IHE Cardiology Implantable Cardiac Device Interrogation (ICDI) Profile Nicholas Steblay 2/3/2006

IHE Cardiology Page 2 ICDI Profile – Abstract Cardiac electro-physiologists follow patients with implantable cardiac devices from multiple vendors. As part of patient follow-up an interrogation of a cardiac device is performed (either in-clinic or remotely from a patients residence). Information is collected about the device such as device identification, therapy settings, device diagnostics, and device testing. These interrogations are performed by vendor proprietary equipment. To improve workflow efficiencies Cardiology and Electro-physiology practices require the management of key summary implantable rhythm control device interrogation information from a central system such as an EHR or a device clinic management system. To address this requirement, the Implantable Cardiac Device Integration (ICDI) Profile defines a standard based translation and transfer of summary device interrogation information from the interrogation system to the information management system.

IHE Cardiology Page 3 ICDI Profile – In Scope / Out of Scope Scheduling is not within scope of the profile for year one. Transactions related to placing, querying, and filling orders have been omitted. These will be incorporated in future versions of this profile. FeatureIn/Out Follow-up ObservationsIn Patient IdentificationIn PDF AttachmentsIn Scheduling / OrdersOut

IHE Cardiology Page 4 ICDI Profile – Recommended Phased Approach Year I (2007) Current Scope Year II (2008) Scheduling / Orders Waveforms (Standards work required) Year III (2009) CDA

IHE Cardiology Page 5 ICDI Profile – Status of Standards Development HL7 Implantable Device Domain – Cardiac Device Negative ballots reviewed during HL7 meeting in Phoenix Negatives deemed Non-Persuasive or Non-Substantive Reconciliations in process Normative in next ballot cycle IEEE 1073 ICD Terms Met with IEEE committee during HL7 meeting in Phoenix Have agreed upon, peer reviewed set of terms Clean up and structuring of content needed, final peer review, target completion date is March April – form Ballot Group and submit ballot for vote – 45 day process Subsequent ballot cycles are only 2 weeks Anticipate normative terms by July

IHE Cardiology Page 6 ICDI Profile – Actor Diagram

IHE Cardiology Page 7 ICDI Profile Actors Observation Creator A system that creates and transmits diagnostic or therapeutic observational data. HL7 Message Router A system that receives HL7 messages, routes them to one or more configured actors, and handles transport level acknowledgements. Observation Processor A system that receives clinical observations and further processes them for inclusion within derivative products, such as clinical reports, databases, or trans-coded / reformatted results Observation Repository A system that receives clinical observations and stores them for subsequent retrieval and display.

IHE Cardiology Page 8 ICDI Profile – Actor Groupings Observation Creator / ATNA - Secure Node HL7 Message Router / ATNA - Secure Node This grouping defines the approach that is required to secure transactions during a remote interrogation that transfers information across an unsecured network. Observation Processor / PDQ - Patient Demographics Consumer This grouping defines the approach that is required to cross reference patient identifiers.

IHE Cardiology Page 9 ICDI Profile – Transactions CARD-14 Send Observation The CARD-14 transaction is an unsolicited HL7 V2.5 ORU message containing discrete data elements and PDF document attachments associated with the device interrogation. Standards: –HL7 Therapeutic Device Domain : Implantable Cardiac Device Topic –IEEE 1073 Implantable Cardiac Device Terms –In lieu of HL7 v3 adoption a HL7 v2.x conformance specification will be included as part of profile –HL7 v3 message may be encapsulated within OBX of HL7 v2.x message pending public comment cycle –Standard network protocols: TCP/IP, HTTPS, FTP, etc.

IHE Cardiology Page 10 ICDI Profile – Sequence Diagram