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Overview & Update HIMSS Webinar – 3 August

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1 Overview & Update HIMSS Webinar – 3 August
Todd Cooper, Breakthrough Solutions Foundry Ken Fuchs, Mindray North America Steve Merritt, Baystate Health John Rhoads, Philips Healthcare Patient Care Devices Overview & Update HIMSS Webinar – 3 August 1

2 IHE Patient Care Devices - Overview and Update
Devices and Interoperability Medical Devices - Not a Simple Problem!! IHE PCD – Overview IHE PCD – Profiles IHE PCD – Testing and Demonstrations Getting to Yes!! Questions & Answers 2

3 2009 – Obama vows to continue the HIT Plan begun by President Bush
President Barack Obama announces an audacious plan: Computerize all health records within five years. - January 12, 2009 February 17, 2009 – the American Reinvestment and Recovery Act (ARRA) is signed into law HITECH Act component of ARRA provides a $19 billion program to stimulate the adoption and use of HIT, with a focus on meaningful use of certified EHR-S

4 What about Device Connectivity? Download HITSP/TN905 @ www.HITSP.org

5 HITSP/TN905 Roadmap

6 Medical Device HIT: No longer a “nice to have”
The Dream! Heterogeneity Multiple manufacturers + multiple device & application modalities coexisting & interoperating over a shared infrastructure Enables… “Best of Breed” Selection Ability to base product acquisition on most appropriate technology without requiring HIT re-engineering. Semantic Comparability Harmonized semantics (terminology & models) enable next generation applications, incl. real-time CDSS. Comprehensive, Real-time Availability Timely health care decisions based on richer, more complete information. Medical Device HIT: No longer a “nice to have” 6

7 The Benefits! Integration – Provider value propositions…
Integrity of data – automatic population of all information systems – reducing medical errors Automated systems saves time for clinicians Improved agility of enterprises to meet varied patient loads Improved life-cycle cost of ownership Automated clinical data capture for EHR Access to patient data across devices and systems so custom communication interfaces can be eliminated. Allows for best of breed selection 7

8 IHE Patient Care Devices - Overview and Update
Devices and Interoperability Medical Devices - Not a Simple Problem!! IHE PCD – Overview IHE PCD – Profiles IHE PCD – Testing and Demonstrations Getting to Yes!! Questions & Answers 8

9 Multiple Care Contexts
(Jan Wittenber, Philips Medical, HITSP/TN905) 9

10 Device Integration for Multiple Applications
(Jan Wittenber, Philips Medical, HITSP/TN905) 10

11 Medication Administration
It’s not just interfacing the infusion pumps! Many clinical systems must be integrated – from many vendors – using many technologies! (Erin Sparnon, ECRI Institute, IHE-PCD Infusion Pump Summit, , wiki.ihe.net) 11

12 Example: CDSS & Multi Data Sources
(John Zaleski, Nuvon, HITSP/TN905) 12

13 IHE Patient Care Devices - Overview and Update
Devices and Interoperability Medical Devices - Not a Simple Problem!! IHE PCD – Overview IHE PCD – Profiles IHE PCD – Testing and Demonstrations Getting to Yes!! Questions & Answers 13

14 IHE Patient Care Devices
IHE-PCD Charter The Patient Care Device Domain is concerned with use cases in which at least one actor is a patient- centric point-of-care medical device. The PCD coordinates with other IHE clinical specialty based domains such as medical imaging and lab to ensure consistency of medical device integration solutions across all IHE technical frameworks. NOTE: Formed in 2005 & sponsored by HIMSS & ACCE 14

15 IHE PCD Overview Information Consumers: (HIS, PhIS, eMAR, EMR)
ADT, Orders Physiological and Operational Data (PCD) Technical Framework Physiological and Operational Data (PCD) Physiological and Operational Data (PCD) Server/Gateway ADT, Orders ADT, Orders Information Reporters: Medical Devices with Server/Gateway Information Reporters: Standalone Medical Devices 15

16 PCD Domain Overview PCD Profile Primary Objectives:
Heterogeneity – … coexistence in a multi-vendor & multi-modality world, leveraging shared infrastructure Semantic Interoperability – … from the sensor to the EHR Real-time Availability – … facilitating more timely clinical decisions Ultimately providing improved – … safety, quality of care & workflow efficiency 16

17 Profiles Simplify Development
All implementation detail! 17

18 IHE PCD Profiles Current Profiles: Work in Process:
Enterprise sharing of Patient Care Data (DEC) Subscribe to Patient Data (SPD) Rosetta Stone Terminology Project (RTM) PCD Alarm Communication Management (ACM) Point-of-care Infusion Verification (PIV) Work in Process: Device Point-of-care Integration (DPI) Waveform Communication Management (WCM) Event Communication (EVT) Medical Equipment Management (MEM) Patient – Device Association (PDA) Initial device classes… vital signs / physiological monitors, infusion pumps and ventilators 18

19 IHE PCD – Profile Overview
Physiologic Monitoring System CPOE/ Pharmacy System Clinical Decision Support System Ventilation/ Anesthesia System ACM, DEC, WCM ACM, DEC, WCM ACM, DEC, WCM Barcode Medication Administration System EMR/EHR Infusion Pump PIV ACM, DEC IDCO Implantable Device CIS DEC ACM, MEM ACM, DEC, WCM Equipment Management System Home Based System Other Devices ACM: Alarm Communication Management DEC: Device Enterprise Communication IDCO: Implantable Device – Cardiac – Observation MEM: Medical Equipment Management PIV: Point-of-Care Infusion Verification WCM: Waveform Communication Management Current PCD Future PCD Future Non- PCD 19

20 IHE Patient Care Devices
2009 White Paper Proposals Device Point-of-care Integration (DPI) Medical Equipment Management (MEM) – Complete! Medical Device Semantic Architecture Regulatory Considerations in Deploying Systems Incorporating IHE PCD Profiles IHE PCD Users Handbook What is & is not specified in PCD Profiles How to assess PCD profile support System verification & validation testing considerations 20

21 IHE Patient Care Devices - Overview and Update
Devices and Interoperability Medical Devices - Not a Simple Problem!! IHE PCD – Overview IHE PCD – Profiles IHE PCD – Testing and Demonstrations Getting to Yes!! Questions & Answers 21

22 PCD Published Profiles Device to Enterprise Communication
DEC Profile Device to Enterprise Communication Trial Implementation 22

23 DEC Profiles PCD DEC profile supports the communication of patient clinical data from devices. This data can include: Vital Signs (profile available) Alarm information (2008/2009 profile) Waveform information (emerging profile) Device configuration information (MEM) Etc.

24 Device to Enterprise Comm. (DEC)
The Device to Enterprise Communication (DEC) profile allows a consuming device to receive patient clinical information including vitals, settings, demographics and location from a reporting device.

25 PCD-01 Message Example MSH|^~\&|INFO_SRC_PHILIPS^ACDE ABCD^EUI-64|||| ||ORU^R01^ORU_R01|PMS | P|2.5|||NE|AL||8859/1 PID|||AB60001^^^Philips Medical^PI||Brooks^Albert^^^^^L|| |M PV1||I|UNIT_1^^Bed1 OBR|1|PMS ^INFO_SRC_PHILIPS^ACDE ABCD^EUI-64| PMS ^INFO_SRC_PHILIPS^ACDE ABCD^EUI-64| ^MDC_DEV_METER_PHYSIO_MULTI_PARAM_MDS^MDC||| OBX|1|ST|184326^MDC_ECG_STAT_ECT^MDC| |""||||||F OBX|2|ST|184327^MDC_ECG_STAT_RHY^MDC| |Sinus Rhythm||||||F OBX|3|NM|150456^MDC_PULS_OXIM_SAT_O2^MDC| |99|262688^MDC_DIM_PERCENT^MDC|||||F OBX|4|NM|147842^MDC_ECG_HEART_RATE^MDC| |81|264864^MDC_DIM_BEAT_PER_MIN^MDC|||||F OBX|5|NM|150037^MDC_PRESS_BLD_ART_ABP_SYS^MDC| |126|266016^MDC_DIM_MMHG^MDC|||||F OBX|6|NM|150038^MDC_PRESS_BLD_ART_ABP_DIA^MDC| |76|266016^MDC_DIM_MMHG^MDC|||||F OBX|7|NM|150039^MDC_PRESS_BLD_ART_ABP_MEAN^MDC| |92|266016^MDC_DIM_MMHG^MDC|||||F OBX|8|NM|148065^MDC_ECG_V_P_C_CNT^MDC| |0|264864^MDC_DIM_BEAT_PER_MIN^MDC|||||F OBX|9|NM|150045^MDC_PRESS_BLD_ART_PULM_SYS^MDC| |26|266016^MDC_DIM_MMHG^MDC|||||F OBX|10|NM|150046^MDC_PRESS_BLD_ART_PULM_DIA^MDC| |9|266016^MDC_DIM_MMHG^MDC|||||F OBX|11|NM|150047^MDC_PRESS_BLD_ART_PULM_MEAN^MDC| |14|266016^MDC_DIM_MMHG^MDC|||||F OBX|12|NM|149538^MDC_PLETH_PULS_RATE^MDC| |55|264864^MDC_DIM_BEAT_PER_MIN^MDC|||||F OBX|13|NM|150067^MDC_PRESS_BLD_ATR_LEFT_MEAN^MDC| |4|266016^MDC_DIM_MMHG^MDC|||||F OBX|14|NM|150087^MDC_PRESS_BLD_VEN_CENT_MEAN^MDC| |12|266016^MDC_DIM_MMHG^MDC|||||F Note: Extensive message examples on the PCD FTP Site: ftp://ftp.ihe.net/Patient_Care_Devices/ConnectathonsIncludingProcessAndTesting

26 Subscribe to Patient Data (SPD)

27 PCD Published Profiles Alarm Communication Management
ACM Profile Alarm Communication Management Trial Implementation 27

28 Alarm Communication Management (ACM)
enables systems to deliver the right alarms, with the right priority, to the right individuals via devices with the right content, escalating to other individuals via devices (based on system configuration) 28

29 ACM Data Flows . . * Disseminate Alarm  PCD Inputs Output Devices
(PM, NC, Resp, Pump, etc.) Output Devices (Marquee Sign, Pager, Wi-Fi Phone or Badge, etc.) Alarm Reporter AR Alarm Management AM Alarm Communication AC * Disseminate Alarm  Report Alarm  Dissemination Status * Alarm Source Alarm Aggregator Alarm Receiver Alarm Coordinator Alarm Disseminator Alarm Communication Alarm Endpoint Alarm Status* Subscribe to Alarm * Alarm Reporter . Gap! . Alarm Cache Report Alarm Subscribe to Alarm *  Alarm Archiver AA Communication detailed in ACM profile HIS, EMR Communication not detailed in ACM profile *Note: Implementation TBD 29

30 ACM Status Update Fill Gap: Alarm Manager (AM) to Alarm Communicator (AC) Define alarm identifier codes (RTM for alarms) Extend implementation of actors & transactions Expand to additional IHE domains

31 PCD Published Profiles Point-of-Care Infusion Verification
PIV Profile Point-of-Care Infusion Verification Trial Implementation 31

32 PIV Objective Point-of-Care Infusion Verification supports the electronic transfer of infusion parameters from a Barcode Point of Care (BPOC) system, also known as a Bar Code Medication Administration (BCMA) system, to an infusion pump. 32

33 PIV Workflow Context This is the focus of PIV … only! Nurse Nurse
Pharmacist reviews Pharmacist reviews Review Review order detail order detail eMAR Entry (Pharmacy (Pharmacy System) System) Physician reviews Physician reviews eMAR updated eMAR updated data and places data and places Orders Orders Nurse Confirms 5 Nurse Confirms 5 Rights: Rights: This is the focus of PIV … only! Right Patient, Right Patient, Medication, Medication, Medication Medication Medication Medication Dose, Time, Route Dose, Time, Route Nurse removes Nurse removes Dispensed Dispensed Administered Administered AT THE BEDSIDE AT THE BEDSIDE Medication Medication from Dispensing from Dispensing Unit or Med Room Unit or Med Room

34 PIV Actors & Data Flows DEC!

35 PCD Published Profiles
IDCO Profile Implantable Device – Cardiac – Observation Trial Implementation

36 IDCO Objective IDCO specifies the creation, transmission, and processing of discrete data elements and report attachments associated with implantable cardiac device interrogations (observations) or messages. 36

37 Implantable Cardiac Devices
Leads for Sensing or Delivering Electrical Therapy 37

38 IDCO Profile Context Device is interrogated via inductive or wireless telemetry in clinic or home environment using vendor proprietary equipment Information is transferred to clinic system as structured HL7 v2.6 ORU message using IEEE IDC nomenclature [PCD-09] 38

39 PCD Published Profiles Rosetta Terminology Mapping
RTM Profile Rosetta Terminology Mapping Trial Implementation 39

40 Rosetta for Semantic Interoperability
40

41 Rosetta for Semantic Interoperability
ISO/IEEE Semantic Standards Vendor Semantics IHE PCD Technical Framework Content HL7 V2 Messages Vendor A Vendor Terms RTM 1400 rows Harmonized Terms hRTM 440 terms HL7 V3 CDA/CCD Vendor B 11073 PnP Comm Vendor C Open consensus process Observation identifiers and co-constraints New terms incorporated into standards hRTM used for conformance testing 41

42 Harmonized Rosetta (hRTM)
Specifies for each IEEE REFID observation identifier: the MDC and UCUM units-of-measure includes dimensional analysis to ensure correct ‘units-math’ enumerated values and measurement sites numeric codes, where appropriate An extract from the hRTM is shown below: Group REFID DIM UOM_MDC UOM_UCUM CVS_ECG_HR MDC_ECG_HEART_RATE T-1 MDC_DIM_BEAT_PER_MIN {beat}/min {beats}/min 1/min /min CVS_ECG_ST MDC_ECG_AMPL_ST_I ML2I-1T-3 ML2I-1T-3 MDC_DIM_MILLI_VOLT MDC_DIM_MICRO_VOLT MDC_DIM_MILLI_M# mV  uV (added by scripting rule)  mm# (voted “off-the-island”) GASMON_AA_ENFL MDC_CONC_ENFL_ET L3L-3 LMT-2L-2 LMT-2L-2 MDC_DIM_VOL_PERCENT MDC_DIM_KILO_PASCAL MDC_DIM_MMHG %{vol}  kPa  mm[Hg] 

43 RTM & hRTM Highlights Unified semantics and semantic model are essential prerequisites for safe and effective interoperability between devices and systems. The hRTM rigorously defines what may be sent and informs recipients of what they may expect to receive. For each observation identifier, the hRTM specifies the units-of-measure, enumerated values, measurement sites and other co-constraints. The hRTM is based on the ISO/IEEE standards and leverages and extends that work by using an open consensus process. The hRTM is publicly available for IHE PCD clinical devices and will be available shortly for IEEE personal health devices. The hRTM supports message conformance testing frameworks that can be used for both clinical and personal health devices.

44 PCD Emerging Profiles Emerging Profiles
Waveform Communication Management (WCM) Medical Equipment Management (MEM) Event Communication Device Point-of-Care Integration (DPI) Real Time Location Tracking Real-time data archiving and communication Mobile, enterprise-wide, reliable vital signs monitoring … many more! 44

45 Device Point-of-Care Integration
PCD Emerging Profiles Device Point-of-Care Integration [DPI] 45

46 Device Point-of-Care Integration
DPI: Scope – Device Point-of-care Integration (DPI) is concerned with use cases that include care contexts that fall within the stated charter of the IHE PCD, namely where "at least one actor is a regulated patient centric point-of-care medical device," and that require device-to-device communication.

47 Device Point-of-Care Integration
Enterprise Integration Real-Time Clinical Decision Support Point-of-Care Applications Device Reporting, Management & Control Semantic Interoperability Monitored Parameters Alarms & Limits Waveforms (Real-Time) Control Parameters Real-Time Closed / Open Loop Control Device Point-of-Care Integration Discovery and Association (PnP) Real-Time Data Reporting Bi-Directional / Symmetric External Control DPI Manager / Enterprise Gateway

48 PCD Emerging Profiles Medical Equipment Management [MEM] Imagine …
What if I.T. & device vendors gave me EVERYTHING I ever wanted?! 48

49 MEM (Medical Equipment Management)
49

50 MEM Status 2009 – White Paper Ongoing work
Cycle 5 Brief Profile Proposal Real Time Location Tracking Location Boundary Alarms Battery Management Semantic Content Requirements

51 Waveform Communication Management [WCM]
PCD Emerging Profiles Waveform Communication Management [WCM] 51

52 Waveform Communication Management
WCM Objective Waveform Communication Management will extend the [DEC] profile to provide a method for passing near real-time waveform data using HL7 v2 observation messages between a Reporter and a Consumer. A filter will be an optional element  STATUS: Supplement currently undergoing TC review

53 Continua / IHE PCD WAN Interface
Devices Aggregation Manager Telehealth Service Center Health Records PAN LAN WAN HRN Personal Area Network Local Area Network Wide Area Network Health Reporting Network 53

54 Continua/IHE PCD DEC WAN
Messaging HL7 V2.6 constrained by IHE DEC PCD-01 and RTM . Semantics IEEE and 104xx terms IEEE terms and –10201 info model Message Transport Web Services WS-I BP IHE IT Infrastructure TF Vol 2 Appendix V Rev 6.0 WS-I BP over SOAP 1.2 Plus WSI-BSP, TLS and IHE ATNA HL7 MLLP IHE HL7 V2 Msg Transport HL7 Minimum Lower Layer Protocol (MLLP) over TCP/IP (beyond the firewall) (behind the firewall) Note: This is new to the IHE PCD … not IHE ITI … test tooling, test scripts, etc.

55 PCD & ASTM “ICE”/CIMIT MDPnP
ICE-PCD Analysis Committee (ICE-PAC) – JWG underway to perform a map & gap analysis between “ICE” use case analyses, ISO/IEEE standards & the IHE DPI WG. (From ICE-PAC Overview Update to IHE PCD)

56 RDC Project ~ Building on Clinical Requirements
Risk Analysis System Modeling Technical Solution and Clinical Implementation Design Engineers Clinical Engineers Scenario Workflow Clinicians Gathering Requirements from Clinical System Providing Traceability of System Requirements Provide Systems Level Risk Analysis Provides Traceability to Mitigating Risk Designing for the System, not modifying the system causing unintended consequences General Building Blocks and Interactions between the blocks are key to Safety If General Building Blocks make up Specific Systems then Systems are safe 56

57 Monitor Device Configuration / Status
RDC Project ~ Logical Actors / Intermediary Architecture Rapid Device Configurator DOC/manager Monitor Device Configuration / Status Auto-Configure Device (external control) DTBR DOR/agent DR DOR/agent Clinician Reviews / Manually Configures Device via User Interface Logically, the actors are relatively simple. DTBR must supply configuration & status info to the RDC. The RDC also retrieves configuration (static & operational) from the DR + interacts with the clinician, especially to resolve non-compatibility DTBR-to-DR issues; RDC may also automatically program the DR if supported; otherwise, it may monitor DR configuration status as the clinician interacts both with it and the DR (manually configuring / confirming). 57

58 IHE Patient Care Devices - Overview and Update
Devices and Interoperability Medical Devices - Not a Simple Problem!! IHE PCD – Overview IHE PCD – Profiles IHE PCD – Testing and Demonstrations Getting to Yes!! Questions & Answers 58

59 IHE Standards Adoption Process
Testing at Connectathons IHE Demonstrations Develop technical specifications Products with IHE Identify available standards (e.g. HL7, DICOM, IEEE, IETF) Improved safety, quality & efficiency! Easy to integrate products Document Use Case Requirements 59 59

60 Locked in the … dungeon?!

61 IHE Technical Framework (IHE Profile Specifications)
IHE Testing Process In-House Testing Demonstration Deploy Systems Testing Results Approves Test Logs IHE Technical Framework (IHE Profile Specifications) Product + Integration Statement Users Sponsors: Project Management Team Vendors Sponsors: Exhibits Implement Profile Actors Develop Testing Tools Connectathon Interview

62 Conformance Testing of an HL7 V2 Message
NIST Tools: Instance System Test Environment Conformance Testing of an HL7 V2 Message Report Test Artifacts Conformance Profile HL7 Tables ‘Device’ Test Agents ISO/IEEE 11073/Rosetta Terminology HL7 V2 Message Validation Services Test Management HL7 V2 Message Validation Test Case Results Validation Report Test Harness (Java Code) Test Execution User Web Application Client Registry/ Repository See NIST HL7-PCD Validation 62

63 NIST Tools: Isolated System Test Environment
IHE-PCD Testing using a Web Application Client Report IHE-PCD DOR/DOF Test Agent HL7 V2 Message Generation DOC Validation Services Test Management Router/Logger/Proxy Vendor IHE PCD Device Application System Under Test IHE-PCD Client Test Scenario Results HL7 V2 Message Validation Reports Test Harness (Java Code) Test Execution Web Client IOR AM IOC AR IDCC IDCR 63

64 NIST Tools: Peer-2-Peer Test Environment
A Framework for Building Test Systems—an SOA Approach Services Test Management User Test Data Validation Test Description Results Generation Test Agent Test Artifacts Evaluation Agent Facilitator Test Harness Test Analyzer Report Time Test Execution Logging Security B Log Analyzer Proxy Monitor System Under Test Specialized Validation Aggregated Services A External Services Other Services Router/Logger/Proxy System Under Test 64

65 IHE Standards Adoption Process
Testing at Connectathons IHE Demonstrations Develop technical specifications Products with IHE Identify available standards (e.g. HL7, DICOM, IEEE, IETF) Improved safety, quality & efficiency! Easy to integrate products Document Use Case Requirements 65 65

66 HIMSS 2010

67 IHE PCD – AAMI Demonstration
Physiologic Monitoring System CPOE/ Pharmacy System Clinical Decision Support System Ventilation/ Anesthesia System ACM, DEC, WCM ACM, DEC, WCM ACM, DEC, WCM Barcode Medication Administration System EMR/EHR Infusion Pump PIV ACM, DEC IDCO Implantable Device CIS DEC ACM, MEM ACM, DEC, WCM Equipment Management System Home Based System Other Devices ACM: Alarm Communication Management DEC: Device Enterprise Communication IDCO: Implantable Device – Cardiac – Observation MEM: Medical Equipment Management PIV: Point-of-Care Infusion Verification WCM: Waveform Communication Management AAMI Demo Current PCD Future PCD Future Non- PCD 67

68 HIMSS ’07 IHE PCD Showcase

69 HIMSS ’08 IHE PCD Showcase

70 HIMSS ’09 IHE PCD Showcase
70

71 HIMSS ’10 Atlanta Showcase Floorplan HIMSS ’10? Too big for a single diagram!

72 IHE PCD – HIMSS ’10 Wall 1 72

73 IHE PCD – HIMSS ’10 Wall 2 73

74 IHE PCD – HIMSS ’10 Wall 3 74

75 IHE PCD – HIMSS ’10 Wall 4 75

76 IHE Patient Care Devices - Overview and Update
Devices and Interoperability Medical Devices - Not a Simple Problem!! IHE PCD – Overview IHE PCD – Profiles IHE PCD – Testing and Demonstrations Getting to Yes!! Questions & Answers 76

77 Great Expectations? IHE PCD – Vendor value propositions…
Simplify product development process Spend time innovating rather than supporting infrastucture work – again & again & ... Facilitate clinical decision support - innovation - increased functionality Reduce regulatory impact/work Improve patient safety - reduce liability - make operations easier - device aware 77

78 The Dream … Deferred! Why has it not yet happened?
Incomplete standards … but no longer the case! Uncoordinated & inconsistent demand from providers and other user stakeholders Undefined stakeholder value propositions Resources – esp. for standards–related projects Dr. Brailer: Infrastructure is a hard sell: Concentrated cost – Diffuse benefit A business issue – not a lack of technology! 78

79 IHE Patient Care Devices - Overview and Update
Devices and Interoperability Medical Devices - Not a Simple Problem!! IHE PCD – Overview IHE PCD – Profiles IHE PCD – Testing and Demonstrations Getting to Yes!! Questions & Answers 79

80 Find out more at www.ihe.net
Q & A Find out more at 80


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