D4.2.1 ‘Standardisation And Interoperability Analysis’

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Competitiveness and innovation FrameworkProgrammeCIP-ICT-PSP-2012-6 325137European Network fOr FALL Prevention, Intervention& Security E-NO FALLSProject Number:Acronym:Title:Call (part) identifier:Start date:Duration:325137E-NO FALLSEuropean Network fOr FALL Prevention,Intervention & Security E-NO FALLSCIP-ICT-PSP-2012-628/01/201337 monthsD4.2.1‘Standardisation and interoperability analysis’Nature1: RDissemination level2: PUDue date: Month 19Date of delivery: Month 20Partners involved: FHP Associação Fraunhofer Portugal Research AAIF Fundatia Ana Aslan International, Romenia NFT Nordforce Tecnology, Sweden (Task Leader T4.2) NEN Stichting Nederlands Normalisatie Instituut (Deliverable Leader D4.2.1) McR McRoberts, the Netherlands SIV Siveco Romania (Work Package Leader WP4)Authors: Liliana Ferreira (FhP), Ana Doscan (AAIF), Luiza Spiru (AAIF), Ileana Turcu(AAIF), Ligia Prisaca Manesi (AAIF), Stefan Strömberg (NFT), Marlou Bijlsma (NEN), Robvan Lummel (McR), Ghenadie Gandrabura (SIV)1R Report, P Prototype, D Demonstrator, O OtherPU Public, PP Restricted to other programme participants (including the Commission Services),RE Restricted to a group specified by the consortium (including the Commission Services), CO Confidential, only for members of the consortium (including the Commission Services)2

Competitiveness and innovation FrameworkProgrammeCIP-ICT-PSP-2012-6 325137European Network fOr FALL Prevention, Intervention& Security E-NO FALLSRevision 01-31NENNEN4.2.1 templatePreparation for meeting 5feb in DelftAgreed new structure,chapter headings andresponsibilitiesContribution chapterheadings and indexChapters and commentsfrom Vilanova meetingSubchapter headings forcomments to E-No fallspartnersChapters included fordiscussion at the telco onJune 12.First draft for internalreviewFor comments N92014-08-04NEN102014-08-21NEN112014-09-01NENDraft for review E NO FALLSconsortiumUpdate based onconsortium/ partner reviewReferences PCFinal versionFinal revisionFinal approval2NameMarlou BijlsmaMarlou BijlsmaAllNFT, AAIF, NENNENSIV, AAIF, McR, FhP,NFT,NFT, AAIF, FHP, NENRevised chapters NTF,AAIF,McRoberts, FhP,NEN and SIVECOSIVECO, NENNFT, AAIF, McRoberts,FHP, SIVECO and NENAAIF, SIVECO, NFT,McRobertsMarlou BijlsmaJaume RomagosaAndreu Català

Competitiveness and innovation FrameworkProgrammeCIP-ICT-PSP-2012-6 325137European Network fOr FALL Prevention, Intervention& Security E-NO FALLSDISCLAIMERThe work associated with this report has been carried out in accordance with thehighest technical standards and the E-NO FALLS partners have endeavoured toachieve the degree of accuracy and reliability appropriate to the work in question.However since the partners have no control over the use to which the informationcontained within the report is to be put by any other party, any other such party shallbe deemed to have satisfied itself as to the suitability and reliability of theinformation in relation to any particular use, purpose or application.Under no circumstances will any of the partners, their servants, employees or agentsaccept any liability whatsoever arising out of any error or inaccuracy contained inthis report (or any further consolidation, summary, publication or dissemination ofthe information contained within this report) and/or the connected work and disclaimall liability for any loss, damage, expenses, claims or infringement of third partyrights.3

Competitiveness and innovation FrameworkProgrammeCIP-ICT-PSP-2012-6 325137European Network fOr FALL Prevention, Intervention& Security E-NO FALLSList of FiguresFigure 1. Proportion of state contribution to pensions . 15Figure 2. European pension expenditure . 16Figure 3. Retirees expenditure structure . 16Figure 4. The ADEQUACY challenge – Population (65 ) living at risk of poverty or socialexclusion, 2011 . 18Figure 5. At-Risk-of-Poverty Rate (65 years or more), 2011. 19Figure 6. Severe material deprivation (65 years or more) by Gender, 2011 . 19Figure 7. Old-Age Population Dependency Rates vs. Pension System Dependency Rates inEastern European and Former Soviet Countries, Most Recent Year Available . 20Figure 8. Attachment of the activity monitor . 37Figure 9. Explanation of the report by the lung consultant . 37Figure 10. Cost of care per day . 39Figure 11. Clinical pathway COPD. 41Figure 12. HIC health Informatics . 42Figure 13. Fallers landscape . 43Figure 14. Activity recognition process pipeline (Anguita, Ghio, Oneto, Parra, & Reyes-Ortiz,2012) . 46Figure 15. ISO 9241-210 (2010) Human-centered design process for iterative systems . 52Figure 16. PDS diagram . 55Figure 17. Concurrent use landscape . 73Figure 18. Adoption of international standards in eHealth in WHO survey . 774

Competitiveness and innovation FrameworkProgrammeCIP-ICT-PSP-2012-6 325137European Network fOr FALL Prevention, Intervention& Security E-NO FALLSTable of contents1.Abstract/executive summary.72.Introduction .83.4.2.12.22.3Standardisation and Interoperability . 8Standardisation and Interoperability Analysis in the Work Package . 9Methodology . 9User perspectives . 113.1Introduction.113.2Elders perception about falling .113.3Usability .123.4Accessibility .153.4.1Affordability .153.4.2Availability .213.5Other stakeholders perspective .233.6Conclusions .25Clinical Perspectives . 264.1Introduction.264.2ICT in Falls Prevention - Perspectives on Europe .264.2.1Telecare.284.2.2telehealth.284.2.3eHealth .284.2.4Assistive Technology .294.2.5Smart Homes .294.3Protocols and Clinical Guides in Falls Prevention .294.3.1Clinical Test for Falls Prevention .304.3.2Impact of Falls Prevention in Primary Care .314.4Devices for Falls Prevention and Detection .334.4.1Existing Devices .334.5Romania Facts .334.6Conclusions .345.6.Industrial Perspectives . 365.15.25.35.45.55.6Introduction.36Market Analysis .36Technical Devices (Medical Device Directive) .39Services.40Standardisation and interoperability .41Conclusion .43ICT Research and Development Perspective . 456.1Research and development on falls and activity monitoring .456.1.1Current Technologies .456.1.2Smartphone Based Solutions on Falls and Activity Monitoring .466.1.3Architecture and Common Standards for Mobile Solutions .476.1.4Usability Challenges and Recommendations for Mobile Solutions .486.1.5OS Specific Guidelines .516.1.6Design Standards .525

Competitiveness and innovation FrameworkProgrammeCIP-ICT-PSP-2012-6 325137European Network fOr FALL Prevention, Intervention& Security E-NO FALLS6.2Framework of the Portuguese National Health System .526.2.1Organization of Resources, Provision of healthcare and Funding.526.2.2Portuguese Healthcare Data Platform – Plataforma de Dados de Saúde.536.2.3Architecture, Protocols and Data Protection.546.3Conclusions .567.Regulatory Perspective . 577.1Introduction.577.2Applicable EU Directives .577.3Overview of EU Regulatory Framework for Medical Devices .617.3.1Current Regulatory Framework .617.3.2Proposed Changes .637.4Two Alternative Regulatory Pathways to the Market for ICT Based FallPrevention & Intervention Devices .637.5Is the MDD an appropriate regulatory framework for ICT based fallprevention & intervention devices? .647.6National Barriers for Deployment of Services/Products Resulting from fallsICT-based Solutions.657.6.1Requirements for National Registration of Medical Devices .657.6.2Requirements for Standards Compliance .667.7Summary .678.Standardization perspective . 688.1Existing Standards in eHealth and mHealth.688.1.1Medical Record Standards .688.1.2Messaging Standards .718.1.3Vocabulary Standards .758.2Use of Standards in ICT Solutions for Fall Prevention and Management .768.2.1Use of Standards in eHealth and mHealth .768.2.2Which standards are used in the ICT based fall prevention solutions? .818.2.3Case Study Sona .818.2.4Case Study Standardization Initiative Service Chain Social Care Alarms .848.3Conclusions discrepancy between existing standards and use of thesestandards in ICT solutions for fall prevention and management .859.Conclusions . 8810.References. 8911.Annex . 966

Competitiveness and innovation FrameworkProgrammeCIP-ICT-PSP-2012-6 325137European Network fOr FALL Prevention, Intervention& Security E-NO FALLS1. Abstract/Executive SummaryEffective use of technology for health can streamline processes as well as offering new waysproviding healthcare. eHealth and mHealth provide tools and solutions to improve healthsystems and services, such as respecting the rights of the patient (giving them more informationabout, and increased control over their health choices) and efficiently utilizing human, financialand other resources.The standardization of crucial aspects of eHealth and mHealth: interoperability, integration inexisting technical systems and organizational procedures, patient safety and privacy areprerequisites for the development and deployment of ICT-based fall prevention and effectiveintervention solutions for elderly people in Europe.Standards define consistent interfaces enabling the interoperability and exchangeability ofdifferent components; they define safety requirements or permit service offerings to becompared.International and European standards are developed by ‘all parties concerned’ expertcommittees an published by standards bodies such as ISO, IEC, ITU, CEN, CENELEC or ETSI.Standard documents are stakeholder consensus agreements of voluntary requirements andrecommendations. Standards only become mandatory if a law explicitly requires compliancewith a certain standard or set of standards.In addition to these official standards there are also “industry standards” or “de-factostandards”, “publicly available specifications”, “pre-standards” or “application guides”. Thesedocuments are developed and published by a large variety of committees, including theEuropean Commission, WHO, IEEE, IETF, OASIS, HL7 and Continua. Compared to officialstandards, industry standards can often be developed and published faster since the rules forpublic comment and voting may be simplified. Correspondingly, industry standards often play amajor role in fields where technology changes very quickly, such as Information andCommunication Technology (ICT) (AALIANCE2, 2013).This report summarizes the findings of the E-NO FALLS project with regard to the analysis ofthe use of standards and interoperability in the field of ICT solutions for fall prevention andmanagement. The issues and requirements relevant for ICT solutions for fall prevention andmanagement are presented from the perspectives of the different stakeholders:- User perspective- Clinical perspective- Industrial perspective- Researcher perspective- Regulatory perspective- Standardization perspectiveEach of the chapters addresses one of the perspectives.

Competitiveness and innovation FrameworkProgrammeCIP-ICT-PSP-2012-6 325137European Network fOr FALL Prevention, Intervention& Security E-NO FALLS2. Introduction2.1 Standardisation and InteroperabilityThe standardization of crucial aspects of eHealth: interoperability, integration in existingtechnical systems and organizational procedures, patient safety and privacy are prerequisites forthe deployment of ICT-based fall prevention and effective intervention solutions for elderlypeople in Europe.Standards define consistent interfaces enabling the interoperability and exchangeability ofdifferent components; they define safety requirements or permit services to be compared.International and European standards are developed by ‘all parties concerned’ expertcommittees and published by standards bodies such as ISO, IEC, ITU, CEN, CENELEC orETSI. Standard documents are consensus agreements with voluntary requirements andrecommendations. Standards become mandatory when a law explicitly requires compliance witha certain standard or set of standards. An example is the medical device market, where the EUmaintains an official list of “harmonized standards” (European Commission, 2013) whichrequires compliance for every product placed on the EU market that falls within the scope of theMedic

Competitiveness and innovation Framework Programme CIP-ICT-PSP-2012-6 325137 European Network fOr FALL Prevention, Intervention . D4.2.1 ‘Standardisation and interoperability analysis’ Nature1: R Dissemination level2: PU Due date: Month 19

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