Dies ist eine Übersichtsseite mit Metadaten zu dieser wissenschaftlichen Arbeit. Der vollständige Artikel ist beim Verlag verfügbar.
Global Harmonization of Artificial Intelligence-Enabled Software as a Medical Device Regulation: Addressing Challenges and Unifying Standards
27
Zitationen
1
Autoren
2024
Jahr
Abstract
The growing incorporation of artificial intelligence (AI) into medical device software offers substantial prospects and regulatory hurdles. As AI software as a medical device (AI-SaMD) continues to advance, ensuring its safety, effectiveness, and security is paramount. Nevertheless, the regulatory environment needs more cohesion, with various regions implementing diverse strategies. This paper underscores the necessity for globally harmonized AI-SaMD regulations by examining key regulatory frameworks from the United States, the European Union, China, and Australia. The article also explores crucial elements for harmonization, including algorithm transparency, risk management, data security, and clinical evaluation. Furthermore, the paper advocates for implementing international standards and global data security protocols, emphasizing the significance of cross-border cooperation to ensure the worldwide safety and efficacy of AI-SaMD.
Ähnliche Arbeiten
Explainable Artificial Intelligence (XAI): Concepts, taxonomies, opportunities and challenges toward responsible AI
2019 · 8.460 Zit.
Stop explaining black box machine learning models for high stakes decisions and use interpretable models instead
2019 · 8.341 Zit.
High-performance medicine: the convergence of human and artificial intelligence
2018 · 7.791 Zit.
Proceedings of the 19th International Joint Conference on Artificial Intelligence
2005 · 5.781 Zit.
Peeking Inside the Black-Box: A Survey on Explainable Artificial Intelligence (XAI)
2018 · 5.536 Zit.