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Standards for Interoperability in Digital Health: Selection and Implementation in an eHealth Project

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Requirements Engineering for Digital Health

Abstract

The complexity increase of healthcare processes together with wider adoption of eHealth systems imposes stringent consideration of interoperability across deployed services. Addressing this, standard organizations are proposing standards, sometime enforced through regulation, to develop interoperable eHealth services. Facing an increasingly important number of standards, industrial associations are building application-specific interoperability profiles identifying subset of standards relevant for the targeted applications. This chapter proposes an approach for eHealth service developers to efficiently capture interoperability requirements using these profiles and illustrate it through its application to a transnational project.

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Notes

  1. 1.

    European Telecommunications Standards Institute.

  2. 2.

    European Committee of Normalisation.

  3. 3.

    European Committee for Electrotechnical Standardization.

  4. 4.

    http://wiki.ihe.net/index.php?title=Scheduled_Workflow

  5. 5.

    http://www.ihe.net/connectathon/

  6. 6.

    https://www.oasis-open.org/committees/download.php/16790/wss-v1.1-spec-os-SOAPMessageSecurity.pdf and http://docs.oasis-open.org/wss/v1.1/

  7. 7.

    www.epsos.eu

  8. 8.

    http://whatis.cmmiinstitute.com

  9. 9.

    http://www.itil-officialsite.com

  10. 10.

    http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=54534

  11. 11.

    The goal of EXPAND is to maintain and expand the already existing resources and assets and act as a catalyst for real operational use by member states.

  12. 12.

    http://wiki.ihe.net/index.php?title=Profiles

  13. 13.

    www.istqb.org

  14. 14.

    D3.C.1—Proof of Concept testing strategy v1.0

  15. 15.

    https://openncp.atlassian.net/wiki/display/ncp/OpenNCP+Community+Home

  16. 16.

    D3.7.2 Security policy v1.0

References

  1. European commission. eHealth Action Plan 2012–2020: innovative healthcare for the 21st century. https://ec.europa.eu/digital-agenda/en/news/ehealth-action-plan-2012-2020-innovative-healthcare-21st-century

  2. Van der Veer H, Wiles A (2008) Achieving technical interoperability—the ETSI approach, ETSI White Paper No. 3. http://www.etsi.org/images/files/ETSIWhitePapers/IOP%20whitepaper%20Edition%203%20final.pdf

  3. eHealth-INTEROP Report in response to eHealth Interoperability Standards Mandate, SA/CEN/ENTR/000/2007-20 eHealth Mandate M/403-Phase 1, 10 Feb 2009. http://www.ehealth-interop.eu

  4. IEC 62304:2006—Medical device Software—Software life cycle processes. ISO Standards. http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=38421

  5. ISO 9241-210:2010—Ergonomics of human-system interaction—Part 210: Human-centred design for interactive systems. ISO standards. http://www.iso.org/iso/catalogue_detail.htm?csnumber=52075

  6. ISO/TR 16982:2002—Ergonomics of human-system interaction—Usability methods supporting human-centred design. http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=31176

  7. ISO 62366:2007—Medical devices—Application of usability engineering to medical devices. http://www.iso.org/iso/catalogue_detail.htm?csnumber=38594

  8. HL7 Architecture Board (ArB). HL7 Services-Aware Enterprise Architecture Framework (SAEAF): Enterprise Conformance and Compliance Framework (ECCF), Dec 2009. http://wiki.hl7.org/images/9/96/ECCF_DECeditFINAL_clean_12228009.doc

  9. ISO 14915 Software ergonomics for multimedia user interfaces (3 parts). ISO 14915-1:2003—Part 1: Design principles and framework. ISO 14915-2:2003—Part 2: Multimedia navigation and control. ISO 14915-3:2003—Part 3: Media selection and combination. http://www.iso.org/iso/catalogue_detail.htm?csnumber=25578

  10. IEC/TR 61997 ed 1.0—Guidelines for the user interface in multimedia equipment for general purpose use. http://webstore.iec.ch/Webstore/webstore.nsf/ArtNum_PK/27914!opendocument&preview=1

  11. ISO 15223:2012—Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied (2 parts). ISO 15223:2012 Part 1: General requirements. http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=50335. ISO 15223:2010 Part 2: Symbol development, selection and validation. http://www.iso.org/iso/catalogue_detail?csnumber=42343

  12. ISO/TR 16142:2006—Medical devices—Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices. http://www.iso.org/iso/catalogue_detail.htm?csnumber=38401

  13. IEC 80001:2010—Application of risk management for IT-networks incorporating medical devices (5 parts). IEC 80001:2010: Part 1: roles, responsibilities and activities. http://www.iso.org/iso/catalogue_detail.htm?csnumber=44863

  14. ISO 14971:2000 Medical devices—Application of risk management to medical devices. http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=31550

  15. ISO 13485: 2003—Medical devices—Quality management systems—Requirements for regulatory purposes. http://www.iso.org/iso/catalogue_detail?csnumber=36786

  16. Directive 1995/46/EC, Official Journal 1995, L281/31

    Google Scholar 

  17. ISO/IEC 25010:2011—Systems and software engineering—Systems and software Quality Requirements and Evaluation (SQuaRE)—System and software quality models. http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=35733

  18. Implementation. IHE. http://wiki.ihe.net/index.php?title=Implementation

  19. Open health tools. http://www.openhealthtools.org/index.htm

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Correspondence to Franck Le Gall .

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Bourquard, K., Le Gall, F., Cousin, P. (2015). Standards for Interoperability in Digital Health: Selection and Implementation in an eHealth Project. In: Fricker, S., Thümmler, C., Gavras, A. (eds) Requirements Engineering for Digital Health. Springer, Cham. https://doi.org/10.1007/978-3-319-09798-5_5

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  • DOI: https://doi.org/10.1007/978-3-319-09798-5_5

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