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The need for a system view to regulate artificial intelligence/machine learning-based software as medical device

FDA need to widen their scope from evaluating medical AI/ML-based products to assessing systems. This shift in perspective—from a product view to a system view—is central to maximizing the safety and efficacy of AI/ML in health care, but it also poses significant challenges for agencies like the FDA who are used to regulating products, not systems. We offer several suggestions for regulators to make this challenging but important transition

When Autonomous Vehicles Are Hacked, Who Is Liable?

Who might face civil liability if autonomous vehicles (AVs) are hacked to steal data or inflict mayhem, injuries, and damage? How will the civil justice and insurance systems adjust to handle such claims? RAND researchers addressed these questions to help those in the automotive, technology, legal, and insurance industries prepare for the shifting roles and responsibilities that the era of AVs may bring.

Standardisation in support of the Cybersecurity Certification

The document presents the value of the cybersecurity standardisation efforts for certification, the roles and responsibilities of Standards Developing Organisations (SDOs) in this context, and discusses various ways how standardisation can support efficiently the process of certification schemes creation by following a step by step methodology.

Artificial Intelligence in Society

“The artificial intelligence (AI) landscape has evolved significantly from 1950 when Alan Turing first posed the question of whether machines can think. Today, AI is transforming societies and economies. It promises to generate productivity gains, improve well-being and help address global challenges, such as climate change, resource scarcity and health crises. Yet, as AI applications are adopted around the world, their use can raise questions and challenges related to human values, fairness, human determination, privacy, safety and accountability, among others. This report helps build a shared understanding of AI in the present and near-term by mapping the AI technical, economic, use case and policy landscape and identifying major public policy considerations. It is also intended to help co-ordination and consistency with discussions in other national and international fora”. (OECD)

A European strategy for data

The EU can become a leading role model for a society empowered by data to make better decisions -in business and the public sector. To fulfil this ambition, the EU can build on a strong legal framework – in terms of data protection, fundamental rights, safety and cybersecurity and its internal market with competitive companies of all sizes and varied industrial base.
In the period 2021-2027, the Commission will invest in a High Impact Project on European data spaces and federated cloud infrastructures.

WHITE PAPER On Artificial Intelligence – A European approach to excellence and trust

The purpose of this White Paper is to set out policy options on how to achieve these objectives. It does not address the development and use of AI for military purposes.The Commission invites Member States, other European institutions, and all stakeholders, including industry, social partners, civil society organisations, researchers, the public in general and any interested party, to react to the options and to contribute to the Commission’s future decision-making in this domain.

Ley: diseño de Inteligencia Artificial éticamente alineado (IEEE)

EAD, Primera edición, incluye comentarios sobre cómo la ley debe responder a una serie de desafíos éticos y legales específicos que plantea el desarrollo y despliegue de A/IS (Autonomous and Intelligent Systems) en la vida contemporánea. También se centra en el impacto de A/IS en la práctica del derecho mismo. Más específicamente, se estudia tanto …

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Regulación de la Inteligencia Artificial en 7 puntos estratégicos mundiales y conclusiones

|Autor: Juan Antonio Lloret Egea ||© 2019. Licencia de uso y distribución: Creative Commons CC BY 4.0 | Escrito: 25/10/2019. Actualizado: 25/10/2019 | | Preprint DOI 10.13140/RG.2.2.14464.38402 | 9.3-1.- Introducción Una encuesta de organizaciones internacionales describe el enfoque que los organismos de las Naciones Unidas y las organizaciones regionales han adoptado hacia la IA Para describir …

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