From Standards to Medical Device Integration An Ongoing Adventure

Transcription

1 From Standards to Medical Device Integration An Ongoing Adventure DISCLAIMER: The views and opinions expressed in this presentation are those of the author and do not necessarily represent official policy or position of HIMSS.

2 Conflict of Interest Disclosure Ken Fuchs, M.Eng. MBA Sr. Principal Engineer Mindray North America Co-Chair IHE PCD Planning Committee Has no real or apparent conflicts of interest to report HIMSS

3 Learning Objectives Discuss Standards relevant to Medical Device Integration Understand the role of the IHE PCD* Domain in Medical Device Integration and Interoperability Understand current IHE PCD profiles and development projects Identify how to specify IHE PCD profiles in Requests for Proposals Summarize current availability of IHE PCD compliant devices *Integrating the Healthcare Enterprise Patient Care Device Domain

4 Integration vs. Interoperability Why Should I Care?

5 Integration What, Me Worry? Integration of patient connected medical devices with IT Systems is increasingly becoming a clinical requirement. Is there a problem? Most, if not all, EMRs can connect to devices We have a growing contingent of vendors (Capsule, Nuvon, Cerner, etc.) providing device integration middleware and services. Patient monitoring vendors have created integrated systems incorporating many 3rd party devices. Clinicians have developed many demonstrations and applications showing device integration.

6 However, There is a Problem Some issues with our current reality Each new device integration is a custom effort requiring months of effort using skilled engineers Clinicians desiring to use a new device must wait for their application vendor to develop a new driver (which may never happen) The complexity of device interfacing may be hindering research which could lead to improved patient care Purchasing decisions are driven by whether an interface to specific devices exists Safety issues can arise due to the sizable software effort and on-site customization required to integrate devices

7 However, There is a Problem More issues with our current reality Costs to Providers for system integration services are very high There is reduced assurance that all data is accurate and complete Not all required data to accomplish a Use Case may be available There can be finger pointing when trying to resolve problems Too much complexity in maintaining each link in the communication chain As device or system software is updated solutions break

8 Are Standards the Solution? Well, we have plenty of standards: HL7 IEEE , 10xxx, etc. IEEE , 40xxx, etc. ASTM F2761 (ICE) DICOM ISO TC215, CEN TC251, IEC, etc. Standards are just a starting point.

9 Is Interoperability the Solution? What is Interoperability? Unfortunately current definitions of Interoperability are not helpful Interoperability is the ability of health information systems to work together within and across organizational boundaries in order to advance the effective delivery of healthcare for individuals and communities. (HIMSS) So we already have Interoperability in the medical device space! I call this Dysfunctional Interoperabilty

10 So, What is the Solution? The solution is Device Interoperability based on Framework(s) of Open Standards, Profiles, Conformance Testing, Certification Testing, Regulatory Pathways, etc. Incentives that drive all parties to comply with these Framework(s) Call this Open Interoperability How does IHE PCD contribute to the concept of Open Interoperability?

11 IHE PCD (Integrating the Healthcare Enterprise Patient Care Device) Overview

12 On the Road to Open Interoperability: From Standards to Profiles Base Standards from SDOs IETF Profile Development ehealth Projects IHTSDO CPs

13 IHE Organizational Structure IHE International Board Regional Deployment Global Development IHE North America IHE Asia-Oceania Canada China Japan Radiology IT Infrastructure Laboratory USA Korea Taiwan Cardiology Patient Care Coordination Pathology IHE Europe Radiation Oncology Patient Care Devices Eye Care Austria Italy France Norway Germany Netherlands Spain Sweden UK Public Health, Quality and Research Pharmacy Professional Societies / Sponsors ACC ACCE ACEP ACP ACOGH IMSS RSNA SFR SFIL COCIR EAR-ECR DRG SIRM BIR EuroRec ESC JAHIS JIRA JRS METI-MLHW MEDIS-DC JAMI Contributing & Participating Vendors

14 Role of IHE PCD IHE PCD was formed in 2005 to address issues related to integration of Point-of- Care medical devices: With each other With enterprise systems IHE PCD wants to raise the bar from the current state of integration projects to out of the box, open, interoperable solutions. IHE PCD s co-sponsors are HIMSS and ACCE.

15 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.

16 IHE Development Process IHE Profiles Drafted & Revised Test at IHE Connectathons IHE Technical Framework Developed Published For Public Comment Trial Implementation Posted month 6-13 month Publish in IHE s Product Registry Demonstrate at a Profile Selection by Committees IHE Call for Proposals Opens month 1-5 IHE Improves, Safety, Quality and Efficiency in Install Interoperable products in Clinical Settings worldwide

17 IHE PCD From Use Cases to Profiles

18 From Use Cases to Profiles The IHE process starts with an open call for Work-Item Proposals to all stakeholders. The proposals are reviewed and voted on by the Planning Committee. Proposals are evaluated on clinical benefit, technical feasibility and volunteer availability. So far most accepted proposals are related to enterprise connectivity (as contrasted with Point of Care). Vendor gateways (MDDS) to enterprise systems are easier to modify than regulated devices. Profiles are typically developed in 18 months or less. Some vendors are starting to implement PCD profiles directly in point-of-care medical devices.

19 Use Cases to Profiles - Developed Use Case: Time synchronization across multiple devices and systems Profile: [CT] Continuous Time, based on NTP Use Case: Reporting of device data (heart rate, infusion volume, airway pressure, etc.) to consuming systems Profile: [DEC] Device to Enterprise Communications, based on HL7 syntax and ISO/IEEE Device Model and Nomenclature. Also adopted by Continua for WAN reporting.

20 Rosetta Terminology Mapping [RTM]

21 Use Cases to Profiles - Developed Use Case: Reporting of implantable device data (Device state, ECGs, etc.) to EHRs Profile: [IDCO] Implantable Device Cardiac Observation based on HL7 syntax and ISO/IEEE Nomenclature. Use Case: Reporting of alarm/alert information to various systems such as alarm consolidator and paging solutions Profile: [ACM] Alarm Communications Management, based on HL7, ISO/IEEE and WCTP Standards.

22 Use Cases to Profiles - Developed Use Case: Communication of orders to the infusion device directly from the BPOC/BCMA (confirmed by the clinician). Profile: [PIV] Point of Care Infusion Verification, based on HL7 and ISO/IEEE Nomenclature Standards. Use Case: Communication of waveform information (snapshots or continuous) from devices. Profile: [WCM] Waveform Content Message, based on HL7 and ISO/IEEE Device Model and Nomenclature Standards.

23 Use Cases to Profiles In Process Use Case: Retrospective data retrieval from device data stores to backfill EMRs or supply Clinical Decision Support Systems. Profile: [ADQ] Asychronous Data Query Use Case: Communication of device data and control at the Point of Care (PoC). Profile: [DPI] Device Point of care Integration

24 Use Cases to Profiles In Process Use Case: Improved association between devices and the patient. Profile: [PCIM] Point of Care Identity Management Use Case: Communication of Events (pump stopped, bolus given, etc.) from devices to consuming systems. Profile: [IPEC] Infusion Pump Event Communication

25 Use Cases to Profiles In Use Case: Process Management of medical devices: Profile: Device location Device cyber security Device technical management (access to device logs, error logs, SW and HW revisions, etc.) [MEM] Medical Equipment Management

26 IHE PCD From Profiles to Release

27 IHE Development Process IHE Profiles Drafted & Revised Test at IHE Connectathons IHE Technical Framework Developed Published For Public Comment Trial Implementation Posted month 6-13 month Publish in IHE s Product Registry Demonstrate at a Profile Selection by Committees IHE Call for Proposals Opens month 1-5 IHE Improves, Safety, Quality and Efficiency in Clinical Settings. Install Interoperable products in Clinical Settings worldwide

28 NIST Testing Tools HL7 Message Definitions Value Set Constraints IEEE / Rosetta Nomenclature Test Case Specific Assertions Etc.

29 Connectathon

30 HIMSS 2010 PCD HIMSS 2011

31 What Can You Do? Plan, Evaluate, Purchase IHE Conforming Devices In continuing discussions with vendors at all levels Push IHE Interoperability Refer to lower deployment, maintenance costs Encourage vendors active IHE participation Lower development, installation, support costs Refer to profiles Leverage public and objective commitments In Purchasing Activities Refer to profiles, Conformance Statements Use Conformance Statements to nail down vendor s representations Adopt very specific language

32 IHE PCD Compliant Systems (as of October 2011) COMPANY SYSTEM SYSTEM TYPE PCD PROFILES Accent on Integration, Inc. (AOI) Accelero Connect Medical Device Integration DEC Amcom Messenger Alarm Manager ACM B Braun DoseTrac Infusion Management Software Gateway software DEC, ACM, PIV BIOTRONIK SE & Co. KG Home Monitoring Service Center Implantable Cardiac Device Observer System IDCO Carefusion CGW Gateway DEC Cerner CareAware ibus Device Connectivity Platform DEC Epic EpicCare Inpatient and associated modules EMR/EHR DEC, PIV,IDCO GE HealthCare CARESCAPE Gateway Gateway DEC Hospira Hospira MedNet Infusion pump gateway PIV imdsoft MetaVision Suite CIS, AIMS DEC isirona DeviceConX Medical Device Integration DEC Mindray DS USA, Inc. egateway HL7 Gateway ACM, DEC Mindray DS USA, Inc. A5 Anesthesia machine DEC Nuvon VEGA Gateway DEC OZ Systems esp Interface DEC Philips Emergin IntelliSpace Event Management Alarm Manager ACM Philips Healthcare Philips IntelliVue and Philips IntelliBridge SC200 Monitoring central station and gateway DEC ScottCare ScottCare OneView Sysrtem Implantable Cardiac Device Observer System IDCO St. Jude Medical, Inc. Merlin.net MN5000 Implantable Cardiac Device Observer System IDCO Surgical Information Systems SIS Periop CIS, EHR, AIMS ACM, DEC Welch Allyn Connex VM Vital Signs Monitor DEC

33 Conclusion The current environment of Dysfunctional Interoperability is not desirable. Users and vendors need a roadmap which allows us to achieve Open Interoperability. Prioritized Use Cases Assessment of Current Standards Profiles of Standards to achieve Use Cases Ecosystem for rigorous conformance and certification testing based on complete and computable representations of standards Incentives for vendors to offer and providers to demand compliant medical devices. IHE PCD is making real progress towards attaining this goal.

34 Thank you for your attention Questions? 2/19/