Artificial Intelligence Act
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Artificial Intelligence Act
The Artificial Intelligence Act (AI Act) is a proposed regulation by the European Commission which aims to introduce a common regulatory and legal framework for artificial intelligence. Its scope encompasses all sectors (except for military), and to all types of artificial intelligence. As a piece of product regulation, the proposal does not confer rights on individuals, but regulates the providers of artificial intelligence systems, and entities making use of them in a professional capacity. The proposed regulation classifies artificial intelligence applications by risk, and regulates them accordingly. Low-risk applications are not regulated at all, with Member States largely precluded via maximum harmonisation from regulating them further and existing national laws relating to the regulation of design or use of such systems disapplied. A voluntary code of conduct scheme for such low risk systems is envisaged, although not present from the outset. Medium and high-risk systems w ...
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European Commission
The European Commission (EC) is the executive of the European Union (EU). It operates as a cabinet government, with 27 members of the Commission (informally known as "Commissioners") headed by a President. It includes an administrative body of about 32,000 European civil servants. The Commission is divided into departments known as Directorates-General (DGs) that can be likened to departments or ministries each headed by a Director-General who is responsible to a Commissioner. There is one member per member state, but members are bound by their oath of office to represent the general interest of the EU as a whole rather than their home state. The Commission President (currently Ursula von der Leyen) is proposed by the European Council (the 27 heads of state/governments) and elected by the European Parliament. The Council of the European Union then nominates the other members of the Commission in agreement with the nominated President, and the 27 members as a team are then ...
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Regulation (European Union)
A regulation is a legal act of the European Union that becomes immediately enforceable as law in all member states simultaneously. Regulations can be distinguished from directives which, at least in principle, need to be transposed into national law. Regulations can be adopted by means of a variety of legislative procedures depending on their subject matter. Description The description of regulations can be found in Article 288 of the Treaty on the Functioning of the European Union (formerly Article 249 TEC). Article 288 To exercise the Union's competences, the institutions shall adopt regulations, directives, decisions, recommendations and opinions. A regulation shall have general application. It shall be binding in its entirety and directly applicable in all Member States. A directive shall be binding, as to the result to be achieved, upon each Member State to which it is addressed, but shall leave to the national authorities the choice of form and methods. A decision ...
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Artificial Intelligence
Artificial intelligence (AI) is intelligence—perceiving, synthesizing, and inferring information—demonstrated by machines, as opposed to intelligence displayed by animals and humans. Example tasks in which this is done include speech recognition, computer vision, translation between (natural) languages, as well as other mappings of inputs. The ''Oxford English Dictionary'' of Oxford University Press defines artificial intelligence as: the theory and development of computer systems able to perform tasks that normally require human intelligence, such as visual perception, speech recognition, decision-making, and translation between languages. AI applications include advanced web search engines (e.g., Google), recommendation systems (used by YouTube, Amazon and Netflix), understanding human speech (such as Siri and Alexa), self-driving cars (e.g., Tesla), automated decision-making and competing at the highest level in strategic game systems (such as chess and Go). ...
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Maximum Harmonisation
Maximum harmonisation is a term used in EU law. If a piece of law (usually a directive but occasionally also a regulation) is described as maximum harmonisation, national law may not exceed the terms of the legislation. In practice, that prohibits gold-plating of EU legislation when it is transposed into national law. It may also result in the repeal or amendment of existing national law, such as the effect of the Unfair Commercial Practices Directive on the British Trade Descriptions Act 1968. Traditionally it was fairly uncommon for European legislation to be drafted on such a basis. However, deregulation has risen in the political agenda in the EU, as have concerns that member states occasionally use the national implementation of EU law as an opportunity to indulge in backdoor protectionism. It is quite common for a directive or recommendation to consist of a mixture of maximum harmonisation and minimum harmonisation Minimum harmonisation is a term used in Europea ...
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Conformity Assessment
Conformance testing — an element of conformity assessment, and also known as compliance testing, or type testing — is testing or other activities that determine whether a process, product, or service complies with the requirements of a specification, technical standard, contract, or regulation. Testing is often either logical testing or physical testing. The test procedures may involve other criteria from mathematical testing or chemical testing. Beyond simple conformance, other requirements for efficiency, interoperability or compliance may apply. Conformance testing may be undertaken by the producer of the product or service being assessed, by a user, or by an accredited independent organization, which can sometimes be the author of the standard being used. When testing is accompanied by certification, the products or services may then be advertised as being certified in compliance with the referred technical standard. Manufacturers and suppliers of products and services rely ...
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Notified Body
A notified body, in the European Union, is an organisation that has been designated by a member state to assess the conformity of certain products, before being placed on the EU market, with the applicable essential technical requirements. These essential requirements are publicised in European directives or regulations. A manufacturer can use voluntarily European harmonised standards to demonstrate that a product complies with some (or all) of the EU essential requirements; alternatively, a notified body assess the conformity to these essential requirements. Conformity assessment can include inspection and examination of a product, its design, and the manufacturing environment and processes associated with it. For example, a notified body may designate that a medical device conforms to the essential requirements of the Medical Devices Regulation (MDR (EU) 2017/745) which defines the applicable legislation, including the general safety and performance requirements, for medical de ...
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Regulation (EU) 2017/745
Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and sale of medical devices for human use. It repeals Directive 93/42/EEC (MDD), which concerns medical devices, and Directive 90/385/EEC, which concerns active implantable medical devices, on 26 May 2021. The regulation was published on 5 April 2017 and came into force on 25 May 2017. Originally approved medical devices will have a transition time of three years (until 26 May 2021) to meet new requirements. Changes Changes compared to the Medical Device Directive include changes in device classification and device scope, stricter oversight of manufacturers by Notified Bodies, introduction of the "Person Responsible for Regulatory Compliance" (PRRC) and of the economic operator concept, the requirement of Unique Device Identification marking for devices, EUDAMED registration (see below Below may refer to: *Earth *Ground (other) *Soil *Floor *Bottom (other) Bot ...
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EUR-Lex
Eur-Lex (stylized EUR-Lex) is an official website of European Union law and other public documents of the European Union (EU), published in 24 official languages of the EU. The Official Journal (OJ) of the European Union is also published on EUR-Lex. Users can access EUR-Lex free of charge and also register for a free account, which offers extra features. History Data processing of legal texts at the European Commission started way back in the 1960s, still using punch cards at the time. A system was being developed to capture relationships between documents and analyse them to extract and re-use metadata, but also to make retrieval easier. Through the years, the system and its scope grew as the Commission started collaborating with other institutions of the European Union and as the Union started expanding. It was named CELEX (Communitatis Europae Lex) and soon became a well-used interinstitutional tool. While initially used only internally, the system went through various de ...
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Policies Of The European Union
Policy is a deliberate system of guidelines to guide decisions and achieve rational outcomes. A policy is a statement of intent and is implemented as a procedure or protocol. Policies are generally adopted by a governance body within an organization. Policies can assist in both ''subjective'' and ''objective'' decision making. Policies used in subjective decision-making usually assist senior management with decisions that must be based on the relative merits of a number of factors, and as a result, are often hard to test objectively, e.g. work–life balance policy... Moreover, Governments and other institutions have policies in the form of laws, regulations, procedures, administrative actions, incentives and voluntary practices. Frequently, resource allocations mirror policy decisions. Policy is a blueprint of the organizational activities which are repetitive/routine in nature. In contrast, policies to assist in objective decision-making are usually operational in nature ...
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European Digital Strategy
European, or Europeans, or Europeneans, may refer to: In general * ''European'', an adjective referring to something of, from, or related to Europe ** Ethnic groups in Europe ** Demographics of Europe ** European cuisine European cuisine comprises the cuisines of Europe "European Cuisine."European Union ** Citizenship of the European Union **
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2021 In Law
1 (one, unit, unity) is a number representing a single or the only entity. 1 is also a numerical digit and represents a single unit (measurement), unit of counting or measurement. For example, a line segment of ''unit length'' is a line segment of length 1. In conventions of sign where zero is considered neither positive nor negative, 1 is the first and smallest Positive number, positive integer. It is also sometimes considered the first of the sequence (mathematics), infinite sequence of natural numbers, followed by 2, although by other definitions 1 is the second natural number, following 0. The fundamental mathematical property of 1 is to be a multiplicative identity, meaning that any number multiplied by 1 equals the same number. Most if not all properties of 1 can be deduced from this. In advanced mathematics, a multiplicative identity is often denoted 1, even if it is not a number. 1 is by convention not considered a prime number; this was not universally ac ...
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