OpenICE. Prepared for May 2014 IEEE 11073/HL7 Dev WG Meeting Phoenix, Az By Tracy Rausch, CCE CEO DocBox Inc

Transcription

1 OpenICE Prepared for May 2014 IEEE 11073/HL7 Dev WG Meeting Phoenix, Az By Tracy Rausch, CCE CEO DocBox Inc

2 Agenda What is OpenICE? Components of OpenICE What are the status of the components? Deep Dive of proposed IDL

3 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

4 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.

5 Components of OpenICE Clinical Scenario Repository Clinical Research Implementations Requirements Repository Regulatory Research MDFire Contract Language Reference Implementation And Open Source Code/Tools Commercially Available Products Risk and Hazard Analysis Validation & Verification Tools and Test Environment

6 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.

7 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.

8 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.

9 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.

10 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)

11 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.

12 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)

13 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

14 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

15 Commercial OpenICE Deployments Q3 of 2014 DocBox in MGH Q OpenICE Medanta the Medicity ICU Q OpenICE Deployments over 48 months in 14,000 beds. Remaining 1250 beds at Medanta 5 countries with hospital footprints 32 countries with affiliates

16 Reference Implementation And Open Source Code/Tools 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

17 Reference Implementation And Open Source Code/Tools mdpnp.sourceforge.net Current Testing of Code with Future Release Dates Research Partners and lab Implementing IDL using 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

18 ICE IDL

19 Functional Elements of the Integrated Clinical Environment ASTM standard F Published January 2010 Clinician Integrated Clinical Environment (ICE) ICE Supervisor External Interface Network Controller Data Logger ICE Interface Medical Device ICE Interface Other Equipment Patient

20 Data-centric Approach Medical App 1 Medical App 2 Medical App n DDS RTPS Bus EMR/Other IS Systems Device 1 Device 2 Device n

21 Data-centric Approach Medical App 1 Medical App 2 Medical App n Data Logger Supervisor ICE Controller DDS RTPS Bus External Interface EMR/Other IS Systems Device Interface Device 1 Device 2 Device n

22 Smart PCA System App Enterprise Lab Results Patient Demographics and History Conditions Medication Orders CDS Algorithm(s) Point of Care Observations Sensor Data Other Infusions Safety Interlock Clinician Other Devices PCA Pump (Actuator) Patient

23 Components Topics Definition IDL Interface Definition Language Syntax document QoS Policies Security Policies

24 DIM Patient Operator Location Alarm

25 DDS Characteristics Discovery Service Extensibility Types Final Extensible Mutable Time QoS Security

26 Systems Topics MDS identification MDS Identification request MDS Battery Topic Clock Topic

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28 Device Topics VMD Topic Channel Topic

29 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

30 Alarm Topics Information Signal Reminder Signal Physiological Alarm Signal Technical Alarm Signal Alarm Settings Set Alarm (Alarm Setting Request)

31 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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