New Paper–“Big Data: Destroyer of Informed Consent”

Just posted: A near-final draft of my latest paper, Big Data: Destroyer of Informed Consent. It will appear later this year in a special joint issue of the Yale Journal of Health Policy, Law, and Ethics and the Yale Journal of Law and Technology.

Here’s the tentative abstract (I hate writing abstracts):

The ‘Revised Common Rule’ took effect on January 21, 2019, marking the first change since 2005 to the federal regulation that governs human subjects research conducted with federal support or in federally supported institutions. The Common Rule had required informed consent before researchers could collect and use identifiable personal health information. While informed consent is far from perfect, it is and was the gold standard for data collection and use policies; the standard in the old Common Rule served an important function as the exemplar for data collection in other contexts.

Unfortunately, true informed consent seems incompatible with modern analytics and ‘Big Data’. Modern analytics hold out the promise of finding unexpected correlations in data; it follows that neither the researcher nor the subject may know what the data collected will be used to discover. In such cases, traditional informed consent in which the researcher fully and carefully explains study goals to subjects is inherently impossible. In response, the Revised Common Rule introduces a new, and less onerous, form of “broad consent” in which human subjects agree to as varied forms of data use and re-use as researchers’ lawyers can squeeze into a consent form. Broad consent paves the way for using identifiable personal health information in modern analytics. But these gains for users of modern analytics come with side-effects, not least a substantial lowering of the aspirational ceiling for other types of information collection, such as in commercial genomic testing.

Continuing improvements in data science also cause a related problem, in that data thought by experimenters to have been de-identified (and thus subject to more relaxed rules about use and re-use) sometimes proves to be re-identifiable after all. The Revised Common Rule fails to take due account of real re-identification risks, especially when DNA is collected. In particular, the Revised Common Rule contemplates storage and re-use of so-called de-identified biospecimins even though these contain DNA that might be re-identifiable with current or foreseeable technology.

Defenders of these aspects of the Revised Common Rule argue that ‘data saves lives’. But even if that claim is as applicable as its proponents assert, the effects of the Revised Common Rule will not be limited to publicly funded health sciences, and its effects will be harmful elsewhere.

This is my second foray into the deep waters where AI meets Health Law. Plus it’s well under 50 pages! (First foray here; somewhat longer.)

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Florida Legalizes Fully Autonomous Vehicle Testing

Waymo Self-driving car
Source: Grendelkhan

Florida law now allows the testing of fully autonomous vehicles without a backup driver.

Since autonomous car tend to have trouble with bad weather–snow and sometimes rain–flat, sunny Florida would seem to be a natural testing grounds. Indeed, Ford is supposedly running or planning to run a test in Miami, although I haven’t heard of actual sightings yet. Then again, we have some of the craziest drivers in the US, which could be seen as a positive or negative, depending on what sort of torture test you want to give the AIs.

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Florida’s Political Fulcrum: the I-4 Corridor

Master Florida psephologist Steve Schale does a deep dive as to why the road to winning Florida is the I-4 corridor (that’s the Orlando to Tampa link in the middle of the state).  The rest of us, it seems, are fairly predictable. Another nugget: some of the swing vote in the I-4 area are transplantees from the mid-West. (Does that make it Biden country?)

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Anthony Eudelio Varona Will Be MiamiLaw’s Next Dean

I’m very excited to announce the identity of our new Dean, who will take over in less than two months: Anthony Eudelio Varona, currently of American University.  Tony comes to us with a great deal of energy, ideas — and a local connection.

Here’s the official announcement from our Provost, Jeffrey L. Duerk:

June 11, 2019
To the University of Miami Community:

I am thrilled to share that Anthony Eudelio Varona, an attorney and educator who specializes in administrative law, communications and media law, and sexuality and gender law, has been named the new dean at the School of Law, effective August 1.

Tony is currently professor of law at American University Washington College of Law, where he teaches contracts, administrative and public law, and media law. He has been with American University Washington College of Law since 2005, serving two years as vice dean, associate dean for faculty and academic affairs for six years, and also serving as the Doctor of Juridical Science program director and a member of the faculty review/advisory boards of the Administrative Law Review and the Journal of Gender, Social Policy & the Law. Tony has also acted as faculty advisor to the Latino/a Law Students Association and the Lambda Law Society. He entered teaching full-time as an associate professor of law at Pace University School of Law in 2002.

Tony serves on the national board of directors for Stonewall National Museum and Archives (SNMA), for which he co-founded and for its first year co-chaired the SNMA National Advisory Council. Before entering academia, he spent nearly five years as as chief counsel and then general counsel and legal director for the Human Rights Campaign (HRC), the nation’s largest LGBTQ civil rights organization. He represented HRC and the HRC Foundation in various coalition work groups, including the Leadership Conference on Civil Rights judicial nominations task force.

Earlier in his career, he was an associate at Skadden Arps and Mintz Levin, and an honors program enforcement attorney at the Federal Communications Commission.

Tony is a consummate and respected professional in the area of law, and is immersed in critical issues impacting our country and culture. His insightful and innovative approach to educating the next generation of lawyers will have a profound impact on the School of Law and in courtrooms across the country.

Born in Cuba, he left the island with his mother and grandparents at age 3, settling for a short time in Spain before the family reunited with his father in Newark, New Jersey. He has family in South Florida and visits the Miami area frequently.

Tony earned his Juris Doctor from Boston College Law School, where he worked as a student attorney at the Greater Boston Legal Services-affiliated poverty law clinic BC Legal Assistance Bureau in Waltham, Massachusetts, and later earned a Master of Laws from Georgetown University Law Center with a focus in civil rights and civil liberties. He received his Bachelor of Arts in political science and French from Boston College.

I would like to once again thank Dean Trish White for her decade of visionary leadership at Miami Law.

A special thank you goes to the members of the search committee, led by Business School Dean John Quelch, for their focused effort and great work in identifying and recommending the ideal candidate.

Please join me in welcoming Tony to the University of Miami.

Jeffrey L. Duerk, Ph.D.
Executive Vice President for Academic Affairs and Provost

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Machine M.D. in Ottawa

I’m in Ottawa today for the Machine M.D. conference.  My panel, on “Regulating Health and Safety” started at 8:30am, so now that it’s over I get to enjoy the rest of the very packed schedule.

(I’m missing the also wonderful annual Privacy Law Scholars conference to be here, an example of the difficulties in trying to write in, and keep up in, multiple areas even within technology law.)

My argument in my talk was that, contrary to a number of articles by others that are now in press, we don’t want a super-AI regulator, but rather need to find a way to strengthen the AI capacity of existing sectoral regulators like the FDA, NHTSA and many others.  The exception(s) to this general rule arise(s) only if the AI aspect of a regulatory question predominates over the sectoral — something I argue is rare, and probably limited to issues regarding access to data, to data quality, to job losses due to AI, and possibly to the regulation (or at least liability for) AI emergent behavior.

Unsurprisingly, some members of the audience, many of whom are health professionals, pushed back against the idea that when it comes to AI health really isn’t all that different from transport, finance, sentencing, or other predictive profiling applications. A polite discussion — we are after all in Canada — ensued.

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What Scares Floridians

Has poisonous scaly spines, belongs on the list.

Steve Schale, who usually writes informed wonky stuff about Florida politics, took a break to write about Things that scare Floridians, sort of ranked. Example:

Driving.    As my friend Tom Eldon says, Floridians drive as though they are a complete peace with God.  Others have suggested that turn signals here are a sign of weakness.  Florida interstates are kind of a bad combo of Mad Max, Survivor, and Seinfeld.   I’ve driven in some unique foreign places, and well, I’ll take most over I-4.   Add into it 100 million tourists a year, and yeah, Floridians know driving here is bad.

For my money, the whole list pretty much nails what it covers, but he left out lion fish and Portugese Man-of-wars, both of which at least ought to be on the ‘Tiny bit scared of’ list, and he exaggerates by about ten degrees Fahrenheit on the temperature thing.  We can handle 55 degrees in the Winter, no problem.

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