Device location Device identity (FDA/UDI) Universal time Network dependency maps Performance dashboards Power monitor, mgt Pre-acquisition specifications (ECRI), evidence databases, assessment, simulations, demos, standards, testing, certification Design partnerships Workforce training, labor negotiations, tools Supply chain mgt., supplies, green sustainability Staging, provisioning, safety tests MD/FIRE contract requirements ITIL compliance Asset Mgt. (UNSPSC, UDI), deploy, retire Service Mgt , Service Level Agreements Remote device management, troubleshooting Planned maintenance/PMs Incident mgt/corrective maintenance Problem mgt, root-cause analysis Performance metrics, analytics, reports Move-add-change activity Patch, upgrade, update Security update Automated inventory Version updates Self-monitoring and self-reporting Predictive failure checks Event logs Data buffers, caches Business continuity, disaster recovery statusing Pt. identification, device pairing Barcode scanners Proximity sensors, activators Displays, Data Visualization Alarms, Alerts, Notifications Paging Secure, high confidence network mgt. Clinical checklists Clinical practice guideline conformance Carepath, workflow re-engineering Safety interlocks Institutional research Clinical decision support Multi-core processors Hypervisors EMR transactions Episode of care log, billing, coding Availability Mgt System Lifecycle Mgt Model Configuration Mgt Reliability, Risk Management Peripherals Mgt Network Transaction Mgt Integrated Clinical Environment (ICE) Mgt Procedure Health Informatics Drug Vision, Strategy, Policy *Sector, Enterprise *Clinical *Operations Technology Assessment, Planning, Budgets Integration Planning, Testing, Certification Contracting, Procurement Deployment Operations Support Refresh, Recycle Next-Generation Medical Devices and Systems will go well beyond Clinical functions to include complex Network Transactions and System Lifecycle Management functions as well Evolutionary inter-dependencies Fred Hosea, Ph.D. Kaiser Permanente Contact • Program Manager, Clinical Technology Research and Innovation • 1795 Second St. • Berkeley, California 94710 •[email protected] [email protected] •510-559-4842 office 510-812-5086 cell •510-684-6925 cell B14 Frameworks for addressing the increased complexity, networking and interoperability of medical devices ©Fred Hosea, Ph.D. - 2010 Systems- of- Systems Clinical Systems Medical Device RESEARCH REGULATION BEST PRACTICES COST STRUCTURE WELLNESS, TELEHEALTH, TELEMEDICINE Enterprise Architecture Transition planning: IPv4 ->6 , HL7 v2->v3, ICD-9->10, SNOMED, LOINC, UMLS etc. Electronic Medical Record transactions, data warehousing Quality of Service Environments (deterministic vs. probabilistic; wireless spectrum mgt. life critical vs. business) Data, messaging, image standards and updates (HL7, CDL, XML, RIM, DICOM, syntactic, semantic interoperability) Connectivity, logon, session management, security, confidentiality Device, facility data cacheing