Annexes to COM(2020)64 - Report on the safety and liability implications of Artificial Intelligence, the Internet of Things and robotics

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dossier COM(2020)64 - Report on the safety and liability implications of Artificial Intelligence, the Internet of Things and robotics.
document COM(2020)64 EN
date February 19, 2020
Annex I, Article R2.7 reads: “Manufacturers shall ensure that the product is accompanied by instructions and safety information in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned.”

(37)

     Article 10 (8) referring to the instructions for the end user and Annex VI referring to the EU Declaration of Conformity

(38)

   So far “self-learning" is used in the context of AI mostly to indicate that machines are capable of learning during their training; it is not a requirement yet that AI machines continue learning after they are deployed; on the contrary, especially in healthcare, AI machines normally stop learning after their training has successfully ended. Thus, at this stage, the autonomous behaviour deriving from AI systems does not imply that the product is performing tasks not foreseen by the developers.

(39)

     This is in line with section 2.1 of the ‘Blue Guide’ on the implementation of EU products rules 2016’

(40)

     Article 5 of Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety.

(41)

   In case of any change to the railway system that may have an impact on safety (e.g. technical, operational change or also organisational change which could impact the operational or maintenance process), the process to follow is described in Annex I to COM Implementing regulation (EU) 2015/1136 (OJ L 185, 14.7.2015, p. 6).

   In case of ‘significant change’ a safety assessment report should be provided to the proposer of the change by an independent ‘assessment body’ (could be the national safety authority or another technically competent).

   Following the risk analysis process, the proposer of the change will apply the appropriate measures to mitigate risks (if the proposer is a railway undertaking or infrastructure manages, the application of the regulation is parts of its safety management system, whose application that is supervised by the NSA).

(42)

     Policy and Investment Recommendations for Trustworthy AI, High-Level Expert Group on Artificial Intelligence, June 2019.

(43)

     This does however not exclude that oversight may be necessary in a given situation as a result of some of the existing more general obligations concerning the placing on the market of the product

(44)

   WHO Constitution, first bullet point: “Health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity.” (https://www.who.int/about/who-we-are/constitution)

(45)

     Social Robots: Technological, Societal and Ethical Aspects of Human-Robot Interaction, pp.237-264, Research, Neziha Akalin, Annica Kristoffersson and Amy Loutfi, July 2019.

(46)

      https://ec.europa.eu/futurium/en/ai-alliance-consultation/guidelines#Top  

(47)

   Based on the key requirements proposed by the High-Level Expert Group in the Ethics guidelines for trustworthy AI: https://ec.europa.eu/futurium/en/ai-alliance-consultation/guidelines  

(48)

   Regulation (EC) No. 2008/765 and Decision (EC) No. 2008/768 and harmonised sectorial product safety legislation e.g. Machinery Directive 2006/42/EC.

(49)

     Article 2 of the General Product Safety Directive specifies that a safe product shall take into account “the effect on other products, where it is reasonably foreseeable that it will be used with other products”.

(50)

     Section 1.2.1 of Annex I of the Machinery Directive

(51)

      The Blue Guide on the implementation of EU product rules, 2016

(52)

     Radio modules are electronic device that transmit and/or receive radio signals (WIFI, Bluetooth) between two devices

(53)

     Article 3 (3) (i) of the Radio Equipment Directive,

(54)

     Pursuant to Article 16(2) of Directive 2014/33/EU

(55)

     In the Lifts Directive 2014/33/EU the installer is the equivalent of the manufacturer and must take the responsibility for the design, manufacture, installation and placing on the market of the lift.

(56)

     Machinery Directive, Annex I, Article 1.7.4.2 reads “Each instruction manual must contain, where applicable, at least the following information” (i) “assembly, installation and connection instructions, including drawings, diagrams and the means of attachment and the designation of the chassis or installation on which the machinery is to be mounted;”

(57)

     Harmonised for motor vehicles by Directive 2009/103/EC relating to insurance against civil liability in respect of the use of motor vehicles, and the enforcement of the obligation to insure against such liability.

(58)

     In most Member States strict liability is applied for the person in whose name the motor vehicle is registered.

(59)

     Liability for Artificial Intelligence and other emerging technologies’ Report,

https://ec.europa.eu/newsroom/dae/document.cfm?doc_id=63199

(60)

     Liability for Artificial Intelligence and other emerging technologies’ Report,

https://ec.europa.eu/newsroom/dae/document.cfm?doc_id=63199

(61)

     Cf. unmanned aircraft systems referred to in Commission Implementing Regulation (EU) 2019/947 of 24 May 2019 on the rules and procedures for the operation of unmanned aircraft.

(62)

     Liability for Artificial Intelligence and other emerging technologies’ Report,

https://ec.europa.eu/newsroom/dae/document.cfm?doc_id=63199

(63)

     See the Report from the New Technologies formation, p. 3 and the policy recommendation 27.2. of the High Level Expert Group on Artificial Intelligence.