“ Jericho / UT Austin Pilot” Privacy with Dynamic Patient Review November 5, 2013 Presented by: David Staggs JD, CISSP Jericho Systems Corporation

211/5/2013 Agenda Administrative issues Pilot scope Pilot data flow Implementation guidance document –Previously discussed sections –Additional sections General discussion Pilot timeline Plan of action

311/5/2013 Pilot Administrivia This pilot is a community led pilot –Limited support provided by the ONC Johnathan Coleman (Security Risk Solutions) Zachary May (ESAC) Scott Weinstein (ONC Sponsor) In conjunction with DS4P bi-weekly return of an All Hands meeting Access to DS4P Wiki, teleconference, and calendar Meeting times: Tuesdays 11AM (ET) –Dial In: Access code: URL: d= d=

411/5/2013 Scope of the Pilot 1.Define the exchange of HL7 CDA-compliant PCD between a data custodian and a PCD repository that includes a report on the outcome of the request to the healthcare consumer (subject). 2.Additional goal: use identifiers to identify the subject/ PCD repository for use in reporting the outcome of the “secondary user” request use case to subject by subsequent EHR custodians. 3.Stretch goal: mask and/or redact the clinical document based on data segmentation and PCD choices retrieved from the PCD repository.

511/5/2013 Pilot Data Flow Custodian of Data being Provided at  Patient PCD Repository 2 nd Requestor 1 st Requestor   B ,  = Clinical data A,B = PCD data = audit record And Subsequent Custodian of Data being Provided at 

611/5/2013 J-UT Implementation Guidance PCD returned to the document custodian should be specific to the document custodian and the requestor PCD should be requested for each type of network exchange that could reveal PHI: ITI-55, ITI-38, and ITI-39 Data labels should be passed in the PCD request if they exist in the document being requested Document Custodian should return release decision as an ATNA audit message to the PCD repository PCD repository should allow edit of PCD and review of release decisions through standard interfaces docx/ /SIFramework_DS4P_UC_Jericho_4NOV2013.docx

711/5/2013 Previously Discussed IG Sections PCD should be dynamically filtered specifically for the document custodian and requestor (§2.2) PCD should be requested for each type of data exchange that could reveal PHI (§3.0) PCD request should include any data labels identified in the requested information (§2.3) Release decision should be returned to the PCD repository using an ATNA audit message (§2.4) PCD repository should be securely accessible to patients using standard interfaces PCD alternative representation should be XACML and should be lightweight (§2.6) PCD repository location and account information can be embedded in a CDA clinical document (§2.5)

811/5/2013 Additional Topics Added to the IG Introduction: creation of the pilot (§1.0) Use Case Scenario: implementation of user story 3 (§2.0) Architecture: The J-UT data flow (§2.1) IHE ITI-55 Transactions: diagram and data sets for patient discover request received at the gateway (§3.1) IHE ITI-38 Transactions: diagram and data sets for document list request received at the gateway (§3.2) IHE ITI-39 Transactions: diagram and data sets for document request received at the gateway (§3.3) Test Participants: List of members who played roles in the test scenario (§4) Summary of J-UT Implementation Guidance: Summary of the major guidance from the pilot (§5)

911/5/2013 General Discussion Implementation guidance document –Do we need more time to review? –Does the content need additions / deletions? Are there issues with the remaining artifacts? –Mapping / gap analysis of functionality to standards? –Test cases, test artifacts, and/or test video? Additional activities –More demonstrations and/or J-UT meetings? –Approval of the implementation guidance document? –Bringing the IG to standards organizations (profiles)?

1011/5/2013 Pilot Timeline General Timeline, conditioned on agreement of stakeholders

11 Plan of Action Upon agreement of the participants the POA is: Identify the elements available from previous DS4P pilots Scope level of effort, decide on extended scenario Determine first draft of functional requirements Review standards available for returning information on requests Determine any gaps or extensions required in standards Stand up information holders and requestors Create XDS.b repository holding PCD Identify remaining pieces, create test procedures Document and update IG with results of our experience 11/5/2013

1211/5/2013 Backup Slides

DS4P Standards Material Location of DS4P Standards Inventory: Location of DS4P Standards Mapping Issues: xlsx/ /Copy%20of%20DataMappingsIssues% xlsx General Standards Source List: %20Analysis.xlsx/ /General%20SI%20Framework%20Standards%20A nalysis.xlsx Standards Crosswalk Analysis monizationhttp://wiki.siframework.org/Data+Segmentation+for+Privacy+Standards+and+Har monization (at bottom of page, exportable) Implementation Guidance 20Guidance_consensus_v1_0_4.pdf/ /Data%20Segmentation%20Impl ementation%20Guidance_consensus_v1_0_4.pdf 11/5/201313

1411/5/2013 DS4P References Use Case: ases ases Implementation Guide: nsensus nsensus Pilots Wiki Page: +Pilots+Sub-Workgroup +Pilots+Sub-Workgroup

Test Cases 11/5/ Consent To Patient Discovery : No Consent 2.Consent To Document Query : No Consent 3.Consent To Document Retrieve : No Consent 4.Consent To Patient Discovery : 1 st Requestor (1 st ) 5.Consent To Document Query : 1 st To PC - Allow 6.Consent To Document Query with POU 1 st to PC – Deny 7.Consent To Document Retrieve : 1 st to PC - Allow 8.Consent To Patient Discovery : 2 nd Requestor (2 nd ) 9.Consent To Document Query : 2 nd To PC - Deny 10.Consent To Document Retrieve : 2 nd To PC – Deny 11.Consent To Document Query : 2 nd to SC - Deny 12.Consent To Document Retrieve : 2 nd to SC - Deny 13.Consent To Document Retrieve : With Segmentation

Test Cases (Visual Representation) 11/5/ ScenarioPCDITI-55ITI-38ITI-39 1 st Requestor → PCY45/67 2 nd Requestor → PCY nd Requestor → SCY st Requestor → PCN123 Clinical Data SegmentationY13 PC = Primary Custodian SC = Secondary Custodian Test Document available for review (since 9/16/2013) at: Video of the test will be available shortly.

Test Participants Participants in the September 20, 2013 DS4P Pilot Execution Script: 11/5/ ParticipantActing AsStory RoleHome Community Id UT-AustinSecondary Custodian Research University2.2 UT-AustinFirst RequestorResearch University2.2 ConemaughSecond RequestorMarketing Network5.5 Jericho SystemsPrimary CustodianFirst Network1.1 Jericho SystemsPatient Consent Repository 1.1 Edmond Scientific Secure Labeling Service First Network infrastructure piece

1811/5/2013 Pilot Data Flow Custodian of Data being Provided at  Patient PCD Repository 2 nd Requestor 1 st Requestor   B ,  = Clinical data A,B = PCD data = audit record And Subsequent Custodian of Data being Provided at 

1911/5/2013 Pilot Data Flow Custodian of Data being Provided at  Patient PCD Repository 2 nd Requestor 1 st Requestor Clinical exchange #  Clinical exchange #  B ,  = Clinical data A,B = PCD data = audit record And Subsequent Custodian of Data being Provided at  Fetch PCD Send audit

2011/5/2013 Pilot Data Flow (1) Custodian of Data being Provided at  Patient PCD Repository 2 nd Requestor 1 st Requestor  ,  = Clinical data A,B = PCD data = audit record

2111/5/2013 Pilot Data Flow (2) Custodian of Data being Provided at  Patient PCD Repository 2 nd Requestor 1 st Requestor  ,  = Clinical data A,B = PCD data = audit record

2211/5/2013 Pilot Data Flow (3) Custodian of Data being Provided at  Patient PCD Repository 2 nd Requestor 1 st Requestor  B ,  = Clinical data A,B = PCD data = audit record And Subsequent Custodian of Data being Provided at 

2311/5/2013 Pilot Data Flow (4) Custodian of Data being Provided at  Patient PCD Repository 2 nd Requestor 1 st Requestor  ,  = Clinical data A,B = PCD data = audit record And Subsequent Custodian of Data being Provided at 

2411/5/2013 Pilot Data Flow (5) Custodian of Data being Provided at  Patient PCD Repository 2 nd Requestor 1 st Requestor ,  = Clinical data A,B = PCD data = audit record And Subsequent Custodian of Data being Provided at 

2511/5/2013 Pilot Data Flow (updated) Custodian of Data being Provided at  Patient PCD Repository 2 nd Requestor 1 st Requestor   B ,  = Clinical data A,B = PCD data = audit record And Subsequent Custodian of Data being Provided at 