Análisis y Evaluacion de iniciativas de mHealth -Health20 Sevilla
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Presentación 9 de Noviembre de 2017 Repaso a las iniciativas de evaluación y catalogación de Apps en Eropa
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Análisis y Evaluacion de iniciativas de mHealth -Health20 Sevilla
- 1. 1 Health 2.0 Sevilla, 9 de noviembre de 2017 www.fudacioniSYS.org Análisis y evaluación de iniciativas de Salud Digital
- 2. 2 ¿Apps o software de salud?
- 3. Introducción
- 4. 4 ¿Valoramos el instrumento o la intervención con él?
- 5. Monitoring and evaluating digital health interventions A practical guide to conducting research and assessment (WHO,2016) Introducción
- 6. La monitorización engloba los primeros estadios de desarrollo, como los prototipos, que incluye: Introducción 1. La funcionalidad, o evaluar que las funciones se ejecutan según lo esperado, 2. la estabilidad, en el sentido que la reproducibilidad es correcta, 3. la fidelidad o desarrollo de la intervención según lo esperado, 4. y la calidad o la excelencia está asociada a la actividad esperada.
- 7. Y cuando la intervención digital en salud se está desarrollando se debería evaluar: Introducción 5. la usabilidad, esto es, si desarrolla la función según lo esperado para el usuario final, 6. la factibilidad, los outputs son correctos en un contexto dado, 7. la eficacia, 8. la efectividad, 9. la evaluación de la viabilidad económica, 10.y, por último, aunque no lo último, la implementación o la correcta integración en el contexto de políticas de salud.
- 8. 8 ¿Cuando una App / software es producto sanitario?
- 9. ¿Mi App es un producto sanitario?: Producto Sanitario 1. ¿Es un programa informático? O¿un documento digital? 2. ¿Genera o modifica datos? 3. ¿Está pensaba para beneficiar a pacientes individuales? 4. ¿Está diseñada para ser usada como un producto sanitario? Fuente: @ilarraya
- 10. Mi App es un producto sanitario Producto Sanitario 1. Montar Sistema de Gestión de Calidad (ISO 13.485) 2. Ciclos de vida del software (UNE-EN 62.304) 3. Proceso de gestión de riesgos (UNE-EN-ISO 14.971) 4. Evaluación clínica 5. El seguimieno post- comercialización Fuente: @ilarraya Normativa Productos sanitarios: La Directiva 93/42/CE con sus actualizaciones posteriores, transpuestas en España en el Real Decreto 1591/2009. Guía Iñaki Larraya: Protección de datos de carácter personal •Directiva 95/46/CE, transpuesta en España en la LOPD 15/1999, y en el reglamento 1720/2007 que la desarrollada. •Acceso a datos personales creados por otras aplicaciones (geoposicionamiento, datos de contacto, etc …) eDirectiva (2002/58/CEE) y el RDL 13/2012 que la transpone a la legislación española.
- 11. 11 Apps de salud/médicas en el mercado
- 12. Apps en el Mercado
- 13. Apps en el Mercado
- 14. Apps en el Mercado 15% muestra isysScore 22% Revisión sistemática Cáncer
- 15. Apps en el Mercado CE Markets (iTunes-GooglePlay) Catálogos
- 16. 16 Abordajes 1. Policy Makers/ Agencias Evaluación/ Administraciones/ Evaluación Acreditación Homologación Clasificación Normativa 2. Organizaciones Sanitarias/ Clínicos Evaluación Recomendación Incorporación-uso desarrollo 3. Desarrolladores / Fabricantes iOT/ Promotores Desarrollo Ajuste a Normativa Reglas (Homologación Acreditación) Pacientes/ Ciudadanos
- 18. 18 TOP20 y catálogo dinámico Si quieres inscribir tu App al TOP20 de 2017/18:
- 19. 19 TOP20 y catálogo dinámico Si quieres inscribir tu App al TOP20 de 2017/18:
Notas del editor
- The quality of health information related to non-professional users, available through the internet is an important and widely debated topic. Various administrations have begun to regulate health-related applications in an effort to improve their quality In September 2013, for example, the FDA issued guidelines guidance of the mobile industry. Also the EU is taking action on the matter.
- The quality of health information related to non-professional users, available through the internet is an important and widely debated topic. Various administrations have begun to regulate health-related applications in an effort to improve their quality In September 2013, for example, the FDA issued guidelines guidance of the mobile industry. Also the EU is taking action on the matter.
- The quality of health information related to non-professional users, available through the internet is an important and widely debated topic. Various administrations have begun to regulate health-related applications in an effort to improve their quality In September 2013, for example, the FDA issued guidelines guidance of the mobile industry. Also the EU is taking action on the matter.
- The quality of health information related to non-professional users, available through the internet is an important and widely debated topic. Various administrations have begun to regulate health-related applications in an effort to improve their quality In September 2013, for example, the FDA issued guidelines guidance of the mobile industry. Also the EU is taking action on the matter.
- The quality of health information related to non-professional users, available through the internet is an important and widely debated topic. Various administrations have begun to regulate health-related applications in an effort to improve their quality In September 2013, for example, the FDA issued guidelines guidance of the mobile industry. Also the EU is taking action on the matter.
- The quality of health information related to non-professional users, available through the internet is an important and widely debated topic. Various administrations have begun to regulate health-related applications in an effort to improve their quality In September 2013, for example, the FDA issued guidelines guidance of the mobile industry. Also the EU is taking action on the matter.
- The quality of health information related to non-professional users, available through the internet is an important and widely debated topic. Various administrations have begun to regulate health-related applications in an effort to improve their quality In September 2013, for example, the FDA issued guidelines guidance of the mobile industry. Also the EU is taking action on the matter.
- The quality of health information related to non-professional users, available through the internet is an important and widely debated topic. Various administrations have begun to regulate health-related applications in an effort to improve their quality In September 2013, for example, the FDA issued guidelines guidance of the mobile industry. Also the EU is taking action on the matter.
- The quality of health information related to non-professional users, available through the internet is an important and widely debated topic. Various administrations have begun to regulate health-related applications in an effort to improve their quality In September 2013, for example, the FDA issued guidelines guidance of the mobile industry. Also the EU is taking action on the matter.
- The quality of health information related to non-professional users, available through the internet is an important and widely debated topic. Various administrations have begun to regulate health-related applications in an effort to improve their quality In September 2013, for example, the FDA issued guidelines guidance of the mobile industry. Also the EU is taking action on the matter.
- The quality of health information related to non-professional users, available through the internet is an important and widely debated topic. Various administrations have begun to regulate health-related applications in an effort to improve their quality In September 2013, for example, the FDA issued guidelines guidance of the mobile industry. Also the EU is taking action on the matter.
- 1. Identify the Need for a Guideline Develop new guidance. Extend existing guidance. Implement existing guidance. 2. Review the Literature Identify previous relevant guidance. Seek relevant evidence on the quality of reporting in published research articles. Identify key information related to the potential sources of bias in relevant studies. 3. Obtain Funding for the Guideline Initiative 4. Identify Participants 5. Conduct a Delphi Exercise 5.1. Generate a List of Items for Consideration at the Face-to-Face Meeting. Present and Discuss Results of Pre-meeting Activities and Relevant Evidence (Face-to-face meeting) 6. Develop the Guidance Statement 6.1. Pilot test the checklist. 7. Develop an Explanatory Document (E&E) 8. Develop a Publication Strategy
- 1. Identify the Need for a Guideline Develop new guidance. Extend existing guidance. Implement existing guidance. 2. Review the Literature Identify previous relevant guidance. Seek relevant evidence on the quality of reporting in published research articles. Identify key information related to the potential sources of bias in relevant studies. 3. Obtain Funding for the Guideline Initiative 4. Identify Participants 5. Conduct a Delphi Exercise 5.1. Generate a List of Items for Consideration at the Face-to-Face Meeting. Present and Discuss Results of Pre-meeting Activities and Relevant Evidence (Face-to-face meeting) 6. Develop the Guidance Statement 6.1. Pilot test the checklist. 7. Develop an Explanatory Document (E&E) 8. Develop a Publication Strategy