BETA

Activities of Margrete AUKEN related to 2020/2012(INL)

Shadow opinions (1)

2020/09/16
Committee: ENVI
Dossiers: 2020/2012(INL)
Documents: PDF(195 KB) DOC(70 KB)
Authors: [{'name': 'Adam JARUBAS', 'mepid': 197517}]

Amendments (17)

Draft opinion
Recital B

B. Whereas the artificial intelligence (AI) global leadership race, which will ~~determine~~affect the source of ethical values and standards shaping the sector worldwide, is picking up the pace; whereas the integration of big data and AI technologies into public health systems and society must be accompanied by appropriate rules, standards and legislation that protect the fundamental rights of individuals and address new ethical challenges;

2020/06/12
Committee: ENVI

Draft opinion
Recital C

C. Whereas AI solutions and other emerging digital technologies may benefit society in the areas of green transition, environment protection, waste management, climate change, energy management and efficiency, air quality e.g. smart grids and electro-mobility; whereas the use of algorithmic systems for surveillance and behavioural regulation represents a serious threat to European values and algorithmic transparency;

2020/06/12
Committee: ENVI

Draft opinion
Recital D a (new)

Da. Whereas the application of AI, robotics and related technologies should not diminish or harm the doctor-patient relationship, but should provide doctors with assistance in diagnosing and/or treating patients more effectively;

2020/06/12
Committee: ENVI

Draft opinion
Recital E

E. Whereas current policy and ethical guidelines for AI are lagging behind ethical challenges that must be identified and mitigated, since AI has tremendous capability to threaten patient preference, safety, and privacy; whereas the boundaries between the roles of physicians and machines in patient care need to be outlined and education of both healthcare workers and patients is needed;

2020/06/12
Committee: ENVI

Draft opinion
Paragraph 1

1. Stresses that the Union ~~must~~should establish a pan-European network of health experts and leading ethicists to work in a transparent manner to undertake all necessary steps to guarantee that its ethical values, as expressed in the acquis, apply effectively to all AI areas within its territory and to promote its standards worldwide;

2020/06/12
Committee: ENVI

Draft opinion
Paragraph 1 a (new)

1a. Considers it essential that AI, robotics and related technologies support the achievement of sustainable development, climate neutrality and circular economy goals; considers also that the use of these technologies should be environmentally friendly and support the achievement of environmental and public health goals, such as waste reduction, lowering the carbon footprint, reversing climate change and environmental degradation;

2020/06/12
Committee: ENVI

Draft opinion
Paragraph 2

2. Underlines that overregulation may hamper AI sector innovation, especially for SMEs and Start-ups; considers that hindering the Union AI sector in delivering benefits of AI applications in e.g. healthcare, environment protection and food quality to the citizens, may also bear ethical weight, especially in the context of global competition, where securing full respect of Union ethical values may pose a challenge;deleted

2020/06/12
Committee: ENVI

Draft opinion
Paragraph 2 a (new)

2a. Notes that the law of Member States is not harmonised with regard to liability rules that are applicable to damage or injury that could result from the application of emerging digital and behavioural technologies; calls on the Commission and Member States to focus on the vulnerability and liability gaps in AI, robotics and related technologies as well as on adjustments that need to be made to existing Union legislation, such as the Product Liability and Medical Devices Directives;

2020/06/12
Committee: ENVI

Draft opinion
Paragraph 3

3. ~~Welcom~~Notes the fact that the Risk- Based Approach methodology defined in the Commission White Paper of 19 February 20201 recognises healthcare, transport and energy as high risk sectors by default, and proposes to introduce listed AI requirements beyond existing-Union rules in these sectors~~, unl~~; recalls the vagueness of the ~~manner in which AI is used does not involve significant risk; stresses that the Union AI ethical framework should address especially the above high-risk sectors~~sector-specific approach outlined in the White Paper; underlines that there are many kinds of risk and levels of risk that evolve over time through more advanced future technologies; stresses that the Union AI ethical framework should address all sectors that adopt the use of these technologies as having equivalent levels of risk, rather than the two-tier (high/low) risk approach proposed; _________________ 1White Paper On Artificial Intelligence - A European approach to excellence and trust, COM(2020)0065

2020/06/12
Committee: ENVI

Draft opinion
Paragraph 4

4. Notes that, with the rapid development of AI and the uncertainty that lies ahead, a common Union AI ethical framework ~~will expand~~that is enforceable and binding should develop an ecosystem of trust as defined in the Commission White Paper, whether in environmental protection, healthcare or food safety applications, thus supporting the ecosystem of excellence in legal certainty and ethical excellence in providing an effective response to the challenges yet not defined in courtrooms, management meetings or scientific laboratories;

2020/06/12
Committee: ENVI

Draft opinion
Paragraph 4 a (new)

4a. Underlines the need to ensure that health data and data belonging to vulnerable groups such as persons with disabilities, patients, children, minorities and migrants are protected; stresses that the gathering, processing, sharing and access to data, must be in full respect of the established case-law of the European Court of Justice and of other European and international instruments that apply in the Union;

2020/06/12
Committee: ENVI

Draft opinion
Paragraph 6

6. Calls for securing the full enforcement of Union legal framework on data protection and privacy, relevant notably in the healthcare AI applications and related sensitive data, to strengthen the “Right to an explanation” foreseen in Article 22 of Regulation (EU) 2016/679 of the European Parliament and of the Council (General Data Protection Regulation, (GDPR))2 ~~and higher interpretability requirements for high-risk AI;~~ ; encourages the Commission during the GDPR review to specifically assess whether Union data protection legislation is fit for purpose or whether additional regulatory safeguards are required, such as: rules on harmonized data anonymization techniques for health data; rules on data access and data control when it comes to the use of algorithm-based solutions/automated decisions and multiple-source data; quality and safety standards for all information systems where health data is processed, as well as the mechanism to monitor compliance of all parties involved in the processing of personal biomedical data with privacy protection laws, product liability, transparency, accountability and other ethical norms; _________________ 2Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).

2020/06/12
Committee: ENVI

Draft opinion
Paragraph 6 a (new)

6a. Emphasises the need to ensure that AI-driven medical devices should comply with the safety and performance requirements of the European Medical Devices Regulation; calls on the Commission and Member States to ensure that the Medical Devices Regulation is implemented with a view to these technologies; considers new guidelines and specifications are required for the evaluation of safety and effectiveness of software, AI and deep-learning powered devices throughout the entire usage cycle;

2020/06/12
Committee: ENVI

Draft opinion
Paragraph 6 b (new)

6b. Underlines that, in addition to clear regulatory requirements on accountability and liability, there is also a need to ensure algorithmic transparency, so that it is possible to track the moment when 'things went wrong' and allow for the timely intervention by experts; considers algorithmic transparency as crucial to prevent situations where medical decision-making is done in a 'black-box' environment; underlines that black-box algorithms that make inexplicable decisions are unacceptable in any sector but in a context where AI decision-making has an impact on life or death decisions, the consequences of algorithmic failure could be grave; calls on the Commission and Members States to open dialogue with key stakeholders from the fields of medicine, IT, mathematics, physics, medical data technology, clinical psychology, bioengineering and pharmaceutical to establish dialogue-building platforms and assess the impact on the doctor-patient relationship and the dehumanisation of medical care.

2020/06/12
Committee: ENVI

Draft opinion
Paragraph 6 c (new)

6c. Reiterates that opportunities and risks inherent to these technologies have a global dimension that requires a consistent harmonised approach at international level; calls on the Commission to work in bilateral and multilateral settings to advocate and ensure ethical compliance;

2020/06/12
Committee: ENVI

Draft opinion
Paragraph 7 a (new)

7a. Supports the recommendation of the High-Level Expert Group on AI to establish 720 expert chairs for AI ethics, 'one for every major European university'; considers that experts appointed to these positions could also strengthen links between science and civil society by convening public debates, interpreting research and offering interdisciplinary input to a new generation of students;

2020/06/12
Committee: ENVI

Draft opinion
Paragraph 8

8. Highlights the benefits of AI for disease prevention and control, exemplified by AI predicting the COVID19 epidemic before WHO; urges the Commission to equip ECDC in its reform, which was brought about by the COVID19 crisis, with the legal framework and resources allowing for gathering necessary anonymized data independently, including, among others, AI solutions;

2020/06/12
Committee: ENVI