Best Practices for Embedded Medical Device and Gateway Software Applications. Shahid N. Shah

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1 Best Practices for Embedded Medical Device and Gateway Software Applications Shahid N. Shah

experience 12+ years of healthcare IT and medical devices experience (blog at

com) 15+ years of technology management experience (regulated systems, government,

2 Who is Shahid? I build things. 20+ years of software engineering and multi-site healthcare system deployment experience 12+ years of healthcare IT and medical devices experience (blog at years of technology management experience (regulated systems, government, non-profit, commercial) 10+ years as architect, engineer, and implementation manager on various EMR and EHR initiatives (commercial and nonprofit) Author of Chapter 13, You re the CIO of your Own Office 2

3 Agenda Predictions Implications Device, Gateway, and Ecosystem Architectures Gateway Architecture Connectivity Best Practices How to design new devices for connectivity and integration Next steps and how to build all this 3

4 Predictions for Hardware Consumerization of Devices Thick Devices Thin Devices Virtual Devices Sensors Only with Built-in Wireless Sensors on mobile phones, platforms 4

5 Predictions for Software Consumerization of Apps Software for algorithms Software for functionality Software for connectivity Software only 5

6 Predictions for Connectivity Consumerization of IT Stand-alone and monolithic Connectivity within own organization Multivendor connectivity System of Systems (SoS) 6

7 Predictions for Integration Changes in Practice Models Single-purpose devices standalone Multi-purpose standalone Multi-purpose with documentation connectivity Multi-purpose with cooperating connectivity Multi-purpose with analytical connectivity 7

8 Implications Get your software house in order (IEC 62304, DO 178B/C, etc.) Move from hardware to software focus Move to algorithms and data Understand system of systems (SoS) Plan for integration and coordination Start building simulators 8

9 Legacy device architecture and how next generations must be better DEVICE, GATEWAY, AND ECOSYSTEM ARCHITECTURES

10 Typical Legacy Device Architecture Sensors Storage Display User Device Logic Interface Connectivity (USB, Serial) Device OS (Custom, QNX, etc.) Healthcare Enterprise Serial Concentrator Serial Serial to Ethernet Converter Not much happens with device data Greatly oversimplified 10

11 Next Generation Device Architecture PoE Device Components Sensors Storage Display Plugins Event Architecture Location Aware 4 Device OS (Linux, QNX, Windows) 5 Web Server, IM Client Connectivity Layer (DDS, HTTP, XMPP, SIP) 3 HTTP/REST UI DDS RT Messaging XMPP Non-RT SNMP 3 rd Party Plugins App #1 App #2 Plugin Container / Safety-controls Manager 1 2 Security / Logging / Persistence Layer Cellular RJ-45 USB n/i Bluetooth Zigbee Patient Context Healthcare Enterprise Device Gateway (DDS, ESB) Inventory Management Dashboards Workflow Data Transformation (ESB, HL7) 9 Enterprise Data Notifications TCP/IP External Cloud Shahid s Ultimate Medical Device Architecture 11

Next Gen Gateway Architecture Patient Manager Secure Messaging Social Networks HCP Directories Target multiple devices like PC, SmartPhone, Tablet, Voice HIE/NHIN Integration EHR Integration NLP &

12 Next Gen Gateway Architecture Patient Manager Secure Messaging Social Networks HCP Directories Target multiple devices like PC, SmartPhone, Tablet, Voice HIE/NHIN Integration EHR Integration NLP & Patterns Med Device Integration Security & Auditing App Store Themes IM / Single sign on (LDAP, SAML) EHR Modules Documents Forms Content Management System Secure, HIPAA-Compliant, Web Server Alerting Dashboards Reporting Biz Intel Med Device Tethering HIPAA Encryption & RBAC Provisioning & Auditing Legacy App Connectivity Mobility Stack EII Metadata Rules Engine Gateway Data Mining Notifications ETL OLAP Process Mgmt Integration HL7 X.12 CCR DDS Analytics Enterprise Service Bus Web Application Stack Data Integration Stack Secure, MU- and HIPAA-Compliant, Clinical Data Repository (CDR) and Master Patient Index (MPI) Relational Database Graph DB (RDF) Content Repository Taxonomy Full Text Search LDAP Data Services and Persistence Stack On-Premise Appliance or Cloud Deployment As defined by Netspective Medigy Platform 12

Service Remote Surveillance Management Dashboards Enterprise Data Alarm Notifications HIT / EHR

13 Connectivity Ecosystem End State Device Teaming External Cloud Patient Context Monitoring Device Gateway (DDS, XMPP, ESB) Device Data Data Transformation (ESB, HL7) Cross Device App Workflows Remote Service Remote Surveillance Management Dashboards Enterprise Data Alarm Notifications HIT / EHR Integration Analytics & Reporting Device Management Inventory Shahid s Ultimate Medical Device Architecture 13

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