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

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

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

©2013 GlobalLogic Inc.

Introduction

Who Is GlobalLogic?
Engineering Centers

Experience Design Studios

250
Active

Clients

10
Years

7000
People

Medical device
development
experience

ISO 13485 certified

• Product Development Services
• Headquartered in Silicon Valley

• Established practice in Ukraine; expanding to India
Technical Expertise:
Embedded, Mobile, Cloud, Analytics, and Security

Introduction

M2M Introduction | Agenda
Machine-toMachine (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
Elastic
compute
capabilities

High bandwidth
access to distributed
resources

Unlimited
storage

Devices connect to processes and
servers through Gateway

Gateway built
into device

Gateway as
separate device


M2M | Gateway Topologies
Device
contains its
own gateway

Device connects
to a gateway in
the cloud
Telemedicine App


Device connects
to a separate
gateway


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)

Secure Connection

Wired Connection


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




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



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


02 Regulatory Considerations

13

CONFIDENTIAL


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.)

03 M2M Patient Care Examples

17

CONFIDENTIAL


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

Handheld
Controller
Insulin
Pump
Glucose
Sensor


Meter

PC
USB Dongle


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


WiFi/Cellular

WiFi/Cellular


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


User Devices

desktop/
laptop

Tablet

Smart
Phone


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


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.



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 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


M2M and Patient Care: Emergency Medicine

− 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


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


Wired Telephone
Connection


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



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!


Bluetooth LE
Enabled Gateway

M2M Cloud

Implantable Loop
Recorder
Clinician Frontend


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


Transtelephonic
Cardiac Event Recorders


− 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

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 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.



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


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 Sound
GPS Data Identity


Intelligent
Routing


−

−

−

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/

04 Summary, Futures and Conclusion

39

CONFIDENTIAL

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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