Proposed CMS Sanctions Threaten Theranos’ Future

By Katherine Kwong

The news for blood testing company Theranos has gotten even worse since this blog’s last discussion of the company’s woes. Despite the company’s statements at the end of March that it would correct all of the issues CMS had found, new reports have emerged that Theranos’ California lab may see its federal license revoked. Additionally, Theranos’ founder, Elizabeth Holmes, and Theranos’ president, Sunny Balwani, may be banned from owning or operating any testing laboratories for two years. These potential sanctions have been proposed after regulators concluded Theranos has failed to adequately address concerns raised about its tests by the Centers for Medicare and Medicaid Services (CMS).

How did Theranos get to this point? Read More

Monday, 4/18, HLS Health Law Workshop with Robert Cook-Deegan

April 18, 2016, 5-7 PM
Hauser Hall 105
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA 02138

The materials for the presentation, “Mining the Genomic Data Mountain: Legal and Policy Challenges,” can be downloaded here.

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 (Trinity College of Arts & Sciences). He was the founding director for Genome Ethics, Law & Policy in Duke’s Institute for Genome Sciences & Policy from July 2002 through December 2012.  He is the author of The Gene Wars: Science, Politics, and the Human Genome and an author on over 250 articles.

Dr. Cook-Deegan’s areas of expertise include genomics and intellectual property, history of genomics, global health, science and health policy, and health research policy. His current research focuses on policy implications of genomics, bioethics, intellectual property, and innovation.

Leo Beletsky on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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This week we interviewed Leo Beletsky, Associate Professor of Law and Health Sciences at Northeastern University. Leo utilizes empirical and theoretical approaches to analyze how legal mechanisms can help curb substance abuse, prevent the spread of HIV and other infectious diseases and improve patient care. By highlighting discrepancies between black letter law and its real-world implementation, he also examines the relationship between police practices, public health outcomes and human rights of vulnerable groups.

We had plenty of opportunity to apply Leo’s expertise to the topic we focused on this week: opioid addiction. Recent studies have demonstrated a rapidly rising rate of opioid abuse, with troubling consequences for individuals and communities. This drug use has also attracted a host of legal responses, which Leo has expertly dissected in past work (including some recent studies here).

Our lightning round featured discussions of recent research on income and life expectancy, the emerging natural experiment in Kentucky on Medicaid rollback, and insurer mergers.

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