software and systems division medical device communication test effort ihe-pcd f2f wg meetings...
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IHE-PCD F2F WG Meetings
Medical Device CommunicationMedical Device CommunicationTest EffortTest Effort
IHE-PCD WG Meetings (Boston/Holliston, Massachusetts)
21-23 October 2008
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Medical Device Test EffortMedical Device Test EffortNIST Team Members
• John Garguilo ([email protected], 301-975-5248)
• Sandra Martinez ([email protected], 301-975-3579)
• Maria Cherkaoui ([email protected] Guest Researcher)
• Richard Theimer ([email protected] Group, Inc., Contractor)
www.nist.gov/medicaldevices
http://hl7v2tools.nist.gov/
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Meeting Topics/Discussion
• NIST Tooling– IHE-PCD Profile/Message Validation– NIST V2 Validation Tools– ICSGenerator
• Supporting IHE-PCD• Enhancements for X73-20601 and 104xx
– ValidatePDU • Validates APDU syntax against X73 DIM specifications and the X73 Application
Profiles – Base Standard and • Validates APDU semantic/content against device profile.
• RTM Management Service– Use Case– UML System Model, and Package diagram
• Standards development– NIST P11073-10202 DIM XSchema (PAR)– X73-10202 Documentation– Needs
• Validation and Verification (currently only through tooling)
• http://www.nist.gov/medicaldevices
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NIST Tooling IHE-PCD Profile/Message Validation
• NIST V2 Testing Tools– Validate HL7 V2 profiles (Msg_type^Event_type^ e.g., ORU^R01^…) – Validate HL7 V2 messages (e.g., PCD-01)
Message structure (e.g., MSH,PID,PV1,OBR,NTE,{OBX},OBX,OBX,OBX,…})
– Generate HL7 V2.x messages • ICSGenerator Tool
- Model Device according to x73 (DIM and Nomenclature)- Generate device profiles (device specialization in XML format)- Device profile becomes part of a “Medical Device Semantic Database”
- Used for semantic/content validating and system configuration.
• Proposed RTM “Management Service”– A web application/service to facilitate RTM terminology authoring, review, and
reporting– The “Harmonized” Rosetta table will become part of a
“Medical Device Semantic Database” for purposes of semantic testing.
• Medical Device Semantic Database (Yet to come…)– To include semantic related information such as:
• Terminology based on Rosetta Terminology Mapping (RTM) – The “Harmonized” Rosetta Table.
• ISO/IEEE 11073-10101 Nomenclature• Device specializations (IHE-PCD Vol. 3 Content Profiles),
PHD 104xx specializations – – Will include terminology from RTM and from ISO/IEEE 11073-10101 Nomenclature
entered by the user via ICSGenerator.
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NIST V2 Testing Tools IHE-PCD: PCD-01
NIST V2 Testing tools(MessageValidator)
PCD-01 HL7 V2 msg.
Validation Report
HL7Profile
(XML)MSH,PID,PV1,OBR,NTE,{OBX},OBX,OBX,OBX,
…
NISTMedical Dev Semantic DB
NISTMedical Dev Semantic DB
PCD-01 HL7 V2 Assertions
(XML)(validation context)
V2Test Scenario
+
NISTICSGenerator
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• HL7 Profile (typically from MWB)– MWB profile: .mwb file– MWB table: .mwt file(s)
• A Validation Context (for NIST V2 Validation Tools)– Context must be provided where the user specifies the
elements of the message to be validated. • Referred to as “failure types”: User-provided (XML)
‘validation context’ file in a specific format.• User provided tables or databases
– E.g., Medical Device Semantic Database or – By providing the values in the ‘validation context’ file…
• Test Scenarios for each profile (e.g., IHE-PCD ACM, PIV Profiles)– Tied to Framework Docs (supplements)
NIST Testing Tools Validating IHE-PCD Transactions
(messages)What’s Needed?
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IHE-PCD MWB: HL7 V2.5 PCD-01 Profile
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• Validation performed at the HL7 profile level
• NIST V2 Tooling does not provide the capability of conditional validation (e.g., validating that a REF_ID has the proper unit associated to it.)
• Semantic validation at Element Level – Based on the “Medical Device Semantic Database”– Includes:
• * observation identifier (REF_ID)• CF_CODE10• CODE10• Units• Enum_Values• ContainedBy
NIST Testing Tools Validating IHE-PCD Transactions
(messages)What is and is NOT validated?
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NIST Testing Tool provides validation in the following areas (failure types):
• VERSION*: The version in the message and in the profile should match. • MESSAGE_STRUCTURE_ID*: The message type (MSH.9 element) in the
profile and in the message should match. • MESSAGE_STRUCTURE: The message should have a valid message
structure (correct usage, correct cardinality, and correct element name). • USAGE: R elements should be present; X elements should not be present in
the message. • CARDINALITY: Elements should be present at least the minimum times and
at most the maximum times specified in the profile. It should also take into account the usage of the element (X element with a minimum of 4 should not be present in the message).
• LENGTH: The value of the element should have a length equal or less than the value specified in the profile.
• DATATYPE: For the datatype NM, DT, DTM, SI and TM, the value of the element should match the regular expression defined in the standard.
• DATA: The value of the element should match a constant specified in the profile, a value set specified in a table, a value or a regular expression specified in the message validation context.
• MESSAGE_VALIDATION_CONTEXT*: This is a user input error when the location specified in the message validation context can't be found in the message.
• TABLE_NOT_FOUND*: This is a user input when a table can't be found in the table files (TableProfileDocument).
• AMBIGUOUS_PROFILE*: The profile should not be ambiguous.
NIST V2 Testing Tools: PCD-01 and Rosetta relationship
(RTM Validation at the Device/Gateway Message Level)
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RTM Validation Sample Validation Context
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RTM Validation Sample Validation Context (Continued)
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NIST ToolingMedical Device Semantics
• Medical Device Semantic Database (Yet to come…)– To include semantic related information such as:
• Terminology based on Rosetta Terminology Mapping (RTM) – The “Harmonized” Rosetta Table.
• ISO/IEEE 11073-10101 Nomenclature• Device specializations (IHE-PCD Vol. 3 Content Profiles), PHD
104xx specializations –
– Will include terminology from RTM and from ISO/IEEE 11073-10101 Nomenclature entered by the user via ICSGenerator.
Medical Dev Semantic DB
Medical Dev Semantic DB
DeviceXML Profile
+ ICSs
RTMHarmonized(Terminology, UoM)
X73Nomenclature
(11073-10101)
NIST V2Test Scenario
+
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Meeting Topics/DiscussionXML Schema: Normative Addition to x73-DIM
• Standards development– NIST P11073-10202 DIM XML Schema (PAR)– X73-10202 Documentation
• No update since last IEEE/HL7 WG meeting– “ieee-11073-10202-d01a-2008-04-30-clean-jjg.doc”– “ieee-11073-10202-d01a-2008-04-30-deltas-jjg.doc”
• Call for reviewers and help with documentation
– Needs• Validation and Verification of XML Schema
(currently only through tooling)• V & V is ongoing
– As ICSGenerator is further enhanced and developed– As RTM work comes to fruition and is incorporated into tooling– As IHE-PCD model device specializations (content profiles – in
Technical Framework Volume III)– As PHD WG approves PHD devices and models (validating -
20601 and 104xx [as tied to Nomenclature – 10101 and DIM – 10201])
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Thank You!
• Questions/Discussion
• Thank you!
• www.nist.gov/medicaldevices• http://hl7v2tools.nist.gov/
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Rosetta Terminology ServiceF2F Agenda Item
• RTM “Management Service”– Proposed Service– Proposed Steps to implement– Use Case– UML System Model– Package Diagram– Entity Relationship Diagram– Task List and Proposed Project Plan
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NIST Tooling To Support RTM Process Proposed “RTM Management Service”
• The tool will be a web application to allow vendors and reviewers access, retrieval, and reporting of Rosetta Tables over the internet in conformance to RTM.
- Addresses RTM requirement : “Any corrections or additions will be reflected back in the vendor’s table and a new version of the merged table (and XML files) will be created.
• The tool will provide the capability of saving information in XML format as defined by RTM proposal
• The tool will provide the capability to apply XSLT transformations specified by the RTM proposal to harmonize the tables
– Merge individual vendor table(s) into a single table.• Provide a report identifying differences
– RTM example: “Create a list of the MDC reference identifiers and the vendors that select it, and MDC identifiers that were selected by only a single vendor --would be examined and compared with similar terms”.
• Provide a report identifying missing or new terms (no mapping).- RTM requirement: “Any missing or new MDC reference identifiers
will be submitted to the appropriate standards group to create and add the new terms to the relevant standard”.
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“RTM Management Service” Proposed Steps
• Database/XML Service initially prototyped and located at NIST
• Once there’s a road: Migrate ‘protoype’ to ‘pilot’ application• Down the road: Migrate ‘pilot’ tool into a web service.• Further down the road: vetted ‘pilot’ system/functionality is
moved to SDO which becomes “owner” and “maintainer”
• A set of assertions extracted from RTM will be used to make sure we take into consideration all normative requirements and to facilitate the tool development process.
NOTE: The final merged table will be used as basis for testing ICSGenerator, ValidatePDU and NIST V2 Testing Tool
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RTM Management SystemUse Case
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RTM UML Model
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RTM Packages
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RTM Database Entity Relationship
Diagram
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RTM Management SystemProposed Project Plan: ~2.5 months
• Create and populate database • Get data from “Rosetta” excel document
– Extract data for each vendor– Populate all tables
• View vendors, “Rosetta” or “Harmonized-Rosetta” tables• Edit/add vendor data
– Display possible group values– Display possible reference ids– Display possible units– Verify mandatory information has been supplied
• Add comments to “Rosetta” by reviewers – Display time of comment and name of the user– Update vendor table
• Save data – Vendor data and update “Rosetta”– Save “Rosetta” and update vendor data
• Download XML “Rosetta” and xml Harmonized-”Rosetta”– Generate XML form database
• Generate harmonized “Rosetta”– Highlight conflicts in “Rosetta” (verify that a reference id is always
associated to one term code, verify that mandatory fields are filled, etc...)
– If no conflicts detected generate harmonized “Rosetta”
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Thank You!
• Questions/Discussion
• Thank you!
• www.nist.gov/medicaldevices