BETA

15 Amendments of Margrete AUKEN related to 2015/2103(INL)

Amendment 31 #
Draft opinion
Paragraph 1 a (new)
1a. considers that although robotics can bring societal benefits, they can at the same time dramatically change the ways people interact with each other and therefore have a real impact on current societal structures; therefore, underlines the urgent need for extensive and informed public debate around this new technological revolution;
2016/09/21
Committee: ENVI
Amendment 52 #
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; notes that CPS technologies or robots can only augment human care and make the rehabilitation process more targeted, so that medical staff and caregivers can allocate more quality time for diagnosis and better treatment options;
2016/09/21
Committee: ENVI
Amendment 54 #
Draft opinion
Paragraph 6
6. notes that early forms of robots and smart CPS devices are already used in healthcare, such as e-Health devices and surgical robots and that in the near future this technology will continue to develop, having the potential to also reduce healthcare costs, making more budget available for better adjustment to the diversity of patients’ needs, continuous training of the healthcare professionals and research;
2016/09/21
Committee: ENVI
Amendment 61 #
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 enhance a holistic approach to health, 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;
2016/09/21
Committee: ENVI
Amendment 68 #
Draft opinion
Paragraph 10
10. stresses that medical CPS should meet the high standards set for medical equipment, through effective verification and certification procedures which allow assessment by adequately trained staff of the safety and effectiveness of the proposed technology, even at the design stage;
2016/09/21
Committee: ENVI
Amendment 73 #
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 in order to safeguard the overarching interests of the patients, notably through enhancing prior informed consent and insurances schemes as there must be full transparency for patients to their own data and full transparency to the public on failed and successful trials; further notes that the responsibility of failed trials and CPS must be clear to patients and the public;
2016/09/21
Committee: ENVI
Amendment 78 #
Draft opinion
Paragraph 12
12. points out that while the development of technology is increasing exponentially, our social systems cannot respond as quickly, and healthcare systems have an even slower response; stresses that these discoveries have a significant impact on civilisation as we know it , and that it is therefore imperative to apply the precautionary principle and assess the moral andlong term ethical implications of new technologies in the early phase of their development;
2016/09/21
Committee: ENVI
Amendment 92 #
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 and amount of electric and electronic waste; emphasises the need to apply the principles of regenerative design, increase energy efficiency by promoting the use of renewable technologies for robotics, use and reuse of secondary raw materials, and to reduce waste;
2016/09/21
Committee: ENVI
Amendment 98 #
Draft opinion
Paragraph 15 a (new)
15a. emphasises that all negative externalities should be taken into account in the price setting; (To be inserted before the subheading ‘Safety’)
2016/09/21
Committee: ENVI
Amendment 104 #
Draft opinion
Paragraph 16 a (new)
16a. calls on the Commission to put in place without delay systems for centralised premarket approval, traceability and post-market surveillance , that include correspondent publicly accessible databases; the criteria for approval should include the following: safe, effective and necessary technology, positive risks/ benefits balance for the patients, societal readiness to take the risks via sufficient available insurance coverage, clear identification of liability, non-discriminatory sharing of the benefits and the risks among society. "Pioneer" patients should not be used as representatives of all patients. Instead, estimation of users' actual wishes must be given priority before the implementation of CPS;
2016/09/21
Committee: ENVI
Amendment 110 #
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. The codes of conduct on medical professional secrecy should be reviewenhanced concerning the health data stored on CPS systems that can be accessed by third parties;
2016/09/21
Committee: ENVI
Amendment 114 #
Draft opinion
Paragraph 17 a (new)
17a. considers that the only possible owner of the data should be the patient and that by no means should it be allowed to sell data generated by robotics in the health sector;
2016/09/21
Committee: ENVI
Amendment 115 #
Draft opinion
Paragraph 17 b (new)
17b. Insurance companies or any other service provider should not be allowed to use e-health data to introduce discriminations in the setting of prices, as this would contradict the fundamental right for access to the highest attainable standard of health;
2016/09/21
Committee: ENVI
Amendment 120 #
Draft opinion
Subheading 8 a (new) and paragraph 18 a (new)
Liability 18a. Acknowledges that robotics can introduce a high level of uncertainty regarding responsibility and liability issues. Therefore is of opinion that an interim solution could be to consider the one(s) who find economic benefits in this business should be held liable by default in case of injuries due to a dysfunction of the robot and responsible for proper disposal of electric and electronic waste generated;
2016/09/21
Committee: ENVI
Amendment 121 #
Draft opinion
Paragraph 18 b (new)
18b. Is of the opinion that the mere existence of these technologies should not be translated into a review minimising industrial risks to health, such as nuclear risk, with the argument that it would make possible to avoid exposing humans to dangerous conditions: the high dependency of these technologies on energy supply makes them extremely vulnerable and unreliable in an emergency situation such as a natural or industrial accident in energy supply, a terrorist attack or war.
2016/09/21
Committee: ENVI