1. Potential Posters for HIMSS11 PCD and Continua; Integration of home, personal and regulated medical devices

2. Continua-IHE interoperability standard alignment is an example of medical system and ICT convergence that was precipitated by the global demand for interoperable hospital, eHealth, telemedicine, and telehealth solutions: Allows almost any brand of Continua personal health device and/or IHE clinical (medical) device can be used or interchanged in any appropriate setting; TECHNOLOGY can finally assure automatic and accurate data capture and eliminate error-prone manual entry (similar to most other industries like aviation and manufacturing); and Can provide near real-time update of Electronic Health Record/Personal Health Record. NOTE: Must specify the Continua-WAN interface for IHE compatibility

3. IHE-PCD and Continua live in two different but overlapping worlds Continua – Personal Health Devices non-regulated personal appliances, non-life-critical settings like home, car, gym, simple data sets – Personal wellness status, chronic illness home care IHE-PCD – Full-on clinical devices and applications, from home chemotherapy through intensive care, implanted devices, and surgery – Becoming MUCH more mobile, including relative acute care management at the home Both products must co-exist in the home, with overlapping missions, different price-points

4. © 2010 Elliot Sloane, all rights reserved. 4 Beginning this Fall, a single data interface architecture can be used by all Continua Personal Health Devices, all IHE-PCD Medical Devices, and all IHE EHRs! With permission, Continua Alliance

5. Continua and IHE-PCD Collaborative solutions! The Continua Health Alliance focuses on Personal Health Devices, principally oriented towards non-life- critical health and wellness management outside of hospital settings – Primarily focused on gathering chronic disease diagnostic health data, and wellness monitoring data, into Personal Health Records www.ContinuaAlliance.org The IHE Patient Care Device Domain deals with all clinical settings, life-critical applications, and chronic disease diagnosis and treatment (acute/intensive care, surgery, implants, physician offices, and home care) – Focused on device safety and integrating data into Electronic Medical Records/Electronic Health Records and Personal Health Records www.IHE.net/PCD

6. IHE Patient Care Device Clinical Areas CPOE/ Pharmacy System Ventilation/ Anesthesia System ACM, DEC, WCM Physiologic Monitoring System ACM, DEC, WCM ACM, DEC, WCM Clinical Decision Support System Barcode Medication Administration System PIV Infusion Pump ACM, DEC EMR/EHR CIS ACM, DEC, WCM IDCO ACM, MEM Implantable Device Equipment Management System Current PCD Future PCD Future Non PCD Other Devices ACM: Alarm Communication Management DEC: Device Enterprise Communication IDCO: Implantable Device – Cardiac – Observation MEM: Medical Equipment Management PIV: PointofCare Infusion Verification WCM: Waveform Communication Management 32 1 2 3 4 5 6 7 Home Based Systems eHealth & TeleHealth 8

7. Profiling has emerged as a POWERFUL enabler IHEs and Continuas Integration Profiles take myriad base standards such as DICOM, ICD9/10, HL7, or IEEE andCONSTRAINS THE OPTIONALITIES – e.g., Each standard has a different (or many different) coding choices and data structure locations for Date and Time – An Integration Profile specifies the SOLE option to be used for each standard AND specifies a SOLE Global Standard for Universal Timekeeping (typically internet time)

8. The EMBS IEEE 11073.x standards are foundational to both Continua and IHE

9. IHEs Rosetta Project maps ALL vendor clinical coding to each other via IEEE 11073

10. IHE Rosetta Project Now over 400 columns of vendor-specific mappings of clinical variables and globally- harmonized UCUM units of measurements – e.g., Every brand of ECG monitor, EHR, or IV pump can know the kinds of data that other branded products might send, and can therefore translate that information correctly – This is ESSENTIAL for life-critical data preservation, interpretation, and, ultimately, closed-loop multi- vendor systems

11. All IHE and IHE-PCD profiles are FREE to download and use www.IHE.net and www.IHE.net/PCD www.IHE.netwww.IHE.net/PCD Continua Alliance profiles are proprietary, and require membership in the Community

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

13. 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 11073 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 11073 personal health devices. The hRTM supports message conformance testing frameworks that can be used for both clinical and personal health devices.

14. For further information Integrating the Healthcare Enterprise IHE Web: www.ihe.net PCD Web: www.ihe.net/pcd and www.accenet.org/ihewww.ihe.netwww.ihe.net/pcdwww.accenet.org/ihe Wiki: http://wiki.ihe.net/index.php?title=Patient_Care_Devicehttp://wiki.ihe.net/index.php?title=Patient_Care_Device PCD Getting Started: http://wiki.ihe.net/index.php?title=PCD_Getting_Startedhttp://wiki.ihe.net/index.php?title=PCD_Getting_Started PCD Users Handbook: http://www.ihe.net/Resources/handbook.cfmhttp://www.ihe.net/Resources/handbook.cfm Continua Health Alliance Web: http://www.continuaalliance.orghttp://www.continuaalliance.org Continua Wiki: http://en.wikipedia.org/wiki/The_Continua_Health_Alliancehttp://en.wikipedia.org/wiki/The_Continua_Health_Alliance Continua Overview Presentation, Video, Flyers: http://www.continuaalliance.com/about-the-alliance.html http://www.continuaalliance.com/about-the-alliance.html National Institute of Standards and Technology Web: http://www.nist.govhttp://www.nist.gov Medical Devices: http://www.nist.gov/medicaldeviceshttp://www.nist.gov/medicaldevices

15. NIST Conformance Testing NIST has the following mission in regards to Health IT Interoperability Standards: Ensure health IT standards are complete and robust, Establish a health IT standards testing infrastructure that supports effective industry consensus standards development processes, and Provide the U.S. healthcare IT industry and federal activities with robust conformance and interoperability testing.

16. IHE and NIST Collaboration IHE and NIST have an had active collaboration for the past six years, with a strong focus on the IHE PCD profiles. NIST supports IHE PCD HL7 V2 message conformance testing, including syntax and semantics, with the latter constrained by hRTM. NIST is establishing a framework for IHE PCD covering increasing complexity over the next five years, including support for virtual and face-to-face connectathons as well as year round testing. Other collaboration and development, beyond IHE PCD: – ISO/IEEE 11073 Standard (X73): Medical Device Communication – ISO/IEEE 11073 Personal Health Devices (X73_PHD) Visit http://www.nist.gov/medicaldeviceshttp://www.nist.gov/medicaldevices