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La Sociedad de Medicina Digital lanza recursos para explorar las vías regulatorias de la salud digital global
  • USA - English
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Delivering clinical quality resources on a tech timeline to advance the safe, effective, ethical, and equitable use of digital medicine to optimize human health.

News provided by

Digital Medicine Society (DiMe)

Nov 19, 2024, 12:46 ET

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Los recursos acelerarán la expansión de los productos de salud digitales en todo el mundo, mejorando el acceso global de los pacientes

BOSTON, 19 de noviembre de 2024 /PRNewswire/ -- La Digital Medicine Society (DiMe) presentó hoy un conjunto de recursos para orientar a la industria en la evaluación de las vías regulatorias internacionales. Estos recursos brindan a los desarrolladores de tecnología de salud digital herramientas esenciales para comparar y navegar por los entornos regulatorios complejos y en constante evolución de un conjunto inicial de mercados clave en Asia Pacífico, Europa y Norteamérica. Con estas herramientas en la mano, los desarrolladores podrán optimizar sus estrategias globales de comercialización y llevar sus soluciones al mercado de manera más rápida y eficiente para el beneficio de los pacientes de todo el mundo.

Los recursos de DiMe responden a la incertidumbre de los desarrolladores sobre los requisitos y las diferencias entre las vías de aprendizaje en Australia, China, Inglaterra, Francia, Alemania, Japón, Corea del Sur y Estados Unidos. Incluyen herramientas como guías regulatorias específicas de cada país, diagramas de flujo paso a paso y pautas de IA/ML que ofrecen a los desarrolladores de DHT vías claras y prácticas para abordar los requisitos en diversos mercados.

"A medida que las tecnologías de salud digital continúan transformando la atención médica, es vital que los innovadores incorporen una estrategia regulatoria en su estrategia comercial general, un enfoque que les permitirá llevar estos productos a los pacientes de todo el mundo", afirmó Megan Coder, vicepresidenta de productos y políticas de DiMe. "Gracias a nuestros nuevos recursos, los desarrolladores pueden navegar por los panoramas regulatorios de manera efectiva, impulsando su retorno de la inversión y asegurando que sus soluciones digitales fiables y de alta calidad lleguen a los pacientes que más las necesitan. Estamos orgullosos de lanzar este conjunto de recursos hoy y planeamos trabajar con socios para expandir este conjunto inicial a otros mercados clave en el futuro cercano".

El lanzamiento de estos recursos marca una expansión de la cartera regulatoria de DiMe, ayudando a los innovadores a navegar los requisitos regulatorios para llevar nuevos productos al mercado en nuevas geografías y escalar globalmente.

"Navegar por los caminos regulatorios internacionales ha sido una tarea abrumadora para los desarrolladores que buscan llevar productos innovadores a nuevos mercados. Hasta la fecha, ha sido un proceso largo y tedioso comparar mercados e incorporar los hallazgos en una estrategia de comercialización estratégica", añadió Ariel Dora Stern, profesora de Alexander von Humboldt y presidenta de Salud Digital, Economía y Política en el Clúster de Salud Digital del Instituto Hasso Plattner. "Los recursos de DiMe serán un punto de inflexión para los desarrolladores, tanto principiantes como experimentados, que buscan ampliar el acceso a sus productos, poniéndolos en manos de los pacientes y los equipos de atención más rápidamente y permitiéndoles centrarse en el desarrollo de productos de alta calidad".

Los responsables de las políticas y los inversores también pueden utilizar los nuevos recursos para evaluar y comparar mejor los mercados regulatorios globales para los productos de salud digitales. Esto se traduce en una mayor transparencia y un mayor acceso a la tecnología que mejorará la atención médica en todo el mundo.

DiMe se compromete a ayudar a los desarrolladores a ampliar el alcance de sus productos en nuevos mercados y mejorar la vida de las personas en todo el mundo. Si desea asociarse con nosotros para desarrollar recursos adicionales para su país, comuníquese aquí.

Acerca de la Digital Medicine Society: DiMe es una organización sin fines de lucro global y el hogar profesional de todos los miembros de la comunidad de medicina digital. Juntos, abordamos los desafíos más difíciles de la medicina digital, desarrollamos recursos de calidad clínica en un cronograma tecnológico y entregamos estos recursos prácticos al campo a través de canales de código abierto y programas educativos.

Contacto de medios: Carla English, [email protected]

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