OSEHRA Medical Device Integration Adapter

(MDIA) ProjectBriefing

Medical Device Integration Adapter (MDIA) ProjectThe 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.

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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

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

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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

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MDIA Information Flow direct or using a Device or Vendor Manager

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sd Information Flow - systems only

Device Manager

Pulse Oximeter

Information SystemPCD-01 Pulse Oximetry Content Profile - Vol 3

«flow»

PCD-01 Pulse Oximetry Content Profile - Vol 3«flow»

PulseOximetryResults

«flow»

Measured results, abnormal flags, error

information

VistA CPRS

Device Manager Vital Signs

Vital Sign MonitorPulse Oximeter

Device results

PCD-01 Standard Message (Device results)

PCD-01 Standard Message (Device results)

Desired Future State (application enhancement)

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sd Information Flows - continuous

Patient

Device Manager

Probe

Pulse Oximeter

Information System

Verifier

PCD-01 Pulse Oximetry Content Profile - Vol 3

«flow»

Alarm

«flow»

PulseOximetryResults

«flow»

Verification

«flow»

Verification

Vendors may provide a solution consisting of devices managed

by a single devicemanager computer system.

Standards-based Transactions

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 O2Sat

Device reported

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

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Proposed Vital Signs Medical Device Integration Adapter

Components

MedicalDevice

Vital Signs

Device Manager System

(Vendor-specific)

VistA Vitals

Adapter

Cache DB

FileMan

PCD-01HL7 V 2.7MLLP

FHIR (http POST)

Test id Map

Enhanced

dm Vital Signs

GMRV_VITALS_PARAMETERS

«column»* RowId :VARCHAR*PK IEN :VARCHAR = $$next^%apiSQL(...* NAME :VARCHAR QUICK_ORDER_PROTOCOL_COUNTER :NUMERIC GMRV_INITIALIZATION_SWITCH :NUMERIC STOP_DATE_DEFAULT :NUMERIC CANCEL_ON_WARD_TRANSFER :VARCHAR CANCEL_ON_SERVICE_TRANSFER :VARCHAR* ABNORMAL_TEMPERATURE__HIGH :NUMERIC* ABNORMAL_TEMPERATURE__LOW :NUMERIC* ABNORMAL_PULSE__HIGH :NUMERIC ABNORMAL_PULSE__LOW :NUMERIC ABNORMAL_RESPIRATION__HIGH :NUMERIC ABNORMAL_RESPIRATION__LOW :NUMERIC ABNORMAL_SYSTOLIC__HIGH :NUMERIC ABNORMAL_DIASTOLIC__HIGH :NUMERIC ABNORMAL_SYSTOLIC__LOW :NUMERIC ABNORMAL_DIASTOLIC__LOW :NUMERIC* ABNORMAL_CVP__HIGH :NUMERIC* ABNORMAL_CVP__LOW :NUMERIC* ABNORMAL_O2_SATURATION__LOW :NUMERIC PHASE_I_COMPLETED :VARCHAR PHASE_II_COMPLETED :VARCHAR PHASE_II_LAST_RECORD :NUMERIC

«PK»+ IDKeyIndex(VARCHAR)

GMRV_VITAL_MEASUREMENT

«column»* RowId :VARCHAR*PK IEN :VARCHAR = $$next^%apiSQL(...* DATETIME_VITALS_TAKEN :TIMESTAMP*FK PATIENT :VARCHAR*FK VITAL_TYPE :VARCHAR* DATETIME_VITALS_ENTERED :TIMESTAMP*FK HOSPITAL_LOCATION :VARCHAR*FK ENTERED_BY :VARCHAR RATE :VARCHAR SUPPLEMENTAL_O2 :VARCHAR ENTERED_IN_ERROR :VARCHAR FK ERROR_ENTERED_BY :VARCHAR

«PK»+ IDKeyIndex(VARCHAR)

«FK»+ FKey_VITAL_TYPE(VARCHAR)+ FKey_HOSPITAL_LOCATION(VARCHAR)+ FKey_ENTERED_BY(VARCHAR)+ FKey_ERROR_ENTERED_BY(VARCHAR)+ FKey_PATIENT(VARCHAR)

GMRV_VITAL_TYPE

«column»* RowId :VARCHAR*PK IEN :VARCHAR = $$next^%apiSQL(...* NAME :VARCHAR* ABBREVIATION :VARCHAR RATE :VARCHAR NODE_1 :VARCHAR RATE_INPUT_TRANSFORM :VARCHAR RATE_HELP :VARCHAR PCE_ABBREVIATION :VARCHAR* MASTER_ENTRY_FOR_VUID :VARCHAR* VUID :VARCHAR

«PK»+ IDKeyIndex(VARCHAR)

+FKey_VITAL_TYPE

(VITAL_TYPE = IEN)

«FK»

+IDKeyIndexSyntax Support:

HL7 V2 ER7FHIR XSD

Transport Support:

TCP/IP MLLPHTTP POST

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

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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)

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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/

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