BETA

Activities of Elena GENTILE related to 2015/2103(INL)

Plenary speeches (1)

Civil Law Rules on Robotics (debate) IT
2016/11/22
Dossiers: 2015/2103(INL)

Shadow opinions (1)

OPINION with recommendations to the Commission on Civil Law Rules on Robotics
2016/11/22
Committee: ENVI
Dossiers: 2015/2103(INL)
Documents: PDF(137 KB) DOC(56 KB)

Amendments (17)

Amendment 12 #
Draft opinion
Recital C a (new)
Ca. having regard to the nature of CPS and the need to achieve specific, more detailed standards that are the same throughout the European Union;
2016/09/21
Committee: ENVI
Amendment 19 #
Draft opinion
Recital D a (new)
Da. whereas under no circumstances should the use of robotic or high- technology diagnostic or treatment instruments result in increased liability for the doctors or healthcare personnel who are required to use them; whereas it is therefore considered advisable to increase the liability of the healthcare facilities or manufacturers involved;
2016/09/21
Committee: ENVI
Amendment 23 #
Draft opinion
Recital D b (new)
Db. whereas the use of such technology should not diminish or harm the doctor-patient relationship, but should provide doctors with assistance in diagnosing and/or treating patients;
2016/09/21
Committee: ENVI
Amendment 42 #
Draft opinion
Paragraph 3
3. notes that CPS are able to change the life of people suffering from a disability for the better, as smart technologies can be used for prevention, assistance, monitoring and companionship;
2016/09/21
Committee: ENVI
Amendment 45 #
Draft opinion
Paragraph 4
4. underlines that elder care robot research and development has, in time, grown more mainstream and cheaper, producing products with greater functionality and broader consumer acceptance; notes the wide range of applications of such technologies providing prevention, assistance, monitoring and companionship to elderly people and people suffering from dementia;
2016/09/21
Committee: ENVI
Amendment 51 #
Draft opinion
Paragraph 5
5. stresses that although CPS has the potential to enhance the mobility and sociability of people with disabilities and elderly people, human caregivers will still be needed and provide an important source of social interaction for them that is not totally replaceable; notes that CPS technologies or robots can only considerably augment human care and make the rehabilitation process more targeted, so that medical staff and caregivers can allocate more time for diagnosis and better treatment options;
2016/09/21
Committee: ENVI
Amendment 62 #
Draft opinion
Paragraph 9
9. notes that recent years have seen significant changes in the medical education and training sector; further notes that, as medical care has become increasingly complex, the climate in academic health centres provides an opportunity to rethink the way medical education and lifelong learning is delivered, while preserving the core competence of doctors to retain their expertise and authority over robots; calls on the Member States to promote training and specialisation courses to encourage the free movement of surgeons who intend to use robots to carry out their operations; calls on the Commission, therefore, to promote high training standards at EU level for surgeons who are planning to use robotic technologies;
2016/09/21
Committee: ENVI
Amendment 69 #
Draft opinion
Paragraph 10 a (new)
10a. stresses the importance of distinguishing surgical robots from prostheses and exoskeletons from robot companions whose function is to assist persons with disabilities or those who are temporarily incapacitated; stresses the importance of subjecting both species to checks to be carried out in accordance with standards that are as precise and detailed as possible and are monitored by a specific European authority;
2016/09/21
Committee: ENVI
Amendment 70 #
Draft opinion
Paragraph 11
11. calls on the Commission to consider adapting the existing trial procedures designed for testing medicines to the purpose of testing new medical robotic devices;deleted
2016/09/21
Committee: ENVI
Amendment 75 #
Draft opinion
Subheading 3 a (new ) and paragraph 11 a (new)
European Robotics Authority: adaptation of legislation, control, safety, standardisation 11a. recommends the establishment of an independent European authority with expertise in robotics, which will be responsible for oversight in the sector, with the aim of adapting EU legislation to progressive rapid technological developments, by preventing structural delays and governing, also from a social point of view (in terms of Responsible Research and Innovation), the development of a market and a European robotics industry in accordance with uniform criteria throughout the Union;
2016/09/21
Committee: ENVI
Amendment 81 #
Draft opinion
Paragraph 12 a (new)
12a. stresses the importance, as regards ethical standards, of ensuring that robotic products respect the fundamental rights of individuals and society, which should be protected at EU level, by providing for any necessary technical measures which ensure such respect as from the design stage, in accordance with the so-called privacy by design approach;
2016/09/21
Committee: ENVI
Amendment 88 #
Draft opinion
Paragraph 13
13. acknowledges the vulnerability of patients with special needs, including children, elderly and people suffering from disabilities, who may develop an emotional connection with CPS and robots, and underlines the ethical considerations posed by their possible attachment; suggests that the Commission supplement existing legislation with a legislative proposal that makes it compulsory for manufacturers, at the design stage, to adapt to criteria that prevent the feelings of patients or users, especially if they are sick, children, or persons with disabilities, from being manipulated, so that inappropriate emotional bonds are not created, or to prevent humans from being deceived into thinking that the machine is sentient and has feelings that it does not actually possess;
2016/09/21
Committee: ENVI
Amendment 89 #
Draft opinion
Paragraph 13 a (new)
13a. calls on the Commission and on the Member States to promote the development of assistive technologies, also through liability schemes that are different from those currently applicable, in order to facilitate the development and adoption of these technologies by those who need them, in accordance with Article 4 of the UN Convention on the Rights of Persons with Disabilities, to which the Union is party;
2016/09/21
Committee: ENVI
Amendment 91 #
Draft opinion
Subheading 4 a (new) and paragraph 14 a (new)
Human enhancement: ethical profiles and regulations 14a. Notes that the adoption of CPS raises the issue of human enhancement, which is defined as the enhancement of existing natural human skills or the conferral of new skills, allowing individuals to overcome disability; in this regard, considers it necessary to address the issues raised by this phenomenon in order to ensure equal access to this new technology;
2016/09/21
Committee: ENVI
Amendment 93 #
Draft opinion
Paragraph 15
15. acknowledges the need to minimise the possible environmental or ecological footprint of robotics, as the use of CPS and robots is expected to increase overall energy consumption; emphasises the need to increase energy efficiency by promoting the use of renewable technologies for robotics and to reduce waste; stresses the importance of a European framework for remotely piloted systems that are used in the sea and below the sea's surface to protect the safety of EU citizens and of the environment, and calls on the Commission to supplement and update EU regulations concerning such matters;
2016/09/21
Committee: ENVI
Amendment 100 #
Draft opinion
Paragraph 16
16. Safety of medical robotic devices is a precondition for their introduction in the healthcare sector. The effectiveness and safety of care and medical robots should be assessed against special, very detailed, safety safeguards and standard certification procedures, with special attention given to their use by impaired users or in emergency situations; calls on the Commission to promote the adoption of very specific and detailed EU-wide standards;
2016/09/21
Committee: ENVI
Amendment 112 #
Draft opinion
Paragraph 17
17. Medical CPS and the use of a robot as an “electronic health record” raise questions concerning laws on patient privacy, medical professional secrecy, and data protection in the area of public health. Union data protection rules should be adapted to take into account the increasing complexity and interconnectivity of care and medical robots handling highly sensitive personal information and health data; they should comply with the concept of privacy by design, as laid down in Regulation (EU) 2016/679 concerning privacy. The codes of conduct on medical professional secrecy should be reviewed concerning the health data stored on CPS systems that can be accessed by third parties;
2016/09/21
Committee: ENVI