Multi-parameter Vital Signs Monitors - Interoperability and Communication Standards

1. Multi-parameter Vital Signs Monitors
Interoperability and Communication
Standards
Everton Luís Berz, PhD
everton.berz@gmail.com
August /2015

2. Organizations
• Health Level Seven International (HL7)
• ANSI-affiliated organization
• HL7 domain is clinical and administrative data
• Founded in 1987
• Provides interoperability standards in order to improve healthcare systems, optimize
dataflows, reduce ambiguities and enhance the data exchange
• Integrating the Healthcare Enterprise (IHE)
• Healhcare professionals effort
• Promotes the coordinate use of established standards such as DICOM and HL7
• Provides interoperability specifications, tools and services
• Founded in 1998
• All documents, specifications and e-mails are freely available on the IHE website
• There are annual fees for member organizations. Members can submit equipment to tests
and standards check.
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3. HL7 vs IHE
• HL7 provides vocabulary and
basic grammar to the integration
language
• IHE Technical Frameworks
organize these elements,
providing the most relevant
standards, decreasing confusion
and ambiguity
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4. IHE :: Specifications
• IHE Domains
• IHE is organized by clinical and operational domains
• Cardiology, odontology, ophthalmology, laboratory, patient care coordination, patient
care device, TI infrastructure, radiology, …
• Each domain has one or more Integration Profiles
• IHE Integration Profiles
• Provide a standards-based framework for sharing information within care
sites and across networks
• IHE Profiles are compiled into IHE Technical Frameworks-detailed technical
documents that serve as implementation guides and Technical Frameworks
freely available online
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5. IHE :: IT Infrastructure Domain (ITI)
• Most equipment must cover some IT Infrastructure profiles, for
instance:
• Consistent Time (CT)
• Defines mechanisms to synchronize the time base between multiple actors and
computers (NTP)
• Patient Administration Management (PAM)
• Establishes the continuity and integrity of patient data, and additional information such
as related persons (primary caregiver, guarantor, next of kin, etc.)
• …
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6. IHE :: Domain and Profiles for Vital Signs
Monitors
• Domain: Patient Care Device (PCD)
• Released in 2005
• Address the integration of medical devices into the healthcare enterprise, from
the point-of-care to the EHR
• PCD Integration Profiles for Vital Signs Monitors
• [DEC] Device Enterprise Communication
• [POI] Pulse Oximetry Integration
• [ACM] Alert Communication Management
• [WCM] Waveform Communication Management
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7. IHE :: PCD Profiles
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8. IHE :: Integration Profiles PCD
• [DEC] Device Enterprise Communication
• Supports publication of information acquired from point-of-care medical devices to applications such as
clinical information systems and electronic health record systems, using a consistent messaging format
and device semantic content
• [POI] Pulse Oximetry Integration
• Specifies how implementers could use the existing DEC and PCD-01 transaction to exchange pulse
oximetry observation sets with clinical information systems
• [ACM] Alert Communication Management
• Enables the remote communication of point-of-care medical device alert conditions ensuring the right
alert with the right priority to the right individuals with the right content
• [WCM] Waveform Communication Management (under development)
• Extend the [DEC] profile to provide a method for passing near real-time waveform data using HL7 v2
observation messages
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9. IHE :: Integration Profiles PCD
• Pulse oximetry is the only device that has a specific profile [POI]
• Other devices must comply DEC requirements (PCD, vol. 3, section 7.3)
• Glucometer semantic table was not found, only the ISO document
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10. IHE :: Profile DEC :: Actors
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11. IHE :: DEC Profile :: Trigger events
• Can be sent with or without a preceding order
• While a DOR Actor may be implemented directly on a medical device,
it is more often implemented on a gateway or intermediary device as
an application which implements the DOR, receiving data from one or
more patient care devices
• Trigger interval: several times per minute, typical interval of 1 minute
• The minimum and maximum intervals are configured at implementation
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12. Comercial Vital Signs Monitors with
IHE+PCD+DEC+DOR profiles
COMPANY SYSTEM SYSTEM TYPE
PCD
PROFIL
ES
ACTORS ITI PROFILES Email Name
Philips Healthcare IntelliBridge Enterprise
Philips
SureSigns VS
Monitor with
Gateway
DEC DOR CT john.rhoads@philips.comJohn Rhoads
SunTech Medical, Inc. VitalShare
Vital Signs
Device
Interface
DEC DOR CT, PDQ
klupino@suntechmed.co
m
Kent Lupino
July, 2015.
There are other 27 devices, mostly gateways that translate proprietary structures and
protocols to IHE/HL7 standards
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13. HL7 :: Versions
• v2 (1990)
• Most popular version, used by IHE profiles
• Minor versions: 2.1, 2.2, 2.3, 2.3.1, 2.4, 2.5, 2.5.1, 2.6
• Some minor versions are mutually incompatible (for instance: 2.5.1 and 2.3)
• v3 (2006)
• XML as message format
• FHIR - Fast Healthcare Interoperable Resources (2012)
• Specification for exchanging healthcare data in a modern and developer
friendly way
HTTP based RESTful protocol
• Most recent (under development)
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14. HL7 :: Message format
• HL7 v2 – ER7
• Most popular format
• Used since the first HL7 version
• Multi-line and pipe as field separator
• HL7 v2 – XML
• Not widely used
• “Direct” conversion from ER7 to well-
structured format
• HL7 v3 – XML
• Many details and validations
• Largest message size
• FHIR – JSON or XML
Incompatible
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15. Example of HL7 v2 EL7 message - Glucose
MSH: Message Header
PID: Patient Identification
OBR: Observation Request
OBX: Observation Result
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16. Network protocols
• MLLP (Minimum Lower Layer Protocol) [HL7/IHE]
• Traditional way with TCP sockets, used since the HL7 launch
• Used in HL7 v2 as well as HL7 v3
• SOAP-WebServices [IHE]
• Released circa 2011, not widely used
• ER7 format encapsulated in a XML SOAP. IHE provides WSDL, XML schema, etc.
• IHE DEC profile suggests MLLP or WebServices (PCD Vol 2 Appendix I e J)
• ebXML (Electronic Business Extensible Markup Language) [HL7]
• SOAP based, but HL7 v2/v3 are converted to “ebXML” format
• HL7 over HTTP [HAPI]
• Launched in ~2012, not so popular
• HL7 over HTTP is an initiative to provide a standardized transport mechanism to send HL7 v2 messages
over a network using the HTTP protocol
• HTTP resources can be used (criptography, authentication, etc), therefore some overhead must be
taken into account
• HL7 FHIR HTTP (REST) [HL7]
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17. HAPI (HL7 application programming interface)
• Open-source, object-oriented HL7 2.x parser for Java
• Not affiliated with the HL7 organization
• Java API
• Full featured Java API you can use to add HL7 capabilities to your applications
• TestPanel 
• Full featured HL7 message editor, transmitter and receiver
• HAPI-FHIR
• Open-source implementation of the FHIR specification in Java
• HAPI ignores HL7 v3
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18. Example of systems architecture – HL7 integration
Middleware
Hospital Management Software
EHR (Electronic Health Record)
Multi-parameter
vital signs monitor
HL7 v3
XML
FHIR
(JSON/XML)
Hospital Management Software
EHR (Electronic Health Record)
Other
interoperability
standards
Communication protocol
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19. References
• Health Level Seven International (HL7), 2015. [Online]. Available: http://hl7.org/
• Integrating the Healthcare Enterprise (IHE), 2015. [Online]. Available: http://www.ihe.net/
• Integrating the Healthcare Enterprise (IHE), “IHE Domains,” 2015. [Online]. Available: http://www.ihe.net/IHE_Domains/
• Integrating the Healthcare Enterprise (IHE), “IHE Technical Frameworks,” 2015. [Online]. Available:
http://www.ihe.net/Technical_Frameworks/
• P. R. Sherman, “PCD's Commercially Available list,” 07 2015. [Online]. Available:
https://groups.google.com/forum/#!topic/ihepcdtech/TmeWLdxtf8Q
• HL7 Analyst, 2011. [Online]. Available: https://hl7analyst.codeplex.com/
• National Institute of Standards and Technology (NIST), “HL7 Tools,” 2015. [Online]. Available: http://hl7v2tools.nist.gov/
• HAPI, 2015. [Online]. Available: http://hl7api.sourceforge.net/
• University Health Network, 2015. [Online]. Available: http://www.uhn.ca/
• HAPI-FHIR, 2015. [Online]. Available: http://jamesagnew.github.io/hapi-fhir/index.html
• M. C, “SmartHL7,” 2011. [Online]. Available: http://smarthl7.com/
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20. Multi-parametric Vistal Signs Monitors
Interoperability and Communication
Standards
Everton Luís Berz, PhD
everton.berz@gmail.com
August /2015