IHE USA ® Medical Device Interoperability and Data Integration Testimony to HIT Standards Committee 28 March, 2011 – Washington, DC Elliot B. Sloane Drexel University Center for Healthcare Information Research and Policy Co-Chair, IHE International

Some of the current FAQs: Elliot B. Sloane, PhD, CCE, FHIMSS Director of Health Systems Engineering, Drexel University, & Founder, Center for Healthcare Information Research and Policy HIMSS roles: Past Chair, HIMSS Security and Privacy Steering Committee Board of Directors, Delaware Valley HIMSS HIMSS Annual Conference Education Committee IHE roles: Co-Chair, IHE International Board of Directors Board of Directors, IHE-USA Other professional roles: Sponsor, IEEE Medical Informatics Standards Past President, American College of Clinical Engineering Past Board of Directors, IEEE EMBS Past Board of Directors, ANSI/HITSP project &

36+ Years Medical Devices and Information Systems Experience 15 years in non-profit research, development, & independent testing, standards, and forensic investigation of medical technologies At ECRI Institute, from “bench” to CIO and COO - Worked with FDA on medical device standards - Arrhythmia detection disclosure and apnea monitors - Investigated medical technology injuries and deaths - Developed computer systems for medical device nomenclatures, “Hazard Reports,” feature comparisons, product directories, and medical device maintenance and safety assurance 10 years in publicly-traded corporation, medical device manufacturing, repairs, 24x7 rental/delivery, and med/surg/drug manufacturing and distribution At MEDIQ Life Support Services, from COO through CTO and CRO Registered with FDA as device and drug manufacturer Owned and managed a fleet of 500,000 medical devices nationwide 11 years as a professor, focused on Medical Informatics, Health Systems Engineering, Medical Device Data Systems Research, Wireless Medical Devices, and Patient Safety

IHE USA ® Incorporated in 2010 as an independent non-profit agency in the state of Illinois, and is filing with the IRS as a 501(c)(3) educational foundation Legally independent, and separate Board of Directors, from HIMSS, RSNA, and IHE International Receives donations, tuition, membership and Connectathon fees, and grant funding Provides educational, teaching, and research grants and scholarships, and pays for the development and dissemination of critical Open Source, free testing and implementation tools for hospitals, government agencies, and manufacturers

Standards for Medical Device Interoperability

IHE Patient Care Device (PCD) Domain Began work in 2003 to achieve reliable medical device data interoperability regardless of brand or type of device. Focus: automating reliable, secure, and consistent data flow and transfer between devices and electronic medical record systems.

The IHE-PCD Rosetta Project The way we separate one piece of medical data from another, and how we ensure data transparency across vendors, products, and medical device modalities. Led by Dr. Paul Schluter, who is here today if you have questions.

IHE-PCD Rosetta Project Cross-vendor measurement Semantics Interoperability

Open consensus process Observation identifiers and co-constraints New terms incorporated into standards hRTM used for conformance testing 53 Rosetta for Semantic Interoperability

54 GroupREFIDDIMUOM_MDC UOM_UCUM( 1GZa3R1le?q=Barack+Obama) 1GZa3R1le?q=Barack+Obama CVS_ECG_HRMDC_ECG_HEART_RATET-1 MDC_DIM_BEAT_PER_MIN {beat}/min ( 3R1le?q=Barack+Obama) 3R1le?q=Barack+Obama {beats}/min 1/min /min CVS_ECG_STMDC_ECG_AMPL_ST_I 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_ENFLMDC_CONC_ENFL_ETL3L-3 LMT-2L-2 MDC_DIM_VOL_PERCENT MDC_DIM_KILO_PASCAL MDC_DIM_MMHG %{vol} kPa mm[Hg] 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:

55 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.

Are medical device interoperability standards necessary? YES! Provides a HUGE reduction in complexity and cost Helps enhance medical care

Interfaces are an n 2 challenge!

Without a national standard, interfaces will become an n 2 revenue stream for vendors, but an n 2 expense for providers! Providers Custom Interface Vendors

With a national standard: only 1 common interface per device! 3 devices = 3 interfaces 500 devices = 500 interfaces (NOT 600,000 interfaces!)

Value of a single medical device interface standard? For 500 devices, reduces a potential 600,000 interface purchase to 500 standard interfaces plus a common “enterprise bus gateway”

Connecting Medical Devices to the Electronic Health Record is our passion –Thanks to ONC’s support from , the HITSP/IS77 Remote Monitoring and HITSP/TN905 Common Medical Device Communications documentation were created –One happy outcome of that work was that in 2010, the IHE-PCD and Continua-WAN specifications were finally aligned, and a SINGLE data standard is now used by ALL IHE-PCD and Continua-WAN devices to consistently transfer clinical data directly from any device into an EMR

Standardized interface decision may have a huge impact on FDA MDDS compliance cost and complexity! Each interface may need FDA MDDS registration. –The interface is a software and/or hardware “contrivance” that may affect diagnosis or therapy IF the interface is embedded in the medical device itself, it is covered by the manufacturer IF the interface is added externally, that manufacturer – or the hospital – must register as a medical device manufacturer with the FDA and comply with the QSR (Quality System Regulations) –I happen to agree that MDDS regulation is probably important for patient safety Is the manner time-, cost-, and risk-appropriate?

Some MDDS & QSR Compliance steps Hospital registers with FDA as a manufacturer Compliance with FDA Quality Systems Regulations, including: -Master product files for each component in the system; -Written change management procedures for each hardware and software component and subsystem; -written evidence of component, subsystem, and system verification; -Validation, and re-verification and validation of each component, subsystem, and system after all maintenance, repairs, recalls, or changes; -Failure tracking, analysis, and documentation for continuous quality management; and -Periodic or on-demand reporting and site visits to FDA’s satisfaction; Hospital keeps detailed written identification, inventory, and feature documentation of each component of the hospital’s MDDS; Written and tested failure and recall systems to ensure that any affected component, sub-system, or system is removed from service Compliance with mandatory Medical Device Reporting regulation Intellectual property and risk management consultants ] Staff, including the technical and administrative staff to support the above activities, Liability and D&O insurance that covers the institution and individuals in the event of a law suit by FDA, patient, family, or other party.

MDDS + Non-Standardized Interfaces?

Conclusions

IHE-PCD Solutions Well developed and demonstrated: –Vital signs data acquisition and transfer to EMR –Acute care device data acquisition –Home and wellness integration with Continua Health Alliance products Strong progress: –Alarm and alert communication and transfer btwn devices and EMRs –Real time waveform data streaming –Patient-device information binding Continued development: –Integration with Integrated Clinical Environment and MD PnP interfaces; –Device-Device Communications and Control –Equipment management

IHE-USA’s Recommendations: Put HITSP IS77 and TN905 to work! 1. Add Remote Monitoring to Meaningful Use Stages 2 & Stage 3 requirements: chronic diseases & practice automation –Designates the IHE-PCD profiles and Rosetta Project for the US Uses HL7v2.6, ISO/IEEE base standards, and the IHE-PCD- designated core IHE Infrastructure & Patient Care Coordination elements such as Consistent Time (CT), to assure data validity and reliability –CMS may need to consider reimbursement for home remote monitoring, as differentiated from current clinician- and video-based telemedicine –IHE-PCD can explore w/ONC potential NHIN DIRECT roles 2. Add IHE-PCD automated acute care data capture to Meaningful Use Stage 3 requirements These commitments by ONC will help improve clinical care, patient safety, and cost effectiveness

IHE is Powered by Volunteers IHE’s Volunteers donate tens of thousands of hours, day by day, year by year, to one shared vision: creating a world that will improve patient care by ensuring health data is secure, interoperable, complete, and readily available at the point and moment of care, regardless of location. IHE is pleased to work with HHS, this Committee, ONC, FDA, CMS, and others in every possible way to “geth the job done!”

Put this country’s money into Patient Care and Wellness, not ancillary costs!

IHE USA ® – here to serve. Thank you for allowing me to share these perspectives with the ONC FACA today. Elliot B. Sloane, PhD, CCE, FHIMSS