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Research Paper | Information Technology | United States of America | Volume 13 Issue 7, July 2024 | Rating: 5.8 / 10
Validation and Verification of Artificial Intelligence Containing Products Across the Regulated Healthcare or Medical Device Industries
Nirali Shah
Abstract: This article examines the validation and verification (V&V) of artificial intelligence (AI) tools in regulated healthcare and medical device industries, focusing on the necessity of adhering to ISO standards and FDA guidelines. The study employs a detailed analysis of current V&V techniques, regulatory frameworks, and case studies to evaluate the efficacy and challenges of integrating AI in healthcare. Key findings highlight the importance of robust data protection, mitigation of algorithmic bias, and establishing clear accountability frameworks to ensure patient safety and trust. The research underscores the ethical and safety considerations essential for the responsible deployment of AI technologies. The novelty of this work lies in its comprehensive approach, combining traditional validation methods with innovative AI - specific strategies, providing a holistic perspective on ensuring the reliability and effectiveness of AI in healthcare.
Keywords: artificial intelligence, healthcare, medical devices, validation, verification, ISO standards, FDA guidance, data protection, algorithmic bias, ethical considerations
Edition: Volume 13 Issue 7, July 2024,
Pages: 66 - 71