Medical Device Communication: A Harmonized Approach

Tuesday, April 14, 2015

John J. Garguilo, Computer Scientist, NIST

Paul Schluter, PhD, Principal Engineer, GE Healthcare

DISCLAIMER: The views and opinions expressed in this presentation are those of the author and do not necessarily represent official policy or position of HIMSS.

Conflict of Interest John J. Garguilo, Computer Scientist, Federal Government Has no real or apparent conflicts of interest to report.

Paul Schluter, PhD Salary: GE Healthcare Receipt of Intellectual Property Rights/Patent Holder: GE Healthcare Ownership Interest: GE Healthcare

© HIMSS 2015

Learning Objectives • Explain the difference between Conformance testing and Interoperability

testing

• Explain how IHE Patient Care Device domain addresses interoperability

• Describe and demonstrate a harmonized standards-based medical device nomenclature repository which is publically available

• Identify available software tooling used in medical device communication and develop understanding of IHE tooling developed by NIST

• Develop understanding of criteria addressed by message validation tools developed by NIST (and likely to be identified by Meaningful Use)

An Introduction to the Benefits Realized for the Value of Health IT

http://www.himss.org/ValueSuite

Health IT Value Steps Anticipated Benefits

S Satisfaction Patient; Provider; Staff; Other

Promotes greater patient (home and personal health) and provider choice of devices and systems. Reduces dependency on limited availability of established IT interfaces.

T Treatment / Clinical Safety; Quality of Care; Efficiency

Reduces potential safety issues due to extensive field integration and on-site customization. Improves availability of data by reducing dependency on availability of established IT interfaces.

E Electronic information / Data Evidence Based Medicine; Data Sharing and Reporting

Facilitates data aggregation and analytics in a multi-vendor environment. Facilitates semantic data sharing and reporting within a single organization and across multiple organizations. Enables real-time data collection of vital signs and other device data, facilitating exchange/interoperability with data aggregation and analytics without loss of semantics.

P Prevention and Patient Education Prevention; Patient Education

Provides means, accurate and verifiable tooling, and access to data for prevention and patient education. Provides near real-time surveillance of patient status to locations beyond patient’s bed-side.

S Savings Financial / Business; Efficiency Savings; Operational Savings

Standards facilitate more economically effective connectivity solutions by amortizing cost of design over many implementations. Reduces need for expensive “middleware” and custom integrations. Semantic content remains intact.

Section One: Aspects of Interoperability

Introduction

As hospitals deploy EMRs into their most critical care areas, the need to acquire data directly from medical devices becomes increasingly evident.

– Device data capture is “real-time” • Data is up-to-date • Decision support algorithms can run on more timely data

– Device data capture is “automatic” • Reduce nursing workload

– Device data capture is “accurate” • Automated data capture is less error prone than manual

charting

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Example Device Communication

Patient

A patient arrives at hospital’s Intensive Care Unit (ICU) in critical condition

Example Device Communication

Patient Monitor

Patient

Ventilator Infusion Pumps

A patient needs to be associated with any number of medical devices … Medical Equipment Management – are devices available, clean, up-and-running, patched, secure, and batteries charged?…

Anesthesia Machine

Example Device Communication

Patient Monitor

Patient

Ventilator Infusion Pumps

Anesthesia Machine

A patient is connected to one or more vital signs monitors, receiving drugs or other fluids from an infusion pump and anesthesia device, and later to a ventilator

Example Device Communication

Patient Monitor

Patient

Ventilator Infusion Pumps

Anesthesia Machine

Voluminous data records are being created for each patient, continuously from the output of all these devices.

Example Device Communication

Patient Monitor

Patient

Ventilator Infusion Pumps

Anesthesia Machine

Relevant information is not always being captured, integrated, and consequently processed in order to achieve a better understanding of the condition of the patient.

Nurse

What is Interoperability?

HIMSS defines Interoperability as … Interoperability means the ability of health

information systems to work together within and across organizational boundaries in order to advance the effective delivery of healthcare for individuals and communities.

the AAMI definition is more device-centric ... Medical device interoperability is the ability of

medical devices, clinical systems, or their components to communicate in order to safely fulfill an intended purpose.

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How can we Improve Interoperability?

• Use standards to provide more economically effective solutions by amortizing the cost of design over many implementations.

• Profile standards to reduce optionality and simplify implementation and testing.

• Provide computable definitions of message syntax and semantics. • Use rigorous conformance and certification testing. • Use other incentives to promote acceptance …

This presentation will focus primarily on the work of the National Institute for Standards and Technology (NIST) and IHE Patient Care Devices (PCD) domain.

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Section Two: IHE PCD and Interoperability

Role of the IHE PCD

• IHE PCD was formed in 2005 to address issues related to integration of Point-of-Care medical devices:

– with each other and – with enterprise systems

• IHE PCD mission is to “raise the bar” from the current state of expensive integration projects to “out of the box” interoperable solutions.

• IHE PCD Sponsor organizations are: ACCE American College of Clinical Engineering AAMI Association for the Advancement of Medical Instrumentation HIMSS Healthcare Information and Management Systems Society

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Foundational Standards and Profiles

• HL7 V2.6

• IEEE 11073 Medical Device Communication – IEEE 11073-10101 Nomenclature (and extensions) – IEEE 11073-10201 Domain Information Model

• IHE ITI and other profiles – Consistent Time (CT, aka NTP) – Patient Administration Management (PAM) – Patient Demographics Query (PDQ) – Rosetta Terminology Mapping (RTM, NIST RTMMS)

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Profiles Simplify Development!

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Standards

IHE PCD Technical

Frameworks

IHE PCD Profiles

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Device Enterprise Communication (DEC) Rosetta Terminology Management (RTM) Alert Communication Management (ACM) Implantable Device Cardiac Observation (IDCO) Point-of-care Infusion Verification (PIV) Event Communication (EC) (formerly IPEC) Subscribe to Patient Data (SPD) Waveform Communication (WCM) Retrospective Data Query (RDQ) Patient Care Identity Management (PCIM) Medical Equipment Management (MEM) (CMMS, Security, RTLS, … ) Device Management Communication (DMC) and Location Services (LS) Whitepaper Pulse Oximetry Integration (POI) Optimized Message Syntax (OMS) Whitepaper Device Point-of-care Integration (DPI)

Final Text - Developed

Trial Implementation

Color key: Mature, Deployed, Foundational Mature, Deployed Mature, Less Widely Deployed

Device to Enterprise Communication [DEC]

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© 2010 Elliot

Sloane, all rights

d

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Personal Connected Health Alliance (PCHA) uses IHE PCD DEC for WAN Interface

With permission, Continua Alliance

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Section Three: Semantic Interoperability

Objective: Communicate medical device data using a single

unified nomenclature and semantic model that can be rigorously defined and enforced to facilitate safe and effective plug-and-play interoperability.

[RTM] Rosetta Terminology Management

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Vendor Terms

RTM 1619 rows

Harmonized Terms

hRTM 671 terms

ISO/IEEE 11073 Semantic Standards

Vendor A

Vendor B

Vendor C

HL7 V2 Messages

HL7 V3 CDA/CCD

11073 PnP Comm

Vendor Semantics

IHE PCD Technical Framework Content

• Open consensus process • Observation identifiers and co-constraints • New terms incorporated into standards • hRTM used for conformance testing

IHE PCD Harmonized Rosetta (hRTM)

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Group REFID DIM UOM_MDC UOM_UCUM CVS_ECG_HR MDC_ECG_HEART_RATE T-1 MDC_DIM_BEAT_PER_MIN {beat}/min {beats}/min 1/min /min CVS_ECG_ST MDC_ECG_AMPL_ST_I

ML2I-1T-3 ML2I-1T-3

MDC_DIM_MILLI_VOLT MDC_DIM_MICRO_VOLT MDC_DIM_MILLI_M#

mV uV (added by scripting rule) mm# (voted “off-the-island”)

GASMON_AA_ENFL MDC_CONC_ENFL_ET

L3L-3 LMT-2L-2 LMT-2L-2

MDC_DIM_VOL_PERCENT MDC_DIM_KILO_PASCAL MDC_DIM_MMHG

%{vol} kPa mm[Hg]

Specifies for each IEEE 11073 REFID observation identifier: • the 11073 MDC and UCUM units-of-measure

- includes dimensional analysis to ensure correct ‘units-math’ • enumerated values and measurement sites • numeric codes, where appropriate

An extract from the hRTM is shown below:

Available at http://wiki.ihe.net/index.php?title=PCD_Profile_Rosetta_Terminology_Mapping

Section Four: NIST RTMMS

Rosetta Terminology Mapping Management System

John J. Garguilo, DoC/NIST

NIST and the Importance of Standards

Article 1, Section 8: The Congress shall have the power to . . . fix the standard of weights and measures

Estimated that 80% of global merchandise trade is influenced by testing and other measurement-related requirements of regulations and standards.

Measurements, testing, and standards are the basis for developing and deploying technology.

• National Bureau of Standards established by Congress in 1901

• Eight different “authoritative” values for the gallon • Electrical industry needed standards • American instruments sent abroad for calibration • Consumer products and construction materials

uneven in quality and unreliable

Standards Perspective – Why is NIST involved? • Trusted industry neutral entity • Help write better (and better) standards • Iterative feedback to standards bodies and domain groups • Healthcare Information Technology ‘Test Infrastructure’

– Need at once (for testing) – Re-usable component with common interfaces for consistent usage

• Interoperability ‘Test Bed’ – To execute testing over a variety of domains / test events – Enable ‘users’ to quickly devise test tooling to meet needs

• Get away from one development effort needed for each test event • Enable users with domain knowledge to drive testing

Standards are Necessary! Why?

• Value of Standards – Common and repeatable use – Consensus established by recognized body

• Common, definition, meaning, and attributes

• Provide use, rules, guidelines for activities of their results

• Aimed at the achievement of the optimum degree of order in a given context

Conformance and Interoperability, continued Conformance CAN NOT be definitively determined* - but gives a level of confidence based on quality and quantity of test(s) performed

– (*unless specification is very basic)

Conformance Interoperability

“A is Conformant, B is Conformant”…

The above does not say anything about interoperability between A and B

Work Products: Standards, Domains & NIST Test Tools

• IHE-PCD • HL7 – Health Level 7 Device-to-EHR/EMR

• Pre-Connectathon • Connectathon • RTMMS - hRTM

• ISO/IEEE 11073 Medical Device Communication -Family of Standards

Device-to-Device Model: Manager <-> Agent (Receives Data) (Provides data)

• RTMMS - Nomenclature

• ‘ICSGenerator’ • DIM Modeling – ‘DeviceEditor’

• ‘ValidatePDU’

Medical Device Domain

NIST Tools

Medical Device Interoperability Using ‘Profiles’ To Advance Rigorous Testing

Integrating the Healthcare Enterprise (IHE) Patient Care Devices (PCD)

Assertions HL7 v2

Standard Message Definition

IHE TF Message

Transaction Constraints

HL7 v2 Standard

Value Sets

IHE TF Message

Transaction Value Set

Constraints

Harmonized Rosetta

Terminology Mapping

Constraints

ISO/IEEE 11073

Nomenclature

Validation Context

File (XML)

Table Library (XML)

Conformance Profile (XML)

Test Case Specific

Test Assertions

IHE-PCD TF Message

Transaction Test

Assertions

Validation Context

File (XML)

User / Device

Message E.g., HL7 V2

Specification Constraints

Standards Profile

Domain Framework

Test Case/ Value(s)

Based on Use Case(s)

Terminology/ Nomenclature

Report

Validation Test

Management

Test Services

Test System Development Components

Test Harness

Test Resources

Test System Instance

Testable Assertions: IHE-PCD Validation Requirements

Used by NIST Test Tools

Medical Device Interoperability NIST Test Environments and Services

Integrating the Healthcare Enterprise (IHE) Patient Care Devices (PCD)

Report

Test Artifacts Conformance Profile HL7 Tables ‘Device’ Test Agents ISO/IEEE

11073/Rosetta Terminology

HL7 V2 Message Validation

Services

User / Device

Test Management HL7 V2 Message

Validation Test Case Results

HL7 V2 Message Validation Report

Test Harness (Java Code)

Test Execution Web

Application Client

HL7 V2 Message

Registry/ Repository

Report

IHE-PCD DOR/DOF Test Agent

HL7 V2 Message

Generation

IHE-PCD DOC

Test Agent

HL7 V2 Message Validation

Services Test

Management

Router/Logger/Proxy

Vendor

System Under Test

Test Artifacts • Conformance Profiles • HL7 Tables • Validation Context Files • Generation Context Files

IHE-PCD Client Test Scenario Results

HL7 V2 Message Validation Reports

IHE-PCD IOR

Test Agent

IHE-PCD AM

Test Agent

IHE-PCD IOC

Test Agent

IHE-PCD AR

Test Agent

IHE-PCD IDCC

Test Agent

IHE-PCD IDCR

Test Agent

Test Harness (Java Code)

Test Execution

Web Application

Client

Instance Test Environment E.g., IHE-PCD Conformance Testing of an HL7 V2 IHE-PCD Message using a

NIST Web Application Client

Isolated System Test Environment E.g., IHE-PCD Functional Behavior

Conformance Testing using a NIST Web Application Client and Test Agents

Terminology RTMMS – Rosetta Terminology Mapping Management System

• A web application that allows vendors and reviewers access, retrieval, and reporting of Rosetta Tables over the internet in conformance to RTM

• Aids in the harmonization process by: – Identifying missing terms – Facilitating the proposal of new terms – Facilitating discussion of the proposed term – Automatic generation of the “Harmonized Rosetta Table”

• A web service/tool used as part of SDO’s ballot / approval process • Fulfills Critical Need of Conformance Tooling

– Message verification and conformance (semantics) – Leading to interoperability…

RTMMS – What is it?

• ‘General user’ – Views Rosetta Tables

• ‘Reviewer’ – Participates in discussions

• ‘Contributing Organizations’ – Vendor/Contributor ‘sandbox’ – Modifies Vendor Rosetta Table – Suggests new terms – Modifies Units and Enumerations Table

• ‘SDO’ (Standard Development Organization) – Modifies Units and Enumerations Table – Register new terms

• ‘Admin’ – Manages System and User Accounts

RTMMS Users

Terminology – Rosetta – Example: ‘ECG Heart Rate’ The Rosetta table contains the observation identifiers, units-of-measure and enumerations that vendors currently support on their gateways and how they plan to map these to the ISO/IEEE 11073-10101 nomenclature and its extensions.

Terminology – harmonization by Vendors hRTM – harmonized Rosetta Terminology Mapping

The Harmonized Rosetta table contains terms agreed upon during the harmonization process.

Terminology – units of measurement – Example: beats per min

This table defines all the allowed units-of-measure and normative mapping between the ISO/IEEE 11073-10101 units-of-measure (by Reference IDs and numeric codes) and the equivalent UCUM term(s). It also defines: • groups of related units-of-measure, such as units used for drug dose, concentration. • the dimensionality of each unit-of-measure to ensure that all the units associated with an observation

identifier are consistent. The units table includes additional information required for publication in ISO/IEEE 11073-10101 standard so that all of the units-of-measure information can be updated and maintained in a single repository.

Terminology – enumerations

This table defines groups of enumerated values (either token strings or as IEEE Reference IDs and numeric codes) that are referenced from the main 'Rosetta' table.

PCD-01 Message Example, HL7 V2.6

MSH|^~\&|HL7^080019FFFF4F6AC0^EUI-64|MMS|||20070118133700||ORU^R01|a4e2e3:11036b5cdbb:-|P|2.6|20070118133700||NE|AL||8859/1 PID|||GE101^^^DefaultDomai||JACKSON^IRWIN^^^^^L PV1||E|3WICU^305^305 OBR|1|080019FFFF4F6AFE200701|080019FFFF4F6AC0200701|126.3.3.1^2000^MDC|||20070118133700 OBX|1|NM|147842^MDC_ECG_HEART_RATE^MDC|1.6.1.1|80|/min^/min^UCUM|||||R OBX|2|NM|148065^MDC_ECG_V_P_C_CNT^MDC|1.6.1.2|0|/min^/min^UCUM|||||R OBX|3|NM|150035^MDC_PRESS_BLD_ART_MEAN^MDC|1.3.1.1|96|{mm[Hg]}^{mm[Hg]}^UCUM|||||R OBX|4|NM|150033^MDC_PRESS_BLD_ART_SYS^MDC|1.3.1.2|120|{mm[Hg]}^{mm[Hg]}^UCUM|||||R OBX|5|NM|150034^MDC_PRESS_BLD_ART_DIA^MDC|1.3.1.3|80|{mm[Hg]}^{mm[Hg]}^UCUM|||||R OBX|6|NM|149522^MDC_BLD_PULS_RATE_INV^MDC|1.2.1.1|80|/min^/min^UCUM|||||R OBX|7|NM|150047^MDC_PRESS_BLD_ART_PULM_MEAN^MDC|1.4.2.1|15|{mm[Hg]}^{mm[Hg]}^UCUM|||||R OBX|8|NM|150045^MDC_PRESS_BLD_ART_PULM_SYS^MDC|1.4.2.2|24|{mm[Hg]}^{mm[Hg]}^UCUM|||||R OBX|9|NM|150046^MDC_PRESS_BLD_ART_PULM_DIA^MDC|1.4.2.3|10|{mm[Hg]}^{mm[Hg]}^UCUM|||||R OBX|10|NM|150344^MDC_TEMP^MDC|1.10.1.1|26.4|cel^cel^UCUM|||||R OBX|11|NM|150344^MDC_TEMP^MDC|1.10.1.2|37.4|cel^cel^UCUM|||||R OBX|12|NM|151610^MDC_VENT_CO2_RESP_RATE^MDC|1.5.1.1|12|{{breath}/min}^{{breath}/min}UCUM|||||R OBX|13|NM|151804^MDC_PRESS_AWAY_END_EXP_POS^MDC|1.5.1.2|4|{cm[H20]}^{cm[H20]}^UCUM|||||R OBX|14|NM|152008^MDC_VENT_VOL_MINUTE_AWAY^MDC|1.5.1.3|0.0|l/min l̂/min^UCUM|||||R OBX|15|NM|151920^MDC_VENT_CONC_AWAY_O2_INSP^MDC|1.5.1.4|21|%^%^UCUM|||||R OBX|16|NM|151980^MDC_VENT_VOL_TIDAL^MDC|1.5.1.5|920|ml^ml^UCUM|||||R OBX|17|NM|151957^MDC_VENT_PRESS_MAX^MDC|1.5.1.6|17|{cm[H20]}^{cm[H20]}^UCUM|||||R OBX|18|NM|151784^MDC_PRESS_RESP_PLAT^MDC|1.5.1.7|31|{cm[H20]}^{cm[H20]}^UCUM|||||R OBX|19|NM|151792^MDC_PRESS_AWAY^MDC|1.5.1.8|36|{cm[H20]}^{cm[H20]}^UCUM|||||R OBX|20|NM|151808^MDC_PRESS_AWAY_END_EXP_POS_INTRINSIC^MDC|1.5.1.9|1|{cm[H20]}^{cm[H20]}^UCUM|||||R

‘Heart Rate’ ‘/min’ UOM

Termcode OBX-4,

containment Unified Code for Units Regenstrief Institute

Value

ReferenceID

NIST’s RTMMS & IEEE Royalty Free Agreement (20 Dec 2012) • NIST may freely present the “Works” via the RTMMS • Vetted through NIST Legal, ITL HQ, and IEEE legal

The “Works”: • Reference ID • Terminology Code • Description • Systematic Name • Common Term

Cross Disciplinary Research- Clinical Terminology

LOINC – Logical Observation Identifiers Names and Codes • Regenstrief Institute, Inc.

– International non-profit housing LOINC (http://loinc.org/background) – Focus: electronic movement (results) of clinical data from laboratories (and other

clinical observations) that produce the data to hospitals, physician’s offices and payers who use the data for clinical care and management purposes

• National Library of Medicine – LOINC ↔ IEEE 11073 (distribution available on NIST RTMMS)

SNOMED CT - Systematized Nomenclature of Medicine – Clinical Terms

IHTSDO – International Health Terminology Standards Development Organization – Non-profit Association – Own and maintain SNOMED CT (Clinical Terms) – Most comprehensive, multilingual clinical healthcare terminology in the world

(www.ihtsdo.org/snomed-ct/)

– SNOMED CT ↔ IEEE 11073 (distribution available on NIST RTMMS)

Issues / Key Work Items

• Integration of SNOMED-CT Terms – Expertise needed – mappings provide equivalence between

SNOMED-CT and IEEE 11073

• Integration of LOINC Terms – Mapping must be provided by experts

e.g. by Clem McDonald and colleagues at NLM

• Long-term – who owns and maintains RTMMS – ongoing discussions with NLM and others

RTMMS by the numbers • 1619 Rosetta terms • 667 hRTM terms • 224 Groups • 8 Unit Groups

– 445 Units (MDC) – 444 Units (UCUM)

• 28 Enumeration Groups – 273 Enumerations

• 57 Contributing Organizations now Registered!

NIST MDC Testing Project Web Sites

Project Web site: www.nist.gov/medicaldevices NIST HL7 V2 Test Tooling Web sites:

IHE-PCD Pre-Connectathon:

• http://ihe-pcd-precon.nist.gov

IHE-PCD Connectathon: • http://ihe-pcd-con.nist.gov

NIST Medical Device Terminology Service: • Rosetta Terminology Mapping Management System (RTMMS):

http://rtmms.nist.gov

Semantic Interoperability of Medical Devices 44

A Review of Benefits Realized for the Value of Health IT Value Step E: Electronic Information/Data

Heterogeneity – Multiple manufacturers + multiple device modalities coexisting over a shared infrastructure Semantic Interoperability ( comparability) – Ability to respond to clinical context, compare information from different healthcare facilities, and interrogate systems across enterprises, driving clinical decision support systems with an economic business model. Real-Time Availability – Ability to provide data in a time frame appropriate to the physiologic function being measured, displayed or affected (controlled). Facilitates data aggregation and analytics in a multi-vendor

environment. Facilitates semantic data sharing and reporting within a single

organization and across multiple organizations. Enables real-time data collection of vital signs and other device data,

facilitating exchange/interoperability with data aggregation and analytics without loss of semantics.

Questions Thank You!

• Paul Schluter, PhD

Principal Engineer, GE Healthcare Paul.Schluter@med.ge.com

• John J. Garguilo Computer Scientist, NIST john.garguilo@nist.gov

Extra Slides