sds & harmonization hed leadership agenda wg call presentations during thursday wg meeting...

SDS & Harmonization HeD Leadership Agenda• WG call presentations during Thursday WG meeting• Update on progress & decisions made last week• HeD Standards Selection Risks• Timeline review• Detailed Data Requirement Analysis• Follow-up on discussion with Dave Shields• IG Update

– Conformance Verbs – Data Model Approach– Functional Interaction Types– Vocab & Codeset inclusion into HeD UC2 IG: update from HL7?

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SDS & Harmonization HeD Leadership Agenda• WG call presentations during Thursday WG meeting• Update on progress & decisions made last week• HeD Standards Selection Risks• Timeline review• Detailed Data Requirement Analysis• Follow-up on discussion with Dave Shields• IG Update


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Discussion Points and Activities for Week of 5/13 WG call presentations during Thursday WG meeting

o vMR: Claude Nanjo & David Shields presenting?• 11:15-12pm EST

o C-CDA: Calvin Beebe presenting• 12pm-12:30pm EST

o Can we extend meeting/webex past 12:30pm in case there are questions?

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SDS & Harmonization HeD Leadership Agenda• HeD WG Agenda for 5/16• Update on progress & decisions made last week• HeD Standards Selection Risks• Timeline review• Detailed Data Requirement Analysis• Follow-up on discussion with Dave Shields• IG Update


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Discussion Points and Activities for Week of 5/13

Update on progress & decisions made last weeko Initial feedback of the Solution Plan and Gap Mitigation Plan due by COB on Tuesday,

5/14o Solution Plan and Gap Mitigation plan will continue to be reviewed with the SWG on 5/15.

FINAL feedback will be due COB 5/21

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HeD Community Decisions:Viable Implementation Options

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Implementation Option Transaction Service Organizer/

Container Payload Transport Notes/Rationale

3 II01 - Request DSS CCDA CCDA SOAP 1. Further discussion needed on utilization of vMR vs. CCDA and

SOAP vs. REST

4 II01 - Request DSS CCDA CCDA REST

1. Further discussion needed on utilization of vMR vs. CCDA and SOAP vs. REST

2. There is currently implementation guidance on DSS to be used with SOAP, not REST

5 II01 - Request DSS VMR VMR SOAP 1. Further discussion needed on utilization of vMR vs. CCDA and

SOAP vs. REST

6 II01 - Request DSS VMR VMR REST

1. Further discussion needed on utilization of vMR vs. CCDA and SOAP vs. REST


9 II02 - Response DSS HeD UC1

IG VMR SOAP 1. Consistent with UC1

10 II02 - Response DSS HeD UC1

IG VMR REST

1. Consistent with UC1


HeD Community Decisions:Non Viable Implementation Options

For the request transaction, vMR or CCDA should be used for both the Organizer/Container and Payload, instead of a combination of both. They are not meant to be separated in this manner. All implementation options that combined vMR and CCDA were eliminated

CCDA is not a commonly used standard for the response transaction, therefore any implementation option that had CCDA as the Item Payload standard was eliminated

Adoptability of HL7 Version 3 Order Set Standard for the response transaction was decided to be low, therefore any implementation option that had HL7 Version 3 Order Set Item Payload standard was eliminated

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Discussion Points and Activities for Week of 5/13

HeD Standards Selection Riskso vMR vs. CCDAo SOAP vs. REST

• Update from Pilots Call on SOAP/REST• Information on use of SOAP today?

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Health eDecisions (HeD) Standards RiskvMR vs. C-CDA

Background• vMR and C-CDA could both potentially support the payload of the request for CDS guidance

• C-CDA is in wide use today within EHRs and is cited in regulation, but there is currently no template specifically for CDS use, and existing templates may require population of data that is non-essential to a CDS guidance request

• vMR is used more heavily for clinical decision support and was the basis for the HeD UC1 solution, but there may be push back from EHR community if we required them to conform to both C-CDA (currently regulated in certification criteria) and vMR (would be regulated for CDS in certification criteria)

• The community is torn between the two, and is unsure which solution would be better for sending a request for CDS guidance to a CDS service

Risk • The HeD community is currently exploring the option of writing Implementation Guidance for both vMR and C-CDA and

using pilots to determine which solution would be better for HeD. • Community time and support team resources would be spent developing implementation guidance that may never

be used (depending on which standard is selected after pilots)

Ongoing and Planned Mitigation Actions• C-CDA and vMR overview presentations will be given to the community this week in order to give them a better idea of

how it could be used to support a CDS Guidance Request• HeD Leadership is considering developing vMR as its primary implementation guidance, and developing C-CDA guidance

only as time and resources allow• Another option that is being considered is the use of a C-CDA-to-vMR transform, which would allow EHRs to continue

using C-CDA alone but still utilize vMR within the CDS Guidance Request

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Health eDecisions (HeD) Standards RiskvMR vs. C-CDA (continued)

IG Options

ID Description Pros Cons

A vMR alone; no C-CDA guidance within HeD UC2 IG

• This solution would most likely support the full scope of HeD UC2 and would be consistent with HeD UC1

• EHRs would have to build in new logic to support vMR, even if they already support C-CDA

B C-CDA alone; no vMR IG for HeD UC2

• This solution would require minimal updates from EHRs that currently support C-CDA

• This would not be consistent with HeD UC1• It is unclear how well C-CDA can support HeD

UC2 requirements as-is, and at minimum may require new C-CDA template(s)

C vMR & C-CDA guidance in HeD UC2 IG; selection made at a future point in time

• This solution would allow us to thoroughly investigate both standards before determining which to go with, therefore giving more weight to a decision either way

• This would require more work than a single-standard approach

• Time and resources would be spent developing implementation guidance that would never be used outside of pilots

D vMR with vMR-to-C-CDA transform specified as an appendix within IG

• This solution would have all of the benefits of both the vMR and C-CDA options, without having to use resources for guidance that may never be used

• This would require more work than a single-standard approach

• Unclear if a C-CDA-to-vMR transform would also be necessary (i.e. for response) and if so, how feasible it would be

• C-CDA may still require new template(s) to support a transform to vMR

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Health eDecisions (HeD) Standards RiskSOAP vs. REST

Background• SOAP is widely used in the industry today; REST is considered to be the future standard for the industry

Risk • The HeD community would like to develop Implementation Guidance for both as different vendors may have a preference

for one vs. the other• However, if the use of SOAP vs. REST varies from vendor to vendor, ultimately this would necessitate EHRs and/or CDS

Service Suppliers to support both, which would be a burden on implementers

Ongoing and Planned Mitigation Actions• We are raising this risk to the HeD Pilot community to get there input on how much of a burden this would be, and if they

would instead prefer either SOAP or REST (and which one)

Solution Options

ID Description Pros Cons

A SOAP alone • SOAP is in wide use today • Vendors have stated they will not pilot if REST is not included

B REST alone • The industry seems to be moving towards REST

• Vendors which currently support SOAP alone for other interfaces would have to develop a RESTful interface

C SOAP and REST in Implementation Guidance

• Vendors with a preference of SOAP vs. REST would be able to pilot whichever they are more comfortable with

• Would require more time and resources to develop IG• Could result in burden on implementers to support both

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Discussion Points and Activities for Week of 5/13 (Continued…)

Detailed Data Requirement Analysiso Review approach to complete documento Should we be using the data elements from the schema instead of in conjunction with the

elements from Use Case 2?• SDC team noticed that the Actions section had additional elements in the schema that

weren’t in the Use Case

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SDS & Harmonization HeD Leadership Agenda• HeD WG Agenda for 5/16• Update on progress & decisions made last week• HeD Standards Selection Risks• Timeline review• Detailed Data Requirement Analysis• Follow-up on discussion with Dave Shields and Aziz Boxwala• IG Update


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Update on Conversation with Dave ShieldsTransactional Layers

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Transport and SecurityResponse Service: e.g., DSS Response ElementResponse Items Organizer/Container: e.g., HeD Action Groups Element Response Item Payload: e.g., VMR Proposal

Transport and SecurityRequest Service: e.g., DSS Request ElementRequest Items Organizer/Container: e.g: VMR or CCDARequest Item Payload: e.g., VMR Clinical

Statement

The response needs to include context elements (e.g., patient) that were not part of the HeD UC1 spec.

The request and response should have parallel approaches

The response wrapper would be in a class/complexType called CDSOutput

• This type would incorporate appropriate pieces of the HeD schema (e.g., actionGroup, actionSentences, etc).

To not have a two-way dependency between vMR and HeDS (HeD schema from UC1), we will move the current CDSInput and CDSOutput types from the vMR namespace into a new namespace

• The cdsInput and CDSOutput will continue to be part of the vMR specification and project

So the response will look like this:

DSS Response Element

Contains

CDSOutput (new name space, new type that imports HeDS types)

Contains

vMR Clinical Statements (in vMR namespace; further CDSOutput will be designed so that clinical statements from other types can be incorporated (e.g., FHIR), but this is out of scope for HeD UC2)



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Discussion Points and Activities for Week of 5/13 (Continued…) IG update

o Have determined which sections will be populated internally, and which sections will be community homework. Have also drafted a timeline for completion of each section. Internal team beginning to populate the Introduction section, and will be ready for Leadership review on 5/21

o Should Conformance Verbs include the full HL7 v3 list or to cut out the May/Need Not per ONC’s direction?

• SHALL: an absolute requirement• SHALL NOT: an absolute prohibition against inclusion• SHOULD/SHOULD NOT: best practice or recommendation. There may be valid reasons

to ignore an item, but the full implications must be understood and carefully weighed before choosing a different course

• MAY/NEED NOT: truly optional; can be included or omitted as the author decides with no implications

o Data Model Approach• Talking point at HL7 Patient Care/SD/CDS WG Joint session: the XML format of HeD

schema/expression language is not as useful/valuable as a more generalizable model (e.g. UML) would be

• What’s useful to an implementer?• What’s in our purview?

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Discussion Points and Activities for Week of 5/13 (Continued…) IG update (continued…)

o Functional Interaction Types• How many should we focus on?

– Drug Dosing Calculation– Immunization Forecasting– Disease Management – Quality Measure Evaluation– Transition of Care Support– Prediction Rule Evaluation – APACHE score, AHRQ Pneumonia Severity Index, etc.– Severity of Illness Assessment – Charlson index, etc.

• Will these be included in the main IG document, or can they be submitted as examples (allowing them to come after the other materials)

o Vocab & Codeset inclusion into HeD UC2 IG: update from HL7?• How will we leverage Vocab & Terminology WG/work

o Reinstate scrum calls – Friday only?

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Appendix

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Use Case 2 – CDS Guidance Service Transactions

CDS Guidance Requestor

2. CDS Response(Clinical Data, Supporting Evidence, Supporting

Reference, Actions, Attribute-Value List, Response Metadata & Exceptions)

CDS Guidance Supplier

1. CDS Request (Clinical Data & Context)

INSERT SELECTED STANDARDS HERE

INSERT SELECTED STANDARDS HERE

Use Case 2: CDS Guidance Service Transactions - Standards per Transaction

# Transaction Service Organizer/Container Item PayloadsReference

Information Model

1CDS Request (patient data

and potentially context)

• Decision Support Service (DSS)

• Context Aware Retrieval Application (Infobutton)

• CDS Knowledge Artifact Implementation Guide (HeD UC1 IG)

• Consolidated CDA• Virtual Medical Record

(vMR)


• Virtual Medical Record (vMR)• Consolidated CDA (hL7 Clinical

Statements)• HL7 Version 3 Standard: Order Set

Publication, Release 1

• Federal Health Information Model (FHIM)

• HL7 v2.x• HL7 v3

2 CDS Response (guidance

and/or other response elements)

• Decision Support Service (DSS)


• CDS Knowledge Artifact Implementation Guide (HeD UC1 IG)

• HL7 Version 3 Standard: Order Set Publication, Release 1

• Consolidated CDA• Virtual Medical Record

(vMR)


• Virtual Medical Record (vMR)• Consolidated CDA (HL7 Clinical

Statements)• HL7 Version 3 Standard: Order Set

Publication, Release 1

• Federal Health Information Model (FHIM)

• HL7 v2.x • HL7 v3

Use Case 2: CDS Guidance Service Transactions - Standards per Transaction

# Transaction Transport Authentication/Authorization Encryption Vocab & Code Set

1CDS Request (patient data

and potentially context)

• SOAP• REST

• SAML • TLS • LOINC• SNOMED CT• CVX• Manufacturers of Vaccines (MVX)• OID• RxNorm• ICD-9-CM and ICD-10-CM• HCPCS• C80 - Clinical Document and

Message Terminology Component • NQF Value Sets

• ICD-10-PCS• UCUM• CPT• C154• NDC• FDA Route Administration• HL7 Vocabulary• Diagnostic and Statistical Manual

of Mental Disorders, Fourth Edition (DSM-IV)

2 CDS Response (guidance

and/or other response elements)

• SOAP • REST

• SAML • TLS • LOINC• SNOMED CT• CVX• Manufacturers of Vaccines (MVX)• OID• RxNorm• ICD-9-CM and ICD-10-CM• HCPCS• C80 - Clinical Document and

Message Terminology Component • NQF Value Sets

• ICD-10-PCS• UCUM• CPT• C154• NDC• FDA Route Administration• HL7 Vocabulary• Diagnostic and Statistical Manual

of Mental Disorders, Fourth Edition (DSM-IV)

CDS Guidance Request Transaction: Service Standards Rationale

StandardSummary of

Findings from UCR Crosswalk

Keep? Rationale

Decision Support Service (DSS)HITSC Rating:*M: 78.69A: 88.6SI: 33.33T: 72.71

(Y) Fits: (Sender) CDS Request; (Receiver) CDS Request; (Sender) CDS Response; (Receiver) CDS Response; Exceptions

(P) Partially Fits: Response Metadata;

(N) Does not Fit:

Yes • One significant gap is DSS will tie to SOAP. There is significant industry movement towards REST.

• DSS has 2 levels, one is model of the service which is implementation agnostic. Could support standard with implementation based on REST, but it would have to be developed.

• DSS is designed to be able to support patient data, unlike Infobutton.

• Has broader scope than Infobutton•

* M: Maturity A: Adoptability SI: S&I Specific T: Total

Context Aware Retrieval Application (Infobutton)

HITSC Rating*M: 90.08A: 92.11SI: 47.62T: 82.07

(Y) Fits: Context; Supporting Evidence; Supporting Resource

(P) Partially Fits: (Sender) CDS Request; (Receiver) CDS Request; (Sender) CDS Response; (Receiver) CDS Response

(N) Does not Fit: Clinical; Actions; Attribute Value List; Response Meta Data

No

• Can send some patient data, but not designed to support rich patient data payload like DSS

CDS Guidance Response Transaction: Service Standards Rationale

StandardSummary of


Keep? Rationale

Decision Support Service (DSS)HITSC Rating:*M: 78.69A: 88.6SI: 33.33T: 72.71


(P) Partially Fits: Response Metadata;

(N) Does not Fit:

Yes • One significant gap is DSS will tie to SOAP. There is significant industry movement towards REST.

• DSS has 2 levels, one is model of the service which is implementation agnostic. Could support standard with implementation based on REST, but it would have to be developed.

• DSS is designed to be able to support patient data, unlike Infobutton.

• Has broader scope than Infobutton



HITSC Rating:*M: 90.08A: 92.11SI: 47.62T: 82.07




No

• Can send some patient data, but no designed to support rich patient data payload like DSS

CDS Guidance Request Transaction: Organizer/Container Rationale

StandardSummary of


Keep? Rationale

CDS Knowledge Artifact Implementation Guide (HeD UC1 IG)HITSC Rating:*M: 61.39A: 86.84SI: 35.71T: 64.62

(Y) Fits: (Sender) CDS Response; (Receiver) CDS Response; Clinical; Supporting Evidence; Supporting Resource; Actions; Attribute Value List;

(P) Partially Fits: Context; Response Metadata

(N) Does not Fit: Exceptions

No • UC1 is not designed to carry patient data

• If CCDA is chosen, would probably have to use related HL7 Clinical statements for the Item Payload bucket.

• If vMR is chosen, would probably have to use the vMR Clinical Statements for the Item Payload bucket

• External options may exist for transforming CCDA request into a vMR component

• Develop options for both CCDA and vMR


Consolidated CDAHITSC Rating:*M: 53.59A: 80.70SI: 33.33T: 58.48

(Y) Fits: Clinical;

(P) Partially Fits:

(N) Does not Fit: Context, Supporting Evidence; Supporting Resource; Actions; Attribute Value List; Response Metadata; Exceptions

Yes • Can transform CCDA request into a vMR component from the execution system

• Not everything from CCDA goes easily into vMR, but vMR is designed to easily accept CCDA components

CDS Guidance Request Transaction: Organizer/Container Rationale (continued…)

StandardSummary of


Keep? Rationale

Virtual Medical Record (vMR)HITSC Rating:*M: 78.06A: 81.58SI: 33.33T: 70.08

(Y) Fits: Clinical; Attribute Value List

(P) Partially Fits: CDS Request; (Receiver) CDS Request; (Sender) CDS Response; (Receiver) CDS Response; Context; Supporting Evidence; Supporting Resource; Actions;

(N) Does not Fit: Response Metadata; Exceptions

Yes • Lighter weight than the other options• Developed specifically for clinical decision

support computability• Intended to be used for this initiative, and

has recently been enhanced in this respect


CDS Guidance Response Transaction: Organizer/Container Rationale

StandardSummary of


Keep? Rationale

CDS Knowledge Artifact Implementation Guide (HeD UC1 IG)HITSC Rating:*M: 61.39A: 86.84SI: 35.71T: 64.62

(Y) Fits: (Sender) CDS Response; (Receiver) CDS Response; Clinical; Supporting Evidence; Supporting Resource; Actions; Attribute Value List;

(P) Partially Fits: Context; Response Metadata

(N) Does not Fit: Exceptions

Yes • Fits Clinical; Supporting Evidence; Supporting Resource; Actions data requirements

• Attribute value list is not supported in UC1 schema, however the schema does allow extensions using XSD

• Would use subset of HeD UC1 schema that may require further modifications



(Y) Fits: Clinical;

(P) Partially Fits:


Probably No

• There is a profile in IHE that uses DSS and returns IHE as an output. But hasn’t been finalized within IHE

• Lacks the ability to group and organize things the way that UC1 does

• Do not anticipate using, unless modification or subset of UC1 approach does not work

CDS Guidance Response Transaction: Organizer/Container Rationale (continued…)

StandardSummary of


Keep? Rationale





No(Probably)

• Does fit this situation, however CDS Knowledge artifact may be the better option

• UC1 action would need to be modified to represent payload for UC2 regarding vMR

• May need a model agnostic response • Do not anticipate using, unless

modification or subset of UC1 approach does not work


HL7 Version 3 Standard: Order Set Publication, Release 1HITSC Rating:*M: 46.20A: 75.44SI: 33.33T: 53.31

(Y) Fits: Supporting Evidence; Supporting Resource; Response Metadata

(P) Partially Fits: Clinical; Context; Actions

(N) Does not Fit: Attribute Value List; Exceptions

No(Probably)

• Some vendors may want to support this as an option, however CDS Knowledge Artifact is the better option

• Adoption of this standard is low, so there is not a driving reason to extend support to it

CDS Guidance Request Transaction: Item Payloads Rationale

StandardSummary of


Keep? Rationale

Context Aware Retrieval Application (Infobutton)HITSC RatingM: 90.08A: 92.11SI: 47.62T: 82.07




No • The information that is contained in infobutton is already represented in vMR, or if not can be

• Can use infobutton as a reference to modify vMR or CCDA






Yes • The vMR has relevant information in a reasonable format

• The contents and scope of the vMR are aligned with the requirements of the Use Case

• Maintained by CDS WG• As a reference model, part of its purpose

is to provide exchangeable representation clinical information

CDS Guidance Request Transaction: Item Payloads Rationale (Continued…)

Standard Summary of Findings from UCR Crosswalk Keep? Rationale


(Y) Fits: Clinical;

(P) Partially Fits:


Yes • Several stake holders have a business need to have this supported

• A methodology is needed to be able to reflect changes, which currently does not exist






No • Order Set does not hold patient data, not suitable for request transaction

CDS Guidance Response Transaction: Item Payloads Rationale

StandardSummary of


Keep? Rationale






No • The information that is contained in infobutton is already represented in vMR, or if not can be

• Can use infobutton as a reference to modify vMR or CCDA






Yes • The vMR has relevant information in a reasonable format

• The contents and scope of the vMR are aligned with the requirements of the Use Case

• Maintained by CDS WG• As a reference model, part of its purpose

is to provide exchangeable representation clinical information

CDS Guidance Response Transaction: Item Payloads Rationale (Continued…)

StandardSummary of


Keep? Rationale

Consolidated CDA


(Y) Fits: Clinical;

(P) Partially Fits:


No • Several stake holders have a business need to have this supported

• A methodology is needed to be able to reflect changes, which currently does not exist

• However, CCDA is not a commonly used standard for the response transaction






No • Order set model contains recommendations for clinical actions, which is applicable to the types of outputs relevant in the Use Case

• Unsure of adoptibility of this standard in CDS Guidance

CDS Guidance Request Transaction: Transport Rationale

StandardSummary of


Keep? Rationale

SOAP



(P) Partially Fits:

(N) Does not Fit:

Yes • There is currently implementation guidance on DSS to be used with SOAP, not REST

• Has the capabilities and functions needed for this initiative


REST



(P) Partially Fits:

(N) Does not Fit:

Yes • Industry is moving towards using REST• Guidance could be written for DSS to work

with REST

CDS Guidance Response Transaction: Transport RationaleStandard Summary of Findings from

UCR Crosswalk Keep? Rationale

SOAP



(P) Partially Fits:

(N) Does not Fit:

Yes • There is currently implementation guidance on DSS to be used with SOAP, not REST

• Has the capabilities and functions needed for this initiative


REST

HITSC Rating:M: 100.00A: 100.00SI: 42.86T: 88.30


(P) Partially Fits:

(N) Does not Fit:

Yes • Industry is moving towards using REST• Guidance could be written for DSS to work with

REST

CDS Guidance Request Transaction: Authentication/Authorization Rationale

StandardSummary of


Keep? Rationale

SAMLHITSC Rating:*M: 100.00A: 100.00SI: 100.00T: 100.00


(P) Partially Fits:

(N) Does not Fit:* M: Maturity A: Adoptability SI: S&I Specific T: Total

CDS Guidance Response Transaction: Authentication/Authorization Rationale

StandardSummary of


Keep? Rationale

SAMLHITSC Rating:*M: 100.00A: 100.00SI: 100.00T: 100.00


(P) Partially Fits:


CDS Guidance Request Transaction: Encryption

StandardSummary of


Keep? Rationale

TLSHITSC Rating:*M: 100.00A: 100.00SI: 42.86T: 88.30


(P) Partially Fits:


CDS Guidance Response Transaction: Encryption

StandardSummary of


Keep? Rationale

TLSHITSC Rating:*M: 100.00A: 100.00SI: 42.86T: 88.30


(P) Partially Fits:

(N) Does not Fit: * M: Maturity A: Adoptability SI: S&I Specific T: Total

Solution Plan

• View the different combination of standards, across the different buckets, and determine the viability of each implementation option

• Decide which implementation option(s), and therefore combination of standards, is the best approach

• Document reasons why certain implementation options were chosen or not chosen

Solution Plan Next Steps

• Decide which implementation option(s), and therefore combination of standards, will be used as the approach in the IG and incorporated into the final design

Gap Mitigation Plan

• Identify any gaps for all standards under consideration

• Determine if the gap is for the request or response transaction, or both

• Document recommendations on how to close the gap (i.e. modification to existing standard)

Gap Mitigation Plan Next Steps:

• Pull out the standards which have gaps requiring modifications and document in the IG

• Contact the SDO to initiate modification needed

• Gaps that are related to a standard being utilized in a manner which it has not previously been designed for will be addressed and written into the IG

sds & harmonization hed leadership agenda wg call presentations during thursday wg meeting...

Documents

hed uc2 ig

hed community decisions

wg meeting update

wg meeting o vmr

discussion points

utilization of vmr

implementation guidance

progress decisions