This is an in depth technical presentation delivered at OSCon 2012 on how to define, design, and build modern safety-critical medical device platforms and Meaningful Use compliant EHR gateways. The talk starts with a quick background on comparative effective research (CER) and patient-centered outcomes research (PCOR) and the kinds of data the government is looking to leverage in the future to help reduce healthcare costs and improve health outcomes. After defining why data is important, the workshop will cover the different techniques for collecting medical data – such as directly from a patient, through healthcare professionals, through labs, and finally through medical devices; the presentation will cover which kinds of data are easy to collect and what are more difficult and how technical challenges to collection can be overcome.
After covering the data collection area the workshop will dive deep into a modern medical device platform architecture which the speaker calls “The Ultimate Medical Device Connectivity Architecture” – providing an in-depth overview and answering questions around architecture, specifications, and design or modern (connected) medical devices.
Presentations of open source software and other inexpensive design techniques for implementing connected architectures will be covered. Finally, the talk will cover details about medical device gateways, what new Meaningful Use rules might require when connecting EHRs to gateways, and how to design and architect gateways that can stand the test of time and be interoperable over the long haul.
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Building safety-critical medical device platforms and Meaningful Use EHR gateways
1. Building open source safety-critical
medical device platforms and
Meaningful Use EHR gateways
Inherent connectivity creates significant
opportunities in medical science
2. NETSPECTIVE
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 nonprofit)
www.netspective.com
Author of Chapter 13, “You’re
the CIO of your Own Office”
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3. NETSPECTIVE
What’s this talk about?
Health IT / MedTech Landscape
Key Takeaways
• 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.
• 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
www.netspective.com
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4. NETSPECTIVE
What if we had access to all this data?
• 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
Source: Jan Whittenber, Philips Medical Systems
www.netspective.com
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5. 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
www.netspective.com
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6. NETSPECTIVE
Data changes the questions we ask
Simple visual facts
www.netspective.com
Complex visual facts
Complex computable
facts
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7. NETSPECTIVE
Data can change medical science
The old way
The new way
Identify problem
Identify data
Ask questions
Generate questions
Collect data
Mine data
Answer questions
Answer questions
www.netspective.com
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9. NETSPECTIVE
Types of medical data we care about
Phenome
Genome
Proteome
Phenotype is a
composite of our
observable
characteristics or
traits
Genotype is the
entirety of our
hereditary
information (DNA,
RNA, etc.)
Proteome is our set
of proteins
expressed by our
genome and
changes regularly
over time
This is what we’ve
been studying for
centuries
Genetics is the
study of the
genome
Proteomics is the
study of the
proteome
www.netspective.com
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10. NETSPECTIVE
Unstructured patient data sources
Patient
Source
Self reported by
patient
Health
Professional
Observations by
HCP
Labs &
Diagnostics
Computed from
specimens
Errors
High
Medium
Slow
Slow
Low
Medium
Megabytes
Megabytes
Megabytes
Data type
PDFs, images
PDFs, images
PDFs, images
Availability
Common
Common
Common
Computed from
specimens
High
Data size
Computed realtime from patient
Medium
Reliability
Biomarkers /
Genetics
Low
Time
Medical Devices
www.netspective.com
Uncommon
Uncommon
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11. NETSPECTIVE
Structured patient data sources
Patient
Source
Self reported by
patient
Health
Professional
Observations by
HCP
Labs &
Diagnostics
Specimens
Medical Devices
Real-time from
patient
Biomarkers /
Genetics
Specimens
Errors
High
Medium
Low
Low
Low
Time
Slow
Slow
Medium
Fast
Slow
Reliability
Low
Medium
High
High
High
Kilobytes
Kilobytes
Kilobytes
Megabytes
Gigabytes
Gigabytes
Gigabytes
Uncommon
Uncommon
Discrete size
Streaming size
Availability
www.netspective.com
Uncommon
Common
Somewhat
Common
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12. NETSPECTIVE
Predictions for Device Hardware
Consumerization of Devices
Thick Devices
www.netspective.com
Thin Devices
Virtual
Devices
Sensors Only
with Built-in
Wireless
Sensors on
mobile
phones,
platforms
12
13. NETSPECTIVE
Predictions for Device Software
Consumerization of Apps
Software for
algorithms
www.netspective.com
Software for
functionality
Software for
connectivity
Software
only
13
14. NETSPECTIVE
Predictions for Device Connectivity
Consumerization of IT
Stand-alone
and
monolithic
www.netspective.com
Connectivity
within own
organization
Multi-vendor
connectivity
System of
Systems
(SoS)
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15. NETSPECTIVE
Predictions for Gateways
Changes in Practice Models
Single-purpose
devices
standalone
Multi-purpose
standalone
Multi-purpose
with
documentation
connectivity
Multi-purpose
with cooperating
connectivity
Multi-purpose
with analytical
connectivity
www.netspective.com
15
16. NETSPECTIVE
Predictions for Self-Management
The Patient is in charge
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
www.netspective.com
16
17. 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
www.netspective.com
17
19. NETSPECTIVE
OSS revolution in device capabilities
Most obvious benefit
Least attention
Most promising
capability
www.netspective.com
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20. NETSPECTIVE
OSS revolution in Gateways
Corporate Cloud (Data Center)
Development
HTTPS, SOAP, REST, HTTP
SFTP, SCP, HL7, X.12
SMTP, XMPP, DDS
Customers & Partners
Apps MQs Services
VPN
Services
Remote
Facilities
Apps
Registry
HTTPS, REST, SOAP
SFTP, SCP, HL7, X.12
SMTP, XMPP, DDS
Corporate Gateway (ESB)
Central
DB
Security
www.netspective.com
Service
DB
Management
Services
Firewall
App
DB
NOTE: Initial design is for a non-federated
backbone. If performance or security
demands require it, a federated solution will
be deployed.
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21. NETSPECTIVE
OSS revolution in integration
Device
Teaming
Cloud
Services
Patient
Self-Management
Platforms
SSL VPN
Patient Context
Monitoring
Device Gateway
(DDS, XMPP, ESB)
Device
Data
Cross Device
App Workflows
Data Transformation (ESB, HL7)
Remote
Surveillance
Management
Dashboards
HIT
Integration
www.netspective.com
Report
Generation
Enterprise
Data
Alarm
Notifications
Device
Management
Inventory
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22. NETSPECTIVE
OSS revolution in manageability
Security
• Is the device
authorized?
Teaming
Inventory
• Device grouping
• Where is the device?
Presence
• Is a device connected?
www.netspective.com
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23. NETSPECTIVE
Key OSS questions
Will the FDA accept
open source in
safety-critical
systems?
www.netspective.com
Is open source safe
enough for medical
devices?
23
24. NETSPECTIVE
Simple answers
Will the FDA accept
OSS in safetycritical systems?
Is OSS safe enough
for medical
devices?
Yes
Yes
but you must prove it
www.netspective.com
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25. NETSPECTIVE
It’s not as hard as we think…
• Modern real-time operating systems (open
source and commercial) are reliable for safetycritical 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.
www.netspective.com
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26. 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
www.netspective.com
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27. 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
www.netspective.com
Build for extensibility
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