Thank you for 3 great years!

Three years ago today, we launched the Bill of Health blog to create a one-stop-shop for readers interested in news, commentary, and scholarship in the fields of health law policy, biotechnology, and bioethics. We have been thrilled at the blog’s success and reach so far.

A few quick stats:

  • We have 90 contributors from 49 institutions around the globe.
  • More than 350,000 unique visitors from more than 200 countries have visited the blog since it was first launched.
  • The blog gets more than 17,000 page views per month.
  • We’ve clocked in over 2,000 blog posts covering a wide range of topics:
    • Health insurance, health care finance, health care reform
    • Reproductive health and rights
    • Pharmaceutical regulation
    • Food safety and regulation
    • Human subjects research
    • Personhood and animal rights
    • General health law, policy, and bioethics

As a sample, here are the top five most viewed posts from each academic year:

2012 – 2013

  1. The High Cost of Health Care: Why Some Pay $240 for a $9 Bottle of Pills, by Jonathan Darrow
  2. Finasteride as an FDA-Approved Baldness Remedy: Is It Effective?, by Jonathan Darrow
  3. Liability for Failure to Vaccinate, by Arthur Caplan
  4. Discrimination in the Doctor-Patient Relationship, by Holly F. Lynch
  5. At $28,000 a Dose, How Effective Is Acthar?, by Jonathan Darrow

2013 – 2014

  1. Capsule Endoscopy Instead of Colonoscopy? The FDA Approves the PillCam COLON, by Jonathan Darrow
  2. Taking China’s Food Safety Problem Seriously (I), by Ching-Fu Lin
  3. Medical Marijuana Delivery May Not Be As “Eazy” As It Seems, by Arielle Lusardi
  4. Taking China’s Food Safety Problem Seriously (II), by Ching-Fu Lin
  5. Ethical Concerns, Conduct and Public Policy for Re-Identification and De-identification Practice: Part 3, by Daniel Barth-Jones

2014 – 2015

  1. Highlights from the 21st Century Cures Act, by Rachel Sachs
  2. Savior Siblings in the United States, by Zachary Shapiro
  3. New browser app shines light on conflicts of interest, by Christine Baugh
  4. A New Cholesterol-Lowering Drug at What Price?, by Kate Greenwood
  5. Pain on the Brain: A Week of Guest Posts on Pain Neuroimaging & Law by Amanda C. Pustilnik

Thanks to our many contributors – and to our readers!  We look forward to many more years of growth.  And always, if you have any comments or suggestions, make sure to send them our way: petrie-flom@law.harvard.edu.  Happy reading!

Glenn and Holly 
Bill of Health Co-Editors

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Malpractice at the Front Desk

By Alex Stein

Georgia’s Court of Appeals recently categorized a clinic’s front-desk person’s failure to communicate a patient’s complaints to the doctors as ordinary negligence rather than medical malpractice. Wong v. Chappell, 773 S.E.2d 496 (Ga.App. 2015).

This categorization has four important implications:

First, it allows an aggrieved patient to file her suit and proceed to trial without obtaining expert testimony and a preliminary affidavit (or certificate of merit) from a qualified physician.

Second, it frees plaintiffs from the stringent limitations and repose rules that apply in medical malpractice actions. Read More

Ohio State Seeks Founding Director of New Program on Data, Law, Ethics and Policy

By:  Efthimios Parasidis

The Ohio State University Moritz College of Law seeks a mid-level to senior tenured professor to serve as Professor of Law and founding director of the Program on Data, Law, Ethics and Policy (“DLEAP”) at the College, part of the Ohio State University’s Translational Data Analytics Discovery Theme initiative. The successful candidate will demonstrate excellence in scholarship and a commitment to outstanding teaching.   The position, a 51% FTE appointment, will begin in the 2016-17 academic year.

As a faculty member the successful candidate will be expected to teach core and specialized courses in the law curriculum. The research and teaching interests of the successful candidate will likely focus on privacy law and regulation, information- and cyber-security, big data and data mining, and/or related health law and intellectual property issues.   As the director of DLEAP, he or she will be responsible for building the research program, with a small staff and an assortment of affiliated faculty. A successful candidate must be capable of leading DLEAP in employing legal, regulatory, and policy expertise to focus on the social and ethical impact of big data and in serving as a complement and resource for other Translational Data Analytics initiatives at Ohio State and to the broader data analytics community. Read More

Worth Reading This Week

By Nicolas Terry

Call for Papers: Designing Ethical Review Processes for Big Data Research

By Michelle Meyer 

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 on personal information. Authors are invited to submit papers for presentation at a full-day program to take place on December 10, 2015. Papers for presentation will be selected by an academic advisory board and published in the online edition of the Washington and Lee Law Review. Four papers will be selected to serve as “firestarters” for the December workshop, awarding each author with a $1000 stipend. Submissions, which are due by October 25, 2015, at 11:59 PM ET, must be 2,500 to 3,500 words, with minimal footnotes and in a readable style accessible to a wide audience. Publication decisions and workshop invitations will be sent in November. Details here.

‘The Week in Health Law’ Podcast

By Nicolas Terry

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Nic welcomes studio guests law professor Barbara Evans & bioethicist Eric Meslin. The primary topic is the future of research and its regulation, leading to a broad-ranging discussion that includes the future of the FDA, emerging research models, and how consent & autonomy fit into this changing ecosystem. Eric mentioned an interesting article by Neal Lane and you should check out some excellent contributions by Barbara dealing with the FDA and Genomic Tests and other regulatory issues.

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 RadioTunein 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

Doubling Down on Prosecutorial Discretion

By Zack Buck

Health care entities should be “on high alert” following the Southern District of New York’s decision in Kane v. Continuum Health Partners that I blogged about here earlier this month.

The case, which serves as the first and most consequential interpretation of when an overpayment is “identified” for purposes of False Claims Act (FCA) liability, provides a measure of much-needed guidance for attorneys and compliance officers in an area that is rife with confusion. But not too much.

Read More

New DTCA Guidance — Enough to Empower Consumers?

Bill of Health contributor Christopher T. Robertson has a new Op-Ed out in the New England Journal of Medicine:

As one of only two countries that permit direct-to-consumer advertising (DTCA) of pharmaceuticals, the United States tasks the Food and Drug Administration (FDA) with regulating that advertising to ensure that it doesn’t mislead consumers. When a drug maker publishes or broadcasts a claim that its drug has benefits in a particular disease, the FDA requires it to include information on the product’s risks as well. Since it’s not feasible for companies to include all the important information about their products in a television ad, the FDA requires them to refer viewers to more complete information, such as that in a printed magazine ad. Companies have tended to comply with this requirement by supplementing colorful, persuasive ads with one or two pages of dry text providing the required disclosures, often simply using language that the FDA has approved for other purposes, such as package inserts for prescribers. But research shows that most patients who attempt to read these disclosures find them difficult to understand, and many don’t even try to make sense of them.1 Now, the FDA is in the process of adjusting its DTCA rules, aiming to provide greater assurance that patients receive due warning of the most significant risks — but its tweaks probably don’t go far enough to really empower consumers to make smart decisions about the drugs they put into their bodies. […]

Read the full article here.

(UPDATED) Defendants’ Motion for Summary Judgment Granted in Looney v. Moore (SUPPORT trial lawsuit)

By Michelle Meyer

UPDATE: Plaintiffs have filed an appeal in the U.S. Court of Appeals for the Eleventh Circuit. Their brief is due on October 19.

The district court has granted summary judgment (opinion pdf) for all remaining defendants as to all of plaintiffs’ remaining claims in Looney v. Moore, the lawsuit arising out of the controversial SUPPORT trial, which I last discussed here. This therefore ends the lawsuit, pending possible appeal by the plaintiffs.

Plaintiff infants include two who were randomized to the low oxygen group and survived, but suffer from “neurological issues,” and one who was randomized to the high oxygen group who developed ROP, but not permanent vision loss. In their Fifth Amended Complaint (pdf), plaintiffs alleged negligence, lack of informed consent, breach of fiduciary duty, and product liability claims against, variously, individual IRB members, the P.I., and the pulse oximeter manufacturer. What unites all of these claims is the burden on plaintiffs to show (among other things) that their injuries were caused by their participation in the trial. Read More