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Artificial intelligence requires input of data in order to advance its training. Some issues concern where the data may come from, ensuring patient privacy, and how to standardize regulations across all models.
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Currently, the FDA has established a framework for evaluating AI-based medical devices focusing on premarket review, post-market surveillance, and continuous learning.
AI models are assessed based on their intended use, risk to patients, and the nature of their algorithm. Diagnostic AI tools, which directly inform clinical decision without human intervention, carry a higher risk if they fail or provide inaccurate results. Consequently, they require comprehensive validation and monitoring to ensure their safety and effectiveness.
The WHO guidance on Ethics and Governance of Artificial Intelligence for Health, developed over eighteen months by experts in various fields, addresses the promise of AI in improving health related functions such as diagnosis, treatment, and public health response. The report emphasizes that AI technologies must prioritize ethics and human rights, ethical challenges, and six principles to ensure AI benefits all countries, and provides recommendations for governing AI.
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