11073 dim and ice · – pre-clinical test implementations for clinical and research deployments...
TRANSCRIPT
OpenICE
Prepared for May 2014 IEEE 11073/HL7 Dev WG Meeting Phoenix, Az
By Tracy Rausch, CCE CEO DocBox Inc
Agenda
• What is OpenICE? • Components of OpenICE • What are the status of the components? • Deep Dive of proposed IDL
OpenICE
The development and implementation of open, safe and effective interoperable systems, based on clinical requirements, creating evidence based improvements in clinical care. Work product developed beginning in 2004 with $20M+ in research funding from DoD, NIH, NIST, NSF, Industry and Private Foundation Funding. OpenICE under development since October 2012
OpenICETM
• OpenICE encompasses – Medical Device Interfaces – Patient Simulation – HIS Connectivity – Safety Assurance – Validation and testing – Regulatory Pathway – ICE Application eXchange (ICE AX)
• Med apps, device management
• Everything is open source • OpenICETM is a work in progress
– Now at an beta level of development – Currently useful for clinical and CS research,
prototyping, standards development/ref implementation, starting point for med device deployment, etc.
ICE = Integrated Clinical Environment Bitly.com/open_ice
Components of OpenICE
Clinical Scenario Repository
Requirements Repository
MDFire Contract Language
Reference Implementation
And Open Source
Code/Tools
Risk and Hazard Analysis
Clinical Research Implementations
Regulatory Research
Validation & Verification Tools
and Test Environment
Commercially Available Products
Clinical Scenario Repository
Repository for the documentation of scenarios and events which could be improved in healthcare. Status: initial repository developed transition to a community of Beta users.
Clinical Scenario Repository
Requirements Repository
Repository of Clinical, and System Requirements derived from clinical needs. Status: Initial requirements uploaded and implemented in Beta with research partners.
Clinical Scenario Repository
“Clinical” Requirements • Current State
– Clinical means clinician • Data used primarily for display, storage • Stored data considered “invalid” until clinician validation • Spurious data, out of order data, gaps in data filtered by human clinician • Reconnecting/power-cycling a system is “goto” strategy; systems must be
resilient to hostile human actors • Future State
– Must meet current state requirements! – In addition clinical means clinical application (algorithm)
• Data used as inputs for clinical algorithm. • Algorithm state must be direct outcome of actual data and not result of
transport (packet loss, delay, etc.) • Cooperating apps must have coherent view of system state to cooperate
safely. • Algorithm must rely on some validity/coherence of data inputs.
Clinical Requirements • SCR1: The ICE system shall be aware of the required frequency /
accuracy / reliability of the incoming data for each parameter based on clinical significance, and shall choose the closest available frequency / accuracy / reliability on the device and provide this information to the clinician for review.
• SCR2: If the device connected to the ICE system is not capable of providing the required frequency / accuracy / reliability of the incoming data for each parameter based on clinical significance, the ICE system shall choose the closest available frequency / accuracy / reliability on the device and provide this information to the clinician for review.
• SCR3: The ICE System shall notify users when it loses connectivity with any of its components.
V&V Tools and Test Environment • MDPnP Lab being developed as a test bed for interoperable
systems. – Hospital Systems Engineers to learn and educate themselves on
integration Requirements. – Pre-clinical test implementations for clinical and research
deployments – Interoperable Device V&V environment
• Status: – Partners Healthcare e-care implementation (in progress) – Medanta Healthcare (New Delhi, India) with hospitals in 5
countries in Africa, SE Asia, Europe and affialate hospitals in 32. – DocBox Partners Healthcare Clinical Research Platform
Implementation (in progress)
Validation & Verification Tools
and Test Environment
Risk and Hazard Analysis
• Research Platform • Apps related to PCA, OR to ICU Handoff, F2761
Scenarios • Status: In process, early releases of
information to AAMI/UL2800 Committees for use.
Risk and Hazard Analysis
Provider Contract Language
• Updates of MDFire in process • Current signatories include Kaiser, VA,
Partners Healthcare, Johns Hopkins Status: Adding additional HDOs as signatories. New more detailed version to be released date TBD (6 to 12 months)
MDFire Contract Language
Regulatory Research
To Develop a regulatory pathway for devices intended to be used as components of interoperable systems. • De Novo Submission of ICE System and
supplement submitted to FDA • DocBox Pre-submissions and FDA filings for
commercial platform to be released date TBD
Regulatory Research
Clinical Research Implementations • Open Source code distributed to clinical research
partners for research data collection for CDS Apps, Closed Loop Control Apps, and basis of research.
Status – Various hospital systems research groups have
implemented and providing feedback – Next 6 months more research partners are implementing
for clinical studies with a international presence – OpenICE team is gathering feedback from clinical
researchers on usability, functional and non-functional requirements
– Matlab DDS link with IDL July/August Release
Clinical Research Implementations
Commercial OpenICE Deployments
• Q3 of 2014 – DocBox in MGH • Q4 – 2014 OpenICE Medanta the Medicity ICU • Q1 – 2015 OpenICE Deployments over 48
months in 14,000 beds. – Remaining 1250 beds at Medanta – 5 countries with hospital footprints – 32 countries with affiliates
Reference Implementation and Open Source Code/Tools
• RTI DDS ICE community – Provides free licenses of RTI DDS under a research license
agreement • PrismTech Implementation also available in lab • DDS Compatibility shown at Smart American
Hackathon Event. • Publically released code on Source Forge
– Legacy Device Drivers and documentation – Initial IDL – Demo Apps
• Implementations in the lab and demos at conferences
Reference Implementation
And Open Source
Code/Tools
Current Testing of Code with Future Release Dates
– Research Partners and lab • Implementing IDL using 11073 DIM and Nomenclature* • DDS QoS profiles • Security Requirements (DoD/Govt and Commercial) • DDS Security Profile • External Interfaces to CHCS (DoD), VISTA, RDF, Hadoop
Databases • External Interface to Epic
Reference Implementation
And Open Source
Code/Tools mdpnp.sourceforge.net
ICE IDL
ICE Supervisor
Network Controller
ICE Interface
Data Logger
External Interface
Medical Device
ICE Interface
Other Equipment
Integrated Clinical Environment (ICE)
Functional Elements of the Integrated Clinical Environment ASTM standard F2761-2009 Published January 2010 Clinician
Functional Elements of the Integrated Clinical Environment
Patient
Data-centric Approach
Device 1 Device 2 Device n
Medical App 1
Medical App 2
Medical App n
EMR/Other IS Systems
DDS RTPS Bus
Data-centric Approach
Device 1 Device 2 Device n
Medical App 1
Medical App 2
Medical App n
EMR/Other IS Systems
DDS RTPS Bus
ICE Controller
External Interface
Device Interface
Supervisor
Data Logger
Smart PCA System App Patient
Demographics and History
Medication Conditions Orders
Sensor Data
Enterprise
Point of Care
CDS Algorithm(s)
Observations
Lab Results
PCA Pump (Actuator)
Other Infusions
Other Devices
Safety Interlock
Clinician
Patient
Components
• Topics Definition • IDL – Interface Definition Language
– Syntax document
• QoS Policies • Security Policies
DIM Patient
Operator
Location
Alarm
DDS Characteristics
Discovery Service Extensibility Types
– Final – Extensible – Mutable
Time QoS Security
Systems Topics
• MDS identification • MDS Identification request • MDS • Battery Topic • Clock Topic
Device Topics
• VMD Topic • Channel Topic
Metric Topics • Numeric, Real Time Sample Array, Time Sample Array,
Distribution Sample Array, Enumeration, • Metric types divided into 3 Topics measurements,
calculations and settings • i.e. Numeric Measurement , Numeric Setting, Real
Time Sample Array Setting • Metric Attributes in Observed Values and Context
(Static and Dynamic Attributes Combined) • i.e. Numeric Measurement Observed Value, Numeric
Measurement Context • Setting Request Topics
Alarm Topics
• Information Signal • Reminder Signal • Physiological Alarm Signal • Technical Alarm Signal • Alarm Settings • Set Alarm (Alarm Setting Request)
Other ICE Topics • Patient Demographics (HL-7) • Location (HL-7) • Operator (HL-7) • Allergy Intolerance (HL-7) • Medications (HL-7) • Conditions (HL-7)
• Lab • Clinical Assessments • Patient Consent