Author: Frank Pasquale

Greene & Kesselheim vs. Kardashian

Jeremy Greene and Aaron Kesselheim have a fascinating piece on the new challenges facing the FDA as selfie-driven marketing reaches Instagram. After promoting an anti-nausea drug (for morning sickness, not in anticipation of celebrity-phobic viewers), Kardashian had to follow up with the following “corrective advertisement:”

#CorrectiveAd I guess you saw the attention my last #morningsickness post received. The FDA has told Duchesnay, Inc., that my last post about Diclegis (doxylamine succinate and pyridoxine HCl) was incomplete because it did not include any risk information or important limitations of use for Diclegis.

As Greene and Kesselheim observe:

The rise of social media has raised a parade of new questions for the agency: How is it supposed to monitor person-to-person pharmaceutical recommendations? Can something be considered an advertisement if it’s only 140 characters long? Who is responsible for the accuracy of tweets about a drug? But this isn’t the first time evolving technology has forced the FDA to rethink its role. Before Instagram, television advertising was once new; before television, radio. Since the agency’s founding, its ability to regulate drugs has been consistently challenged by new forms of communication.

For more on the controversy, check out The Week in Health Law, where Nicolas Terry and I discuss the case with Kesselheim. And don’t worry, it’s not all about Kardashians–we also cover a new study of ACOs, proposed budget cuts for AHRQ, worry over unintended consequences of readmission penalties, and EHR gag clauses (and developer codes of conduct).

The Week in Health Law, Back to School Edition

If you want to learn about a fast-changing field, check out health law. It’s hard to keep track of all the recent developments in subfields of it (bioethics, insurance regulation, malpractice, EHRs and privacy, among others), let alone the field as a whole. Fortunately, there are many scholars and practitioners who are diligently working on all these issues. Nic Terry interviewed many of them for our “Back to School” podcast on health law.

Here are the contributors, with links to articles on the issues they discussed:
Micah Berman – PBS Unnatural Causes
Erin Fuse Brown – Physician Self-Referral Updates (STARK)
Glenn Cohen – Egg freezing and egg banking: empowerment and alienation in assisted reproduction
Brietta Clark – Pickup v. Brown
Nicole Huberfeld – Armstrong v Exceptional Child Center Inc. 
Elizabeth Weeks Leonard – King v. Burwell
Frank Pasquale – Narrow Networks
Ross Silverman – Should childhood vaccination against measles be a mandatory requirement for attending school? Yes
Norman G. Tabler, Jr.–  Can an Arbitrator Rule Against a Hospital for Not Violating the Anti-Kickback Statute?
Nicolas Terry – North Carolina State Board of Dental Examiners v. Federal Trade Commission

Show notes and more are at If you have comments, an idea for a show or a topic to discuss you can find us on twitter: @nicolasterry and @HealthPI (for my health tweets) or @FrankPasquale (for law & tech, surveillance, algorithms & political economy). @WeekInHealthLaw is the show feed.


Berlusconi-fication: Cutting Out the Middle Man

2630085549_eebd0ce895_oRecently Rick Perlstein described American elections as a “plutocrat’s right to choose.” Such concerns have also been raised by conservative media. A political economy premised on the trading of money for power, and power for money, gives rise to an oligarchic constitutional order. Political science responds with “investor theories” of politics, where the key players are not the voters, but the donors. Politicians become vessels for their agendas.

As Jeffrey Winters observes, many types of oligarchies can develop. Americans might be interested in learning more about what might be deemed a “direct” oligarchy, where one-time donors forego buying the favor of leaders, and simply run for office themselves. Some very wealthy candidates of the right and left have fit this bill, and done passably as leaders. But the independence afforded by great wealth can also lead to flamboyantly erratic behavior, particularly among men long unaccustomed to accounting for their actions to others. Consider, for instance, the billionaire Silvio Berlusconi, a long-time Italian leader:

Perhaps the most famous example of Berlusconian rule-bending—and the one with the most popular results—was his takeover of Italian TV. Television was introduced to Italy, in 1954, through a single channel, RAI, administered by the ruling Christian Democratic Party; the highlight of its programming was the Pope’s Sunday-morning Mass, which is still on the air. For decades, the government controlled television: in the seventies, political parties were allotted news coverage in exact proportion to their votes in parliament. Then, in 1976, the Italian Supreme Court ruled that private broadcasting could be allowed on a local level. Berlusconi, who had made a fortune building suburban housing developments, began buying up local stations and broadcasting the same content on all of them. In order to comply with the letter of the court’s ruling, he staggered the broadcasts by a few seconds on each network.

Technically, these were local broadcasts; effectively, as Berlusconi made clear to advertisers, he had a national market, which he glutted with American programs like “Dallas,” “Dynasty,” and “Falcon Crest”—stories of sex and money…Berlusconi…believed that appetites existed to be stoked and sated, and he imported both American entertainment and the advertising environment that supported it. “I’m in favor of everything American before even knowing what it is,” he once told the Times.

Despite a long record of self-dealing, scandal, and outrageous statements, Berlusconi spent 9 years as Prime Minister. He had great appeal as a rascally anti-hero, exulting in a mix of la dolce vita and la vida loca. Thank goodness America, a mature democracy, could never fall for such a dubious mix of wealth and celebrity.

Photo Credit: CluPix.

A Tribute to Marc Poirier

marc-poirier-176x220I want to mark the passing of a former colleague of mine, Seton Hall’s Marc Poirier. Marc was an exceptional scholar, teacher, and colleague.

Marc was a deeply learned man, conversant in areas ranging from the jurisprudence of interpretation to the science of global warming. He wrote on property, environmental law, and civil rights, and combined the fields in innovative ways. His “Virtues of Vagueness in Takings Law” was both widely cited, and elegantly argued. Essays like “Science, Rhetoric, and Distribution in a Risky World” were philosophically informed readings of fundamental controversies in environmental policy. Throughout his scholarship, there was a concern for the marginal: the victims of environmental racism, sexual orientation discrimination, climate change, and many other contemporary scourges. But there was also a wise awareness of the limits of law and the complexities of advocacy.

It is thanks to the efforts of people like Marc that marriage equality has come to America. I say this not only because an article like “The Cultural Property Claim in the Same-Sex Marriage Controversy” clarified the stakes of the term “marriage” so eloquently and empathetically. Marc’s service and faculty advising modeled, for all of us, a patient way of working for justice in slow-moving courts and agencies, and in institutions affiliated with a “church that can and cannot change.” Marc explored gender and LGBTQ equality in so many dimensions: legal, sociological, anthropological, economic. I have little doubt that his work will be consulted again and again, as scholars reflect on his illuminating efforts to balance liberty and equality, tradition and innovation, individual self-expression and institutional self-governance.

Marc was also deeply involved in the community. He devoutly maintained a meditation practice, both as a leader of group meditation sessions and a member of area sanghas. He offered his teaching to all at Seton Hall, and organized sittings and other opportunities for us to experience meditation’s compelling combination of relaxation and focus. While some might see meditation as an unlikely practice for lawyers, Marc helped us understand both professional judgment and spiritual practice as complementary ways of gaining a broader perspective on reality. Groups like the Association for Contemplative Mind in Higher Education have shown how important these opportunities can be for both faculty and students alike. I will always be grateful to Marc for bringing these practices to Seton Hall.

Marc was also a very committed teacher. He went above and beyond in his administrative law class to include extra material on state and local government that few other courses in the area covered. The standard for his seminars was exceptionally high, and he’d have frequent meetings with students to help them perfect their papers. He was available all the time, and always happy to talk.

Finally, I will always remember Marc as wonderfully effervescent. He was such a delight to have lunch or dinner with. And he would talk about just about anything: how to argue a difficult point in an article, how to navigate administrative mazes, or what were the best parks and beaches in New Jersey. He was such a good listener. I think this was part of his meditative practice: to open himself up to whatever colleagues or students wanted to chat about, knowing exactly when to inject a note of skepticism, a considered reflection, a guffaw.

I will so miss those conversations with Marc. There is some small sense of consolation in reading his articles, artifacts of a gentle yet meticulous intellect making connections among concepts that only someone of his deep understanding and learning could accomplish. But I wish we’d had more time to learn from him. I hope I can do some justice to his memory by trying to imitate the empathy, reflectiveness, and openness he showed to so many.

Three on the Gig Economy

July has been a big month for public discussion of the gig economy. For those interested in the issue, here are three of my recent pieces:

1) Is Your Digital Boss Cheating You? (part of a collection of “5 Ways to Take Back Tech”)

2) Serfing the Web: On-Demand Workers Deserve a Place at the Table (with Trebor Scholz). If you have comments for the FTC on the gig economy, their deadline is August 4.

3) Uber and the lawlessness of ‘sharing economy’ corporates (with Siva Vaidhyanathan)

In related news: for anyone interested in the future of legal regulation of the interaction between software and work, please submit an abstract to “Unlocking the Black Box: The Promise and Limits of Algorithmic Accountability in the Professions” (due by August 23).

Air Traffic Control for Drones

8435473266_16e7ae4191_zRecently a man was arrested and jailed for a night after shooting a drone that hovered over his property. The man felt he was entitled (perhaps under peeping tom statutes?) to privacy from the (presumably camera-equipped) drone. Froomkin & Colangelo have outlined a more expansive theory of self-help:

[I]t is common for new technology to be seen as risky and dangerous, and until proven otherwise drones are no exception. At least initially, violent self-help will seem, and often may be, reasonable even when the privacy threat is not great – or even extant. We therefore suggest measures to reduce uncertainties about robots, ranging from forbidding weaponized robots to requiring lights, and other markings that would announce a robot’s capabilities, and RFID chips and serial numbers that would uniquely identify the robot’s owner.

On the other hand, the Fortune article reports:

In the view of drone lawyer Brendan Schulman and robotics law professor, Ryan Calo, home owners can’t just start shooting when they see a drone over their house. The reason is because the law frowns on self-help when a person can just call the police instead. This means that Meredith may not have been defending his house, but instead engaging in criminal acts and property damage for which he could have to pay.

I am wondering how we might develop a regulatory infrastructure to make either the self-help or police-help responses more tractable. Present resources seem inadequate. I don’t think the police would take me seriously if I reported a drone buzzing my windows in Baltimore—they have bigger problems to deal with. If I were to shoot it, it might fall on someone walking on the sidewalk below. And it appears deeply unwise to try to grab it to inspect its serial number.

Following on work on license plates for drones, I think that we need to create a monitoring infrastructure to promote efficient and strict enforcement of law here. Bloomberg reports that “At least 14 companies, including Google, Amazon, Verizon and Harris, have signed agreements with NASA to help devise the first air-traffic system to coordinate small, low-altitude drones, which the agency calls the Unmanned Aerial System Traffic Management.” I hope all drones are part of such a system, that they must be identifiable as to owner, and that they can be diverted into custody by responsible authorities once a credible report of lawbreaking has occurred.

I know that this sort of regulatory vision is subject to capture. There is already misuse of state-level drone regulation to curtail investigative reporting on abusive agricultural practices. But in a “free-for-all” environment, the most powerful entities may more effectively create technology to capture drones than they deploy lobbyists to capture legislators. I know that is a judgment call, and others will differ. I also have some hope that courts will strike down laws against using drones for reporting of matters of public interest, on First Amendment/free expression grounds.

The larger point is: we may well be at the cusp of a “this changes everything” moment with drones. Illah Reza Nourbakhsh’s book Robot Futures imagines the baleful consequences of modern cities saturated with butterfly-like drones, carrying either ads or products. Grégoire Chamayou’s A Theory of the Drone presents a darker vision, of omniveillance (and, eventually, forms of omnipotence, at least with respect to less technologically advanced persons) enabled by such machines. The present regulatory agenda needs to become more ambitious, since “black boxed” drone ownership and control creates a genuine Ring of Gyges problem.

Image Credit: Outtacontext.

Corporate Experimentation

Those interested in the Facebook emotional manipulation study should take a look at Michelle N. Meyer’s op-ed (with Christopher Chabris) today:

We aren’t saying that every innovation requires A/B testing. Nor are we advocating nonconsensual experiments involving significant risk. But as long as we permit those in power to make unilateral choices that affect us, we shouldn’t thwart low-risk efforts, like those of Facebook and OkCupid, to rigorously determine the effects of those choices. Instead, we should…applaud them.

Meyer offers more perspectives on the issue in her interview with Nicolas Terry and me on The Week in Health Law podcast.

For an alternative view, check out my take on “Facebook’s Model Users:”

[T]he corporate “science” of manipulation is a far cry from academic science’s ethics of openness and reproducibility. That’s already led to some embarrassments in the crossover from corporate to academic modeling (such as Google’s flu trends failures). Researchers within Facebook worried about multiple experiments being performed at once on individual users, which might compromise the results of any one study. Standardized review could have prevented that. But, true to the Silicon Valley ethic of “move fast and break things,” speed was paramount: “There’s no review process. Anyone…could run a test…trying to alter peoples’ behavior,” said one former Facebook data scientist.

I just hope that, as A/B testing becomes more ubiquitous, we are well aware of the power imbalances it both reflects and reinforces. Given already well-documented resistance to an “experiment” on Montana politics, it’s clear that the power of big data firms to manipulate even the very political order that ostensibly regulates them, may well be on the horizon.

Is the Happiness Industry Creating Algorithmic Selves?

In a recent podcast called “Thinking Allowed,” host Laurie Taylor covered two fascinating books: The Wellness Syndrome, and The Happiness Industry. One author discussed a hedge fund that’s now managing what it calls “biorisk” by correlating traders’ eating, drinking, and sleeping habits, and their earnings for the firm. Will Davies, author of The Happiness Industry, discussed less intrusive, but more pervasive, efforts to assure that workers are fitter, happier, and therefore more productive. As he argues in the book,

[M]ood-tracking technologies, sentiment analysis algorithms and stress-busting meditation techniques are put to work in the service of certain political and economic interests. They are not simply gifted to us for our own Aristotelian flourishing. Positive psychology, which repeats the mantra that happiness is a personal ‘choice’, is as a result largely unable to provide the exit from consumerism and egocentricity that its gurus sense many people are seeking.

But this is only one element in the critique to be developed here. One of the ways in which happiness science operates ideologically is to present itself as radically new, ushering in a fresh start, through which the pains, politics and contradictions of the past can be overcome. In the early twenty-first century, the vehicle for this promise is the brain. ‘In the past, we had no clue about what made people happy – but now we know’, is how the offer is made. A hard science of subjective affect is available to us, which we would be crazy not to put to work via management, medicine, self-help, marketing and behaviour change policies.

The happiness industry thrives in a culture premised on an algorithmic model of the self. People (or “econs“) are seen a bundle of inputs (data collection), algorithmic processes (data analysis), and outputs (data use). Since the demands of affect can only be extirpated in robots, the challenge for the happiness industry is to optimize some quantum of satisfaction for its human subjects, compatible with their maximum productivity. Objectively, the algorithmic self is no more (nor less) than the goods and services it uses and creates; subjectively, it strives to convert inputs of resources into outputs of joy, contentment–name your positive affect. As “human resources,” it is simply raw material to be deployed to its most profitable use.

Audit culture, quantification (e.g., the quantified self), commensuration, and cost-benefit analysis all reflect and reinforce algorithmic selfhood. Both the Templeton Foundation and the Social Brain Centre in Britain are developing some intriguingly countercultural alternatives to big data-driven behaviorism. As he highlights the need for such alternatives, Davies deserves great credit for exposing the political economy behind corporate appropriations of positive psychology.

Worker Replaceability: A Question of Values

One reason I decided to write on law practice technology was because of a general unease about the shape of debates on automation. Technologists and journalists tend to look at jobs from the outside, presume that they are routine, and predict they’ll be further routinized by machines. But some reality checks are important here.

As David Rotman observes, “there is not much evidence on how even today’s automation is affecting employment.” Many economists believe that technology will create more jobs than it destroys. MIT’s David Autor, writing for the Federal Reserve Bank of Kansas City’s economic policy symposium on “Reevaluating Labor Market Dynamics,” states that “journalists and expert commentators overstate the extent of machine substitution for human labor and ignore the strong complementarities”—in other words, the ways that automation can increase, rather than decrease, the value of human labor. Consider, for instance, the use of voice recognition software: it may put transcriptionists out of work, but increases the value of the labor of a person who can now, say, transcribe what they’ve dictated 24 hours a day, rather than just when the transcriptionist is near. The selfie-stick may have a similar effect on cameramen and journalists. Legal tech may put some lawyers out of a job, while creating jobs for others.

It’s also easy to overestimate the scope of automation. Autor gives a sobering example of windshield repair:

Most automated systems lack flexibility—they are brittle. Modern automobile plants, for example, employ industrial robots to install windshields on new vehicles as they move through the assembly line. But aftermarket windshield replacement companies employ technicians, not robots, to install replacement windshields. Why not robots? Because removing a broken windshield, preparing the windshield frame to accept a replacement, and fitting a replacement into that frame demand far more real-time adaptability than any contemporary robot can

The distinction between assembly line production and the in-situ repair highlights the role of environmental control in enabling automation. While machines cannot generally operate autonomously in unpredictable environments, engineers can in some cases radically simplify the environment in which machines work to enable autonomous operation.

Admittedly, the “society of control” scenario discussed here, or even milder versions of the “smart city,” may lead to far more controllable environments. But they also raise critical questions about privacy, fair data practices, and liberty.

There are also conflicts over values at stake in worker replacement. Osborn & Frey’s study The Future Of Employment: How Susceptible Are Jobs To Computerisation? tries to rank order 702 positions on the degree of likelihood of their automation. They characterize recreational therapists as least automatable, and title examiners and searchers as the second most automatable. But many video games offer forms of therapy, and therapeutic jobs (like masseur) and even higher-touch jobs could, in principle, be computerized. Furthermore, at least in the United States in the wake of MERS, there has been a loss of “confidence in real property recording systems.” Title insurance may hinge on legal questions that are still up in the air in certain states. Yes, further automation and recognition of things like MERS might “cut the Gordian knot,” but that solution would also inevitably trench on other values of legal regularity and due process.

In summary: automation anxieties could be as overblown now as they were in the 1960s. And the automation of each occupation, and tasks within occupations, will inevitably create conflicts over values and social priorities. Far from a purely technical question, robotization always implicates values. The future of automation is ours to master. Respecting workers, rather than assuming their replaceability of, would be a great start.

Dulce et Decorum Est: Critics of Student Loan Forgiveness Rally the Troops

For years, critics of loan forgiveness programs for students have argued that they are a form of “welfare,” when in fact they’re a necessary corrective to the excessively harsh bankruptcy regime imposed on student debt. But the critics are getting a hearing, and guess where the money is probably going:

[A]t some point, there is going to be a deal on appropriations and raising the debt ceiling. There is a lot of pressure to raise defense spending. Some of these student loan items [like the Public Service Loan Forgiveness Program] could wind up on the table in such a deal.

We’ve seen this pattern again and again: 1) create a scare about excessive “entitlement” spending, 2) spur either tax cuts for the rich or reallocation of “entitlement” money to the force or finance sectors, and 3) repeat once excess military spending once again drives budgetary imbalances. The PLSF is a low-cost program designed to promote provision of important services to the underserved. It’s amazing to think, of all the expenditure lines that could be attacked, this was the one chosen. But it is of a piece with larger social trends to shift money away from human services, and toward force and finance.
Read More