FitBits Be Free: General Wellness Products Are Not (Generally) Medical Devices

By Nicolas Terry

The FDA has issued a final guidance on low risk wellness devices, and it is refreshingly clear. Rather than applying regulatory discretion as we have seen in the medical app space, the agency has made a broader decision (all usual caveats about non-binding guidances aside) not to even examine large swathes of wellness products to determine whether they are Section 201(h) devices. As such, this guidance more closely resembles the 2013 guidance that declared Personal Sound Amplification Products (PSAPs) not to be medical devices (aka hearing aids).

The FDA approach to defining excluded products breaks no new ground. First, they must be intended for only general wellness use and, second, present a low risk. As to the former, FDA has evolved its approach to referencing specific diseases or conditions. Make no such reference and your product will sail through as a general wellness product. Thus, claims to promote relaxation, to boost self-esteem, to manage sleep patterns, etc., are clearly exempt. On the other hand, the agency will clearly regulate products that claim to treat or diagnose specific conditions. Continue reading

Jon Mark Hirshon on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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Listen here! Our guest this week is Jon Mark Hirshon, M.D., M.P.H., Ph.D., an Associate Professor in the Department of Emergency Medicine and in the Department of Epidemiology and Public Health at the University of Maryland School of Medicine. Jon Mark is also on the board of the American College of Emergency Physicians, and is an internationally recognized expert on acute care. His teams have trained approximately 900 physicians from countries in the Middle East in topics ranging from clinical care of trauma patients to disaster preparedness to research methods.Our lightning round featured discussions of an issue brief, “How Has the Affordable Care Act Affected Health Insurers’ Financial Performance?,” as well as a news story on some insurers’ dissatisfaction with the ACA. While health costs may increase GDP, they are hurting some insurers’ bottom lines. On the health IT front, we focused on ransomware and non-covered entities’ data. And continuing our wellness coverage, we mentioned employers’ new enthusiasm for mobile monitoring of employees’ mental health–what Rachel Emma Silverman’s twitter feed has jokingly called “#textualhealing.”

During his interview, Jon Mark focused on policy issues in acute care. He discussed a lawsuit filed by the American College of Emergency Physicians against the federal government reflecting ACEP’s concerns about reimbursement. Jon Mark also described the many challenges now facing emergency departments, ranging from narrow networks that fail to fairly compensate care, to user-unfriendly IT systems. Jon Mark also offered practical solutions for increasing access to acute care–an urgent policy concern given America’s dismal overall grades for access to emergency care.

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

Mehrsa Baradaran on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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Listen here!

Our guest this week is Mehrsa Baradaran, J. Alton Hosch Associate Professor of Law at the University of Georgia. Author of the acclaimed book How the Other Half Banks, Baradaran described the increasingly difficult financial landscape for poorer Americans. We discussed the impact of inequality and financial exclusion on many aspects of health care finance, including providers’ collections policies, hospital-as-lender models, and high-deductible health plans. Baradaran offers many important insights on how new financial realities affect both monetary flows and consumer protection in health care.

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

Deborah Lupton on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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Listen here!

This week our guest is Professor Deborah Lupton, one of the world’s leading digital sociologists. Her new book, The Quantified Selfis the basis of most of our discussion–and it has fascinating lessons for health care lawyers, providers, and patients.

Deborah joined the University of Canberra in early 2014 as a Centenary Research Professor associated with the News & Media Research Centre in the Faculty of Arts & Design. Her research and teaching is multidisciplinary, incorporating sociology, media and communication and cultural studies. Deborah has previously held academic appointments at the University of Sydney, Charles Sturt University and the University of Western Sydney.

Deborah is the author of 15 books and over 150 journal articles and book chapters on topics including the social and cultural dimensions of: medicine and public health; risk; the body; parenting cultures; digital sociology; food; obesity politics; and the emotions. She is an advocate of using social media for academic research and engagement, including Twitter (@DALupton) and her blog This Sociological Life.

Those interested in further exploring the social theory of digital selfhood may be interested in Frank’s piece, The Algorithmic SelfAnd for some forward-thinking reflections on new technologies of digital health, check out Nic’s recent post at Health Affairs on hearing aids and regualtory arbitrage.

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

Hearing Aids And The Sound Of Mobile Health Disruption

By Nicolas Terry

Business disruption, Christensen’s classic observation of disruptive technologies leveraged by market entrants attacking mainstream industry incumbents, has generally failed in health care. There are several reasons why innovative businesses harnessing modern technologies have found health care a difficult nut to crack. The most likely reason is that the misaligned incentives caused by third-party reimbursement discourage consumers from choosing new, lower-cost alternatives.

However, there are additional explanations. Sometimes the arcane, fragmented nature of health care proves to be a poor fit for technologies successfully implemented in other businesses. In other cases—think electronic health records—a lack of common data standards allows proprietary data formats to cause customer lock-in.

But, what is the impact of health care regulation? Beyond the traditional trope that regulation stifles innovation, how does health care regulation impact disruption? Recent developments in the markets for hearing aids suggest some answers and even a possible regulatory approach to the broader and burgeoning category of mobile health apps and wearables.…

Read the full post at the Health Affairs Blog!

Rachel Sachs on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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This week we spoke with Rachel E. Sachs, who will join the faculty of the Washington University in St. Louis School of Law in Fall 2016. Rachel earned her J.D. in 2013 magna cum laude from Harvard Law School, where she was the Articles Chair of the Harvard Law Review and a student fellow with both the Petrie-Flom Center and the John M. Olin Center for Law, Economics, and Business. Rachel has also earned a Master of Public Health from the Harvard School of Public Health. We focused on Rachel’s work on drug pricing and innovation for global health. As part of a broader academic agenda for developing access to knowledge, Rachel’s work illuminates the many trade-offs involved in optimizing innovation law. She has also illuminated the importance of “innovation beyond IP,” and the importance of legal synergies in accelerating or impeding innovation.

Listen here! 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

‘The Week in Health Law’ Podcast Talks Health Law and Social Media

By Nicolas Terry and Frank Pasquale

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This week and fresh from ASLME’s Health Law Professors’ Conference in Boston: a special TWIHL! Pharmalot’s Ed Silverman joins a cavalcade of past show guests (Rachel SachsRoss Silverman, and Nicholas Bagley) for a conversation about social media and health law, scholarship, and policy. Some of the works cited: Mark Carrigan, Social Media for AcademicsTressie McMillan Cottom, Microcelebrity and the Tenure Track; Tressie McMillan Cottom, When Marginality Meets Academic Microcelebrity; UW Stout, Rubrics for Assessing Social Media Contributions; Wiley, Altmetrics. And thanks to the audience for great questions!

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

Hank Greely on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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This week we talked with Henry T. (“Hank”) Greely, who has many positions and offices at Stanford University: Edelman Johnson Professor of Law; Director, Center for Law and the Biosciences; Professor (by courtesy) of Genetics, Stanford School of Medicine; Chair, Steering Committee of the Center for Biomedical Ethics; and Director, Stanford Program in Neuroscience and Society.We focused our discussion on Hank’s just-released book, The End of Sex and the Future of Human Reproduction. Having chaired California’s Human Stem Cell Research Advisory Committee and served on the Advisory Council of the NIH’s National Institute for General Medical Sciences, Hank has been an important voice in bioethics for decades. Be sure to listen to the podcast and read the book for a uniquely insightful perspective on the new challenges to ethics and social order posed by emerging reproductive technologies.

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

George Annas on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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This week we talked with George J. Annas, Chairman of the Bioethics & Human Rights Department, and William Fairfield Warren Distinguished Professor, at Boston University. George’s work is legendary among health policy experts; a 1998 tribute from Jay Katz gives some sense of its breadth and depth. Having reviewed numerous works, Katz states:”I have barely conveyed the richness of George Annas’ observations on the ambiguities in motivations and actions that persist in current research practices. The many recommendations he makes, should be of valuable assistance to those interested in reforming current rules governing research on humans. Plagued by Dreams…reveal[s] another facet of George Annas’ personality: His commitment to public advocacy. He values scholarship but he also wants it to have an impact on shaping institutions and health care policies…In the many settings in which I have encountered George Annas over the years, I have admired his boldness, intellect, compassion and moral vigor.” Our conversation had the theme  “paternalism & its critics,” based on articles George had recently authored (or co-authored with last week’s guest, Wendy Mariner) on informed consent, genomics, and sugary drinks.

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

TWIHL Special: Wendy Mariner Analyzes the New Wellness Regulations

By Nicolas Terry and Frank Pasquale

twihl 5x5A special TWIHL episode with analysis of the new EEOC regulations under the ADA and GINA on Employer Wellness Plans. Nic is joined by Professor Wendy Mariner. Professor Mariner is the Edward R. Utley Professor of Health Law at Boston University School of Public Health, Professor of Law at Boston University School of Law, Professor at Boston University School of Medicine, and Co-Director of the J.D.-M.P.H. joint degree program, and a member of the faculty of the Center for Health Law, Ethics and Human Rights at BUSPH. Professor Mariner’s research focuses on laws governing health risks, including social and personal responsibility for risk creation, health insurance systems, implementation of the Affordable Care Act, ERISA, health information privacy, and population health policy.

Our discussion concentrated on the ADA regulation and examined how the agency responded to comments (including ours), the concept of voluntariness, the status of EEOC v. Flambeau, Inc., data protection (including issues raised when  employers research the health of their employees), and the policy flaws in the wellness space.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

Elizabeth Sepper on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

 

This week we interviewed Elizabeth Sepper, Associatetwihl 5x5 Professor of Law at Washington University. Elizabeth’s work explores the interaction of morality, professional ethics, and law in health care and insurance. She has written extensively on conscientious refusals to provide reproductive and end-of-life healthcare In recent work, Elizabeth has argued that, in resisting compliance with antidiscrimination laws, pharmacy regulations, and insurance mandates (most prominently, the Affordable Care Act’s contraceptive mandate), businesses make claims more reminiscent of market libertarianism than of religious freedom.

Our conversation covered many aspects of conscience claims by contemporary health providers. Our timing was perfect, since HHS just finalized a rule on one of Elizabeth’s areas of expertise: prohibitions on discrimination based on race, color, national origin, sex, age or disability. Elizabeth weighed in on the rule and its implications for the future of health care.

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

Christina Ho on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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This week we interviewed Christina S. Ho, Associate Professor of Law at Rutgers University. Christina worked on the Domestic Policy Council at the White House and later led Senator Hillary Rodham Clinton’s health legislative staff.

In our lightning round, we discussed an important new study on medical errors as a leading cause of death in the United States. We also addressed the news of Google’s access to health data in Britain, and ongoing controversies at HSCIC (now rebranded NHS Digital).

We asked Christina about her cutting edge work on the Chinese health care system, the right to health care, and comparative health law generally.While China only spends about 5.5% of GDP on health care, almost 50% of the spending is on pharmaceuticals. Christina offers an insightful look at the past, present, and likely near future of Chinese health reforms.

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

James Hodge on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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This week’s guest was James G. Hodge, Jr., JD, LLM, Professor of Public Health Law and Ethics and Director of the Public Health Law and Policy Program at the Sandra Day O’Connor College of Law, Arizona State University. Through scholarship, teaching, and applied projects, Professor Hodge delves into multiple areas of health law, public health law, global health law, ethics, and human rights.

Our lightning round this week focused on drug prices. Nic analyzed a California referendum proposal and the general potential of state drug price cap laws. Frank noted that New York’s Medicaid program and private insurers now must take a much more humane approach with respect to state-of-the-art treatment for Hepatitis C.

Our conversation with James focused on his recent work addressing the Zika virus. We covered topics ranging from the genetic modification of mosquitoes to the Puerto Rico financial crisis, and legal interventions ranging from budget requests to quarantines to price controls for condoms and mosquito repellent.

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

Heather Howard on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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This week we talked with Heather H. Howard, Lecturer in Public Affairs at Princeton University and Director of the State Health Reform Assistance Network. She served as New Jersey’s Commissioner of Health and Senior Services from 2008-2010, overseeing a cabinet-level agency with a budget of $3.5 billion and staff of 1,700 responsible for public health services, regulation of health care institutions, senior services, and health care policy and research.

Our lightning round “closed the loop” on some prior stories. Nic noted a big fine against a hospital which may end ER reality shows (or at least raise the price of their insurance policies), and a smaller action from OCR with a simple message: covered entities need to complete their BAAs! Prior show guest Nicholas Bagley offered an administrative end run around Gobeille. We also discussed the kaleidoscopic complexity of modern insurance markets.

Our conversation with Heather touched on her pastpresent, and future work on ACA 1332 waivers. If you care about innovation in state health policy, this podcast is for you.

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

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

‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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Our return guest this week is Wendy Parmet, Matthews Distinguished University Professor of Law, Professor of Public Policy and Urban Affairs, Director of the Program on Health Policy and Law, and Associate Dean for Interdisciplinary Education and Research Support at Northeastern University School of Law.  Professor Parmet is a leading voice internationally on cutting edge issues in public health.

In the opening, lightning round, Nic and Frank discussed:
1) Zubik v. Burwell, and the long line of First Amendment cases in the area.
2) The FTC’s new interactive tool for mobile apps.
3) The Part 2 proposed rule, and AMIA’s comment.
4) In the series Frontiers in the Financialization of Health Care, mortgages for expensive treatments, and crowdfunded funerals.

Our focus on Flint, Michigan this week featured Wendy’s insightful work on solidarity in bioethics, and “invisible victims” of public health failures. We also discussed the Docs v. Glocks saga, and the limits of regulation of professional speech.

And finally, attention all listeners: Northeastern will be hosting a conference on the future of public health law this Friday, and Wendy’s book “Welcoming Newcomers” will be out this Fall!

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

‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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This week we interviewed Christopher Robertson, a professor and associate dean at the James E. Rogers College of Law, University of Arizona, and affiliated faculty with the Petrie Flom Center for Health Care Policy, Bioethics and Biotechnology at Harvard. Robertson also leads the Regulatory Science program, a partnership with the Arizona Health Sciences Center and the Critical Path Institute.

We mainly discussed Robertson’s new book with past TWIHL guest Aaron Kesselheim, Blinding as a Solution to Bias:  Strengthening Biomedical Science, Forensic Science, and Law. The book is a tour de force collection of approaches to improving our knowledge of optimal medical, legal, and forensic practices.

We also discussed some of Robertson’s recent contributions to insurance law and policy, including Scaling Cost-Sharing to Wages: How Employers Can Reduce Health Spending and Provide Greater Economic Security, as well as A Randomized Experiment of the Split Benefit Health Insurance Reform to Reduce High-Cost, Low-Value Consumption. The latter work, combined with Episode 47’s discussion with Mark Hall about employer-based exchanges, may well signal a gradual transition toward defined contribution (rather than defined benefit) health insurance plans.

‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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This week we talked with prolific health law scholar Mark Hall, Director of the Health Law and Policy Program and Fred D. & Elizabeth L. Turnage Professor of Law at Wake Forest University School of Law.

Our discussion started with Medicaid expansion and a fascinating paper, Medicaid Expansion Costs in North Carolina: A Frank Discussion (with Edwin Shoaf) that takes a rigorous cost-benefit approach to the topic. Next up we discussed the potential for employer private exchanges and some of their legal implications. Finally, we looked back on Mark’s 2014 frank assessment of the ACA. Check out Mark’s SSRN page for more of his contributions to the health law and policy literature.

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

‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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This week we talked to Professor Erin C. Fuse Brown of Georgia State University’s College of Law (a previous guest on episodes 5 and 22!).  We discussed her fascinating work on the law & policy of health care pricing, including work on cost-control and consolidation (with Jaime S. King). Be sure to check out her SSRN Page for other important work on ongoing efforts to bend the cost curve in health care and assure more universal access to care.

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

‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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This week we talked with Professor Efthimi Parasidis, who holds a joint appointment with The Ohio State University Moritz College of Law and the College of Public Health, and is a faculty affiliate of College of Medicine’s Center for Bioethics and Medical Humanities. His scholarship focuses on the regulation of medical products and human subjects research, the interplay between health law and intellectual property, and the application of health information technology to public health policy.The Greenwall Foundation awarded Professor Parasidis a Faculty Scholar in Bioethics fellowship for 2014-2017.

We started the podcast with a discussion of SCOTUS’s latest ERISA preemption case, GobeilleWe then moved on to HHS’s proposed rule on EHR certification. (For background on the latter topic, see Frank’s “Private Certifiers & Deputies in US Health Care.”). Finally, a big congratulations to Nic on his invitation to the White House’s recent Precision Medicine Initiative.

We tried to cover the range of Efthimi’s latest publications and research, but it was difficult! The discussion ranged from empirical research on “natural food” labeling (and its First Amendment implications), research ethics regarding cognitive enhancement of soldiers, the future of pharmacovigilance, and the diversity of views of vaccine objectors. Hop over to his SSRN page to see his work on these and other topics.

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