AI Article Synopsis
- The newly adopted EU AI Act marks a significant step in regulating AI across various industries, setting strict requirements for AI systems.
- The article explores how the Act affects AI/ML-enabled medical devices, including their classification and compliance obligations for providers.
- It also discusses the broader implications of the AI Act for the future of regulated digital medical products.
Article Abstract
The newly adopted EU AI Act represents a pivotal milestone that heralds a new era of AI regulation across industries. With its broad territorial scope and applicability, this comprehensive legislation establishes stringent requirements for AI systems. In this article, we analyze the AI Act’s impact on digital medical products, such as medical devices: How does the AI Act apply to AI/ML-enabled medical devices? How are they classified? What are the compliance requirements? And, what are the obligations of ‘providers’ of these AI systems? After addressing these foundational questions, we discuss the AI Act’s broader implications for the future of regulated digital medical products.
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Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11379845 | PMC |
| http://dx.doi.org/10.1038/s41746-024-01232-3 | DOI Listing |
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