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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Infant monitoring specialist Owlet’s Dream Sock has received CE Mark certification by the European Union, meeting its required safety and health requirements and paving the way for the device to be sold in Germany,…
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With the advent of artificial intelligence and Big Data – projects, the necessity for a transition from analog medicine to modern-day solutions such as cloud computing becomes unavoidable. Even though this need is now…
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The U.S. government and the European Union both realize the need for measured control over the latest technology. Implement too many regulations too quickly and you stifle innovation. Move too slowly and you risk…
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