Validation Plan. Version 4.0 September 8, Copyright 2014 Healtheway, Inc. All rights reserved.

Transcription

1 Validatin Plan Versin 4.0 September 8, 2014 Cpyright 2014 Healtheway, Inc. All rights reserved.

2 Status: FINAL Apprved by CC Effective Date: 9/8/14 Versin: 4.0 Final 1 Purpse and Scpe Defined Terms Scpe Apprach ehealth Exchange Testing Prcess Overview ehealth Exchange Participant Testing and Onbarding Prcess ehealth Exchange Prduct Testing Prcess ehealth Exchange Testing Plicies System Under Test Retesting Due t System Changes Retesting When Specificatins and Test Materials Change Breaking Changes ehealth Exchange Prfiles and Data Cntent Requirements Prfile Definitin Universal Requirements Authrizatin framewrk Messaging platfrm Patient discvery / Query / Retrieve Dcument submissin Publish / subscribe Optinal Service-Related Specificatins: ehealth Exchange Prfiles ehealth Exchange Data Cntent Requirements and Cnfrmance Expectatins Attachment #1: ehealth Exchange Prfiles, Specificatins and Test Cases Attachment #2 - Test Materials Appendix A - Dcument Change Histry /8/14 Cpyright 2014 Healtheway, Inc. All rights reserved. Page 1

3 1 Purpse and Scpe The ehealth Exchange Validatin Plan describes the scpe, apprach and Testing prcess fr verifying that an Applicant r existing Participant in the ehealth Exchange cmmunity cmplies with the Perfrmance and Service Specificatins. In additin, this plan utlines the requirements fr prducts t becme ehealth Exchange Validated. The ehealth Exchange Testing prgram supprts the fllwing: - Applicants wh wish t jin the ehealth Exchange as Participants; - Existing ehealth Exchange Participants wh wish t test new capabilities r retest as a cnditin f cntinued participatin in the ehealth Exchange; and - Develpers f Systems wh wish t have their prduct validated as ehealth Exchange cmpliant. The ehealth Exchange Testing prgram verifies that a System bth cmplies with the ehealth Exchange Specificatins and has the ability t interperate with ther ehealth Exchange Participant Systems. 1.1 Defined Terms All capitalized terms in this dcument have the meaning put frth in the Data Use and Reciprcal Supprt Agreement (DURSA), unless utlined belw. Breaking Changes mean issues that are identified while Testing an applicant r participant. Issues uncvered real-time during the Testing prcess. Messages are intended t mean the transactins that are exchanged. Mdified System shall mean changes made t a System that impact cmpliance with the Perfrmance and Service Specificatins. Prductin Ready shall mean that develpment and Testing f the System is cmplete, and that the System is deplyed n a tier that replicates, as clsely as pssible, the prductin envirnment. Specificatins shall mean the set f implementatin specificatins adpted by the Crdinating Cmmittee pursuant t the DURSA t prescribe the data cntent, technical, and security requirements t enable the Applicants t Transact Message Cntent. Specificatins may include, but are nt limited t, specific Netwrk standards, services and plicies. System shall mean sftware, prtal, platfrm, r ther electrnic medium cntrlled by an applicant thrugh which it cnducts its health infrmatin exchange (HIE) related activities as part f the ehealth Exchange. Fr purpses f this definitin, it shall nt matter whether the applicant cntrls the sftware, prtal, platfrm, r medium thrugh wnership, lease, license, r therwise. 9/8/14 Cpyright 2014 Healtheway, Inc. All rights reserved. Page 2

4 System Under Test shall mean identificatin f which underlying Systems, such as HIE r EHR System and/r gateway t be tested and used in prductin. This shuld include the System cmpnents that are relevant t validatin, including thse cmpnents used t create r mdify Messages in accrdance with the Perfrmance and Service Specificatins, as well as generating the clinical dcumentatin that is exchanged. Test Materials shall mean the set f Testing requirements that must be successfully demnstrated and validated t cmply with the Specificatins. This may include, but is nt limited t test cases, test scenaris, cnfrmance checklists, etc. Test Reprt means a written reprt issued by Healtheway that dcuments the utcmes f the Testing Prcess; that is, the Applicant s cmpliance with the Specificatins and Test Materials. Testing shall mean validatin f Applicant s HIE Technlgy used fr interperable health infrmatin exchange, t assess cnfrmity with the Specificatins, Validatin Plan and Test Materials. Validatin Plan shall mean the framewrk fr Testing and demnstratins fr parties seeking t becme ehealth Exchange Participants and fr Systems t becme ehealth Exchange Validated. The Validatin Plan is Attachment 2 in the DURSA, and is amended frm time t time in accrdance with DURSA Sectins and The Validatin Plan is als referenced in the ehealth Exchange Prduct Testing Agreement that Vendrs sign when seeking t have a System tested and deemed t be ehealth Exchange Validated. 1.2 Scpe The scpe f the ehealth Exchange Testing prgram is limited t the Specificatins; the infrmatin utlined in the Validatin Plan and related Test Materials adpted by the Crdinating Cmmittee, cllectively called Perfrmance and Service Specificatins. Testing requirements may vary depending upn Specificatin versin(s), as well as the prfiles (i.e. use cases) that an Applicant r Participant wishes t supprt. Fr details, see Attachment #1. Changes t the prfiles, Specificatins, Validatin Plan and Test Materials may be made in accrdance with the applicable change prcesses described in the DURSA. 1.3 Apprach The ehealth Exchange Testing prgram is designed t verify that Systems used t cnduct health infrmatin exchange (HIE) via the ehealth Exchange cmply with the ehealth Exchange Specificatins and Test Materials. Systems brught frward fr Testing must be Prductin Ready. Healtheway currently supprts tw Testing prgrams: 1) ehealth Exchange Participant Testing Prgram: This prcess verifies that Systems used by rganizatins wh wish t participate in the ehealth Exchange ( Applicants ), r thse wh wish t 9/8/14 Cpyright 2014 Healtheway, Inc. All rights reserved. Page 3

5 remain a participant in the ehealth Exchange ( Participants ) satisfy the requirements established by the DURSA. The Testing prgram verifies that the System used by Applicants and Participants cmply with the Specificatins. 2) ehealth Exchange Validated Prduct: This prcess verifies that the Systems used by Applicants and Participants cmply with the Specificatins prir t being implemented in the Applicant s and Participant s prductin envirnment. The bjective is t establish built-in cnfrmance and interperability int these Systems t minimize variability in System cmpliance in prductin. 2 ehealth Exchange Testing Prcess 2.1 Overview Healtheway supprts a highly autmated Testing prcess and augments the autmated apprach with sme manual review t verify cnfrmance f Systems used in the ehealth Exchange. Healtheway has partnered with AEGIS t prvide an autmated Testing envirnment called the Develpers Integratin Lab (DIL). The DIL Testing envirnment facilitates gateway-t-gateway Testing. The DIL Testing platfrm autmates the tests and enables Applicants t cnduct practice Testing n a self-service basis, with real-time feedback regarding issues f nn-cmpliance. In additin, Healtheway uses additinal mechanisms t validate that Systems cmply with the Specificatins. The fllwing tw sectins describe hw Testing prcess wrks, including the steps that Applicants, ehealth Exchange Participants and Vendrs must fllw t cmplete the Testing prcess. 2.2 ehealth Exchange Participant Testing and Onbarding Prcess T jin the ehealth Exchange, Applicants must fllw an eight-step prcess, as described belw. The criteria fr being accepted as a Participant in the ehealth Exchange are described in Operating Plicy and Prcedure (OPP) #1: Review and Dispsitin f Applicatins fr Participatin. A cpy f this OPP is fund here: 1. Apply t ehealth Exchange Cmplete and submit an Applicatin Package which includes the belw dcuments t: admin@healthewayinc.rg ehealth Exchange Applicatin (New Applicants: The Testing Services Agreement is included in the Applicatin) DURSA (Versin May 3, 2011) DURSA Amendment (Versin September 30, 2014) ehealth Exchange Participatin Agreement 9/8/14 Cpyright 2014 Healtheway, Inc. All rights reserved. Page 4

6 Testing Services Agreement Healtheway Testing Readiness Checklist (Applicants may need t enlist help frm the HIT vendr t cmplete this checklist) Pay Testing Fees (listed in the Healtheway Testing Agreement) t Healtheway via check, ACH r credit card: Mail checks (payable t Healtheway, Inc.) t: Healtheway, Inc Tysns Bulevard, 8th Flr McLean, Virginia, T pay via credit card r fr ACH & Wire instructins r t request an invice, please cntact admin@healthewayinc.rg Nte: Applicants may als pay the ehealth Exchange participatin fees at this time. Payment f the participatin fees can either be made in cnjunctin with the Testing fees r separately nce in prductin n the ehealth Exchange. 2. Crdinating Cmmittee Apprves Applicatin fr Participatin and Refers Applicant t Begin Practice Testing The Crdinating Cmmittee will review an Applicatin fr Participatin and determine whether an Applicant satisfies the eligibility criteria. (Fr details, see Operating Plicy and Prcedure #1). If apprved as eligible, Healtheway will verify whether the Applicant s Testing Readiness Checklist is cmplete. If cmplete and the Applicant has paid Testing fees, Applicant will be directed t get set up in the Develpers Integratin Lab (DIL). See Step #3 belw fr details. If an Applicant wishes t cnnect t the Scial Security Administratin (SSA) and/r Veterans Health Administratin (VHA), the SSA and VHA will require Applicant t d additinal partner testing. See Step #7 belw fr details. 3. Set up and Cnduct Practice Testing in the Develpers Integratin Lab (DIL) Cmplete DIL Setup Checklist: Applicants shuld wrk with the HIT System vendr t cmplete the DIL Setup Checklist, which utlines the required steps t get set up in the DIL Testing envirnment. Cmpleted DIL Setup Checklists shuld be sent t Testing@healthewayinc.rg Applicants wh are new t the DIL are encuraged t review this infrmatin: Testing/90-dil-guides 9/8/14 Cpyright 2014 Healtheway, Inc. All rights reserved. Page 5

7 Register in the DIL: DIL Setup Checklist Test Case Dcumentatin and Data Lad Set Applicant s vendr may assist r register the Applicant rganizatin in the DIL; hwever nly the Applicant s name shuld be registered in the DIL, nt the vendr. DIL DIL Training and Demnstratin Vide DIL User Guide DIL UDDI Registratin Guide DIL Certificate Instructins Updated Patient Mapping Guide Cnduct Practice Testing: If Applicant s vendr is assisting the Applicant with practice Testing, the vendr shuld ntify Applicant when practice Testing is cmpleted. Any questins r issues regarding DIL set up r issues encuntered during practice Testing may be referred t the DIL Supprt Team: dil_supprt@aegis.net. 4. Run Tests and Submit Results Applicant is expected t cmplete practice Testing and determine when the Applicant can successfully pass all f the tests. When the Applicant is ready t have the results frmally evaluated by Healtheway, Applicant shuld run the tests and "Submit" results in the DIL t have the results validated. Applicant must ntify testing@healthewayinc.rg nce the tests have been submitted, alng with the crrespnding DIL Executin Unique ID. If Applicant is testing fr cntent (i.e. C32, C-CDA), Applicant must submit sample dcuments t the crrespnding NIST validatr tl and verify that the dcument cmplies accrdingly. Once Applicant is satisfied that the dcument meets the cntent requirements, Applicant shuld submit a sample dcument t testing@healthewayinc.rg fr frmal evaluatin. Healtheway will review the test results, including any test evidence submitted, and identify issues f nn-cmpliance. 9/8/14 Cpyright 2014 Healtheway, Inc. All rights reserved. Page 6

8 5. Crdinating Cmmittee Apprves Applicant Test Results Healtheway will verify that all Applicant test results have been received and will submit a Test Reprt t the Crdinating Cmmittee fr apprval. The Crdinating Cmmittee will determine whether the Applicant has satisfied the general and technical requirements fr participatin in the ehealth Exchange, in accrdance with Operating Plicy and Prcedure #1. Applicant will be ntified regarding the Crdinating Cmmittee s decisin. 6. Activate in Prductin Envirnment If Applicant is frmally ntified by Healtheway that Applicant has been apprved as a Participant in the ehealth Exchange, Applicant must file a supprt ticket t get prvisined in the ehealth Exchange prductin envirnment. T file a ticket, send an t techsupprt@healthewayinc.rg Applicant will receive a supprt ticket #, as well as instructins and frms t cmplete the set up prcess, including: i) issuance f an x.509 certificate, which must be successfully installed in Participant s prductin envirnment; ii) entries int the prductin ehealth Exchange web services registry (i.e. UDDI registry); and iii) identificatin f the Participant s peratinal pints f cntact. Healtheway will schedule an activatin briefing with the Applicant t review prductin peratins, bligatins, and t learn mre abut participating in the ehealth Exchange cmmunity. 7. Applicant Cmpletes Partner Testing (Optinal) The SSA and VHA require additinal partner testing prir t exchanging data. If Applicant wishes t exchange data with the SSA and VHA, Applicant must be prvisined in the ehealth Exchange test envirnment (i.e. with a test x.509 certificate and entries int the Test versin f the UDDI web services registry). T be prvisined in the Test envirnment, submit an t the Healtheway Technical Supprt Team at techsupprt@healthewayinc.rg with a request t issue a validatin digital certificate and t be set up in the validatin web services registry (the UDDI). Applicant will receive a supprt ticket, as well as instructins and frms t cmplete the set up prcess. Applicant may cnduct partner testing with SSA befre, after, r in parallel with Testing in the DIL. Partner Testing with VHA will begin after Applicant cmpletes Testing in the DIL. 9/8/14 Cpyright 2014 Healtheway, Inc. All rights reserved. Page 7

9 8. Pst-Prductin Mnitring Perid ehealth Exchange Participants are subject t a 90-day pstprductin-mnitring perid. This is a prbatinary perid during which an ehealth Exchange Participant s cmpliance with Perfrmance and Service Specificatins is assessed. Issues f nn-cmpliance shuld be reprted t admin@heathewayinc.rg. Healtheway will triage reprted issues and ntify the Participant if remediatin is required t assure cmpliance with the Perfrmance and Service Specificatins. The Crdinating Cmmittee may take actin if nn-cmpliance issues are nt reslved in a timely manner. 2.3 ehealth Exchange Prduct Testing Prcess The ehealth Exchange Prduct Testing Prgram is designed t verify that Systems used by Participants in the ehealth Exchange cmply with the Specificatins. By Testing that the underlying System cmplies, Participants shuld have greater assurance that the System cmplies when implemented and used in prductin. In additin t mitigating risks t prductin, using ehealth Exchange Validated Systems will significantly ff-set the tests that Participants must cmplete t participate in the ehealth Exchange. The prcess utlined belw reflects the steps that develpers f HIE Systems ( Vendrs ) must fllw t their System tested and verified by Healtheway as being ehealth Exchange Validated. 1. Cmplete the Prduct Testing Applicatin. The applicatin includes the Prduct Testing Services Agreement. Once cmpleted, and executed, the applicants and Prduct Testing Services Agreement shuld be submitted t admin@healthwayinc.rg 2. Pay Testing Fees (listed in the Healtheway Testing Agreement) t Healtheway via check, ACH r credit card: Mail checks (payable t Healtheway, Inc.) t: Healtheway, Inc Tysns Bulevard, 8th Flr McLean, Virginia, T pay via credit card r fr ACH & Wire instructins r t request an invice, please cntact admin@healthewayinc.rg 3. Set up and Cnduct Practice Testing in the Develpers Integratin Lab (DIL) Cmplete DIL Setup Checklist: 9/8/14 Cpyright 2014 Healtheway, Inc. All rights reserved. Page 8

10 Vendr shuld cmplete the DIL Setup Checklist, which utlines the required steps t get set up in the DIL Testing envirnment. Cmpleted DIL Setup Checklists shuld be sent t testing@healthewayinc.rg Register in the DIL: Vendrs wh are new t the DIL are encuraged t review this infrmatin: Testing/90-dil-guides DIL Setup Checklist Test Case Dcumentatin and Data Lad Set The fllwing prvides additinal instructins fr the registratin prcess, as well as use f the DIL: DIL DIL Training and Demnstratin Vide DIL User Guide DIL UDDI Registratin Guide DIL Certificate Instructins Updated Patient Mapping Guide Cnduct Practice Testing: The vendr shuld cnduct practice Testing and verify that that prduct can successfully pass all tests. Any questins r issues regarding DIL set up r issues encuntered during practice Testing may be referred t the DIL Supprt Team: dil_supprt@aegis.net. 4. Run Tests and Submit Results The vendr is expected t cmplete practice Testing and determine when the vendr s prduct can successfully pass all f the tests. When the vendr is ready t have the results frmally evaluated by Healtheway, vendr shuld run the tests and "Submit" results in the DIL t have the results validated. Vendr must ntify testing@healthewayinc.rg nce the tests have been submitted, alng with the crrespnding DIL Executin Unique ID. If the vendr is testing fr cntent (i.e. C32, C-CDA), vendr must submit sample dcuments t the crrespnding NIST validatr tl and verify that the dcument cmplies accrdingly. Once vendr is satisfied that the dcument meets the cntent requirements, vendr shuld submit a sample dcument t testing@healthewayinc.rg fr frmal evaluatin. 9/8/14 Cpyright 2014 Healtheway, Inc. All rights reserved. Page 9

11 5. Test Results Reprt Healtheway will review the test results, including any test evidence submitted, and identify issues f nn-cmpliance. Vendr will have an pprtunity t retest in accrdance with the terms f the ehealth Exchange Prduct Testing Agreement. Once all Testing and retesting is cmpleted, Healtheway will determine whether the prduct has successfully demnstrated cmpliance with the Specificatins and Test Materials and will dcument such results in a Test Reprt. Healtheway will send the vendr a cpy f the final Test Reprt. If vendr s prduct des nt pass testing, vendr may re-apply at a later date and pay the Testing fees in effect at the time the new applicatin is submitted. If the Applicant s prduct successfully passes all tests, Healtheway will wrk with vendr t have its validated prduct added t the ehealth Exchange Validated Prduct List. 6. ehealth Exchange Validated Prduct Listing Healtheway will send vendr a cpy f the ehealth Exchange Validated lg, and usage guidelines. Vendr may nly use the ehealth Exchange Validated lg as permitted by the usage guidelines and in accrdance with the ehealth Exchange Prduct Testing Agreement. 9/8/14 Cpyright 2014 Healtheway, Inc. All rights reserved. Page 10

12 3 ehealth Exchange Testing Plicies 3.1 System Under Test Applicants and Vendrs shall: Bring frth a Prductin-Ready System fr validatin. Identify and include the System cmpnents that are relevant t validatin, including thse cmpnents used t create r mdify ehealth Exchange Messages in accrdance with the Perfrmance and Service Specificatins in effect fr the ehealth Exchange. Identify when t bring frward its System fr retesting when it makes System changes that impact its cmpliance with the Perfrmance and Service Specificatins. The ability t exchange Messages can be affected, r adversely impacted, by mdificatins t cmpnents invlved in creating r mdifying Exchange Messages. Therefre, Applicants and Participants shuld retest in rder t cnfirm that System mdificatins have nt intrduced nn-cmpliant behavirs. T request guidance, retesting r revalidatin, the Applicant and/r Participant shuld cntact the ehealth Exchange Testing Prgram Manager at testing@healthewayinc.rg. 3.2 Retesting Due t System Changes ehealth Exchange Participants are required as a cnditin f cntinued participatin in the ehealth Exchange t cmply with the DURSA and assure that its Systems cmply with the Specificatins. Similarly, ehealth Exchange Validated prducts must als remain cmpliant with the Specificatins t retain ehealth Exchange Validated status. It is acknwledged that Participant and ehealth Exchange Validated Systems may be changed ver time t assure apprpriate maintenance and functinality f the System. Retesting fr every change wuld be burdensme and cstly t Vendrs and Participants, particularly when changes d nt impact the HIE functinality related t the ehealth Exchange. That said, nging cmpliance with the Specificatins is necessary t have reasnable assurances that Participant Systems can interperate in prductin. In lieu f having Participants and Vendrs retest with each release f a System, the fllwing plicy shall apply: Onging Mnitring fr Cmpliance Healtheway shall have the right t mnitr, audit and inspect Participant and Vendr Systems which have been validated fr the ehealth Exchange t verify that the System remains in cmpliance with the Specificatins. Such mnitring, auditing and inspectins may be undertaken by Healtheway at any time including, but nt limited t, in respnse t a cmplaint submitted t Healtheway alleging that the Participant r ehealth Exchange Validated System are nn-cmpliant with the Specificatins. Any such audits r inspectins f the System, facilities, data and recrds shall be cnducted during business hurs and perfrmed s as t nt unreasnably disrupt the Participant s r Vendr s business peratins. Healtheway shall prvide reasnable advance ntice t Applicant prir t any such inspectin r audit, 9/8/14 Cpyright 2014 Healtheway, Inc. All rights reserved. Page 11

13 unless such advance ntice, in Healtheway s pinin, wuld prejudice Healtheway s ability t ascertain the infrmatin desired frm the inspectin r audit. The Participant r Vendr shall cperate with and prvide such assistance as Healtheway shall reasnably require in cnnectin with any such inspectins and audits, including by making persnnel available t Healtheway fr interviews. Based n its mnitring, auditing r inspectin findings, Healtheway may require the Participant r Vendr t submit the System fr additinal Testing Retesting Upn a Finding f Nn-Cmpliance If, after reasnable mnitring, auditing r inspectin, Healtheway determines that the System is likely t be nn-cmpliant with the Specificatins, the Participant r Vendr shall retest. Retesting must begin within thirty (30) days f being prvided with ntice f nn-cmpliance, as well as payment f applicable Testing fees Validatin Perid Once a System has successfully been tested by Healtheway, the validatin f that System shall be in effect fr a perid f up t three (3) years frm either f the fllwing apprval dates ( Apprval Dates ): - Fr ehealth Exchange Participants: The date that the Crdinating Cmmittee apprves the Applicant as an ehealth Exchange Participant. - Fr Vendrs f ehealth Exchange Validated Prducts: The date that Healtheway prvides fficial ntice t the Vendr that the System has been apprved as an ehealth Exchange Validated System Retesting after Validatin Perid In rder t remain an ehealth Exchange Participant r t retain ehealth Exchange Validated status, a System must be retested prir t the end f the Validatin Perid. If Participant r Vendr s System fails t successfully cmplete r pass retesting prir t the end f the Validatin Perid, the fllwing may ccur: - Fr ehealth Exchange Participants: The Crdinating Cmmittee may terminate participatin in the ehealth Exchange r suspend participatin until Participant remediates the nn-cmpliance and successfully cmpletes and passes retesting. - Fr Vendrs f ehealth Exchange Validated Prducts: Healtheway may revke the ehealth Exchange Validated status fr a nn-cmpliant System; r require that the Vendr implement a remediatin plan acceptable t Healtheway and successfully cmplete and pass retesting in a timeframe t be determined by Healtheway. 9/8/14 Cpyright 2014 Healtheway, Inc. All rights reserved. Page 12

14 3.3 Retesting When Specificatins and Test Materials Change Onging cmpliance with the Specificatins is required as a cnditin f cntinued participatin in the ehealth Exchange and fr Systems t retain ehealth Exchange Validated status. In the event there are changes in the ehealth Exchange Perfrmance and Service Specificatins, the Crdinating Cmmittee shall, with Participant and Vendr input, assess the impact f changes prduct exchange amng ehealth Exchange Participants and establish a ratinale shuld retesting be warranted. 3.4 Breaking Changes Backgrund: Testing ften uncvers Breaking Changes that are identified while testing an Applicant r Participant. Issues uncvered real-time during the Testing prcess shuld be handled as described belw: Validatin fr the ehealth Exchange shuld be bjective and repeatable, with cnsistent results based upn cnfrmance with the Specificatins, Validatin Plan and test cases in effect at the time the System is Tested. The testing prcess shuld nt be subjective r discretinary t avid intrducing incnsistencies and ptential fr bias in the utcmes. If errrs are discvered due t ambiguity / errrs in the Specificatins, then the issue shuld be addressed issue thrugh the Specificatin change management prcess. Systems must cnfrm t the Specificatins in effect at the time they test until Specificatins are crrected thrugh the change management prcess. If there is an errr in the test scripts r test lab, but the entity is cnfrming t the Specificatins: The entity shuld be fund cnfrmant. An errr in the lab r test cases shuld nt prevent a System frm prceeding thrugh the Testing prcess r ging int prductin if the System cmplies with the Specificatins. The testing prcess is nt intended t de-bug issues in Systems. Systems brught frward fr Testing are expected t be Prductin-Ready. The ehealth Exchange testing prcess is nt intended t partner-specific requirements r t debug and test Systemspecific issues. Examples f Breaking Changes: Changes in which tests are required fr a given candidate (e.g. based upn functins supprted) Make a critical fix t the Validatin Plan r Test Materials used during Testing. Changes in cntent t the Testing artifacts, such as: 9/8/14 Cpyright 2014 Healtheway, Inc. All rights reserved. Page 13

15 - Add cverage within a given feature (e.g. mre Testing f negative paths) - Changes t Testing methds that als include substantive changes (e.g. Autmate a previusly manual test) - Update a test case - Add Testing fr a new feature (e.g. asynch, r Query fr Dcs (FindAssciatins)) - Add Testing fr a new spec - Add Testing fr a new versin f a spec - Sunset Testing fr an ld versin f a spec The fllwing types f changes t Test Materials shuld NOT be subject t the change management prcess in the DURSA. - Changes t test data - Fixes t testing tls r the test lab that d nt therwise change the test requirements and expected utcmes. - Editrial changes (e.g. t Test Materials shuld nt be subject t the change management prcess.) 4 ehealth Exchange Prfiles and Data Cntent Requirements The ehealth Exchange has adpted a prfile-based apprach, which enables participants t determine which use cases and related specificatins / cntent requirements they wish t supprt in prductin. ehealth Exchange prfiles define hw a cmmunity f ehealth Exchange Participants wishes t exchange data using transprt, service and cntent specificatins t supprt their business needs. This apprach enables the ehealth Exchange t supprt a myriad f use cases, based upn a cmmn set f standards and specificatins. 4.1 Prfile Definitin - Prfiles shall identify and describe business purpse and specificatins required and specify hw t cnstrain r implement thse specificatins. - Prfiles may als specify the fllwing: 9/8/14 Cpyright 2014 Healtheway, Inc. All rights reserved. Page 14

16 Whether ptinal specificatins are used, including versin(s) supprted; Data cntent requirements, including the versin(s) f cntent supprted; and Other requirements, agreed upn by the cmmunity fr that prfile. - Prfiles may be updated t reflect new versins f specificatins adpted fr the ehealth Exchange. 4.2 Universal Requirements All ehealth Exchange prfiles must supprt the Universal Requirements utlined in this plicy. Universal requirements may be revisited ver time Secure Transprt must specify the current versin in effect fr ehealth Exchange and be updated t reflect new versins. - Authrizatin framewrk - Messaging platfrm Service specificatins must specify at least ne exchange pattern used and require the versin in effect fr the ehealth Exchange. - Patient discvery / Query / Retrieve - Dcument submissin - Publish / subscribe Versin Frequency: Versin updates may ccur every cuple years, with a perid fr dual use and a final cutff date, cmparable t the apprach used fr HIPAA Transactin and Cde Set standards. 4.3 Optinal Service-Related Specificatins: Optinal Specificatins Tw ther specificatins may be used by ehealth Exchange Participants, but are nt required: - Web services registry (UDDI) - Access cnsent plicies (ACP) Supprt fr Multiple Use Cases: Optinal service-related specificatins are nt intended t be linked t any particular prfile, but are available fr implementatin acrss a myriad f use cases. 9/8/14 Cpyright 2014 Healtheway, Inc. All rights reserved. Page 15

17 4.3.3 Versin Frequency: Versin updates shuld ccur n a regular basis (e.g. annually), with a perid fr dual use and a final cutff date, cmparable t the apprach used fr HIPAA Transactin and Cde Set standards Implementatin Implicatins: Participants wh exchange fr multiple use cases may need t supprt different versins fr the same specificatin during the perid f dual use 4.4 ehealth Exchange Prfiles There are currently three prfiles supprted in the ehealth Exchange. The fllwing table describes each prfile and identifies the crrespnding implementatin specificatins. Prfile Required Specificatins Optinal Specificatins Query and Retrieve Dcuments Supprts multiple use cases, such as: treatment, transitins f care, care crdinatin, referrals and Scial Security disability benefits determinatin Query and Retrieval f Immunizatin Data fr Treatment Purpses Prviders with immunizatin data may respnd t queries frm ther participants fr treatment purpses. NOTE: This is nt related t reprting t immunizatin registries Submit Dcumentatin t CMS Currently, CMS accepts data fr the - Authrizatin framewrk - Messaging platfrm - Patient Discvery - Query fr Dcuments - Retrieve Dcuments - One r mre f the Summary Patient Recrd Dcument cntent standards - Authrizatin framewrk - Messaging platfrm - Patient Discvery - Query fr Dcuments - Retrieve Dcuments - Immunizatin data requirements in C32 and C-CDA - Authrizatin framewrk - Messaging platfrm - Administrative - Web Services Registry - Access Cnsent Plicies - Deferred Patient Discvery - Web Services Registry - Access Cnsent Plicies - Deferred Patient Discvery - Web Services Registry 9/8/14 Cpyright 2014 Healtheway, Inc. All rights reserved. Page 16

18 Prfile Required Specificatins Optinal Specificatins End Stage Renal Disease Prgram (ESRD) Distributin - Dcument Submissin - Required CMS cntent requirements (which varies by prgram) Other prfiles may be added t the ehealth Exchange ver time. 4.5 ehealth Exchange Data Cntent Requirements and Cnfrmance Expectatins ehealth Exchange participants wh share data in supprt f care crdinatin, including sub use cases such as the sharing f immunizatin data fr treatment purpses, transitins f care, and the SSA disability determinatin prcess shall, at a minimum, supprt ne r mre f the fllwing dcuments and satisfy related Testing: CCD, versin 2.5 (Meaningful Use, Stage editin Standard) Participant shall attest that participant has successfully pass cnfrmance Testing using the crrespnding Healtheway designated validatr tl, r that the participant uses a System which was certified fr meaningful use, stage 1 (2011 editin. Bridge C32 Summary Patient Recrd Cntent Specificatin (ehealth Exchange EHR HIE Interperability Wrkgrup (IWG) Harmnized Cntent Specificatin, dated April 2013). Participant shall be required t test with Healtheway, t demnstrate cmpliance with this specificatin. Cnslidated CDA (Meaningful Use, Stage editin Standard US Realm Versin 1.1) Participant shall attest that participant has successfully passed cnfrmance Testing using the crrespnding Healtheway designated validatr tl, r that the participant uses a System which was certified fr meaningful use, stage 2. Immunizatin Data Requirements (fr Treatment Sub-Use Case) ehealth Exchange participants wh share immunizatin data fr treatment purpses are subject t the fllwing additinal requirements: 9/8/14 Cpyright 2014 Healtheway, Inc. All rights reserved. Page 17

19 Declare cnfrmance with ne f the 3 cntent standards supprted in the ehealth Exchange, and als cmply with the crrespnding vcabularies required fr meaningful use. Run sample files against the crrespnding Healtheway designated validatr t validate 3 sectins f the dcument (patient infrmatin, infrmatin surce and immunizatins) Submit an attestatin statement regarding whether the specimen validated by the Healtheway designated tl was cnfrmant with the cntent standard and vcabularies and Meaningful Use Supply the resulting Healtheway designated tl lg files and cntent specimen submitted t Healtheway fr archival purpses Participants may share ther types f dcuments via the ehealth Exchange such as: Other versins f the CCD thrugh the ehealth Exchange. Testing f nn-standard CCDs is nt required. In this scenari, ehealth Exchange Participants wh use nnstandard data cntent are expected t address incmpatibilities directly with each ut. Unstructured dcuments, in accrdance with available standards; hwever, testing f unstructured dcuments is nt within the scpe f the current ehealth Exchange testing prgram. 9/8/14 Cpyright 2014 Healtheway, Inc. All rights reserved. Page 18

20 Attachment #1: ehealth Exchange Prfiles, Specificatins and Test Cases Prfile Descriptin Specificatins Summary f Test Cases Test Methd Treatment Transmitting clinical dcumentatin t supprt treatment f an individual, care crdinatin r transitins f care 2010 versin f the fllwing Messaging Platfrm Authrizatin Framewrk Patient Discvery Smke tests (2010) Run tests against Develpers Integratin Lab (DIL) Testing envirnment Results validated by Healtheway Query fr Dcuments Authrized Release f Infrmatin (SSA) Transmit clinical dcumentatin t the Scial Security Administratin (SSA) fr the purpses f supprting a claimant s eligibility fr Scial Security disability benefits Retrieve Dcuments 2011 versin f the fllwing Messaging Platfrm Authrizatin Framewrk Patient Discvery Smke tests (2011) Security interperability tests (2011) Run tests against Develpers Integratin Lab (DIL) Testing envirnment Results validated by Healtheway Query fr Dcuments 9/8/14 Cpyright 2014 Healtheway, Inc. All rights reserved. Page 19

21 Prfile Descriptin Specificatins Summary f Test Cases Test Methd Retrieve Dcuments At least ne f the fllwing clinical dcument types Basic C32 Bridge C32 HL7 C-CDA v1.1 US Realm Set up test data Generate sample Message Run sample Message thrugh the crrespnding NIST validatr tl Results validated by Healtheway Fr a detailed list f test cases, please refer t Attachment # ehealth Exchange Specificatins These initial prductin specificatins are in limited use and the participants currently using the 2010 specificatin are migrating t supprt 2011 specificatins in preparatin fr their future sunset. The sunset date is yet t be determined. Organizatins using a previusly validated System under the prir nbarding prgram have the ptin f nly cnducting the belw tests: 2011 ehealth Exchange Specificatins These prductin specificatins are currently in effect and are required fr rganizatins that are nt using a previusly validated System under the prir nbarding prgram and use a System supprting the 2011 specificatins. 6 smke tests interperability tests (2011) 9/8/14 Cpyright 2014 Healtheway, Inc. All rights reserved. Page 20

22 19 security interperability test sets 52 Prvisinal Security Test (Prduct Testing Prgram ONLY) Cntent At a minimum, Participants wh supprt cntent must test at least ne f the belw cntent specificatins. Cntent Testing is waived if an rganizatin uses a prduct that was certified fr Stage 1 / 2 Meaningful Use r if they will nly be transprting cntent prvided by cnnected certified electrnic health recrd prducts identified in the Certified Health IT Prduct Listing (CHPL). Basic C32 (2011 Editin f EHR Certificatin Criteria fr Stage 1 Meaningful Use) Bridge C32 HL7 C-CDA v1.1 US Realm (2014 Editin f EHR Certificatin Criteria fr Stage 2 Meaningful Use) 9/8/14 Cpyright 2014 Healtheway, Inc. All rights reserved. Page 21

23 Attachment #2 - Test Materials The fllwing list represents the set f service sets, test scenaris and test cases that are ready and available fr the ehealth Exchange Testing Prgrams Fr mre details: These materials reflect the fllwing: Change Lg - The Official ehealth Exchange Specificatins page lists, near the tp, the Official Technical Errata and Change Lg. This is the single authritative surce fr changes t the Testing prgram, r specificatins. Prduct Test Case Dcumentatin - List f dcuments fr the required and prvisinal Healtheway Prduct Testing Prgram. Includes the applicatins required and listing f all prduct test cases, dcumentatin, prvisinal tests, cnfrmity assessment checklists, Testing data lad set and dcuments, and a descriptin f cntent tests. Participant Testing Prgram Overview - A brad verview f the prcess, applicatins and dcumentatin fr the Participant Testing Prgram. List f all participant test cases, dcumentatin, prvisinal tests, cnfrmity assessment checklists, Testing data lad sets and dcuments and a descriptin f cntent tests fr the current Healtheway Participant Testing Prgram Healtheway AEGIS Develpers Integratin Lab (DIL) Guides 9/8/14 Cpyright 2014 Healtheway, Inc. All rights reserved. Page 22

24 Appendix A - Dcument Change Histry Versin Date Items Changed Since Previus Versin Changed By /17/09 Apprved by Crdinating Cmmittee n 12/17/09. ONC 2.0 5/7/10 Mdified t allw simpler updating as new specificatin service sets cme nline; redefined HIEM service set definitin. Simplified prcess descriptin. Added infrmatin regarding prduct cnfrmance. Clarified pre-applicatin validatin prcess /01/2012 Updated Testing apprach. Remved references t NHIN acrnym. Updated prcess descriptin; remved reference t Technical Cmmittee in rles and respnsibilities table; updated Technical Qualificatin System t include Task Grup recmmendatins cncerning Participant System expectatins. ONC ONC 4.0 DRAFT rev. 6 07/05/2014 Revised t reflect new Testing prgram supprted by Healtheway, cnslidated plicies and Testing prcess int single dcument. Added Prduct Testing Prgram. Healtheway 4.0 DRAFT rev. 7 7/9/2014 Added TOC and crrect Heading links fr frmatting purpses. Healtheway 4.0 DRAFT rev. 8 7/14/2014 Remved Sectin 3.5 Digital Credentials. This plicy wasn t specific t testing and Healtheway will develp a mre general plicy artifact fr this type f dcuments. Healtheway 9/8/14 Cpyright 2014 Healtheway, Inc. All rights reserved. Page 23