Artificial Intelligence and Medical Liability (Part II)

By Shailin Thomas

Recently, I wrote about the rise of artificial intelligence in medical decision-making and its potential impacts on medical malpractice. I posited that, by decreasing the degree of discretion physicians exercise in diagnosis and treatment, medical algorithms could reduce the viability of negligence claims against health care providers.

It’s easy to see why artificial intelligence could impact the ways in which medical malpractice traditionally applies to physician decision-making, but it’s unclear who should be responsible when a patient is hurt by a medical decision made with an algorithm. Should the companies that create these algorithms be liable? They did, after all, produce the product that led to the patient’s injury. While intuitively appealing, traditional means of holding companies liable for their products may not fit the medical algorithm context very well.

Traditional products liability doctrine applies strict liability to most consumer products. If a can of soda explodes and injures someone, the company that produced it is liable, even if it didn’t do anything wrong in the manufacturing or distribution processes. Strict liability works well for most consumer products, but would likely prove too burdensome for medical algorithms. This is because medical algorithms are inherently imperfect. No matter how good the algorithm is — or how much better it is than a human physician — it will occasionally be wrong. Even the best algorithms will give rise to potentially substantial liability some percentage of the time under a strict liability regime.

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2/22: Michael Sandel & author Yuval Harari discuss new book Homo Deus

Register for this event

Harvard Book Store and welcomes the bestselling author of Sapiens Yuval Noah Harari for a discussion of his latest book, Homo Deus: A Brief History of Tomorrow. Harari will be joined in conversation by Harvard’s Michael Sandel, author of Justice: What’s the Right Thing to Do? and What Money Can’t Buy: The Moral Limits of Markets.

This event is open to the public, but tickets are required. Tickets are available online only via the Harvard Book Store. Ticket price of $34.75 includes a copy of the book. Purchase tickets now! Read More

Rebecca Dresser on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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This week features Professor Rebecca Dresser of Washington University. She is the author of Silent Partners: Human Subjects and Research Ethics (Oxford University Press, 2016) and When Science Offers Salvation: Patient Advocacy and Research Ethics (Oxford University Press, 2001), along with many other insightful articles on bioethics and law. Our discussion focused on Silent Partners, including Rebecca’s work’s relevance to current debates on research ethics and informed consent.

Rebecca is a past member of the President’s Council on Bioethics and National Institutes of Health Recombinant DNA Advisory Board. She is a prolific speaker and panelist at national and international symposia, conferences, and workshops on such topics as bioethics and cancer; advance treatment directives; stem cell research; biomedical research policy; and human cloning.

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

Defeating Death (And Taxes)

By Seán Finan

“It is one of the most powerful tools our species has created. It helps doctors fight disease. It can predict global weather patterns. It improves education for children everywhere. And now, we unleash it…on your taxes.”

Super Bowl 2017 was an absolute cracker. My passport is not American and my accent is not Bostonian, but somewhere amidst the drama and the crowd and the cheesy nachos, I was drawn in and hooked. I roared and gasped and choked on cheap beer all the way to that nail-biting finish. Go Pats.

But, as it was my very first Super Bowl, I was told to keep an eye on the ads. Sure enough, they were hilarious, inspiring, maddening and perplexing by turn. One of them, however, hit me harder than Keanu Neal.

This ad, from H&R Block, announced that they will be using IBM’s Watson to deliver their services. Watson is, perhaps, the most impressive artificial intelligence that our species has yet produced. H&R Block is a consumer tax services provider.

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Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of January. The selections feature topics ranging from pharmacist-industry relationships, to returns from six-month market exclusivity extensions, to financial conflicts of interest among patient advocacy organizations. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Ahn R, Woodbridge A, Abraham A, Saba S, Korenstein D, Madden E, Boscardin WJ, Keyhani S. Financial ties of principal investigators and randomized controlled trial outcomes: cross sectional study. BMJ. 2017;356:i6770.
  2. Califf RM. Benefit-Risk Assessments at the US Food and Drug Administration: Finding the Balance. JAMA. 2017 Jan 20. [Epub ahead of print]
  3. Hakim A, Ross JS. High Prices for Drugs With Generic Alternatives: The Curious Case of Duexis. JAMA Intern Med. 2017 Jan 23. [Epub ahead of print]
  4. Kesselheim AS, Rome BN, Sarpatwari A, Avorn J. Six-Month Market Exclusivity Extensions To Promote Research Offer Substantial Returns For Many Drug Makers. Health Aff (Millwood). 2017 Jan 18. [Epub ahead of print]
  5. Kesselheim AS, Treasure CL, Joffe S. Biomarker-Defined Subsets of Common Diseases: Policy and Economic Implications of Orphan Drug Act Coverage. PLoS Med. 2017;14(1):e1002190.
  6. Rose SL, Highland J, Karafa MT, Joffe S. Patient Advocacy Organizations, Industry Funding, and Conflicts of Interest. JAMA Intern Med. 2017 Jan 17. [Epub ahead of print]
  7. Saavedra K, O’Connor B, Fugh-Berman A. Pharmacist-industry relationships. Int J Pharm Pract. 2017 Jan 18. [Epub ahead of print]

A New Day For Oversight Of Human Subjects Research

This new post by Holly F. Lynch appears on the Health Affairs Blog in a series stemming from the Fifth Annual Health Law Year in P/Review event held at Harvard Law School on Monday, January 23, 2017.

On January 19, 2017—President Obama’s last day in office—the Federal Register published a Final Rule to amend the Federal Policy for the Protection of Human Subjects, the set of regulations applicable to most human subjects research conducted or supported with federal funds, and more typically referred to as the “Common Rule.” This rule change had been a long time coming, with an Advance Notice of Proposed Rule Making (ANPRM) published in July 2011 and a Notice of Proposed Rule Making (NPRM) published in September 2015. The seriousness of its impact on the research community, patients, and the public is evidenced by the more than 3,300 public comments submitted during the rulemaking process. So what changed?

First, it is important to understand where things stood. The Common Rule was initially adopted in 1991, with each relevant agency codifying the same set of regulations (the Department of Health and Human Service’s codification is found at 45 C.F.R. Part 46). The primary functions of the Common Rule are to require that research with human subjects be approved by an Institutional Review Board (IRB) and that subjects provide informed consent to research participation, with some important exceptions on each front. (FDA has similar, but not identical requirements, for clinical investigations, which are now likely to be harmonized with the new Common Rule.) […]

Continue reading here.

Housing Equity Week in Review

This week was all about fair housing. Particularly, the Affirmatively Further Fair Housing rule and recent attempts to dismantle it. Here’s the round-up for last week, January 29 – February 5, 2017:

  • Two bills are attempting to abolish the Affirmatively Further Fair Housing rule of the Obama administration. A review of Fair Housing, the rule, and the proposed bill in the context of a tradition opposing desegregation, via City Lab
  • Scott Burris and Abraham Gutman contribute to Philly.com and dive into Section 3 of the bill, which bans funds for geo-spatial data on housing disparities and the dangers of that to evidence based policy.
  • Ten States where People Can’t Really Afford Rent.” CheatSheet.org shares the 2016 National Low Income Housing Coalition Out of Reach Report

We’ve talked a little about fair housing before. In case you missed it, we interviewed Christopher Bonastia about his book, “Knocking at the Door” back in November.

Did we miss any big housing, law and equity stories this week? Let us know!

Looking Forward: The Next Generation of Biosimilars

Looking Forward: The Next Generation of Bio
similars

February 7, 2017 12:00 PM

Description

Many of today’s important medications are biological products made from living organisms, manufactured through biotechnology, derived from natural sources, or produced synthetically. Biosimilars are a type of biological product approved by FDA on the basis of being highly similar to an already approved biological reference product, like a generic drug.

This panel of experts will discuss the current state of biosimilars in the healthcare ecosystem and what comes next from a technical and legal perspective. Topics include how the next generation of biosimilars can improve patient access to standard-of-care therapies, the concept of “biobetters,” economic and intellectual property considerations, and policy approaches to support existing and future biosimilars.

Panelists

This event is free and open to the public. Lunch will be provided.

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

Tort Law: Public and Private

By Alex Stein

Readers interested in medical malpractice might be interested in seeing—and commenting on—my new article, The Domain of Torts, forthcoming in 117 Colum. L. Rev. (2017).

This Article advances a novel positive theory of the law of torts that grows out of a careful and extensive reading of the case law. The Article’s core insight is that the benefit from the harm-causing activity determines the form and substance of tort liability. This finding is both surprising and innovative, since tort scholars universally believe that the operation of the doctrines that determine individuals’ liability for accidents—negligence, causation, and damage—is driven by harms, not benefits. The key role of benefits in the operation of our tort system has eluded the searching eye of scholars, even though it is fully consistent with the case law.

Specifically, this Article shows that our tort system operates in two parallel modes—private and public—rather than just one, as conventional accounts erroneously suggest. Furthermore, the system’s mode of operation and the rules allocating liability for accidental harm are dictated by the type of the benefit sought by the alleged tortfeasor. If the benefit sought by the tortfeasor is purely private, she will be held liable for the harm resulting from her actions whenever she exposes her victim to a nonreciprocal risk. The tort system never allows actors to inflict harm on others when the benefit they seek to derive from their activity is purely private, no matter how significant that private benefit is relative to the victim’s harm. The system consequently does not hesitate to discourage the production of private benefits even when they are economically more valuable than the victim’s safety. That is, in cases of private benefit, tort law excludes cost-benefit analysis in favor of the reciprocity and equality principles. When the benefit that accompanies the harm-causing activity is public, by contrast, tort law adopts a strictly utilitarian approach and focuses exclusively on minimizing the cost of accidents and the cost of avoiding accidents as a total sum. Liability in such cases is imposed based on the famous Learned Hand formula (and similar formulations). Accordingly, if the benefit from the harm-causing activity is greater than the expected harm and precautions are too costly, no liability will be imposed. The consequent reduction in the victim’s protection is counterweighted by society’s need not to chill the production of public benefits that the victim enjoys on equal terms with all other members of her community. Read More

Chimeras with benefits? Transplants from bioengineered human/pig donors

By Brad Segal

In January of this year, Cell published a study modestly titled, Interspecies Chimerism with Mammalian Pluripotent Stem Cells. It reports success bioengineering a mostly-pig partly-human embryo. One day before, Nature published a report that scientists had grown (for lack of a better word) a functioning genetically-mouse pancreas within the body of a genetically-modified rat. The latest study raises the likelihood that before long, it will also be scientifically possible to grow human organs within bioengineered pigs.

The implications for transplantation are tremendous. But hold the applause for now. Imagine a chimera with a brain made up of human neurons which expressed human genes. Would organ procurement without consent be okay? That troubling possibility raises  questions about whether manufacturing chimeras with human-like properties for organs is even appropriate in the first place. Here’s what University of Montreal bioethicist Vardit Ravitsky told the Washington Post:

“I think the point of these papers is sort of a proof of principle, showing that what researchers intend to achieve with human-non-human chimeras might be possible … The more you can show that it stands to produce something that will actually save lives … the more we can demonstrate that the benefit is real, tangible and probable — overall it shifts the scale of risk-benefit assessment, potentially in favor of pursuing research and away from those concerns that are more philosophical and conceptual.”

I respectfully disagree. Saving more lives, of course, is good. Basic science is also valuable – even more so if it might translate to the bedside. This line of research, though, is positioned to upend our entire system of transplantation, and so its implications go beyond organ supply. In this post I will argue that to assess this technology’s implications for organ procurement in particular, there is good reason to focus on harms, not benefits. Read More