Medicina | šŸ‡¬šŸ‡§ Medicine

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Artificial Intelligence and Machine Learning in Software as a Medical Device: discussion Paper and Request for Feedback

7 de May de 2020

Artificial intelligence and machine learning technologies have the potential to transform health care by deriving new and important insights from the vast amount of data generated during the delivery of health care every day. Medical device manufacturers are using these technologies to innovate their products to better assist health care providers and improve patient care. The FDA is considering a total product lifecycle-based regulatory framework for these technologies.

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

20 de April de 2020

FDA need to widen their scope from evaluating medical AI/ML-based products to assessing systems. This shift in perspectiveā€”from a product view to a system viewā€”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

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Cyber Europe 2020: Preparing healthcare sector to respond to cyber crises

15 de April de 2020

In 2020, European countries and the EU Agency for Cybersecurity (ENISA) should have organised the 6th pan European cyber crisis exercise, Cyber Europe 2020 (CE2020). However, due to the current health crisis Cyber Europe will be shifted to a later date, yet to be announce. CE2020 is part of the bi-annual Cyber Europe series of exercises launched in 2010.

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ICT security certification opportunities in the healthcare sector

15 de April de 2020

Digital solutions for healthcare open a plethora of new possibilities in this area. They provide a technical base for easy testing, they improve significantly the quality of service by allowing immediate access to medical data ā€“ results of tests, history of treatment; they facilitate correct diagnosis by easier analytics and correlation of data and easier monitoring of patientsā€™ health parameters. They facilitate setting up appointments with appropriate doctors at a convenient time

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EUvsVirus, a pan-European hackathon: When? 24, 25 and 26 April

12 de April de 2020

The European Commission, in close collaboration with EU member states, will host a pan-European hackathon to connect civil society, innovators, partners and buyers across Europe to develop innovative solutions to overcome coronavirus-related challenges.