# Presentation: 704481

## Integrating the Healthcare Enterprise, IEEE 1073 and The National Institute of Standards and TechnologyPatient Care Devices DomainTest EffortMay 2006

## Introduction

- _NIST PCD Team_
- John Garguilo (_[john.garguilo@nist.gov](mailto:john.garguilo@nist.gov)_, 301-975-5248)
- Sandra Martinez (_[sandra.martinez@nist.gov](mailto:sandra.martinez@nist.gov)_, 301-975-3579)
- Rick Rivello (_[richard.rivello@nist.gov](mailto:richard.rivello@nist.gov)_, 301-975-3519)
- _Agenda_
- Involvement in IHE PCD and IEEE 1073
- Year 1, Year 2+
- High Level Diagram
- NIST Conformance Test Tools
- Message Maker
- Input POC (HL7) XML message profiles
- Data source (physiologic)
- Output: HL7 test messages
- Test framework
- ICSGenerator
- Implementation Conformance Statements
- ValidatePDU
- PDU syntax (and later semantics?)
- NIST 1073 XSchema

## Goals

- Describe high-level test focus areas
- Provide Tool Inventory/update
- Brief description
- Pointer/Links for more detail and contact information
- Feedback on tool enhancements
- Reconcile Outstanding Issues
- Provide update on NIST XSchema
- Reconcile differences between 1073 DIM and Nomenclature Documents
- Discovered through tool/XSchema development

## Integrating the Healthcare Enterprise IHE and NIST

- IHE defines a _Technical Framework_ for the implementation of established messaging standards to achieve specific clinical goals.
- NIST supports IHE fundamental objective:
- To ensure that in the care of patients all required information for medical decisions is both _correct and available_ to healthcare professionals.
- NIST contributes to a rigorous testing process for the implementation of the Technical Framework.
- Conformance claims by products must still be made in direct reference to specific standards.
- Vendors implementing IHE integration capabilities shall use an IHE Integration Statement to describe the conformance of their product to the specifications in the IHE Technical Framework.

**Notes:**
This slide is a re-iteration that the direction of IHE (via technical framework documents within specified domains) is in alignment of the NIST mission to “enhance economic security and improve the quality of life...”

A rigorous test effort/process is critical to better enable conformance of implementations to specifications (in the IHE Technical Framework and various standards such as IEEE 1073 and HL7).

## IHE/PCD Year 1 Use Cases

- The Patient Care Devices Domain is concerned with Use Cases in which at least one actor is a regulated patient care device.
- Year One Profiles:
**Profile 1:** **The Enterprise Communication of Patient Care Device Data Integration Profile**
**Goal**: Communicate PCD data to enterprise information systems.
**Profile 2:** **The Patient Identification Integration Profile**
**Goal**: Bind enterprise unique patient identification to the PCD Data which is communicated to the enterprise

## ISO/IEEE 11073-60101 HL7(V2.x) ORI [IEEE P1073.6.1.1](Application Gateway)

- 1073-based communications network where 1073 devices interact and
- an HL7-based communications network, where HL7-based systems interact.
- Problem: A  communication gateway is needed between these two worlds!
- Solution: ISO/IEEE 11073-60101 HL7(V2.x) ORI [IEEE P1073.6.1.1]

**Notes:**
The 1073 Observation Reporting Interface (ORI) is the linkage between what we see as two test efforts.
While the test efforts are distinct, they are inter-related from the standpoint of sharing critical PCD data within the healthcare arena.
The 1073 test effort is in it’s infancy and work will continue to define a more comprehensive test framework.
The IHE test effort will be described in more detail over the next several slides.

## 11073 Application GatewayORI

- Can take non-complying data and translate it, permitting owners of legacy devices to transmit data to the enterprise in a consistent way.
- Major  partitions of the ISO/IEEE  standards and “architectural” components are mapped:
- Data types (VITAL vs. HL7)
- Nomenclature Codes (VITAL vs. LOINC)
- Information Model (Objects & attributes) to HL7 segments and fields.
- Encoding Rules (VITAL ASN.1/MDER/XML to HL7 ER, XML(v2.x/v3)
- Correlate message types (1073 [profiles, GET/SET, CREATE/DELETE, Event Report, etc.] vs. HL7 [interrogatives, imperatives & declaratives])

## How Message Maker and ICS-Generator could contribute to the IHE/PCD year one Initiative...

- 1073
- Standard
- (DIM)

- How Message Maker and ICS-Generator *could* contribute to the IHE/PCD year one Initiative...

- (XSLT)

- Testing
- Framework(***Year 2+)***

***NIST***

*******HL7 v2.x Message Profile: **Captures and describes a set of HL7v2.x messages used to solve a Use Case.

***(Year 2+***** )**

**Notes:**
The IHE Technical Framework identifies the transactions and the standards that it references.
NIST could develop HL7v2.x test messages for an IHE (HL7v2.x) message profile that was based on a transaction that uses HL7 Messaging Standard v2.x or a transaction that uses 1073 medical device data that was mapped to HL7v2.x using the HL7v2.x ORI (gateway) specification. 

Year 2 and beyond:  The ICSGenerator could potentially generate a data set based on users/vendors/implementers selected conformance attributes.
The Testing Framework would be developed to enable test messages (produced from Message Maker) to be utilized as test cases/suites within the enterprise environment.

## Conformance Test Tools

_***Message Maker***_
- Message Maker dynamically constructs HL7 messages based on an HL7 message profile.
- Data values for the primitive elements (i.e., Field, Component, and Subcomponent) defined in the profile are obtained from a number of data sources.
- NIST developed database of HL7 primitive data items, HL7 tables, User tables, External tables, local tables, example values from the profiles and default values.
- Test messages can be valid or invalid and contain variation from message to message.
- Example of invalid message is a missing data item for a required field.
- A number of test parameters control the variation in the construction of a message.
- These may include segment and field cardinality, the usage of certain primitive fields, value sets, data content, and more.
- Data content variation is achieved by randomly selecting items from the HL7 items database.
**http://www.nist.gov/messagemaker**
**Robert Snelick (robert.snelick@nist.gov)**

## Conformance Test Tools (continued)(based on 11073 DIM Schema)

- Conformance Test Tools (continued)(based on 11073 DIM Schema)

_***ICSGenerator***_
- Facilitates creation of vendor conformance statements [*as well as potential selection of tests applicable to testing a particular device]*.
- Provides Medical device data such as parameters or attributes with value ranges and restrictions.  [*This data can be used as needed by MessageMaker (in addition to testing options, data source(s) and HL2 V2.x profile file) to build the test messages*.]
**http://www.nist.gov/medicaldevices**

## Conformance Test Tools (continued)(based on 11073 DIM Schema)

_***ICSGenerator ***_
- Capability of reloading an existing ICS
- Added term codes
_***Future Enhancements***_
- Add capability to dynamic build containment tree
- Add Service Support ICS

## Conformance Test Tools (continued)(based on 11073 DIM Schema)

- Conformance Test Tools (continued)(based on 11073 DIM Schema)

_***ValidatePDU***_
- Provides a basic syntax and structure check for a set of captured messages.
_**Future Enhancements**_
- Translating BER/MDER XML
- Needed for 1073 syntax/structure/semantic testing
**http://www.nist.gov/medicaldevices**

## 1073 XML Schema

_***NIST 1073 XSchema represents:***_
- X73 DIM including:
- Common Data type definitions
- Managed Object Class definitions
- attributes, behaviors and notifications definitions
- Attribute groups (not included yet)
- Base classes (not included yet)
- Containment tree
- ICS Model
- Service Model
- Term codes for Managed Objects, attributes, behaviors and notifications
- ASN.1 included in other X73 documents
- Used by NIST conformance tools
_***ICSGenerator***_ : A device profile developed using this tool could  potentially “claim” conformance to the X73 DIM standard.
***ValidatePDU: ***X73 message validator for syntax and structure
- Possible use by other efforts (e.g., IHE PCD tooling, IEEE 1073 standard development

## (IEEE 1073) Issues/Discussion

- Medical Device Communication Test Suite Issues
- General
- Object name labels – Is there a standard list of labels?