“ Jericho / UT Austin Pilot” Privacy with Dynamic Patient Review July 16, 2013 Presented by: David Staggs, JD, CISSP Jericho Systems Corporation

207/16/2013 Agenda Administrative issues Pilot scope Data flow diagram Test Cases Functional requirement cross-walk Potential Test Cases Conformance Effort Timeline Questions POA&M Meeting Schedule Announcement

307/16/2013 Pilot Administrivia This pilot is a community led pilot –Limited support provided by the ONC Apurva Dharia (ESAC) Jeanne Burton (Security Risk Solutions) Melissa Springer (HHS) 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=

407/16/2013 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 back to the healthcare consumer. 2. Additional goal: use of identifiers that can uniquely identify the healthcare consumer and PCD repository used to report the outcome of the request back to the healthcare consumer by healthcare consumer’s provider and subsequent EHR custodians. 3. Stretch goal: use of the PCD repository as a proxy allowing direct authentication by the healthcare consumer to the provider, subsequently reducing correlation errors. 4. Stretch goal: mask and/or redact the clinical document based on PCD choices retrieved from the PCD repository.

507/16/2013 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 

607/16/2013 Test Methodology (from 6/18)

J-UT Pilot Sequence Detail (1) 07/16/ Applying PCD / reporting during patient discovery

807/16/2013 Consent to Patient Discovery Test Case Title: –Consent to Patient Discovery Test Case Description: –Verify PCD is applied to patient discovery request Test Case Detail –Document custodian receives XCPD request –Document custodian identifies potential matching subjects –Document custodian sends data set A to PCD repository –PCD repository applies data set A to filter returned PCD –Document custodian sends response to XCPD request –Document custodian audit data set A to PCD repository –PCD repository stores audit data set A

J-UT Pilot Sequence Detail (2) 07/16/ Applying PCD / Reporting when retuning document list

1007/16/2013 Consent to Document Set Query Test Case Title: –Consent to Documents Query Test Case Description: –Verify PCD is applied to query for list of available documents Test Case Detail –Document custodian receives “retrieve document set” request –Document custodian identifies potential matching documents –Document custodian sends data set B to PCD repository –PCD repository applies data set B to filter returned PCD –Document custodian sends response to request –Document custodian audit data set B to PCD repository –PCD repository stores audit data set B

J-UT Pilot Sequence Diagram (3) 07/16/ Applying PCD / Reporting when retuning the clinical document

1207/16/2013 Consent to Retrieve Document Test Case Title: –Consent to Retrieve Document Test Case Description: –Verify PCD is applied to request for a clinical document Test Case Detail –Document custodian receives “retrieve document” request –Document custodian identifies matching document –Document custodian sends data set C to PCD repository –PCD repository applies data set C to filter returned PCD –Document custodian sends response to request –Document custodian audit data set C to PCD repository –PCD repository stores audit data set C

Functional Requirements Summary Precondition Functional Requirements –Document format for establishing authentication exchange * –Document format for exchange of repository account holder and HIO identifiers? (in proxy) * –Document format for clinical data request (NwHIN) Functional Requirements –Document format for requesting consent directive –Document format for returning consent directive –Document format for sending result of decision to consent directive repository Post-Condition Functional Requirements –Document format for exchange of repository location and account holder identifier to 2nd requestors associated with data 07/16/201313

1407/16/2013 Additional Possible Test Titles Possible Test Case Titles: –Establishing authentication exchange Use of profile to exchange PCD and document custodian identifiers after authenticating the patient to a portal –Exchange of repository location in clinical document Use of Identifiers in the CDA-r2 document sufficient to identify source of the PCD for certain blocks of data previously requested –Masking data in returned clinical documents based on the PCD Use of HCS labels to exchange content the subject does not want to disclose

J-UT Pilot Sequence Diagram (1) 07/16/

J-UT Pilot Sequence Diagram (2) 07/16/

1707/16/2013 Conformance Effort The J-UT will document changes to the IG based on our pilot Create and track conformance against IG (with our additions) –Conformance statements tested –Conformance statements used Add issues for discussion/resolution in the IG –Input from implementers (e.g. filtering PCD on demand) –Standards gaps Change, removal for some items in the IG –Discussion of pilot recommendations may be needed

07/16/2013 UT Student Contribution Students: John Bender and Adrian Tan Requirements for Request of a PCD (within PCD scope): –Sensitivity, POU, requester role, custodian metadata Fields of HL7 Security Observation Vocabulary: –Sensitivity, POU, requester role, custodian metadata Other data that can be included in exchange (not in PCD scope): –Identifying Service Location –Clinical Reports (ex. Behavioral health assessment) –Payment Type (ex. 42 CFR or Veteran's Health Benefits) –Obligations, Refrain Policies Response from PCD Repository: –1. Custodian of Data will receive PCD –2. Custodian of Data will be notified of denial

1907/16/2013 Pilot Timeline General Timeline, conditioned on agreement of stakeholders

20 Relevant Standards Standards from previous discussions: XCA and/or XDS.b (IHE) XUA (IHE) – IHE profile includes SAML (OASIS) XCPD (IHE) – not fully integrated into DS4P IG ATNA (IHE) in ISO format – returned access decision log CDA r2 (HL7) – for PCD location in released clinical document – for format of the directive (includes XACML) XACML (OASIS) – specifically to PCD NwHIN specification ODD (IHE) - On-Demand Documents (Trial) Supplement Note: PCD (HL7) – just updated last WGM, will re-ballot 07/16/2013

2107/16/2013 Questions? For example: How do we identify the test points and conformance in the test documentation?

22 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 Document and update IG with results of our experience 07/16/2013

2307/16/2013 Meeting Announcement No meeting next week: Next meeting will be on July 30 Expected topics will be progress on the pilot demonstration and test documentation

2407/16/2013 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 07/16/201325

2607/16/2013 DS4P References Use Case: ases ases Implementation Guide: nsensus nsensus Pilots Wiki Page: +Pilots+Sub-Workgroup +Pilots+Sub-Workgroup

2707/16/2013 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 

2807/16/2013 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

2907/16/2013 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

3007/16/2013 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

3107/16/2013 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 

3207/16/2013 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 

3307/16/2013 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 

3407/16/2013 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 