1. OSEHRA Medical Device Integration Adapter (MDIA) Project Briefing

2. Medical Device Integration Adapter (MDIA) Project The Medical Device Integration Adapter (MDIA), Open-Source Project group is undertaking the development of a Java-based component to receive, process, and persist the exchange of standards-based device measurements, using Integrating the Healthcare Enterprise (IHE) Patient Care Devices (PCD) conformant, HL7 Version 2.7 and HL7 FHIR RESTful services. The MDIA will provide conformance testing capability for standards-based interoperability with OSEHRA VistA, leveraging existing NIST test tools for IHE PCD. After initial development and testing, the adapter will be used within a series of HI industry demonstrations and connectathons, encompassing a variety of standards-based medical devices. Upon completing this initial v1.0 functionality testing and demonstration, the project scope may be expanded to address additional functional aspects of medical device interoperability integration, management, and tracking (e.g. FDA guidelines on Universal Device Identifier, Medical Device Data System), identified throughout v1.0 development. 2

3. Overview Concept: In conjunction with VA membership in the Open Source Electronic Health Record Alliance (OSEHRA), we will develop an Open Source VistA, Medical Device Integration Adapter (MDIA) to enable interoperability between standards-based Medical Devices and associated HIT system or components Background: OSEHRA (Open Source Electronic Health Records Alliance) is a community for the development of open-source healthcare informatics Currently no organic VA capability to test commercial devices for interoperability with VistA or explicit support for specific device interoperability Home Telehealth program experience multiple issues due to lack of rigorous testing Pulse Oximetry Integration was created as a new specification to support VA needs The VA has not participated to date in the annual IHE North American Connectathon A virtual VA test platform for medical device integration would be desirable 3

4. MDIA Value Proposition 3-Point Value Proposition: Substantial improvement in patient safety through providing automatic access to complete standards-based medical device measurements (e.g. vitals, pulse oximetry), as well as device identity from the point of care (i.e. patient-device association). Overall semantic interoperability improvements MDIA could be a first component of several intended to enhance VistA interoperability Provision for 24/7 test capability of standards-based device interoperability with OSEHRA VistA 4

5. Additional benefits Lower the cost of integration Fixed/low cost integration for standard-based devices Create a market of standard-based devices Promote standard-based devices by providing on-going testing and validation Require standard-based device interoperability Increase the usability of integrated device solutions Integrate workflow processes across from patient care  documentation  review Lower the cost of acquiring new devices to the VistA end-users New, innovative, standard-based device become more accessible to VA clinicians Remove vendor lock-in using customized solutions Develop new capabilities alongside the open-source community Open Source EHR Alliance 5

6. MDIA Information Flow direct or using a Device or Vendor Manager 6 Measured results, abnormal flags, error information VistA CPRS Device Manager Vital Signs Vital Sign Monitor Pulse Oximeter Device results PCD-01 Standard Message (Device results)

7. Desired Future State (application enhancement) 7 Verification Vendors may provide a solution consisting of devices managed by a single device manager computer system. Standards-based Transactions

8. Standards-based Automatic Medical Device Results Reporting Automatic Process including Clinician Validation: Associate the device with the patient Start measurements Review measurements in VistA Vitals or CPRS Chart Click the flowsheet to refresh Mark “in error”, if needed Vitals Lite VistA Vitals Pulse and O 2 Sat Device reported

9. Project Milestone Dates – MDIA V 1.0 Phase I – Project Scope Definition/Charter approval (completed) Phase II – Development/Testing Presentation at the 2015 OSEHRA Open Source Summit (29 July, 2015) IHE Connectathon Unit Testing (November 2015) IHE Connectathon, Cleveland (January 2016) HIMSS Interoperability Showcase, Las Vegas (February 2016) Optional: FHIR Connectathon, Atlanta (May, 2015) Deployment (starting March 2016) Code review and integration into OSEHRA code base and unit testing dashboard March 2016 – revisit the charter and needs for v2 evolution development 9

10. Proposed Vital Signs Medical Device Integration Adapter Components Medical Device Vital Signs Device Manager System (Vendor-specific) VistA Vitals Adapter Cache DB FileMan PCD-01 HL7 V 2.7 MLLP FHIR (http POST) Test id Map Enhanced Syntax Support: HL7 V2 ER7 FHIR XSD Transport Support: TCP/IP MLLP HTTP POST

11. Medical Device Integration Adapter Requirements Enhancements to the input data stream Add FHIR resource creation support Support for HTTP listener in addition to TCP/IP listener Optional, if available – reuse FHIR Patient resource for patient identity lookup (generic capability, reusable by other adapters) Mapping test identifiers for vitals, not only Pulse Oximetry Enhanced data persistence Add support for FileMan RPC for persistence Define algorithm for data sampling (new Open-source VistA application update) Based on relevant data changes (significant vitals changes) Based on relevant sampling intervals (e.g. every minute, every 5 minutes) Validation for medical record keeping 11

12. Medical Device Integration Adapter Requirements Allows standards-based devices to interoperate with VistA/Open-Source VistA Lowers the cost for VA to acquire standard-based based devices Provides a 24/7 testing solution for third-party medical device vendors Allowsclinicians improved use of medical device measurements Eliminates the human burden and error of manually entered results Support validation/verification of measurements acquired from devices and elimination of “artifacts” Improves patient safety Supports patient-to-device association Future enhancements are possible to bring patient identity validation to the point-of-care Eliminates erroneous assignment of medical device measurement to a patient record (i.e. currently one patient’s chart could be corrupted with results intended for another patient) 12

13. Follow up Weekly call on Wed @ 11 am EST – updates the MDIA project blog: http://www.osehra.org/groups/medical-device-integration-adapter Issues http://issues.osehra.org/browse/MDIA/ 13