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
ICE = Integrated Clinical Environment OpenICE TM Bitly.com/open_ice • 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 • OpenICE TM 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.
Components of OpenICE Clinical Scenario Repository Requirements Clinical Research Repository Implementations Regulatory Research Reference Implementation And Open Source Code/Tools MDFire Contract Language Validation & Verification Tools Commercially and Test Available Environment Risk and Hazard Products Analysis
Clinical Scenario Repository 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.
Requirements Repository Clinical Scenario Repository Repository of Clinical, and System Requirements derived from clinical needs. Status: Initial requirements uploaded and implemented in Beta with research partners.
“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.
Validation & Verification Tools and Test Environment 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)
Risk and Hazard Analysis 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.
MDFire Contract Language 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)
Regulatory Research 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
Clinical Research Implementations 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
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 Reference Implementation Implementation And Open Source Code/Tools 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 mdpnp.sourceforge.net 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
ICE IDL
Functional Elements of the Integrated Clinical Environment Functional Elements of the Integrated Clinical Environment ASTM standard F2761-2009 Published January 2010 Clinician Integrated Clinical Environment (ICE) ICE Supervisor External Network Data Interface Controller Logger ICE Interface ICE Interface Medical Device Other Equipment Patient
Data-centric Approach Medical Medical Medical App 2 App n App 1 DDS RTPS Bus Device n Device 1 Device 2 EMR/Other IS Systems
Data-centric Approach Medical Medical Medical Data Logger App 1 App 2 App n Supervisor ICE Controller DDS RTPS Bus Device Interface External Interface Device n Device 1 Device 2 EMR/Other IS Systems
Smart PCA System App Enterprise Patient Lab Medication Conditions Orders Demographics Results and History CDS Algorithm(s) Point of Care Observations Sensor Data Other Infusions Safety Interlock Other PCA Pump Devices (Actuator) 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
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