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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The European Union (EU) is in the middle of transformative efforts to digitalise healthcare systems across the continent, with initiatives focused on everything from electronic health record (EHR) interoperability to more comprehensive digital tools…
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Diabetes management company Glooko is partnering with Copenhagen-based Hedia to integrate its app into Glooko’s remote monitoring platform. The Hedia Diabetes Assistant allows patients to input their blood glucose, meals and activity levels and provides…
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We'd like to present to you our new episode of Digital Health Interview with an amazing Aline Noizet – Digital Health Connector https://www.digitalhealthconnector.com/.This is our small anniversary since this is our 30th episode and…
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