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1 Embracing the IoT: Ideas are Easy, Execution is Hard Session #160 February 13, 2019 Julian Goldman, MD Director of Medical Device Interoperability and Cybersecurity Program, Massachusetts General Hospital David Niewolny, MBA Director of the Healthcare Segment, Real-Time Innovations (RTI)

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Page 1: Embracing the IoT: Ideas are Easy, Execution is Hard · • Data Distribution Service (DDS) is an open industry standard for data-centric connectivity ... Simplified Integration

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Embracing the IoT:Ideas are Easy, Execution is Hard

Session #160February 13, 2019

Julian Goldman, MDDirector of Medical Device Interoperability

and Cybersecurity Program, Massachusetts General Hospital

David Niewolny, MBADirector of the Healthcare Segment,

Real-Time Innovations (RTI)

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Our Speakers

David Niewolny, MBAJulian Goldman, MDDirector, Healthcare Market

Real-Time Innovations (RTI)

United States • Austin, TX

Medical Director of Biomedical Engineering at Partners HealthCare

Anesthesiologist at Mass General Hospital

Director of the MD PnP Program

United States • Boston, MA

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Julian Goldman, MD

Has no real or apparent

conflicts of interest to report.

Conflict of Interest

David Niewolny, MBA

Has no real or apparent

conflicts of interest to report.

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• The Current State of Healthcare

• The IoT is Changing the World

• Ideas are Easy, Execution is HARD

• How to Harness the Power of the IoT

• Real World Implementations / Clinical Outcomes

Agenda

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• Explain the benefits of plug-and-play

interoperability within a healthcare environment

• Analyze the wide range of healthcare

data-connectivity requirements

• Compare and contrast the most common

connectivity architectures in healthcare

• Identify the best system level architecture for

the transportation and analysis of unprecedented

amounts of data securely, reliably, and in real time

Learning Objectives

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17.8%

25%

37%

The Current State of Healthcare

In the US today:

• Preventable medical errors in

hospitals are the 3rd highest

cause of death behind cancer

and heart disease.

• 200,000 – 400,000 deaths

• Lack of medical device

interoperability costs >$30B

to the healthcare system.

• 900 million elders age 60+

• 1.2 billion by 2025

• Estimated physician shortage

of >50,000 by 2025

US HEALTHCARE

SPENDINGAS SHARE OF GDP

ACTUAL 2018

PROJECTED 2050

PROJECTED 2025

Source: World Health Organization – McKinsey, Continua Alliance, AEI

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The “good old days”?

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More Devices, More Complexity

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Typical Medical Device Data ArchitectureOn-Site Servers Data CenterPatient Bedside

V4 IntegrationServer

FirewallV1 Integration Server

FirewallV4 AppServer

V5 AppServer

Physiologic Monitor

V4 App/EHRKiosk

Nurses Station

EHR

Enterprise Integration

Server

V1/V2/V3 Networks

V4 Central Kiosk

FirewallV2 DB Server

Fetal Monitors

V5 Kiosk

QA & Research

Other 3rd Party Devices

V5

Vendor Location

Vendor Remote Access

(LAN to LAN tunnel)

Firewall

V2 App Server

VM

V1/V2CentralStation

Supported Anesthesia or

Ventilator

PHS &Vendor

Proprietary

PHS Enterprise

V4 Terminal Server

V5 Terminal Server

V5 VCPServers

FirewallV3 IntegrationServer

V3 Interface

Physiologic Monitor

V1/V2 Adapter

BLUE = Location Zone

RED = DMZ Network

GREEN = Enterprise Network

VM = Virtual Machine

V1-V5 = Integration Vendor

1 thru 5

LEGEND

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We can do better!

“We need complete, accurate and contextually aware data”

“I want to monitor every patient at every bed in every

country I have a hospital”

“Why can’t an infusion pump be paused when the

person is overdosing?”

“How many ventilators do I have in use right now?”

“How do I take my 30 years of experience and use it to

help a new physician provide high quality healthcare?”

“Why can’t this be automatically put in the medical record?”

“We need to change what is expected

of technology in healthcare”

Questions/User Needs from MGH’s MDPnP Program Clinical Scenario Repository

Near

Patient Data

1-2 GB/day

EMR

100-200

MB/day

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Mistakes Kill & Inefficiency is Costly

Hospital error is the

3rd leading cause of

death in the U.S.

and inefficiency

reduces patient

outcomes“… the anesthesiologist forgot to resume ventilation after separation from cardiopulmonary bypass…---Every surgical team surveyedhas experienced this error!

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What if… Integrating Clinical Environments can enable

apps to rapidly and safely implement solutions?

ICE Platform

An Integrated Clinical Environment (ICE)

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Real-Time CDS

App detects Pulseless

Electrical Activity and

provides real-time Clinical

Decision Support

(RTCDS)

Developed on OpenICE,

an open source research

platform built by MD PnP.

www.openice.info

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What is the Internet of Things?

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The IoT Transforms Industries

MusicPhysical records -> Subscription streaming

RetailBrick-and-mortar -> Digital marketplaces

PublishingPrinted newspapers -> Online news feeds

TelevisionCable -> TV-on-Demand

TransportationPersonal cars -> Ride-share -> Self-driving ride-share

HealthcareCapital equipment -> Usage-based

Fee for service -> Value-based care

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Why is this so HARD to implement?

SecurityWhat does this even mean?

ConnectivitySo many choices….

InteroperabilityIs it even possible?

Real-Time AnalyticsAre we even ready for this?

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Conventional View of the IoT

• Cloud-centric

• Consumer application-focused

• Limited scalability and performance

• Poor robustness

• Reduced capabilityand utility

• Limited security

Analytics and Services

in the Cloud

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The Evolution of the IoT

Artificial Intelligence

Dat

a In

terc

on

nec

tivi

ty

MONITORING

OPTIMIZATION

AUTONOMY

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The Next Phase of the IoT

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Decentralized Peer to Peer Systems

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Edge Intelligence in Healthcare

Fo

gE

dg

eIT

/Clo

ud

Mobile

Ward

Room

System Apps Clinical Apps

HIS PAC LIS EMR AMT Cloud Server

Data LakeSystem Apps

Database

Ward Databus (DDS)

System Apps Clinical Apps

MedicalDevice

MedicalDevice

MedicalDevice

MedicalDevice

Database

Patient Room, Operating Room or ICU Databus (DDS)

IT Systems/Enterprise Databus (DDS)

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Standards Based Interop Platform

Medical Interoperability Platform

(API based Architecture)

DDS Databus

Applications

Application Support, Security, Service Orchestration

EMR AnalyticsClinical Apps

Point of Care

Devices Gateways

Remote Management

Access and Security

External Systems

Se

curity

Ga

tew

ay

Networks PLHR

Internal Systems

Data Storage

MPIIT

Systems

Se

curity

Ga

tew

ay

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DDS: Open IoT Standard

• Data Distribution Service

(DDS) is an open industry

standard for data-centric

connectivity

• From OMG, the world’s

largest systems software

standards organization– UML, DDS

– Industrial Internet Consortium (IIC)

Interoperability between source

written for different vendors

Interoperability between applications

running on different implementations

DDS API

Distribution Fabric

DDS-RTPS ProtocolReal-Time Publish-Subscribe

DD

S S

ecu

rity

Plu

g-I

n

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Designed to Manage Complexity

Point-to-Point

TCP

Sockets

Client/Server

MQTT

XMPP

OPC

CORBA

Publish/Subscribe

Fieldbus

CANbus

ZeroMQ

JMS

Queuing

AMQP

Active MQ

Data-Centric

DDS

Brokered

ESB

Daemon

Shared Data Model

Databus

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Key Connectivity Standards

Transport

Link

Framework

Distributed Data

Interoperability and Management

Physical

Network

DDS oneM2M Web Services OPC-UA

DDSI-RTPS

TCP

coAP HTTP OPC-UA Bin

IP

MQTT

UDP TCP

TSN /

Ethernet

(802.1,

802.3)

Wireless

PAN

(802.15)

Wireless

LAN

(802.11 Wi-

Fi)

Wireless

2G/3G/LTE

(3GPP)

Wireless

Wide Area

(802.16)

Manufacturing

Origin

Telecommunications

Origin

Source: Industrial Internet Consortium Reference Architecture

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• Data Centric

– Applications interface only to data

– Every application gets everything it

needs, when it needs it

• High Performance

– <10us Latency

– >40GB/s Thoughput

• Highly Reliable and Secure

– Deployed in 1000’s of mission critical

applications

• Interoperable

– Provides syntactic interoperability via

open DDS standard technology

• Scalable

– Proven scalability to millions of nodes

via layered databus architecture

DDS – Medical Grade Connectivity

Shared Global Data Space

DDS Databus

Naturally, massively parallel

DataTopic

Type

QoS

DataTopic

Type

QoS

DataTopic

Type

QoS

Enables “Data Everywhere”

Abstraction

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Secure Dataflow

• Complete ProtectionUtilize DDS Security by appropriately securing the data (by type) in real time

• Dataflow Level SecuritySecure each piece of data in

addition to securing the “pipe”

Data Item Authentication Access Control Integrity Non-Repudiation Confidentiality

Device

Diagnostic DataX X

Remote

CommandsX X X X

Patient Data X X X X

State Alarms SetPoint

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DDS Availability and Adoption

~6 Commercial DDS Vendors

~6 Open Source DDS Implementations

Adopted by major standards bodies:

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A Data-Centric Healthcare IoT Platform

Devices

Medical

Interoperability

Platform

Applications

vMobile

Data Model

Quality

of

Service

Security

DDS-RTPS Messaging Protocol

API Governance

Data Resource Model

Publish-Subscribe Request-Reply Discovery

Exception Handling

ID and Addressing

Data Type System Lifecycle (CRUD)

State Management

Devices at the Point of Care(Room, Ward, Hospital, Hospital Group)

HIS PACS LISSystem

Apps

Clinical

AppsADTEMR

Data

LakeCloud

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DDS - The Foundation of Healthcare IoT

Interoperability Reliability Secure and Seamless

Data Flows

Interfaces to

External Systems

Scalability Support ALL Necessary

Data Types

Open, Member/Vendor

Neutral, No Blocking

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Benefits for Providers

Clinicians C-Suite IT & Clinical Engineers

Patient Specific Solutions

Real-Time

Clinical Decision Support

Contextualized Workflow

Data-Rich Decisions

Improved Quality Metrics

Transforming the IndustryOptimize Assets and

Technology

Simplified Management and

Maintenance

Simplified Integration

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Benefits for the Ecosystem

Patients Payers Device OEMs

Lowers Risk of Medical Error

Improved Clinical Experience

Lower Cost

Complete Visibility in Patient

Stay and Cost

Audit Trail

More Complete Public Health

Data

Speeds Development

Lowers Development Cost

Simplified Integration

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Key Components Needed for Success

• Data Model for Near Patient Data (Semantic/Organizational)

• This architecture is only successful with a comprehensive and extensible, widely-

accepted and widely-adopted data model.

• Ideally there would be a small number of harmonized data model driven by

system integrators, major medical device OEMs, provider networks, or a

standards organization.

• Suggest starting with existing standards and expanding as needed to meet the

needs of a diverse set of clinical scenarios.

• Ability to Interface with Legacy and Enterprise Architectures

• Proprietary Device (Coms Protocol/Data Structure) <-> DDS + Data Model

• DDS + Data Model <-> Restful API + FHIR Data Model

• 3rd party ecosystem should develop to optimize development efforts

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Timeline for Adoption

Source: Hype Cycle (Gartner), Crossing the Chasm (Geoffrey Moore)

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MD PnP (OpenICE Platform)

Example of collaborators

http://mdpnp.mgh.harvard.edu/

• Program established 2004 at Mass General

Hospital/Partners Healthcare

• Lab opened 2006 for research on achieving safe,

secure interoperable medical systems

(standards, technologies, products). Expanded

2017.

• Clinical, biomed, computer science, and IT

subject matter experts

• Publish research to enable safe interoperability

• Develops OpenICE open-source interoperability

research platform www.openice.info

• $22M research funding primarily from DOD, NIH,

NSF, DHS (FDA-MITRE)

• Multiple collaborative lab prototyping and public

demonstrations with industry, academia, and

government

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DocBox Platform

• Vision - Utilize an standard approach to create an infrastructure where

data can be leveraged at motion and at rest in order to improve,

safety, efficiency and efficacy of care.

• Simplified Infrastructure - Data is aggregated in real-time; it is stored,

analyzed, and available in an standard format.

• Enable Key Apps - Data is made available for applications to connect

in real-time and retrospectively. This enables solutions for

visualization, automation, and real-time decision support.

• Framework for Safety and Security - Platform provides a shared

infrastructure which is leveraged by applications to enhance patient

safety and cybersecurity

Clinicians Interact

via Apps

Connects and

Standardizes

Device Data

Data is sent to Big

Data Respository

Medical

Device 3

ADT

EHR

Lab

Pharmacy

DocBox

Medical

Device 2

Medical

Device 1

3rd Party

AppApp 1 App 2 New

App

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GE Healthcare

"GE Healthcare is leveraging the RTI Connext DDS-based architecture to

connect medical devices, cloud-based analytics, and mobile and

wearable instruments.”

Matt Grubis

Chief Engineer @ GE Healthcare - Mobile Digital Health Solutions

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It’s Time to Change the World

• We have the opportunity to save >200,000 lives and $30B in

healthcare costs by fully utilizing the power and capabilities of

the IoT.

• Technology is NOT the problem. Ideas are NOT the problem.

• We need to begin executing on a common mission to drive

data liquidity in Healthcare.

• The standards-based system architecture described

today could be the foundational tool to align the industry

to start EXECUTING!

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Next Steps

• Stop by the RTI Booth 8542 on the HIMSS 2019 Exhibition Hall to see a DDS-based system in action (DocBox).

• Reach out to Dr. Goldman to get involved with the Medical Device Plug and Play Program.

• Review the Industrial Internet Consortium’s guidance documents on Connectivity Frameworks (IICF) and Security Architecture (IISF).

• Advocate for the adoption of DDS-based Medical IoT architectures with Device Vendors, MDDS Vendors, and Standards Groups.

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Questions and Contact Info

Thank You!

David Niewolny Dr. Julian Goldman

[email protected]

512-785-9255

[email protected]

617-768-8765