Joint Inter-Ministerial Policy Dialogue on ehealth Standardization and Second WHO Forum on ehealth Standardization and Interoperability

Transcription

1 Joit Iter-Miisterial Policy Dialogue o ehealth Stadardizatio ad Secod WHO Forum o ehealth Stadardizatio ad Iteroperability February 2014 Geeva, Switzerlad

2 Joit Iter-Miisterial Policy Dialogue o ehealth Stadardizatio ad Secod WHO Forum o ehealth Stadardizatio ad Iteroperability February 2014 Geeva, Switzerlad

3 World Health Orgaizatio 2014 All rights reserved. Publicatios of the World Health Orgaizatio are available o the WHO web site ( or ca be purchased from WHO Press, World Health Orgaizatio, 20 Aveue Appia, 1211 Geeva 27, Switzerlad (tel.: ; fax: ; bookorders@who.it). Requests for permissio to reproduce or traslate WHO publicatios whether for sale or for o-commercial distributio should be addressed to WHO Press through the WHO web site ( The desigatios employed ad the presetatio of the material i this publicatio do ot imply the expressio of ay opiio whatsoever o the part of the World Health Orgaizatio cocerig the legal status of ay coutry, territory, city or area or of its authorities, or cocerig the delimitatio of its frotiers or boudaries. Dotted lies o maps represet approximate border lies for which there may ot yet be full agreemet. The metio of specific compaies or of certai maufacturers products does ot imply that they are edorsed or recommeded by the World Health Orgaizatio i preferece to others of a similar ature that are ot metioed. Errors ad omissios excepted, the ames of proprietary products are distiguished by iitial capital letters. All reasoable precautios have bee take by the World Health Orgaizatio to verify the iformatio cotaied i this publicatio. However, the published material is beig distributed without warraty of ay kid, either expressed or implied. The resposibility for the iterpretatio ad use of the material lies with the reader. I o evet shall the World Health Orgaizatio be liable for damages arisig from its use.

4 Table of cotets Ackowledgemets...iv List of acroyms... v Executive summary...1 Note to the reader...4 Backgroud...5 Opeig remarks...6 Pael 1: Policy approaches i ehealth stadardizatio ad iteroperability...7 Pael 2: Successful policy itervetios to overcome barriers i stadards adoptio... 9 Pael 3: Goverace, stewardship, equity ad health systems itegratio of data stadards ad iteroperability...13 Pael 4: Policy ad statutory authority compoets...16 Pael 5: Regioal perspectives o goverace ad stewardship of ehealth stadardizatio...19 Pael 6: Essetials of a good policy framework for adoptio of stadards for iteroperability...21 Pleary sessio...25 Aex A meetig ageda...29 Aex B list of participats...32 Aex C thematic questios...37

5 10-11 February 2014 Geeva, Switzerlad Ackowledgemets The Joit Iter-Miisterial Policy Dialogue o ehealth Stadardizatio ad Secod WHO Forum o ehealth Stadardizatio ad Iteroperability was a ladmark evet. It was held accordig to the recommedatios of the first Forum o ehealth Stadardizatio ad Iteroperability ad the World Health Assembly Resolutio o ehealth Stadardizatio ad Iteroperability. This report represets the summary of two days of deliberatios. We are idebted to all the paellists ad participats for their full egagemet ad cotributios. This evet would ot have bee possible without the support of Member States; Permaet Missios to the UN i Geeva; iteratioal stadards developmet ad maiteace orgaizatios; o-govermetal orgaizatios; iter-govermetal orgaizatios; academia; idustry; ad WHO techical uits ad regioal offices. The Forum was atteded by delegates ad techical experts represetig 59 Member States, as well as members of stadards developmet orgaizatios. The Forum was hosted by WHO s Kowledge, Ethics ad Research departmet withi the Health Systems ad Iovatio cluster. It was co-chaired by Najeeb Al Shorbaji ad Ramesh Krishamurthy, with assistace from Nathalie Chamboiere, Diae De Clavier ad Yvoe Schuapp. Special recogitio is due to Marie-Paule Kiey for presidig over the Iter-Miisterial sessio of the Forum. We ackowledge the orgaizatioal assistace of Catherie Coru, Joa Dzeowagis, Jia Li, Sarah Guther, David Imo, Walter Suarez ad Diaa Zadi. Our sicere thaks also go to the departmets of Goverig Bodies ad Exteral Relatios, Security Services ad Coferece ad Meetig Services at WHO Headquarters for their assistace. We ackowledge the editorial assistace of Mark Nu ad layout desig by Jea-Claude Fattier. iv

6 Joit Iter-Miisterial Policy Dialogue o ehealth Stadardizatio ad Secod WHO Forum o ehealth Stadardizatio ad Iteroperability List of acroyms AFRO WHO regioal office for Africa AMRO WHO regioal office for the Americas CEN Europea Committee for Stadardizatio COACH Caada s Health Iformatics Associatio CSO Civil society orgaizatios EHR Electroic health records EMRO WHO regioal office for the Easter Mediterraea EU Europea Uio EURO WHO regioal office for Europe GS1 Global Laguage for Busiess HIE Health Iformatio Exchage HL7 Health Level 7 ICD-11 Iteratioal Classificatio of Diseases, 11th editio ICT Iformatio ad commuicatios techology IEEE Istitute of Electrical ad Electroics Egieers IGO(s) Iter-govermetal orgaizatio(s) IHE Itegratig the Health care Eterprise IHTSDO Iteratioal Health Termiology Stadards Developmet Orgaizatio IMIA Iteratioal Medical Iformatics Associatio ISO Iteratioal Orgaizatio for Stadardizatio IT Iformatio techology ITU Iteratioal Telecommuicatios Uio NGO(s) No-govermetal orgaizatio(s) NHS Natioal Health Service (Uited Kigdom) PAHO Pa-America Health Orgaizatio PHDSC Public Health Data Stadards Cosortium SDO(s) Stadards developmet orgaizatio(s) SEARO WHO regioal office for South-East Asia SMO(s) Stadards maiteace orgaizatio(s) SNOMED-CT Systematized Nomeclature of Medicie Cliical Terms WHA World Health Assembly WHO World Health Orgaizatio WPRO WHO regioal office for the Wester Pacific v

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8 Joit Iter-Miisterial Policy Dialogue o ehealth Stadardizatio ad Secod WHO Forum o ehealth Stadardizatio ad Iteroperability Executive summary As the Uited Natios (UN) agecy for health, the World Health Orgaizatio (WHO) recogizes the importace of health data stadardizatio i ehealth systems ad services, ad the eed for iteroperability of data ad devices betwee ad withi those systems ad services. WHO coveed the secod Forum o ehealth Stadardizatio ad Iteroperability i Geeva from 10 to 11 February The objective was to facilitate cotiued dialogue amog health data stadards developmet orgaizatios (SDOs), stadards maiteace orgaizatios (SMOs), academic istitutios, subject matter experts ad Member States toward the developmet of a policy framework for full implemetatio of health data stadards for iteroperability of ehealth systems withi coutries. Participats i the Forum icluded delegates of Member States, represetatives from SDOs ad SMOs, UN agecies, academic ad research istitutios, implemetig parters, door orgaizatios, subject matter experts ad WHO techical programmes of both headquarters ad regioal offices. Over 190 idividuals from 59 coutries cotributed to the dialogue, icludig oe Miister of Health; delegates of Miisters of Health from Member States; Ambassadors; represetatives from Member States permaet missios to the Uited Natios i Geeva; ad seior officials of Miistries of Health. Other participats followed the evet through live webcastig. The Forum addressed 19 key questios (Aex B) related to six thematic areas. The Forum s six thematic areas were as follows: Policy approaches i ehealth stadardizatio ad iteroperability Successful policy itervetios to overcome barriers i stadards adoptio Goverace, stewardship, equity ad health systems itegratio of data stadards ad iteroperability Policy ad statutory authority compoets Regioal perspectives o goverace ad stewardship of ehealth stadardizatio Essetials of a good policy framework for adoptio of stadards for iteroperability of ehealth systems. The outcomes of the evet were summarised i the pleary sessio as follows. 1

9 10-11 February 2014 Geeva, Switzerlad ehealth policy for stadardizatio ad iteroperability i a atioal cotext should: Be embedded i a atioal health pla, ad a egovermet pla if oe exists. Its view must be log term, provide cotiuity, ad commit to log-term ivestmet. Developmet ad implemetatio of atioal ehealth policies for stadardizatio ad iteroperability should be a atioal effort ad must iclude stakeholders from the health sector, o-health sectors of atioal govermets, ad o-state actors. Be patiet-cetred, emphasisig service quality, equity, patiet outcomes, patiet safety ad populatio outcomes. Be based o mutual trust ad uderstadig ad geuie collaboratio betwee all stakeholders from lawmakers to patiets, facilitated from the start by a participative approach to policy-makig, ad ecompassig public ad private parterships where ecessary. Support a evidece base for the socio-ecoomic beefits of ehealth, ad ecompass user utility ad outreach programmes to esure that all stakeholders, icludig patiets, are aware of the use, beefit ad risks of ehealth ad are egaged i related discourse ad decisio-makig, ad its implemetatio. Adopt appropriate electroic Health Iformatio Exchage (HIE) techology, icludig at atioal ad subatioal levels, i vertical programmes, ad i public ad private health care facilities. Set health data ad health IT stadards to esure iteroperability at data-, devicead system-levels, i a framework cotaiig a fixed core set of maitaied stadards allowig for a degree of iovatio outside that core set ad allowig for developmet based o the capacity ad maturity of ehealth systems ad services; ad regulate a appropriate degree of adoptio i the coutry cotext. Use existig iteratioal stadards where possible ad adapt specific stadards to suit atioal cotexts (takig ecessary care to esure iteroperability ad backward compatibility, as applicable). Provide uique idetifiers for patiets, health care workers ad health care facilities, with verificatio ad autheticatio procedures. Esure the safety of iteroperable medical devices, ad esure security, defiig privacy ad security policies addressig techology use i health care delivery. Build capacity from coutry ad miistry level dow to that of frotlie health workers. This icludes fiacial ad academic capacity as well as techical ad huma resource capacity. Esure good goverace, balacig top-dow ad bottom-up approaches, ecompassig: equity ad accessibility; legality; user rights i lie with huma rights; privacy; resposibility; ad accoutability to citizes ad to the state. Compatibility of techologies, efficiecy, ope dialogue ad a shared visio o use of data are ecessary for implemetatio. I moitorig compliace, clear goals ad key idicators for moitorig ad evaluatio are eeded, with mechaisms for social participatio. 2

10 Joit Iter-Miisterial Policy Dialogue o ehealth Stadardizatio ad Secod WHO Forum o ehealth Stadardizatio ad Iteroperability Support competecy-based educatio ad capacity buildig i health iformatics, with stadardized curricula ad measurable learig objectives at atioal ad subatioal levels. Traiig should be for the health workforce, icludig social workers, ad should cover ehealth policy developmet ad plaig, commuicatios ad leadership as well as techical cotet. Traiig, icludig i-service traiig, ca provide a valuable opportuity for partership with academia, techical colleges ad other relevat bodies. Ecourage relevat miistries of atioal govermets to iclude ehealth core competecies i job descriptios for relevat posts. The remaiig pages of this documet summarize the proceedigs ad outcomes of the Forum. 3

11 10-11 February 2014 Geeva, Switzerlad Note to the reader I a attempt to keep this report simple ad readable, commets are ot attributed to persos. This report codeses each Pael discussio icludig itervetios from the participats accordig to the themes addressed, rather tha attemptig to provide a summary of the dialogue. Withi the themes of each pael sessio, i order to guide the discussio speakers were asked to address specific thematic questios (Aex C). Where applicable, the report of the Forum summarizes each sessio accordig to these questios, groupig both the cotet of the itervetios ad the subsequet discussio accordigly. Where appropriate, these questios form the subheadigs i the report of each sessio. Full access to the deliberatios of the Forum ad audio ad video recordig of the etire proceedigs, icludig the opeig remarks ad itervetios from paellists ad participats, is available at 4

12 Joit Iter-Miisterial Policy Dialogue o ehealth Stadardizatio ad Secod WHO Forum o ehealth Stadardizatio ad Iteroperability Backgroud It is widely recogized that policy-eabled eviromets are essetial for advacig the use of iformatio ad commuicatios techology (ICT) i health care delivery. I lie with the recommedatios of the first Forum o Health Data Stadardizatio ad Iteroperability held i December 2012, ad highlightig the importace of policy ad recet WHA Resolutio , WHO held the secod Forum i February Its goal was to facilitate a dialogue o the eed for policy ad goverace mechaisms for health data stadards adoptio i coutries, ad to draft high-level cotet for use i creatig a policy ad goverace framework for full adoptio of stadards at atioal ad sub-atioal levels. The itet of the Forum was to facilitate a iitial global dialogue amog a group of Member States ad o-state actors. This dialogue was sythesized to form the basis for deliberatios by WHO s goverig bodies o Policy for ehealth Stadardizatio at atioal ad sub-atioal levels. Due to the coutry-specific ature of policy, the deliberatios of the Forum ad the outcome are iteded for further refiemet ad adoptio i coutry cotext through successive coutry-level dialogues. The outcome of the Forum is also iteded as a step i the later developmet of a complete Policy ad Goverace Framework for ehealth Stadardizatio th World Health Assembly Resolutio o ehealth Stadardizatio ad Iteroperability, WHA66.24, 27 May

13 10-11 February 2014 Geeva, Switzerlad Opeig remarks Dr Marie-Paule Kiey, Assistat Director-Geeral of the Health Systems ad Iovatio Cluster, WHO, welcomed the participats to the Forum ad to Geeva. She also passed o the welcome ad full support of WHO Director-Geeral Dr Margaret Cha, alog with Dr Cha s best wishes for a fruitful discussio. Dr Kiey uderlied the clear commitmet by WHO ad Member States to stadardizatio of data ad related ehealth systems, ad remided participats that settig orms ad stadards, ad promotig ad moitorig their implemetatio, is oe of WHO s six core fuctios. I that cotext she particularly welcomed the fact that this Forum was a multi-stakeholder evet ivolvig a multiplicity of parters from both the public ad private sectors. She stressed that collaboratio ad coordiatio are essetial to stadardizatio, ad uderlied WHO s strog track record i this area, which icludes collaboratio with the IHTSDO o SNOMED-CT ad ICD; log-term cooperatio with sister agecy the ITU; ad work with HL7 to make their stadards available free of charge to low- ad middle-icome coutries through the WHO portal. WHO also collaborates with WHO Collaboratig Cetres ad Iteratioal SDO s such as ISO, CEN, PHDSC, IEEE, GS1 ad may others, icludig atioal stadardizatio bodies. While atioal policies are essetial for the adoptio of health data ad health IT stadards at coutry level, Dr Kiey said that techical work aloe o stadardizatio is isufficiet. To that ed, she remided the audiece of the major milestoe achieved i May 2013, i the adoptio of World Health Assembly (WHA) Resolutio o ehealth stadardizatio ad iteroperability. A key ext step towards the ecessary atioal policies is to draft a policy ad goverace framework that will be useful to Member States for stadards adoptio at atioal level. Dr Kiey outlied some of the challeges. Gaps i policies ad a lack of adequate goverace mechaisms ca make implemetatio of stadards a hard task for some Member States. A lack of clear atioal-level madates, policies, ad goverace mechaisms also hiders the full adoptio of stadards, ad thereby hiders iteroperability of health data systems. Therefore, she said, WHA Resolutio stresses the eed for policy ad goverace mechaisms for stadards adoptio; for Member States to coduct high-level policy dialogue; ad for the developmet of policy guidace for full implemetatio of stadards-compliat ehealth systems ad services. Dr Kiey cocluded by recogizig that the Forum was a valuable chace to lear from Member States experieces. She stressed the fudametal importace of collaboratio ad cooperatio, ad wished the Forum success. 6

14 Joit Iter-Miisterial Policy Dialogue o ehealth Stadardizatio ad Secod WHO Forum o ehealth Stadardizatio ad Iteroperability Pael 1: Policy approaches i ehealth stadardizatio ad iteroperability Theme: Highlights of policy approaches to adoptio ad implemetatio of health data stadards for fuctioal ehealth systems ad services The first sessio was composed of itervetios from Member States, with delegatios from six coutries (Bagladesh, Chia, Estoia, Filad, Idia, Switzerlad) presetig a broad overview of their experieces with stadardizatio. I a wide-ragig high-level sessio focussed o the atioal overview, delegates addressed barriers to policy o oe had, ad its eablers o the other; outlied their thoughts o the roles of local ad atioal govermets, the private sector ad civil society i desigig ad implemetig policy; ad idetified some of the priority policy areas for health data stadardizatio. Itervetios provided a spectrum of differet types of coutry experiece ragig from atioal strategies for e-health i coutries like Estoia ad Filad with relatively log track records of implemetig ehealth (the latter datig back to 1996), to the issues of desigig atioal policy i Switzerlad where oversight ad budgets are devolved to 26 catos, to problems posed by the varyig readiess of parts of the Idia health system, which ecompasses both sigle-cliicia primary health cliics i poor rural areas ad 7,000-bed corporate mega-hospitals. Bagladesh outlied issues surroudig the adoptio of health data stadards ad use of ICT i a health care system facig may atural ad geographic challeges. As part of their atioal health care reform, Chia remarked that over the last four years its atioal govermet has ivested over 10 billio RMB (the official currecy of the People s Republic of Chia) i ehealth projects. A atioal health iformatio stadards committee ad pilot project o stadards adoptio have bee established i Chia though some policy, techical, legal ad maagemet barriers eed to be overcome i order to achieve the full implemetatio of health iformatio stadards. Key themes emerged o the essetial elemets of policy for adoptig ad implemetig health data ad health IT stadards for ehealth systems. Some recommedatios were specific i ature: the paellists ad the participats were i broad agreemet, for example, that policy should cotai rules allowig uique idetifiers for patiets ad health care professioals; that it should guaratee privacy ad security of data; ad that it should promote safety ad patiet-ceteredess, with a focus o patiet outcomes. There was also agreemet that effective collaboratio betwee stakeholders across differet sectors was crucial to a eablig policy eviromet. Participats agreed that policy must focus o work ad collaboratio of both the public ad the private sectors, ad where applicable that it should also help establish fair public-private parterships. Ackowledgig that a lack of capacity was ofte a major barrier to adoptio ad implemetatio, cosesus emerged that policy should promote traiig i order to 7

15 10-11 February 2014 Geeva, Switzerlad build i-coutry capacity to work o stadards for iteroperability ad implemet them; ad that WHO ad other iteratioal orgaizatios should take a lead i defiig a miimum set of stadards ecessary for coutries ad particularly low- ad middleicome coutries to address stadardizatio ad iteroperability. It was also recogized that WHO ad parters have a key resposibility to help avoid the global proliferatio of duplicate stadards, ad guard agaist cosequet disruptio of the health care market. Ackowledgig these capacity limitatios, participats cocluded that policy should seek to couter overly rapid ad hoc implemetatio of stadards i developig coutries, especially those lackig i huma resources ad techical capacity a dagerous situatio likely to occur by default if ot coutered. Further, it was recogized that Member States eed to support a movemet away from ad hoc implemetatio of ehealth activities to well-plaed implemetatio with adherece to iteratioal stadards. This is importat i order to avoid the proliferatio of fragmeted ad diverse stadards existig i some idustrialized coutries, a challege idetified by some paellists. It was also recogized that stadards should iclude the stadardizatio of termiologies i public use for medicies. It was evidet durig deliberatios that may challeges to implemetig stadardsbased ehealth services were commo to several Member States. These icluded techical challeges posed by sematic iteroperability ad the secodary use of data to provide cotiuity of care; the eed for strog regulatio of widespread systems icludig laws, classificatio, termiologies ad techical stadards that are mutually supportive; a lack of specialists to desig, build ad maage ehealth systems; a lack of people who ca traslate the techical ad the sematic (i.e. health care providers who ca commuicate their eeds i the laguage of IT techicias, ad vice versa); ad a lack of capacity to use iteratioal stadards like SNOMED i Member States with limited or o domestic experts. Cocer was also expressed about the dager of stadards becomig obstacles to iovatio, ad the eed to avoid this through the use of appropriate maagemet systems. Aother shared cocer that would be repeated throughout the two-day Forum was that of the tesio betwee health systems eeds for clear ad available data, ad idividual rights to privacy ad security. Policy for data maagemet ad ethics was agreed to be of pricipal importace. 8

16 Joit Iter-Miisterial Policy Dialogue o ehealth Stadardizatio ad Secod WHO Forum o ehealth Stadardizatio ad Iteroperability Pael 2: Successful policy itervetios to overcome barriers i stadards adoptio Themes: ifrastructure ad workforce barriers; regulatory ad compliace barriers; fiacig the implemetatio process; evidece-iformed policy tools ad approaches; ad policy approaches i ehealth stadardizatio ad iteroperability Overcomig ifrastructure ad resources barriers The pael reached cosesus o a umber of aspects of a policy framework that would address challeges idetified i the previous sessio. These icluded measures to icrease the availability of qualified, experieced huma resources for stadards implemetatio, ad esurig that policy overcomes implemetatio barriers by promotig simple regulatio of a basic framework allowig maiteace of stadards ad iovatio of ew stadards where eeded. To prepare for such a framework i a time of widespread resource costraits, it was recogized that policymakers ad advocates are obliged to focus o buildig evidece for the case that ehealth systems ad services icrease efficiecy ad productivity, ad move coutries towards sustaiable health care systems. Commercial vedors must also be egaged. It was argued, for example, that commercial vedor solutios for iter-applicatio compatibility are curretly usatisfactory; oe suggested solutio was for coutries to iclude clear text articulatig the eed for iteroperability i every request for a vedor proposal or public procuremet aoucemet. It was also recogized that WHO must lead i makig stadards free or affordable for coutries, assistig low- ad middle-icome Member States by providig guidace ad tools, promulgatig stadards ad levellig the playig field. Addressig regulatory ad admiistrative barriers Regulatory ad admiistrative barriers to stadardizatio ca be addressed through educatio programmes desiged to show regulatory agecies the promise of stadards i movig the global ehealth ageda forward, ad to demostrate to fiace ad maagemet staff at regioal, local ad health facility levels how health IT leads to reductios i burde. This effort would be greatly supported by the provisio of simple guidelies o stadards implemetatio. It was also suggested that coutries might cosider establishig collaborative idepedet atioal agecies to maage the sustaiability of techical ad sematic 9

17 10-11 February 2014 Geeva, Switzerlad iteroperability ad stadards. This agecy could cotribute to overcomig umerous barriers by egagig with key stakeholders; egagig with iteratioal stadards adoptio forums; exchagig best ad failed practices; ad egagig SDOs, esurig that they maitai existig stadards ad avoid market disruptio with ew oes uless clearly justified. SDOs themselves ca help by workig to uderstad ad respod to health care busiess eeds, focussig o what is relevat to the immediate health care busiess problems of prospective users. Stadards eve large ad complex oes should be provided with clear, cocise guidace for swift implemetatio. Curret approaches ad best practices The outcomes of the discussio most relevat to policy icluded makig sure that the educatio ad commuicatio iitiatives previously metioed esure support for deploymet by all stakeholders: it is importat to deploy stadards with the support of policy ad admiistrative agecies, vedors, cliicias ad patiets. To that ed, policy must impose a compellig visio ad goals shared by all, thereby esurig collaboratio betwee the may orgaisatios i the stadards space with overlappig eeds ad skills. It was agreed that without mutual trust betwee all stakeholders little or othig could be achieved. A degree of top-dow orgaisatio is, however, ecessary, as is policy to esure that participats exchage iformatio ad recogise ad address local eeds i all implemetatios. Iteroperability of ehealth systems requires efficiet policy. While legal ad orgaisatioal iteroperability are the resposibility of Miistries ad public health authorities, techical ad sematic iteroperability are also crucial, ad policy requires pragmatic details i these areas to esure market relevace ad acceptace. Deploymet is the key goal: emphasis should ot be o particular stadards, but o adoptio ad deploymet. It was uderlied agai that policy must also clarify privacy ad data requiremets. A simple ad harmoised regulatory framework is required, based o targeted objectives: i the face of techical ad fiacial barriers to implemetatio it was argued that policy should always seek to build upo existig stadards ad ifrastructure ad adapt them to health care settigs rather tha creatig ew health care-specific ifrastructure; ad that ehealth should ot be used as justificatio to create markets, but istead to advace health care delivery for all persos (as outlied i the priciples of Uiversal Health Coverage 2 ). A theme emerged here that would come to domiate proceedigs: while the use of iteratioally accepted stadards was recogized to be crucial, it was argued by may that oe size does ot fit all. Miistries should thik global ad act local, tailorig iteratioal stadards ad vedor solutios to coutry ad local cotexts. It was argued that vedors are able to offer valuable help i this regard because they are ot costraied to coutries; they ca therefore use their iteratioal experiece to provide iformatio o what has worked elsewhere. 2 Uiversal Health Coverage. 10

18 Joit Iter-Miisterial Policy Dialogue o ehealth Stadardizatio ad Secod WHO Forum o ehealth Stadardizatio ad Iteroperability It was cocluded that the eed for top-dow orgaizatio (possibly with WHO assistig coutries to move towards a miimum set of stadards for Member States) must be complemeted by a bottom-up approach i which coutries make decisios ad allow for local cotext. Addressig the eed for relevat competecy-based skills ad expertise, awareess ad uderstadig, fiacial resources, ad political support; covicig stakeholders of the beefits of relevat policies for stadards implemetatio With most coutries experiecig issues with the risig costs of health care, the pael agreed that efforts to make care efficiet ad sustaiable must come from a globally coordiated joit effort o stadards. Forums for discussio like this should make strog recommedatios to decisio-makig bodies to take ew approaches. The pael recogized that policies should address eeds at atioal level first, providig leadership ad fiacial support ad outliig clearly the eeds that stadards are iteded to meet. It was also suggested that policy should look at leveragig vedors talets so that they start to provide competecy ad skill-based traiig to the health workforce, or build capacity i other ways. It was recogized that SDOs, for their part, must covice govermets ad other stakeholders of the importace of this work, agreeig o a core set of stadards that is simple to implemet, cosistet across levels of care ad betwee levels of govermet ad admiistratios, ad with a clear evidece base. This will require a uified message comprehesible to all stakeholders. It was also argued that the developmet of the ecessary evidece base was likely to take time possibly years ad that stakeholders should have realistic expectatios i this regard. The WHO Secretariat remided the audiece that a special editio of the World Health Bulleti had already bee published o ehealth evidece, ad suggested that aother could be published by 2016 o the impact of stadards ad iteroperability o the quality ad efficiecy of health iformatio systems. It was cocluded that WHO had a part to play i esurig kowledge is available i coutries; supportig relevat i-coutry discussios; ad helpig coutries achieve iteroperability betwee oe aother by supportig a commo data structure ad systematic approach. Evidece-iformed policy developmets ad approaches to assist Member States i implemetatio of stadards; fillig the gaps i policies for evidecebased adoptio of stadards at coutry level Oce agai the poit was strogly made that oe size does ot fit all i policy makig; the tesio betwee uiversality ad atioal cotext must be resolved. 11

19 10-11 February 2014 Geeva, Switzerlad Withi this restrictio a umber of themes emerged. The pael recogized that a policyeablig eviromet required a commitmet to evidece-based log-term ivestmet i policies seekig to cultivate trust ad coordiatio betwee all stakeholders, iformed by the best available research evidece, with a focus o health outcomes. Policy dialogue should be balaced with a policy brief, ad policy itself should be guided by a cotext map icludig istitutioal ad idividual stakeholders. Collaboratio betwee these groups is fudametal; the policy process requires the willigess of policy makers to egage fully with all stakeholder groups. The WHO Secretariat described the WHO EVIPNet programme, which worked with teams i 42 Member States to develop tools to assist i developig policies iformed by the best available evidece, ad to facilitate policy implemetatio. These support tools ca be foud at 12

20 Joit Iter-Miisterial Policy Dialogue o ehealth Stadardizatio ad Secod WHO Forum o ehealth Stadardizatio ad Iteroperability Pael 3: Goverace, stewardship, equity ad health systems itegratio of data stadards ad iteroperability Themes: iformig the desig ad choice of policy compoets; compliace moitorig ad evaluatio; goverace ad stewardship mechaisms; curret approaches ad good practice Coutry examples of goverace mechaisms to oversee certificatio ad implemetatio of, ad compliace with, stadards After itese deliberatios the pael agreed that good goverace is based o equality; accessibility; legality ad protectio of users rights; privacy; resposibility; accoutability to citizes ad to the state; compatibility of techologies; efficiecy; ope dialogue; ad a shared visio o use of data with clear goals, key idicators for moitorig ad evaluatio ad mechaisms for social participatio. It was recogized that goverace must balace top-dow ad bottom-up approaches, a balacig process that should be led at WHO level by aalysig the implicatios of differet approaches. Good goverace goverace that is resposive, iclusive ad accoutable uses legislatio ad related implemetatio ad eforcemet mechaisms, such as iformatio systems certificatio, to eable data stadardizatio ad iteroperability betwee systems. This icludes a umber of core iteroperability stadards tailored to the specific cotext ad icluded i the procuremet process for ehealth projects. Implemetatio requires more tha decisio-makig or aoucig policy; it requires capacity, trust, uderstadig, ad geuie collaboratio betwee all stakeholders. This last poit, cited as a major theme i every pael of the day, was fast becomig a theme of the Forum. Examples of existig mechaisms icluded the establishmet i the Uited States i 2004 of the Office for the Natioal Coordiator of Health Iformatio Techology. This was the result of over te years of work settig a policy framework ad regulatios as a foudatio for the use of this type of data exchage atiowide. It aimed to achieve equality of access to care for vulerable groups, especially those without health isurace. Other cited examples icluded Cape Verde s atioal promotio of policies for iteroperability amog various parts of govermet; ad North America ad EU approaches to stadardizatio, which are mature eough to have idetified issues that others may ow avoid. It was observed that atioal level itegratio of health iformatio systems brigs beefits to subatioal levels. However, this itegratio requires electroic health iformatio exchage techology across vertical programmes, public ad private health care facilities, ad populatio-level data. HIE ca allow secure ad appropriate electroic access to health care data by patiets ad providers. 13

21 10-11 February 2014 Geeva, Switzerlad It was recogized that WHO s role i goverace should be to lead i facilitatig creatio of global stadardized models; to assist capacity-buildig by workig with academics to geerate miimum educatio stadards o ehealth ad ehealth stadards; ad to orgaize workshops with Miistries, health service providers (state-led ad others) ad other key stakeholders to test readiess for ehealth, esure capacity for use, ad esure leadership o this critical issue. Equity priciples for developig a policy framework The pael ad the audiece agreed that a balace betwee a top-dow approach of federalised implemetatio ad the eeds of local practice is critical to achievig true iteroperability ad that, oce agai, this must be guided by patiet- ad populatiolevel outcomes. It was recogized that populatio-based ad primary care data are essetial i order to get a overall picture of health equity, ad that particular attetio eeded to be paid to more vulerable populatios. Policy must support user participatio i stadardizatio efforts by all stakeholder groups, icludig frotlie health workers, patiets ad caregivers: stakeholder awareess of beefits is crucial to achievig widespread use. ICT developmets ad use must take ito accout the viewpoits of all stakeholders, ad resources allocated to the policy framework must be able to support ad adapt to cotiually evolvig techologies ad chages i health care practice. I this cotext policies must address equity from the positio of software architectures ad how they implemet health iformatio exchage. Policy must coordiate with ICT ifrastructure to make services available at all levels, ad vertical programmes. It must also iclude recommedatios for laguage traslatio based o stadard codig ad termiologies. To address a physical equity gap policymakers should cosider creatig reliable high powered computig ifrastructure across otherwise deprived areas, focussig o providig broadbad to rural areas to allow access to computig ifrastructure from a varied umber of devices. Importat poits were made about health data ad health IT stadardisatio, ad quality ad depth of data: to icrease equity data must be complete ad caot overlook either the poorest, who do ot egage fully with health services, or the richest, who patroise private facilities. Likig data is crucial to equity, as is the capacity for usig it for evidece-based policy makig. Stakeholders must be able to access datasets for aalysis ad use i decisio-makig, ad a culture of use should be created aroud the data to esure that it is used. Simultaeous public commuicatio is essetial so that the most vulerable ad margialised groups are aware of the services available to them, ad ecouraged to egage. Egagig civil society orgaizatios Deliberatios bega with the cosesus that a wider policy framework is eeded for the mutual developmet of policy. I this it was recogized that WHO s ivolvemet was key. The suggestio was made of establishig a goverace structure withi WHO 14

22 Joit Iter-Miisterial Policy Dialogue o ehealth Stadardizatio ad Secod WHO Forum o ehealth Stadardizatio ad Iteroperability to guide this effort. It was agreed that maagemet of health systems beefits hugely from social participatio at subatioal level, through establishmet of multisectoral groups icludig all stakeholders, ad smaller represetative groups. These ca be complemeted at atioal level by iter-sectoral coucils for atioal health with the madate to iteract with civil society. It was agreed that civil society orgaizatios (CSOs) are a key iterface betwee commuities ad the health sector, ad that atioal spaces are eeded for ope dialogue betwee the health sector, CSOs ad commuitylevel iterest groups. Meaigful egagemet with CSOs is a critical compoet of iclusive goverace that ca esure more resposive ad equitable outcomes for CSOs ad the differet costituecies they represet ad with which they iteract. I this cotext it was cocluded that oe fudametal resposibility of govermet is to act as a coveer of civil society ad other stakeholders, providig a mechaism by which differet types of orgaizatios with differet madates ca sit at the same table. To create a eviromet eablig egagemet with CSOs, the Forum recogized that govermets eeded to apply rigorous eforcemet of stadards across society, alog with trasparet accoutig showig equitable represetatio of diverse stakeholder iterests. A cautioary ote was souded: if this priciple of balaced represetatio is lost, trust ad participatio ca be destroyed, thereby decreasig the effectiveess of the overall health IT programme because certai iterests domiate. Fially, it was recogized that WHO should cosider establishig a geder group. This group would have the goal of esurig greater participatio of wome at all levels i makig ehealth systems iteroperability a reality, beeficial ad comprehesible to every category of user. 15

23 10-11 February 2014 Geeva, Switzerlad Pael 4: Policy ad statutory authority compoets Themes: compositio, role ad fuctio; oversight, eforcemet ad compliace; certificates of authority Critical role ad fuctios of a statutory authority Two of the previous day s key themes were quickly reiterated: i establishig statutory authorities for stadardizatio, oe size does ot fit all, ad trust betwee stakeholders is critical. It was suggested by the pael that as a couterpoit to a madatory authority, to achieve full egagemet coutries should cosider establishig a collaborative authority based o cosesus decisios of all stakeholders withi a defied process, the providig a coordiatig fuctio ad brigig the orgaizatios together. It was agreed that the critical basic role of the ehealth authority is to lead ehealth policy; it must coordiate ad guide programmes ad activities of both private ad public etities, idetifyig ad prioritizig health care fuctios that support rapid stadards adoptio. The pael highlighted the fact that capacity issues aroud techical kowledge of stadards ad iteroperability ca challege coutries, particularly lower- ad middleicome atios. To combat this they emphasized buildig capacity through educatio ad traiig outreach with collaboratio across sectors ad geographical bodies. It was stressed that statutory authorities should look at existig structures before creatig ew oes, leveragig existig bodies of kowledge. Examples of traiers already providig this fuctio icluded the IEEE. I additio to traiig it was recogized that authorities must provide goverace by defiig a visio ad directio for atioal ehealth efforts; adoptig the ecessary techology; esurig privacy ad security of data; settig or ecouragig a regulatory framework usig stadards to esure patiet safety; addressig the use of medical devices i cliical ad remote health care eviromets; regulatig the use of patiet data; settig atioal programme priorities ad activities (with primary focus o patiet ad populatio health); providig a awareess-raisig fuctio ecouragig wide egagemet with stadards; actig as assessors ad clearig houses for available stadards; providig certificatio oversight; ad prevetig health iformatio piracy. Above all a authority must guard ad maage patiet safety, through review ad evaluatio; compliace ad eforcemet; ad moitorig ad trackig. It was agreed that i order for stadards to recogized as such they have to be broadly adopted, ad that authorities have a resposibility to esure this. Adoptio was recogized to be a fuctio of a umber of drivig factors that statutory authorities must address, icludig cliicias eeds for access to health data with miimum disruptio; 16

24 Joit Iter-Miisterial Policy Dialogue o ehealth Stadardizatio ad Secod WHO Forum o ehealth Stadardizatio ad Iteroperability ease of implemetatio; capability ad readiess of the health system; egagemet by vedors, suppliers ad idustry; ad the effective use of stadards. It was recogized by the audiece that WHO has a role to play, developig miimum sets of stadards; creatig a set of guidace documets to help coutries idetify ad defie policies; ad establishig a series of workig groups after this Forum i order to maitai mometum across these areas. A questio was also raised regardig the methodology of certifyig iteroperability betwee systems, especially as regards the sematic compoet, which correlates directly with the accuracy of iformatio shared. It was oted that the developmet of processes to certify whether shared iformatio is correct are demadig i terms of time ad huma resources. Certificatio of shared iformatio is the resposibility of the ower of iformatio. Member coutries were ecouraged to share relevat experieces ad methodologies i subsequet forums ad techical meetigs. Approaches for establishig a etity to serve as a certificate of authority at atioal level The Forum uderlied the eed for a atioal body that ca esure implemetatio of health data ad health IT stadards at atioal ad subatioal levels. It was agreed that such a body should have expertise, but should also egage with all stakeholders, this beig ecessary to achieve true adoptio. It was suggested by the participats that govermet ca steer stadardizatio by usig existig Natioal Stadards Bodies, which are already i place i 163 coutries: there are examples where this has worked well, ad such bodies ca provide a source of the log-term stability ecessary for stadardizatio that is otherwise hard to achieve i policy eviromets subject to chage by political cycles. It was poited out, however, that i may cases atioal bodies also eeded to chage, becomig kowledge cetres for stadards from all SDOs, ot just a particular oe. Examples of statutory compoets Some of the pael deliberated that arms-legth, collaborative authorities are more effective tha madatory oes, providig examples icludig the Caadia Approved Stadards effort; Caada Health Ifoway s EHR architecture model; ad the Caada s Health Iformatics Associatio (COACH) credetialig ad educatio models. Examples of umerous collaborative models with varyig capacity levels were discussed ad Demark was cited as a example of policy developed with iteroperability i mid to allow market growth. It was eve argued that i some cases a formal structure is ot the first aswer at all; rather, more collaborative areas eve iformal oes ivolvig all stakeholders ca iitially be more efficiet tha settig up a formal structure. 17

25 10-11 February 2014 Geeva, Switzerlad Other issues The participats discussio i this sessio raised a umber of issues. Oe was aroud the capacity of market drivers to become de facto authorities: the IEEE802 series for wired ad wireless commuicatios was cited as a model where idustry worked together to create stadards accepted by the market. There was argumet agaist this model, o the basis of worries about how market acceptace fits ito the picture of policy for privacy, security ad patiet safety. Other questios icluded how to defie a miimum set of stadards whe requiremets differ greatly eve betwee differet stakeholders i the same coutry; how to covice stakeholders to sped moey o stadardizatio i a restricted fiacial cotext; ad i coutries where the health system has bee devolved how to avoid the risk of a statutory body ecroachig o devolved authority. Issues were also raised aroud idetifyig the poit of readiess for adoptio, especially i large coutries with complex health systems ecompassig differet actors ad istitutios of differig states of readiess; idetifyig the poit of implemetatio for a stadard; ad the pros ad cos of differet certificatio models. With regard to this last poit, there was call for WHO to produce a guidace documet for model selectio. 18

26 Joit Iter-Miisterial Policy Dialogue o ehealth Stadardizatio ad Secod WHO Forum o ehealth Stadardizatio ad Iteroperability Pael 5: Regioal perspectives o goverace ad stewardship of ehealth stadardizatio Themes: perspectives from select Member States; perspectives from WHO regios; role of WHO This sessio was composed of itervetios from coutry delegatios ad WHO regioal offices, with delegatios from eight coutries presetig broad overviews of their experieces with stadardizatio, ad a further six WHO regioal offices outliig their experieces supportig coutries i this area. A rich discussio ra over time as coutries as others had doe i the first sessio addressed barriers to policy ad its eablers; the roles of local ad atioal govermets, the private sector ad civil society i desigig ad implemetig policy; ad priority policy areas for health data stadardizatio. Members from WHO regioal offices provided overviews of ehealth progress i their respective regios, ad isight ito policy barriers ad eablers from various regioal perspectives. Codesig across this broad perspective, the followig themes emerged. Coutries still have a lot of work to do: there is widespread absece of or weakess i atioal strategies; but there are may examples of good practice too, ad sharig of more ad less successful examples, from small ad big coutries, is of cetral importace. There is a eed for miistry- ad coutry-level capacity buildig across all regios, ad a accompayig eed for WHO leadership ad support. Participatio of iteratioal stadards associatios i the policy process is also essetial, i order for stadards to be desiged i accordace with atioal eeds. It is also importat i may cotexts to ivestigate ad eable cotext-appropriate public-private parterships. Key policy eablers iclude political will, with Miistries of Health providig trasparet recogitio, owership ad support; havig health data stadards implemetatio as a key elemet i atioal strategies for ehealth, with clear implemetatio procedures ad support for local level professioals; havig well-defied atioal goverace processes for stadards implemetatio; ad esurig that all relevat miistries, atioal health stadards associatios, private sector represetatives, patiet orgaizatios ad other key stakeholders are egaged. There is widespread eed for developmet ad equitable use of resources ad ifrastructure to allow the use of Health IT ad sharig of iformatio betwee health orgaizatios ad across borders. Reliable etworks, iteret access, ad electric power are widely eeded. These must be accompaied by legal frameworks to support the implemetatio of ehealth stadards ad esure security of iformatio. Full stakeholder egagemet is crucial, right dow to patiet level: patiet focus ad patiet awareess are essetial to the success of ehealth iitiatives. 19

27 10-11 February 2014 Geeva, Switzerlad While developig ad maitaiig iteroperable stadards poses oe challege, the fudametal issue remais how to take the use of stadards forward, esure they are uiformly adopted ad followed, establish mechaisms for their maiteace ad compliace, ad resolve questios of data owership. Withi all of these issues ad throughout all cotexts certai eeds appear costat: capacity buildig ad coordiatio are of primary importace aroud the globe; stakeholders should be egaged i the policy process from its iceptio; the dialogue aroud policy should be coducted i laguage that people uderstad; people must be accoutable to their commitmets ad what they implemet; atioal ad regioal collaboratio should be fostered by buildig commuities of practice with shared visios; plaig is eeded at atioal ad subatioal levels; certificatio ad accreditatio processes are of great importace; ad as a meas of drivig adoptio, coutries should cosider makig ehealth itegratio ecessary for the accreditatio of health care facilities. 20

28 Joit Iter-Miisterial Policy Dialogue o ehealth Stadardizatio ad Secod WHO Forum o ehealth Stadardizatio ad Iteroperability Pael 6: Essetials of a good policy framework for adoptio of stadards for iteroperability Themes: essetial policy elemets for implemetatio of stadards at atioal level; critical success factors for implemetatio of stadards I advace of the pleary, this sessio provided paellists with the opportuity to distil discussio to the essetials for a good policy framework. Importat elemets ad compoets of a policy framework The Forum recogized that log-term policy commitmets were crucial: to provide the requisite support, commitmet ad accoutability, ehealth policy must be embedded i atioal health plas, or i egovermet plas if they are i place. There was cosesus that plas must be affordable, effective ad acceptable; must have specific compoets dealig with ehealth; ad must iclude participatory mechaisms for ivolvig all stakeholders, icludig parliametarias, CSOs, patiets, health workers, academia, patiets ad health care service providers. Implemetatio plas must clarify who does what which istitutios, which idividuals, ad their likages ad all stakeholders must have familiarity with the stadards ad their beefits. There was also repeated emphasis o the eed for policy to esure privacy ad security of data. It was also widely recogized that policy ad plaig must iclude data for populatio idetificatio; uique idetifiers for patiets, health care workers ad istitutios; ad short-, medium- ad log-term idicators. To brig dow costs ad icrease efficiecy, ehealth policies ad their implemetatio should be based o full adoptio of iteratioal stadards, ad the customized to coutry cotext ad local realities. There was also a strog argumet that SDOs must esure that everybody has access to relevat omeclatures, ad that stadards must be freely available, especially for lowicome coutries (though there were some dissetig voices to this last poit). Critical steps i adoptig ad implemetig the policy framework It was argued that coutries should work o the basis of expected outcomes: if stadards ad iteroperability are the aswer, what s the questio? It was stressed that stadardizatio ad iteroperability should be outcome-drive, ad that stadards implemetatio has a umber of key steps. These iclude idetifyig the eeds that data stadards ca address; esurig accessibility; holdig thoughtful ad egaged cosultatios o specific themes for deep discussio; thorough cotext mappig based o eed; ad the buildig of the ecessary orgaizatioal arragemets to achieve mutually beeficial outcomes. It was stressed that parterships should oly be egaged 21

29 10-11 February 2014 Geeva, Switzerlad whe eed is idetified, ad with shared values ad visios; ad that they eed ot always be moetary i ature. Two basic areas of requiremets were proposed for implemetatio: socio-cultural, ad techical. The socio-cultural aspect requires awareess of the wider ecosystem ad its great complexity; all participats must be recogized or outcomes will fail. Withi the techical aspect there was cosesus that most Member States eeded a framework where core immutable stadards are defied ad maitaied, with the expectatio that outside this core set stadards could still be susceptible to iovatio. Efficiet, equitable rollout was advocated, with the use of iteratioal stadards ad the avoidace of proprietary solutios. The importace of collaboratio was also stressed agai, icludig collaboratio across other fields ad spheres (such as the legal, cultural, ad ecoomic domais, as well as across regioal cotexts ad authorities). It was also poited out that while policies must be cosistet with overall govermet objectives, they must also preserve cotiuity as techology, ideology ad govermets chage. The poit about privacy ad security of data was elaborated by a itervetio suggestig policymakers should coduct advocacy to data protectio agecies. These agecies have very differet frames of referece to health actors ad privacy regulatios ca be a sigificat barrier to iteroperability; it is therefore importat to egage with the educatio of privacy orgaisatios regardig the ature ad eeds of health care. Fially, the importace was uderlied of learig from all available experieces: coutries with the opportuity for implemetatio should appreciate the value of examples of successful ad less successful implemetatios. Systematic research ca help iform elemets of a policy framework, the processes leadig to the framework, its resposiveess to chagig eeds, ad how the policy is implemeted to achieve its objectives. Each implemetatio of stadards should be approached as a experimet that must be regarded as uique, ad ogoig work must be adapted to particular coditios ad moitored with appropriate outcome-based measures. Acquisitio of ad access to health iformatics stadards by Member States It was poited out that SDOs resposible for developmet ad maiteace of stadards caot provide stadards for free without fidig a meas to fud the developmet ad maiteace of those stadards. Forum attedees therefore requested separate discussios to elaborate this matter. Similarly, Member States requested clarificatio through separate discussios of the use ad maiteace of ope stadards ad their relevace to stadards implemetatio at atioal- ad sub-atioal levels. I additio, Member States asked for techical assistace i measurig the fiacial retur o ivestmet of stadards implemetatio. The participats suggested further discussio the ways to assess the busiess models used by various SDOs. 22

30 Joit Iter-Miisterial Policy Dialogue o ehealth Stadardizatio ad Secod WHO Forum o ehealth Stadardizatio ad Iteroperability Issues The forum discussed the HINARI model, a public-private partership that provides free or low cost access to may olie jourals ad electroic books to over 5000 istitutios i 116 eligible Member States. The HINARI model was referred to as a example of a gateway for providig health iformatics stadards to Member States. Other proposals were offered from the participats, icludig a proposal for doors to chael fudig through ISO, gettig ISO to egotiate with SDOs ad make a deal whereby for a certai amout of moey stadards could be made freely available to coutries; gettig WHO to look at differet atioal blueprits, keepig a cesus ad mappig treds i stadards usage, rather defiig a core set of stadards; ad the rapid publicatio of a series of papers/aalyses to see what stadards are i use aroud the world, ad map them agaist eeds. It was also poited out that it is crucially importat to map stadards to those developmet goals o which global cosesus has already bee achieved. 23

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32 Joit Iter-Miisterial Policy Dialogue o ehealth Stadardizatio ad Secod WHO Forum o ehealth Stadardizatio ad Iteroperability Pleary sessio Theme: propose a draft text for policy framework for ehealth stadardizatio ad iteroperability The pleary sessio was a opportuity to preset the rapporteur s summary of the Forum. This summary was proposed as a startig poit for the draftig of a policy framework for ehealth stadardizatio ad iteroperability. The summary was preseted ad a umber of itervetios were take from the audiece, some of which were icorporated ito the summary poits to create the revised versio preseted here. These poits are to be validated through a subsequet cosultatio process before work begis o draftig the framework. 25

33 10-11 February 2014 Geeva, Switzerlad Themes of the Forum ehealth policy for stadardizatio ad iteroperability i a atioal cotext should: Be embedded i a atioal health pla, ad a egovermet pla if oe exists. Its view must be log term, provide cotiuity, ad commit to log-term ivestmet. Developmet ad implemetatio of atioal ehealth policies for stadardizatio ad iteroperability should be a atioal effort ad must iclude stakeholders from the health sector, o-health sectors of atioal govermets, ad o-state actors. Be patiet-cetred, emphasisig service quality, equity, patiet outcomes, patiet safety ad populatio outcomes. Be based o mutual trust ad uderstadig ad geuie collaboratio betwee all stakeholders from lawmakers to patiets, facilitated from the start by a participative approach to policy-makig, ad ecompassig public ad private parterships where ecessary. Support a evidece base for the socio-ecoomic beefits of ehealth, ad ecompass user utility ad outreach programmes to esure that all stakeholders, icludig patiets, are aware of the use, beefit ad risks of ehealth ad are egaged i related discourse ad decisio-makig, ad its implemetatio. Adopt appropriate electroic Health Iformatio Exchage (HIE) techology, icludig at atioal ad subatioal levels, i vertical programmes, ad i public ad private health care facilities. Set health data ad health IT stadards to esure iteroperability at data-, devicead system-levels, i a framework cotaiig a fixed core set of maitaied stadards allowig for a degree of iovatio outside that core set ad allowig for developmet based o the capacity ad maturity of ehealth systems ad services; ad regulate a appropriate degree of adoptio i the coutry cotext. Use existig iteratioal stadards where possible ad adapt specific stadards to suit atioal cotexts (takig ecessary care to esure iteroperability ad backward compatibility, as applicable). Provide uique idetifiers for patiets, health care workers ad health care facilities, with verificatio ad autheticatio procedures. Esure the safety of iteroperable medical devices, ad esure security, defiig privacy ad security policies addressig techology use i health care delivery. Build capacity from coutry ad miistry level dow to that of frotlie health workers. This icludes fiacial ad academic capacity as well as techical ad huma resource capacity. 26

34 Joit Iter-Miisterial Policy Dialogue o ehealth Stadardizatio ad Secod WHO Forum o ehealth Stadardizatio ad Iteroperability Esure good goverace, balacig top-dow ad bottom-up approaches, ecompassig: equity ad accessibility; legality; user rights i lie with huma rights; privacy; resposibility; ad accoutability to citizes ad to the state. Compatibility of techologies, efficiecy, ope dialogue ad a shared visio o use of data are ecessary for implemetatio. I moitorig compliace, clear goals ad key idicators for moitorig ad evaluatio are eeded, with mechaisms for social participatio. Support competecy-based educatio ad capacity buildig i health iformatics, with stadardized curricula ad measurable learig objectives at atioal ad subatioal levels. Traiig should be for the health workforce, icludig social workers, ad should cover ehealth policy developmet ad plaig, commuicatios ad leadership as well as techical cotet. Traiig, icludig i-service traiig, ca provide a valuable opportuity for partership with academia, techical colleges ad other relevat bodies. Ecourage relevat miistries of atioal govermets to iclude ehealth core competecies i job descriptios for relevat posts. Requests were also oted for WHO leadership i: Idetifyig ad providig a core set of miimum stadards Providig techical support for implemetatio of stadards i collaboratio with IGOs, NGOs ad SDOs Helpig uify data ad settig stadards for codig ad data sharig across coutries Helpig build policies for data sharig. Settig iteroperability goals ad providig support to coutries i achievig them Coordiatig activities of health data ad health IT stadards developmet ad maiteace orgaizatios to serve WHO Member States. Cotiuig to facilitate discussio o aspects of stadardizatio ad iteroperability Providig guidelies to support coutries i decisio-makig o stadards ad related policy. 27

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36 Joit Iter-Miisterial Policy Dialogue o ehealth Stadardizatio ad Secod WHO Forum o ehealth Stadardizatio ad Iteroperability Aex A meetig ageda Joit Iter-Miisterial Policy Dialogue o Stadardizatio ad Secod WHO Forum o ehealth Stadardizatio ad Iteroperability Executive Board Room, WHO Headquarters February Geeva, Switzerlad Ageda The use of ehealth ad mhealth should be strategic, itegrated ad support atioal health goals. I order to capitalize o the potetial of ICTs [Iformatio ad Commuicatios Techology], it will be critical to agree o stadards ad to esure iteroperability of systems Health Iformatio Systems must comply with these stadards at all levels, icludig systems used to capture patiet data at the poit of care. Commo termiologies ad miimum data sets should be agreed o so that iformatio ca be collected cosistetly, easily ad ot misrepreseted. I additio, atioal policies o health-data sharig should esure that data protectio, privacy, ad coset are maaged cosistetly. Keepig Promises, Measurig Results Commissio o Iformatio ad Accoutability for Wome s ad Childre s Health. WHO, 2011, p14. Forum objectives: Facilitate a dialogue o the eed for policy ad goverace mechaisms for adoptio of health data stadards i coutries Propose a policy ad goverace framework for stadards adoptio at atioal ad sub-atioal levels 29

37 10-11 February 2014 Geeva, Switzerlad Day 1 Moday, 10 February :30 10:00 Coffee ad registratio 10:00 10:15 Welcome remarks Dr Marie-Paule Kiey, Chair of the Forum Assistat Director-Geeral, Health Systems ad Iovatio Cluster, World Health Orgaizatio Objectives ad expected outcomes WHO Secretariat 10:15 12:00 Pael 1: Policy approaches i ehealth stadardizatio ad iteroperability 12:00 13:30 Luch Highlights of policy approaches to adoptio ad implemetatio of health data stadards for fuctioal ehealth systems ad services Pleary discussio 13:30 15:00 Pael 2: Successful policy itervetios to overcome barriers i stadards adoptio Ifrastructure ad workforce barriers 15:00 15:30 Break Regulatory ad compliace barriers Fiacig the implemetatio process Evidece-iformed policy tools ad approaches Pleary discussio 15:30 17:00 Pael 3: Goverace, stewardship, equity ad health systems itegratio of data stadards ad iteroperability Process of iformig the desig ad choice of policy compoets Compliace moitorig ad evaluatio Goverace ad stewardship mechaisms Curret approaches ad good practices Pleary discussio 17:00 17:10 Aoucemets ad adjour 18:00 20:00 Receptio WHO Restaurat 30

38 Joit Iter-Miisterial Policy Dialogue o ehealth Stadardizatio ad Secod WHO Forum o ehealth Stadardizatio ad Iteroperability Day 2 Tuesday, 11 February :00 10:30 Pael 4: Policy ad statutory authority compoets Compositio, role ad fuctio 10:30 11:00 Break Oversight, eforcemet ad compliace Certificate of authority Pleary discussio 11:00 12:30 Pael 5: Regioal perspectives o goverace ad stewardship of ehealth stadardizatio Perspectives from select Member States 12:30 14:00 Luch Role of WHO Pleary discussio 14:00 15:30 Pael 6: Essetials of a good policy framework for adoptio of stadards for iteroperability Essetial policy elemets for implemetatio of stadards at atioal level 15: Break Critical success factors for implemetatio of stadards Pleary Discussio Propose a Policy Framework for ehealth Stadardizatio ad Iteroperability Pleary discussio Coclusio 31

39 10-11 February 2014 Geeva, Switzerlad Aex B List of participats Represetatives of WHO Member States Last ame First Name Coutry of Origi Abbasi Ghulam Asghar Pakista Abou Mrad Lia Lebao Abu Al Hassa Haider Kuwait Al Jobori Mia Swede Alimuzzama Mohamad Bagladesh Asser Mari Estoia Azad Abul Kalam Bagladesh Bertoi Alberto Italy Boer Gabrielle Germay Corrales-Hidalgo J. Paama Dabre S.M. Gisèle Burkia Faso de Milo Terrazzai Johaes Moaco Deae Samuel Barbados Deiz Umut Turkey Djukic Vladimir Serbia Domiguez Labrador Elea Spai Erhola Maria Filad Fardo Kathy Uited Kigdom Foes Guy Chile Hale Aa Swede Hämäläie Päivi Filad Haa Abdul Bagladesh Hardhaa Boga Idoesia Hartoo Setyo Budi Idoesia Heyward Madeleie Australia Hosek Marti Switzerlad Islam Kazi Mohiul Bagladesh Jai R.K. Idia Kamau Oesmus Keya Kim Gaglip Republic of Korea Kik Pille Estoia Kulikov Alexey Russia Lateri Carole Moaco Lemma Kefelew Yemisrach Ethiopia Lütschg Nicolai Switzerlad Maurille B. Bei Miah Md. Neazuddi Bagladesh Mic Daiel Czech Republic Mi I-Soo Republic of Korea 32

40 Joit Iter-Miisterial Policy Dialogue o ehealth Stadardizatio ad Secod WHO Forum o ehealth Stadardizatio ad Iteroperability Nasim Mohammed Bagladesh Ousmae Ly Mali Padilla Rodriguez Liliaa Mexico Perche Moacyr Esteves Brazil Podviskis Peteris Latvia Poll Sylvia Costa Rica Purwadiato Agus Idoesia Rama Sigh Dipedra Nepal Realii Gilles Moaco Sadat Md Azam E Bagladesh Schmid Adria Switzerlad Sei Aye Aye Myamar Sera Liga Latvia Siha Arbidra Kumar Nepal Thoet Michèle Frace Tioco Roxaa Costa Rica Vega Molia Gozalo Spai Vih V Dao Quag Vietam Wag Caiyou Chia Warida Mokhtar Egypt Xu Peihai Chia Zhag Lili Chia Techical Area Experts Last ame First Name Coutry of Origi Ab Rahim Fathullah Iqbal Malaysia Abdel Aziz Mua Uited Kigdom Althauser Care Uited States Ash William Uited States Balkhair Ahmed M. Saudi Arabia Bartels Patricia Switzerlad Bertii Lapo Belgium Blachi Christophe Uited States Boussalham Aissa Frace Bradstaetter Juerge Austria Chute Christopher Uited States Correia Artur Cape Verde Correia Agata Switzerlad Datta Gora Uited States Dejoy Nicole Belgium Dixo Hughes J. Richard Australia Edel Gottfried Austria Eskadar Hai Switzerlad Facchietti Terezio Germay 33

41 10-11 February 2014 Geeva, Switzerlad Ferguso James Uited States Frame Shao Switzerlad Fraser Hamish Uited Kigdom Gehro Michael Uited States Geissbuhler Atoie Switzerlad Gerome Paul Switzerlad Gilhooly Deis Uited States Gupta Rajedra Idia Guyodo Gaeta Swede Harriso Oliver Uited Kigdom Hasselberg Marie Swede Hay Christia Switzerlad Horowitz Marc Uited States Igerso-Mahar Michael Uited States Jaffe Charles Uited States Jamoussi Bilel Switzerlad Jolliffe Bob Irelad Kha Mohammad Uited States Kijsaayoti Boochai Thailad Klei Guar Swede Kotze Paula South Africa Kratz Mary Uited States Kwakam Yukap Switzerlad Laflamme Lucie Swede Lam Mary Australia Lastic Pierre-Yves Frace Lemaire Jea-Paul Frace Leert Lelsie Uited States Leslie Heather Australia Li Wei Uited States Maset David Frace Medeiros Doa Uited States Millar Jae Demark Mirza Muza Uited States Mohamed Amiza Malaysia Moidu Khalid Uited States Murray Peter Uited Kigdom Naboulsi Halima Frace Newma Carl Uited States Newsham Do Caada Nguye Liem Vietam Niehaus Egelbert Germay Njoka Eliud Karigo Keya O Doell Kevi Uited States 34

42 Joit Iter-Miisterial Policy Dialogue o ehealth Stadardizatio ad Secod WHO Forum o ehealth Stadardizatio ad Iteroperability Orlova Aa Uited States Pardave Marco Mexico Paye Joatha Uited States Pelaprat Mary Lou Switzerlad Raimudo Maria Switzerlad Romao Mario Belgium Rossig Emil Switzerlad Rubio César Spai Satas Xeopho Uited States Severace Hayley Uited States Sheikh Ahmad Md Khadzir Malaysia Siha Chaitali Caada Slade-Joes Hadley Qatar Sloae Elliot Uited States Sog Seugjae South Korea Starig Kut Norway Suarez Walter Uited States Sweete Doald Demark Thouveot Veroique Ies Frace Udayasakara Jai Gaesh Idia Veltos Philippe Switzerlad Vreema Daiel Uited States Wybor Adrew Uited Kigdom Ye Maurice Burkia Faso Zhog Daidi Chia Members of WHO Secretariat Last ame First Name WHO HQ/Regio Al-Shorbaji Najeeb WHO HQ Campaella Nado WHO AMRO Chikersal Jyotsa WHO SEARO Coltart Ia WHO HQ Coru Catherie WHO HQ Dzeowagis Joa Hele WHO HQ Gaita Ruiz WHO HQ Güther Sarah WHO HQ (voluteer) Hamilto Clayto WHO-EURO Imo David WHO HQ (voluteer) Karam Ghassa WHO HQ Kiey Marie-Paule WHO HQ Krishamurthy Ramesh Saligrama WHO HQ Ladry Mark S. WHO WPRO Li Jia WHO HQ Majdzaddeh Reza WHO EMRO 35

43 10-11 February 2014 Geeva, Switzerlad Mbabazi Pamela Sabia WHO HQ Mehl Garrett WHO HQ Mikhail Miriam WHO HQ Mohamed Hai Farouk WHO EMRO Moujokai Jeremie WHO AFRO Moussy Fracis Gabriel WHO HQ Novillo Ortiz David WHO AMRO Paisset Ulysses WHO HQ Parker Sweatt Catherie WHO HQ Peixoto Miguel WHO AFRO Pujari Sameer WHO HQ Roberts Ia WHO HQ Rocoo Nava WHO HQ Sahlu Getachew WHO HQ/ITU Schaupp Yvoe WHO HQ Schitzler Johaes WHO HQ Sega Mikiko WHO HQ Szilagyi Tibor WHO HQ Timimi Hazim Bakir WHO HQ Ustu Tevfik Bedirha WHO HQ va Ommere Mark WHO HQ Velazquez Berume Adriaa WHO HQ Velez Laura WHO HQ Wachsmuth Isabelle WHO HQ Zadi Diaa WHO HQ Zhag Qi WHO HQ 36

44 Joit Iter-Miisterial Policy Dialogue o ehealth Stadardizatio ad Secod WHO Forum o ehealth Stadardizatio ad Iteroperability Aex C Thematic questios Pael 1: Iter-Miisterial Dialogue: Policy approaches i ehealth stadardizatio ad iteroperability Highlights of policy approaches to adoptio ad implemetatio of health data stadards for fuctioal ehealth systems ad services Are there ay policy barriers to implemetatio of stadards you are facig i your coutry? If so, would you provide a brief syopsis? What are the most sigificat policy eablers for health data stadards implemetatio at atioal ad sub-atioal levels i your coutry? What policy issues eed further attetio? What are the priority policy areas for health data stadardizatio you thik are importat? What is the role of govermet, private sector ad civil society i facilitatig compliace to policy? Pael 2: Successful policy itervetios to overcome barriers i stadards adoptio - Ifrastructure ad workforce barriers; Regulatory ad compliace barriers; Fiacig the implemetatio process; Evidece-iformed policy tools ad approaches How do we overcome ifrastructure ad resources barriers? How do we address regulatory ad admiistrative barriers? Are there ay curret approaches or best practices? How to address the eed for relevat skills ad expertise, awareess ad uderstadig, fiacial resources, ad political support? Ad how to covice the stakeholders the beefits of relevat policies for stadards implemetatio? What are some of the evidece iformed policy developmet ad approaches that are eeded to assist Member States i implemetatio of stadards? How ca the gaps i the evidece-based stadards adoptio policies be addressed at coutrylevel? 37

45 10-11 February 2014 Geeva, Switzerlad Pael 3: Goverace, stewardship, equity ad health systems itegratio of data stadards ad iteroperability - Process of iformig the desig ad choice of policy compoets; Compliace moitorig ad evaluatio; Goverace ad stewardship mechaisms; Curret approaches/good practice What are some good coutry examples of goverace mechaisms i-place to oversee the certificatio, implemetatio ad compliace to stadards What are some equity priciples we eed to take ito accout for developig a policy framework. How do we egage civil society orgaizatios? Pael 4: Policy ad statutory authority compoets - Compositio, role ad fuctio - Oversight, eforcemet ad compliace - Certificate of authority I the cotext of stadards adoptio at atioal-level, what are some of the critical role ad fuctios of a statutory authority? What are some of the approaches for establishig a etity or that ca serve as a certificate of authority at atioal-level? Are there some examples of key statutory compoets-the directives, evaluatio compoet, HR capacity, educatio, traiig ad outreach, that we ca lear from? Pael 5: Regioal perspectives o goverace ad stewardship of ehealth stadardizatio - Perspectives from select Member States - Role of WHO Brief Itervetios from Member States WHO Regioal Focal poits o ehealth would provide perspectives Pael 6: Essetials of a good policy framework for adoptio of stadards for iteroperability - Essetial policy elemets for implemetatio of stadards at atioal level - Critical success factors for implemetatio of stadards What are the most importat elemets ad compoets of a policy framework? What are the most critical steps i adoptig ad implemetig the policy framework? 38

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