1. Device Observation Semantic Bridge (DSB/DOSB) Phase 1 IHE Proposal Draft Graphics September 04, 2014 Amended Based on NLM/IHTSDO Meeting – September 09, 2014 (last slide) 1

2. Team VHA – Ioana Singureanu – Greg Staudenmaier – Loren Stevenson – Dan Morford – Catherine Hoang IHE – Alex Lippitt (HIMSS, IHE) – Paul Sherman – Technical Project Manager – IHE Patient Care Device Domain(retired VHA) – John Garguilo (NIST) – Paul Schluter (GE) 2

3. The Device Observation Semantic Bridge (DSB/DOSB) Challenge Getting semantically correct data from patient care devices into clinical applications is difficult for a number of reasons: – The applicable nomenclature from medical devices, IEEE 11073 10101, is not one of the Meaningful Use approved nomenclatures, reducing the incentive to use IEEE 11073 data in clinical applications – There are no commonly accepted mappings of IEEE 11073 10101 to Meaningful Use approved nomenclatures (LOINC and SNOMED primarily) for clinical measures although there are vendors who have done so as proprietary interfaces – There are still many circumstances where the specific numeric measures are not codified in a generally accepted standard, for example the current work with ventilators – There are no good filtering standards to drive constraining device streams to be usable by clinical applications 3

4. The Patient Data is Here.... 4

5. But Not Here............... 5

6. BENEFITS of Patient Care Device Clinical and Operations Data Acquisition Improved workflow Improved data collection Improved safety Improved patient care

7. Proposed Constraints Principles – Avoid semantic transformation where possible; work with both nomenclatures to align terminology and value sets with each other (include whole chunks of 11073 101101 nomenclature where possible) – needs to merge into clinical realm - a lot of work done – This is the start of an on-going process to ensure device / clinical harmonization over time Scope Deferred – Use cases beyond inpatient vital signs, events and alerts – Usage with consumer devices – Usage with portable lab devices Environmental Goals – Obtain approval to include this standard as a gap closer in the ONC Interoperability Roadmap – Obtain approval for IEEE 11073 10101 to be recognized as an MU approved nomenclature/vocabulary Prove acceptance of a certain set of IEEE data; Obtain approval to add an MU 3 requirements requirement for hospitals and ambulatory clinics to use this standard to obtain vital signs from medical devices, with incremental (stretch goal) 7

8. Proposed Inpatient Use Case – ICU, Step Down, Observation, General/Surgical DeviceClinical Data (Typical) Smart BedWeight with Alerts Physiologic MonitoringVital Signs with Alerts Pulse Oximeter O2 % BldC Oximetry with Alerts 8 Patient is admitted – monitors are attached:

9. Nomenclature / Terminologies Used Device (IHE PCD Technical Framework Volume 3 – Semantic Content) – IEEE 11073 10101 Nomenclature – MDC terms Clinical (HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1) – LOINC (observations) – SNOMED (constraints primarily) Device Information Model (DIM) – how a device maps to a hierarchical, containment tree model – GMDN. MDNS assumed in use but being phased out 9

10. HIT Detail Messaging – HL7 V2.6 constrained by IHE DEC PCD-01 and RTM – Device Operations – Consolidated CDA, IHE Health Story Consolidation, DSTU R1.1* - Clinical Observations Message Transport – Minimum Lower Layer Protocol (MLLP) over TCP/IP – Device Operations – Web Services(REST/SOAP) - Clinical Observations Systems Impacted – EHRs primarily currently – Over time: Clinical Decision Support, Population Management, Clinical Research * FHIR impact likely 10

11. Content Type and Direction 11 Type of InteractionNomenclature – Device SideNomenclature – Clinical Side Device Numerics ExportIEEE 11073 10101LOINC (observations) SNOMED (constraints) Device Waveforms ExportIEEE 11073 10101 Device Annotations ExportIEEE 11073 10101 Device Events ExportIEEE 11073 10101 Device Alerts ExportIEEE 11073 10101 Configuration/Subscription Import / Retro Query Order Import from DOC to DOF N/A?

12. Value Sets 12 Value Sets(MU2 C-CDA)Code System – Device SideCode System – Clinical Side Respiratory Rate??LOINC Heart Rate??LOINC O2 % BldC Oximetry??LOINC BP Systolic??LOINC BP Diastolic??LOINC Body Temperature??LOINC Height??LOINC Height (Lying)??LOINC Head Circumference??LOINC Weight Measured??LOINC BMI (Body Mass Index)??LOINC BSA (Body Surface Area)??LOINC

13. Vital Sign Observation Vocabulary Constraints 13 Constraints (MU2 C-CDA)Device Side (MDC Term Codes – IHE PCD Tech Framework Volume 3 Semantic Content) Clinical Side Requirements (assume 1 instance unless otherwise noted) Clinical Side Term Codes classCode SHALLOBS moodCode SHALLEVN templateID SHALL Id SHALL / 1 to Many Code (vital sign result type) SHALL Text (including link potential)SHOULD statusCode (completed)SHALL(ActStatus) = completed effectiveTimeSHALL valueSHALL InterpretationCode (qualifier)MAY methodCode (qualifier)MAY targetSiteCode (qualifier)MAY authorMAY Encoded values come from SNOMED UCUM used for Units of Measureyes

14. Actor Definitions, Data Stores and Interactions (Key) 14 Existing IHE Actor Event NA Document or Transaction Data / Image / Document Repository Trigger Proposed IHE Actor

15. IHE Actors Diagram (Current State) 15 Device Observation Consumer (DOC) Device Observation Filter (DOF) Note – limited implementation with infusion pumps (ex: 1 per minute observations) Device Observation Reporter (DOR) Device Observation Bridge (DOB) PCD-02: Subscribe to PCD Data (inactive) PCD-01: Communicate Device Data

16. Actor Definitions and Interactions (Initial Use Case) 16 Device Observation Reporter (DOR) Device Observation Consumer (DOC) A (EHR) Device Observation Filter (DOF) Device Observation Consumer (DOC) B (CDS) Device Observation Consumer (DOC) C (Population Mgmt.) Device Observation Consumer (DOC) D (Clinical Research) Patient Records CDS Audit Trail Population Data Warehouse Clinical Research Data Warehouse 1 Configure/subscribe/ query Device Operations Repository Device Observation Clinical Repository Device Observation Bridge (DOB): mapping and transform where necessary – (DOB) Publish Feed Availability / Publish Notification 1 2 3 4 5 6 7 Added value: Research Patient safety CDS 8 HL7 v2.6 messaging C-CDA payload 4

17. Inpatient Use Case Steps – ICU, Step Down, Observation, General/Surgical 17 1.Configuration for Device DOF/DOB – stream and timing scope, auto push / pull mode requirements 2.Device sends data to DOR 3.DOR sends observation stream to DOF; 4.DOF filters stream to retain what is useful for retrospective work and stores filtered stream in Device Operations Repository; minimally includes alerts in initial phase 5.DOB maps clinical observations from filtered HL7 v2.6 messages to C-CDA and applies data transformations required for LOINC and SNOMED nomenclatures 6.DOB sends stream to Device Observation Clinical Repository, for storage 7.Repositories a) trigger availability notification to applicable DOC or b) DOC auto pushes depending on configuration 8.DOCs query streams as appropriate

18. Filtered Clinical and Device Operations Data: Avoiding Flooding 18 Sample at specified intervals – EHR maintains sample data : all devices Intermittent example – PCA pump overdose, endangering patient: oxygen saturation: limited devices (may add or replace) Intermittent example – noninvasive blood pressure – clinician initiated

19. IHE Technical Solution 19 Numerics Waveforms Annotations Events Alerts Configuration Commands ISO/IEEE 11073 mapping to SNOMED and/or LOINC for vital sign numerics IHE PCD DEC WCM, EC, ACM, … Device Observation Reporters (DOR) Network Gateways Device Integration Engines Individual Devices Device Observation Consumers (DOC) Enterprise EMR, EHR, … 1 3 2 4

20. IHE Technical Solution 1.Enterprise gateways, device integration engines (e.g. Capsule, Iatric, iSirona, Nuvon) and possibly individual devices send near real-time medical device data using the IHE PCD DEC Profiles (HL7 V2.6 messaging and ISO/IEEE 11073 nomenclatures. Filtering needs to be applied to meet data requirements without flooding. 2.For numeric vital signs observations, a normative mapping from ISO/IEEE 11073 to SNOMED and/or LOINC are developed (by organizations representing SNOMED and/or LOINC) and are made available on the NIST RTMMS and other nomenclature repositories. Enterprise “Device Observation Consumers” would use the normative mapping table to translate the ISO/IEEE 11073 nomenclature to SNOMED and/or LOINC. 3.Device-centric data (waveforms, events, alerts, configuration and commands) would use the ISO/IEEE 11073 nomenclature. 4.The IHE PCD DEC (Device Enterprise Communication) Technical Framework and ISO/IEEE 11073 nomenclature are recognized as “Meaningful Use” or equivalent profiles and standards for medical device data transfer to and from enterprise entities. 20

21. HL7 / IEEE / IHE Asks from NLM/IHTSDO Clarification on the scope of IEEE 11073 10101 Nomenclature: US, Europe, International: where would there be interest/need regarding the work proposed? Clarification on the level of adoption of IEEE 11073 10101 Nomenclature: US, Europe, International? Any reference / contacts regarding anesthesia work harmonizing IEEE 11073 and SNOMED in the past List of the high-priority 100+ concepts from IEEE 11073 to be mapped to LOINC/SNOMED 21