1. Interoperabilität von patientennahen Medizingeräten openSDC Update Joint meeting of IEEE EMBS 11073 & HL7 Health Care Devices (DEV) WG, 2014/05/27, Stefan Schlichting

2. openSDC Update Agenda 1.openSDC Update 2.Convergence Project 3.Standardization Roadmap An architecture for distributed systems of medical devices in high acuity environments2 |

3. openSDC update History An architecture for distributed systems of medical devices in high acuity environments3 | Last WG Meeting we proposed “an architecture for distributed systems of medical devices in high acuity environments” for standards adoption.

4. openSDC update What is openSDC? Extensible openSDC protocol stack for clinical workplace service-oriented medical device architectures BICEPS (Message & Service Model) MDPWS & DPWS (Transport) An architecture for distributed systems of medical devices in high acuity environments4 |

5. openSDC update openSDC Reference Implementation openSDC downloads since January WG Meeting New Version beta03 will be out end of Q2/2014 See http://sourceforge.net/projects/opensdc/ An architecture for distributed systems of medical devices in high acuity environments5 |

6. openSDC update BICEPS changes since last WG Meeting Update of the BICEPS model V2 Get closer to the classic DIM Incorporate change request from OR.NET Bug fixes The BICEPS model V3 will be published in openSDC beta03. Expect a BICEPS V3.1 in Q3/2014 (openSDC beta04) Optimized representation of the transmitted messages An architecture for distributed systems of medical devices in high acuity environments6 |

7. openSDC Update Agenda 1.openSDC Update 2.Convergence Project 3.Standardization Roadmap An architecture for distributed systems of medical devices in high acuity environments7 |

8. Convergence Project Summary of the convergence project An architecture for distributed systems of medical devices in high acuity environments8 |

9. Convergence Project Use Cases An architecture for distributed systems of medical devices in high acuity environments9 |

10. Convergence Project What is Common? Example for Discovery openSDC may use DNS, but only with the focus of name resolution. An architecture for distributed systems of medical devices in high acuity environments10 | Discussed Discovery Security: IPSec vs TLS/DTLS QoS for Transport: IntServ vs DiffServ

11. Convergence Project Harmonization potential Convergence vs. Coexistence? An architecture for distributed systems of medical devices in high acuity environments11 |

12. Convergence Project Coexistence - Multi-protocol Gateway model Medical Device Standards-based Clinical “Ecosystem” (aka Clinical Gateway) integrating an IEEE 11073 Mgr-Agt pair with a BICEPS-based Proxy-Supervisor pair. An architecture for distributed systems of medical devices in high acuity environments12 | Common MDIB

13. Convergence Project Coexistence - Multi-protocol Gateway model BICEPS Clinical Gateway part An architecture for distributed systems of medical devices in high acuity environments13 | Common MDIB BUS-API BICEPS Supervisor ProxyBICEPS Supervisor

14. Convergence Project Common MDIB - Alert models An architecture for distributed systems of medical devices in high acuity environments14 | 11073 Alert Package modelBICEPS model

15. AlertSystem Detects AlertConditions and - as appropriate - generates AlertSignals. ALARM SYSTEM (From 60601-1-8) parts of ME EQUIPMENT or a ME SYSTEM that detect ALARM CONDITIONS and, as appropriate, generate ALARM SIGNALS An architecture for distributed systems of medical devices in high acuity environments15 |

16. Convergence Project Common MDIB – Alert Models An architecture for distributed systems of medical devices in high acuity environments16 | AlertCondition Contains the information about a potentially or actually hazardous situation. Example: An AlertLimit has been exceeded, or a Sensor has been unplugged. LimitAlertCondition is derived from AlertCondition ALARM CONDITION (From 60601-1-8) state of the ALARM SYSTEM when it has determined that a potential or actual HAZARD exists

17. Convergence Project Common MDIB – Alert Models An architecture for distributed systems of medical devices in high acuity environments17 | AlertSignal Contains information about the way an AlertCondition is communicated to someone. It is generated by an AlertSystem to indicate the presence or occurence of an AlertCondition. ALARM SIGNAL (From 60601-1-8) type of signal generated by the ALARM SYSTEM to indicate the presence (or occurrence) of an ALARM CONDITION

18. Convergence Project Common MDIB – Alert Models An architecture for distributed systems of medical devices in high acuity environments18 | AlertSignal Example AlertSignal could be a lamp (-> Visible Manifestation) on a remote device, such as the nurses handheld (-> SignalDelegationSupported), which starts flashing when the heart rate is exceeding 150bmp (-> ConditionSignaled) for more than 2 seconds (-> DefaultSignalGenerationDelay) and keeps flashing, until the nurse confirms the alarm, even if the AlarmCondition is not present anymore (-> Latching).

19. Convergence Project Common MDIB – Alert Models AlertStates for AlertSystem AlertCondition AlertSignal Alert Processing In order to retrieve the overall alert state of an MDS, a client has to subscribe to all AlertSystems. An AlertCondition has a rank that represents the overall rank of the Alarm Condition in the MDS. An AlertSignal has a slot that represents the overall ordering number of the signal in the MDS. In order to retrieve the overall alert condition state of an MDS, a client has to subscribe to all AlertConditions. In order to retrieve the overall alert signal state of an MDS including remote signals, a client has to subscribe to all AlertSignals. An architecture for distributed systems of medical devices in high acuity environments19 |

20. Convergence Project Summary http://mdcx73-working.wikispaces.com/MDCx73_UseCases-UCs An architecture for distributed systems of medical devices in high acuity environments20 | Stefan’s View Clinical Gateway seems feasible incl. a common MDIB. Only limited value for a real “converged” network specification NTP is essential even for a Clinical Gateway Security Infrastructure including role model should be harmonized Common Requirements Glossary + recommendations for Transport QoS, Security,.. based on UC More Info

21. openSDC Update Agenda 1.openSDC Update 2.Convergence Project 3.Standardization Roadmap An architecture for distributed systems of medical devices in high acuity environments21 |

22. Standardization Roadmap OR.NET project An architecture for distributed systems of medical devices in high acuity environments22 | OR.NET Partners http://www.ornet.org/

23. Standardization Roadmap OR.NET project An architecture for distributed systems of medical devices in high acuity environments23 | Source: http://ws4d.e-technik.uni-rostock.de/2014/or-net-and-ws4d-org-at-cebit- 2014/

24. Standardization Roadmap openSDC & OR.NET Summary of a telco in April The OR.NET standardization project & Dräger closely work together to publish a technical specification for a service-oriented architecture implementation for a distributed system of medical devices in the OR and related areas. The technical specification for medical device communication should be published under the umbrella of IEEE 11073. The technical specification is based on “openSDC” & OR.NET work An architecture for distributed systems of medical devices in high acuity environments24 |

25. Device Connectivity OR Workstation Medical Devices OR table Light srcs Navigation Tracking Imaging HF dissector Insufflator Endos. Cams Media Ctrl Standardization Roadmap OR.NET project – Protocol View IT (EHR, PDMS,…) Device 2 Enterprise (HL7, DICOM,…) According to J. Dehm (OR.NET – Standardization)

26. Standardization Roadmap An architecture for distributed systems of medical devices in high acuity environments26 | openSDC/OR.NET Technical Specification Nomenclature Additions Device Specializations Clinical Gateway Spec ICE Implementation Guide MDPWS + BICEPS Spec 2012 MDPWS + BICEPS Spec 2014

27. Thank you for your attention. Contact Dr. Stefan Schlichting Research Unit, Drägerwerk AG stefan.schlichting@draeger.com

28. Use case discussion with MDPnP Follow-up discussion on the HIMSS 2014 An architecture for distributed systems of medical devices in high acuity environments28 |