Creating Interoperable Medical Devices that fit into Hospital Enterprise IT Environments

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.

Transcript

1. Creating Interoperable Medical Devices that fit
   into Hospital Enterprise IT Environments
   By Shahid N. Shah
   

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2. NETSPECTIVE
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   Who is Shahid?
   • 20+ years of software engineering and multi-
   site healthcare system deployment experience
   • 12+ years of healthcare IT and medical
   devices experience (blog at
   http://healthcareguy.com)
   • 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”
   

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3. NETSPECTIVE
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   Topics
   • 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
   Key takeaways
   • 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.
   What you’ll learn in this briefing
   Wireless capable medical devices with significant software and data integration are the future
   

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4. NETSPECTIVE
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   Life expectancy is increasing…
   …but the rate of growth is slowing
   

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5. NETSPECTIVE
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   Bacteria used to kill us the most…
   Per 100k population, Historical Statistics of the United States, Millennial Edition
   

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6. NETSPECTIVE
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   We’ve got most infections beat…
   …except the flu and pneumonia
   Per 100k population, Historical Statistics of the United States, Millennial Edition
   

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7. NETSPECTIVE
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   Top killers today
   Heart disease Cancer
   Chronic lower
   respiratory
   diseases
   Top killers in 1900
   Pneumonia
   and influenza
   TB
   Diarrhea and
   enteritis
   Infectious diseases used to kill us…
   …but what’s left seem only to be “manageable” not easily “curable”
   Per 100k population, Historical Statistics of the United States, Millennial Edition
   

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8. NETSPECTIVE
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   Death by age group, 1900 Death by age group, Today
   From cures to management…
   …young people don’t dye of diseases often now
   http://siteresources.worldbank.org/INTHSD/Resources/topics/Health-Financing/HFRChap1.pdf
   

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9. NETSPECTIVE
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   The new realities of patient populations
   • Obesity Management
   • Wellness Management
   • Assessment – HRA
   • Stratification
   • Dietary
   • Physical Activity
   • Physician Coordination
   • Social Network
   • Behavior Modification
   • Education
   • Health Promotions
   • Healthy Lifestyle Choices
   • Health Risk Assessment
   • 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
   Prevention Management
   26 % of Population
   4 % of Medical Costs
   35 % of Population
   22 % of Medical Costs
   35 % of Population
   37 % of Medical Costs
   4% of Population
   36 % of Medical Costs
   Source: Amir Jafri, PrescribeWell
   

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10. NETSPECTIVE
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    Healthcare industry / market trends
    PPACA
    “Affordable Care
    Act”
    ACO
    “Accountable
    Care Org”
    PCMH
    “Medical
    Home”
    MU
    “Meaningful Use”
    Health
    Home
    mHealth
    PCPCC
    “Patient Centered
    Care”
    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
    

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11. NETSPECTIVE
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    Implications of healthcare trends
    PPACA ACO
    MU PCMH
    Health
    Home
    mHealth
    DATA
    Evidence Based Medicine
    Comparative Effectiveness
    Software
    Regulated IT and Systems
    Integration Services
    

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12. NETSPECTIVE
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    The new world order
    General
    Wellness
    Specific
    Prevention
    Self Service
    Physiologics
    Self Service
    Monitoring
    Self Service
    Diagnostics
    Care Team
    Monitoring
    Care Team
    Diagnostics
    Healthcare
    Professional
    Monitoring
    Healthcare
    Professional
    Diagnostics
    Hospital
    Monitoring
    Hospital
    Diagnostics
    

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13. NETSPECTIVE
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    Wireless BAN Ecosystem
    Source: Qualcomm
    

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14. NETSPECTIVE
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    Don’t give up data to others without a fight
    Software vendors, systems integrators, and others don’t have your best interest in mind
    Cloud
    Services
    Management
    Dashboards
    Data Transformation (ESB, HL7)
    BaaS Gateway
    (DDS, XMPP
    , ESB)
    Enterprise Data
    RCM, Financials,
    EHRs
    Device Inventory
    Cross Device
    App Workflows
    Alarm
    Notifications
    Patient Context
    Monitoring
    Device
    Teaming
    Device
    Management
    Report
    Generation
    HIT
    Integration
    Remote
    Surveillance
    Device
    Data
    SSL VPN
    Patient
    Self-Management
    Platforms
    Device Utilization
    Device reimbursement
    Device profitability
    

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15. NETSPECTIVE
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    Data is getting more sophisticated
    Proteomics
    Emerging
    •Must be continuously collected
    •Difficult today, easier tomorrow
    •Super-personalized
    •Prospective
    •Predictive
    Genomics
    Since 2000s,
    started at $100k
    per patient, <$1k
    soon
    •Can be collected infrequently
    •Personalized
    •Prospective
    •Potentially predictive
    •Digital
    •Family history is easy
    Phenotypics
    Since 1980s,
    pennies per
    patient
    •Must be continuously collected
    •Mostly Retrospective
    •Useful for population health
    •Part digital, mostly analog
    •Family History is hard
    Admin
    Since 1970,
    pennies per
    patient
    •Business focused data
    •Retrospective
    •Built on fee for service models
    •Inward looking and not focused
    on clinical benefits
    Biosensors
    Social Interactions
    

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16. NETSPECTIVE
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    The business needs
    • Quality and performance metrics
    • Patient stratification
    • Care coordination
    • Population management
    • Surveys and other direct-from-
    patient data collection
    • Evidence-based surveillance
    The technology strategy
    • Aggregated patient registries
    • Data warehouse / repository
    • Rules engines
    • Expert systems
    • Reporting tools
    • Dashboarding engines
    • Remote monitoring
    • Social engagement portal for
    patient/family
    Data is key for move from FFS to ACOs
    Integrated and aggregated data is the only way to get to ACOs and PCMHs
    

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17. NETSPECTIVE
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    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
    Customer base has
    shifted from clinical to
    clinical + IT + system
    integration
    Clinical customer goals
    have shifted from basic
    automation to advanced
    process optimizations
    Device manufacturer’s
    access to regulated IT
    and system integration
    skills is growing
    You can use OSS to disrupt existing health IT
    

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18. NETSPECTIVE
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    Needed: diagnostic quality mHealth
    

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19. NETSPECTIVE
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    Needed: predictive analytics
    

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20. NETSPECTIVE
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    Needed: care team involvement
    HEALTHCAR
    E PROVIDER
    PATIENT/
    CONSUMER
    HOSPITAL
    FAMILY
    CAREGIVER
    ALTERNATE
    SITE OF
    CARE
    Care Team
    CALL CENTERS AND
    REMOTE SUPPORT
    

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21. NETSPECTIVE
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    Needed: automated diagnostics
    

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22. How data changes science and what that
    means to medical device designs
    

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23. NETSPECTIVE
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    Data changes the questions we ask
    Simple visual facts Complex visual facts Complex computable
    facts
    

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24. NETSPECTIVE
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    Data can change medical science
    The old way
    Identify problem
    Ask questions
    Collect data
    Answer questions
    The new way
    Identify data
    Generate questions
    Mine data
    Answer questions
    

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25. NETSPECTIVE
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    Unstructured patient data sources
    Patient Health
    Professional
    Labs &
    Diagnostics
    Medical Devices Biomarkers /
    Genetics
    Source Self reported by
    patient
    Observations by
    HCP
    Computed from
    specimens
    Computed real-
    time from patient
    Computed from
    specimens
    Errors High Medium Low
    Time Slow Slow Medium
    Reliability Low Medium High
    Data size Megabytes Megabytes Megabytes
    Data type PDFs, images PDFs, images PDFs, images
    Availability Common Common Common Uncommon Uncommon
    

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26. NETSPECTIVE
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    Structured patient data sources
    Patient Health
    Professional
    Labs &
    Diagnostics
    Medical Devices Biomarkers /
    Genetics
    Source Self reported by
    patient
    Observations by
    HCP
    Specimens Real-time from
    patient
    Specimens
    Errors High Medium Low Low Low
    Time Slow Slow Medium Fast Slow
    Reliability Low Medium High High High
    Discrete size Kilobytes Kilobytes Kilobytes Megabytes Gigabytes
    Streaming size Gigabytes Gigabytes
    Availability Uncommon Common Somewhat
    Common
    Uncommon Uncommon
    

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27. NETSPECTIVE
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    Application focus is biggest mistake
    Application-focused IT instead of Data-focused IT is causing business problems.
    Healthcare Provider Systems
    Clinical
    Apps
    Patient
    Apps
    Billing
    Apps
    Lab
    Apps
    Other
    Apps
    Partner Systems
    Silos of information exist across
    groups (duplication, little sharing)
    Poor data integration across
    application bases
    

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28. NETSPECTIVE
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    NCI
    App
    NEI
    App NHLBI
    App
    Healthcare Provider Systems
    Clinical
    Apps
    Patient
    Apps
    Billing
    Apps Lab
    Apps Other
    Apps
    Master Data Management, Entity Resolution, and Data Integration
    Partner Systems
    Improved integration by services
    that can communicate between applications
    The Strategy: Modernize Integration
    Need to get existing applications to share data through modern integration techniques
    

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

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30. NETSPECTIVE
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    Predictions for Software
    Software for
    algorithms
    Software for
    functionality
    Software for
    connectivity
    Software
    only
    Consumerization of Apps
    

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31. NETSPECTIVE
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    Predictions for Connectivity
    Stand-alone
    and
    monolithic
    Connectivity
    within own
    organization
    Multi-vendor
    connectivity
    System of
    Systems
    (SoS)
    Consumerization of IT
    

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

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33. NETSPECTIVE
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    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
    

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34. NETSPECTIVE
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    Key regulatory questions
    Will the FDA accept
    networked safety-
    critical 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, MedicalConnectivity.com
    

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35. NETSPECTIVE
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    Regulatory Strategy
    510(k) PMA,
    Class 3, Class 2,
    etc.
    Unregulated
    EHR or others
    510(k)
    Class 2
    “Data Bridges”
    “Everything else”
    Customer registry
    Patient registry
    Patient profile
    Study Management
    Billing
    “The Device”
    Class 1
    MDDS
    

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36. NETSPECTIVE
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    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
    

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37. NETSPECTIVE
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    Key marketing & product management questions
    Can your sales
    team sell it?
    Can customer
    manage the
    technology?
    Does customer
    have the existing
    infrastructure?
    Can you deliver
    after you build it?
    Can your
    solutions team
    customize it?
    Yes, if they’re
    incentivized and
    trained
    They need a good
    IT and test
    environment to
    ensure reliability
    They need reliable
    power, broadband
    coverage, and
    good WiFi
    You need
    installation,
    provisioning,
    testing, and
    remote support
    infrastructure
    Yes, if you build for
    customization
    

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38. NETSPECTIVE
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    Key human capital questions
    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?
    You can’t go it alone, get help now
    

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39. Connectivity strategy
    The most important aspect of a data bridge is its connectivity
    

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40. NETSPECTIVE
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    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.
    

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41. NETSPECTIVE
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    Legacy Physical Connectivity
    Device
    USB Converter
    Data
    Concentrator
    (IEEE 11073?)
    Hospital Network
    Gateway
    (Data Mediator)
    Corporate Cloud
    Hospital Systems
    Serial Converter
    11073 assumes desire for
    multi-vendor connectivity
    

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42. NETSPECTIVE
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    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
    

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43. NETSPECTIVE
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    Next Gen Physical Connectivity
    Device
    Hospital
    Network
    Gateway
    Corporate
    Cloud
    Hospital
    Systems
    Option 1 (hospital IT integration required or no cellular access)
    Device
    Corporate
    Cloud
    Option 2 (cellular access and no hospital IT integration required)
    Could be a Home
    Network, too
    Wired
    Wireless
    Bluetooth,
    WiFi, Zibee, etc.
    Wireless, Cellular
    

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44. NETSPECTIVE
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    Legacy Protocols Best Practices
    Device
    Serial
    Converter
    USB
    Converter
    Data
    Concentrator
    Hospital
    Network
    Corporate
    Gateway
    Corporate
    Cloud
    Hospital
    Systems
    DDS
    REST
    DDS
    Ethernet
    Serial
    HL7
    X.12
    If multi-vendor
    connectivity is
    required,
    add data translator
    and homogenization
    capability
    MPEG-21
    

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45. NETSPECTIVE
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    Next Gen Protocols Best Practices
    Device
    Hospital
    Network
    Corporate
    Gateway
    External
    Cloud
    Hospital
    Systems
    Option 1 (no cellular access or hospital IT integration required)
    Device
    External
    Cloud
    Option 2 (cellular access and no hospital IT integration required)
    DDS
    REST
    HL7
    X.12
    DDS REST
    MPEG-21
    MPEG-21
    Could be a Home
    Network, too
    Wired
    Wireless
    Bluetooth,
    WiFi, Zibee, etc.
    Wireless, Cellular
    

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46. Device, Gateway, and Ecosystem Architectures
    Legacy device architecture and how next generations must be better
    

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

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48. NETSPECTIVE
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    External
    Cloud
    Management
    Dashboards
    Data Transformation (ESB, HL7)
    Device Gateway (DDS, ESB)
    Healthcare Enterprise
    Enterprise
    Data
    Next Generation Device Architecture
    Inventory
    Workflow
    Notifications
    Patient Context
    Device Components 3rd Party Plugins
    App
    #1
    App
    #2
    Security / Logging / Persistence Layer
    Device OS
    (Linux, QNX, Windows)
    Sensors Storage Display Plugins
    Web Server, IM Client
    Connectivity Layer (DDS, HTTP, XMPP, SIP)
    • HTTP/REST UI
    • DDS RT Messaging
    • XMPP Non-RT
    • SNMP
    Plugin Container / Safety-controls Manager
    Event Architecture
    Location
    Aware
    1 2
    3
    4
    5
    6
    7
    8
    9
    TCP/IP
     Shahid’s “Ultimate Medical Device Architecture”
    RJ-45
    Cellular 802.11n/i Bluetooth Zigbee
    USB 3.0
    PoE
    

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

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50. NETSPECTIVE
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    Ensure transport flexibility
    Embeddable Integration Backbone
    Service
    DB
    Management
    Services
    Security
    Firewall
    HTTPS, REST, SOAP
    SFTP, SCP, MLLP
    SMTP, XMPP, TCP
    TCP, HTTPS, SOAP, REST
    HTTP, SFTP, SCP, MLLP
    SMTP, XMPP
    Vendors & Partners
    Apps MQs Services
    Apps Services
    Hospital or Cloud
    Development
    App
    DB
    Central
    DB
    Registry
    Remote
    Center
    VPN
    

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51. NETSPECTIVE
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    Make data available early
    ?
    Responsiveness Proactive Reactive
    Time Elapsed Minutes 1 Month
    1 Day/Week
    CPOE
    Operations
    Financial
    Labs
    Meds
    HIS / EHR
    Automated
    Analysis
    Scheduled Reports
    Alerts Response
    Manual Analysis
    Source: Informatica Corporation
    

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52. NETSPECTIVE
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    Don’t limit the format types
    HL7 HL7 RIM CDISC Excel, CSV
    Access,
    SQL
    SEND CCD CCR
    RDF, RDFa ATOM Pub X.12
    

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53. NETSPECTIVE
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    Choose tools that can do it all
    Connect
    Collect &
    Cleanse
    Exchange
    Standardize
    (Map & Link)
    Federate Store Analyze Report
    Secure Audit
    Guarantee
    HIPAA
    Compliance
    

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54. NETSPECTIVE
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    Structured Data Format Suggestions
    Item Standard
    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 The CMS Physician Quality Reporting Initiative (PQRI)
    2009 Registry XML Specification
    

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55. NETSPECTIVE
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    Coded Vocabulary Suggestions
    Item Standard
    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 OMB Statistical Policy Directive No. 15
    

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56. NETSPECTIVE
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    Privacy and Security Standards
    Item Standard
    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
    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
    

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57. Thank You
    Visit
    http://www.netspective.com
    http://www.healthcareguy.com
    E-mail shahid.shah@netspective.com
    Follow @ShahidNShah
    Call 202-713-5409
    

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