With the increasing digital transformation of healthcare and improvements in the quality of data, IT systems in healthcare are becoming an increasingly attractive target for malicious actors. A cyberattack can cripple an institution, cause…
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The European Union has released Guidelines to provide legal clarity on the prohibited uses of AI within the EU AI Act to ensure effective, consistent and uniform application and protect European citizens’ rights and…
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What You Should Know:
– Medtronic (NYSE:MDT), a global leader in healthcare technology, announced it has received CE Mark approval for its groundbreaking BrainSense™ Adaptive deep brain stimulation (aDBS) technology in the European Union and…
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During his tenure as head of the Portuguese Digital Health Agency between 2013 and 2020, Henrique Martins was responsible for advancing the nation’s eHealth strategy, including projects such as the health information sharing platform…
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Linus Health, a digital health company focused on early detection of Alzheimer’s and other dementias, announced that its Core Cognitive Evaluation (CCE) platform has obtained European Union (EU) Medical Device Regulation (MDR) Class IIa…
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The European Union (EU) Medical Device Regulation and In Vitro Medical Device Regulation have introduced more rigorous regulatory requirements for medical devices, including new rules for post-market surveillance. However, EU market vigilance is limited…
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Digital medical devices (DMDs) present unique opportunities in their regulation and reimbursement. A dynamic landscape of DMD assessment frameworks is emerging within the European Union, with five clusters of prevailing approaches identified. Despite notable…
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This paper focuses on how regulatory bodies respond to artificial intelligence (AI)-enabled medical devices. To achieve this, we present a comparative overview of the United States (USA), European Union (EU), and China. Our search…
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Regulatory frameworks for artificial intelligence (AI) are needed to mitigate risks while ensuring the ethical, secure, and effective implementation of AI technology in healthcare and population health. In this article, we present a synthesis…
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The European Union’s recently adopted Artificial Intelligence (AI) Act is the first comprehensive legal framework specifically on AI. This is particularly important for the healthcare domain, as other existing harmonisation legislation, such as the…
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