‘The Week in Health Law’ Podcast

By Nicolas Terry

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This week we are joined by Michelle Meyer, Professor and Director of Bioethics Policy in the Union Graduate College–Icahn School of Medicine at Mount Sinai Bioethics Program. We primarily discussed the ethics of digital experimentation and e-Research, with an eye to controversies over Facebook and OkCupid and the launch of innovative research platforms such as ResearchKit.

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

Worth Reading This Week

By Nicolas Terry (comments to @nicolasterry on twitter)

‘The Week in Health Law’ Podcast

By Nicolas Terry

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This week we are joined by Thad Pope, one of the country’s leading scholars on end-of-life issues. Thad is professor of law and director of the Health Law Institute at Hamline Law. He curates a particularly useful web site, Medical Futility & Non-Beneficial Treatment Cases, at ThaddeusPope.com and authors the Medical Futility Blog. He joins us to discuss VSED (some background here) and Assisted Suicide. His scholarship on the topic includes papers here and here. The British Columbia case he discusses is here. In addition we discuss regulation of dietary supplements and the problem of agency capture and the HHS-ONC Report on HIT Information Blocking and a recent FTC letter to ONC.

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

‘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

Worth Reading This Week

By Nicolas Terry (comments to @nicolasterry on twitter)

‘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

‘The Week in Health Law’ Podcast

By Nicolas Terry

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This week Erin Fuse Brown joins us to discuss Irrational Hospital Pricing, Price Transparency, the likely SGR Fix, and Non-Profit Tax Status.

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

Should Health Lawyers Pay Attention To The Administration’s Privacy Bill?

By Nicolas Terry

Cross Posted from Health Affairs Blog

Health care lawyers justifiably ignored the 2012 Obama administration consumer privacy framework because it expressly and broadly exempted entities subject to HIPAA, stating “To avoid creating duplicative regulatory burdens, the Administration supports exempting companies from consumer data privacy legislation to the extent that their activities are subject to existing Federal data privacy laws.”

In contrast, the administration’s 2015 draft bill, the Consumer Privacy Bill of Rights Act, though based on that framework, substantially affects health care entities, including those subject to HIPAA, and so demands more attention in the health law community.

The “HIPAA clause” in the draft bill is subtly different (and noticeably narrower than its preemption of state law clause): “If a covered entity is subject to a provision of this Act and a comparable provision of a Federal privacy or security law [the list includes HIPAA] such provision of this Act shall not apply to such person to the extent that such provision of Federal privacy or security law applies to such person.” Continue reading

Is there an IRB inside your Phone?

Apple’s interest in the healthcare space continues to grow. Although the implications of last year’s Health app and HealthKit SDK are still unclear, the company is now entering the crowd-sourced research space with the newly announced ResearchKit.

Apple’s Health app is a powerful health platform, the full promise of which won’t be proven until the imminent launch of Watch, Apple’s first wearable, or some powerful diagnostic apps rather than more mere FitBit clones. As discussed previously Apple, while astutely navigating FDA device regulation, seems to be stepping up to the plate in its embrace of patient privacy in the HIPAA-free mobile app space.

ResearchKit is another edgy innovation. And, again, one marked by the technology giant’s ability to forge partnerships with major stakeholders. ResearchKit was announced in concert with several apps from major healthcare research institutions including Stanford and Mass. General. Early reports suggest that research subjects are signing up in droves, cutting subject recruitment times dramatically. Continue reading

‘The Week in Health Law’ Podcast

By Nicolas Terry

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This week Lindsay Wiley joins us to discuss “New Public Health” and we debate the value and validity of wellness plans.

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 at @nicolasterry @FrankPasquale

Worth Reading This Week

By Nicolas Terry

‘The Week in Health Law’ Podcast

By Nicolas Terry

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This week Abigail Moncrieff joins us to discuss the King v. Burwell oral arguments, the story behind the amicus brief she authored, and what it was like to hear Justice Kennedy talk about the very issue she raised.

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 at @nicolasterry @FrankPasquale

Worth Reading This Week

By Nicolas Terry

‘The Week in Health Law’ Podcast

By Nicolas Terry

twihl 14x14Frank Pasquale and Nicolas Terry are pleased to announce The Week in Health Law Podcast. We (and our guests) enjoy 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.

This week, a special treat, as we are joined by Nicole Huberfeld to discuss Medicaid expansion (as well as Google health searches and bending the safety curve).

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 at @nicolasterry @FrankPasquale

Worth Reading This Week

By Nicolas Terry

Time for a Healthcare Data Breach Review?

By Nicolas Terry

Given the increasing numbers of health data breaches, including this week’s announcement from Anthem (potentially exposing 80m records, mine included) a brief review on the subject may be appropriate.

At the federal level both the Security Rule and the Breach Notification Rule are in play. In large part the Security Rule requires covered entities and their business associates to base their security precautions on risk assessment. Required precautions include administrative, physical, and technical safeguards. Many of these are required, for example unique user identities for access and tracking. Some precautions, however, are only “addressable.”

This latter is the case with data encryption, defined in the Security Rule as “the use of an algorithmic process to transform data into a form in which there is a low probability of assigning meaning without use of a confidential process or key.” In practical terms data may need to be encrypted end-to-end (during transmittal) or while stored (at rest). Being only ‘addressable,’ the question whether to encrypt stored data depends on the data custodian’s assessment whether that technology “is a reasonable and appropriate safeguard in its environment, when analyzed with reference to the likely contribution to protecting electronic protected health information.” If the risk assessment goes against encryption that decision must be documented and a reasonable and appropriate alternative safeguard implemented. Continue reading

Raising the King v. Burwell Stakes

By Nicolas Terry

Today, the Washington Post ran an interview with Laurence Tribe about the King v. Burwell subsidy litigation (recall that oral arguments are scheduled for March 4). Tribe speculated that Chief Justice Roberts will once again be the swing vote, as he was in Nat’l Fed. of Independent Bus. v. Sebelius. Tribe seems to predict another pragmatic Roberts opinion (and one that might bring Justice Kennedy along), finding the subsidy provisions are at worse ambiguous and that the executive is owed deference as argued by the eminently reasonable Nick Bagley.

Even though Tribe wouldn’t label Roberts as a consequentialist, he does believe that the pragmatic Roberts would be influenced by the impact on the States, the disruption of insurance markets, and the consequences for the newly insured. If the Chief wants more data on those issues he could do no better than to consult two excellent reports from the Urban Institute. The first estimates that a declaration that the subsidies are invalid “would increase the number of uninsured in 34 states by 8.2 million people… and eliminate $28.8 billion in tax credits and cost-sharing reductions in 2016 ($340 billion over 10 years) for 9.3 million people.” Perhaps as important, the Urban Institute’s model also predicts general turmoil in private, non-group insurance markets as the young and healthy would disproportionately drop coverage, causing a predicted 35% increases in premiums.

The second and most recent brief from the Urban Institute begins to put faces on those who will suffer: “Over 60 percent of those who would become uninsured are white, non-Hispanic and over 60 percent would reside in the South. More than half of adults have a high school education or less, and 80 percent are working.”

The executive shouldn’t need such help given the ACA’s clear intent as to how the federal and state exchanges were meant to function. But, if a dose of pragmatism is required to secure a majority of the Court, the stakes couldn’t be any clearer.

Worth Reading This Week

By Nicolas Terry

Worth Reading This Week

By Nicolas Terry

Worth Reading This Week

By Nicolas Terry