Building open source safety-critical medical device ...assets.en.oreilly.com/1/event/80/Building...

Building open source safety-critical

medical device platforms and

Meaningful Use EHR gateways Inherent connectivity creates significant

opportunities in medical science

NETSPECTIVE

www.netspective.com 2

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”

http://healthcareguy.com/

NETSPECTIVE


What’s this talk about?

Health IT / MedTech Landscape

• Data has potential to solve some hard healthcare problems and change how medical science is done.

• The government is paying for the collection of clinical data (Meaningful Use or “MU”).

• All the existing MU incentives promote the wrong kinds of data collection: unreliable, slow, and error prone.

Key Takeaways

• Medical devices are the best sources of quantifiable, analyzable, and reportable clinical data.

• New devices must be designed and deployed to support inherent connectivity.

• OSS is ideal for next generation and innovative medical devices and gateways

NETSPECTIVE


What if we had access to all this data?

Source: Jan Whittenber, Philips Medical Systems

• Cardiac output

monitors

• Defibrillators

• Fetal monitors

• Electrocardiographs

• Infant incubators

• Infusion pumps

• Intelligent medical

device hubs

• Interactive infusion

pumps

• MRI machines

• X-Ray machines

• Physiologic monitors

• Ventilators

• Vital signs monitors

NETSPECTIVE


What problems can data help solve?

Cost per patient per

procedure / treatment

going up but without

ability to explain why

Cost for same

procedure / treatment

plan highly variable

across localities

Unable to compare

drug efficacy across

patient populations

Unable to compare

health treatment

effectiveness across

patients

Variability in fees and

treatments promotes

fraud

Lack of visibility of

entire patient record

causes medical errors

NETSPECTIVE


Data changes the questions we ask

Simple visual facts Complex visual facts Complex computable

facts

NETSPECTIVE


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

NETSPECTIVE


Evidence-based medicine is our goal

Eminence

• Trust me

Evidence

• Prove it

NETSPECTIVE


Types of medical data we care about

Proteome is our set of proteins expressed by our genome and changes regularly over time Proteomics is the study of the proteome

Proteome

Genotype is the entirety of our hereditary information (DNA, RNA, etc.)

Genetics is the study of the genome

Genome

Phenotype is a composite of our observable characteristics or traits

This is what we’ve been studying for centuries

Phenome

NETSPECTIVE


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

NETSPECTIVE


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

NETSPECTIVE


Predictions for Device Hardware

Thick Devices Thin Devices Virtual Devices

Sensors Only with Built-in

Wireless

Consumerization of Devices

Sensors on mobile phones,

platforms

NETSPECTIVE


Predictions for Device Software

Software for algorithms

Software for functionality

Software for connectivity

Software only

Consumerization of Apps

NETSPECTIVE


Predictions for Device Connectivity

Stand-alone and

monolithic

Connectivity within own

organization

Multi-vendor connectivity

System of Systems

(SoS)

Consumerization of IT

NETSPECTIVE


Predictions for Gateways

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

NETSPECTIVE


Predictions for Self-Management

Physicians manage paper

“charts” independently

Physicians and Hospitals

manage paper charts together

Electronic Health Records (EHRs) manage data in

systems

Health Information

Exchange allow coordination

Patients manage their

own data

The Patient is in charge

NETSPECTIVE


Implications

Make sure the patient is in the

middle

Move from hardware to

software focus

Move to algorithms and

analytics

Understand system of

systems (SoS)

Plan for integration and

coordination

Start building simulators

NETSPECTIVE


OSS revolution in device design

Device Components 3rd Party Plugins

App #1

App #2

Security and Management Layer Device OS (QNX, Linux, Windows)

Sensors Storage Display Plugins

Web Server, IM Client

Connectivity Layer (DDS, HTTP, XMPP)

• Presence • Messaging • Registration • JDBC, Query

Plugin Container

Event Architecture

Location Aware

1 2

3

4

5

6

7

NETSPECTIVE


OSS revolution in device capabilities Most obvious benefit Least attention

Most promising

capability

NETSPECTIVE


OSS revolution in Gateways

Corporate Gateway (ESB)

Service

DB

Manag

em

ent

Service

s

Secu

rity Fire

wall

HTTPS, REST, SOAP

SFTP, SCP, HL7, X.12

SMTP, XMPP, DDS

HTTPS, SOAP, REST, HTTP

SFTP, SCP, HL7, X.12

SMTP, XMPP, DDS

Customers & Partners

Apps MQs Services Apps Services

Corporate Cloud (Data Center)

Development

App

DB Central

DB

Registry

Rem

ote

Facilitie

s

VPN

NOTE: Initial design is for a non-federated

backbone. If performance or security

demands require it, a federated solution will

be deployed.

NETSPECTIVE


OSS revolution in integration

Cloud

Services

Management

Dashboards

Data Transformation (ESB, HL7)

Device Gateway

(DDS, XMPP, ESB)

Enterprise

Data

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

NETSPECTIVE


OSS revolution in manageability

Security

• Is the device

authorized?

Inventory

• Where is the device?

Presence

• Is a device connected?

Teaming

• Device grouping

NETSPECTIVE


Key OSS questions

Will the FDA accept

open source in

safety-critical

systems?

Is open source safe

enough for medical

devices?

NETSPECTIVE


Simple answers

Will the FDA accept

OSS in safety-

critical systems?

Is OSS safe enough

for medical

devices?

Yes

Yes but you must prove it

NETSPECTIVE


It’s not as hard as we think…

• Modern real-time operating systems (open source and commercial) are reliable for safety-critical medical-grade requirements.

• Open standards such as TCP/IP, DDS, HTTP, and XMPP can pull vendors out of the 1980’s and into the 1990’s.

• Open source and open standards that promote enterprise IT connectivity can pull vendors into the 2010’s and beyond.

NETSPECTIVE


But it’s not easy either…we need

Risk

Assessments Hazard Analysis

Design for

Testability

Design for

Simulations

Documentation Traceability Mathematical

Proofs Determinism

Instrumentation Theoretical

foundations

NETSPECTIVE


OSS / open standards applicability

Project / Standard Subject area D G Comments

Linux or Android Operating system Various distributions

OMG DDS (data distribution

service)

Publish and subscribe

messaging

Open standard with open source

implementations

AppWeb, Apache Web/app server

OpenTSDB Time series database Open source project

Mirth HL7 messaging engine Built on Mule ESB

Alembic Aurion HIE, message exchange Successor to CONNECT

HTML5, XMPP, JSON Various areas Don’t reinvent the wheel

SAML, XACML Security and privacy

DynObj, OSGi, JPF Plugin frameworks Build for extensibility

Conclusion and Questions

Thank you

@ShahidNShah

[email protected]

www.HealthcareGuy.com

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