Kick-Off Meeting

Data Provenance Task Force

Lisa Gallagher, Chair

January 6, 2015

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Agenda

• Opening Remarks: Steve Posnack, Director, Office of Standards and Technology– Use of FACA Task Forces– Comments from 11/18/14 HITSC Meeting– Task Force Charge

• Task force membership• High-level work plan• Overview of Standards and Interoperability (S&I)

Framework• Overview of Data Provenance Initiative• Next steps

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FACA Task Forces

• Federal Advisory Committee Task Forces (TFs) are charged with addressing ONC questions requiring interdisciplinary advice.– Convene multi-disciplinary task forces to address questions

and make recommendations on specific issues– Task Forces consist of several members from workgroups

whose disciplines will be applied to the question at hand– Task Forces may include additional SMEs

• Data Provenance has been cited as a priority item by the HITSC. This TF is being asked to look at the Data Provenance Initiative’s work to date, and provide recommendations to the HITSC on where they should focus moving forward.

Task Force Example

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Semantics

Content

Transport

Security

Architecture, Services, APIs

Implementation, Testing &

Certification

HITSC & WorkgroupDisciplines

TaskForce

HITSC(Full Committee)

(Steering Committee)

ONC Identifies Question

1ID Chairs for New Task Force & Form Task Force

2Task Force Operational

3Deliver Rec’s to HITSC

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Task Force Ends

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HITSC

X

HITSC

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Summary of Feedback/Comments from 11/18/14 HITSC Meeting*

• Ensure integrity of data from its point of origin to its point of use • Focus on the value to the clinician / physician• Identify the parsimonious number of use cases, but do not over

simplify• Consider existing standards that are simple, have successes in

implementation • Consider not just who authored / sent the data but also its

source (e.g., enterprise system, mobile device, patient generated, etc.)

• Ensure that the data and provenance are retained and the patient can act as an exchange

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Charge

Specific Question from ONC:Given the community-developed S&I Data Provenance Use Case, what first step in the area of data provenance standardization would be the most broadly applicable and immediately useful to the industry?

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Task Force Members

Member Name OrganizationLisa Gallagher, Chair HIMSSRebecca D. Kush CDISCJohn Moehrke GEFloyd Eisenberg, MD iParsimony, LLC

Aaron Seib National Association for Trusted Exchange (NATE)

Mike Davis (Workgroup Federal Ex Officio) US Department of Veterans Affairs

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Workplan

Timeline Task

January 5th – 9th • Tue, Jan 6th, 2:00pm – 4:00pm EST• Review charge• Identify action steps• Review Use Case and Executive Summary documents• Review sample recommendations • Takeaway Assignment #1: Be prepared to discuss thoughts

on Use Case scenarios at next meetingJanuary 12th – 16th • Fri, Jan 16th, 3:00pm – 5:00pm EST

• Discuss Task Force member input on Assignment #1 and agree on a “theme” or “scope” for the straw recommendations

• Extended public comment opportunity• Takeaway Assignment #2: Build on straw recommendations

and be prepared to review/discuss/approve final recommendations at next meeting

January 19th – 23rd • Fri, Jan 23rd 9:00am to 10:30am EST• Finalize recommendations

January 27th • Present recommendations to HITSC

Standards & Interoperability Framework Overview

Overview for the HITSC Data Provenance Task Force

January 6th , 2015

What is the S&I Framework?

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• ONC kicked-off the Standards & Interoperability Framework in 2010.

• The S&I Framework is an open, collaborative community made up of stakeholders from the public and private sectors.

• Each S&I initiative is focused on a critical interoperability challenge and does so through a well defined process that includes:

Development of clinically-oriented user stories and use cases. Harmonization of interoperability specifications and

implementation guidance. Real-world experience and implementer support through new

initiatives, workgroups and pilot projects. Mechanisms for feedback , evaluation, and implementation

testing.

S&I Framework: The Value of Community Participation

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ONC Programs

Community S&I Framework

HIT Standards CommitteeHIT Policy Committee

SDOs

• State HIE Program & CoPs• REC Program & CoPs• Beacon Program

• Technology Vendors• System Integrators• Government Agencies

(National & International)• Industry Associations• Providers• Individuals/Consumers• Other Experts

• HL7• IHE• CDISC• Other SDOs

ENABLING

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Phase Planned Activities 1. Pre-Discovery Development of Initiative Synopsis

Development of Initiative Charter Definition of Goals & Initiative Outcomes

2. Discovery Creation/Validation of Use Cases, User Stories & Functional Requirements Identification of interoperability gaps, barriers, obstacles and costs Review of Vocabulary

3. Implementation Evaluation of candidate standards Development of Standards Solution Plan Creation of Implementation Guidance

4. Pilot Validation of aligned specifications, testing tools, and reference implementation tools Revision of documentation and tools Development and presentation of Pilot Proposals

4. Evaluation Measurement of initiative success against goals and outcomes Identification of best practices and lessons learned from pilots for wider scale

deployment Identification of hard and soft policy tools that could be considered for wider scale

deployments

Initiative Activities:S&I Framework

S&I Data Provenance InitiativeOverview for the HITSC Data Provenance Task Force

January 6th , 2015

Julie Anne Chua, PMP, CAP, CISSPOffice of the Chief Privacy OfficerOffice of the National Coordinator for Health Information Technologyjulie.chua@hhs.gov

Johnathan Coleman, CISSP, CISM, CBRM, CRISCInitiative Coordinator OCPO/OST/ONC/HHS (CTR)jc@securityrs.com

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Outline of Topics

• The need for Data Provenance standards• Data Provenance Initiative Purpose & Goals• Initiative Participation and Progress• Candidate Standards (work in progress)• Data Provenance Initiative Use Case Summary• Questions originally asked to the HITSC:

1) Did the Data Provenance Initiative community miss something that’s potentially more impactful?

2) Where in the Use Case should we start in terms of evaluating standards to meet Use Case requirements?

3) Are there any architecture or technology specific issues for the community to consider?

• Response/Guidance from the HITSC on Questions

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Why do we need data provenance standards?

• Health care providers need confidence in the authenticity and integrity of health data they review/access/receive.

• Ever expanding role for individuals to contribute data toward their health and care through the use of health IT.

• Trends away from documents and toward “atomizing” data.

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• To establish a standardized way for capturing, retaining, and exchanging the provenance of health information.

• The community will:– Define an initial set of provenance metadata and vocabulary.– Create technical specifications to standardize data

provenance:• At creation (i.e., point of origin);• When its exchanged; and • When data is integrated across multiple health

information systems. – Develop guidance for handling data provenance in content

standards, including the level to which provenance should be applied.

Initiative Purpose and Goals

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Data Provenance Initiative Participation to Date

• 134 Participants from 89 Different Organizations represented, including:– 24 Health IT Vendors (EHR, EMR, PHR, HIE etc)– 20 Federal/State/Local Agency representatives – 7 Healthcare Professionals (including 5 Medical Doctors)– 8 individuals from Research Organizations– 4 Healthcare Payer/Purchaser or Payer Contractors– 4 individuals from Hospitals/Health Systems/Academic Health Systems– 3 from Professional Associations– 2 from Labs

• The rest are a mixture of other categories such as contractors, or “unknown”.

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• Achieved consensus on Charter (June 2014)• Achieved consensus on Use Case (October 2014)• Participated in development of HL7 Implementation

Guide for CDA® Release 2: Data Provenance (DSTU – September 2014 Ballot)

• Identified Candidate Standards for consideration during Harmonization Phase

Initiative Progress

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Note – This list will continue to be updated based on community feedback.

Candidate Standards

• Cross Enterprise Document-Sharing (XDS)• Simple Object Access Protocol (SOAP)• Representation State Transfer (RESTful)• HL7 Clinical Documentation Architecture Release 2 (CDA R2)• HL7 IG for CDA R2: Data Provenance – Sep 2014 Ballot• HL7 Version 2 Vocabulary & Terminology Standards• HL7 Implementation Guide: Data Segmentation for Privacy (DS4P), Release 1• HL7 FHIR DSTU Release 1.1 Provenance Resource• W3C PROV: PROV-AQ, PROV-CONTRAINTS, PROV-XML• HL7 Health Care Privacy and Security Classification System, Release 1• HL7 Version 3 Standard: Privacy, Access and Security Services (PASS)• HL7 Record Lifecycle Event Metadata using FHIR (project underway 2014)• HL7 EHR Records Management and Evidentiary Support (RM-ES) Functional Model, Rel 2• HL7 EHR System Functional Model Release 2• HL7 EHR Lifecycle Model (2008)• ISO/HL7 10781 EHR System Functional Model Release 2 (2014)• HL7 Digital Signature• ISO 21089 Health Informatics: Trusted End-to-End Information Flows• Personal Health Record System Functional Model

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Data Provenance Initiative Use Case Summary

Scenario 1: Start Point -> End Point. Describes simple provenance requirements when transferring healthcare data from a Start Point (sending system) to an End Point (Receiving System).

Scenario 2: Start Point -> Transmitter -> End Point. Includes use of a third party as a conduit/transmitter to transfer information from Start Point to End Point. There may be use cases where it is important to know how the information was routed, as well as who originated it and who sent it.

Scenario 3: Start Point ->Assembler / Composer -> End Point. Uses a third party system to aggregate or combine information from multiple sources, either in whole or in part, to produce new healthcare artifacts. The new artifacts may contain information previously obtained from multiple sources, as well as new information created locally.

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Data

Pro

vena

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Initi

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Use

Cas

e Su

mm

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Task Force Discussion

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Summary of HITSC Commentson Data Provenance November 18, 2014

• Use Cases– Should ensure integrity of data from its point of origin to its point of use – Focus on the value to the clinician / physician– Identify the parsimonious number of use cases, but do not over simplify

• Two Primary (Direct clinical care, Clinical veracity of the data)• One Secondary (Decision support – use of data from elsewhere which may

require greater provenance)– Apply user stories to identify and itemize minimum amount of data needed

• Standards– Do not try to address all of the standards identified by the community– Do consider existing standards that are simple, have successes in

implementation and associated lessons learned to offer. Examples: • FDA• Standards used in other countries• Usability (e.g., NIST 7804)

*Transcript of the 11/18/14 HITISC meeting http://healthit.gov/FACAS/sites/faca/files/HITSC_Transcript_Final_2014-11-18.pdf

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Summary of HITSC Commentson Data Provenance November 18, 2014

• Consider not just who authored / sent the data but also its source (e.g., enterprise system, mobile device, patient generated, etc.)

• Do not disintermediate the patient as a source of clinical information

• Ensure that the data and provenance are retained and there is some sort of field that allows the patient to act as an exchange– Example: Build in the ability to include a tamper-proof field that

shows the author of a piece, pieces, of data as they are passed from source to source (e.g., in a CCDA and/or patient generated health data template or health record

– May require coordination with CCDA patient generated health template header

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Charge

Task Force Charge/Question from ONC:Given the community-developed S&I Data Provenance Use Case, what first step in the area of data provenance standardization would be the most broadly applicable and immediately useful to the industry?

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Example Recommendations:

Ideal recommendations might suggest priorities for the Initiative’s future harmonization work. The following is an example only - the Task Force may choose a different approach.• Task Force recommends the following priorities for the S&I Data Provenance

Initiative:1) Define the minimum dataset for provenance for health information at point of creation, and at rest in the following: (produce a list in priority order)

• EHR systems, Patient Generated Data in PHRs, Medical Devices, HIEs, Etc…

2) Select/recommend standards to define common system behavior for provenance metadata pertaining to the following information interchanges: (list in order) • PHR to EHR, EHR to EHR , Medical Device to PHR, Etc…

3) 3) Focus on technology / architecture drivers according to the following priorities: (list in order)• FHIR, SOAP/SAML, DIRECT (push), Etc.

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Questions for the Task Force

1) Do the 3 scenarios in the Use Case, and the Use Case’s identified scope, address key data provenance areas, or is something missing?

a) Yes, the scenarios address key provenance areas b) No, some key data provenance areas are missing

To help address this question, three supporting questions can be used to facilitate the discussion:

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Questions for the Task Force

2) The Use Case is broad and spans a lot of challenges. Where in the Use Case should the Initiative start in terms of evaluating standards to meet Use Case requirements?

a) At the point of data creation in a Patient Controlled Device (PCD) or PHR?

b) At the point of origin/data creation in an EHR or HIE?c) With the transfer of data from a PCD/PHR to an EHR

system?d) With exchange of data between EHRs?

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Questions for the Task Force

3) Are there any architecture or technology specific issues for the community to consider?

a) Content: Refining provenance capabilities for CDA/C-CDA while supporting FHIR?

b) Exchange: Push (e.g. DIRECT), Pull (SOAP and REST-based query responses)?

c) Others?

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Task Force Discussion

• Other questions/comments from the TF?

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Next Steps

• Prepare for Meeting #2:– Review Data Provenance Use Case– Consider questions asked in this meeting– Prepare to discuss your thoughts and present at

the next meeting