitted invited testimony to the U.S. Senate on competition policy and health care reform.

Hopkins faces $1B lawsuit over role in government study that gave subjects STDs

The Petrie-Flom Center’s Executive Director Holly Fernandez Lynch and Faculty Director I. Glenn Cohen weigh in on the issue in the

Nearly 800 former research subjects and their families filed a billion-dollar lawsuit Wednesday against the Johns Hopkins University, blaming the institution for its role in 1940s government experiments in Guatemala that infected hundreds with syphilis, gonorrhea and other sexually transmitted diseases. […]

Legal experts said the lawsuit’s arguments could be a stretch. Today, professors who frequently serve on a volunteer basis with the National Institutes of Health, for example, are generally considered to be acting independently and not in their capacity as university faculty, said Holly Fernandez Lynch, executive director of the Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics at Harvard University Law School.

[…] Because the experiments occurred so long ago, most if not all of the subjects are dead, and it could be difficult for someone to prove that a relative was part of the study, Lynch said. She and colleague I. Glenn Cohen, a professor at Harvard Law School, argued in a 2012 New York Times opinion piece that the Tuskegee experiment and others provide precedent for a fair recourse.

In the Tuskegee case, a legal settlement included lifetime medical benefits for study subjects and their wives, widows and children, as well as federal grants to promote research and health care ethics, they said. U.S. aid applied directly to Guatemalan health could be appropriate in this case, Lynch said.

“Congress and the [Obama] administration must step up more than they have, by offering financial restitution to Guatemalans with plausible claims of harm,” Lynch and Cohen wrote. “Even if the lawsuits were appropriately dismissed, justice has not been done.”

Read More

Recent Judicial Rulemaking Leaves Life Science Patents Hanging In The Balance

This new post by Claire Laporte of Foley Hoag LLP appears on the Health Affairs Blog, as part of a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015.

Do patents nurture or stifle innovation?

In a recent series of decisions, the Supreme Court has begun to express concern that some patents suppress innovation. And it has done so in a number of cases that turn on what used to be a sleepy backwater of the patent law: 35 U.S.C. § 101. This statute says, simply, that “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, … may obtain a patent therefor, subject to the conditions and requirements of this title [i.e., the other requirements of the patent law].”

You might think that this language means that all you have to do is figure out whether an invention falls into one of the permitted categories. If it does, it’s something that can be patented (assuming you meet the other requirements — which are numerous). But no! Over the past few decades, the Supreme Court has engrafted a whole new set of judge-made requirements onto this statute: you cannot get a patent on something that is a “law of nature,” a “product of nature,” or an “abstract idea.” And starting in 2010, the Court put real teeth into these doctrines. […]

See the full post here.

4/14: The FDA’s Impact on Pharmaceutical Innovation: A Lecture by Neil Flanzraich

The FDA’s Impact on Pharmaceutical Innovation: A Lecture by Neil Flanzraich

15.04.14, Flanzraich poster FINAL DPI AdjustApril 14, 2014 12:00 PM

Harvard Law School
Griswold Hall, Room 110
1525 Massachusetts Ave.
Cambridge, MA [Map]

Please join us for a lecture by Neil Flanzraich, Chairman and CEO of Cantex Pharmaceuticals, Inc., discussing the balance between speed and safety in FDA’s regulation of pharmaceutical products. Topics will include how FDA’s approach has ebbed and flowed over time, the various tools FDA has introduced to reach this balance, and the potential impact of FDA’s various approaches on products and companies, especially start-ups.

Neil Flanzraich graduated from Harvard Law School in 1968 and was appointed by Dean Martha Minow as an Expert in Residence at the Harvard Innovation Lab (i-lab) in fall 2012.

This event is free and open to the public. Lunch will be provided. Full event details are here.

Watch Mr. Flanzraich’s previous lecture for the Petrie-Flom Center, “Responsibility and Integrity in the Pharmaceutical Industry.”

NEXT WEEK (4/8): Moral Decisions in the Law: What’s the Brain Got to Do with It?

Moral Decisions in the Law: What’s the Brain Got to Do with It?

brainscan_colored_slide_270_174_85April 8, 2015 12:00 PM

Harvard Law School
Wasserstein Hall, Room 3019
1585 Massachusetts Ave.
Cambridge, MA [Map]

Law – particularly criminal law – is infused with moral judgment and calls upon prosecutors, judges, and jurors to make morally-informed decisions. But where does morality come from? How do we “do” moral decision-making? Come join experimental philosopher and neuroscientist Fiery Cushman for a fascinating and provocative discussion of the current state of neuroscience research on morality. Dr. Cushman will present his computational models of learning and moral decision-making to describe how we learn what morality is within our own cultures, how we internalize moral rules, and how we make moral judgments about others. Amanda Pustilnik, Senior Fellow in Law and Applied Neuroscience at the Petrie-Flom Center and the Center for Law, Brain, and Behavior at Massachusetts General Hospital, will respond.

This event is free and open to the public. Lunch will be provided.

 Part of the Project on Law and Applied Neuroscience.

‘The Week in Health Law’ Podcast

By Nicolas Terry

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This week Ross Silverman joins us to discuss HR2 Minutiae, his NEJM take on Vaccination Law & Policy, and Indiana’s HIV Emergency Order.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy.

Subscribe at iTunes, listen at Stitcher Radio and Podbean, or search for The Week in Health Law in your favorite podcast app.

Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw