1. Catherine Hoang Ioana Singureanu Greg Staudenmaier Detailed Clinical Models for Medical Device Domain Analysis Model 1

2. Overview Detailed Clinical Model (DCM) – Atomic clinical information – Promote semantic clarity and reuse Standard Terminology is built-in rather than an afterthought (e.g. primary and secondary standard-based coding system) Structured information to support – Process improvement – Interoperability and automation Reusable in many contexts – New standards – Profiling existing standards – Application development – Interoperability Domain Analysis Model (DAM) – Describe the stakeholders requirements to a integrators, developers, vendors, etc. – Assist communication among stakeholder groups – Uses a Std. modeling language (UML) improves communication, identifies main concepts, and leads to consensus – Models can be used to generate code or other models (e.g. ontology) – Methodology that supports the development of DCMs Context for DCMs 2

3. Glossary DAM: Domain Analysis Model UML: Unified Modeling Language – a standard developed by the Object Management Group DCM: Detailed Clinical Model – reusable information models, standardized LOINC: Logical Observation Identifiers Names and Codes – standard codes for laboratory SNOMED-CT: Systematized Nomenclature of Medicine-- Clinical Terms – Terminology System ISO: International Organization for Standardization – standards development organization HL7: Health Level Seven- healthcare interoperability standards development organization IHE: Integrating the Healthcare Enterprise – standards-related consortium Continua Health Alliance – standards-related consortium specialized in personal healthcare devices 3

4. May 2011: Ballot Details This ballot is informative and will expanded as new requirements and use cases are identified The ballot artifacts are intended to be used: – by providers To express semantic interoperability requirements (e.g. RFP) – by consortia (e.g. IHE, Continua Health Alliance) To develop Integration and Content Profile – by standard development organizations (e.g. HL7, ISO) To develop new standards for interoperability Ballot: V3 Ballot  Domain Analysis Models: – http://www.hl7.org/v3ballot/html/dams/uvdmd/uvdmd.html http://www.hl7.org/v3ballot/html/dams/uvdmd/uvdmd.html Project Site: http://gforge.hl7.org/gf/project/dcmmd/ http://gforge.hl7.org/gf/project/dcmmd/ – Releases: http://gforge.hl7.org/gf/project/dcmmd/frs/http://gforge.hl7.org/gf/project/dcmmd/frs/ – Latest project artifacts 4

5. Specification history September 2010 - Draft for Comment Initial version documenting the Domain Analysis for the following use cases: Intubate Patient - Unplanned Manage Patient on Ventilator Liberate Patient from Ventilator, Planned May 2011 - Informative In addition to addressing the ballot comments, this ballot includes additional use cases that are a high priority for the project stakeholders.: Post-Operative Patient Transport Patient-to-device Association Time Synchronization for Networked Devices and for Legacy Devices 5

6. Approach 1.Gathered requirements illustrated by scenarios, standard operating procedures, and stakeholder requirements 2.Use cases that were derived from clinical scenario illustrate the requirements in a precise way. Use cases identify the capabilities and user or system roles involved. 3.Next we elaborated the use cases as workflows, step by step, identify the type of information produced or required by each step 4.Refine the information structures (correspond to device data) required to support workflow – Includes standard terminology bindings – Interoperability requirements with the information systems between devices Consistent, repeatable approach/methodology 6 1 1 2 2 3 3 4 4 Ballot Document Structure and Process

7. Actors to specify roles for business users relative to the use cases in scope Identify the users roles and/or system roles for users and systems involved in the clinical scenario(s) 7 Is a Care Team Member… Clinician roles Is a Clinician… Care Team Member roles

8. Business Use Case Analysis to specify… Use Cases – Active verb – Based on requirements and clinical scenarios – Narrative description Preconditions Steps  Workflow Postconditions Actors – Participants in use cases – A role relative to the use case Users, systems 8 3 3 Actor participation …based on Workflow Use Case Business Use Case Reference to workflow Technical Use Case

9. Device State Transition Condition Device to Patient Association – State Transitions Patient associated to one more devices Device undergoes state changes – connected/disconnected to patient – settings configured 9 Patient Ready Patient Not Available Device Assigned to a Patient

10. Clinical Workflow 10 Role Process Step Information as input into a step Information produced by a step Trigger Device Data produced by a step Decision

11. Post-0perative Transport 11 EHR Data

12. Post-0perative Transport 12 Device Data

13. Post-0perative Transport 13 Information Received

14. Technical Use Case Actors: System Roles The process steps are described as system interactions Synchronize Time is a high-priority requirements 14 System role Technica l Use Case System role Technical Use Case

15. Time Synchronization for Legacy Devices Legacy Devices are unable to synchronize time automatically – Missing network connection – Missing support for protocol (SNTP) Device Manager required to – report device observation and parameters – Synchronized – It supplies time correction information (synchronized time) 15 Device Manager Medical Device Network Time Server

16. Time Synchronization +Time Correction 16 Time correction Synchronization Use case is realized differently for legacy devices vs. networked/interoperable devices

17. Patient to Device Association – Interoperable Medical Device 17 Choice 1: Using Hospital Info System (ADT) Choice 2: Enter at point-of-care

18. Patient to Device Association – Legacy Medical Device 18 Choice 1: Location based Choice 3: Patient association using Device Manager Device Manager Choice 2: Patient assigned at point-of-care

19. Information Derived from Workflow Analysis High-level, identifies the information used or produced, precursors to DCMs 19 Device Observation Device Configuration Common/ Shared Information EHR Data Required

20. Focus of the analysis: Medical Device Interoperability Emphasis on device-to-device and device-to-system interoperability and automation We specify the structure of relevant types of data 20 Device Observation Device Configuration Common/ Shared Information

21. Information Analysis to specify context for DCMs 21 attribute class association repetitions data type for date/time

22. DCMs provide the final level of detail : Standard Terminology 22 DCM Candidate Parameter properties Terminology Constraints Inherited Constraints Is a “Ventilator Setting” Reusable data that may be used in information exchanges