This document discusses the use of open source software and technologies in safety-critical medical device platforms. It argues that medical device vendors should be using open source to implement safety-critical requirements, contribute to open source projects, and create their own open source projects. Open source can help address the need for more connectivity and interoperability between devices as healthcare moves towards integrated systems. However, open source also presents compliance, reliability and security challenges that require risk assessments, hazard analysis, and processes to validate code from open source projects.

1. Open Source Software (OSS) and Technologies
in Safety-critical Medical Device Platforms
Using Open Source to Design Connected Medical Devices
Shahid N. Shah, CEO

2. NETSPECTIVE
Who is Shahid?
• Chairman, OSEHRA.org Board of Advisors
• 20+ years of software engineering and
multi-discipline complex IT implementations
(Gov., defense, health, finance, insurance)
• 12+ years of healthcare IT and medical
devices experience (blog at
http://healthcareguy.com)
• 15+ years of technology management
experience (government, non-profit,
commercial)
www.netspective.com
Author of Chapter 13, “You’re
the CIO of your Own Office”
2

3. NETSPECTIVE
Open source software (OSS) is in your future
• You’re moving from standalone boxes to fully integrated
systems
• mHealth demands more interoperability
• Your customers demand flexible workflows with enhanced
functionality
• Your customer demand data integration with their systems
• Security of medical devices is under great scrutiny and
excuses aren’t going to be accepted
www.netspective.com
3

4. NETSPECTIVE
The new realities of patient populations
Prevention
•
Education
•
Health Promotions
•
Healthy Lifestyle Choices
•
Health Risk Assessment
Management
•
•
Obesity Management
Wellness Management
•
•
•
•
•
•
•
Assessment – HRA
Stratification
Dietary
Physical Activity
Physician Coordination
Social Network
Behavior Modification
•
•
•
Diabetes
COPD
CHF
•
•
•
•
•
Stratification & Enrollment
Disease Management
Care Coordination
MD Pay-for-Performance
Patient Coaching
•
•
•
•
Physicians Office
Hospital
Other sites
Pharmacology
•
Catastrophic Case
Management
Utilization Management
Care Coordination
Co-morbidities
•
•
•
26 % of Population
35 % of Population
35 % of Population
4% of Population
4 % of Medical Costs
22 % of Medical Costs
37 % of Medical Costs
36 % of Medical Costs
Source: Amir Jafri, PrescribeWell
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4

5. NETSPECTIVE
Wireless BAN Ecosystem is complex without OSS
Source: Qualcomm
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5

6. NETSPECTIVE
Data is getting more sophisticated, analysis even more so
It’s hard today but will be even harder tomorrow
Economics
Administrative
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Phenotypics
Behavioral
Biochemical
Genomics
Proteomics
IOT sensors
6

7. NETSPECTIVE
Implications of healthcare trends
PPACA
ACO
Software
Regulated IT and Systems
Integration Services
MU
Health
Home
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PCMH
mHealth
DATA
Evidence Based Medicine
Comparative Effectiveness
7

8. NETSPECTIVE
What users want vs. what they’re offered
Data visualization requires integration and aggregation
What’s being offered to users
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What users really want
8

9. NETSPECTIVE
Evolving Healthcare IT Enterprise Architecture
You need to fit into a complex environment
Device
Teaming
Cloud
Services
Patient
Self-Management
Platforms
SSL VPN
Patient Context
Monitoring
BaaS Gateway
(DDS, XMPP ESB)
,
Device
Data
Data Transformation (ESB, HL7)
Remote
Surveillance
Management
Dashboards
HIT
Integration
Report
Generation
Device reimbursement
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Enterprise Data
RCM, Financials,
EHRs
Device
Management
Cross Device
App Workflows
Device Utilization
Device profitability
Alarm
Notifications
Device Inventory
9

10. • Should medical device vendors be using
open source to implement their safetycritical requirements?
• How about contributing to open source
projects?
• How about creating their own open
source projects?
www.netspective.com
10

11. Yes!
• If you’re not using open source projects in your
own devices then you’re doing far more
engineering work than is necessary.
• If you’re not contributing to open source then
you’re not making code you rely on better.
• If you’re not creating open source then you’re
missing a valuable marketing opportunity.
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11

12. NETSPECTIVE
Connectivity is a must, OSS is answer
Most obvious benefit
Least attention
Most promising
capability
This talk focuses on
connected devices
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12

13. NETSPECTIVE
Appreciate tradeoffs
The more connectionfriendly a device, the
harder it is to validate it
Integrationfriendliness
Ease of
validation
Lesson: Demand Testability
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13

14. NETSPECTIVE
What are we afraid of when it comes to OSS?
Compliance
Reliability
Will the FDA and other
regulators accept open
source code in safetycritical systems?
Is open source code safe
enough for medical
devices?
www.netspective.com
14

15. Yes, of course.
Proof: we did it at American Red Cross in 1996 for a Class 3
device built on a modern enterprise IT ecosystem
Lesson: Risk managers and quality leadership often use
regulators as an excuse to prevent OSS use because of OSS
illiteracy, not legitimate strategy or actual evidence of harm.
Reality: Regulators don’t care about your use of open source,
they care about safe systems that meet intended use.
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15

16. NETSPECTIVE
Code you write is not necessarily safer
There is significantly more and better
testing of large open source projects
than you could ever do
In an integrated ecosystem, you have to
learn how to rely on others and do so
safely and effectively
Modern IT systems’ custom
components
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16

17. 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.
www.netspective.com
17

18. How to start using OSS immediately

19. NETSPECTIVE
Remove OSS illiteracy from decision making
Understand open
source licensing,
remove the fear of
IP loss
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Understand where
code is coming
from and what test
harnesses included
Get in touch with
the open source
developers to find
out the current
utilization
19

20. NETSPECTIVE
Choose the right OSS projects
Requirements
traceability
possible?
Code reviews
conducted by OSS
code authors?
Unit testing
conducted by
authors?
Continuous
integration system
employed?
Integration testing
conducted?
Performance
testing
conducted?
Safety testing
conducted?
Security testing
conducted?
www.netspective.com
20

21. NETSPECTIVE
Engender trust in the code’s provenance
Connect to
the revision
control
system of the
open source
project
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Create your
own binaries
Create a
process to
securely sign
the binaries
Create your
own
deployment
packages
21

22. NETSPECTIVE
Integrate OSS into your QSR process
Employ continuous
integration (CI) for
your own and OSS
project components
Create a process to
test the binaries
using code
coverage tools
Keep an eye on
changes coming in
from the source and
retest regularly
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Conduct continuous
hazard and risk
analysis of outside
code
Review your process
with the compliance
officers and get
their regular buy in
22

23. 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
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23

24. NETSPECTIVE
OSS hazard and risk assessment
• What is the intended use for the device or system?
• How will the OSS product you’re planning to use going to be
tied to your intended use?
• What is the risk associated with the OSS product for that
particular intended use?
R = S h x Ph
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24

25. NETSPECTIVE
Risk is related to severity and harm
R = risk
Sh = severity of harm
Ph = probability of harm
R = S h x Ph
• Harm is damage done to a person
• Severity is the degree of harm done
• Probability is the frequency and duration of exposure
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25

26. NETSPECTIVE
Examples of Severity & Probability
Severity
Probability
• multiple fatalities
• fatalities
• severe injury (non-reversible, requires
hospitalization)
• moderate injury (reversible, requires
hospitalization)
• minor (reversible, requires first aid)
• very minor (no first aid)
•
•
•
•
•
•
•
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Constant exposure
Hourly
Daily
Weekly
Monthly
Yearly
Never
26

27. NETSPECTIVE
Formal risk assessment methods
What-if analysis
Preliminary
hazard analysis
(PHA)
Fault tree
analysis (FTA)
www.netspective.com
Failure modes
and effects
analysis (FMEA)
Hazard and
operability
studies
27

28. NETSPECTIVE
OSS Risk analysis steps - FMEA
Define the function of the OSS product being analyzed.
Identify potential failures of the OSS.
Determine the causes of each failure types.
Determine the effects of potential failures.
Assign a risk index to each of the failure types.
Determine the most appropriate corrective/preventive
actions.
• Monitor the implementation of the corrective/preventive to
ensure that it is having the desired effect.
•
•
•
•
•
•
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28

29. NETSPECTIVE
Good summary of FMEA
• http://en.wikipedia.org/wiki/
Failure_mode_and_effects_analysis
www.netspective.com
29

30. NETSPECTIVE
Sampling of OSS / open standards
Project / Standard
Subject area
D
G
Linux or Android
Operating system


OMG DDS (data
distribution service)
Publish and subscribe
messaging


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
Comments
Open standard with open
source implementations
Build for extensibility
30

31. NETSPECTIVE
OSS applicability to connectivity
Physical
• Wired, wireless (WiFi, cellular, etc.)
Logical
• Device  Gateway  Data Routers  Systems
Structural
• Security, Numbers, Units of Measure, etc.
Semantic
• Presence, Vitals, Glucose, Heartbeats, etc.
www.netspective.com
31

32. NETSPECTIVE
OSS applicability to manageability
Security
• Is the device
authorized?
Teaming
Inventory
• Device grouping
• Where is the device?
Presence
• Is a device connected?
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32

33. NETSPECTIVE
OSS enables extensible devices
Legacy
Devices
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Future
Devices
33

34. NETSPECTIVE
Shahid’s “Ultimate Connectivity Architecture”
5
Device Components
Sensors
Storage
Display
Web Server, IM Client
• Presence
6
• Messaging
• Registration
• JDBC, Query
Plugins
3rd Party Plugins
App
#1
App
#2
7
4 Connectivity Layer (DDS, HTTP, XMPP)
3 Plugin Container
2
1
Security and Management Layer
Device OS
Event Architecture
Location
Aware
(QNX, Linux, Windows)
SSL VPN
Healthcare Enterprise
8
Patient Context
Device Gateway (DDS, ESB)
Inventory
Notifications
Cloud
Services
Data Transformation (ESB, HL7)
Management
Dashboards
www.netspective.com
Workflow
9
Enterprise
Data
34

35. NETSPECTIVE
OSS in Ultimate Architecture Core
Connectivity is
built-in, not added
Device Components
Think about
Plugins from day 1
Build on
Open Source
Connectivity Layer (DDS, HTTP, XMPP)
Plugin Container
Device OS
(QNX, Linux, Windows)
Don’t create
your own OS!
www.netspective.com
Security and Management Layer
Create code as
a last resort
Security isn’t
added later
35

36. NETSPECTIVE
OSS enables plugin architecture
Device Components
3rd Party Plugins
App
#1
App
#2
Plugins
Event Architecture
Location
Aware
Plugin Container
Device OS
(QNX, Linux, Windows)
www.netspective.com
Connectivity Layer (DDS, HTTP, XMPP)
Security and Management Layer
36

37. NETSPECTIVE
OSS in connectivity components
Surveillance &
“remote display”
Remote Access
Alarms
Device Components
Design all functions
as plugins
Event Viewer
Web Server, IM Client
• Presence
• Messaging
• Registration
• JDBC, Query
Connectivity Layer (DDS, HTTP, XMPP)
Plugin Container
Device OS
(QNX, Linux, Windows)
www.netspective.com
Security and Management Layer
37

38. NETSPECTIVE
OSS in device components
Virtualize!
Device Components
Sensors
“On Device”
Workflow
Patient
Context, too
www.netspective.com
Storage
Web Server, IM Client
Display
Event Architecture
Location
Aware
3rd Party Plugins
Plugins
Connectivity Layer (HTTP, XMPP)
Plugin Container
Device OS
(QNX, Linux, Windows)
Security and Management Layer
38

39. NETSPECTIVE
OSS enables enterprise integration
Device
Teaming
Cloud
Services
Patient
Self-Management
Platforms
SSL VPN
Patient Context
Monitoring
BaaS Gateway
(DDS, XMPP ESB)
,
Device
Data
Data Transformation (ESB, HL7)
Remote
Surveillance
Management
Dashboards
HIT
Integration
Report
Generation
Device reimbursement
www.netspective.com
Enterprise Data
RCM, Financials,
EHRs
Device
Management
Cross Device
App Workflows
Device Utilization
Device profitability
Alarm
Notifications
Device Inventory
39

40. Visit
http://www.netspective.com
http://www.healthcareguy.com
E-mail shahid.shah@netspective.com
Follow @ShahidNShah
Call 202-713-5409
Thank You