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Desafíos actuales y el camino a seguir para las bases de datos regulatorias de inteligencia artificial como
Ariel Yuhan Ong1,2,3,4, Aditya U Kale5,6,7, Joe Antoun8
1Moorfields Eye Hospital NHS Foundation Trust, London, United Kingdom. ariel.ong@nhs.net.
NPJ digital medicine
|February 11, 2026
Resumen
Asegurar la seguridad de la inteligencia artificial como un dispositivo médico (AIaMD) requiere una supervisión regulatoria efectiva. Mejorar la calidad y la accesibilidad de los datos en las bases de datos regulatorias es crucial para acelerar la innovación y la seguridad del paciente.
Área de la Ciencia:
- El Reglamento de Dispositivos Médicos.
- Inteligencia Artificial en el cuidado de la salud.
- Informática de la salud Informática de la salud.
Sus antecedentes:
- La supervisión regulatoria efectiva es esencial para la implementación clínica segura de AIaMD.
- Las bases de datos regulatorias internacionales son fuentes clave de información para la evaluación de AIaMD.
- La experiencia multidisciplinaria es vital para abordar los desafíos regulatorios de AIaMD.
Objetivo del estudio:
- Proporcionar información sobre los desafíos e iniciativas en la supervisión regulatoria de AIaMD.
- Para resaltar la cuestión crítica de la calidad de los datos y la disponibilidad en las bases de datos regulatorias.
- Proponer consideraciones para un ecosistema de datos regulatorios de próxima generación para AIaMDs.
Principales métodos:
- Análisis de las bases de datos regulatorias internacionales.
- Revisión de expertos y conocimientos multidisciplinarios.
- Identificación de los desafíos clave y las iniciativas emergentes en la regulación de AIaMD.
Principales resultados:
- Se identificaron cuatro desafíos clave en la regulación de AIaMD.
- Se discutieron los intentos de eludir las limitaciones regulatorias.
- Se destacó el problema persistente de la calidad y disponibilidad de los datos de entrada en las bases de datos regulatorias.
Conclusiones:
- Es necesario mejorar la accesibilidad y la transparencia de los datos regulatorios.
- Se necesita un ecosistema de datos regulatorios de próxima generación para AIaMDs.
- La alineación global de las partes interesadas es crucial para una hoja de ruta para la innovación segura de AIaMD y la mejora de los resultados de los pacientes.
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