Up conf-2013-m2 m-and-patient-care-final

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  • Machine-to-Machine (M2M) concept and gateway devicesPatient Care Examples:Wireless blood glucose monitoring systemImplantable inducer firmware support systemRemote cardiac implant monitorRemote EMT emergency cardiac monitoringRemote neuro implant monitoringChallengesBig Data opportunities- - Who is GlobalLogic?Product Development ServicesHeadquartered in Silicon ValleyExperience Design studios in San Francisco, New York and LondonEngineering centers in the US, Ukraine, India, Argentina, China250 active clients7,000 people10 years medical device development experience; ISO 13485 certifiedEstablished practice in Ukraine; expanding to IndiaTechnical Expertise: Embedded, Mobile, Cloud, Analytics, Security
  • What is Machine-to-Machine Communication?Can refer to peer-to-peer communication between devices, but also used to describe remote communication through a networkImplies some intelligence in the system—either in the devices or in the connection between them—not just data capture and displayIn today’s context we will discuss intelligent device-to-device communication via the Cloud
  • Cloud Provides Devices with:High-end, elastically scalable computational and analytic capabilitiesHigh-bandwidth access to distributed resourcesUnlimited storageTypically data processing and data storage takes place in the Cloud rather than on the devicesGenerally devices act as sensors and support user interactionDevices connect to a process or server in the Cloud through a “gateway” interface which may be separate or built into the device itself
  • Three basic gateway topologies:Device contains its own gatewayDevice connects to a separate gatewayDevice connects to a gateway in the cloud
  • Smart Devices as GatewaysMedical M2M GatewaysThe Gateway:Authenticates the device and userProvides a secure connection between the medical device and the telemedicine applicationMay cache data from the device, and information or updates from the telemedicine application, for disconnected useMay provide scalability by integrating results from multiple devicesCommon Gateways:A smartphone or dedicated gateway deviceA web services interface in a cloud processAn embedded communications and protocol translation systemCommon in hospital devices, for exampleImpact of the Cloud and M2M:Cloud has Raised Expectations for data availability: Medical Device data can be gathered from anywhere devices are locatedData is available to Medical Personnel and, increasingly, to Patients any time, any placeMachine-to-Machine enables data exchange:Data may be transparently gathered from any device anywhereFirmware and configuration data can be gathered and kept current
  • Obvious: Reduce cost for device maker and customerImprove availability of most recent software to the end userRemote capture of configuration data allows in-field replacement of pre-configured equipmentIf device is used by children, for example, they may drop it in a pool or break itBy capturing configuration information remotely, a service center can pre-configure a replacement device before sending it to the patientAllows delivery of a pre-configured device direct to the patient without requiring a clinic visit—important in remote or rural areasDirect connect of device to Cloud avoids the need for device registrationFor economic reasons, most devices connect to Cloud via a gateway and therefore require bluetooth or other configurationIf the gateway is on the device, it does not need to be registered before use as it can be shipped with a pre-configured data planDevice data and readings are uploaded to the Cloud anonymously, identified only by device serial numberLater an application can be used to correlate the anonymous readings to an individual patient in a secure way
  • Up conf-2013-m2 m-and-patient-care-final

    1. 1. Cloud-based Machine to Machine (M2M) Technology: A Means to Improving Patient Care James F. Walsh, Ph.D., CTO, GlobalLogic ©2013 GlobalLogic Inc.
    2. 2. Introduction Who Is GlobalLogic? Engineering Centers Experience Design Studios 250 Active Clients 10 Years 7000 People Medical device development experience ISO 13485 certified ©2013 GlobalLogic Inc. • Product Development Services • Headquartered in Silicon Valley • Established practice in Ukraine; expanding to India Technical Expertise: Embedded, Mobile, Cloud, Analytics, and Security
    3. 3. Introduction M2M Introduction | Agenda Machine-toMachine (M2M) ©2013 GlobalLogic Inc. Patient Care Examples Challenges Big Data Opportunities
    4. 4. M2M and Patient Care M2M | Machine-to-Machine Peer-to-peer communication between devices ©2013 GlobalLogic Inc. Involves intelligence not just data transfer Device to device communication through the cloud
    5. 5. M2M and Patient Care What the Cloud Provides Elastic compute capabilities High bandwidth access to distributed resources Unlimited storage Devices connect to processes and servers through Gateway Gateway built into device ©2013 GlobalLogic Inc. Gateway as separate device
    6. 6. M2M and Patient Care M2M | Gateway Topologies Device contains its own gateway Device connects to a gateway in the cloud Telemedicine App ©2013 GlobalLogic Inc. Device connects to a separate gateway
    7. 7. M2M and Patient Care Smart Devices as Gateways What’s in the Cloud Longitudinal analytics | progress reports Communication with provider Outcome tracking | studies Social networking | advice Telemedicine App Secure Connection Wireless Connection (Bluetooth / Zigbee / Bluetooth low energy) ©2013 GlobalLogic Inc. Secure Connection Wired Connection
    8. 8. M2M and Patient Care Drill Down | What’s in the Device Itself? Communication Framework Transport Interface Abstraction Layer M2M Gateway Device-specific Communication Protocol Device Logic Sensor data pre-processing Actuator / Sensor Control … Device Functionality Device Functionality ©2013 GlobalLogic Inc. Device Functionality
    9. 9. M2M and Patient Care Drill Down | What’s in the Gateway? … Business Logic Gateway Apps Gateway Apps Communication Framework Management Device Discovery Device Control M2M Gateway Security Metrics Delivery Connectivity Routing Messaging Universal Device Interface … Device Adapters Device Adapter Device Adapter Transport Interface Abstraction Layer ©2013 GlobalLogic Inc.
    10. 10. M2M and Patient Care Medical M2M Gateways − The Gateway: • Authenticates the device and user • Provides a secure connection between the medical device and the telemedicine application • May cache data from the device, and information or updates from the telemedicine application, for disconnected use • May provide scalability by integrating results from multiple devices − Common Gateways: • A smartphone or dedicated gateway device • A web services interface in a cloud process • An embedded communications and protocol translation system − Common in hospital devices, for example ©2013 GlobalLogic Inc.
    11. 11. M2M and Patient Care Impact of the Cloud and M2M − Cloud has raised expectations for data availability: • Medical device data can be gathered from anywhere devices are located • Data is available to medical personnel and, increasingly, to patients any time, any place ©2013 GlobalLogic Inc.
    12. 12. M2M and Patient Care Impact of the Cloud and M2M − Machine-to-Machine enables ubiquitous data transport: • Data may be transparently gathered from any device anywhere • Firmware and configuration data can be gathered and kept current ©2013 GlobalLogic Inc.
    13. 13. 02 Regulatory Considerations 13 CONFIDENTIAL
    14. 14. M2M and Patient Care Types of M2M Patient Care Applications We are Currently Seeing − Clinical data transmitted and intelligently routed machine to machine − Firmware updates propagated and installed via the cloud − Device activation and management − Customization and configuration data captured for better in-field device support ©2013 GlobalLogic Inc.
    15. 15. M2M and Patient Care Regulation and M2M (*) − The FDA is focusing its efforts on two types of applications: • Applications that are used as an accessory to a regulated medical device; or • Applications that transform a platform into a regulated medical device, i.e. applications that (according to regulated medical device definition from FDA) are intended for use in: − − − diagnosis of disease or other conditions, − or cure, mitigation, treatment, or prevention of disease, in man or other animals Applications under FDA review are evaluated using the same standards the agency applies to other medical devices. Application manufacturers must meet the requirements associated with the applicable medical device classification. Applications may be classified like other medical devices and imply the same regulatory controls: class I (general controls), class II (special controls in addition to general controls), or class III (premarket approval). (*) Summary presented for informational purposes only. This should not be considered as legal advice or counsel. Consult qualified counsel about your specific situation; there are lots of gray areas. ©2013 GlobalLogic Inc.
    16. 16. M2M and Patient Care Regulation and M2M (*) − FDA’s tailored policy focuses on protecting patients while encouraging innovation. − To encourage innovation FDA intends to be discreet about enforcing requirements to some applications that pose minimal risks to consumers, for example: • Health and wellness • Tailored medical information • Coaching for pre-diabetes, substance abuse, psychological conditions • Treatment reminders • Access to electronic health records (although, there are other regulations, i.e. HIPAA, applied to any identifiable patient health data involved) • Information sharing from patient to doctor • Health and lifestyle diaries • Upload and share some medical data (blood pressure, etc.) (*) Summary presented for informational purposes only. This should not be considered as legal advice or counsel. Consult qualified counsel about your specific situation; there are lots of gray areas. ©2013 GlobalLogic Inc.
    17. 17. 03 M2M Patient Care Examples 17 CONFIDENTIAL
    18. 18. M2M and Patient Care Note on Case Studies − Case studies are selected to illustrate Cloud M2M trends GlobalLogic is seeing in the medical domain − These are not made-up examples. All case studies represent projects GlobalLogic has direct knowledge of − Case studies do not disclose proprietary information or announce products. All information shared is already public in one form or another though it has been anonymized and genericized in this presentation. − Case studies and illustrations are intentionally obfuscated to protect client identity. If you recognize any of the devices, note they are for illustration purposes only and the illustrations shown may not be taken from the actual system being described. − In some cases distinct products from the same or different companies are combined to illustrate a concept or trend ©2013 GlobalLogic Inc.
    19. 19. M2M and Patient Care M2M | Patient Care Examples Clinical data transmitted and intelligently routed M2M ©2013 GlobalLogic Inc. Firmware updates propagated and installed via the cloud Customization and configuration data captured for better in-field device support
    20. 20. M2M and Patient Care: Diabetes Care Body Area M2M Network for Insulin Infusion Product Details • A wearable insulin infusion pump is the hub of a body area M2M network • Pump and sensor interface with a handheld controller patient can use to self-administer insulin Handheld Controller Insulin Pump Glucose Sensor ©2013 GlobalLogic Inc. Meter PC USB Dongle
    21. 21. M2M and Patient Care: Diabetes Care Extending Insulin Infusion M2M System to the Cloud Product Details • Use of gateway device extends monitoring to remote systems RF Insulin Pump RF Glucose Sensor RF BGM ©2013 GlobalLogic Inc. WiFi/Cellular WiFi/Cellular
    22. 22. M2M and Patient Care: Diabetes Care Extending Insulin Infusion M2M System to the Cloud: Aggregate data from devices Medical Devices Omron Blood Pressure Monitor Omron Weight Scale A&D Medical Blood Pressure Monitor ©2013 GlobalLogic Inc. User Devices desktop/ laptop Tablet Smart Phone
    23. 23. M2M and Patient Care: Diabetes Care Enhancing Diabetes Care with Additional Health Parameters Monitoring Product Details Monitoring device integrated with other sources of information to provides holistic picture to patient and authorized care providers • Blood glucose measurements, ins ulin intake, carbs, weigh t, blood pressure, etc. • Longitudinal information • Trend analysis ©2013 GlobalLogic Inc.
    24. 24. M2M and Patient Care: Diabetes Care Adding Intelligence and Storage in the Cloud Enables EHR, Social Support and Care Options Product Details • Cloud-based M2M system allows blood glucose and treatment information to be combined with other data—such as weight, food diary and information from other devices—as well as giving access to external resources • Information can be shared for social support, used to supply tailored health education content and made available to providers as part of an electronic health records. ©2013 GlobalLogic Inc.
    25. 25. M2M and Patient Care: Diabetes Care Diabetes Care Software Product Details • Net result is patient has better resources for self-care • Clinician has access to timely information and can structure interventions as needed ©2013 GlobalLogic Inc.
    26. 26. M2M and Patient Care: Diabetes Care Regulatory, Security and Economic Considerations − Regulatory: • Insulin Pump, Glucose Sensor, Handheld controller are regulated • Removing the handheld controller from the loop would raise regulatory requirements • Software on Cloud and Smart Devices may be regulated − Security considerations: • Anti-hacking security critically important for body-connected devices • Patient-identifiable data in the Cloud needs air-tight security − Economics • Subscription for connection of medical devices and/or gateway devices directly to Cloud data services hindering adoption of advanced features • Currently roughly $6/device/month wholesale cost for a low data rate plan (after negotiation) • Economics is driving gateway devices to be hosted on smart devices, which already have data plans (*) Summary presented for informational purposes only. This should not be considered as legal advice or counsel. Consult qualified counsel about your specific situation; there are lots of gray areas. ©2013 GlobalLogic Inc.
    27. 27. M2M and Patient Care: Emergency Medicine EMT Vital Signs Monitoring, Device Management and Firmware Update via Cloud Product Details • Transmission and intelligent routing of vital signs from Emergency Medical System to emergency room and specialists in transit Intelligent Routing Near Real Time Vital Signs • Alerts for incoming information EMS Remote Device Management • Pushes firmware updates to EMS devices in the field • Remotely activates devices and manages device configuration Remote or in-transit Specialist Emergency Room Firmware and Configuration Info ©2013 GlobalLogic Inc.
    28. 28. M2M and Patient Care: Emergency Medicine Regulatory, Security and Economic Considerations − Regulatory: • All components received regulatory review • Updates of the mobile OS (iOS in this case) do not in themselves trigger regulatory review − Security and deployment considerations: • Chain must be encrypted and secure (UDP / SSL from device to private Cloud) for patient privacy and safety • Patient data on phone is transiently displayed and not stored on the device • System must be actively monitored and highly available with uptime > 99.99%, 24x7 • System must be highly scalable (thousands / hour) − Economics • Remote activation, configuration and firmware updates are a radical cost savings to the device owner and major selling point for the devices • Gateway device and connectivity needed for each emergency vehicle (*) Summary presented for informational purposes only. This should not be considered as legal advice or counsel. Consult qualified counsel about your specific situation; there are lots of gray areas. ©2013 GlobalLogic Inc.
    29. 29. M2M and Patient Care: Cardiac Care Remote monitoring of Implanted Cardiac Devices Product Details • Data from implanted device sent to EMR Cloud from home or clinical setting ©2013 GlobalLogic Inc. Wired Telephone Connection
    30. 30. M2M and Patient Care: Cardiac Care Remote Firmware Update of Monitoring Device Product Details • Monitoring device (NOT the implant) receives firmware updates delivered over the cloud ©2013 GlobalLogic Inc.
    31. 31. M2M and Patient Care: Cardiac Care Technically feasible for mobile device to replace dedicated monitor Mobile gateway • Technically feasible to do Cloudbased monitoring and potentially even programming of implantable cardiac devices. • Potential to enable better quality of care for patients with implanted cardiac devices, allowing real time monitoring of live ECG feeds, reviewing event data and programming device remotely. • Caution obviously required on safety, security and regulatory side! ©2013 GlobalLogic Inc. Bluetooth LE Enabled Gateway M2M Cloud Implantable Loop Recorder Clinician Frontend
    32. 32. M2M and Patient Care: Cardiac Care Within the Clinic Product Details • Electronic Health Records (EHR) Cloud is the hub of all Cardiac devices in a clinical setting Transtelephonic Pacemaker Transmitters Device Programmers In-clinic Surface ECG Acquisition EMR Remote Monitoring System ©2013 GlobalLogic Inc. Transtelephonic Cardiac Event Recorders
    33. 33. M2M and Patient Care: Cardiac Care Regulatory, Security and Economic Considerations − Regulatory: • All components including monitoring device received regulatory review • Firmware updates and update transmission must be validated − Security and deployment considerations: • Patient directory and other patient data must be secure • Firmware distribution chain must be secure − Economics • Remote configuration and firmware updates are a radical cost savings to the device owner and major selling point for the devices (*) Summary presented for informational purposes only. This should not be considered as legal advice or counsel. Consult qualified counsel about your specific situation; there are lots of gray areas. ©2013 GlobalLogic Inc.
    34. 34. M2M Examples Some Less Obvious M2M Benefits − Remote capture of configuration data allows in-field replacement of pre-configured equipment − Direct (cellular or wifi) connect of device to Cloud avoids the need for patient device registration ©2013 GlobalLogic Inc.
    35. 35. M2M and Patient Care: Wellness Wellness and Home Care: Vital Sign Monitoring at Home System Description • Software system for vital sign monitoring in the ambulatory / home setting. • App provides the ability to monitor multiple patients in a remote setting—for example, a couple in their home—collecting data through a wirelessly connected devices through an internet gateway and displayed on any webenabled device. ©2013 GlobalLogic Inc.
    36. 36. M2M and Patient Care: Wellness Fitness Monitoring and Social Networking Product Details • Growing number of fitness applications connect to or employ the existing sensors on smart devices Cloud Data Storage, Social Networking, and Longitudinal Analytics • Smart devices act as gateway devices to the Cloud • Data can be analyzed, combined with other information, and socially shared Runner carries smart phone which captures their varying locations and transmits to the cloud ©2013 GlobalLogic Inc. Smart phone also used as a display device for analytics
    37. 37. M2M and Patient Care: Wellness Fall Detector Application (Non-Commercial POC) Product Details • Detects characteristic pattern of a fall using built-in smart device accelerometer • Activates microphone and records sounds immediately after a fall • Transmits recorded sound and GPS location of the phone to emergency contacts / services Recorded Sound GPS Data Identity ©2013 GlobalLogic Inc. Intelligent Routing
    38. 38. M2M and Patient Care: Wellness Regulatory, Security and Economic Considerations − − − Regulatory: • Unless they are specifically marketed as being for diagnosis or cure of a disease, fitness and wellness applications are not generally regulated by the FDA • Application for runners not regulated • Fall detection application MAY be regulated, or may not Security and deployment considerations: • Because fitness data is not regulated, normal commercial means of protecting customer data is appropriate. Normal commercial privacy rules (not HIPAA) apply to client data • Unclear whether fall data would be regulated; though even if it were it could presumably be shared with a care giver or friend given the patient’s permission • Common commercial practice would be that customer identifiable data is shared only with the customers permission; use of data is governed by privacy policy agreed by the customer Economics • Direct connect from device to cloud requires a separate data plan; most connection is therefore done via smart devices • Average revenue per app on the Apple AppStore is $4,000; other appstores have lower average revenues (+) • Generally not economically feasible to ship a stand-alone smartphone application if it’s regulated (*) Summary presented for informational purposes only. This should not be considered as legal advice or counsel. Consult qualified counsel about your specific situation; there are lots of gray areas. (+) http://www.forbes.com/sites/tristanlouis/2013/08/10/how-much-do-average-apps-make/ ©2013 GlobalLogic Inc.
    39. 39. 04 Summary, Futures and Conclusion 39 CONFIDENTIAL
    40. 40. M2M and Patient Care: Summary and Conclusions Current M2M Systems Focus on Communication, Data Capture and Remote Device Support − Clinical data transmission and intelligent routing machine to machine and to EHR / clinical systems − Firmware update propagation and installation via the cloud − Device activation and management − Capture of customization and configuration data for better in-field device support ©2013 GlobalLogic Inc.
    41. 41. M2M and Patient Care: Summary and Conclusions Most Recent and Near Term Future M2M Systems are Adding − Data consolidation from diverse sources and simple Analytics • Weight from in-home digital scales, Blood Glucose level, dosage information, health and food diary, etc. − Patient self-service, wellness and education • Coaching and tailored content − Social support • Similar to fitbit and other wellness products but including social sharing (with permissions and patient controls) of appropriate health information ©2013 GlobalLogic Inc.
    42. 42. M2M and Patient Care: Summary and Conclusions Mid to Long Term Future of M2M Systems − A great deal is technically possible because of • Smart mobile technology: low-cost ubiquitous connectivity • Big data / analytics: Rapid data analysis, forecasting, machine learning, anomaly detection • Cloud-elastic scalability and low cost mass-scale deployment − Limits on M2M are not technical ones ©2013 GlobalLogic Inc.
    43. 43. M2M and Patient Care: Summary and Conclusions Mid to Long Term Future of M2M Systems − Technology is available to support • Analytics to predict and mitigate wellness issues • Closed-loop autonomous control of implanted and other devices based on input from real-time monitors • Personalized coaching and chronic disease management • Fall detection, in-home monitoring • Many other solutions, including “science fiction” ones − Regulatory and economic environment—rather than technology—will determine which M2M possibilities are realized mid- to long-term for patient care ©2013 GlobalLogic Inc.
    44. 44. Thank You James F. Walsh, Ph.D., CTO, GlobalLogic ©2013 GlobalLogic Inc.

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