24

resultat(er)

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Boosting cooperation on health technology assessment

15-04-2019

The European Commission has proposed a regulation on health technology assessment (HTA). HTA is a research-based tool that supports decision-making in healthcare by assessing the added value of a given health technology compared to others. The proposal would provide the basis for permanent EU-level cooperation in four areas. Member States would still be responsible for assessing the non-clinical (economic, ethical, social, etc.) aspects of health technology, and for pricing and reimbursement. While ...

The European Commission has proposed a regulation on health technology assessment (HTA). HTA is a research-based tool that supports decision-making in healthcare by assessing the added value of a given health technology compared to others. The proposal would provide the basis for permanent EU-level cooperation in four areas. Member States would still be responsible for assessing the non-clinical (economic, ethical, social, etc.) aspects of health technology, and for pricing and reimbursement. While Member States could choose to delay participation in the joint work until three years after the rules enter into force, it would become mandatory after six years. Stakeholders have broadly welcomed the proposal. National parliaments, however, are divided in their appreciation of it. The Council has not yet agreed its position; technical discussions continue. Parliament's Committee on the Environment, Public Health and Food Safety adopted its report on 13 September 2018, and the report was voted in plenary on 3 October. However, with interinstitutional trilogue negotiations unable to start, on the Council side, Parliament adopted its final position at first reading on 14 February 2019.

Robots in healthcare: a solution or a problem?

15-03-2019

This report summarises the presentations and discussions of a workshop on the use of robots and AI in healthcare, held at the European Parliament in Brussels on Tuesday 19 February 2019. The aim of the workshop was to provide background information and advice for Members of the ENVI Committee on the status and prospects of applying robotic and artificial intelligence (AI) based technologies in healthcare. The first part of the workshop focused on the practical application of AI and robots in healthcare ...

This report summarises the presentations and discussions of a workshop on the use of robots and AI in healthcare, held at the European Parliament in Brussels on Tuesday 19 February 2019. The aim of the workshop was to provide background information and advice for Members of the ENVI Committee on the status and prospects of applying robotic and artificial intelligence (AI) based technologies in healthcare. The first part of the workshop focused on the practical application of AI and robots in healthcare, while the second part examined the ethical implications and responsibilities of AI and robotic based technologies in healthcare.

Ekstern forfatter

Zrinjka DOLIC, Milieu Consulting Rosa CASTRO, Milieu Consulting Andrei MOARCAS, Milieu Consulting

The benefit of EU action in health policy: The record to date

08-03-2019

European health policy measures taken to date are highly beneficial to and relevant for European citizens, economies and the Member States. The EU does acquit its responsibility and utilises its capacity to act on behalf of EU citizens in this policy area. The study concludes that EU health policy clearly achieves added value.

European health policy measures taken to date are highly beneficial to and relevant for European citizens, economies and the Member States. The EU does acquit its responsibility and utilises its capacity to act on behalf of EU citizens in this policy area. The study concludes that EU health policy clearly achieves added value.

Strengthening EU cooperation on health technology assessment

18-06-2018

The impact assessment (IA) accompanying the Commission proposal on strengthening EU cooperation on Health Technology Assessment clearly defines the problem, as well as the general and specific objectives. However, the IA does not appear to have succeeded in presenting a very convincing range of options. The analysis of impacts focuses on the economic dimension, which is consistent with the manner in which the problems have been defined. In light of the reported concentration of SMEs in the medical ...

The impact assessment (IA) accompanying the Commission proposal on strengthening EU cooperation on Health Technology Assessment clearly defines the problem, as well as the general and specific objectives. However, the IA does not appear to have succeeded in presenting a very convincing range of options. The analysis of impacts focuses on the economic dimension, which is consistent with the manner in which the problems have been defined. In light of the reported concentration of SMEs in the medical technologies sector (95 %), more emphasis could have been put on analysing the impacts of the retained options on them. The stakeholders' views have been illustrated in a satisfactory way. The evidence included or referenced in the IA is copious and up to date. The IA appears to have addressed most of the RSB's recommendations. Finally, the legislative proposal appears to be consistent with the analysis carried out in the IA.

Assistive technologies for people with disabilities

15-01-2018

Assistive technologies (ATs) are designed to improve the functional capabilities of people with disabilities. Some are relatively low-tech and very familiar, such as such as reading glasses, crutches and hearing aids. Others are more advanced, using cutting-edge science and technology, with future ATs under development that could have a huge impact on all our lives. This briefing provides an overview of a scientific foresight study of ATs for three specific types of disability: blindness and visual ...

Assistive technologies (ATs) are designed to improve the functional capabilities of people with disabilities. Some are relatively low-tech and very familiar, such as such as reading glasses, crutches and hearing aids. Others are more advanced, using cutting-edge science and technology, with future ATs under development that could have a huge impact on all our lives. This briefing provides an overview of a scientific foresight study of ATs for three specific types of disability: blindness and visual impairment, deafness and hearing impairment, and autism spectrum disorders.

Understanding artificial intelligence

11-01-2018

Artificial intelligence (AI) systems already permeate daily life: they drive cars, decide on mortgage applications, translate texts, recognise faces on social networks, identify spam emails, create artworks, play games, and intervene in conflict zones. The AI revolution that began in the 2000s emerged from the combination of machine learning techniques and 'big data'. The algorithms behind these systems work by identifying statistical correlation in the data they analyse, enabling them to perform ...

Artificial intelligence (AI) systems already permeate daily life: they drive cars, decide on mortgage applications, translate texts, recognise faces on social networks, identify spam emails, create artworks, play games, and intervene in conflict zones. The AI revolution that began in the 2000s emerged from the combination of machine learning techniques and 'big data'. The algorithms behind these systems work by identifying statistical correlation in the data they analyse, enabling them to perform tasks for which intelligence is required if a human were to perform them. Nevertheless, data-driven AI can only perform one task at a time, and cannot transfer its knowledge. 'Strong AI', able to display human-like intelligence and common sense, and which might be able to set its own goals, is not yet within reach. Despite the fears portrayed in film and TV entertainment, the idea of a 'superintelligence' able to self-improve and dominate humans remains an esoteric possibility, as development of strong AI systems is not predicted for a few decades or more, if indeed development ever reaches this stage. Nevertheless, the development of data-driven AI systems implies adaptation of legal frameworks on the collection, use and storage of data, due to privacy and other issues. Bias in data supplied to AI systems can also reproduce or amplify bias in the decisions they make. However, the key issue remains the level of autonomy given to AI systems to make decisions that could be life-changing, keeping in mind that they only provide recommendations, that they do not understand the tasks they perform, and that there is no way to know how they reach their conclusions. AI systems are expected to impact society, especially the job market, and could increase inequalities. To counter the abuse of probabilistic prediction and the risks to privacy, in April 2016 the European Parliament and the Council of the EU adopted the General Data Protection Regulation. The European Parliament also requested an update of the Union legal framework on robotics and AI in February 2017.

Medical devices and in vitro diagnostic medical devices

10-05-2017

Medical devices and in vitro diagnostic medical devices cover a wide array of products. The EU legal framework for such devices was harmonised in the 1990s. The European Commission presented a pair of proposals for regulations in September 2012. Following Parliament's first readings in April 2014, the Council agreed its positions in October 2015. At the conclusion of the trilogues, agreement was reached on 25 May 2016. This was endorsed by the Council's Permanent Representatives Committee on 15 June ...

Medical devices and in vitro diagnostic medical devices cover a wide array of products. The EU legal framework for such devices was harmonised in the 1990s. The European Commission presented a pair of proposals for regulations in September 2012. Following Parliament's first readings in April 2014, the Council agreed its positions in October 2015. At the conclusion of the trilogues, agreement was reached on 25 May 2016. This was endorsed by the Council's Permanent Representatives Committee on 15 June and confirmed by Parliament's ENVI Committee on the same day. Both draft texts were adopted by the Council on 7 March 2017, and Parliament's second-reading vote on 5 April completed the adoption procedure. The regulation on medical devices will become fully applicable in May 2020, and that on in vitro diagnostic medical devices in May 2022.

Medical devices and in vitro diagnostic medical devices

29-03-2017

The current EU approval system for medical devices (MDs) and in vitro diagnostic medical devices (IVDs) is based on conformity assessment by 'notified bodies'. A number of scandals stressed the need to tighten the regulatory framework for such devices. The European Commission's proposals for regulations on MDs and IVDs, being discussed in parallel, are extensive and will repeal all existing rules. Votes in Parliament at second reading are expected during the April I plenary.

The current EU approval system for medical devices (MDs) and in vitro diagnostic medical devices (IVDs) is based on conformity assessment by 'notified bodies'. A number of scandals stressed the need to tighten the regulatory framework for such devices. The European Commission's proposals for regulations on MDs and IVDs, being discussed in parallel, are extensive and will repeal all existing rules. Votes in Parliament at second reading are expected during the April I plenary.

Medical devices and in vitro diagnostic medical devices

16-01-2017

Medical devices and in vitro diagnostic medical devices cover a wide array of products. The EU legal framework for such devices was harmonised in the 1990s. The European Commission presented a pair of proposals for regulations in September 2012, to update the framework. Following Parliament's first readings in April 2014, the Council agreed its positions in October 2015. At the conclusion of the trilogue meetings, agreement was reached on both proposals on 25 May 2016. This was endorsed by the Council's ...

Medical devices and in vitro diagnostic medical devices cover a wide array of products. The EU legal framework for such devices was harmonised in the 1990s. The European Commission presented a pair of proposals for regulations in September 2012, to update the framework. Following Parliament's first readings in April 2014, the Council agreed its positions in October 2015. At the conclusion of the trilogue meetings, agreement was reached on both proposals on 25 May 2016. This was endorsed by the Council's Permanent Representatives Committee on 15 June and confirmed by Parliament's ENVI Committee on the same day. Political agreement in the Council was reached in September. Both drafts are now undergoing legal-linguistic revision. The formal first reading of the Council is expected early this year, followed by final approval, at second reading, by Parliament. This updates a previous edition, from June 2016: PE 583.812.

What if I had to put my safety in the hands of a robot?

18-11-2016

Will intelligent robots bring us benefits in relation to security and safety, or will the vulnerabilities within these systems mean that they cause more problems than they solve? Cyber-physical systems (CPS) are currently found in a wide range of services and applications, and their numbers are rapidly increasing. CPS are intelligent robotic systems linked to the Internet of Things. They make decisions based on the ability to sense their environment. Their actions have a physical impact on either ...

Will intelligent robots bring us benefits in relation to security and safety, or will the vulnerabilities within these systems mean that they cause more problems than they solve? Cyber-physical systems (CPS) are currently found in a wide range of services and applications, and their numbers are rapidly increasing. CPS are intelligent robotic systems linked to the Internet of Things. They make decisions based on the ability to sense their environment. Their actions have a physical impact on either the environment or themselves. This is what sets CPS apart: they are not solely smart systems, but rather, they have physical aspects to them. These robots are likely to infiltrate our everyday lives in the coming years. Due to this, we must look at what impact they will have on citizens’ safety and security. The question remains, how safe are these technologies?

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