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 ................................................................................................................