DOCSLIB.ORG

Alma Mater Studiorum – Università Di Bologna In

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Alma Mater Studiorum – Università Di Bologna In Alma Mater Studiorum – Università di Bologna In collaborazione con LAST-JD consortium: Università degli studi di Torino Universitat Autonoma de Barcelona Mykolas Romeris University Tilburg University DOTTORATO DI RICERCA IN Erasmus Mundus Joint International Doctoral Degree in Law, Science and Technology Ciclo XXXII – A.A.2016/2017 Settore Concorsuale: 12/H3 Settore Scientifico Disciplinare: IUS/20 TITOLO TESI Ethical and Legal Aspects of Using Brain Computer Interface in Medicine: Protection of Patient’s Neuro Privacy Presentata da: Laman Yusifova Coordinatore Dottorato: Supervisore: Prof.ssa Monica Palmirani Prof.ssa Carla Faralli Esame finale anno 2020 Alma Mater Studiorum – Università di Bologna in partnership with LAST-JD Consoritum Università degli studi di Torino Universitat Autonoma de Barcelona Mykolas Romeris University Tilburg University PhD Programme in Erasmus Mundus Joint International Doctoral Degree in Law, Science and Technology Ciclo XXXII – A.A.2016/2017 Settore Concorsuale: 12/H3 Settore Scientifico Disciplinare: IUS/20 Ethical and Legal Aspects of Using Brain Computer Interface in Medicine: Protection of Patient’s Neuro Privacy Submitted by: Laman Yusifova The PhD Programme Coordinator: Supervisor: Prof. Monica Palmirani Prof. Carla Faralli Year 2020 2 To my mother Afar and father Rafael 3 Abstract A growing application of invasive neuro-modulation in treating the diseases unresponsive to the conventional therapy or resuming lost motor functions requires a renewed look at the long- established conceptions of medical ethics such as privacy and autonomy. Through nano-chips embedded into the brain of a patient, this novel technology- Brain Computer Interface (BCI) traces how information is encoded and decoded by neural circuits in real time and accesses the subjective experience in a completely different way that no other medical technology could do in the past and is able to execute at present. Either in the application of the Deep Brain Stimulation (DBS), the most frequently used method of the Brain Computer Interface which involves machine brain interaction only, or during the treatment with other types of BCIs, when human to machine operation engaging both input and output communication with brain is used, the patient’s privacy raises concerns at every level of the treatment. The research looks into questions of law and ethics raised by BCI which have not yet been explored in detail in academic literature. The benchmark for the analysis is the privacy of the patient in the types of informational and decisional privacy. The issues directly relating to privacy are technical challenges in ensuring data security in this complicated technology handled through a wireless system, ethical and legal concerns such as the level of discreetness of the patient’s state of mind and control over it, and the legal boundaries for its disclosure to third parties, among others. It is the aim of the research, by referring primarily to the European context, to transmit ethical norms protecting privacy in general and in the physician-patient relationships in particular to the application of data protection in the field of neuro-technologies through legal regulation and to elaborate on the newly developing neuro-data conception. 4 Table of Contents Chapter I Introduction ........................................................................................................... 8 1.1 Introduction ......................................................................................................................8 1.2 Research purpose and question ........................................................................................ 11 1.3 Methodology: doctrinal analysis, comparative method and inter-disciplinary research ...... 11 Chapter II. Brain Computer Interface .................................................................................... 14 2.1 Neuroengineering achievements in medical technologies /Milestones in BCI development ...... 14 2.2 Brain Computer Interface Technology: .................................................................................... 17 2.2.a) Overview .................................................................................................................................................. 17 2.2.b) Types of BCIs ............................................................................................................................................ 18 2.2.c) Essential components of BCI .................................................................................................................... 20 2.3 Intracortical, subdural, and extracranial neural signal acquisition in BCI ................................... 21 2.3.a) Control signals in BCI ................................................................................................................................ 22 2.3.b) Technologies for Brain Activity Monitoring in BCI ................................................................................... 28 2.4 Steps of signal processing ....................................................................................................... 36 2.4.a) Feature extraction .................................................................................................................................... 37 2.4.b) Feature translation .................................................................................................................................. 38 2.4.c) Device output ........................................................................................................................................... 39 2.5 BCI applications ...................................................................................................................... 40 2.6 Conclusion: Understanding and decoding brain data: challenges and perspectives ................... 42 Chapter III Conseptualisation of privacy in an era of technological advancement ................. 44 3.1 Introduction ........................................................................................................................... 45 3.2. Predominant approaches to privacy ....................................................................................... 47 3.2.a) Classic conceptions of Privacy .................................................................................................................. 47 3.2.b) Taxonomies of privacy harms .................................................................................................................. 51 3.2.c) Evolvement of typologies of privacy ........................................................................................................ 52 3.3 Emerging approaches to Privacy ............................................................................................. 57 3.3.a) Freedom of thought as brain privacy ....................................................................................................... 57 3.3.b) Conceptualizing privacy in light of emerging technologies/BMI’s impact on privacy ............................. 61 3.3.c) BCI Privacy Typologies .............................................................................................................................. 65 Chapter IV Comparative Overview of Data Privacy Legal Frameworks .................................. 70 4.1 The right to privacy in international law/ Defining privacy as a fundamental right.................... 70 4.2 Overview of privacy and data protection framework in EU law ................................................ 79 4.2.a) Privacy and data protection in EU ............................................................................................................ 79 4.2.b) Specifics of the General Data Protection Regulation ............................................................................... 84 4.3 Constitutional, statutory and tort law (common law) protection of privacy in the U.S. ........... 103 Chapter V Medical Law and Ethics applicable to BCI ........................................................... 116 5.1 Regulating the development of therapeutic BCI .................................................................... 116 5.1.1 Definition of “medical device” ................................................................................................................ 121 5.1.2 Classification of medical devices ............................................................................................................. 124 5.1.3 Pathway to the Market/ Market approval .............................................................................................. 129 5.1.4 Post-Approval / Post-market surveillance............................................................................................... 144 5 5.2 Governance of medical data (neuro-data) in clinical practice ................................................. 147 5.2.a) Breach of confidentiality in common law and medical ethics ............................................................... 147 5.2.b) Health-care provisions of European countries applicable to the patient’s privacy ............................... 152 5.3. Human research and experimentation in Neuroscience: departure from “consent or anonymise” approach to proportionality and principle based one ............................................... 158 Chapter VI Neuro-data as the content of mind transcending the conceptions of privacy and data protection ................................................................................................................
Load more

Recommended publications
  • App Stores for the Brain: Privacy & Security in Brain-Computer Interfaces∗
    App Stores for the Brain: Privacy & Security in Brain-Computer Interfaces∗ Tamara Bonaci1, Ryan Calo2 and Howard Jay Chizeck1 Abstract—An increasing number of Brain-Computer Inter- training time and user effort, while enabling faster and more faces (BCIs) are being developed in medical and nonmedical accurate translation of users’ intended messages. fields, including marketing, gaming and entertainment industries. BCI-enabled technology carries a great potential to improve and This development raises, however, new questions about enhance the quality of human lives. It provides people suffering privacy and security. At the 2012 USENIX Security Sympo- from severe neuromuscular disorders with a way to interact with sium, researchers introduced the first BCI-enabled malicious the external environment. It also enables a more personalized application, referred to as “brain spyware”. The application user experience in gaming and entertainment. was used to extract private information, such as credit card These BCI applications are, however, not without risk. Es- PINs, dates of birth and locations of residence, from users’ tablished engineering practices set guarantees on performance, recorded EEG signals [31]. reliability and physical safety of BCIs. But no guarantees or standards are currently in place regarding user privacy and As BCI technology spreads further (towards becoming security. In this paper, we identify privacy and security issues ubiquitous), it is easy to imagine more sophisticated ”spy- arising from possible misuse or inappropriate use of BCIs. In ing” applications being developed for nefarious purposes. particular, we explore how current and emerging non-invasive Leveraging recent neuroscience results (e.g., [11], [17], [26], BCI platforms can be used to extract private information, and we [37]), it may be possible to extract private information about suggest an interdisciplinary approach to mitigating this problem.
    [Show full text]
  • Neuroscience and Neuroethics in the St Century
    OUP UNCORRECTED PROOF – FIRST-PROOF, 07/10/2010, GLYPH 1 chapter 2 neuroscience and 3 neuroethics in the st 4 century 5 martha j. farah 6 Neuroethics: from futuristic to 7 here-and-now 8 One might not know it to see the numerous chapters of this Handbook summarizing prog- 9 ress on a wide array of topics, but the fi eld of neuroethics is very young. Most would date its 10 inception to the year 2002, when conferences were held on the ethical implications of neu- 11 roscience at Penn and at Stanford-UCF and a few early papers appeared (Farah 2002 ; Illes 12 and Raffi n 2002 ; Moreno 2002; Roskies 2002 ). Initially neuroethics was a predominantly 13 anticipatory fi eld, focused on future developments in neuroscience and neurotechnology. In 14 his introduction to the Stanford conference, “Neuroethics: Mapping the Field,” William 15 Safi re explained the distinctiveness of neuroethics, compared to bioethics more generally, 16 by explaining that neuroscience “deals with our consciousness, our sense of self … our per- 17 sonalities and behavior. And these are the characteristics that brain science will soon be able 18 to change in signifi cant ways” (quoted in Marcus 2002, p. 7, emphasis added). 19 Neuroethics has developed rapidly since then, driven in large part by developments in 20 neuroscience. Th e anticipation and extrapolation that characterized its earliest years, which 21 some skeptics dismissed as science fi ction, has receded. In its place has grown a body of 22 neuroethics research and analysis focusing on actual neuroscience and neurotechnology. 23 What accounts for this change? Part of the shift refl ects the deepening neuroscience exper- 24 tise of many neuroethicists and the migration of neuroscientists to the fi eld of neuroethics.
    [Show full text]
  • The Impact of Neuroscience on Health Law
    Scholarly Commons @ UNLV Boyd Law Scholarly Works Faculty Scholarship 2008 The Impact of Neuroscience on Health Law Stacey A. Tovino University of Nevada, Las Vegas -- William S. Boyd School of Law Follow this and additional works at: https://scholars.law.unlv.edu/facpub Part of the Health Law and Policy Commons, Law and Psychology Commons, and the Medical Jurisprudence Commons Recommended Citation Tovino, Stacey A., "The Impact of Neuroscience on Health Law" (2008). Scholarly Works. 84. https://scholars.law.unlv.edu/facpub/84 This Article is brought to you by the Scholarly Commons @ UNLV Boyd Law, an institutional repository administered by the Wiener-Rogers Law Library at the William S. Boyd School of Law. For more information, please contact [email protected]. Neuroethics (2008) 1:101–117 DOI 10.1007/s12152-008-9010-z ORIGINAL PAPER The Impact of Neuroscience on Health Law Stacey A. Tovino Received: 10 February 2008 /Accepted: 25 March 2008 / Published online: 23 April 2008 # Springer Science + Business Media B.V. 2008 Abstract Advances in neuroscience have implica- human subjects,8 and the regulation of neuroscience- tions for criminal law as well as civil and regulatory based technologies.9 Little attention has been paid, law, including health, disability, and benefit law. The however, to the implications of neuroscience for more role of the behavioral and brain sciences in health traditional civil and regulatory health law issues. insurance claims, the mental health parity debate, and In this essay, I explore the ways in which disability proceedings is examined. neuroscience impacts a range of American health, disability, and benefit law issues, including the scope Keywords Health insurance .
    [Show full text]
  • Neurodata and Neuroprivacy: Data Protection Article Outdated?
    Neurodata and Neuroprivacy: Data Protection Article Outdated? Dara Hallinan Philip Schütz Fraunhofer Institute for Systems and Innovation Research Fraunhofer Institute for Systems and Innovation Research ISI, Germany. ISI, Germany. [email protected] [email protected] Michael Friedewald Paul de Hert Fraunhofer Institute for Systems and Innovation Research Vrije Universiteit Brussel, Belgium. ISI, Germany. [email protected] [email protected] Abstract There are a number of novel technologies and a broad range of research aimed at the collection and use of data drawn directly from the human brain. Given that this data—neurodata—is data collected from individuals, one area of law which will be of relevance is data protection. The thesis of this paper is that neurodata is a unique form of data and that this will raise questions for the application of data protection law. Issues may arise on two levels. On a legal technical level, it is uncertain whether the definitions and mechanisms used in the data protection framework can be easily applied to neurodata. On a more fundamental level, there may be interests in neurodata, particularly those related to the protection of the mind, the framework was not designed to represent and may be insufficiently equipped, or constructed, to deal with. Introduction Neurodata is the description of data directly representing the function of the human brain.1 Information allowing the possessor to peer into the processes of the human brain would be of significant value in a plurality of contexts where one party seeks influence or knowledge about another—especially when it would allow the more complete understanding and prediction of the actions of one, or a group, of individuals.
    [Show full text]
  • Nat ’17 Cponference Rogramme
    The First Biannual Neuroadaptive Technology Conference NAT ’17 CPONFERENCE ROGRAMME July 19 – July 21, 2017, Berlin, Germany The First Biannual Neuroadaptive Technology Conference Conference Programme © 2017 Society for Neuroadaptive Technology This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-nd/4.0/ or send a letter to Creative Commons, PO Box 1866, Mountain View, CA 94042, USA. The First Biannual Neuroadaptive Technology Conference is sponsored by Brain Products GmbH www.brainproducts.com zander laboratories Zander Laboratories BV Liverpool John Moores University Deutsche Forschungsgemeinschaft Technische Universität Berlin Team PhyPA General Chairs Dr Thorsten O. Zander Technische Universität Berlin, Germany Prof. Stephen Fairclough Liverpool John Moores University, UK Organizational Support Lena Andreessen Technische Universität Berlin, Germany - Review Process, Website, Communication, Keynotes, Conference Venue, Conference Programme, Conference Bags Laurens R. Krol Technische Universität Berlin, Germany - Website, Badges, Conference Programme, Conference Bags Kellyann Stamp Liverpool John Moores University, UK - Conference Programme Programme Committee Hasan Ayaz (Drexel University, USA ) Carryl Baldwin (George Mason University, USA ) Benjamin Blankertz (TU Berlin, Germany ) Anne-Marie Brouwer (TNO, The Netherlands ) Marc Cavazza (University of Kent, UK ) Guillaume Chanel (University of
    [Show full text]
  • Cognitive Neuroscience and the Law Brent Garland1,* and Paul W Glimcher2
    Cognitive neuroscience and the law Brent Garland1,* and Paul W Glimcher2 Advances in cognitive neuroscience now allow us to use that measure a brain feature that correlated, even weakly, physiological techniques to measure and assess mental states with a propensity for violence influence how a court under a growing set of circumstances. The implication of this sentences a convicted felon? Could a more complete growing ability has not been lost on the western legal understanding of the neural mechanism for voluntary community. If biologists can accurately measure mental state, decision-making be used to undermine the notions of then legal conflicts that turn on the true mental states of accountability that are used in criminal convictions? individuals might well be resolvable with techniques ranging Although most neurobiologists agree that these are inter- from electroencephalography to functional magnetic esting questions for the future, neuroscientific evidence is resonance imaging. Therefore, legal practitioners have rapidly entering Western legal systems (in this article we increasingly sought to employ cognitive neuroscientific focus on the US legal system, with which we are most methods and data as evidence to influence legal proceedings. familiar) in ways that would probably surprise and con- This poses a risk, because these scientific methodologies cern many scientists. The result is that the work of have largely been designed and validated for experimental use neuroscientists is being increasingly deployed in various only. Their subsequent use in legal proceedings is an legal contexts, whether the neuroscientists are aware of it application for which they were not intended, and for which or not. In this commentary we argue that the neurobio- those methods are inadequately tested.
    [Show full text]
  • Neuroscience and Health Law: an Integrative Approach?
    Scholarly Commons @ UNLV Boyd Law Scholarly Works Faculty Scholarship 2009 Neuroscience and Health Law: An Integrative Approach? Stacey A. Tovino University of Nevada, Las Vegas -- William S. Boyd School of Law Follow this and additional works at: https://scholars.law.unlv.edu/facpub Part of the Health Law and Policy Commons, and the Legal Ethics and Professional Responsibility Commons Recommended Citation Tovino, Stacey A., "Neuroscience and Health Law: An Integrative Approach?" (2009). Scholarly Works. 9. https://scholars.law.unlv.edu/facpub/9 This Article is brought to you by the Scholarly Commons @ UNLV Boyd Law, an institutional repository administered by the Wiener-Rogers Law Library at the William S. Boyd School of Law. For more information, please contact [email protected]. 10-TOVINO_PUB_EDITS.DOC 4/14/2009 1:20 PM NEUROSCIENCE AND HEALTH LAW: AN INTEGRATIVE APPROACH? Stacey A. Tovino, J.D., Ph.D.* I. Mental Disorder Statistics ................................................. 474 II. The Scope of Health Insurance Benefits ........................... 476 III. The Mental Health Parity Debate ...................................... 489 IV. The Scope of Protected Status under Disability Law ........ 497 V. The Distribution of Social Security and Other Benefits .... 502 VI. Conclusion ......................................................................... 506 Appendix A........................................................................ 510 Neuroscience is one of the fastest growing scientific fields in terms of the numbers
    [Show full text]
  • Brain Imaging and Brain Privacy: a Realistic Concern?
    University of Pennsylvania ScholarlyCommons Neuroethics Publications Center for Neuroscience & Society 1-2010 Brain Imaging and Brain Privacy: A Realistic Concern? Martha J. Farah University of Pennsylvania, [email protected] M. Elizabeth Smith University of Pennsylvania Cyrena Gawuga University of Pennsylvania Dennis Lindsell University of Pennsylvania Dean Foster University of Pennsylvania Follow this and additional works at: https://repository.upenn.edu/neuroethics_pubs Part of the Medicine and Health Sciences Commons Recommended Citation Farah, M. J., Smith, M. E., Gawuga, C., Lindsell, D., & Foster, D. (2010). Brain Imaging and Brain Privacy: A Realistic Concern?. Retrieved from https://repository.upenn.edu/neuroethics_pubs/63 Suggested Citation: Farah, M.J. et al. (2010). Brain Imaging and Brain Privacy: A Realistic Concern? Journal of Cognitive Neuroscience. Vol. 21(1). pp. 119-127. © 2010 MIT Press http://www.mitpressjournals.org/loi/jocn This paper is posted at ScholarlyCommons. https://repository.upenn.edu/neuroethics_pubs/63 For more information, please contact [email protected]. Brain Imaging and Brain Privacy: A Realistic Concern? Abstract Functional neuroimaging has been used to study a wide array of psychological traits, including aspects of personality and intelligence. Progress in identifying the neural correlates of individual differences in such traits, for the sake of basic science, has moved us closer to the applied science goal of measuring them and thereby raised ethical concerns about privacy. How realistic are such concerns given the current state of the art? In this article, we describe the statistical basis of the measurement of psychological traits using functional neuroimaging and examine the degree to which current functional neuroimaging protocols could be used for this purpose.
    [Show full text]
  • To the Edge of Data Protection: How Brain Information Can Push the Boundaries of Sensitivity
    To the edge of data protection: How brain information can push the boundaries of sensitivity A doctrinal legal analysis of EEG and fMRI neurotechnologies under EU data protection law Master Thesis LL.M Law & Technology Tilburg Law School Tilburg University 2018 Student: Supervisor: Sara Latini Tommaso Crepax ANR: 843118 Second reader: SNR: 2017637 Sabrina Röttger-Wirtz List of Acronyms and Abbreviations BCI Brain Computer Interface BOLD Blood-oxygen-level dependent CT Computed Tomography DOT Diffuse Optical Tomography DPD Data Protection Directive ECHR European Convention on Human Rights EEG Electroencephalography EROS Event-related Optical Signal EU European Union EU Charter Charter of Fundamental Rights of the European Union fMRI Functional Magnetic Resonance Imaging fNIRS Functional Near-infrared Spectroscopy GDPR General Data Protection Regulation MEG Magnetoencephalography MRI Magnetic Resonance Imaging PET Positron Emission Tomography SPECT Single-photon Emission Computed Tomography SSRN Social Science Research Network WP29 The Article 29 Data Protection Working Party 2 Table of contents List of Acronyms and Abbreviations ....................................................................... 2 Chapter 1: Introduction ............................................................................................ 5 1.1. Background .............................................................................................................................. 5 1.2. Central question and sub-questions .........................................................................................
    [Show full text]
  • The Right to Silence As Protecting Mental Control Dov Fox
    The University of Akron IdeaExchange@UAkron Akron Law Review Akron Law Journals June 2015 The Right to Silence as Protecting Mental Control Dov Fox Please take a moment to share how this work helps you through this survey. Your feedback will be important as we plan further development of our repository. Follow this and additional works at: http://ideaexchange.uakron.edu/akronlawreview Part of the Constitutional Law Commons, and the Privacy Law Commons Recommended Citation Fox, Dov (2009) "The Right to Silence as Protecting Mental Control," Akron Law Review: Vol. 42 : Iss. 3 , Article 5. Available at: http://ideaexchange.uakron.edu/akronlawreview/vol42/iss3/5 This Article is brought to you for free and open access by Akron Law Journals at IdeaExchange@UAkron, the institutional repository of The nivU ersity of Akron in Akron, Ohio, USA. It has been accepted for inclusion in Akron Law Review by an authorized administrator of IdeaExchange@UAkron. For more information, please contact [email protected], [email protected]. Fox: The Right to Silence as Protecting Mental Control FOX 4/27/2009 12:44 PM THE RIGHT TO SILENCE AS PROTECTING MENTAL CONTROL Dov Fox∗ I. Introduction ....................................................................... 763 II. The Privilege Against Compelled Self-Incrimination ....... 765 III. Cognitive Neuroscience and Forensic Evidence ............... 770 IV. The Distinction between Testimonial and Physical Evidence ............................................................................ 779 V. The Mind-Body Distinction
    [Show full text]
  • Finding the Flaws in Copyright When Confronted with Neuro-Technologies and Brain Data
    Finding the flaws in copyright when confronted with neuro-technologies and brain data How neuro-technologies and the protection of brain data change the basic conceptions found in copyright by shaking the structure of the idea-expression dichotomy in both Dutch and European Union law LL.M Law and Technology Tilburg Law School Tilburg Institute for Law, Technology, and Society Tilburg University 2018 Student: Supervisors: Radha M. Pull ter Gunne Mr. Ir. Maurice H.M. Schellekens ANR: 776988 and SNR: 1256360 Dr. Sabrina Röttiger-Wirtz Table of Contents Finding the flaws in copyright when confronted with neuro-technologies and brain data .... 1 List of Abbreviations and Acronyms ..................................................................................... 5 Chapter One .......................................................................................................................... 6 Introducing the EEG, its brain data and copyright ............................................................ 6 1.1 Introduction ................................................................................................................... 6 1.2 The aim of the research ................................................................................................. 9 1.3 Scope ........................................................................................................................... 10 1.4 Research questions ...................................................................................................... 14 1.5 Significance
    [Show full text]
  • 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.
    [Show full text]