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EHR System Function and Information Model (EHR-S FIM) Release 2

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1 EHR System Function and Information Model (EHR-S FIM) Release 2
EHR System Function and Information Model (EHR-S FIM) Release HL7 Project ID# Executive Summary for EHR-S FIM Immunization Capability Prototype , EHR WG Modeling Facilitator , DoD-MHS Proponent February 9, 2012 – Original March 2, 2012 – Last Update Call for Participation This work is being done by the HL7 EHR Interoperability Work-group, meeting every Tuesday at 4PM ET, dial-in: , Passcode: #  The most current artifacts are at: 4/19/2019 DRAFT WORKING DOCUMENT

2 EHR System Function and Information Model EHR-S FIM Vision
Starting with the EHR-S FIM, analysts, engineers and testers can efficiently-specify system functions, information models and interoperability; for EHR system capabilities, components and their messages, documents and services; which are tailored to specific environments and needs. 4/19/2019 DRAFT WORKING DOCUMENT

3 DRAFT WORKING DOCUMENT
Executive Summary For EHR-S FIM Release 2.1, this prototype has the purpose to add conceptual information and data models for each EHR-S function make the EHR-S FM easier to use for analysts and engineers verify and validate EHR-S FM Release 2.0 Service Aware Interoperability Framework (SAIF) DSTU demonstration Support specific profiles (e.g., WG project DAMs, DIMs, DCMs). The Sparx Enterprise Architect modeling tool is being used to represent the EHR-S FIM and then generate appropriate views, reports, XML and HTML renderings of each EHR-S function’s scenarios, requirements, actors, actions/activities, dependencies, business rules, information & data models. The DoD-VA Joint Immunization Capability (JIC), HL7 EHR Diabetes project, ISO Continuity-of-Care harmonization are proposed as a set of demonstration prototypes of increasing complexity. 4/19/2019 DRAFT WORKING DOCUMENT

4 EHR-S FM Release 2.0 Sections
Overarching (O) – 2 major subsections Care Provision (CP) - 9 major subsections Care Provision Support (CPS) – 9 major subsections Population Health Support (POP) – 10 major subsections Administrative Support (AS) – 9 major subsections Record Infrastructure (RI) – 3 major subsections Trust Infrastructure (TI) – 9 major subsections EHR-S FM R2 ballot package can be downloaded at: 4/19/2019 DRAFT WORKING DOCUMENT

5 CP.6.2 Manage Immunization Administration
Statement: Capture and maintain discrete data concerning immunizations given to a patient including date administered, type, manufacturer, lot number, and any allergic or adverse reactions. Facilitate the interaction with an immunization registry to allow maintenance of a patient’s immunization history. Description: During an encounter, recommendations based on accepted immunization schedules are presented to the provider. Allergen and adverse reaction histories are checked prior to giving the immunization. If an immunization is administered, discrete data elements associated with the immunization including date, type, manufacturer and lot number are recorded. Any new adverse or allergic reactions are noted. If required, a report is made to the public health immunization registry or other organization (e.g. military unit commander, refugee program leadership). Example: (Notional Scenario) During an encounter, recommendations based on accepted immunization schedules and previous adverse or allergic reactions are presented to the clinician. If an immunization is administered, discrete data elements associated with the immunization are recorded and any new adverse or allergic reactions are noted. Patient demographic information is harmonized with and reports are made to the appropriate public health immunization registries and organizations (e.g., PHRs, schools), according to scope of practice, organizational policy and/or jurisdictional law. 4/19/2019 RED: Recommend deletion, Blue: Recommended Insertion DRAFT WORKING DOCUMENT

6 DRAFT WORKING DOCUMENT
EHR-FIM Model Legend 4/19/2019 DRAFT WORKING DOCUMENT

7 EHR-FIM Description of Model Diagrams
“Clinician-Activities Mapped to System-Components” shows Row 1: operational activities performed by the clinician, indicating dependencies on Row 2: The EHR System components, which support the clinician’s activities. “CIM Mapped to EHR-S Functions” shows System Components mapped to the EHR-S Functions they support “Conceptual Data Model (CDM)” shows Attributes & operations for System Components. “Information Exchanges Mapped-to Conformance Criteria” shows Conformance Criteria requiring specific information exchanges “CDM Requirements-Traceability” shows Conformance Criteria requiring specific attributes and operations within a Component CIM is Conceptual Information Model CDM is Conceptual Data Model 4/19/2019 DRAFT WORKING DOCUMENT

8 Immunization Management Capability Models
CP.6.2 Clinician-Activities Mapped-to System-Components CP.6.2 Conceptual Information Model (CIM) Mapped to EHR-S Functions CIM for Immunization Management Capability Immunization Management CCs Requiring Information Exchanges CDM for Advanced Directive CDM for Allergy, Intolerance and Adverse Reaction Event CDM for Clinical Decision Support (CDS) CDM for Clinical Document or Note CDM for Event CDM for Lists CDM for Immunization Event CC is Conformance Criteria CIM is Conceptual Information Model CDM is Conceptual Data Model DRAFT WORKING DOCUMENT 4/19/2019

9 CP.6.2 Manage Immunization Administration Clinician-Activities Mapped-to EHR-S Components
RED: Recommend deletion, Blue: Recommended Insertion 4/19/2019 DRAFT WORKING DOCUMENT

10 CP.6.2 Manage Immunization Administration EHR-S Components Mapped to Supporting Functions
RED: delete, Blue: insert 4/19/2019 DRAFT WORKING DOCUMENT

11 Immunization Management Capability Conceptual Information Model (CIM)
DRAFT WORKING DOCUMENT 4/19/2019

12 Immunization Management Capability Conformance Criteria (CC) Requiring Information Exchanges
SHALL CCs have bolded borders. See individual EHR-S Function’s slide deck for CC details at: RED: Recommend deletion, Blue: Recommended Insertion 4/19/2019 DRAFT WORKING DOCUMENT

13 DRAFT WORKING DOCUMENT
Immunization Management Information Exchange Conformance Criteria (CC) Requiring Specific Information Exchanges CP.3.3#07 The system SHOULD provide the ability to link encounters, orders, medical equipment, prosthetic/orthotic devices, medications, and notes to one or more problems (Ref: CP.1.4 [Manage Problem List] cc#9). AS.4.1#01 The system SHOULD provide the ability to exchange structured demographic and clinical information with registries (e.g., local, disease-specific, notifiable, patient, provider, organization, or health services registries). AS.4.1#02 The system MAY provide the ability to render and tag registry information as reviewed and the information's related assessment of validity or applicability for clinical, financial or administrative activities. AS.4.1#03 The system SHOULD provide the ability to maintain information received from registries (e.g., local, disease-specific, notifiable, patient, provider, organization, or health services registries). AS.4.1#04 The system MAY provide the ability to receive structured demographic and clinical information from registries. AS.4.1#05 The system SHOULD provide the ability to harmonize system information with registry information. 4/19/2019 DRAFT WORKING DOCUMENT

14 Advanced Directive Conceptual Data Model (CDM) Traceable to Conformance Criteria (CC)
SHALL CCs have bolded borders. See individual EHR-S Function’s slide deck for CC details at: 4/19/2019 DRAFT WORKING DOCUMENT

15 DRAFT WORKING DOCUMENT
Advanced Directive Conformance Criteria (CC) Applicable to This Component CP.3.3#01 The system SHALL provide the ability to capture and render clinical documentation (henceforth "documentation") including original, update by amendment in order to correct, and addenda. CPS.1.7.2#08 The system SHALL provide the ability to manage the date and/or time an advance directives paper document was signed/completed. CP.3.3#02 The system SHALL provide the ability to capture free text documentation. CP.3.3#03 The system MAY present documentation templates (structured or free text) to facilitate creating documentation. CP.3.3#04 The system SHALL provide the ability to present other existing documentation within the patient's EHR while new creating documentation. CP.3.3#05 The system SHOULD provide the ability to link documentation for a specific patient with a given event (e.g., office visit, phone communication, consult, lab result). CP.3.3#07 The system SHOULD provide the ability to link encounters, orders, medical equipment, prosthetic/orthotic devices, medications, and notes to one or more problems (Ref: CP.1.4 [Manage Problem List] cc#9). CP.3.3#08 The system SHALL provide the ability to update documentation prior to finalizing it. CP.3.3#09 The system SHALL provide the ability to tag a document or note as final. CP.3.3#10 The system SHALL provide the ability to render the author(s) and authenticator(s) of documentation when the documentation is rendered. CP.3.3#11 The system SHALL provide the ability to render documents based on document metadata (e.g., note type, date range, facility, author, authenticator and patient). CP.3.3#12 The system MAY provide the ability for providers to capture clinical documentation using standard choices for disposition (e.g., reviewed and filed, recall patient, or future follow-up). CP.3.3#14 The system SHOULD provide the ability to render clinical documentation using an integrated charting or documentation tool (e.g., notes, flow-sheets, radiology views, or laboratory views). CP.3.3#15 The system MAY provide the ability to capture clinical documentation using specialized charting tools for patient-specific requirements (e.g., age - neonates, pediatrics, geriatrics; condition - impaired renal function; medication). CP.3.3#16 The system SHOULD provide the ability to capture, maintain and render transition-of-care related information. CP.3.3#17 The system SHOULD provide the ability to tag the status of clinical documentation (e.g., preliminary, final, signed). CP.6.2#02 The system MAY auto-populate the immunization administration record as a by-product of verification of administering provider, patient, medication, dose, route and time according to scope of practice, organizational policy and/or jurisdictiona CP.6.2#06 The system SHOULD provide the ability to link standard codes (e.g. NDC, LOINC, SNOMED or CPT) with discrete data elements associated with an immunization. CPS.1.7.2#01 The system SHALL provide the ability to manage advance directive information including the type of directive, relevant dates (e.g., received, reviewed, rescinded, updated), circumstances under which the directives were received, and the ... CPS.1.7.2#02 The system SHALL render an indication that advance directive(s) have been captured. CPS.1.7.2#03 The system SHALL provide the ability to render the type of advance directives captured for the patient (e.g., living will, durable power of attorney, preferred interventions for known conditions, or the existence of a "Do Not Resuscitate" ... CPS.1.7.2#04 The system SHALL provide the ability to manage “Do Not Resuscitate” orders. CPS.1.7.2#05 The system SHOULD conform to function CPS.2.4 (Support Externally Sourced Clinical Images) in order to capture scanned patient advance directive documents and/or “Do Not Resuscitate” orders. CPS.1.7.2#06 The system SHALL provide the ability to manage the date and circumstances of the most recent review of the advanced directives. CPS.1.7.2#07 The system SHALL provide the ability to manage the name and relationship of the principal completing the advance directive for the patient. 4/19/2019 DRAFT WORKING DOCUMENT

16 Advanced Directive Allergy, Intolerance and Adverse Reaction Event Conceptual Data Model (CDM) Traceable to Conformance Criteria (CC) SHALL CCs have bolded borders. See individual EHR-S Function’s slide deck for CC details at: 4/19/2019 DRAFT WORKING DOCUMENT

17 DRAFT WORKING DOCUMENT
Advanced Directive Allergy, Intolerance and Adverse Reaction Event Conformance Criteria (CC) Applicable to This Component CP.1.2#01 The system SHALL provide the ability to manage true allergy, intolerance, and adverse reaction to drug, food or environmental triggers as unique, discrete entries. CP.1.2#02 The system SHOULD provide the ability to manage the reason for entry or maintenance (including update or remove) of the allergy, intolerance or adverse reaction. CP.1.2#03 The system SHALL provide the ability to manage the reaction type as discrete data. CP.1.2#04 The system SHALL provide the ability to manage the severity of an allergic or adverse reaction as discrete data. CP.1.2#07 The system SHOULD provide the ability to manage the source of allergy, intolerance, and adverse reaction information. CP.1.2#13 The system SHALL provide the ability to tag that the list of medications and other agents has been reviewed. CP.1.2#16 The system SHOULD provide the ability to manage allergy information as coded data. CP.1.2#17 The system SHOULD provide the ability to capture and maintain the required documentation of allergies prior to completion of the medication order. CP.1.2#18 The system SHOULD provide the ability to capture and render that the allergies are “Unknown” or “Unable to Assess Allergies". CP.1.2#19 The system SHOULD provide the ability to capture the reason for “Unknown” or “Unable to Assess Allergies” documentation. CP.1.2#21 The system SHOULD provide the ability to capture free text allergies and render them in a manner that distinguishes them from coded allergy entries. CP.1.2#22 The system SHOULD tag and render an indicator that interaction checking will not occur against free text allergies. CP.1.2#24 The system SHOULD provide the ability to link allergic reactions to specific treatment or diagnostic protocols. CP.1.2#25 The system SHOULD conform to function CPS (Support for Medication Interaction and Allergy Checking) to render any potential interactions when capturing or maintaining allergies, intolerances or adverse reactions. CP.1.2#26 The system SHOULD capture information that a provider was presented with and acknowledged a drug interaction notification. CP.6.2#04 The system SHOULD provide the ability to capture, in a discrete field, an allergy/adverse reaction to a specific unization. CP.6.2#09 The system SHALL conform to function CP.1.2 (Manage Allergy, Intolerance and Adverse Reaction List). 4/19/2019 DRAFT WORKING DOCUMENT

18 Clinical Decision Support Conceptual Data Model (CDM) Traceable to Conformance Criteria (CC)
SHALL CCs have bolded borders. See individual EHR-S Function’s slide deck for CC details at: 4/19/2019 DRAFT WORKING DOCUMENT

19 DRAFT WORKING DOCUMENT
Clinical Decision Support Conformance Criteria (CC) Applicable to This Component CPS.3.9#01 The system SHALL provide the ability to maintain the clinical content or rules utilized to generate clinical decision support reminders and alerts. CPS.3.9#02 The system SHOULD provide the ability to render information that will allow validation that the most applicable version (of the decision support rules) is utilized for the update. CPS.3.9#03 The system SHOULD capture the date of update of the decision support rules. CPS.3.9#04 The system MAY tag {track} and store {retain} the version used when guidelines are provided in a patient encounter. 4/19/2019 DRAFT WORKING DOCUMENT

20 Clinical Document or Note Conceptual Data Model (CDM) Traceable to Conformance Criteria (CC)
SHALL CCs have bolded borders. See individual EHR-S Function’s slide deck for CC details at: 4/19/2019 DRAFT WORKING DOCUMENT

21 DRAFT WORKING DOCUMENT
Clinical Document or Note Conformance Criteria (CC) Applicable to This Component CP.3.3#01 The system SHALL provide the ability to capture and render clinical documentation (henceforth "documentation") including original, update by amendment in order to correct, and addenda. CP.3.3#02 The system SHALL provide the ability to capture free text documentation. CP.3.3#03 The system MAY present documentation templates (structured or free text) to facilitate creating documentation. CP.3.3#04 The system SHALL provide the ability to present other existing documentation within the patient's EHR while new creating documentation. CP.3.3#05 The system SHOULD provide the ability to link documentation for a specific patient with a given event (e.g., office visit, phone communication, consult, lab result). CP.3.3#07 The system SHOULD provide the ability to link encounters, orders, medical equipment, prosthetic/orthotic devices, medications, and notes to one or more problems (Ref: CP.1.4 [Manage Problem List] cc#9). CP.3.3#08 The system SHALL provide the ability to update documentation prior to finalizing it. CP.3.3#09 The system SHALL provide the ability to tag a document or note as final. CP.3.3#10 The system SHALL provide the ability to render the author(s) and authenticator(s) of documentation when the documentation is rendered. CP.3.3#11 The system SHALL provide the ability to render documents based on document metadata (e.g., note type, date range, facility, author, authenticator and patient). CP.3.3#12 The system MAY provide the ability for providers to capture clinical documentation using standard choices for disposition (e.g., reviewed and filed, recall patient, or future follow-up). CP.3.3#14 The system SHOULD provide the ability to render clinical documentation using an integrated charting or documentation tool (e.g., notes, flow-sheets, radiology views, or laboratory views). CP.3.3#15 The system MAY provide the ability to capture clinical documentation using specialized charting tools for patient-specific requirements (e.g., age - neonates, pediatrics, geriatrics; condition - impaired renal function; medication). CP.3.3#16 The system SHOULD provide the ability to capture, maintain and render transition-of-care related information. CP.6.2#02 The system MAY auto-populate the immunization administration record as a by-product of verification of administering provider, patient, medication, dose, route and time according to scope of practice, organizational policy and/or jurisdictiona CP.6.2#06 The system SHOULD provide the ability to link standard codes (e.g. NDC, LOINC, SNOMED or CPT) with discrete data elements associated with an immunization. CPS.1.7.2#01 The system SHALL provide the ability to manage advance directive information including the type of directive, relevant dates (e.g., received, reviewed, rescinded, updated), circumstances under which the directives were received, and the ... CPS.1.7.2#03 The system SHALL provide the ability to render the type of advance directives captured for the patient (e.g., living will, durable power of attorney, preferred interventions for known conditions, or the existence of a "Do Not Resuscitate" ... CPS.1.7.2#04 The system SHALL provide the ability to manage “Do Not Resuscitate” orders. CPS.1.7.2#05 The system SHOULD conform to function CPS.2.4 (Support Externally Sourced Clinical Images) in order to capture scanned patient advance directive documents and/or “Do Not Resuscitate” orders. 4/19/2019 DRAFT WORKING DOCUMENT

22 Event Conceptual Data Model (CDM) Traceable to Conformance Criteria (CC)
SHALL CCs have bolded borders. See individual EHR-S Function’s slide deck for CC details at: 4/19/2019 DRAFT WORKING DOCUMENT

23 Event Conformance Criteria (CC) Applicable to This Component
CP.1.6#02 The system SHALL provide the ability to manage, as discrete data elements, data associated with any immunization given including date and time of administration, immunization type and series, lot number and manufacturer, dose and administration CP.1.3#05 The system SHALL provide the ability to capture medications not reported on existing medication lists or medication histories. CP.1.3#08 The system SHALL provide the ability to tag a medication as erroneously captured and excluded from the presentation of current medications. CP.1.3#10 The system SHOULD provide the ability to capture and render information regarding the filling of prescriptions. CP.1.3#13 The system SHALL provide the ability to capture that a medication history is unavailable or incomplete. CP.1.2#14 They system SHALL provide the ability to capture and render the date on which allergy information was entered. CP.1.2#15 The system SHOULD provide the ability to capture and render the approximate date of the allergy occurrence. CP.1.2#25 The system SHOULD conform to function CPS (Support for Medication Interaction and Allergy Checking) to render any potential interactions when capturing or maintaining allergies, intolerances or adverse reactions. CPS.3.9#04 The system MAY tag {track} and store {retain} the version used when guidelines are provided in a patient encounter. AS.4.1#02 The system MAY provide the ability to render and tag registry information as reviewed and the information's related assessment of validity or applicability for clinical, financial or administrative activities. 4/19/2019 DRAFT WORKING DOCUMENT

24 Lists Conceptual Data Model (CDM) Traceable to Conformance Criteria (CC)
SHALL CCs have bolded borders. See individual EHR-S Function’s slide deck for CC details at: 4/19/2019 DRAFT WORKING DOCUMENT

25 Lists Conformance Criteria (CC) Applicable to This Component
CP.1.2#11 The system MAY provide the ability to render the list of allergies, intolerances and adverse reactions in a user defined sort order. CP.1.2#12 The system MAY restrict the ability to render the list in a user defined sort order. CP.1.4#08 The system SHOULD provide the ability to render the list in a user defined sort order. CP.3.3#18 The system SHOULD provide the ability to tag and render lists of patients requiring follow up contact (e.g., laboratory callbacks, radiology callbacks, left without being seen). CP.3.3#06 The system SHOULD provide the ability to render the list in a user defined sort order (Ref: CP.1.4 [Manage Problem List] cc#8). 4/19/2019 DRAFT WORKING DOCUMENT

26 Immunization Event Conceptual Data Model (CDM) Traceable to Conformance Criteria (CC)
SHALL CCs have bolded borders. See individual EHR-S Function’s slide deck for CC details at: 4/19/2019 DRAFT WORKING DOCUMENT

27 DRAFT WORKING DOCUMENT
Immunization Event Conformance Criteria (CC) Applicable to This Component CP.1.2#13 The system SHALL provide the ability to tag that the list of medications and other agents has been reviewed. CP.1.2#20 The system SHOULD provide the ability to tag records and render to providers that the allergies are “Unknown” or “Unable to Assess Allergies” and need to be updated. CP.1.6#02 The system SHALL provide the ability to manage, as discrete data elements, data associated with any immunization given including date and time of administration, immunization type and series, lot number and manufacturer, dose and administration CP.1.6#03 The system SHALL provide the ability to manage, as discrete elements, data associated with any immunization withheld (including date and time, immunization type, series, exception reason and immunization-withholding provider). CP.1.6#05 The system SHALL provide the ability to capture the currently recommended date for an immunization booster dose with each immunization, if needed. CP.3.3#12 The system MAY provide the ability for providers to capture clinical documentation using standard choices for disposition (e.g., reviewed and filed, recall patient, or future follow-up). CP.3.3#13 The system MAY provide the ability to capture, maintain and render the clinician’s differential diagnosis and the list of diagnoses that the clinician has considered in the evaluation of the patient. CP.3.3#18 The system SHOULD provide the ability to tag and render lists of patients requiring follow up contact (e.g., laboratory callbacks, radiology callbacks, left without being seen). CP.3.3#19 The system SHOULD provide the ability to capture patient follow-up contact activities (e.g., laboratory callbacks, radiology callbacks, left without being seen). CP.6.2#01 The system SHALL provide the ability to capture, maintain and render immunization administration details as discrete data, including:(1) the immunization name/type, strength and dose;(2) date and time of administration;(3) manufacturer, lot numb CP.6.2#02 The system MAY auto-populate the immunization administration record as a by-product of verification of administering provider, patient, medication, dose, route and time according to scope of practice, organizational policy and/or jurisdictiona CP.6.2#03 The system SHALL provide the ability to determine and render required immunizations, and when they are due, based on widely accepted immunization schedules, when rendering encounter information. CP.6.2#05 The system SHALL conform to function CP.3.2 (Manage Patient Clinical Measurements) to capture other clinical data pertinent to the immunization administration (e.g., vital signs). CP.6.2#06 The system SHOULD provide the ability to link standard codes (e.g. NDC, LOINC, SNOMED or CPT) with discrete data elements associated with an immunization. CP.6.2#10 The system SHOULD transmit required immunization administration information to a public health immunization registry according to scope of practice, organizational policy and/or jurisdictional law. CP.6.2#16 The system SHALL provide the ability to render the immunization order as written (i.e., exact clinician order language) when rendering administration information. CP.6.2#17 The system SHALL provide the ability to determine due and overdue ordered immunizations and render a notification. CP.6.2#18 The system SHALL provide the ability to render a patient educational information regarding the administration (e.g., Vaccine Information Statement (VIS)). CP.6.2#19 The system SHALL provide the ability to capture that patient educational information (e.g., VIS) was provided at the time of immunization administration. CP.6.2#20 The system SHALL provide the ability to capture documentation that patient educational information (e.g., VIS) was provided at the time of immunization administration. CP.6.2#21 The system SHALL provide the ability to capture the receiving entity (e.g., patient, representative, organization) when patient education information is provided at the time of immunization administration. CP.6.2#22 The system SHOULD provide the ability to capture and maintain immunization refusal reasons as discrete data. CP.6.2#23 The system SHOULD provide the ability to capture patient preferences regarding receipt of immunization (e.g. refusal of certain vaccine types) at time of immunization administration. CPS.3.9#04 The system MAY tag {track} and store {retain} the version used when guidelines are provided in a patient encounter. 4/19/2019 DRAFT WORKING DOCUMENT

28 Methodology Sparx Enterprise Architect views were used to create a separate slide set for an Immunization Management Capability based on CP.6.2 Manage Immunization Administration and its “See Also” Dependencies : Create Activity Model for the function. Map Activities to EHR-S Components Create Conceptual Data Model (CDM) view from step 1. Start with applicable reusable components and their data elements Based on Conformance Criteria, add additional function-specific components Based on Conformance Criteria, add additional attributes or operations Indicate SHALL attributes or operations as “public” with a proceeding “+” Indicate SHOULD or MAY attributes or operations as “private” with a proceeding “-” Create Conceptual Information Model (CIM) view from step 2. Show supporting EHR-S Functions dependencies. Map EHR-S Components to supporting EHR-S Functions (“See Also” Dependencies) Show Conformance Criteria (CC) Requiring Specific Information Exchanges This Executive Summary was created from the resultant model. 4/19/2019 DRAFT WORKING DOCUMENT

29 DRAFT WORKING DOCUMENT
Issues What is normative within the EHR-S Information Model. Activity Diagrams map operational-activities to system components-and-functions. Recommend informative Conceptual Information Models set of applicable components and their relationships … recommend informative Conceptual Data Models ( attributes and operations within components) Recommend normative Distinguish between elements derived from SHALLs vs. those from SHOULDs and MAYs Criteria to determine the “See Also” Dependencies. EHR-S Function dependency on other Functions’ conformance criteria Shared activities & tasks within multiple EHR-S Functions How will we represent the Information Model for Ballot. Tool generated report showing models (e.g., similar to Immunization Prototype) Will ISO accept this? Textural listing of components and data elements similar to HITSP/C83 CDA Content Modules and HITSP/C154 Data Dictionary 4/19/2019 DRAFT WORKING DOCUMENT

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Recommendations EHR-S FIM needs the following additional functions and components: Manage Business Rules Clinical Decision Support (CDS) EHR-System Metadata for realm-specific Information-Exchange Standards Make EHR-S Conceptual Data Model (CDM) Normative Remove data elements from Conformance Criteria. EHR-S FM CP-section should be hierarchically organized. an EHR-S manages Encounters; where, each Encounter is a set of Events, Documents and Lists. Events, Documents and Lists are decomposed into types (immunization, medication). Benefits: Reduced Conformance Criteria duplication Increased Conformance Criteria consistency 4/19/2019 DRAFT WORKING DOCUMENT

31 DRAFT WORKING DOCUMENT
Conclusions EHR-S FIM can be the conceptual foundation for Interoperability Specifications, refined into: HL7 Domain analysis Models (DAMs) and Detailed Clinical Models (DCL) Logical Perspectives Implementable Perspectives (Physical or Serialiazable Models) Messages, Documents, Services EHR-S FIM can be composed into higher level capabilities by functional analysts and system engineers Encourage reuse of EHR-S FIM components Avoid duplication and “stovepipe applications” EHR-S FIM can populate portions of the HL7 SAIF for WGs Information and Computational Dimensions Conceptual Perspective An Enterprise Architecture tool is essential to maintain consistency 4/19/2019 DRAFT WORKING DOCUMENT

32 Next Steps / To Do / Help Needed
SMEs verify and validate Conceptual Data Models (CDMs) Model the remaining EHR-S Functions Overarching (O) – 2 major subsections Care Provision (CP) - 9 major subsections Care Provision Support (CPS) – 9 major subsections Population Health Support (POP) – 10 major subsections Administrative Support (AS) – 9 major subsections Record Infrastructure (RI) – 3 major subsections Trust Infrastructure (TI) – 9 major subsections 4/19/2019 DRAFT WORKING DOCUMENT

33 Reference Information
Glossary of Key Terms EHR-S FIM Verb Hierarchy HL7 SAIF Enterprise Compliance and Conformance Framework (ECCF) Observations by reviewers Backup Slides 4/19/2019 DRAFT WORKING DOCUMENT

34 DRAFT WORKING DOCUMENT
Glossary of Terms A conceptual information model  identifies the highest-level concepts in a domain and the relationships between each concept; however, no attributes are specified and no primary key is specified. Conceptual models are typically human readable though there are ways to build conceptual models that systems can process, such as, the Web Ontology Language (OWL). A logical information model fully describes the data, without regard to how the data will be physically implemented in the database. Features of a logical information model typically include the following: All concepts and relationships between them are defined. All attributes for each concept are specified. Business terms for concepts and attributes are agreed upon and used. (These terms should be part of the agreed upon common terminology.) The primary key for each concept is specified. Foreign keys (keys identifying the relationship between different entities) are specified. Normalization occurs at this level. 4/19/2019 DRAFT WORKING DOCUMENT

35 EHR-S FIM Action Verb Hierarches
Manage (Data) Capture Maintain Render Exchange Determine Manage- Data- Visibility Auto-Populate Enter Import Receive Store Update Remove Extract Present Transmit Export Analyze Decide De-Identify Hide Mask Re-Identify Unhide Unmask Archive Backup Decrypt Encrypt Recover Restore Save Annotate Attest Edit Harmonize Integrate Link Tag Delete Purge 4/19/2019 DRAFT WORKING DOCUMENT

36 Notional Set of HL7 Artifacts within a SAIF Enterprise Compliance and Conformance Framework (ECCF)
Enterprise Dimension “Why” - Policy Information Dimension “What” - Content Computational Dimension “Who/How” - Behavior Engineering Dimension “Where” - Implementation Technical Dimension “Where” - Deployments Conceptual Perspective Business Mission, Vision, Scope , Inventory of Contracts - PSSs Capabilities - RIM Policies Procedures Inventory of Reusable Entities Associations Information Information Models Data Models Inventory of Reusable Scenarios Business Activities System Functions Requirements Accountability, Roles Conformance Criteria Profiles, Behaviors Interactions and Info. Exchanges Inventory of SW Platforms, Layers SW Environments SW Components SW Services Technical Requirements Enterprise Service Bus Key Performance Parameters Inventory of HW Platforms HW Environments Network Devices Communication Devices Technical Requirements Logical Perspective Business Policies Governance Implementation Guides Design Constraints Organization Contracts Information Models Domain IM Detailed Clinical Terminologies Value Sets Content Specifications CCD RMIM Specifications Scenario Events Use Cases Workflow Use Cases Components Interfaces Collaboration Actors Collaboration Types Collaboration Roles Function Types Interface Types Service Contracts Models, Capabilities, Features and Versions for SW Environments SW Capabilities SW Libraries SW Services SW Transports Models, Capabilities, Features and Versions for HW Platforms HW Environments Network Devices Communication Devices HL7 Service Aware Interoperability Framework (SAIF) Enterprise Compliance and Conformance Framework (ECCF) The DoD and MHS EHRWF ECCF’s goal is to ensure Working Interoperability (WI) among various healthcare organizations; WI is also known as compatibility among healthcare systems. Working Interoperability is an instance of two “trading partners” –- human beings, organizations, or systems, successfully exchanging data or information, or coordinating behavior to accomplish a defined task, or both. The ECCF’s purpose is to manage the relationship between architectural artifacts and implementations of those artifacts. The objective of a fully qualified ECCF is to be a clear, complete, concise, correct, consistent and traceable interoperability specification, which is easy to use. An ECCF can be an assessment framework, which supports configuration management baselines and risk assessments throughout a business-capability lifecycle. The ECCF is used to specify information exchange interoperability and conformance statements for documents, messages and services. An ECCF Implementation Guide contains definitions of terms, such as conformance, compliance, consistency and traceability. An ECCF provides a template, called a Specification Stack (SS) that allows you to specify business objects, components, capabilities, applications and systems organized as a matrix of Dimension columns (Enterprise, Information, Computational, Engineering and Technical) and Perspective rows (Conceptual, Logical and Implementable)., as is shown in the slide. DoD and VA must define their common SAIF Implementation Guides, which define their architecture development methodologies and architecture artifacts. To foster consistency, VA has agreed to build a common DoD-VA EHRWF Implementation Guide, based on DoDAF, TOGAF and HL7 SAIF. This slide shows a notional Interoperability Specification template, using the HL7 SAIF ECCF SS. This is a super set of common architectural-artifacts. All the listed artifacts may NOT be required in the DoD-VA EHRWF Implementation Guide; other artifacts may be included. Within each cell You place or reference and discuss appropriate architectural artifacts and specifications. You define or reference conformance statements, which are testable-representations of assumptions that the specifications make. You manage traceability within columns and consistency across layers. An implementation of a Specification Stack (SS) asserts, as true or false, that one-or-more conformance assertions are met; certification asserts as true, that some set of conformance assertions are met. You identify and mitigate risks across the organization’s component development life cycles. Implementable Perspective Business Nodes Business Rules Business Procedures Business Workflows Technology Specific Standards Schemas for Databases Messages Documents Services Transformations Automation Units Technical Interfaces Technical Operations Orchestration Scripts SW Specifications for Applications GUIs Components SW Deployment Topologies HW Deployment Specifications HW Execution Context HW Application Bindings HW Deployment Topology HW Platform Bindings Responsibility: HL7 Organization | EHR-S FIM | HL7 WG Projects | Development Organization See notes page for ECCF description

37 Observation [David Baas]
From where I’m sitting, deriving conceptual information models based on the conformance criteria could be useful for consuming a functional profile. I would assume it could be used as reference for developing a domain analysis model for a project, to fill in blanks of conceptual information not expressed by clinical SMEs, and to shorten the learning curve for projects required to adopt the conformance criteria. Regardless of how modeling evolved on the project, the CDM would still be a bridge to validate addressing information needs at a high level. I would not foresee using the CDM or other artifacts verbatim in modeling for a specific project because some the relationships/associations expressed appear to be more subjective than explicit representation of the conformance criteria. I suggest annotating whether the relationships in the CDM represent explicit conformance criteria or not. For those that are not explicit (SHALL), it should be clear implementers have no obligation to portray those relationships the way they are expressed in the model.  In reviewing the other artifacts (activity diagrams, and conceptual information model) I was a little concerned that the content suggested a more prescriptive view of EHR functionality, which I’m not sure is a good thing. In the case of the activity diagrams being prototyped, I can see they are not attempting to sequence how tasks within an activity are executed, but using activity diagrams suggests that is the intended direction. I think that path would be too restrictive for implementers. I think the CIM raises more questions than it answers. This is another one where I think it best left to specific implementation projects. Perhaps other folks will provide a different perspective, but I think the CDM content is the most useful for understanding the conformance criteria for greater adoption. 4/19/2019 DRAFT WORKING DOCUMENT

38 Observation [Kevin Coonan, HL7 Patient Care WG Co-chair]
We have been having a lot of discussions in patient care, clinical statement, CIMI and MnM regarding representation of clinical content. One of the most important is the recognition and separation of dynamic uses / extracts of information one would see in an EHR-S GUI or CDA v. an information model suited for information exchange, persistence, transformation, analytics, decision support.  A good example of this is the common notions of a “problem list”, “allergy list” or “list of immunizations”.  These are artifacts we are used to seeing in paper charts, since there was no other effective means to address longitudinal data which otherwise would be scattered in the linear ordering progress notes.  In fact, HL7 defines these working lists as ‘..collects a dynamic list of individual instances of Act via ActRelationship which reflects the need of an individual worker, team of workers, or an organization to manage lists of acts for many different clinical and administrative reasons. Examples of working lists include problem lists, goal lists, allergy lists, and to-do lists.’ There are also design patterns well suited for static semantics from the (being revised for May ballot) Patient Care domain, all of which are different entry points into a common model.  These include a pattern for a Care Record, which corresponds best to the conventional notion of the documentation of an encounter.  The Care Record, however, has entries which follow the Health Concern pattern and the Care Plan pattern.    Health Concerns are anything which affects one’s health which need to be managed/tracked over time.  These includes risks, diseases, problems, allergies/intolerances to medications, social circumstances, and complications.   The Care Plan documents interventions, treatments and orders.  Care Plans can have embedded logic, e.g. stating a specific action should (not) be taken if a specific criterion is met.  So things like immunization schedules, insulin sliding scales/sick day rules, or complex oncology protocols have a common design basis.  While we are used to thinking of Concerns and Plans as future looking, the same pattern is used to document things which have happened (e.g. procedure which has been completed), so the Care Plan includes not just what is currently being done, what is planned, but also what has been done in the past. An instance of an encounter’s documentation therefore would have elements from the Care Record (e.g. the signs/symptoms discovered at the time of the encounter), Health Concerns (in a linear narrative like a CDA these typically are organized into the familiar ‘lists’, e.g. allergy list, problem list, PMH), and Care Plan (again in ‘lists’—e.g. medication list).  An encounter would also expect to generate new Care Plans and new Health Concerns as part of the clinical decision making.  (The A&P in Weed’s POMR). By separating the model of use (various lists) from model of meaning (the Patient Care Domain Model plus the derived detailed clinical models which bind terminology, etc.) we can most effectively devise those specifications needed for given use cases. 4/19/2019 DRAFT WORKING DOCUMENT

39 Observation [Kevin Coonan, HL7 Patient Care WG Co-chair]
I am coordinating with Richard Savage (now working for CDC) on immunizations with Patient Care.  I don’t know who the modeling facilitator is for the new immunization project, but if it is a void I might fill in.  I am going to start tacking the immunization (JIC) (analysis/conceptual) models and see if I can get them into something which is a better approximation of  a real information model of the clinical content static semantics.  Do you think this is a good point to start to put together the background and socialization needed to come to some decision regarding the representation of static semantics for iEHR?  I see two related decisions:  #1 what modeling language is going to be used for design, and #2 what is the modeling language used for the wire format.  Obviously, with HL7 v3 there is close traceability between the graphic format in the Visio based RMIM Designer and the resultant MIF2 representation.  I believe that the UML based SMD also does this.  MIF2 è XSD, so there is a close tie between MIF and something which can be implemented.  Of course, we could also use HL7 templates (whatever those are) on top of a base model, rather than having all the explicit details in the MIF2.  We could even use ADL for this, if we were so inclined.  That still leaves us the question about ‘wire format’.  I.e. what one server says to another.  Eventually, I would expect a ‘cleaner’ modeling language to be used for design, with transformation to arbitrary implementable paradigms.  Hopefully CIMI will fill this niche.  Not in time to do the modeling for JIC, Pharmacy, etc. but hopefully just in time to model the core content of an ambulatory documentation system. 4/19/2019 DRAFT WORKING DOCUMENT

40 Immunization Management Capability Scope, (Including Dependent EHR-S Functions)
We started with CP6.2 and included its dependencies: CP.6.2 Manage Immunization Administration CP.1.6 Manage Immunization List CP.1.2 Manage Allergy, Intolerance and Adverse Reaction List CP.1.3 Manage Medication List CP.3.3 Manage Clinical Documents and Notes CPS Manage Patient Advance Directives CPS.3.9 Clinical Decision Support System Guidelines Updates CPS.9.4 Standard Report Generation AS.4.1 Manage Registry Communication Record Infrastructure Trust Infrastructure For details, see separate slide deck for each EHR-S Function. All referenced EHR-S Functions are available at: 4/19/2019 DRAFT WORKING DOCUMENT

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CP.6.2 Manage Immunization Administration Components mapped to Requirements NOTE: SHALL conformance criteria have bolded borders 4/19/2019 DRAFT WORKING DOCUMENT

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CP.6.2 Manage Immunization Administration Components mapped to Requirements NOTE: SHALL conformance criteria have bolded borders 4/19/2019 DRAFT WORKING DOCUMENT

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Immunization Management Capability CP.6.2 Manage Immunization Administration Dependencies DRAFT WORKING DOCUMENT 4/19/2019

44 CP.6.2 Immunization Management “See Also” Dependencies
DRAFT WORKING DOCUMENT RED: delete, Blue: insert 4/19/2019


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