IPOL | Policy Department for Economic, Scientific and Quality of Life Policies
8 PE 638.391
capable of making autonomous decisions, the need arises for a system that deals with the responsibility
for potential harm caused by robots and automated systems
4
.
Regulatory and legal challenges should also be navigated. For instance, regulatory approval for medical
devices is needed to ensure the safety and efficacy of interventions
5
. Following discussions on the need
to adapt to new technological changes, the new EU Regulation on medical devices, which replaced the
previous Directive, includes specific provisions addressing software medical devices
6
. Whether the
existing legal framework is fit to address current or future challenges such as regulating the liability of
all players involved in the design and deployment of AI and robotics applications (e.g., doctors,
producers and healthcare centres), remains an open question
7
. With AI, robotics and the digitalisation
of healthcare building upon the collection, aggregation and analysis of a vast amount of sensitive data,
many questions also arise about privacy, data protection, data security and data sharing
8
. AI research,
and machine learning in particular, involves the access to large quantities of data regarding patients
and healthy citizens – for instance to collect data about genomics, environmental factors and lifestyles.
This raises questions regarding the ownership of data, informed consent and good data sharing
practices, particularly in light of the new GDPR
9
.
Healthcare has been identified as one of the key areas for robotics, AI and digitalisation developments
within several strategic EU documents. Among other initiatives, the European Parliament has been
leading a worldwide debate about the need to establish civil law rules applicable for robotics and
calling for further action by the European Commission to address the challenges in this area
10
. Some of
the responses to this request will be given through the guidance by the European Commission
expected by mid-2019 related to the Product Liability Directive and to the liability and safety rules
applicable to AI and robotics.
The EU Commission’s European strategy published on April 2018 emphasised the need to encourage
the development of AI applications centred on people’s needs in terms of health-related services and
long-term care
11
. The strategy builds upon Europe’s advantages in terms of scientific and industrial
development while it seeks to increase investments in AI (both public and private), prepare for
disruptive socio-economic changes and support an adequate ethical and legal framework.
The strategy also set out a proposal for working with Member States to develop a coordinated plan on
AI in order to maximise the impact of investments both at EU and national levels and foster synergies
and cooperation across the EU. The proposal for a coordinated plan was signed by Member States and
4
European Parliament, Committee on Legal Affairs, Report with recommendations to the Commission on Civil Law Rules on Robotics
(2015/2103(INL)), Rapporteur: Delvaux, Mady.
5
Healthcare Robotics: Current Market Trends and Future Opportunities:
https://www.roboticsbusinessreview.com/healthmedical/healthcare-robotics-current-market-trends-and-future-opportunities/
.
6
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive
2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and
93/42/EEC.
7
See European Parliament resolution of 12 February 2019 on a comprehensive European industrial policy on artificial intelligence and
robotics (2018/2088(INI)), saying that “that the existing system for the approval of medical devices may not be adequate for AI
technologies” and calling on the Commission to oversee the evolution of these technologies to assess whether other changes will be
needed in the future.
8
Pesapane, F., Volonté, C., Codari, M. and Sardanelli, F., 2018. Artificial intelligence as a medical device in radiology: ethical and regulatory
issues in Europe and the United States. Insights into imaging, 9(5), p.745.
9
Stahl. B.C. and Coeckelbergh, M., op. cit.
10
See European Parliament resolution of 16 February 2017 with recommendations to the Commission on Civil Law Rules on Robotics
(2015/2103(INL)).
11
Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and
Social Committee and the Committee of the Regions, Artificial intelligence for Europe, (COM(2018) 237).