1. Norms and Standards for eHealth (Standardisation and Certification) W.J. Meijer Quality Assurance E health EPSO Conference 2 June 2016

2. Content 1.Requirements for E health 2.The NEN-program ‘Safety of E health through norms’ 3.The NEN-selection guide 4.The NEN-application guide 5.Certification 6.Challenges

3. Requirements for E-health Requirements for chain process: NEN 8028/ISO 13131 Manufacturer Healthcare institution Patient/client Healthcare professional Quality management system: ISO 13485 ISO 9001 European Medical Device Directive Professional apparatus Apparapparatus for self- management

4. Requirements Requirements for safety and quality of E health: 1.Statutory requirements: obligatory requirement specified by a legislative body 2.Regulatory requirements: obligatory requirements specified by an authority mandated by a legislative body 3.Norms (ISO, CEN) requirements specified by ISO, CEN, associated member (one standardization Institute per country) 4.Standards

5. Requirements Interrelated statutory requirements, regulatory requirements and norms e.g.: Medical devices Data security

6. The NEN-program ‘Safety of E health through norms’ Two parts: 1.A selection guide to find the relevant norms 2.An application guide

7. The NEN- selection guide: three main processes Governance and management Support Healthcare

8. Requirements regarding healthcare process and information Management Generic Specific for care People: roles and rights Privacy protection: Regulations generic Kwaliteitsmanagementsysteem: ISO 9001 Risicomanagement: ISO 31000 The say on care and information Regulation Specifiek voor de zorg Quality management system: Healthcare institution and E-health: ISO 13131 Manufacturer: ISO 13485 Information security: ISO 27001 Governance Strategy and control: ISO/IEC 38500 Generic, re. ICT/IT Care process

9. Requirements regarding healthcare process and information Information Care processes The say on dataPrivacy regulations Information security ISO 27001 Semantics and/or as in Texas and/or architecture Semantics: ISO 13940 (ContSys) Semantic interoperability: ISO 13606 Architecture: ENV 12967 (HISA) Conceptual framework for continuity of care Framework for modeling ISO 13940 Applications IT-infrastructure

10. Requirements regarding healthcare process and information Applications IT- infrastructure Software life cycle If a medical device is involved European Medical Device Directive Quality, manufacturerISO 13485 Risk management: ISO 14971 ISO 62304 Informatiebeveiliging ISO 27001 Information Care processes

11. The NEN-application guide Approach: Comprehensive, covering safety and quality of E-health by norms Practice-driven Use cases

12. The NEN-program ‘Safety of E health through norms’ Two parts: 1.A selection guide to find the relevant norms 2.An application guide

13. 5. Certification

14. The significance of certification Certification is: An indispensable part of quality and safety improvement An audit: Provides a mirror Defines a milestone Stimulates further improvement

15. Standardization and certification Standar- dization Require- ments E-health Certifi- cation Adjustments

16. The PDSA-cycle and the QMS PDSA- start Plan for O&S O&S report Study report Do : O&S (operations and support) Act/Adjust Plan : - establish context - assess chances and risks - make plan Check/ Study : - assess output - propose improve- ments - decide Quality Management System: Requirements & procedures

17. The PDSA-cycle, standardization and certification PDSA- start Plan for O&S O&S report Study report Do : O&S (operations and support) Act/Adjust Plan : - establish context - assess chances and risks - make plan Check/ Study : - assess output - propose improve- ments - decide Quality Management System: Requirements & procedures Standardization Cer- tifi- ca- tion

18. 6. Challenges

19. Some of the challenges for standardization and certification Quality assurance of the E-health chain across people and organizations: ISO 13131, QAEH (certification) Social alarm systems: new CEN/CENELEC-norm, several national standards, QAEH (certification)

20. Some of the challenges for standardization and certification Mobile E-health and quality assurance: standard for mobile social alarm systems: WDTM, QAEH Privacy: the EU General Data Privacy Regulation, impact on E-health

21. Towards safety in the E health chain Requirements for chain process: NEN 8028/ISO 13131 Manufacturer Healthcare institution Patient/client Healthcare professional Quality management system: ISO 13485 ISO 9001 European Medical Device Directive Professional apparatus Apparapparatus for self- management

22. Thank you