Some Optimism on Brains, Pain, & Law – Let’s See What We Can Achieve

By Martha Farah, Director, University of Pennsylvania Center for Neuroscience & Society

Neurolaw includes some fascinating issues that lack any practical legal significance – for example whether we should consider anyone responsible for anything they do, given that all behavior is physically caused by brain processes.  It also includes some legally important issues that lack intellectual juiciness – like regulatory issues surrounding neurotechnology.

Thank goodness there are also some issues that combine intellectual fascination with practical legal importance. The Petrie-Flom Center at Harvard Law School and the Center for Law, Brain & Behavior at Massachusetts General Hospital recently focused on just such an issue when they convened a meeting of neuroscientists and legal scholars on the brain imaging of pain.

Pain, I learned at this meeting, is at the heart of many legal proceedings. A major problem to be solved in these proceedings is the determination of whether someone is truly in pain. Chronic pain in particular may not have physically obvious causes. There may be clinical and circumstantial evidence of pain – like adhering to a medication regime, seeking surgeries or other interventional procedures, and avoiding pleasurable activities – but often the major evidence of pain is just what someone says that it is. However, the motivation exists to lie about pain – to sue for more money, to obtain disability benefits – and so an objective measure of pain, a “pain-o-meter,” would be helpful.

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Pain-o-meters: How – and Why – Should We Develop Them?

By Karen Davis

The prevalence of chronic pain is staggering.  The Institute of Medicine reported in 2011 that 100 million Americans suffer from chronic pain – more than those with heart disease, cancer and diabetes combined.  The report also highlights that the annual costs for medical care, lost wages and productivity is more than $600B.  These enormous personal and societal costs of chronic pain has driven an effort to “prove” if and how much pain an individual is suffering from for health care providers, insurance companies and legal actors.  This is challenging because pain is a personal and subjective experience.  Ideally, self report would be sufficient to establish the “ground truth” of the pain experience.

However, some are not able to provide self reports accurately, and the potential financial gain associated with claims of pain has tarnished the perceived authenticity of subjective reports.  This has led some to develop brain imaging-based tests of pain – a so-called “painometer.”  Yet, current technologies are simply not able to determine whether or not someone has chronic pain.  Here, I consider specifically how we could develop a brain-imaging based painometer – and whether we would want to do so.  As we ask: “Can we do it?,” we should always ask, “Is this the right thing to do?”

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Pain on the Brain: A Week of Guest Posts on Pain Neuroimaging & Law

By Amanda C. Pustilnik

This week, the Petrie-Flom Center of Harvard Law School and the Center for Law, Brain & Behavior (CLBB) at Massachusetts General Hospital are hosting a series of posts on how brain imaging can help the law address issues of physical and emotional pain. Our contributors are world leaders in their fields, who participated on June 30, 2015, in the CLBB/Petrie-Flom conference Visible Solutions: How Brain Imaging Can Help Law Reenvision Pain.  They addressed questions including:

  • Can brain imaging can be a “painometer” to prove pain in legal cases?
  • Can neuroimaging help law do better at understanding what pain is?
  • How do emotion and pain relate to each other?
  • Does brain imaging showing emotional pain prompt us to reconsider law’s mind/body divide?

Professor Irene Tracey, D.Phil., a pioneer in pain neuroimaging and director of the Oxford Centre for Functional Magnetic Resonance Imaging of the Brain, opened the conference with a keynote explaining what happens when the brain is in pain.

Professor Hank T. Greely, Edelman Johnson Professor of Law and Director of the Program in Neuroscience and Society at Stanford Law School, provided a keynote explaining the many implications of brain imaging for the law.

This conference was the culmination of CLBB’s year of work on pain neuroimaging and law. As the first CLBB-Petrie-Flom Center Senior Fellow on Law & Applied Neuroscience, I focused on pain because it is one of the largest social, economic, and legal problems that can be addressed through new insights into the brain. Pain imaging can be a test case for how neuroscience can contribute positively to law and culture.  (Full conference video proceedings are available here.)  Please read on below! Continue reading

Patent Law, Expertise, and the Court of Appeals for the Federal Circuit

by Zachary Shapiro

Since its creation in 1982, the Court of Appeals for the Federal Circuit (CAFC) has been a magnet for controversy and criticism. While I do not align myself with those critics, it would be foolish to not acknowledge the problems that are present with the CAFC. For instance, for the vast majority of federal law, when law develops differently in different circuits, the Supreme Court is able to observe those developments, and decide which interpretation is most desirable. Because the CAFC has sole jurisdiction over patent law appeals, patent law is not subject to these circuit splits. While splits temporarily hamper uniform justice, they do allow for experimentation, enabling different legal interpretations to be tested in real life. In this way, splits can allow an appellate body to make a more informed decision regarding which interpretation should be followed.

The lack of circuit splits in patent law can be problematic, given accusations that the CAFC has succumbed to a form of institutional capture by the patent lobby.[1] Critics highlight the CAFC’s decision in Amazon[2] and eBay[3] as evidence of this capture. In Amazon, the CAFC found a broad presumption of irreparable harm, allowing for broad extension of preliminary injunctions in future cases of patent infringement (even though they overturned the injunction at issue in the case). This patent-holder-friendly standard was ultimately overruled in eBay,[4] after the CAFC applied its nearly automatic injunction standard. The Supreme Court overturned this decision, and dialed back the presumption, in large part because it was seen as too favorable to patent holders.

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Health Law Year in P/Review: Until Next Year

This new post by Holly F. Lynch, I. Glenn Cohen, and Gregory Curfman appears on the Health Affairs Blog as the final entry in a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015.

It’s been our great pleasure to collaborate with the Health Affairs Blog on this series stemming from theThird Annual Health Law Year in P/Review symposium at Harvard Law School. This annual event takes a look back over the prior year and previews the year to come with regard to hot topics in health law.

After the symposium, we asked our speakers to keep the conversation going online by expanding on their topics from different angles or by honing in on particularly intriguing features. These pieces were published on the Health Affairs Blog through the spring and into summer.

We heard more from Kevin Outterson on how to promote innovation in the development of new antibiotics, from Rachel Sachs on whether the Food and Drug Administration’s proposal to regulate laboratory-developed tests will really stifle innovation, and from Claire Laporte on the impact of recent Supreme Court decisions on bio-IP.

George Annas weighed in on the Ebola outbreak, which has already almost faded from public consciousness but offers important public health lessons, while Wendy Parmet and Andrew Sussman tackled important developments in tobacco control. […]

Read the full post here.

The Impact of Broccoli II and Tomato II on European patents in conventional breeding, GMO’s and Synthetic Biology: A grand finale of a juicy patents tale?

I am pleased to announce our recent paper entitled “The Impact of Broccoli II & Tomato II on European patents in conventional breeding, GMO’s and Synthetic Biology: The grand finale of a juicy patents tale?”, which is available on SSRN, and forthcoming in Biotechnology Law Report, Vol. 34, Number 3 (June 2015), pp. 1-18.

Our analysis deals with a seminal judgment on the controversial and sometimes even emotionally debated European “Broccoli” and “Tomato” patents, which has captivated the European patent and plant science communities for many years: On March 25, 2015, the EBA of the European Patent Office (EBA) finally issued its much awaited decisions on the consolidated referrals G2/12 (“Tomato II”) and G2/13 (“Broccoli II”), clarifying the exclusion from patentability of essentially biological processes, such as conventional crossing and selection, and in particular its impact on the patentability of claims for products resulting from such processes. The so-called “Tomato II” case concerned an invention entitled “method for breeding tomatoes having reduced water content and product of the method,” whereas the so-called “Broccoli II” case involved an invention of a “method for selective increase of the anticarcinogenic glucosinolates in brassica species”. Continue reading

Ariosa v. Sequenom Invalidates the Non-Invasive Prenatal Testing Patent

On Friday, the Court of Appeals for the Federal Circuit affirmed the district court’s judgment of invalidity of several claims in Sequenom’s diagnostic method patent on the grounds that they were not directed to patent-eligible subject matter under the relevant section of the Patent Act, 35 U.S.C. § 101.  The case, Ariosa v. Sequenom, is important not only to those who have been following the recent back-and-forth between the Federal Circuit and Supreme Court on patent-eligible subject matter, but also to those who study medical innovation, as it implicates questions of innovation incentives and of access to an important new technology.

The case involves a technology known as non-invasive prenatal testing, or NIPT.  Previously, pregnant women seeking to determine whether their fetuses possessed particular genetic abnormalities only had the option to undergo procedures, like amniocentesis, which pose a risk to the developing fetus.  The scientists in this case made a startling discovery: there is a small amount of fetal DNA circulating in the pregnant woman’s plasma and serum.  These portions of maternal blood samples had previously been discarded as medical waste, and the idea that genetic abnormalities could be discovered through a non-invasive procedure like a blood draw, which poses no risk to the health of the fetus, was groundbreaking.  A patent on the method of detecting the fetal DNA in the mother’s serum or plasma was obtained, and Sequenom commercialized a test to practice the patent.  Sequenom was soon embroiled in litigation with Ariosa and other companies which it believed were infringing its patent.

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Journal of Law and the Biosciences (JLB): Call for Harvard Student Submissions

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School collaborates with Stanford and Duke Universities to publish  the  Journal  of  Law  and  Biosciences  (Oxford University Press), an online, open-access, peer-reviewed journal. JLB includes a New Developments section, comprised  of  brief  summaries and commentary on recent legislation, regulation, and case law written by graduate students at the collaborating schools. The Petrie-­Flom Center is responsible for providing the New Developments for one issue per annual volume.

We are currently seeking Harvard graduate students to contribute papers to be published in JLB’s New Developments section in early 2016. In previous years, New Developments have been generated from scratch specifically for JLB, based on selection from submitted proposals. This year, we are taking a different approach by publishing already complete (or to-be-completed by the deadline) original student papers (such as student notes, course papers, etc.) written by graduate students from any Harvard school.  New Developments are limited to 5000 words, including footnotes and references,  and  should  be  on  a  topic  of  relevance  to  law  and  the  biosciences,  in particular a topic of relatively recent concern, controversy, or change. They should focus on  describing  the  issue  at  hand,  explaining  why  it  is  relevant  to  scholars  and practitioners, and providing analysis and questions for further consideration.

Interested students should submit their papers and CVs for consideration no later than September 7, 2015 (earlier  is  welcome). Up  to  four  papers will be selected for publication in the New Developments section of JLB. Applicants will be notified by the end of September. Selected students will receive comments on their papers by the end of October, and will also be responsible for providing comments to the other selected students. Revisions will be due by the end of November, and final submissions to JLB will be due by the end of December 2015.

Please send all application materials, and direct all questions, to Holly Fernandez Lynch, hlynch@law.harvard.edu.

New paper on cross-disciplinary collaboration

The nature of today’s most vital challenges and funding policies are driving more and more researchers towards interdisciplinary work. But what are the essential tools for those breaking the silos and leaving the comfort zones of their own disciplines?

Some advice on how to address the particular challenges and opportunities in interdisciplinary research are described in our recent paper “Ten Simple Rules for a Successful Cross-Disciplinary Collaboration” published in the online open access journal PLOS Computational Biology last month. Please find below and abstract of the paper, which has inter alia been discussed and cited by Times Higher Education.

Abstract:

Cross-disciplinary collaborations have become an increasingly important part of science. They are seen as a key factor for finding solutions to pressing societal challenges on a global scale including green technologies, sustainable food production and drug development. This has also been realized by regulators and policy-makers, as it is reflected in the 80 billion Euro “Horizon 2020″ EU Framework Programme for Research and Innovation. This programme puts special emphasis at breaking down barriers between fields to create a path breaking environment for knowledge, research and innovation.

However, igniting and successfully maintaining cross-disciplinary collaborations can be a delicate task. In this article we focus on the specific challenges associated with cross-disciplinary research in particular from the perspective of the theoretician. As research fellows of the 2020 Science project and collaboration partners, we bring broad experience of developing interdisciplinary collaborations [2–12]. We intend this guide for early career computational researchers as well as more senior scientists who are entering a cross disciplinary setting for the first time. We describe the key benefits, as well as some possible pitfalls, arising from collaborations between scientists with backgrounds in very different fields.

Proposed citation:

Knapp B, Bardenet R, Bernabeu MO, Bordas R, Bruna M, Minssen T, et al. (2015) Ten Simple Rules for a Successful Cross-Disciplinary Collaboration. PLoS Comput Biol 11(4): e1004214. doi:10.1371/journal.pcbi.1004214

Bioethicist Art Caplan: Chinese Scientists Try To Alter Genomes In Human Embryos

A new piece by contributor Art Caplan in Forbes:

Bet you did not know that today is National DNA Day. It is. But before we all begin to party over our biological programming, remember this is also the day when the world is trying to figure out how to respond to a paper from a team of scientists in China stating that they tried to alter the genomes of human embryos using a new technique known as CRISPR.

Without getting bogged down in the details, CRISPR it is a new powerful tool that permits editing or clipping out segments of DNA and inserting novel genetic material. The Chinese group used it for the first time in human embryos, thereby taking a baby step across the line to trying out a technology that someday could be used to change the DNA of our descendants to repair genetic diseases, get rid of traits we don’t like or to try and build better, improved babies. Yes, that is the low moan of eugenics you hear in the background of this CRISPR experiment. Happy National DNA Day to you, too. […]

Read the full article here.

Ethics for CRISPR and the Big Leap Forward

By Kelsey Berry

This week, a research group in China published a paper describing a significant step forward in one application of the genome editing technique CRISPR: they used it to modify the genome of non-viable human embryos. Now, the scientific community finds itself grasping for ethical and legal foundations in order to evaluate the implications of this work and its possible extensions. Bioethicists and philosophers have been laying these foundations for years. Yet, the key problem, as always, is in translation: as we shift from science fiction to scientific reality, the robust and rigorous literature on the ethics of human population enhancement must find its way to usefully inform the policy debate and scientific practice. Translation between these camps can be thorny, but it must start with convergence on the issues at stake. Here’s a quick primer on the issue:

The spark: A team out of Sun Yat-sen University in Guangzhou led by Junjiu Huang used the CRISPR technique in non-viable human embryos to modify the gene responsible for a potentially fatal blood disorder. Leading journals Science and Nature denied the group publication on ethical grounds; the paper can be found in Protein & Cell. This is the first time that the CRISPR technique has been used to modify the human germline; however, the team specifically selected non-viable embryos in which to conduct the experiment in order to side step some of the most pressing ethical concerns.

The technology: CRISPR, which stands for “clustered regularly interspaced short palindromic repeats” refers to DNA loci that contain repeated base sequences, separated by other sequences called spacers. These spacers are like memories from previous exposure to a virus, and they tell the biological system which invaders to look out for and destroy – a key part of an adaptive immune system. In 2012, a team led by Doudna and Charpentier showed that CRISPRs could also be used to zero in on DNA sequences of their choosing simply by introducing synthetic guide RNA that matched the DNA sequence they wished to target. The CRISPR system would then slice up the targeted DNA sequence, either knocking out a gene entirely or allowing researchers to insert a “patch,” which if incorporated into the DNA sequence would modify the target gene. Since 2012 this technique has been shown to work in several organisms, including in human cells.

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Bioethicist Art Caplan: Actress Sofia Vergara Can’t Destroy Her Embryos

A new piece by contributor Art Caplan on NBC News:

Nick Loeb and Sofia Vergara once were a huge item. Today, they are back in the tabloid press because of a dispute over frozen, human embryos.

The 42-year-old actress and star of “Modern Family,” one of the top-earning women in Hollywood, announced her engagement to the wealthy, 40-year old businessman in 2012. Last May, Vergara announced they had split amid a host of abuse allegations.

Their squabble now has grown to include Loeb suing Vergara in California to prevent her from destroying two frozen female embryos, which court documents say they created using in vitro fertilization in November 2013. […]

Read the full article here.

TOMORROW (4/14): The FDA’s Impact on Pharmaceutical Innovation: A Lecture by Neil Flanzraich

The FDA’s Impact on Pharmaceutical Innovation: A Lecture by Neil Flanzraich

15.04.14, Flanzraich poster FINAL DPI AdjustApril 14, 2014 12:00 PM

Harvard Law School
Griswold Hall, Room 110
1525 Massachusetts Ave.
Cambridge, MA [Map]

Please join us for a lecture by Neil Flanzraich, Chairman and CEO of Cantex Pharmaceuticals, Inc., discussing the balance between speed and safety in FDA’s regulation of pharmaceutical products. Topics will include how FDA’s approach has ebbed and flowed over time, the various tools FDA has introduced to reach this balance, and the potential impact of FDA’s various approaches on products and companies, especially start-ups.

Neil Flanzraich graduated from Harvard Law School in 1968 and was appointed by Dean Martha Minow as an Expert in Residence at the Harvard Innovation Lab (i-lab) in fall 2012.

This event is free and open to the public. Lunch will be provided. Full event details are here.

Watch Mr. Flanzraich’s previous lecture for the Petrie-Flom Center, “Responsibility and Integrity in the Pharmaceutical Industry.”

The Complex Effects Of The FDA’s Proposal To Regulate Laboratory-Developed Tests

This new post by Rachel Sachs appears on the Health Affairs Blog, as part of a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015.

Last fall, the Food and Drug Administration (FDA) finally took steps toward an action that it had been publicly considering for over four years: the regulation of laboratory-developed tests (LDTs). The FDA defines LDTs as tests which are “designed, manufactured, and used within a single laboratory.”

This definition encompasses a wide range of diagnostics, including complex multigene panels that are performed in just a single laboratory in the United States, and basic diagnostic tests like a complete blood count, which are performed in thousands of laboratories nationwide.

As long as a manufacturer does not make and sell a kit for use in other laboratories, its test can be provided as an LDT. Estimates suggest that tens of thousands of diagnostic tests, including the majority of genetic tests, are currently available as LDTs.

Yet at present, the FDA exercises essentially no regulatory authority over LDTs. As such, they can be performed without any of the safeguards that typically apply to other medical technologies, including pre-market review and adverse event reporting. This is not to say that these tests are entirely unregulated. […]

See the full post here.

Recent Judicial Rulemaking Leaves Life Science Patents Hanging In The Balance

This new post by Claire Laporte of Foley Hoag LLP appears on the Health Affairs Blog, as part of a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015.

Do patents nurture or stifle innovation?

In a recent series of decisions, the Supreme Court has begun to express concern that some patents suppress innovation. And it has done so in a number of cases that turn on what used to be a sleepy backwater of the patent law: 35 U.S.C. § 101. This statute says, simply, that “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, … may obtain a patent therefor, subject to the conditions and requirements of this title [i.e., the other requirements of the patent law].”

You might think that this language means that all you have to do is figure out whether an invention falls into one of the permitted categories. If it does, it’s something that can be patented (assuming you meet the other requirements — which are numerous). But no! Over the past few decades, the Supreme Court has engrafted a whole new set of judge-made requirements onto this statute: you cannot get a patent on something that is a “law of nature,” a “product of nature,” or an “abstract idea.” And starting in 2010, the Court put real teeth into these doctrines. […]

See the full post here.

4/14: The FDA’s Impact on Pharmaceutical Innovation: A Lecture by Neil Flanzraich

The FDA’s Impact on Pharmaceutical Innovation: A Lecture by Neil Flanzraich

15.04.14, Flanzraich poster FINAL DPI AdjustApril 14, 2014 12:00 PM

Harvard Law School
Griswold Hall, Room 110
1525 Massachusetts Ave.
Cambridge, MA [Map]

Please join us for a lecture by Neil Flanzraich, Chairman and CEO of Cantex Pharmaceuticals, Inc., discussing the balance between speed and safety in FDA’s regulation of pharmaceutical products. Topics will include how FDA’s approach has ebbed and flowed over time, the various tools FDA has introduced to reach this balance, and the potential impact of FDA’s various approaches on products and companies, especially start-ups.

Neil Flanzraich graduated from Harvard Law School in 1968 and was appointed by Dean Martha Minow as an Expert in Residence at the Harvard Innovation Lab (i-lab) in fall 2012.

This event is free and open to the public. Lunch will be provided. Full event details are here.

Watch Mr. Flanzraich’s previous lecture for the Petrie-Flom Center, “Responsibility and Integrity in the Pharmaceutical Industry.”

Biosecurity in a Globalised World Conference: The Adoption of the Revised International Health Regulations – 10 Years On

ABSTRACT SUBMISSIONS AND REGISTRATION OPEN

In 2015 it will be 10 years since the adoption of the revised International Health Regulations (IHR). To mark this important anniversary, QUT’s Australian Centre for Health Law Research is pleased to invite you to Biosecurity in a Globalised World: The Adoption of the Revised International Health Regulations – 10 Years On.

The conference will be hosted by the Australian Centre for Health Law Research at Queensland University of Technology’s Gardens Point campus in Brisbane from 27-28 July 2015.

The conference will provide a forum for scholars and policy makers to discuss and present on the progress achieved through the IHR to date, and the important work yet to be done.

The keynote address will be delivered by Professor Lawrence O. Gostin, Founding O’Neill Chair in Global Health Law, Georgetown University, USA.

Themes to be discussed at the conference include:

  • Development of IHR core capacities
  • Regulatory responses
  • Securitisation of infectious disease outbreaks
  • Human rights
  • Papers from all disciplines and areas of expertise are welcome.

For further information please visit http://ihr2015.com/

If you have any questions, or require any assistance, please contact ihr2015@qut.edu.au

REGISTER NOW: ReSourcing Big Data – A Symposium and Collaboration Opportunity (3/23)

From Harvard Catalyst:

REGISTER NOW!

March 23: Symposium
9:00 AM – 5:00 PM
Joseph B. Martin Conference Center
Harvard Medical School

Extant data is an inexhaustible resource that is not yet very well understood and is underutilized. The focus of this symposium is to explore this area from various perspectives – privacy and security, policy, open clinical trial data, systems and disease-oriented synthetic efforts and individually-provided, aggregated crowd-sourced data. The goal is to engage our biomedical and public health research community in a more nuanced appreciation of these and similar issues.

Topics include: data aggregation, access, annotation, refocusing on novel or unanticipated questions, and recombination with diverse demographic/epidemiologic data. Continue reading

Two forthcoming publications on (1) European Stem Cell Patenting, and (2) IP issues in Biobanking

I am happy to announce the following publications:

1) Minssen, Timo and Nordberg, A., The Evolution of the CJEU’s Case Law on Stem Cell Patents: Context, Outcome and Implications of Case C‑364/13 International Stem Cell Corporation (March 11, 2015). Available at SSRN: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2576807  (under review for journal publication)

Abstract:  

On 18th December 2014, the CJEU rendered its’ much-anticipated decision in C‑364/13 International Stem Cell Corporation v Comptroller General of Patents (ISCC). Qualifying its’ earlier ruling in Brüstle v. Greenpeace (Brüstle) with regard to non-fertilised human ova stimulated by parthenogenesis, the Court held that in order to constitute a ‘human embryo’ – and thus to be unpatentable under the EU Biotechnology Directive – the stimulated ovum must have the “inherent capacity to develop into a human being”. This would allow patents on innovative parthenotes which had not been genetically modified to achieve totipotent capabilities. Hence the judgment establishes a crucial limitation of the broad interpretation of “human embryos” in Brüstle, where the CJEU held that parthenotes are covered by the term “human embryo” since they are “capable of commencing the process of development of a human being”. The ISCC decision is to be welcomed since it provides an ethically justifiable leeway for patenting and offers reasonable support to the commercial viability of European cell therapy research. Yet, ISCC’s impact still depends on national implementations and only applies to certain hESC cells. Thus, further clarifications would be helpful concerning other non-totipotent hESCs.

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Problems with fMRI as a tool of lie detection

by Zachary Shapiro

Functional magnetic resonance imaging (fMRI) evidence of lie detection has, appropriately, faced difficulty gaining evidentiary acceptance in criminal courts. While a comprehensive discussion of the case law is beyond the scope of this post, it is important to note that courts have repeatedly refused to admit such evidence, both under a Daubert test, using Federal Rule of Evidence (FRE) 702, as well as under FRE 403.

Under Daubert, which governs the admissibility of expert testimony, courts have found that fMRI lie detection falls short in meeting the necessary standards, including the identification of error rates and maintenance of uniform testing standards. Courts have also pointed out that the motivation to lie may be different in research v. real-world settings.[1] In a laboratory experiment, one can assume that the participant is complying with investigator directions. However, if the scan is to be used in the courtroom, the subject will have a personal interest in the outcome, and may try to employ counter measures, or disregard instructions, in order to “fool” the scanner. Recent research shows that this task may not be hard, at least not for those who know how to effectively “trick” the scanner.

Judges have highlighted that while there are peer-reviewed studies of fMRI lie detection, said studies have very small patient bases (all N<60), and included a range of participants who were not representative of the general population. Courts recognize that neuroimaging, for the purposes of lie detection, is still not generally accepted by the scientific community.[2] Both of these factors limit the applicability of the results to the general population, and to any individual defendant in particular.

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