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Iris Thesis Final REGULATING DIRECT-TO-CONSUMER EEG NEURODATA – WHY LESSONS FROM GENETICS WILL NOT BE ENOUGH By Iris Coates McCall A thesis submitted to Johns Hopkins University in conformity with the requirements for the degree of Master of Bioethics Baltimore, Maryland October 2017 © Iris Coates McCall All Rights Reserved. Abstract Historically, most neurodata – information about the structure and function of the brain – has been obtained in clinical and research settings. However, neurotechnologies are now being sold direct to consumer (DTC) and marketed to the general public for a variety of purposes. Commercially sold DTC electroencephalogram (EEG) devices are a rapidly expanding enterprise. Widespread personal neuroimaging will mean a plethora of neurodata being generated in the public sphere. This raises concerns related to privacy, confidentiality, discrimination, and individual identity. These observations may seem familiar – it may seem as though we have had this conversation before in the DTC genetic testing (DTC-GT) debate. As such it might look like the challenges of DTC-EEG devices could be solved easily within another framework, namely, that developed for the management and regulation of data from DTC-GT. However, there are distinctions between the two types of data that have important implications for their management and regulation. This paper will argue that in the era of big data, DTC commercially obtained EEG neurodata raises unique ethical, legal, social, and practical challenges beyond that of DTC genetic testing, and thus the frameworks developed for the management and protection of genetic data will be insufficient for the management and protection of neurodata. To this end, this paper outlines some of the most salient differences between neurodata and genetic information and highlights the associated challenges that arise relating to those differences. It concludes that special considerations for legislation arising from these challenges must be recognized by policymakers interested in regulating the production, use, and operationalization of neurodata in the public sector. Primary reader: Dr. Travis Rieder Secondary Reader: Dr. Debra Mathews ii Acknowledgements I would like to thank Travis, Debra, and David Peña-Guzmán for all their input, help, and support with this project. I would also like to thank my MBE classmates for their discussion and encouragement throughout this process. iii Table of Contents Abstract..........................................................................................................................ii Acknowledgements.......................................................................................................iii Introduction...................................................................................................................2 Background....................................................................................................................4 The Devices..................................................................................................................10 The Threats: What Problems does DTC-EEG Pose?..................................................16 Privacy.....................................................................................................................................17 Confidentiality........................................................................................................................20 Discrimination........................................................................................................................25 Neurodata – The New Genetic Information Debate?.................................................27 Differences Between Neurodata and Genetic Information.........................................29 Differences in the nature of the information....................................................................29 Differences in beliefs about the information....................................................................32 Effects of the Differences Between Neurodata and Genetic Information..................42 Privacy and confidentiality...................................................................................................43 The operationalizability of neurodata.................................................................................45 Implications for monitoring.................................................................................................47 The Need for Regulation.............................................................................................49 Conclusion....................................................................................................................50 Works Cited..................................................................................................................53 Biography.....................................................................................................................63 iv In a recent article on the Neuroethics Blog,1 Jessie Ginsberg described the potential dangers related to mental privacy in the age of big data. From the story of the girl whose father found out she was pregnant due to Target’s impressive ad targeting analytics,2 to the example of cognitive functioning information collected by brain training programs such as Lumosity,3 Ginsberg describes a dystopian future (or perhaps even present) where our personal mental life and cognitive functioning is wide open for corporate consumption and tracking along with all the other personal data third parties collect through our use of smartphones and other technology. Surprisingly absent, however, from her depiction is a different sort of cognitive functioning information – the information gleaned from neuroimaging devices which can relay data on the structure and function of our brains. As direct to consumer (DTC) neurotechnologies which were once confined to the clinic and lab are increasingly marketed and sold to the public, we are faced with some troubling questions: What exactly does this data reveal about ourselves? Who has access to this data? And what ought we do, if anything, to protect this information? This paper will address the concerns raised by DTC neurotechnologies in the era of big data and argue that, while similar to the issues raised by DTC genetic testing, the problems are not identical and thus current regulations are an insufficient framework for the ethical management of neurodata. 1 Ginsberg, J. (2017). Mental Privacy in the Age of Big Data. The Neuroethics Blog. Retrieved on September 20, 2017, from http://www.theneuroethicsblog.com/2017/06/mental-privacy-in-age-of-big-data.html 2 Duhigg, Charles. “How Companies Learn Your Secrets.” The New York Times Magazine, 16 Feb. 2012, www.nytimes.com/2012/02/19/magazine/shopping-habits.html?_r=1&hp=&pagewanted=all. Accessed 20 Sept. 2017. 3 Purcell, Ryan H., and Karen S. Rommelfanger. "Internet-based brain training games, citizen scientists, and Big Data: ethical issues in unprecedented virtual territories." Neuron 86.2 (2015): 356-359. 1 Introduction Neuroimaging is increasingly capable of revealing information about the contents of the mind previously thought to be the stuff of science fiction. Functional magnetic resonance imaging (fMRI) data can recreate an image of a previously perceived face from memory,4 generate a representation of a viewed image,5 and even generate images of a subject’s own cranio-facial features from their pattern of brain activity.6 The information generated by this form of technology can be referred to as neurodata – data about the structure or functioning of the human brain. Historically, most neurodata has been obtained in clinical and research settings. However, neurotechnologies are now being sold direct to consumer (DTC) and marketed to the general public for a variety of purposes. In the ethics literature, most of the attention paid to these DTC neurotechnologies has focused on transcranial magnetic stimulation (TMS) and transcranial direct-current stimulation (tDCS) devices and whether or not they require regulation as a medical device.7 Less attention, however, has been paid to electroencephalogram (EEG) devices that, rather than altering neural functioning, can provide information about that functioning, thereby generating neurodata. This lack of attention is concerning, because their low cost, ease of use, and portability increase the likelihood that DTC-EEG will bring widespread neuroimaging capabilities to the public. This raises concerns as to the management of the neurodata 4 Lee, Hongmi, and Brice A. Kuhl. "Reconstructing perceived and retrieved faces from activity patterns in lateral parietal cortex." Journal of Neuroscience 36.22 (2016): 6069-6082. 5 Du, Changde, Changying Du, and Huiguang He. "Sharing deep generative representation for perceived image reconstruction from human brain activity." arXiv preprint arXiv:1704.07575 (2017). 6 Toga, Arthur W. "Neuroimage databases: the good, the bad and the ugly." Nature Reviews. Neuroscience 3.4 (2002): 302. 7 Wexler, Anna. "A pragmatic analysis of the regulation of consumer transcranial direct current stimulation (TDCS) devices in the United States." Journal of Law and the Biosciences 2.3 (2016): 669-696. 2 generated by these devices, and the ethical, legal, and social implications of the collection and use of information about people’s mental functioning. Issues of neuroprivacy have been discussed extensively in the academic and legal literature,8 much of which has
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