Del dispositivo físico al algoritmo: evolución y marco actual de la regulación del software médico en Estados Unidos

• Marina Morla González ^[1]
  1. [1] Universidad de León

     Universidad de León

     León, España

     
• Localización: DS : Derecho y salud, ISSN 1133-7400, Vol. 35, Nº. 2, 2025, págs. 39-53
• Idioma: español
• Texto completo no disponible (Saber más ...)
• Resumen
  • español

    El artículo analiza la evolución y el marco actual de la regulación del software médico en Estados Unidos, con especial atención al papel de la FDA y el CDRH. Se abordan los criterios de clasificación por riesgo, los procedimientos de autorización (Premarket Notification, Premarket Approval y De Novo) y la regulación específica de las aplicaciones médicas móviles y del Software as a Medical Device (SaMD).

    Asimismo, se examinan los desafíos que plantea la inteligencia artificial, incluyendo transparencia algorítmica, sesgos y actualización continua. El trabajo propone recomendaciones para un marco regulador ágil, basado en el riesgo y centrado en el paciente, que garantice seguridad, eficacia y equidad en el uso de software médico inteligente.

  • English

    This article examines the evolution and current framework for medical software regulation in the United States, with a focus on the role of the FDA and the CDRH. It addresses risk-based classification criteria, authorization procedures (Premarket Notification, Premarket Approval, De Novo), and the specific regulation of mobile medical applications and Software as a Medical Device (SaMD). The challenges posed by artificial intelligence—such as algorithmic transparency, bias, and continuous updates—are also discussed. The study offers recommendations for a patient-centered, risk-based, and agile regulatory framework that ensures the safety, effectiveness, and fairness of intelligent medical software.

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