“Jericho / UT Austin Pilot”

Privacy with Dynamic Patient Review

July 9, 2013

Presented by:David Staggs, JD, CISSP

Jericho Systems Corporation

207/9/2013

Agenda• Administrative issues • Pilot scope• Data flow diagram• Masking / Redaction• Data Labeling• HL7 Security Observation Vocabulary • HCS in the J-UT Pilot• Identifiers in Clinical Documents• Questions• POA&M

307/9/2013

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: +1-650-479-3208Access code: 662 197 169URL:https://siframework1.webex.com/siframework1/onstage/g.php?t=a&d=662197169

407/9/2013

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.

507/9/2013

Pilot Data Flow

Custodian of Data being Provided at

Patient

PCD Repository2nd Requestor

1st Requestor

B

, = Clinical data

A,B =PCD data

= audit record

And Subsequent Custodian of Data being Provided at

Data Segmentation (6/25/2013)

• Patient’s consent over release of certain clinical data:– What information is available and necessary to filter the

PCD (attributes from the clinical document)– Requires segmentation (data tagging) of the clinical

document being requested• HL7 CDA r2 Confidentiality codes (e.g., ETH) in header• HL7 HCS Sensitivity codes (in data segments)

• If data tags are passed in the request for a PCD, only the patient’s restrictions on those data tags need be sent– Custodian already knows the existence of the data

segment because it sees it in the clinical document

07/9/2013 6

Document Masking/Redaction• Document masking and redaction

– Redaction: Remove information– Masking: Limit access to information (encrypt)

• Prerequisites– Clinical document must be segmented and labeled

• Previous masking and redaction DS4P pilot demonstrations– September 9-14, 2012 at HL7 WGM – March 3-7, 2013 at HIMSS Interoperability Showcase

• Data labeling used in VA/SAMHSA DS4P pilot– HCS Security Labels conform to NIST FIPS PUB 188

Standard Security Label structure

07/9/2013 7

VA/SAMHSA Pilot Overview

07/9/2013 8from: HIMSS 2013 Interoperability Showcase Demonstration Playbook

Data Labeling Scope

07/9/2013 9

from: Guide to the HL7 Health Care Privacy and Security Classification System

HCS Security Labels Detail

07/9/2013 10

from: Guide to the HL7 Health Care Privacy and Security Classification System

HCS Security Labels • Document masking and redaction using HCS Tags

– Can be at CDA header, sections, and/or entries– Requires data segment information

• Binding elements to consent directive – Includes Clinical Facts, Clinical Attributes, Provenance

Attributes, and Security Label Attributes – Examples:

• Medications: RxNorm• Clinical Terms: SNOMED CT• C32 sections: Logical Observation Identifiers Names

and Codes (LOINC) codes• C32 document: CDA header

07/9/2013 11

Security Observations Vocabulary

07/9/2013 12from: Informative Example of HL7 Healthcare Privacy and Security Classification System Release 1 Using HL7 Security Observation Vocabulary

HCS Security Observations Detail

07/9/2013 13

from: Guide to the HL7 Health Care Privacy and Security Classification System

Clinical Fact Clinical Attribute Provenance Security Label

(HL7*)

Diagnosis

<Patient Name > N Source=<Organization> N 111880001 Acute HIV infection (disorder)

hadPrimarySource: SNOMED Code

Restricted, HIV

wasAttributedTo: <Attending>

Medications

<Patient Name > N

11413 Zidovudine (AZT) hadPrimarySource: RxNorm

wasDerivedFrom: Diagnosis

Restricted, HIV

Allergies <Patient Name > wasDerivedFrom:

Encounter N

91936005 (Penicillin) hadPrimarySource: SNOMED CT N

Laboratory Report

8053 (Lipid Panel)

hadPrimarySource: LOINC N

8320 Total Cholesterol

8316 Triglyceride

8429 HDL 7973 LDL

Procedure 86689.Z7 (HIV-1 Western Blot) hadPrimarySource: CPT Restricted,

HIV

Using HCS in the J-UT Pilot• Document masking and redaction scope

– Can be at CDA header, sections, and/or entries– Requires data segment information– Requires shared concept of clinical document content

• Options– Use simple clinical document (C32, Patient Summary)– Apply to segmented and labeled clinical document – Interface with Security Labeling Service as “black box”

• Challenge– Incorporate HCS-required vocabulary and semantics in our

data exchange (both to and from PCD repository)

07/9/2013 14

DS4P Integration• Expectation of being a DS4P pilots:

– Provide integration with other DS4P pilots– Participate in “end-to-end” demonstrations

• Benefits of being a DS4P pilot:– VA/SAMHSA pilot members have agreed to support the

use of the HCS infrastructure in the J-UT pilot– We have access to several Subject Matter Experts (SMEs)

• DS4P pilots explore new approaches– We do not have to boil the ocean

07/9/2013 15

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

06/18/2013 16

Identifiers• Problem: use of identifiers that can uniquely identify the

healthcare consumer and PCD repository • Correlation of the PCD?

– Correlation error results in another’s PCD applied – Identifying (correct) subject of clinical document at multiple

PCD results in conflicts • No correlation of the PCD?

– Subject of clinical document may have moved – Repositories may have moved– Can use correlation as a fall back

07/9/2013 17

Assumptions• Identifier embedded in a clinical document:

– Identify the subject– Identify the Repository

• Registry• Repository Note: two repository SOAP endpointsNote: no issues with distributed XDS.b repositories

– Be compatible with CDAr2 document– Provide access to the audit endpoint

07/9/2013 18

Proposed Construct

07/9/2013 19

<ClinicalDocument> … <authorization>

<templateId … /> <consent> <templateId … /> <id root=”patient id root OID” extension=”232342^1.2.3.4.5.5.66.6&ISO”/> <id root=”audit service reference oid” extension=”atna01.mypcddomain.com”/> <id root=”XDS.b registry service oid” extension=”xds01.mypcddomain.com”/> <id root=”XDS.b repository service oid” extension=”xds01.mypcddomain.com”/> <id root=”XDS.b repository unique id oid” extension=”1.2.3.4.5.56.6.6.77.7.7”/> </authorization> … </ClinicalDocument>

UT Student Contribution• "Definition of Data Sets Exchanged During Request for

Patient Consent Directive (PCD) on e-Health Exchange" – UT Students: Johnny Bender and Adrian Tan

• Current summary:– Ability to mask PCD based on:– Data types, restrictions:

• Normal, Restricted– Specific restrictions – Classifications of data

• Health system planning• Communicable test results

07/9/2013 20

2107/9/2013

Pilot Timeline• General Timeline, conditioned on agreement of stakeholders

22

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 12052 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-ballot06/18/2013

2307/9/2013

Questions?

• For example:• What level of control should the subject have over their records?• When does too much control cause confusion?• Would subjects or algorithms be setting the HCS options?

24

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

07/9/2013

DS4P Standards Material• Location of DS4P Standards Inventory:

http://wiki.siframework.org/Data+Segmentation+-+Standards+Inventory• Location of DS4P Standards Mapping Issues:

http://wiki.siframework.org/file/view/Copy%20of%20DataMappingsIssues%2005102012.xlsx/333681710/Copy%20of%20DataMappingsIssues%2005102012.xlsx

• General Standards Source List:http://wiki.siframework.org/file/view/General%20SI%20Framework%20Standards%20Analysis.xlsx/297940330/General%20SI%20Framework%20Standards%20Analysis.xlsx

• Standards Crosswalk Analysis http://wiki.siframework.org/Data+Segmentation+for+Privacy+Standards+and+Harmonization (at bottom of page, exportable)

• Implementation Guidancehttp://wiki.siframework.org/file/view/Data%20Segmentation%20Implementation%20Guidance_consensus_v1_0_4.pdf/416474106/Data%20Segmentation%20Implementation%20Guidance_consensus_v1_0_4.pdf

07/9/2013 25

2607/9/2013

DS4P References

• Use Case: http://wiki.siframework.org/Data+Segmentation+for+Privacy+Use+Cases

• Implementation Guide: http://wiki.siframework.org/Data+Segmentation+for+Privacy+IG+Consensus

• Pilots Wiki Page: http://wiki.siframework.org/Data+Segmentation+for+Privacy+RI+and+Pilots+Sub-Workgroup

2707/9/2013

Backup Slides

2807/9/2013

Pilot Data Flow

Custodian of Data being Provided at

Patient

PCD Repository2nd Requestor

1st Requestor

B

, = Clinical data

A,B =PCD data

= audit record

And Subsequent Custodian of Data being Provided at

2907/9/2013

Pilot Data Flow

Custodian of Data being Provided at

Patient

PCD Repository2nd Requestor

1st Requestor

Clinical exchange #

Clinical exchange #

B

, = Clinical data

A,B =PCD data

= audit record

And Subsequent Custodian of Data being Provided at Fetch PCD Fetch

PCD

Send auditSend audit

3007/9/2013

Pilot Data Flow (1)

Custodian of Data being Provided at

Patient

PCD Repository2nd Requestor

1st Requestor

, = Clinical data

A,B =PCD data

= audit record

3107/9/2013

Pilot Data Flow (2)

Custodian of Data being Provided at

Patient

PCD Repository2nd Requestor

1st Requestor

, = Clinical data

A,B =PCD data

= audit record

3207/9/2013

Pilot Data Flow (3)

Custodian of Data being Provided at

Patient

PCD Repository2nd Requestor

1st Requestor

B

, = Clinical data

A,B =PCD data

= audit record

And Subsequent Custodian of Data being Provided at

3307/9/2013

Pilot Data Flow (4)

Custodian of Data being Provided at

Patient

PCD Repository2nd Requestor

1st Requestor

, = Clinical data

A,B =PCD data

= audit record

And Subsequent Custodian of Data being Provided at

3407/9/2013

Pilot Data Flow (5)

Custodian of Data being Provided at

Patient

PCD Repository2nd Requestor

1st Requestor

, = Clinical data

A,B =PCD data

= audit record

And Subsequent Custodian of Data being Provided at

3507/9/2013

Pilot Data Flow (updated)

Custodian of Data being Provided at

Patient

PCD Repository2nd Requestor

1st Requestor

B

, = Clinical data

A,B =PCD data

= audit record

And Subsequent Custodian of Data being Provided at