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1. Confirmation of conformity with relevant general safety and performance requirements set out in Annex I under the normal conditions of the intended use of the device, and the evaluation of the undesirable side-effects and of the acceptability of the benefit-risk-ratio referred to in Sections 1...
The EU AI Act foresees the creation of a European database where all providers, ARs, and the AI systems will be registered. It establishes a governance structure for the oversight and enforcement of the regulation. It creates a European Artificial Intelligence Board (EAIB),...
A high-risk AI system may be a safety component of a medical device regulated under the Medical Devices Regulation (European Parliament and European Council 2017) or other specific regulatory regimes (e.g. General Data Protection Regulation (GDPR) of the European Parliament and European Council (...
Products that contain SVHC aren’t necessarily prohibited. However, if your product contains more than 0.1% of any SVHC, you are required to register and enter this fact into the SCIP database. By doing this, you notify the ECHA about the substance’s presence in their product. ...
(text, binary, …) which makes it harder to aggregate and interpret the data. For example, there is often a lack of meta information containing device details such as the used technology, a description of the involved devices, and used signals. This could be mitigated by the introduction of...
Towards a Multi-Dimensional ApproachAdolescent and Youth Sexual and Reproductive Health and RightsAdolescent Depression PreventionAdvances and Effectiveness of School-Based Interventions for Wellbeing and HealthAdvances and Innovations in Mental Health and Public HealthAdvances in Big Data Analytics and Intellig...
For at least six years, law enforcement officials working on a counternarcotics program have had routine access, using subpoenas, to an enormous AT&T database that contains the records of decades of Americans’ phone calls — parallel to but covering a far longer time than the National Security...