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

©2013 GlobalLogic Inc.

Cloud-based Machine to Machine (M2M) Technology:A Means to Improving Patient Care

James F. Walsh, Ph.D., CTO, GlobalLogic


• Product Development Services

• Headquartered in Silicon Valley

• Established practice in Ukraine; expanding to India

Introduction

Who Is GlobalLogic?

Engineering Centers

Experience Design Studios

250Active Clients

7000People

Medical device development experience

10Years

ISO 13485 certifiedTechnical Expertise: Embedded, Mobile, Cloud,

Analytics, and Security


Introduction

M2M Introduction | Agenda

Machine-to-Machine (M2M)

Patient Care Examples

Challenges Big Data Opportunities


M2M and Patient Care

M2M | Machine-to-Machine

Peer-to-peer communication

between devices

Involves intelligence not just

data transfer

Device to device communication

through the cloud



What the Cloud Provides

Gateway built into device

Devices connect to processes and servers through Gateway

Gateway as separate device

Elastic compute

capabilities

High bandwidth access to distributed

resources

Unlimited storage



M2M | Gateway Topologies

Device contains its

own gateway

Device connects to a gateway in

the cloud

Device connects to a separate

gateway

Telemedicine App


Telemedicine App


Smart Devices as Gateways

Secure Connection

Wireless Connection (Bluetooth / Zigbee / Bluetooth low energy)

Secure Connection

Wired Connection

Longitudinal analytics | progress reportsCommunication with providerOutcome tracking | studiesSocial networking | advice

What’s in the Cloud



Drill Down | What’s in the Device Itself?

Device Functionality

Device Functionality Device Functionality…

Transport Interface Abstraction Layer

Device-specific Communication Protocol

Communication Framework

Sensor data pre-processing Actuator / Sensor Control

Device LogicM2M Gateway


Universal Device Interface


Drill Down | What’s in the Gateway?

Business Logic

Device Adapters

Device Adapter Device Adapter

Metrics Delivery

Device Control

Device Discovery Connectivity Routing Messaging

Management Security

…

Gateway Apps Gateway Apps…Communication Framework

Transport Interface Abstraction Layer

M2M Gateway



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



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



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

13 CONFIDENTIAL

Regulatory Considerations02



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



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.



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.)


17 CONFIDENTIAL

M2M Patient Care Examples03



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



M2M | Patient Care Examples

Clinical data transmitted and

intelligently routed M2M

Firmware updates propagated and

installed via the cloud

Customization and configuration data

captured for better in-field device support


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

Glucose Sensor

HandheldController

Insulin Pump

Meter

PC USB Dongle



Extending Insulin Infusion M2M System to the CloudProduct Details• Use of gateway device

extends monitoring to remote systems

RF

Insulin Pump

Glucose Sensor

BGM

WiFi/Cellular

RF

WiFi/Cellular

RF



Extending Insulin Infusion M2M System to the Cloud: Aggregate data from devices

desktop/ laptop

Tablet

SmartPhone

A&D Medical Blood Pressure Monitor

Omron Weight Scale

Omron Blood Pressure Monitor

Medical Devices User Devices



Enhancing Diabetes Care with Additional Health Parameters Monitoring Product DetailsMonitoring device integrated with other sources of information to provides holistic picture to patient and authorized care providers

• Blood glucose measurements, insulin intake, carbs, weight, blood pressure, etc.

• Longitudinal information

• Trend analysis



Adding Intelligence and Storage in the Cloud

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.

Enables EHR, Social Support and Care Options



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



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



M2M and Patient Care: Emergency Medicine

EMT Vital Signs Monitoring, Device Management and Firmware Update via CloudProduct Details• Transmission and intelligent

routing of vital signs from Emergency Medical System to emergency room and specialists in transit

• Alerts for incoming information

• Pushes firmware updates to EMS devices in the field

• Remotely activates devices and manages device configuration

Intelligent Routing

EMS Remote Device

Management

Near Real TimeVital Signs

Remote or in-transit Specialist

Emergency Room

Firmware and Configuration Info


M2M and Patient Care: Emergency Medicine


• 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



M2M and Patient Care: Cardiac Care

Remote monitoring of Implanted Cardiac DevicesProduct Details• Data from implanted device

sent to EMR Cloud from home or clinical setting

Wired TelephoneConnection



Remote Firmware Update of Monitoring DeviceProduct Details• Monitoring device (NOT the implant) receives firmware updates delivered over the cloud



Technically feasible for mobile device to replace dedicated monitor

Bluetooth LE Enabled Gateway

Implantable Loop Recorder

Clinician Frontend

M2M Cloud

Mobile gateway• Technically feasible to do Cloud-

based 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!



Within the Clinic

Product Details• Electronic Health Records

(EHR) Cloud is the hub of all Cardiac devices in a clinical setting

EMR

TranstelephonicCardiac Event Recorders

RemoteMonitoring System

In-clinic Surface ECG Acquisition

Transtelephonic Pacemaker Transmitters

Device Programmers




• 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



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


M2M and Patient Care: Wellness

Wellness and Home Care: Vital Sign Monitoring at HomeSystem 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 web-enabled device.



Fitness Monitoring and Social Networking

Product Details• Growing number of fitness

applications connect to or employ the existing sensors on smart devices

• Smart devices act as gateway devices to the Cloud

• Data can be analyzed, combined with other information, and socially shared

Cloud Data Storage, Social Networking,

and Longitudinal Analytics

Runner carries smart phone which captures

their varying locations and transmits to the cloud

Smart phone also used as a display

device for analytics


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 SoundGPS Data Identity

Intelligent Routing




• 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/

39 CONFIDENTIAL

Summary, Futures and Conclusion04


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



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



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



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


Thank You

James F. Walsh, Ph.D., CTO, GlobalLogic

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