Creating Interoperable Medical Devices that fit into Hospital Enterprise IT Environments


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Creating connected medical devices is challenging but doing so in an interoperable manner that can easily and flexibly fit into modern hospital IT environments is even more difficult. This presentation provides sage advice on how to design connected life-critical medical devices so that they work well within modern hospital environments.

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Creating Interoperable Medical Devices that fit into Hospital Enterprise IT Environments

  1. 1. Creating Interoperable Medical Devices that fit into Hospital Enterprise IT Environments By Shahid N. Shah
  2. 2. NETSPECTIVE Who is Shahid? • 20+ years of software engineering and multisite healthcare system deployment experience • 12+ years of healthcare IT and medical devices experience (blog at • 15+ years of technology management experience (government, non-profit, commercial) • 10+ years as architect, engineer, and implementation manager on various EMR and EHR initiatives (commercial and non-profit) Author of Chapter 13, “You’re the CIO of your Own Office” 2
  3. 3. NETSPECTIVE What you’ll learn in this briefing Wireless capable medical devices with significant software and data integration are the future Topics Key takeaways • Things that kill and harm human beings today are very different than just 100 years ago • Health policy and payments are shifting to deal with new realities • Marketplace and industry challenges for device vendors • Why wireless connectivity is good business • Why wireless connectivity is a disruptive innovation • Wireless is a business enabler but there’s a lot to consider. • Hardware, sensors, and software are transient businesses but data lives forever. He who owns, integrates, and uses data wins in the end. • Data from devices is too important and specialized to be left to software vendors, managed service providers, and system integrators. 3
  4. 4. NETSPECTIVE Life expectancy is increasing… …but the rate of growth is slowing 4
  5. 5. NETSPECTIVE Bacteria used to kill us the most… Per 100k population, Historical Statistics of the United States, Millennial Edition 5
  6. 6. NETSPECTIVE We’ve got most infections beat… …except the flu and pneumonia Per 100k population, Historical Statistics of the United States, Millennial Edition 6
  7. 7. NETSPECTIVE Infectious diseases used to kill us… …but what’s left seem only to be “manageable” not easily “curable” Top killers in 1900 Pneumonia and influenza TB Diarrhea and enteritis Top killers today Heart disease Cancer Chronic lower respiratory diseases Per 100k population, Historical Statistics of the United States, Millennial Edition 7
  8. 8. NETSPECTIVE From cures to management… …young people don’t dye of diseases often now Death by age group, 1900 Death by age group, Today 8
  9. 9. NETSPECTIVE The new realities of patient populations Prevention • Education • Health Promotions • Healthy Lifestyle Choices • Health Risk Assessment Management • • Obesity Management Wellness Management • • • • • • • Assessment – HRA Stratification Dietary Physical Activity Physician Coordination Social Network Behavior Modification • • • Diabetes COPD CHF • • • • • Stratification & Enrollment Disease Management Care Coordination MD Pay-for-Performance Patient Coaching • • • • Physicians Office Hospital Other sites Pharmacology • Catastrophic Case Management Utilization Management Care Coordination Co-morbidities • • • 26 % of Population 35 % of Population 35 % of Population 4% of Population 4 % of Medical Costs 22 % of Medical Costs 37 % of Medical Costs 36 % of Medical Costs Source: Amir Jafri, PrescribeWell 9
  10. 10. NETSPECTIVE Healthcare industry / market trends Major market and regulatory trends that are causing customers and competitors to shift You must learn and be able to talk to customers about all these terms PPACA ACO PCMH “Affordable Care Act” “Accountable Care Org” “Medical Home” Health Home mHealth MU “Meaningful Use” PCPCC “Patient Centered Care” 10
  11. 11. NETSPECTIVE Implications of healthcare trends PPACA ACO Software Regulated IT and Systems Integration Services MU Health Home PCMH mHealth DATA Evidence Based Medicine Comparative Effectiveness 11
  12. 12. NETSPECTIVE The new world order General Wellness Specific Prevention Self Service Physiologics Self Service Monitoring Healthcare Professional Monitoring Care Team Diagnostics Care Team Monitoring Self Service Diagnostics Healthcare Professional Diagnostics Hospital Monitoring Hospital Diagnostics 12
  13. 13. NETSPECTIVE Wireless BAN Ecosystem Source: Qualcomm 13
  14. 14. NETSPECTIVE Don’t give up data to others without a fight Software vendors, systems integrators, and others don’t have your best interest in mind Device Teaming Cloud Services Patient Self-Management Platforms SSL VPN Patient Context Monitoring BaaS Gateway (DDS, XMPP ESB) , Device Data Data Transformation (ESB, HL7) Remote Surveillance Management Dashboards HIT Integration Report Generation Device reimbursement Enterprise Data RCM, Financials, EHRs Device Management Cross Device App Workflows Device Utilization Device profitability Alarm Notifications Device Inventory 14
  15. 15. NETSPECTIVE Data is getting more sophisticated Social Interactions Biosensors Admin Phenotypics Since 1970, pennies per patient Since 1980s, pennies per patient • Business focused data • Retrospective • Built on fee for service models • Inward looking and not focused on clinical benefits • Must be continuously collected • Mostly Retrospective • Useful for population health • Part digital, mostly analog • Family History is hard Genomics Since 2000s, started at $100k per patient, <$1k soon • Can be collected infrequently • Personalized • Prospective • Potentially predictive • Digital • Family history is easy Proteomics Emerging • Must be continuously collected • Difficult today, easier tomorrow • Super-personalized • Prospective • Predictive 15
  16. 16. NETSPECTIVE Data is key for move from FFS to ACOs Integrated and aggregated data is the only way to get to ACOs and PCMHs The business needs The technology strategy Quality and performance metrics Patient stratification Care coordination Population management Surveys and other direct-frompatient data collection • Evidence-based surveillance • • • • • • • • • • • • • Aggregated patient registries Data warehouse / repository Rules engines Expert systems Reporting tools Dashboarding engines Remote monitoring Social engagement portal for patient/family 16
  17. 17. NETSPECTIVE You can use OSS to disrupt existing health IT Customers trapped by their EHR vendors are begging for a way out Device vendors aren’t benefiting from industry trends but can if they’re smart about it Clinical customer goals have shifted from basic automation to advanced process optimizations Customer base has shifted from clinical to clinical + IT + system integration Device manufacturer’s access to regulated IT and system integration skills is growing 17
  18. 18. NETSPECTIVE Needed: diagnostic quality mHealth 18
  19. 19. NETSPECTIVE Needed: predictive analytics 19
  21. 21. NETSPECTIVE Needed: automated diagnostics 21
  22. 22. How data changes science and what that means to medical device designs
  23. 23. NETSPECTIVE Data changes the questions we ask Simple visual facts Complex visual facts Complex computable facts 23
  24. 24. NETSPECTIVE Data can change medical science The old way The new way Identify problem Identify data Ask questions Generate questions Collect data Mine data Answer questions Answer questions 24
  25. 25. NETSPECTIVE Unstructured patient data sources Patient Source Self reported by patient Health Professional Observations by HCP Labs & Diagnostics Computed from specimens Errors High Medium Slow Slow Low Medium Megabytes Megabytes Megabytes Data type PDFs, images PDFs, images PDFs, images Availability Common Common Common Computed from specimens High Data size Computed realtime from patient Medium Reliability Biomarkers / Genetics Low Time Medical Devices Uncommon Uncommon 25
  26. 26. NETSPECTIVE Structured patient data sources Patient Source Self reported by patient Health Professional Observations by HCP Labs & Diagnostics Specimens Medical Devices Real-time from patient Biomarkers / Genetics Specimens Errors High Medium Low Low Low Time Slow Slow Medium Fast Slow Reliability Low Medium High High High Kilobytes Kilobytes Kilobytes Megabytes Gigabytes Gigabytes Gigabytes Uncommon Uncommon Discrete size Streaming size Availability Uncommon Common Somewhat Common 26
  27. 27. NETSPECTIVE Application focus is biggest mistake Application-focused IT instead of Data-focused IT is causing business problems. Silos of information exist across groups (duplication, little sharing) Clinical Apps Billing Apps Lab Apps Other Apps Healthcare Provider Systems Patient Apps Partner Systems Poor data integration across application bases 27
  28. 28. NETSPECTIVE The Strategy: Modernize Integration Need to get existing applications to share data through modern integration techniques Clinical Apps NCI App Billing Apps Lab Other Apps Apps NEI App Healthcare Provider Systems Patient Apps NHLBI App Partner Systems Master Data Management, Entity Resolution, and Data Integration Improved integration by services that can communicate between applications 28
  29. 29. NETSPECTIVE Predictions for Hardware Consumerization of Devices Thick Devices Thin Devices Virtual Devices Sensors Only with Built-in Wireless Sensors on mobile phones, platforms 29
  30. 30. NETSPECTIVE Predictions for Software Consumerization of Apps Software for algorithms Software for functionality Software for connectivity Software only 30
  31. 31. NETSPECTIVE Predictions for Connectivity Consumerization of IT Stand-alone and monolithic Connectivity within own organization Multi-vendor connectivity System of Systems (SoS) 31
  32. 32. NETSPECTIVE 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 32
  33. 33. NETSPECTIVE 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 33
  34. 34. NETSPECTIVE Key regulatory questions Will the FDA accept networked safetycritical systems? Are connected devices safe enough for medical devices? Yes Yes but you must prove it The best regulatory strategy is to abstract design specifications to minimize sustaining engineering: • Intended use • Predicate device(s) • Design approach and how OTS • components are used • Design input specifications • Risk and hazard analysis Abstract Specifications: • Remove dynamic characteristics • Manufacturer, model, version • Performance specifications • Clock speed • Memory • Storage • Industry standards • Third party certifications Source: Tim Gee, 34
  35. 35. NETSPECTIVE Regulatory Strategy “The Device” 510(k) PMA, Class 3, Class 2, etc. Class 1 510(k) Class 2 “Data Bridges” MDDS Unregulated EHR or others “Everything else” Customer registry Patient registry Patient profile Study Management Billing 35
  36. 36. NETSPECTIVE Key design questions Regulatory approach? Wait for standards? Hardware Design? Software Design? IT Infrastructure Design? Component based separation and task-based approach No, use what’s available and make yours the standard Follow mobile phone designs Buy or build a BaaS, M2M, or IOT Solution Interface-based flexibility over defined certainty 36
  37. 37. NETSPECTIVE Key marketing & product management questions Can your sales team sell it? Yes, if they’re incentivized and trained Can customer manage the technology? They need a good IT and test environment to ensure reliability Does customer have the existing infrastructure? Can you deliver after you build it? Can your solutions team customize it? They need reliable power, broadband coverage, and good WiFi You need installation, provisioning, testing, and remote support infrastructure Yes, if you build for customization 37
  38. 38. NETSPECTIVE Key human capital questions You can’t go it alone, get help now Do we have strategy expertise? Do we have development expertise? Do we have unit and internal testing expertise? Do we have systems and customer environment testing expertise? Do we have regulatory expertise? Do we have certification expertise? 38
  39. 39. The most important aspect of a data bridge is its connectivity Connectivity strategy
  40. 40. NETSPECTIVE Connectivity Decisions Required Physical • Wired, wireless (WiFi, cellular, etc.) Logical • Device  Concentrator  Gateway  Enterprise IT  Cloud Structural • Security, Numbers, Units of Measure, etc. Semantic • Presence, Vitals, Glucose, Heartbeats, etc. 40
  41. 41. NETSPECTIVE Legacy Physical Connectivity 11073 assumes desire for multi-vendor connectivity USB Converter Device Data Concentrator (IEEE 11073?) Corporate Cloud Hospital Network Gateway (Data Mediator) Hospital Systems Serial Converter 41
  42. 42. NETSPECTIVE Next Gen Physical Connectors Minimal • • • • Serial USB 2.0 RJ-45 802.11a/b/g Recommended • • • • Serial USB 3.0 RJ-45 Power over Ethernet (PoE) • 802.11n • Bluetooth Advanced • • • • • • • • • • Thunderbolt USB 3.0 + eSata RJ-45 Power over Ethernet (PoE) 802.11n/I Bluetooth Ant+ Zigbee Cellular Zwave 42
  43. 43. NETSPECTIVE Next Gen Physical Connectivity Option 1 (hospital IT integration required or no cellular access) Device Wireless Bluetooth, WiFi, Zibee, etc. Wired Hospital Network Gateway Could be a Home Network, too Corporate Cloud Hospital Systems Option 2 (cellular access and no hospital IT integration required) Device Wireless, Cellular Corporate Cloud 43
  44. 44. NETSPECTIVE Legacy Protocols Best Practices Serial Serial Converter REST Ethernet Device USB Converter DDS Data Concentrator If multi-vendor connectivity is required, add data translator and homogenization capability DDS Hospital Network Corporate Gateway HL7 MPEG-21 Corporate Cloud Hospital Systems X.12 44
  45. 45. NETSPECTIVE Next Gen Protocols Best Practices REST DDS Option 1 (no cellular access or hospital IT integration required) Device Wireless Bluetooth, WiFi, Zibee, etc. Wired Hospital Network Corporate Gateway Could be a Home Network, too HL7 MPEG-21 External Cloud Hospital Systems X.12 Option 2 (cellular access and no hospital IT integration required) Device DDS REST MPEG-21 External Cloud Wireless, Cellular 45
  46. 46. Legacy device architecture and how next generations must be better Device, Gateway, and Ecosystem Architectures
  47. 47. NETSPECTIVE Typical Legacy Device Architecture Sensors Storage Display User Device Logic Interface  Connectivity (USB, Serial) Device OS (Custom, QNX, etc.) Serial Healthcare Enterprise Serial Concentrator Serial to Ethernet Converter Not much happens with device data  Greatly oversimplified 47
  48. 48. NETSPECTIVE Next Generation Device Architecture 5 Device Components Sensors Storage Display Web Server, IM Client • HTTP/REST UI • DDS RT Messaging • XMPP Non-RT 6 • SNMP Plugins 3rd Party Plugins App #1 App #2 7 4 Connectivity Layer (DDS, HTTP, XMPP, SIP) 3 Plugin Container / Safety-controls Manager 2 1 Security / Logging / Persistence Layer Device OS Event Architecture Location Aware PoE (Linux, QNX, Windows) Cellular RJ-45 USB 3.0 802.11n/i Bluetooth Zigbee Healthcare Enterprise 8 Patient Context Device Gateway (DDS, ESB) Inventory TCP/IP Workflow Notifications Data Transformation (ESB, HL7) Management Dashboards 9 Enterprise Data  Shahid’s “Ultimate Medical External Cloud Device Architecture” 48
  49. 49. NETSPECTIVE Next Gen Gateway Architecture Patient Manager Secure Social Messagi Network ng s Single sign on (LDAP, SAML) HCP Directorie s Target multiple devices like PC, SmartPhone, Tablet, Voice HIE/NHIN Integratio n EHR Integratio n NLP & Patterns Med Device Integratio n Med Device Tethering Security & Auditing App Store EHR Modules Alerting Themes Documents Dashboards IM / E-mail Forms Reporting Content Management System  Biz Intel EII Metadata Gateway Data Mining Notifications ETL OLAP Process Mgmt HIPAA Encryption & RBAC Provisioning & Auditing Legacy App Connectivity Rules Engine Analytics Integration Mobility Stack Secure, HIPAA-Compliant, Web Server HL7 X.12 CCR DDS Enterprise Service Bus Data Integration Stack Web Application 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 49
  50. 50. NETSPECTIVE Ensure transport flexibility Hospital or Cloud Development TCP, HTTPS, SOAP, REST HTTP, SFTP, SCP, MLLP SMTP, XMPP Vendors & Partners VPN Services Remote Center Apps Apps Registry MQs Services HTTPS, REST, SOAP SFTP, SCP, MLLP SMTP, XMPP, TCP Embeddable Integration Backbone Central DB Security Service DB Management Services Firewall App DB 50
  51. 51. NETSPECTIVE Make data available early Proactive Responsiveness Reactive Scheduled Reports HIS / EHR Manual Analysis CPOE Operations Financial Automated Analysis Alerts Response Labs Meds Time Elapsed ? Minutes 1 Day/Week 1 Month Source: Informatica Corporation 51
  52. 52. NETSPECTIVE Don’t limit the format types HL7 HL7 RIM CDISC Excel, CSV Access, SQL SEND CCD CCR RDF, RDFa ATOM Pub X.12 52
  53. 53. NETSPECTIVE Choose tools that can do it all Connect Collect & Cleanse Exchange Standardize (Map & Link) Federate Store Analyze Report Secure Audit Guarantee HIPAA Compliance 53
  54. 54. NETSPECTIVE Structured Data Format Suggestions Item In general Follow requirements stipulated by NIST in MU guidance Patient Summary Record HL7 CDA Release 2 CCD or ASTM CCR Electronic Prescribing NCPDP SCRIPT Version 8.1 or 10.6 Electronic Submission of Lab Results to Public Agencies HL7 2.3.1 or HL7 2.5.1 Electronic submission to immunization registries HL7 2.3.1 or HL7 2.5.1 Quality Reporting Standard The CMS Physician Quality Reporting Initiative (PQRI) 2009 Registry XML Specification 54
  55. 55. NETSPECTIVE Coded Vocabulary Suggestions Item In general Follow requirements stipulated by NIST in MU guidance Problem List ICD9-CM / ICD10 or SNOMED CT 2009 Procedures CPT-4 / CPT-5 Laboratory test results LOINC 2.27+ Medications Any source vocabulary that is included in RxNorm Immunizations HL7 Standard Code Set CVX - Vaccines Administered, July 30, 2009 version Race and Ethnicity Standard OMB Statistical Policy Directive No. 15 55
  56. 56. NETSPECTIVE Privacy and Security Standards Item In general Follow NIST 800-53 and related standards Encryption and decryption of electronic health information SSL/TLS Certificates, NIST FIPS 140-2 Record actions related to electronic health information The date, time, patient identification, and user identification must be recorded when electronic health information is created, modified, accessed, or deleted; and an indication of which action(s) occurred and by whom must also be recorded Verification that electronic health information has not been altered in transit SHA-1 or higher (NIST FIPS PUB 180-3) Record treatment, payment, and health care operations disclosures Standard The date, time, patient identification, user identification, and a description of the disclosure must be recorded for disclosures for treatment, payment, and health care operations, as these terms are defined at 45 CFR 164.501 56
  57. 57. Visit E-mail Follow @ShahidNShah Call 202-713-5409 Thank You