REGISTER NOW (1/23)! PFC’s 5th Annual Health Law Year in P/Review

The Fifth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2016 and what to watch out for in 2017. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law. Read More

Tom Price Endangers Women’s Health

By Allison K. Hoffman and Jill Horwitz

In today’s NYTimes, Jill Horwitz and I have an Op-Ed describing why Donald Trump’s selection of Tom Price for secretary of health and human services is a particular threat to women’s health. Read it here!

From the Op-Ed:

With the selection of Representative Tom Price as secretary of health and human services, President-elect Donald J. Trump has taken a giant step toward undermining the health of American women.

It is regrettable, but not surprising, that Mr. Trump has nominated a strident opponent of abortion. It is also no surprise that Mr. Price, an orthopedic surgeon from Georgia, earned a zero rating from Planned Parenthood, an organization he’d like to defund, despite its role in providing preventive health services. […]

Read the full article here!

Naughty or Nice 2016? on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!

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Here it is! Naughty or Nice 2016?, our irreverent but also quite serious annual survey of who or what has been nice or naughty in health law and policy during the last year. Our experts make some great picks and dig deep into the underlying policy coal and candy. Plus, of course, our “surprise” bonus round as we pick who we would like to welcome singing carols outside our homes! Enormous thanks to our guests: Glenn CohenNicole HuberfeldElizabeth Weeks LeonardJessica Roberts, and Lindsay Wiley.

And a very happy holiday season to all our listeners. See you in ’17!

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, Tunein 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

Missed opportunities to learn from patient deaths in the NHS

By John Tingle

The National Health Service (NHS) in England’s quality regulator, the Care Quality Commission (CQC) has recently published a highly critical report on the way patient deaths are investigated in the NHS. The investigation follows events at the Southern Health NHS Foundation Trust where a number of failings were identified in the way patient deaths were identified and investigated. Certain groups of patients including people with a learning disability and older people receiving mental health care were far less likely to have their deaths investigated by this Trust. The Secretary of State for Health called for a CQC investigation into how acute, community and mental health NHS facilities across the country investigate and learn from deaths. The findings of the report are not good and major improvements in this area are needed across the NHS.

There are failings in openness, transparency and missed opportunities to learn important patient safety lessons. Families of patients and carers told the CQC reviewers that they often have a poor experience of investigations and are not always treated with kindness, respect, honesty and sensitivity. The CQC states that across their review they were unable to identify any NHS healthcare facility that could demonstrate good practice across all aspects of identifying, reviewing and investigating deaths and ensuring that learning from the events is implemented. Read More

New Book – Electronic Health Records and Medical Big Data: Law and Policy

Guest Post by author Sharona Hoffman

hoffman-cover-1-002I am pleased to post that my new book, “Electronic Health Records and Medical Big Data: Law and Policy” was recently published by Cambridge University Press.  The book enables readers gain an in-depth understanding of electronic health record (EHR) systems, medical big data, and the regulations that govern them.  It is useful both as a primer for students and as a resource for knowledgeable professionals.

The transition from paper medical records to electronic health record (EHR) systems has had a dramatic impact on clinical care.  In addition, EHR systems enable the creation of “medical big data,” that is, very large electronic data resources that can be put to secondary, non-clinical uses, such as medical research, public health initiatives, quality improvement efforts, and other health-related endeavors.  This book provides thorough, interdisciplinary analysis of EHR systems and medical big data, offering a multitude of technical and legal insights. Read More

LIVE ONLINE TODAY @ NOON: President-Elect Trump’s Health Policy Agenda: Priorities, Strategies, and Predictions

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Webinar: President-Elect Trump’s Health Policy Agenda: Priorities, Strategies, and Predictions

Monday, December 19, 2016, 12:00 – 1:00pm

WATCH LIVE ONLINE!: http://petrieflom.law.harvard.edu/events/details/president-elect-trumps-health-policy-agenda

Submit your questions to the panelists via Twitter @PetrieFlom.

Please join the Petrie-Flom Center for a live webinar to address what health care reform may look like under the new administration. Expert panelists will address the future of the Affordable Care Act under a “repeal and replace” strategy, alternative approaches to insurance coverage and access to care, the problem of high drug prices, innovation policy, support for scientific research, and other topics. The panel will discuss opportunities and obstacles relevant to President-elect Trump’s proposals, as well as hopes and concerns for health policy over the next four years. Webinar participants will have the opportunity to submit questions to the panelists for discussion.

Panelists

  • Joseph R. Antos, Wilson H. Taylor Scholar in Health Care and Retirement Policy, American Enterprise Institute
  • Lanhee J. Chen, David and Diane Steffy Research Fellow, Hoover Institution; Director of Domestic Policy Studies and Lecturer, Public Policy Program; affiliate, Freeman Spogli Institute for International Studies, Stanford University
  • Douglas Holtz-Eakin, President, American Action Forum
  • Moderator:Gregory Curfman, Editor-in-Chief, Harvard Health Publications

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Genomic Testing, Reflective Equilibrium and the Right Not To Know

By Seán Finan

Almost any test can return incidental results. An incidental result is something demonstrated by the test but not an answer to the test’s original question. Trying on a new pair of trousers, for example, can tell you whether or not they fit. It can also return the incidental result that the holiday feasting hadn’t been as kind to your waistline as you had hoped. Incidental results in genetic testing can be even more alarming. Whether done for clinical or research purposes, genetic tests can reveal a range of mutations, markers and predispositions far beyond the range being tested for. As technology advances, it expands the breadth of possible results.

Incidental results can often impart life changing information. Many can be a cause for dramatic but potentially life saving medical intervention: the presence of BRCA1 and BRCA2 variants that indicate an increased risk of breast cancer, for example.Where incidental results suggest that a patient might have an increased risk of developing a condition in the distant future, that information might allow them to act immediately to mitigate that risk. Genetic testing might also reveal inherited or inheritable mutations that could be crucial information for a patient’s entire family. Even outside the realm of disease, a genetic test might reveal something that could have huge psychological or social ramifications for a patient: for example, a test might reveal true paternity. However, the potentially life altering nature of some of these findings, in contexts where they are not being looked for or even expected, has led to questions about whether they should be revealed to the test subject at all.

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Patients in Research: What the Professionals Don’t Get

Guest Post by Rebecca Dresser

When scientists and doctors get together to talk about accelerating medical advances, someone inevitably brings up the need for more research subjects.  Not enough patients are participating in clinical trials, experts complain.  If more patients were part of medical studies, we could make more progress in treating disease and improving human lives.

Why do relatively few patients join studies?  The National Academy of Sciences and similar groups blame the problem on regulatory impediments and an inadequate supply of physician-researchers willing to ask patients to enroll in trials.  They want more funding to support physicians’ research efforts, and they want review committees like IRBs to streamline their work.

But these measures won’t be enough to fix the problem.  To really understand why patients don’t enroll in trials, and why many who do enroll drop out early, you have to ask them. I know, because I was one of the patients who turned down a trial.

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Zack Buck on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!

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This week’s podcast features conversation with University of Tennessee Professor Zack Buck. His recent research suggests an interesting fiduciary approach to dealing with the problem of over-treatment and also ponders the best way to deal with the “financial toxicity” that results from related phenomena.

Zack’s work is archived at SSRN. He has creatively approached the problem of overtreatment in a series of articles, focusing on ways that health care finance and regulation can be reformed in order to better calibrate incentives for optimal care. His work includes “Furthering the Fiduciary Metaphor” and “Caring Too Much: Misapplying the False Claims Act to Target Overtreatment.”

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, Tunein 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