1. ICE + DDS + 11073 Tracy Rausch, CCE CTO and Founder tracy@docboxinc.com 617.997.8375

2. Requirements from Providers Complete and Accurate Data Safe Systems Secure Systems Increased Efficiency – Clinical Workflow – Device and Systems Maintenance Improved Quality Flexible (Inpatient to Outpatient) Able to deal with new and legacy equipment Scalable Facilitation of decision support and data visualization

3. “Achieving higher quality care at lower cost will require fundamental commitments to the incentives, culture, and leadership that foster continuous "learning”, as the lessons from research and each care experience are systematically captured, assessed, and translated into reliable care.” -IOM 2013

4. Example Scenario 1: Patient Controlled Analgesia (PCA) 2-3 Patients per day in the US die from opiate overdose. Very little understanding of the cause Patient presses button to receive intravenous pain medication Patients can call to request more analgesia, but, cannot call for help when over-medicated. Over-medication can cause respiratory and cardiac arrest Comprehensive monitoring is not typically used due to high false/nuisance alarm rate How can we improve safety of this system?

5. Smart PCA System Patient Demographics and History Medication History Diagnosis Co- morbidities Orders Sensor Data Enterprise Point of Care CDS Algorithm(s) Observations Lab Results PCA Pump (Actuator) Other Infusions Other Devices Safety Interlock Clinician Patient

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

7. What is DDS? Mature International Standard from OMG – Platform neutral: OS and programming languages – Deployed worldwide – ~18 Implementations Originally developed for the US Navy Currently mandated – UK Generic Vehicle Architecture – DoD Information Technology Standards and Profile Registry (DESI) Mandates DDS for Pub-Sub API Mandates DDS-RTPS for Interop – Army, OSD Unmanned Vehicle Control Future Airborne Capability – US Navy Open Architecture Mandates DDS for Pub-Sub – Net-Centric Enterprise Solutions for Interoperability (SPAWAR NESI) Mandates DDS for Pub-Sub SOA

8. DDS Deployed Applications

9. Machine App 3 rd Party App CLOUD Enterprise Cloud Security Services Asset Services Real-Time Near Real-Time Heterogeneous Device to device SCADA Multiple Protocols Today: Batch/DB Analytics Future: real-time analytics Historian; store-and- forward Alarms recognized here Single data bus

10. DDS & Quality of Service (QoS) Aside from the actual data (WHAT) to be delivered users often need to specify (HOW) to send it….. – Reliably – How much data – How long before data is regarded as ‘stale’ – How may publishers of the same data is allowed – How to ‘failover’ if an existing publisher stops sending data – How to detect “dead” applications Options are controlled by formally-defined QoS policies DocBox Proprietary 2012

11. QoS QoS is determined per-entity QoS Contract: Request-Offered Publishing and subscribing applications can be notified when QoS contract is violated High availability via automatic failover DocBox Proprietary 2012

12. Features Ability Isolate subsystems Built in discovery service Mechanism to detect entities Data Durability Monitoring of Application Health Monitors Health of data-objects – Deadlines and lifespans Ensures reliable data delivery Built in QoS Built in Security (2013)

13. DDS Entities Domain: World you’re talking about Topic: Group of Similar Objects Similar structures (“type”) Similar way they change over time (“Qos”) Instance: Individual object Datawriter: source of observations about a set of data-objects DataReader: observer of a set of data-objects (Topic)

14. OMG DDS & IEEE 11073 X73 DIM Data Objects DDS Topic IEEE 11073 Components OMG DDS X73 DIM Data Object Attribute Groups DDS IDL Syntax X73 Nomenclature + Other DDS IDL Nomenclature Numeric Sample Array RT Patient Metric Observed Value - Numeric Context Attribute Group (Static + Dynamic) Physiological Parameters in 11073 + SNOMED CT

15. OMG DDS + IEEE 11073 + ASTM F2761 X73 DIM Data Objects DDS Topic IEEE 11073 Components OMG DDS X73 DIM Data Object Attribute Groups DDS IDL Syntax X73 Nomenclature + Other DDS IDL Nomenclature ASTM F2761 Supervisor Functionality Controller Data Logger External Interface

16. ASTM F2761 Functionality Supervisory Functions: Patient Identity Management Provider Identity Management Systems Health Monitoring Interaction Checking Device Management Hosting of CDS Apps Hosting of CLC Apps QoS Monitoring Data Logging Forensic playback

17. PCA Example Data Bus Supervisory Services Patient Mgmt Device Mgmt Systems Health Interaction Checking Logging CDS Algorithm #1 Lab Data SPO 2 CO 2 Patient Hx Infusion Pump Settings IV Pump Control Infusion Pump Measured Values

18. ICU Bedside System of System Data Bus ICE Supervisory Services Patient Mgmt Device Mgmt Systems Health Interaction Checking Logging CDS Algorithm #1 Lab Data SPO 2 CO 2 Infusion Pump Settings IV Pump Control Infusion Pump Measured Values CDS Algorithm #2 CDS Algorithm #n

19. Components for Interoperable System Define IDL Syntax – Starting with Medical Package – Starting with 11073 – IDL’s are extensible therefore backward compatible Define Standard Topics – Starting 11073 Data Objects Define Standard Semantics – Starting with 11073 – Also utilize LOINc and SnoMedCT

20. Distributed System CDS Apps can be located physically anywhere as long as they publish and subscribe to the BUS and follow the rules. Supervisor Services can be located physically anywhere as long as they publish and subscribe to the BUS CDS Apps act as if they are “virtual medical systems”

21. What is needed to be defined Supervisory Services (ICE) IDL Quality of Service Profiles – These could be completely customized but initially guidance profiles should be determined. Security Profiles Safety Nomenclature and Objects to be Developed Data Fusion Alert Nomenclature Quality of Service Nomenclature

22. Questions??? Funding Provided by USAMMRC Integrating Clinical Technology for Military Health (JPC-1 W81XWH-13-C-0107) NIH NIBIB U01 The Healthcare Intranet of the Future

23. 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