IA y dispositivos médicos: laberinto regulatorio internacional

The regulation of artificial intelligence in medical devices is a complex process that seeks to balance patient safety with technological innovation. Since algorithms can present risks inherent to data quality or their implementation, emerging legal frameworks prioritize the assessment of potential hazards. This approach ensures that digital tools do not compromise public health while new clinical solutions are developed. In this context, transparency and information management are fundamental pillars, which are directly relevant to the open data movement. Regulations such as the General Data Protection Regulation (GDPR) require rigorous processing of health data, including explicit consent and privacy protection. To meet these standards without hindering research, it is crucial to have open, standardized, and high-quality datasets that enable auditing of AI models, thereby ensuring their explainability, fairness, and technical safety before competent authorities. Globally, different regulatory models coexist: the European Union implements a strict system based on risk and compliance, while other countries opt for flexible principles or specific vertical regulations. This diversity forces companies to navigate a fragmented yet interconnected legal landscape. The relevance of open data lies in its ability to facilitate interoperability and external validation of these systems, offering a key mechanism for building trust and ensuring that digital health innovation is ethical, safe, and accessible under frameworks such as the AI Act (AIA) or the Medical Devices Regulation (MDR).

Source: elfinancierocr.com
Published on 2023-08-18

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