Soft
ware
an
d S
yste
ms D
ivis
ion
ISO/IEEE 11073, IHE-PCD, PHD and NIST
Medical Device CommunicationMedical Device CommunicationTest EffortTest Effort
HL7/IEEE WG Meetings (Vancouver, British Columbia, Canada)
17-18 September 2008
Soft
ware
an
d S
yste
ms D
ivis
ion
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
Soft
ware
an
d S
yste
ms D
ivis
ion
Meeting Topics/Discussion
• NIST Tooling– IHE-PCD Profile/Message Validation– NIST V2 Validation Tools– ICSGenerator
• Supporting IHE-PCD• Enhancements for X73-20601 and 104xx
• RTM Management Service– Use Case– UML System Model, and Package diagram
• Standards development– NIST P11073-10202 DIM XSchema (PAR)– PAR Project Plan Update– X73-10202 Documentation– Needs
• Validation and Verification (currently only through tooling)
• http://www.nist.gov/medicaldevices
Soft
ware
an
d S
yste
ms D
ivis
ion
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- 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.
Soft
ware
an
d S
yste
ms D
ivis
ion
NIST V2 Testing Tools IHE-PCD: PCD-01
NIST V2 Testing tools(MessageValidator)
PCD-01 HL7 V2 msg.
Validation Report
PCD-01 HL7 V2 Assertions
(XML)(validation context)
HL7Profile
(XML)MSH,PID,PV1,OBR,NTE,{OBX},OBX,OBX,OBX,
…
Medical Dev Semantic DB
Medical Dev Semantic DB
Soft
ware
an
d S
yste
ms D
ivis
ion
• 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…
NIST Testing Tools Validating IHE-PCD Transactions
(messages)What’s Needed?
Soft
ware
an
d S
yste
ms D
ivis
ion
IHE-PCD MWB: HL7 V2.5 PCD-01 Profile
Soft
ware
an
d S
yste
ms D
ivis
ion
• Validation performed at the HL7 profile level• 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 V2 Tooling does not provide the capability of conditional validation (e.g., validating that a REF_ID has the proper unit associated to it.)
NIST Testing Tools Validating IHE-PCD Transactions
(messages)What is and is NOT validated?
Soft
ware
an
d S
yste
ms D
ivis
ion
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)
Soft
ware
an
d S
yste
ms D
ivis
ion
RTM Validation Sample Validation Context
Soft
ware
an
d S
yste
ms D
ivis
ion
RTM Validation Sample Validation Context (Continued)
Soft
ware
an
d S
yste
ms D
ivis
ion
ICSGenerator Supporting IHE-PCD; PCD-01
(<MDS><VMD><CHAN><METRIC>)
X73 GENERAL DEFINITION(Vol. II)
ICSGenerator
PCD-01Vol II
MDS
VMD
CHAN CHAN
NUM NUM ENUM NUM
(SPECIALIZED DEVICE)Vol III, static document
Medical Dev Semantic
DB
Medical Dev Semantic
DB
DeviceXML Profile
+ ICSs
Soft
ware
an
d S
yste
ms D
ivis
ion
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)
Soft
ware
an
d S
yste
ms D
ivis
ion
Meeting Topics/DiscussionXML Schema: Normative Addition to x73-DIM
• Standards development– NIST P11073-10202 DIM XML Schema (PAR)– PAR Project Plan Update
• “x73.10202_9_12_08.mpp”
– X73-10202 Documentation• No update since last 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])
Soft
ware
an
d S
yste
ms D
ivis
ion
Thank You!
• Questions/Discussion
• Thank you!
• www.nist.gov/medicaldevices
Soft
ware
an
d S
yste
ms D
ivis
ion
Meeting Topic/Discussion
• RTM “Management Service”– Proposed Service– Proposed Steps to implement– Use Case– UML System Model– Package Diagram– Entity Relationship Diagram
Soft
ware
an
d S
yste
ms D
ivis
ion
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”.
Soft
ware
an
d S
yste
ms D
ivis
ion
“RTM Management Service” Proposed Steps
• Database/XML Service initially prototyped and located at NIST
• Once there’s a road: Migrate ‘protoype’ to ‘pilot’• Down the road: Migrate ‘pilot’ the 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
Soft
ware
an
d S
yste
ms D
ivis
ion
RTM Management SystemUse Case
Soft
ware
an
d S
yste
ms D
ivis
ion
RTM UML Model
Soft
ware
an
d S
yste
ms D
ivis
ion
RTM Packages
Soft
ware
an
d S
yste
ms D
ivis
ion
RTM Database Entity Relationship
Diagram
Soft
ware
an
d S
yste
ms D
ivis
ion
Thank You!
• Questions/Discussion
• Thank you!
• www.nist.gov/medicaldevices
Soft
ware
an
d S
yste
ms D
ivis
ion
ISO/IEEE 11073, PHD WG and NIST Medical Device CommunicationMedical Device Communication
Test EffortTest Effort
September 18 2008
Soft
ware
an
d S
yste
ms D
ivis
ion
Leveraging NIST Tools For PHD
X73 DIM(IEEE 11073-10201)
ICSGenerator
DIM XSchema
PHD-DIM(IEEE-11073-20601)
PHD XSchema.
DIM XML config.
PHD XML
config.
ValidatePDU
X73-104xx
XMl config.X73-104xx
XMl config.X73-104xx XML config.
X73-104xx
XSchematron.
PHD-DIM(IEEE-11073-104xx)
Device SpecializationsDevice
SpecializationsDevice Specializations
ICS’sICS’s
ICS’s
Soft
ware
an
d S
yste
ms D
ivis
ion
ICSGenerator, DIM XSchema and PHD-DIM PHD XSchema
• A PHD-DIM XSchema has been developed to represent the IEEE P11073 20601 standard.
• The PHD XSchema adopts the DIM XSchema architecture and reuses some of it components, when applicable.– DIM_Data_Type.xsd containing classic x73 ASN.1 definition
included and redefined, when appropriate.
Soft
ware
an
d S
yste
ms D
ivis
ion
PHD_DIM XSchema
PHD_MOC_Defs.xsd
PHD_MOC_Attr_Behav_Notif.xsd
PHD_Data_Types.xsd
(http://www.obj.sys.com/v1.0/XMLSchema)
asn1.xsd
(http://www.nist.gov/x73DIM)
PHD_DIM.xsd
include import
DIM_Data_Types.xsdPHD_Import.xsd
Enumerations_Bases.xsd
redefine
Qual_Bases.xsd
Soft
ware
an
d S
yste
ms D
ivis
ion
ICSGenerator, DIM XSchema and PHD-DIM ICSGenerator Enhancements
• Ability to model X73-PHD 104xx device specializations.• Added interface for dynamic ICS update.• New validation tab to show validation errors and ability to
update the validation reports at any time.• Ability to import a default configuration file from the context
menu of the tree.• Improved comparison capability to support agent to manager
and device to device comparison types. – Agent -> Manager : compares the data model objects for
interoperability purposes.– Device -> Device : compares supported features.
Soft
ware
an
d S
yste
ms D
ivis
ion
ICSGenerator, DIM XSchema and PHD-DIM Validating 104xx Specializations
• A 104xx device specialization configuration file is created using the IEEE P11073-104xx specialization document.– XMLSPY is used to capture attribute, behavior and notification
information in an xml file (partial configuration file).– Merges the xml “partial configuration” file with the IEEE
P11073-20601 configuration file using an in-house program to get the final configuration file for 104xx specialization.
• The merge adds missing information such as datatypes, term codes, object, attribute, behavior and notification ids.
• The newly created P11073-104xx specialization file is validated when the file is loaded into the ICSGenerator tool.– Validation is performed against the IEEE P11073-20601
XSchema and will identify any inconsistencies mostly related to objects, attribute, behavior and notification information.
Soft
ware
an
d S
yste
ms D
ivis
ion
ICSGenerator, DIM XSchema and PHD-DIMSpecialization Profiles
Soft
ware
an
d S
yste
ms D
ivis
ion
ICSGenerator, DIM XSchema and PHD-DIMX73-10441
(Cardiovascular fitness and activity monitor)
Soft
ware
an
d S
yste
ms D
ivis
ion
ICSGenerator, DIM XSchema and PHD-DIM X73-10441
(Cardiovascular fitness and activity monitor)
Soft
ware
an
d S
yste
ms D
ivis
ion
ICSGenerator, DIM XSchema and PHD-DIMX73-10441
(Cardiovascular fitness and activity monitor)
Soft
ware
an
d S
yste
ms D
ivis
ion
ICSGenerator, DIM XSchema and PHD-DIM X73-10404 (Pulse Oximeter)
Soft
ware
an
d S
yste
ms D
ivis
ion
ICSGenerator, DIM XSchema and PHD-DIM X73-10415 (Weighing Scale)
Soft
ware
an
d S
yste
ms D
ivis
ion
ValidatePDU 2.0 and PHD-DIM
• Current version of ValidatePDU validation – Validates APDU syntax against X73 DIM specifications and the
X73 Application Profiles – Base Standard and – Validates APDU semantic/content against device profile.
• ValidatePDU must be enhanced to support IEEE P11073-20601 specification:– Incorporate new and modified PHD data types.– Extract assertions from the PHD specifications.– Develop code to properly validate and parse PHD messages.
Soft
ware
an
d S
yste
ms D
ivis
ion
Next Steps
• Work with Vendors/WGs to validate and verify ICSGenerator Tool and XSchema
• Enhance ValidatePDU to validate PHD type messages.• Obtain X73 APDUs (from Doug’s simulation tool?) to validate
coding (encoding/decoding) of the NIST tool
Soft
ware
an
d S
yste
ms D
ivis
ion
Thank You!
• Questions/Discussion
• Thank you!
• www.nist.gov/medicaldevices
