STOA WorkshopRobots:Enabling the disabledor disabling the abled?Participants' booklet

EPRS | European Parliamentary Research ServiceScientific Foresight Unit (STOA)

PE 547.430

STOA WorkshopRobots: enabling the disabled or disabling the abled

A workshop on assistive technologiesfor people with disabilities

Participants' booklet

23 June 2015, 14:30-17:00JAN building, Room 4Q1

European ParliamentBrussels

Prepared by Guillermo Garrido-Lestache, Mihalis Kritikos and Lieve Van WoenselScientific Foresight Service

mihalis.kritikos@ep.europa.eu

http://www.europarl.europa.eu/stoa/cms/home/events/workshops/inclusion

Contents

1 Context.............................................................................................................................................. 1

1.1 About this event........................................................................................................................ 1

1.2 About STOA.............................................................................................................................. 1

2 Programme....................................................................................................................................... 2

3 Panel Speakers ................................................................................................................................ 3

3.1 Ádám Kósa ................................................................................................................................ 3

3.2 Ron McCallum .......................................................................................................................... 4

3.3 Antal Kuthy............................................................................................................................... 5

3.4 Marjo Rauhala ........................................................................................................................... 6

4 Trends in assistive technologies: a selection............................................................................. 7

4.1 Brain-Computer Interface........................................................................................................ 8

4.2 Cyber-Physical Systems......................................................................................................... 10

4.3 3D printing and Artificial Organs ........................................................................................ 12

4.4 Synthetic Biology .................................................................................................................... 14

4.5 Gene Technology .................................................................................................................... 16

4.6 Biosensors and Nanorobots .................................................................................................. 18

4.7 Drones ...................................................................................................................................... 20

4.8 Autonomous Vehicles............................................................................................................ 22

5 Anticipatory law-making in relation to trends in assistive technologies.......................... 24

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1 Context

1.1 About this event

Ádám Kósa, MEP, requested that STOA carry out a Scientific Foresight project on assistivetechnologies and their role in the creation of an inclusive environment for persons withdisabilities. The STOA Panel decided to host this workshop with Mr Kósa to test the field andacquire knowledge that will be useful in defining and refining the project. The project will bedeveloped in accordance with the Foresight approach developed by the Scientific ForesightService of the EPRS. It will focus on assistive technologies which are intended for persons whoare blind or visually impaired, deaf or hard of hearing, and to those with varying degrees ofautism. Moreover, different assistive technologies should be evaluated in terms of theirapplications for inclusion of persons with disabilities in society, education and employment.This project also will be relevant for the whole European Parliament as it will also pointtowards the deficiencies in terms of inclusion and assistance at the institution itself, whichshould be held at the highest of standards if it presumes to be an example for the rest ofEurope.

1.2 About STOA

STOA is an official body of the European Parliament, established in 1987, with a mission tocarry out impartial expert assessments of the impact of existing and emerging technologicaltrends and innovations. The goal of its work is to assist, with independent information, theMembers of the European Parliament (MEPs) in developing options for long-term, strategicpolicymaking. So, STOA's role is to provide scientific advice to the MEPs and theParliamentary Committees. As part of its work, the STOA secretariat participates in theorganization of workshops, the preparation of projects and the publication of awareness-raising reports on technological trends, such as today's event.

The STOA Panel consists of 24 MEPs nominated from the eight permanent parliamentarycommittees: AGRI (Agriculture & Rural Development), EMPL (Employment & Social Affairs),ENVI (Environment, Public Health & Food Safety), ITRE (Industry, Research & Energy), TRAN(Transport & Tourism), IMCO (Internal Market & Consumer Protection), JURI (Legal Affairs)and CULT (Culture and Education). Mairead McGuinness is the European Parliament Vice-President responsible for STOA. The STOA Chair, for the first half of the 8th Legislature, isPaul Rübig, with Eva Kaili and Evžen Tošenovský as Vice-Chairs.

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2 Programme

Chair: Ádám Kósa, MEP

STOA Secretariat: Mihalis Kritikos

Start at 14h30.

- Welcome and introductory statement by MEP Ádám Kósa.

- Prof. Dr. Ron McCallum, from the United Nations' Committee on the Rights of Persons

with Disabilities, on his experience with assistive technologies as a blind person since

birth and on the legal and labour issues related to disabilities.

- Mr. Antal Kuthy, from KONTAKT, on the opportunities and limitations for researchers

and enterprises.

- Dr. Marjo Rauhala, from the Institute of Design & Assessment of Technology in

Vienna, on the ethical and societal concerns involving assistive technologies and

disabilities.

- Debate, questions/answers section involving the panellists as well as the audience.

- Closing remarks by MEP Ádám Kósa.

Closing at 17h00.

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3 Panel Speakers

3.1 Ádám Kósa

Ádám Kósa was born in Budapest, Hungary. He is deaf and his mother tongue is HungarianSign Language. He graduated from the University of Pázmány Péter, in Hungary as a lawyer in2005. He is president of the Hungarian Association for the Deaf and Hard of Hearing (SINOSZ)since 2005 and a member of the European Parliament since 2009. Between 2009 and 2014 hewas the president of Disability Intergroup in the European Parliament; currently he is co-chair.Mr Kósa got important reports and opinions on people with disabilities such as EuropeanDisability Strategy (2011), general regulation on European funds ("CPR regulation") andinstruments in terms of employment and social affairs (2012) as well as the implementation ofthe anti-discrimination directive in the field of employment and training (2013). Ádám Kósahas been elected as a MEP of Year in 2013 of the European Parliament Magazine. Currently heworks on dossiers on marginalised communities and other equal treatment-related topics.Finally, as a newly appointed rapporteur, he deals with the emerging issue of robotics with aview to civil law.

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3.2 Ron McCallum

Ron McCallum has been blind since his birth in 1948.He was the first totally blind person to be appointedto a full professorship in Australia. He is an emeritusprofessor and former Dean of Law at the Universityof Sydney, specialising in labour law. He usescomputer-based adaptive technology to readdocuments and to download material from theinternet. He uses accessibility apps forcommunicating, reading and navigation.

He was an inaugural member of the UN Committeeon the Rights of Persons with Disabilities (CRPD)from 2009 to 2014, and served as Chairperson from2010-2013. In 2006, he received the designation ofOfficer in the Order of Australia for his services totertiary education, for industrial relations advice togovernments, for assistance to visually impairedpersons and for social justice. He is married toProfessor Mary Crock and they have three children.

He enjoys reading, listening to music and meditation.

Key Message

The social model of disability in the CRPD, recognises that societal barriers lessen the capacityof persons with disabilities to lead full and enriched lives. Over the last 30 years, the advancesin technology have assisted persons with disabilities to surmount these barriers and to obtaineducation and employment. For blind persons, the technological advances have been vast.Previously, most clerical jobs have been unavailable. However, adaptive technology nowenables we blind to scan and to read documents, to deal with emails and to access material onthe internet. In my life as an academic and practising labour lawyer, the handicap of not beingable to read the printed word has been diminished. Accessible apps also enable me to navigatein unfamiliar areas, to instantly access newspapers, podcasts and books.

Advances in technology have also assisted persons with low vision, deaf and hard of hearingpersons, and persons with cognitive disabilities. Advances in wheelchair technology haveassisted persons with mobility impairments. Much of this technology is expensive, especially indeveloping countries. In order to secure employment, many persons with disabilities will needassistance from employers, agencies or governments. It will also be necessary for persons withdisabilities to be trained to utilise these technologies. Finally, it is essential for the communityto learn that with access to technology, we persons with disabilities can play our parts asspouses, partners, parents, employees and employers and entrepreneurs, and thus tocontribute to the wellbeing and development of our nations.

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3.3 Antal Kuthy

Antal is a passionate leader with first classcommunication skills and a long track record ofsuccessful management. He was educated at theBudapest University of Technology and Economics,where he studied telecommunications and ITengineering. He served as Chief Executive Officer Asiaof E-Group Hungary, a software solutions housespecialised in financial payments and electronictransaction solutions.

Mr. Kuthy was the founder of Egus Infosystems Kft,predecessor of E-Group. Upon entering E-Group, heserved as Chief Executive Officer between 2000 and2006, and then moved to Hong Kong to lead its Asianoperations. Moreover, he was Member of thepresidium of the Hungarian Association of ITcompanies from 2005 to 2006.

Key Message

Based on Antal’s very recent experience implementing a nationwide smart platform drivenvideo sign language translation service called KONTAKT for the Deaf and Hard of Hearingcommunity the main socio-economic and financial indicators and the relevance of assistivetechnology will be presented and evaluated.

The case study will demonstrate the importance of forward looking funding model and presentthe cost–benefit analysis of the overall project. Besides the practical example Antal undertakesthe challenge of defining the role of assistive technologies in the 21st century and its importancebeyond.

Why innovation for disability should not ever be considered as a social cost but clearly as highyield investment of our society? Indeed, it is becoming clear that very soon we need toreconsider our definitions, have a better understanding of what disability related innovationreally means and offers to all of us, an opportunity to transform society to enjoy a moreproductive human capacity utilisation model where assistive technology is not narrowing but abroadening term.

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3.4 Marjo Rauhala

Marjo Rauhala (social scientist, ethicist; PhD, MSSc.,BA), is a senior researcher at the Centre for AppliedAssistive Technologies at the Vienna University ofTechnology. Her research interests focus on theethical dimensions of technology R&D, independentliving and user involvement. Currently Dr. Rauhalaworks as an embedded ethicist in an engineeringteam specializing in assistive technologies and activeand assisted living technologies. She investigatestheoretical and practical concerns in ethics andtechnology R&D in the engineering context.

In studying ethical phenomena in their contexts shecombines methods of empirical social research andacademic ethics. Dr. Rauhala has a broad experiencein ethics ranging from academic philosophical

research, ethics management in international and national cooperation projects, to cooperationwith a national ethics commission, and ethics screening and review as an expert of theEuropean Commission (HORIZON 2020 and FP7).

Key Message

Most of us will agree that the assistive technology (AT) and the active and assisted living(AAL) fields could benefit from more systematic attention from the point of view of ethics.Some clarification may be required; however, with regard to what is actually meant by ethics isthis context.

In this presentation, I will provide reasons for why I believe ethics has a significant role in thetrajectory of assistive technology research, design, implementation and use. I will trace someoverall observations about ethics and assistive technology R&D by drawing on hands-onexperiences in collaborating as an ethics manager with a team of engineers specialized in theAT and AAL fields. Furthermore, I will describe some challenges in the implementation ofrequirements of research ethics and of research financiers in national and international ATR&D projects.

Following this I will perspectives, and point to some of the observations made as an ethicsreviewer of research proposals in diverse calls of the European Union's FrameworkProgrammes for Research (FP7 and H2020). These observations include a plea for integratingethics in a way that ethics does not end outsourced or externalized or considered modular oranticipatory in research.

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4 Trends in assistive technologies: a selection

The trends included in this list cover different areas of development in the field of assistivetechnologies. However, 'assistive technologies' is not a clearly defined area of technology, inthat it is a functional category that refers to any technology that may have applications in theaiding or assisting of persons with disabilities. Most of the technological trends explored in thisreport are broad and have multiple applications, but all of them undoubtedly have greatpotential to assist persons with disability. We begin by covering technologies which involvecomputers and artificial intelligence (brain-computer interfaces, cyber-phyiscal systems and 3Dprinting), then transition towards biomedical technologies (artificial organs, sythentic biology,gene technology, biosensors and nanorobots), and finalize with transport and mobilitytechnologies (such as drones and autonomous vehicles).

The methodology used in the elaboration of this report on trends in assistive technologies isdivided into three sections: first, there is a brief overview and description of the technology;this is followed by a consideration of the expected impacts and developments, based on theongoing work and short-term expectations of researchers and enterprises; and finally adiscussion of the unexpected, unavoidable and undesirable impacts that could occur if thetechnology became embedded in society (i.e. if is use becomes widespread and commonplace).

This selection of trends in assistive technologies covers the following topics:

1. Brain-Computer Interface

2. Cyber-Physical Systems

3. 3D printing and Artificial Organs

4. Synthetic Biology

5. Gene Technology

6. Biosensors and Nanorobots

7. Drones

8. Autonomous Vehicles

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4.1 Brain-Computer Interface

A Brain-Computer Interface (BCI) is adirect communication pathway betweenthe brain and an external device. BCIs canbe divided between invasive(neuroprosthetics and brain implants) andnon-invasive. Neuroprosthetics allowpatients to replace a missing body part,which may be lost through trauma,disease, or congenital conditions, andrestore their motor and sensing capacities.These include limb-replacements that cantransmit the sense of touch, cochlear

implants and bionic eyes. Brain implants are devices which connect directly to the brain andare placed on its surface or attached to the cortex. One increasingly common type of brainimplant procedure, called Deep Brain Stimulation (DBS), involves the implantation of amedical device called a brain pacemaker, which sends electrical impulses, through implantedelectrodes, to specific parts of the brain for the treatment of movement and affective disorders(e.g., essential tremor, Parkinson's, dystonia and major depression). Non-invasive BCIs consistof a series of neuroimaging technologies that function as interfaces. Signals recorded in thisway have been used to power bionic implants and restore movement (recently proving thatthey can be just as efficient as invasive methods but without the risks involved in brainsurgery). Although they are easy to wear, non-invasive implants produce poor signalresolution because the skull dampens signals, dispersing and blurring the electromagneticwaves created by the neurons. There are several different types of neuroimaging technologiescapable of recording brain activity based on different measurements, the most common onesbeing: EEG, ERP, MEG, fMRI, PET, NIRS, SPECT, and TMS.

Expected Impacts and Developments

Neuroprosthetics and brain implants have become increasingly common in recent years inrestoring sensor or motor disabilities. For instance, already 120,000 patients in Europe are usingcochlear implants, and it is estimated that by 2020 the majority of children born worldwidewith a hearing loss will have access to cochlear implants before the age of five. However, dueto the high cost of the device, surgery and post-implantation therapy, it is still rarely used indeveloping countries. Deep brain stimulation has been used in over 100,000 patients to treatParkinson’s disease worldwide, but this remains a considerably small figure as 50,000 newpatients are diagnosed each year in Europe alone. Future developments for this type of brainimplant is expected to expand the range of diseases and disorders it can effectively treat, suchas schizophrenia or Alzheimer’s disease, which is currently in the phase of clinical trials. Inrelation to neuroprosthetics, recently a wireless interface device has been developed which, ifproven effective, could give a greater degree of independence to the patients as they will beable to use their neuroprosthetics without the intervention or supervision of doctors. Regardingnon-invasive technology, recent successful experiments have managed to create a telepathic

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connection between two people at a distance, by a combination of EEG (to receive the inputfrom one patient) and TMS (to transmit the output into the other patient) technology, so thatone may transmit words and orders to the other. Moreover, there is already a commerciallyavailable, portable and affordable device that records EEG activity in the brain and can beconnected to computers or smart phones via USB. In the future, neuroimaging technologies canbe expected to become smaller and discreet, to such an extent that people could wear themwithout them being noticeable to them or to others. There is also a great margin ofimprovement in terms of the precision with which thoughts can be interpreted and of theamount of activity that can be recorded at once.

What are the unexpected impacts that could arise if BCIs become embedded in society?

BCI technology has ethical implications which are not to be ignored by policy makers andsociety as a whole. For instance, if neuroimaging technology is perfected to the point of notrequiring any sort of device or one that is unnoticeable, it could grant access to people’sthoughts to whomever possesses the technology for whatever purposes they may have (e.g. fora ‘thought police’ or for criminal intent). If brain implants are connected to the internet, theirusers will be exposed to ill-intended individuals or groups who will be able to monitor theirthoughts and even modify their behaviour without them noticing, effectively becoming robots.Another important issue that may arise with BCIs in the future is that their use may not belimited to restoring ordinary capabilities in patients. Indeed, human enhancement will be aproblem, as implants will be able to improve all sorts of intellectual capacities, such as memory,language skills or calculations. This would radically transform life as we know it, as the effectson society and human nature are unimaginable. A more pressing issue is the question ofhuman identity. Can one claim to be the same person if his behaviour and thought-process ismodified by a brain implant? Patients and their relatives may experience changes caused bybrain implants as resulting in changes in their personalities and identities. It is time for a publicdebate involving the whole of society, based on which policy makers may legislate accordingly.Other ethical questions regarding brain implants and neuroprosthetics are: consent (how arepatients capable of giving consent if it is precisely their brain capacities which need treatment),responsibility in case of malfunction and security issues regarding personal data (what if adoctor finds out something he shouldn't, or wasn't looking for?).

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4.2 Cyber-Physical Systems

Cyber-Physical Systems (CPS) is a system ofcollaborating computational elementscontrolling physical entities, thus includinghumanoid robots, artificial intelligence (AI), theInternet of Things (IoT) and any sort of deviceor machine that is connected to a network ofinformation (i.e. a 'smart home'). Cyber-physicalsystems already are being implemented for theimprovement of efficiency multiple industriesand services. The uses of cyber-physicalsystems for assisting people with disabilities aremultiple. For instance, facial expression

recognition capacities of autistic children are already being treated with robots that canreproduce and recognize human facial expressions. Smart home technology using IoT canallow a disabled person to manage many of the aspects of his living environment with muchless trouble than with traditional methods. Moreover, robots of all sorts are being developed tomake life in general easier for the whole of society, such as disinfecting rooms with ultravioletlight, closing the zipper in your clothes, fixing space stations, explore and clean nuclear plants,efficiently select and transport stock products for delivery companies, sort and packagemedications with less margin of error than humans, take blood samples, or patrol the seashunting down toxic algae blooms, amongst other uses.

Expected Impacts and Developments

Robots are expected to be capable of performing increasingly complex tasks over the followingdecades. By 2030, it is expected that robots will be ubiquitous; however this is not to beconfused with the science-fiction representation of future societies with personal humanoidrobots with immense physical, computational and communicational capacities. Most probably,there will be a multiplicity of devices and a diverse range of types of cyber-physical systems.The main strengths of robots and AI systems will be their capacity to gather information fromtheir environment and learn from it, in order to improve and actualize themselves. Many of theenvisioned uses for robots are in the entertainment area, with robots being developed that canengage in sports, play board or video games, perform magic tricks, and the future possibilitiesin this regard are endless.

Developments are also being done in the applications of robots to fighting fires and assisting innatural disasters, so that in the near future robots may already be saving lives. Themanufacturing sector is one in which robots will become increasingly common, meaning thatdeveloped countries may see a new industrial revolution, with the consequence being thatdeveloping countries which rely heavily on cheap labour for industrial sectors may see theirexports plummet and their economies sink. Experts believe robotics and artificial intelligencewill saturate industries like healthcare, transport and logistics, customer service, and homemaintenance by 2025. Robots in the future will have all sorts of assistive purposes, withcarerobots for the elderly and for the disabled already in development and expected to be

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commercialised within the next decade. Toshiba looks to construct a full communications robotby 2020, which will include speech recognition.

What are the unexpected impacts that could arise if CPS becomes embedded in society?

One major concern regarding robots is the possible impact they may have on the economy,although this is a highly controversial issues. About half of the experts who participated in arecent survey about the economic impact of robotic advances and AI envision a future in whichrobots and digital agents have displaced significant numbers of both blue- and white-collarworkers—with many expressing concern that this will lead to vast increases in incomeinequality, masses of people who are effectively unemployable, and breakdowns in the socialorder. However, the other half expects that technology will not displace more jobs than itcreates by 2025. Experts have noted that robots could increase the gap between sectors ofsociety based on skills, thus destroying the middle class and creating two completely differentsections of society, the political and cultural consequences of which we are not capable topredict. Some have gone as far as arguing that half of the currently existing jobs could becomeautomated by 2025 but the question remains as to whether the efficiency of the market will besuch that employment will be re-allocated as has happened with technologies in the past.

Another concern with robots is whether they will represent an impulse towards better livingstandards or not. Although it is commonly believed that technological progress improves thequality of life as it increases, the opposite has also been argued. This is crucial in defining theactivities to which humans will dedicate their energy and time saved by robots: could violencepervade future societies even more (whether for survival purposes or as a gratuitous, bond-forming activity)? Will AI technology allow for unimaginable forms of entertainment? Willcultural, natural or human interaction diminish or increase? Could it be that robots bring withthem not only computational capacities but also ethical values, meaning they will turn thesociety of the future into one of radical individualism, hedonism and laziness? Could robotsallow humanity to fully explore its creativity, or would they just render it useless bysubstituting it? What are the appropriate measures that we must implement today so as toreach the future we desire with robots?

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4.3 3D printing and Artificial Organs

Stem cell therapy is the use of stem cells to treat orprevent a disease or condition. Research isunderway to develop various sources for stemcells, and to apply stem cell treatments forneurodegenerative diseases and conditions,diabetes, heart diseases, rheumatoid arthritis,Parkinson's disease, Alzheimer's disease,osteoarthritis, stroke and traumatic brain injuryrepair, learning disability due to congenitaldisorder, spinal cord injury repair, anti-cancertreatments, baldness reversal, repair hearing,restore vision, amyotrophic lateral sclerosis,crohn's disease and wound healing. In more recentyears, with the ability of scientists to isolate andculture embryonic stem cells, controversy has

risen in relation to the ethical issues involved with the impact of this medical technology onsociety as a whole. The possibility of repairing human organs with stem cell technology may becombined with advancements being achieved in 3D printing. 3D printing is an additivemanufacturing technology capable making three-dimensional objects of almost any shapeusing a digital model. The technology is already in use most notably in the jewellery, aerospaceand health industries. The use of graphene as a material for 3D printing would open up thenumber of items able to be produced in this way, for example manufacturing entire computersand solar panels. The use of 3D printing to produce organic items is also a possibility. Efforts in'bio-printing' have already produced artificial vascular systems and it is hoped that this willallow for complex, functional human tissues (for example, a heart, an eye or an ear) to beproduced using cells from the patient.

Expected Impacts and Developments

The combination of stem cell research and bioprinting is already being explored. However, wemust remain conservative as to the possibilities for these technologies, for research regardingstem cells has seen how initial excitement gave way to a realistic, slow progress due to thecomplexity of the subject. Nevertheless, many of the efforts regarding stem cells research arebeing directed at countering disabilities, such as neurological disorders or hearing and seeingdamage that cannot be tackled with more conventional medical devices. The medical benefitsoffered by bio-printing are significant, for example there are predictions that we are only yearsaway from being able to treat severe burns with a spray on substance, produced from a bio-printer making use of copies of a patient's own cells and collagen. The 3D4D challenge featuredseveral projects which used 3D printing for socially beneficial causes., just as a taster for therevolutionary, effects 3D printing may have on how we try to resolve societal problems,empowering individuals and helping to create greater equality. A macro-level impact of 3Dprinting could be the way in which it shifts our consumer-based economy and the societalbehaviours associated with this. There is the potential for a mass democratisation of buyinghabits as individuals are able to print their own products, to bespoke specifications, and in the

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comfort of their own homes. Activity would be shifted from traditional shopping methods to atailored and highly personalised shopping experience, thus disrupting the current productionsystem and perhaps re-industrialising first world countries. The design of the product, ratherthan the manufacturing process itself, is what consumers will be paying for and thus there isthe potential for a design-led cottage-industry of 3D printers to emerge. Perhaps mostsignificantly, the widespread use of 3D printing could open the floodgates of creativeinnovation. The shortening of 3D printing supply chains could have multiple impacts on theeconomy, not least the reduction of labour costs to near-zero, potentially shiftingmanufacturing back towards ‘Western developed countries’, with no burden on theenvironment. The possibility of producing objects with individualised specifications will beparticularly helpful for people with disabilities.

What are the unexpected impacts that could arise if 3D-printing becomes embedded insociety?

The implications of 3D printing for the make-up and behaviour of society could be significant,not least changing the shopping habits of citizens. For example, what will the implications befor the level of personal interactions between individuals in society if all of our products wereto be manufactured at home? How would this change our typical buying habits and whatwould be the impact on our economy? Would economies shift towards being design-focusedwith digital design skills having a greater premium than traditional manufacturing methods? Ifthe ability to print everyday items at home becomes a reality, who in society would have thegreatest access to such technology? Excluding a particular demographic section (age, gender,race, income level, disability) from access to 3D printing would increase existing inequalities.As 3D printing require one to have knowledge in computer technology, could this mean thatolder members of society would not be able to benefit from 3D-printed projects? Unevendistribution of the costs and benefits of 3D printing is also an issue when considering 'bio-printing', for example 'printing' of organic material to create personalised 'bio-bandages'. Whowould be the owner of such bio-printed material? How would access to this type of use of 3Dprinting disadvantage those with or without access to the technology? What if 3D printers endup being used for the illegal production of guns, explosives, biological or chemical weapons?Wouldn't the substitution of traditional manufacturing with 3D printers entail huge losses andunemployment rates for countries like China or India?

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4.4 Synthetic Biology

The scientific committees of theEuropean Commission definesynthetic biology as the application ofscience, technology and engineeringto facilitate and accelerate the design,manufacture and/or modification ofgenetic materials in living organisms.This covers any organism, system,material, product, or applicationresulting from introduction, assembly,or alteration of such materials. Itcombines many different fields ofenquiry, including molecular biology,

evolutionary biology, systems biology, biophysics, electrical engineering, genetics, chemistry,computer sciences and bioinformatics. Synthetic biology is not as well-known to the public asgenetic engineering and GMOs, but they are overlapping and related terms. However,synthetic biology differs from genetic engineering for its focus is at a much smaller scale andwith a wider perspective, and for the moment belongs in a safe laboratory environment. Thecurrent developments in synthetic biology include DNA sequencing, synthesis of geneticsequencing, design of unnatural nucleotides, amino acids and proteins, biosensors andprogrammable nanomaterials. DNA synthesis tools have been essential in the creation ofoptimized synthetic sequences, genomes and pathways. Today, almost every sequence can bemail-ordered simply by sending the desired sequence to a DNA synthesis company. Othertools that are used in synthetic biology include protein synthesis tools (rational design anddirected evolution), Multiplex Automated Genome Engineering (MAGE), Omics (profilingtechniques to analyse biological systems), standard biological parts (BioBricks) andcomputational tools which facilitate the design of synthetic systems and allow for thecombination of biological elements (such as the Registry of Standard Biological Parts and theDatabase of Essential Genes).

Expected impacts and developments

Apart from existing methods to engineer natural proteins, there are also projects to designnovel protein structures that match or improve on the functionality of existing proteins.Moreover, unnatural nucleotides and amino acids are being developed, to the point that anexpanded artificial genetic code has been introduced into a living organism's DNA. The futureapplications for synthetic biology are endless and are expected to revolutionize the health,renewable energy and environment sectors. Health applications include the production ofnovel types of pharmaceutics which will be more efficient and intelligent than current ones,environmentally friendly, eventually cheaper and lack their side-effects. Arteminisinin, asynthetically produced anti-malaria medicine, has been integral to the reduction of the globalmalaria burden. In the future, synthetic biologists expect to create a protein that kills onlycancer cells, thus finding the cure to the second most common cause of death in Europe. Theyalso expect to create new types of vaccines which will be safer than the currently available

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ones. In the future, genetic mapping will be done at birth to know what illnesses, diseases andgenetic disorders we are prone to in order to prevent or eliminate them with DNAmodification. Various research institutes and companies are currently working on thedevelopment of micro-organisms with optimized synthetic metabolic pathways for theproduction of biofuels, with the commercial application of these to be expected in the next 5years. Regarding the environment, progress is being done in relation to the development ofbiosensing systems that can detect hazardous environmental contaminants (such as heavymetals or toxins) and the engineering of micro-organisms which could eliminate thesecontaminants in biodegradable ways. There are also great expectations in the development ofprogrammable nanomaterials.

What are the unexpected impacts that could arise if synthetic biology becomesembedded in society?

The development of synthetic biology could entail a series of unexpected and undesiredimpacts on the society of the future. For instance, biohacking could become a serious threat tosafety and security, as ill-intended or malicious actors could have access to the biotechnologyeither by its commercialisation or by illegally replicating it, hence being able to copy themechanisms used to produce novel pharmaceutics to redesign harmful pathogens. Thedistributed and diffuse nature of open-source biotechnology makes it difficult to track,regulate, or mitigate potential biosafety and biosecurity concerns. Another issue that may ariseis that the products of synthetic biology themselves may become a threat to society and theenvironment if they are designed so as to self-replicate and self-reproduce, which would allowthem to spread in an uncontrolled manner. The economic potential for the industry is huge, butit also represents a threat to society as we know it. We must also consider the bioethicalimplications of current synthetic biology and its future ramifications. If we are creating life, andnot only that, but redesigning it to fulfil our purposes, are we not playing God? Where shouldwe draw the line between what is open for synthetic design, biological engineering andgenomic modification and what isn't? The responsibility in this respect resides not merely onpolicy makers and experts, but also on society as a whole insofar as we are all accomplices ofthis process by which humanity includes the design, creation and modification of life at itsmost basic level into the range of skills we have developed in order to perpetuate and enhanceour existence as a species.

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4.5 Gene Technology

Gene technology includes an array of technologies,procedures and treatments that work at the geneticlevel, such as gene therapy, targeting, sequencing andmapping. Gene therapy is the therapeutic delivery ofnucleic acid polymers into a patient's cells as a drug totreat disease. The polymers are either expressed asproteins, interfere with protein expression, or possiblycorrect genetic mutations. The most common formuses DNA that encodes a functional, therapeutic geneto replace a mutated gene. Gene therapy was firstconceptualized in 1972 and by 2015 some 2,000 clinicaltrials had been conducted or approved. These includetreatment of retinal diseases, SCID,adrenoleukodystrophy, leukaemia, multiple myeloma,haemophilia and Parkinson's disease. Gene targeting isa technique that uses homologous recombination tochange an endogenous gene. The method can be used

to delete a gene, remove exons, add a gene, and introduce point mutations. Gene targeting hasbeen widely used to study human genetic diseases by removing ("knocking out"), or adding("knocking in"), specific mutations of interest to a variety of models. These models are the mostaccurate in-vitro models available to researchers to date, and are facilitating the developmentof new personalized drugs and diagnostics. Gene sequencing and mapping are the methodsused to determine the location, order and distance between different nucleotides and genes in aDNA molecule. Researches begin a genetic map by collecting samples of blood or tissue fromfamily members that carry a prominent disease or trait and family members that don't, thusbeing able to find patterns and identify which genes are responsible for any given trait.

Expected Impacts and Developments

Although as of 2015, it is still largely an experimental technique, gene therapy has seen a greatrise of investment in the last couple of years and enterprises expect a continued high growthfor the sector as they become more effective in treating diseases such as heart conditions,Parkinson's, haemophilia and some types of blindness, but have doubts about the sustainabilityof the business model. Indeed, one of the issues involving gene technology is that it is still at astage in which the costs of developing and applying it are very high as the whole process ispersonalised for the individual patient. Nevertheless, the rapid development of novel, faster,and cheaper sequencing technologies is making possible the era of personalized humangenomics. It is expected that in the near future we will be able to create genetic mappings atbirth and anticipate and treat against any genetic disorders we may be predisposed todeveloping, including any motor, sensory, cognitive or developmental disability. Autism,diabetes and heart conditions are some of the complex diseases for which gene mapping will beextremely useful for diagnosis and treatment. In the near future patients will havepharmaceutical drugs exactly customized to their own genomic background. Once they know

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about their actual or potential diseases, they will be able to treat them with gene therapy thatwill deliver DNA to the damaged cells to replace or disrupt them. Alipogene tiparvovec,commercially known as Glybera, is the first gene therapy to be approved by the EC after beingrecommended by the European Medicines Agency. This marks a landmark in the developmentof gene therapy, although the direction and presence that this technology will have in thefuture is highly unpredictable because of its controversial implications. The next step for genetherapy appears to be gene editing of human embryos.

What are the unexpected impacts that could arise if gene technology becomesembedded in society?

If genetic technology becomes increasingly capable of effecting changes in the nature and life ofpatients and doctors start using it as a common or mainstream medical treatment, severalunexpected impacts may arise. For instance, biosafety issues may arise, such as questions ofprivacy, data protection, liability in case of failure in any treatment or procedure involvinggene technology. Could it be that in the future ill-intended 'bio-hackers' will steal informationfrom our genes (for extortion, marketing purposes, political reasons, to sell at a profit in theblack market, etc.), modify the genes or proteins being developed in laboratories (asbioterrorism or to transfer whatever trait they wish) or create and apply on others their owngenetic modifications. Moreover, it is worth considering whether the distinction betweentherapeutic and human enhancement uses of gene technology might be blurrier or even erasedin the future. One objection to the use of gene technology for the treatment of different types ofdisabilities is that there is a hidden implicit assumption being made that people impairedthrough genetic factors need to be treated and made normal. This objection sees gene therapyas a form of discrimination against impaired people and persons with disabilities, and has alsobeen used in relation to other assistive technologies. The problem is that an individual'sfreedom is hindered by the fact that the vast majority of people will be choosing to use thetechnology. We must also consider the identity implications of current gene technology and itsfuture implications. If we are creating life, and not only that, but redesigning it to fulfil ourpurposes, are we not playing God? What would it mean for us as a species, a qualitative jumpin the evolutionary ladder or a loss and alienation from our true nature? The ethical debateregarding gene therapy requires the involvement of all stakeholders, legislators and society asa whole.

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4.6 Biosensors and Nanorobots

Synthetic biology has been developing widelyand vastly in the last few years but not allareas of investigation revolve around geneticmodification and DNA sequencing. It alsoincludes the design, manufacture andapplication of nanomaterials andnanotechnologies, which are already useful inthe fields of healthcare, energy, agriculture,food additives and industrial chemicals.Nanotechnologies require the combination ofmany different fields of enquiry, includingmolecular biology, evolutionary biology,systems biology, biophysics, electrical

engineering, genetics, chemistry, computer sciences and bioinformatics. Two nanotechnologiesin which researchers are concentrating their efforts are biosensors and nanorobots. Broadlyspeaking, a biosensor is an analytical device used for the detection of a substance or chemical,for which it combines a sensitive biological element, a physicochemical 'transducer' or detectorelement, and a reader device or electronic element which presents the results of the interactionin a quantifiable and user-friendly manner. The biological component in many bio-sensors iseither an enzyme, as in biosensors used for blood glucose monitoring in the treatment ofdiabetes, or an antibody, as in most optical biosensors, used in the monitoring ofenvironmental elements (such as fertilizers, pesticides, persistent organic pollutants (POPs),endocrine disrupting chemicals (EDCs), explosives and toxins). Another class of biosensor alsoreferred to as a bioreporter, uses whole living cells as a component, and is used, for instance, inthe detection of mercury and arsenic in the environment. Nanorobots are robots whosecomponents are at the scale of a nanometre (10−9 meters) and consist of biosensors andelectronically engineered motor-capacities (for autonomous or software-led movement).

Expected Impacts and Developments

Synthetic biology remains mostly on its early stages of development as an industry. The globalrevenue of the industry is estimated to be $4.5 billion in 2015 and $ 16.7 billion by 2018 whilesin 2011 it was barely $ 1.5 billion. Although the market is expected to expand, the extent of useof biosensors is constrained due to issues of sensitivity, variable readout times, short life spanof biomolecules and stability of the sensor. Some biosensors need pre-treatment prior to usewhile some are too expensive to manufacture. Because of these difficulties, the current agendafor research in the development biosensors that are miniaturised, highly specific and sensitive,capable of multiple analyte detection and monitoring. Biosensors are being developed for non-invasive healthcare applications, for analysing the presence of pathogens and toxins in food,for monitoring fermentation processes and for the detection of ammonia, heavy metals andmethane. Nanorobots are still in the developing phase, and most researchers work withsimulators or models to examine how their designs would perform if materialised. Potentialmedical applications include early diagnosis and targeted, accurate, effective drug-deliverywithout side-effects for cancer, biomedical instrumentation for surgery, pharmacokinetics

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(digestible sensors can be placed in pills and transmit pill digestion data to physicians) andepidemic control. Types of nanorobots in development include microbivore (which replacewhite blood cells and render antibiotics obsolete), respyrocite (which function as red bloodcells, but carry much more oxygen, which means they can cure anemia and other respiratorydiseases), clottocyte (would function as platelets do, i.e. stopping blood flow near wounds, onlymuch faster) and cellular repair nanorobots (which could replace conventional surgicalinstrumentation and repair specific cells and functions for patients with all sorts of disabilities).

What are the unexpected impacts that could arise if nanotechnologies becomeembedded in society?

One unexpected impact that may arise from biosensors becoming omnipresent is that people'sfreedoms will be hindered, because whether they want it or not data on their bodily functionswill be taken. The right to refuse medical treatment could be threatened in a world in whichmonitorisation becomes omnipresent due to the imperative to always be prepared, to alwaysknow all that can be known. This imperative, which has become a value of our contemporarysocieties, will perhaps turn against our freedom and our well-being. A particular concernregarding nanorobots is the possibility that they may self-actualize and self-replicate. Thequestions of who would be responsible for the actions and outcomes of those nanorobots andeven of whether it is desirable to grant them such freedom are worth dedicating some thought.We should also be aware that both biosensors and nanorobots can be a force for inequality orfor equality, if substantial funding and effort is done to ensure that these technologies areavailable for those who will be aided the most by them. For instance, biosensors could helpblind or vision impaired people know always what is the content of whatever they aretouching or is near them, avoiding accidents and increasing their awareness of theirsurroundings, therefore making their interaction with the world easier. Other ethical, legal andsocietal concerns include: standardization of parts, registries and methods for development ofbiosensors; harmonization of regulatory regime for engineered biosensors, revising current EUframework; biosafety concerns, both for human health and biodiversity and the environment;and intellectual property rights, because the business-side of the industry considers patentsnecessary for sustainability, but the researchers argue that it hinders freedom and productivityof research.

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4.7 Drones

Known as Remotely Piloted Air Systems (RPAS)or Unmanned Aerial Vehicles (UAVs), droneshave become increasingly present due to a sharpdrop in production costs, as a consequence ofrecent innovations in light-weight materials, on-board computers, batteries and fuel tanks. Sincetheir inception, drones have been developed formilitary purposes, with the inclusion of weaponsin them, as well as for surveillance and policingefforts. Recently, however, other uses haveproliferated, in the fields of climate datacollection, scientific exploration, 3-D mapping,infrastructure maintenance, logistics and deliveryservices, professional photography andfilmmaking, entertainment, wildlife protection

and agriculture. The increasing diversity and affordability of drones will surely lead to theirwidespread use amongst corporations, governmental institutions and common citizens. Thus,the legal and ethical issues already associated with drones will most likely become moreprominent and require the appropriate legislative measures at the EU level.

Expected impacts and developments

The use of drones by both military and civilian authorities in the immediate future is likely tobe in discharging core duties of safety, security and policing, particularly in carrying outsurveillance and intelligence gathering. The immediate impact of this will be to reduce thenumber of 'frontline' personnel being deployed in carrying out these activities. Anotherconsequence will be the increase in unauthorised breaches of nations’ airspace, as hashappened recently in the Ukrainian conflict or in France, close to its nuclear plants. In the nearfuture it is expected that drones will be carrying out the most dangerous of activities, such asassisting in fire-fighting or natural catastrophes. The range of commercial applications fordrones is yet to be explored. Major delivery and logistics companies have already startedinvestigating the ways in which drones could improve the efficiency of their operations.Predictions state that 12% of a $98 billion cumulative global spend on aerial drones over thenext decade will be for commercial purposes alone. This could imply that by 2050 there couldbe as many as 150,000 drone-related jobs in Europe. Drones are already being used in areassuch as infrastructure maintenance, where they can be extremely useful at reducing time, costs,personnel needed and effort in routine inspections and reparation procedures of publictransportation, highways, railways, mining complexes, factories, pipelines, oilrigs or evenprivate vehicles and households.

One of the areas in which drone use has the greatest potential is agriculture. There areenterprises already working on the multiple possibilities of involving drones in the differentaspects of farming. Drones could be used to collect all sorts of data from the field withouthaving to spoil part of the land with the use of heavy machinery. They will be able recognise,locate and identify if there are any sorts of diseases, parasites or animals hindering the

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production. Moreover, they will be able to record information on all sorts of variables so as tomake the irrigation and fertilization processes more efficient and cost-saving.

The use of drones for people with disabilities is another area with great potential. Thought-controlled drones already exists so that people with mobility disabilities may use them. Droneshave also been used to enhance the capacity of children with autism to get involved with theirenvironment and become aware of different perspectives. We hope to see new developments inthis regard as there are researcher trying to find applications for drones in order to make theexperience of living easier and more fulfilling for disabled people.

What are the unexpected impacts that could arise if drones became embedded insociety?

If drones were to proliferate in the near future and their use became widespread, what impactwould that have on privacy? With the increasing capacity of drones to collect all sorts of data, itis possible that they will be used by corporations or government agencies in uncontrolled andunlicensed ways. It has been noted that the lack of transparency regarding who is the operatorof a drone and for what purposes it is being used can create a 'chilling effect' in citizens. Couldthis have implications for how citizens behave in public if they feel watched by drones? Theuse of drones in delivery of commercial goods and services would imply the presence of hugenumbers of aerial vehicles occupying urban areas. Therefore, safety issues regarding accidentsmust be taken seriously: drones could collide with buildings, people, other drones and othertypes of aircraft or ground vehicles.

In terms of the use of drones in agriculture, it could transform both the job market and therequired skills in the sector. Indeed, it is important to consider how the new skills andknowledge that will be needed to design, operate and maintain both drones and relatedinfrastructure can be made available to the increasing number of people drawn to thistechnology. We might also consider the possible uses for drones in criminal activities. Forexample, in the illegal drug market there is potential for drones to become prevalent as they arehard to detect and even if they were intercepted no individuals would be brought to justice.Another interesting option to consider is how drones may facilitate the lives of people withmental or physical disabilities. The EU and its Member States must provide the appropriatefinancial support for the development and affordability of drones that can be used to ease thelives of those with greater difficulties.

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4.8 Autonomous Vehicles

The term 'autonomous vehicles' (AVs) coversa wide range of vehicle types, mainlyoperating on the ground but also the air andthe sea. These have the capacity to be operatedautomatically, although in many cases real-time human control is still an option. Theemergence of this technology has been mostassociated with the high-profile developmentof the 'Google Car', for which Google hastaken advantage of the large amount of high-quality mapping data it possesses to

programme travel routes. The technology for autonomous vehicles has developed to such anextent that the EU is focusing now on development of the infrastructure required to facilitatefurther deployment of this technology. The 'V-Charge Consortium', together with €5.6 billioninvested in it by the EU, is exploring ways in which autonomous vehicle technology can beintegrated with existing parking infrastructure to produce 'driverless parking systems'accessible via existing personal electronic devices such as smartphones. The EuropeanCityMobil2 project is demonstrating the use of fully automated road transport systems inEurope and developing guidelines to design and implement such systems.

Expected impacts and developments

With some analysts predicting that by 2022 there will be around 1.8 billion automotiveMachine-to-Machine (M2M) connections it is clear that a large amount of data will begenerated by vehicles in the future. This level of communication between automated vehiclesshould make it possible for such vehicles to navigate to destinations and interact with othervehicles and objects more effectively than a human brain. The implications for a step-change inhealth and safety are significant with Google recently claiming that its cars could save almost30,000 lives a year on highways in the USA and prevent around 2 million traffic-relatedinjuries. The increased connectivity required to facilitate automation of vehicles wouldsignificantly improve the degree of monitoring of the performance of such vehicles. Individualowners would be able to better maintain and enhance their vehicles with improvements in fuelefficiency and safety. An increased ability for vehicles to communicate with each other couldalso lead to vast improvements in terms of traffic flow, particularly at road junctions. Thiscould also provide further benefits such as reduced pedestrian exposure to pollution and lowerrisk of road-traffic and pedestrian incidents occurring, particularly in urban areas. The rise ofautonomous vehicles is also likely to combine with continuing electrification of vehicles astelecommunications software and hardware are further integrated into vehicles. Whilst annualglobal car sales may remain low relative to conventional-fuel vehicles, Electric Vehicles (EVs)are expected to account for more than 5-10% of new car sales by 2025 alone. Rental-orientatedbusiness models for the EV market are likely to emerge from the telecommunications sector.An exponential increase in the use of telematics would likely also facilitate the use of AVs morewidely, driven by their need to communicate through cellular networks.

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Unexpected impacts that could arise if autonomous vehicles become embedded in society?

What if your child drove you to work, dropped you off, transported themselves to school andin the evening picked you up from your place of work? If this became a reality wouldrestrictions, currently in place for operation of manually-controlled vehicles, such as age,competency, possessing a 'clean' licence, etc., still apply to the operation of an AV? Couldsections of the population currently unable to drive manually-controlled vehicles, such as thoseunder the minimum driving age or with a certain disability, then be allowed to get 'behind thewheel'? AVs have great potential as a force for democratisation and equality, because theycould represent a mode of transportation that gives equal access and opportunities to everyonedespite their differences (such as skills, (dis)abilities, gender, age). They would all be equallyable to benefit from advantages of AVs. It is therefore useful to re-explore the definition of a'responsible driver' in the context of AVs. At present, responsibility tends to lie with humandrivers of vehicles but if AVs were to be operated by members of society such as youngchildren, could this change the concept of 'responsibility' throughout EU society? How couldthis mean for responsibility for children in relation to other areas of everyday life? It is alsoimportant to consider the implications of AV use for personal driving skills and road safety.Could AV users be expected to have a new set of IT skills in addition to a practical ability todrive and operate a more 'digital' type of machine? How might this impact upon existingvehicle users in terms of requiring re-training, particularly those less able to learn a new set ofskills so easily? There could also be impacts upon our environment and our modes oftransportation. How will our use of public transport change if we have individualised versionsof public transport and how would this effect public investment in transport services?Moreover, given AVs are likely to be an electrified form of transport, localised vehicle-exhaustpollution could thus be significantly reduced. Could our future living habits change as a directresult of changing transport behaviours? Will autonomous transport simply become aninterchangeable extension of our homes and workplaces? If distance from workplaces ortransport hubs becomes a less significant factor for decisions on where to live then how shouldfuture development be planned?

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5 Anticipatory law-making in relation to trends in assistivetechnologies

Assistive Technology refers to products or equipment that are used to maintain, increase orimprove the functional capabilities of people with disabilities. Thus, when approaching thesetechnologies from a legal or regulatory point of view, it is important to assess whether thecurrent EU product liability and product quality standards fit well with the particularchallenges associated with these advanced technological devices. Given the wide variations inthe delivery systems for assistive technology in the Member States in terms of the establishedInformation, prescription, assessment, delivery, financing, mechanisms and procedures, aquestion arises as to whether existing EU legislation can cope well with the respective legalchallenges in an efficient manner. Among these challenges, one should highlight the structuraldifferences in the way social protection schemes are designed at the national level and the lackof coordination, classification, sharing and validation of any information concerning theassessment and market use of assistive technology products, as well as the need to enhancetransparency on markets, products, acceptance and public procurement procedures when itcomes to assistive technology products.

How can EU Law ensure that assistive devices are easily accessible to all people withimpairments given the complexity of the health care and social systems that organise andregulate the provision of assistive devices? Can we think of our legal system paving the wayfor a “one-stop shop” for people with disabilities without necessarily removing the variousnational procurement systems for example? How could regulatory bodies and authoritiesensure transparent acceptance procedures for assistive devices or even introduce standards onquality levels that could apply across all EU Member States? Given the wide range of concernswith regard inter alia to setting high standards of quality and safety for assistive technologyproducts and devices, one may raise the question about whether it is feasible, in legal terms, tohave uniform testing procedures for assistive technology products. Or should policy-makersmove forward through softer approaches that are based on an exchange of best practices, dataand experience or even through the compilation of regulatory EU-wide databases andcatalogues?

In view of the recently attributed legally binding value of the Charter of Fundamental Rights ofthe European Union, which brings together in a single text all the personal, civic, political,economic and social rights that people enjoy within the EU, the legal terms of referenceconcerning the use of assistive technologies may have to be reconsidered. In particular, Article21 of the Charter prohibits discrimination on various grounds, including disability, and Article26 recognises the right of persons with disabilities to benefit from measures designed to ensuretheir independence, social and occupational integration and participation in the life of thecommunity. Could assistive technologies be considered as falling under the scope of measuresdestined to safeguard the interdependence, integration and social participation? If yes, wouldthat trigger any legal effects upon the way the use of these technological products has beenapproached in a medical or employment context? Could existing EU legal references to thesetechnologies be updated to reflect this significant constitutional development? Additionally,article 35 of the Charter provides that everyone has the right of access to preventive healthcare

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and the right to benefit from medical treatment under the conditions established by nationallaws and practices. Could certain applications of assistive technologies of medical, primarilycharacter, ‘benefit’ from the enforcement and actual contextualisation of this right in terms ofits legal integration into the respective rules on social policies and equal access to thesetechnologies at the EU level?

A further challenge stems from the lack of a horizontally accepted definition of disability. Dothe definitions offered in the frame of the EU Employment Equality Directive suffice also forother legal contexts where assistive technologies start becoming gradually introduced? Withinthis frame, additional supportive measures designed to ensure the independence, social andoccupational integration and participation of disabled people in the life of the community needto be considered from a horizontally legal perspective. Similarly, the rapid technologicaldevelopments in the field of assistive technologies raise multiple questions regarding theshaping, application and eventual interpretation of concepts such as autonomy and integrityand the potential ramifications of the latter upon the development and implementation of therelevant pieces of EU secondary legislation. Furthermore, given the contextual limitationsimposed by the allocation of competences between the EU and the Member States, variouspieces of EU legislation that impose obligations on operators to provide assistance topassengers with disabilities or reduced mobility (such as the Air Passengers Regulation, theRail Passengers Regulation, the Sea and Inland Waterways Regulation and the Bus and CoachRegulation) may have to be reconsidered in view of the increasingly important role thatassistive technologies may exert in relation to the enhancement of personal mobility in thecontext of various transport contexts.

Moreover, given the variety of personalised data that assistive technology devices ofmonitoring character may collect, data protection and the privacy of their users, is a thornyissue. How would the privacy policies for each device apply and how could a user be expectedto keep track of these? EU data protection legislation is currently under revision, thus the issueof secondary use or of the definition of the owner or processor of data in the frame of operationof assistive technologies is crucial. Medical negligence is also of relevance to policy-makers andlegislators if the delivery of patient care changes significantly due to greater use of assistivetechnologies. Would a technological fault still lead to liability for negligence? How wouldtechnology impact upon the legal standard that professionals, such as doctors, should adhereto? In case of the use of drones or automatically driven vehicles as forms of assistivetechnology, a multiplicity of legal and ethical questions come to the fore including issues ofliability and privacy. In the case of implanted devices that can track an individual who is inneed of constant surveillance and care, issues of informed consent and the appropriate meansto guarantee that individual rights involved such as physical integrity, liberty, identity, privacyare well protected come into play. As far as Brain-Computer Interfaces (BCI) are concerned,the main legal issue concerns whether and to what extent the will expressed by the individualthrough these biomedical “media” can be considered legally relevant and valid; or in the caseof the use of cybernetic devices for disabled people, policy-makers may need to reconstruct orredefine key legal concepts of personhood, of identity and autonomy. Related to the latter,legal questions arise concerning the use of robots as companions for disabled people, mostly interms of the robots’ legal status and to allotment of liability for the damages caused to theirusers and to third parties.

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The wide variety of assistive technologies poses also the question for a normative classificationof their relevant challenges and the relevance of the latter to the reshaping of legal conceptssuch as legal capacity and competence, identity, privacy, health, bodily integrity. The myriadethical, legal and social effects of the commercial development and use of these technologiesmay signify a paradigm shift of tort law, insurance law or may even affect the interactionsbetween science, ethics and law. Last but not least, given the fragmentation of the EU marketfor assistive devices and the dynamic interface between market innovation and ethicalconsiderations, EU legislators need to perform a social fitness test of the current frameworkmostly in terms of whether it manages to reflect the needs of people with disabilitiesadequately in the fields of product and service development. Accessibility should be a keyregulatory outcome in all ongoing and future efforts to enhance standardisation and theformulation of specific standards for the improvement of the proper functioning of the internalmarket for accessible assistive technology products and services. The Digital Agenda andInnovation Union flagships may also have to be viewed through the prism of the EuropeanDisability Strategy especially with regard to its regulatory and legislative components.

PE 547.430

This is a publication of theDirectorate for Impact Assessment and European Added ValueDirectorate-General for Parliamentary Research Services, European Parliament