Standards & Interoperability (S&I)Structured Data Capture (SDC)

FHIR Profile IG SWG

Meeting Reminders

• Tentative Ad-Hoc working session to be scheduled for this Friday 4:00PM-6PM

Objectives

• To create HL7 content profile for SDC using FHIR– Create FHIR content profiles to represent SDC content including

• Form Design• Form Instances• Completed Forms• CDEs

• To define FHIR Rest based transactions required for SDC– Retrieve form including support for transmission of pre-pop data– Submit completed forms

Develop FHIR ProfilesDescription

• Develop FHIR Content Profile(s) based on SDC-MFI model

• Develop bi-directional transformation from FHIR based SDC forms and native SDC XML forms based on MFI-13

• Utilize FHIR Exchange Framework to retrieve and submit Forms

Assumption

• The FHIR content profiles and FHIR REST interactions will conform to/meet all requirements identified by the conformance statements in the SOAP SAML IG.

Business Justification

• FHIR is an upcoming standard that is getting noticed and adopted widely across vendors

• Developing FHIR based forms may increase adoption of SDC

• FHIR already has a Questionnaire resource. Currently the authors intend to develop profiles to address similar use cases as SDC. Early alignment while FHIR is in DSTU will reduce risk of multiple Form Model Standards.

Concerns

• For implementers, multiple options to create SDC/MFI conformant forms creates the conflict of: “Which do I choose?”

– S&I core group comment: We provide for multiple options as well as the ability to transform between forms designed using one option into the other.

• Could create a shift of momentum on current SDC work

– S&I core group comment: Any open items related to ongoing SDC work including pilots will keep moving forward.

FHIR Content Profiles-Scope• Develop Normative FHIR Content Profiles for

– Form Design Package Normative• SDC Conformant MFI-13 Form Design• SDC Conformant MDR Mapping along with SDC Content Model

Extension• SDC Form Design MFI- 13 Administrative Information

– Form Instance Informative• HTML rendered instance of Form

– Completed Form Normative– FHIR CCDA – CCD Profile re-use only**– FHIR Profile for Consent Directive

• Based on HL7 v3 CDA R2 Implementation Guide for Consent Directives re-use only**

** These are not in scope for development as part of SDC

FHIR Content Profiles-Assumptions• Profiles / Identified resources Must conform to MFI-13 and Must

conform to SDC extensions to MFI-13• Since MFI-13 is technology agnostic, actual element / attribute

names are not required to be the same as the XML based SDC Form Design. As long as the structure and semantic meaning of the class is not changed

• MFI-13 is our primary guide, SDC extensions are added requirements

• As a part of Q/A, a reference implementation, realizing one of the user stories described in the SDC charter, will need to be part of the Implementation Guide package

SDC FHIR Transactions- Scope • Re-use/Extend FHIR Exchange Framework to

– Retrieve a Form Design from a Form Repository– Retrieve a Form Instance from a Form Repository– Provide Patient Data- CCD or its FHIR equivalent as part of the

Query to the Form Repository. • The Retrieved form should be a fully/partially filled form instance

– Submit a Completed Form to an Intended recipient

FHIR SDC Interactions- Assumptions• Security Considerations including Authentication, Auditing, as

described in the SDC SOAP SAML IG must be met.• Transmission of Consent Directives when Pre-population data is

transmitted to a Form repository as part of the Retrieve Form Query, must be supported.

• Support for transmission of digital signature of a completed Form , along with the Form, must be supported. Currently we use the XAdES profile for this purpose.

• If FHIR profiles for CCDA- CCD and /or CDA based Consent Directives are not available in time for the release of the FHIR SDC profile, then we have the option to transmit the CDA as binary Resources.

Control

HL7

Timeline

Socialization

JulJunMayAprMarFeb

SDC FHIR Profile Introduction

Manage plan

Conduct reviews

Manage comment log

Aug

Execute

Assess FHIR Baseline

Build FHIR Profile for Form Design

Build FHIR Profile for Form Instance

Define FHIR based SDC transactions

Project Scope Statement

Notification of intent to ballot

Final Content

Ballot

Develop IG and Consensus voting

FHIR Introduction

Jul 5

May 18

Jun 29 Aug

3

FHIR Resource Identification for SDC March 27

March 13 March 14

March 27

FHIR Connectathon May 2

March27

Form Design

Form Instances

Transactions

FHIR Baseline Assessment

Execute Phase

Community feedback and revision

Draft resources are reviewed with community

Support team drafts FHIR resources

Community feedback and revision

Draft resources are reviewed with community

Support team drafts FHIR resources

Community feedback and revision

Transactions are reviewed with community

Support team draftstransactions

FHIR Resource Identification for SDC by support team

Community feedback and revision

Draft IG sections are reviewed with community

Support team draftssections

FHIR Profile IG Development and Consensus

July 5

Jan- Feb ‘14 Mar- Apr 4 May- Jun ‘14 Jul- Aug ‘14 Sept- Oct ‘14 Nov- Dec ‘14M

ilest

ones

HL7 Ballot (Aug 8- Sept 8)

SDC

HL7 Project Scope Statement (May 18)

SDC FHIR Profile IG Development and Consensus/ End-to-end Review

HL7 Rest/OAuth Ballot Preview Period

HL7

HL7 Notification of Intent to Ballot (June 29)

HL7 Initial Content Deadline (Jul 13)

HL7 WG Meeting (Sept 14-19)

HL7 Final Content Due (Aug 3)

FHIR Baseline Assessment for SDC

SDC FHIR Profile Timeline Feb 2014 – Dec 2015

FHIR Resource Identification (March 15)

SDC FHIR Profile IG(July 5)

HL7 Ballot Package Development

HL7 Ballot Reconciliation

FHIR Connectathon (May 2-May 3)

FHIR Connectathon

• Goal: Testing of Connectathon Track 2 Usecases• Date: Saturday May 2 and Sunday May 3, 2014• Location: Phoenix, Arizona• Track 2 - Questionnaire

1. Retrieve a completed Questionnaire

2. Retrieve a template

3. Save a Questionnaire

4. Generate resources

5. Pre-populate a questionnaire

Approach

• Manage in iterations– Initial iteration:

• Broad identification of Resources/ Gaps across all key SDC classes and interactions MARCH 27

– 1st iteration is Content: • Form Design Package (including MDR Mapping)• CDEs ?

– 2nd iteration is Content: • Form instance• Completed Form

– 3rd iteration is Transport: • Retrieve Form (no pre-pop)

– 4th iteration is Transport:• Submit Form

– 5th iteration is Transport: • Retrieve Form (with pre-pop)

Approach (cont’d)• Iteration Phases:

– IDENTIFY• Identify candidate resources for key SDC classes • Classify as:

– Complete match– Extensions required– New FHIR resource required

• Community review/approval

– ANALYZE• Generate attribute level map between SDC Class and FHIR resource• Include value set maps

– DESIGN• Define new resource • Design extensions to existing resource

– FINALIZE• Community review

FORM DESIGN Package class Logical View- Form Design Package

SDC Form Design package

Administrative Information

MDR Mapping Package

Form Design Element to CDE

Association

Form Design Element to Content

Model Mapping

Form_Design

«FHIR Bundle»SDC Form Package

Profile

«FHIR Resource»Provenance

«FHIR Resourc...ConceptMap

«FHIR Resource»SDC Questionnaire Profile

0..1

0..*

0..1

0..*

«trace»

«trace»

«trace»

«trace»

custom Logical View- Form Design

Form_Design

Header

Section

Footer

Media

Section Instruction

Additional Instruction

Question

Prompt

Instruction

Input Field

Text Field

Lookup Field

List Field

List Item

«FHIR Resource»SDC Questionnaire

Profile

«FHIR Resource»Group

«FHIR Res...Media

«FHIR Res...Question

Question Text

Answer

Choice

Options

«trace»

«trace»

«trace»

«trace»

«trace»

«trace»

«trace»

«trace»

«trace»

«trace»

«trace»

«trace»

APPENDIX

Legend

Authentication& Authorization

Query response

TLS v 1.0 or higher

FHIR Questionnaire Profile representing an instance of a SDC Form

Get QueryREST

TLS v 1.0 or higher

EHR System Form/Template Repository

Query response

TLS v 1.0 or higher

FHIR Query responseMyserver/message/header/bundle of

resources

Get Query for Pre-pop

TLS v 1.0 or higher

TBD

EHR System Form/Template Repository

FHIR Questionnaire ProfileFHIR SDC Query for pre-pop data

Privacy Consent Directive Document*

EHR System External Data Repository

FHIR Questionnaire

TLS v 1.0 or higher

1. Form Data [XML Name-Value pairs]2. Privacy Consent Directive Document*

Form/Template Exchange without Patient Data

Form/Template Exchange with Patient Data

Completed Form/Template Structured Data

A A

B B

C

Service

Transport

Security

Items Metadata

Item Payload

FHIR Questionnaire Profile

OAuth

TBD

* Optional

OAuth REST

REST OAuth

OAuth REST

REST OAuth

TasksProgressTask

Complete In Progress Not Started

High Medium Low

DecNovOctSepAug

TBD

TBD