ISO 13482:2014 and Its Confusing Categories: Building a...

Joint International Doctoral (Ph.D.) Degree in Law, Science and Technology

ISO 13482:2014 and Its Confusing Categories: Building a Bridge between Law and Robotics

Eduard Fosch Villaronga

PhD Candidate in the Joint International Doctoral (Ph.D.) Degree Erasmus Mundus in Law, Science and Technology coordinated by CIRSFID, Università di Bologna, Italy. Fellow in IDT-UAB, Universitat Autònoma de Barcelona, Spain


SAFETY

-  User -  Environment -  Device


SAFETY

-  User -  Environment -  Device

Who is responsible if there is a failure and the human being falls? Can companion robots cause psychical harm? Can we address cosmesis in robotics? Can robots create fear of presence? Are roboticists liable for it?

Is secure the cloud platform that robots use?


(*) Robot kills man at Volkswagen plant in Germany

(*) Google Cars involved in accidents: even if they did not cause them.


But we are not analyzing all service robots, only PERSONAL CARE ROBOTS

Those service robots that ‘perform actions contributing directly towards improvement in the quality of life of humans, excluding medical applications’ 1. Mobile Servant Robot

2. Physical Assistant Robot 3. Person Carrier Robot

According to ISO 13482:2014


“Although clarity may be missing in the legal domain, robot creators are still legally liable for their creations”

Because

IGNORANTIA JURIS NON EXCUSAT

ISO 13482:2014 is the only existing document addressing Personal Care Robots. There are no laws governing specifically this technology.

But


THING Law

Social Norms

Market

Architecture

Lessig, L. Code Version 2.0. Basic Books, NY, p. 121 (2006)


Personal Care

Robots Law

Social Norms

Market

Architecture


Personal Care

Robots Law

Social Norms

Market

Architecture

1. Mobile Servant Robot 2. Physical Assistant Robot 3. Person Carrier Robot

Technical Standards: ISO 13482:2014


Personal Care

Robots Law

Social Norms

Market

Architecture



Depending on their aim: empathy, education, ethics, etc. Also social acceptance.


Personal Care

Robots Law

Social Norms

Market

Architecture



Supply and Demand law Depending on their aim: empathy, education, ethics, etc. Also social acceptance.


Personal Care

Robots Law

Social Norms

Market

Architecture



Supply and Demand law Depending on their aim: empathy, education, ethics, etc. Also social acceptance.

Standards are non-binding documents There is no law enforcement behind

But even if there are no laws governing specifically Personal Care Robots, yes there are some laws regarding: Data Protection Consumer Protection Liability Environmental Regulation Medical Law


In order to create a new Law that can answer all the questions arisen by robots, we need to communicate to roboticists to better understand what: -  Purpose their technology has -  Are the robot capabilities -  (who) Is going to be intended user

Reading the technical standard ISO 13482:2014, a Lawmaker might find: -  Some inaccuracies in the definitions given by ISO -  Some confusing categories between the in-scope and the out-scope robots -  There are issues still missing: liability, ethics, privacy, etc.

This can lead us to: -  Comply with some laws, but not the ones under which the device might fall

(and be liable for any damage the robot might cause) -  No protection of the final user -  Loss in economical terms, but also in trust


We said that ISO defines Personal Care Robots as service robots that perform actions contributing directly towards improvement in the quality of life of humans, excluding medical applications This is what in legal terms is called “undefined legal concept”: a)  Not only the word ‘improvement’ pictures a blurred reality

because we do not know when we can talk about improvement, if this improvement is general for everyone, etc.;

b)  But also ‘quality of life’ is quite unclear, because it depends on several factors like cultural, age, gender, and different interpretations of quality of life could be given

Confusion Regarding Definitions


The level of “personal care” in Personal Care Robots: -  No definition of Personal Care is given by ISO -  Collins dictionary defines it as the ‘help given to elderly or infirm

people with essential everyday activities such as washing, dressing and meals’

-  Elderly Accommodation Counsel of the UK (EAC) sustains that it is the ‘assistance with dressing, feeding, washing and toileting, as well as advice, encouragement and emotional and psychological support’

But mobile person carrier robots, physical assistant robots or mobile servant robots are nowadays a bit far away of developing all these activities

Confusion Regarding Definitions


In theory ISO 13482:2014 regarding Personal Care Robots explicitly excludes: •  Robots Travelling Faster than 20 km/h; •  Robot Toys; •  Water-borne Robots and Flying Robots; •  Industrial Robots (ISO 10218); •  Robots as Medical Devices; •  Military or Public Force Application Robots; •  Space Robots.

Confusion Regarding in/out scope Categories


PERSON CARRIER ROBOTS 1 Restrictions -  Robot toys -  Medical devices


Robot toys being used as person carrier robots (‘physical therapy’)

Electric-powered child-sized robot toy cars offer mobility to children with disabilities. As explained by Galloway, wheelchairs are reserved for children over 3 years old and new robotic devices to help disabled children’s mobility cost tens of thousands of euros (and they are very heavy). To cope with such limitations, he founded the project ‘Go Baby Go’ in order to take already commercialized car toys and to transform and adapt them for children with cerebral palsy or Down syndrome to move.


PERSON CARRIER ROBOTS 2 Restrictions -  Personal care


Person Carrier Robots (sub-category of Personal Care Robots) are intended to convey persons from one place to another, like wheelchairs. Toth, in DOMEO Project, said that segways were for indoor contexts. The more and more we see segways on the streets that might not fulfil the criterion “contributing directly towards improvement in the quality of life” because they are not used by disable people, nor elderly. Wheelchairs tend to be considered as medical devices (then they can be prescribed by doctors). What are the differences between a Segway-Care Robot and the one used in CityTours? Is ISO 13482:2014 still applicable?

ISO 13482:2014


PHYSICAL ASSISTANT ROBOTS 1 Restrictions -  Medical devices


ISO 13485:2013 defines medical devices as ‘any instrument [...] to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of: diagnosis, prevention, monitoring, treatment or alleviation of disease [...]’ The recommendation to roboticists is to apply for both ISOs to be sure that there are no extra responsibilities derived from usage not covered by the scope of the chosen instrument


PHYSICAL ASSISTANT ROBOTS 2 Restrictions -  Military Robots


HULC is an exoskeleton intended to be used in warfare environments. This exoskeleton gives supplementation of force and increases ability, strength and endurance. What kind of regulation (even if soft-law) is governing this use of exoskeletons?

This situation poses lots of yet unanswered ethical questions: -  Is it ethical to use physical assistant robots

to increase human force in warfare? -  Can physical assistant robots be

considered part of the human body and be treated as human parts for indemnification reasons in case of harm?

-  How can we address the delegation that human gives to the machine when using an exoskeleton?

-  Is the law prepared to deal with ‘super-humans’ due to exoskeletons that, in theory, were intended to be just simple personal care robots?


MOBILE SERVANT ROBOTS Confusions -  Person Carrier Robots


Resyone is assessed according to the criteria for mobile servant robots. Mobile servant robots are meant to travel to perform serving tasks in interaction with humans, such as handling objects or exchanging information. Whereas Resyone seems to be more a restraint-free assistant robot because ISO defines them as those which ‘assist elderly/tired person to and from a chair, bed, etc. To assist in basic mobility tasks on flat ground with or without help from partner. To help provide more ease and comfort in daily life for independent living’


THERAPEUTIC ROBOTS Confusions -  Personal Care Robots -  Medical Devices -  * Robot Toy


In the USA, according to the FDA, the seal robot is considered a medical device, whereas in Europe it only fulfills the Restriction of Hazardous Substances Directive 2011/65/EC. Actually, PARO has the Conformite ́ Européenne mark but it is still not considered as a medical device in Europe, even if it is used in Therapy Contexts.

There are cognitive therapeutic robots (PARO) and and physiotherapeutic robots like Fisiobot.

But, a person could go to visit Fisiobot for a pleasure massage, or use PARO without being under a treatment. The seal is neither monitoring the person’s activity nor diagnosing anything (which are typical activities for medical devices).


A final legal remark

There are cases where the applicants seek the medical device certification regardless of whether their product really falls under the category of medical devices. For instance, the creators of a robot may be interested in obtaining the certification not because they need to comply with particular regulations, but only to get some benefits. In fact, end users could get discounts for medical devices, consequently this would inevitably increase the number of buyers, and thus the income of the company. The Law does not permit that. Actually, it is a bit dangerous for the creators of a robot. Roboticists need to be aware that they do not get only rights from regulations but also duties and obligations.


Conclusions •  A robot poses several legal and ethical challenges overlooked by

technical standards, but ignorantia juris non excusat.

•  Having only those international standards might lead us to an infra-/over- regulated scenario where users could be in fact not protected.

•  A theoretical categorization of robots through function leads to confusion in the legal layer. That might be very useful to create new robot applications, but not to give protection to consumers in legal terms.

•  A robot needs to be compliant with the existing legal framework according to its own capabilities, besides their compliance with technical guidelines. Indeed, a robot may have some default capacities (communication capabilities, a data collection system, autonomous behavior, etc.) that could in fact cause different problems in legal terms, independently of how the robot is used and of the ISO certifications it may have obtained.


•  Great efforts from both legal and technical communities need to be made in order to create understandable bridges within both communities.

•  Only together we can create grounded regulations that can at the same time give protection to users, protect roboticists from unnecessarily liability issues and promote development in a green, user-friendly way.

Conclusions


Interdisciplinary Workshop on Legal and Ethical Aspects of Educational and Therapeutic Robots

Conference: NEWFRIENDS2015.ORG FRIDAY 23 OCT 2015 ALMERE, THE NETHERLANDS https://legalrobotics.wordpress.com

IMPORTANT DATES Submission Deadline: 31 July 2015 Notification of Acceptance: 15 August 2015 Camera Ready: 1 September 2015 Workshop: 23 October 2015

ORGANISERS Eduard Fosch Villaronga [email protected] / [email protected]), Università di Bologna, Italy. IDT-UAB, Universitat Autònoma de Barcelona, Spain. Jordi Albó Canals [email protected]), Tufts University, CEEO, Massachusetts, US. Mohamed Bouri [email protected]), École Polytechnique Féderale de Lausanne, EPFL, Switzerland.


Thank you for your attention Eduard Fosch Villaronga [email protected] [email protected] PhD Program: last-jd.eu

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