Creating connected medical devices is challenging but doing so in an interoperable manner that can easily and flexibly fit into modern hospital IT environments is even more difficult. This presentation provides sage advice on how to design connected life-critical medical devices so that they work well within modern hospital environments.
2. NETSPECTIVE
Who is Shahid?
• 20+ years of software engineering and multisite 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”
www.netspective.com
2
3. NETSPECTIVE
What you’ll learn in this briefing
Wireless capable medical devices with significant software and data integration are the future
Topics
Key takeaways
• Things that kill and harm human
beings today are very different than
just 100 years ago
• Health policy and payments are
shifting to deal with new realities
• Marketplace and industry challenges
for device vendors
• Why wireless connectivity is good
business
• Why wireless connectivity is a
disruptive innovation
• Wireless is a business enabler but
there’s a lot to consider.
• Hardware, sensors, and software are
transient businesses but data lives
forever. He who owns, integrates, and
uses data wins in the end.
• Data from devices is too important
and specialized to be left to software
vendors, managed service providers,
and system integrators.
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5. NETSPECTIVE
Bacteria used to kill us the most…
Per 100k population, Historical Statistics of the United States, Millennial Edition
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6. NETSPECTIVE
We’ve got most infections beat…
…except the flu and pneumonia
Per 100k population, Historical Statistics of the United States, Millennial Edition
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7. NETSPECTIVE
Infectious diseases used to kill us…
…but what’s left seem only to be “manageable” not easily “curable”
Top killers in 1900
Pneumonia
and influenza
TB
Diarrhea and
enteritis
Top killers today
Heart disease
Cancer
Chronic lower
respiratory
diseases
Per 100k population, Historical Statistics of the United States, Millennial Edition
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8. NETSPECTIVE
From cures to management…
…young people don’t dye of diseases often now
Death by age group, 1900
Death by age group, Today
http://siteresources.worldbank.org/INTHSD/Resources/topics/Health-Financing/HFRChap1.pdf
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9. 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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10. NETSPECTIVE
Healthcare industry / market trends
Major market and regulatory trends that are causing customers and competitors to shift
You must learn and be able to talk to customers about all these terms
PPACA
ACO
PCMH
“Affordable Care
Act”
“Accountable
Care Org”
“Medical
Home”
Health
Home
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mHealth
MU
“Meaningful Use”
PCPCC
“Patient Centered
Care”
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11. 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
11
12. NETSPECTIVE
The new world order
General
Wellness
Specific
Prevention
Self Service
Physiologics
Self Service
Monitoring
Healthcare
Professional
Monitoring
Care Team
Diagnostics
Care Team
Monitoring
Self Service
Diagnostics
Healthcare
Professional
Diagnostics
Hospital
Monitoring
Hospital
Diagnostics
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14. NETSPECTIVE
Don’t give up data to others without a fight
Software vendors, systems integrators, and others don’t have your best interest in mind
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
14
15. NETSPECTIVE
Data is getting more sophisticated
Social Interactions
Biosensors
Admin
Phenotypics
Since 1970,
pennies per
patient
Since 1980s,
pennies per
patient
• Business focused data
• Retrospective
• Built on fee for service models
• Inward looking and not focused
on clinical benefits
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• Must be continuously collected
• Mostly Retrospective
• Useful for population health
• Part digital, mostly analog
• Family History is hard
Genomics
Since 2000s,
started at $100k
per patient, <$1k
soon
• Can be collected infrequently
• Personalized
• Prospective
• Potentially predictive
• Digital
• Family history is easy
Proteomics
Emerging
• Must be continuously collected
• Difficult today, easier tomorrow
• Super-personalized
• Prospective
• Predictive
15
16. NETSPECTIVE
Data is key for move from FFS to ACOs
Integrated and aggregated data is the only way to get to ACOs and PCMHs
The business needs
The technology strategy
Quality and performance metrics
Patient stratification
Care coordination
Population management
Surveys and other direct-frompatient data collection
• Evidence-based surveillance
•
•
•
•
•
•
•
•
•
•
•
•
•
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Aggregated patient registries
Data warehouse / repository
Rules engines
Expert systems
Reporting tools
Dashboarding engines
Remote monitoring
Social engagement portal for
patient/family
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17. NETSPECTIVE
You can use OSS to disrupt existing health IT
Customers trapped by
their EHR vendors are
begging for a way out
Device vendors aren’t
benefiting from industry
trends but can if they’re
smart about it
Clinical customer goals
have shifted from basic
automation to advanced
process optimizations
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Customer base has
shifted from clinical to
clinical + IT + system
integration
Device manufacturer’s
access to regulated IT
and system integration
skills is growing
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20. NETSPECTIVE
Needed: care team involvement
PATIENT/
CONSUMER
HEALTHCAR
E PROVIDER
Care Team
FAMILY
CAREGIVER
CALL CENTERS AND
REMOTE SUPPORT
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HOSPITAL
ALTERNATE
SITE OF
CARE
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22. How data changes science and what that
means to medical device designs
23. NETSPECTIVE
Data changes the questions we ask
Simple visual facts
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Complex visual facts
Complex computable
facts
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24. 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
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25. 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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26. 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
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Uncommon
Common
Somewhat
Common
26
27. NETSPECTIVE
Application focus is biggest mistake
Application-focused IT instead of Data-focused IT is causing business problems.
Silos of information exist across
groups (duplication, little sharing)
Clinical
Apps
Billing
Apps
Lab
Apps
Other
Apps
Healthcare Provider Systems
Patient
Apps
Partner Systems
Poor data integration across
application bases
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28. NETSPECTIVE
The Strategy: Modernize Integration
Need to get existing applications to share data through modern integration techniques
Clinical
Apps
NCI
App
Billing
Apps
Lab
Other
Apps
Apps
NEI
App
Healthcare Provider Systems
Patient
Apps
NHLBI
App
Partner Systems
Master Data Management, Entity Resolution, and Data Integration
Improved integration by services
that can communicate between applications
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32. NETSPECTIVE
Predictions for Integration
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
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33. NETSPECTIVE
Implications
Get your software
house in order
(IEC 62304, DO 178B/C,
etc.)
Move from
hardware to
software focus
Move to
algorithms and
data
Understand
system of
systems (SoS)
Plan for
integration and
coordination
Start building
simulators
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34. NETSPECTIVE
Key regulatory questions
Will the FDA accept
networked safetycritical systems?
Are connected
devices safe enough
for medical devices?
Yes
Yes
but you must prove it
The best regulatory strategy is to abstract
design specifications to minimize sustaining
engineering:
• Intended use
• Predicate device(s)
• Design approach and how OTS
• components are used
• Design input specifications
• Risk and hazard analysis
Abstract Specifications:
• Remove dynamic characteristics
• Manufacturer, model, version
• Performance specifications
• Clock speed
• Memory
• Storage
• Industry standards
• Third party certifications
Source: Tim Gee, MedicalConnectivity.com
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35. NETSPECTIVE
Regulatory Strategy
“The Device”
510(k) PMA,
Class 3, Class 2,
etc.
Class 1
510(k)
Class 2
“Data Bridges”
MDDS
Unregulated
EHR or others
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“Everything else”
Customer registry
Patient registry
Patient profile
Study Management
Billing
35
36. NETSPECTIVE
Key design questions
Regulatory
approach?
Wait for
standards?
Hardware
Design?
Software
Design?
IT
Infrastructure
Design?
Component based
separation and
task-based
approach
No, use what’s
available and
make yours the
standard
Follow mobile
phone designs
Buy or build a
BaaS, M2M, or IOT
Solution
Interface-based
flexibility over
defined certainty
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37. NETSPECTIVE
Key marketing & product management questions
Can your sales
team sell it?
Yes, if they’re
incentivized and
trained
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Can customer
manage the
technology?
They need a good
IT and test
environment to
ensure reliability
Does customer
have the existing
infrastructure?
Can you deliver
after you build it?
Can your
solutions team
customize it?
They need reliable
power, broadband
coverage, and
good WiFi
You need
installation,
provisioning,
testing, and
remote support
infrastructure
Yes, if you build for
customization
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38. NETSPECTIVE
Key human capital questions
You can’t go it alone, get help now
Do we have strategy
expertise?
Do we have
development
expertise?
Do we have unit
and internal testing
expertise?
Do we have systems
and customer
environment testing
expertise?
Do we have
regulatory
expertise?
Do we have
certification
expertise?
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39. The most important aspect of a data bridge is its connectivity
Connectivity strategy
40. NETSPECTIVE
Connectivity Decisions Required
Physical
• Wired, wireless (WiFi, cellular, etc.)
Logical
• Device Concentrator Gateway Enterprise IT Cloud
Structural
• Security, Numbers, Units of Measure, etc.
Semantic
• Presence, Vitals, Glucose, Heartbeats, etc.
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41. NETSPECTIVE
Legacy Physical Connectivity
11073 assumes desire for
multi-vendor connectivity
USB Converter
Device
Data
Concentrator
(IEEE 11073?)
Corporate Cloud
Hospital Network
Gateway
(Data Mediator)
Hospital Systems
Serial Converter
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42. NETSPECTIVE
Next Gen Physical Connectors
Minimal
•
•
•
•
Serial
USB 2.0
RJ-45
802.11a/b/g
www.netspective.com
Recommended
•
•
•
•
Serial
USB 3.0
RJ-45
Power over Ethernet
(PoE)
• 802.11n
• Bluetooth
Advanced
•
•
•
•
•
•
•
•
•
•
Thunderbolt
USB 3.0 + eSata
RJ-45
Power over Ethernet
(PoE)
802.11n/I
Bluetooth
Ant+
Zigbee
Cellular
Zwave
42
43. NETSPECTIVE
Next Gen Physical Connectivity
Option 1 (hospital IT integration required or no cellular access)
Device
Wireless
Bluetooth,
WiFi, Zibee, etc.
Wired
Hospital
Network
Gateway
Could be a Home
Network, too
Corporate
Cloud
Hospital
Systems
Option 2 (cellular access and no hospital IT integration required)
Device
www.netspective.com
Wireless, Cellular
Corporate
Cloud
43
44. NETSPECTIVE
Legacy Protocols Best Practices
Serial
Serial
Converter
REST
Ethernet
Device
USB
Converter
DDS
Data
Concentrator
If multi-vendor
connectivity is
required,
add data translator
and homogenization
capability
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DDS
Hospital
Network
Corporate
Gateway
HL7
MPEG-21
Corporate
Cloud
Hospital
Systems
X.12
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45. NETSPECTIVE
Next Gen Protocols Best Practices
REST
DDS
Option 1 (no cellular access or hospital IT integration required)
Device
Wireless
Bluetooth,
WiFi, Zibee, etc.
Wired
Hospital
Network
Corporate
Gateway
Could be a Home
Network, too
HL7
MPEG-21
External
Cloud
Hospital
Systems
X.12
Option 2 (cellular access and no hospital IT integration required)
Device
DDS
REST
MPEG-21
External
Cloud
Wireless, Cellular
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45
46. Legacy device architecture and how next generations must be better
Device, Gateway, and Ecosystem Architectures
47. NETSPECTIVE
Typical Legacy Device Architecture
Sensors
Storage
Display
User Device Logic
Interface
Connectivity
(USB, Serial)
Device OS
(Custom, QNX, etc.)
Serial
Healthcare Enterprise
Serial Concentrator
Serial to Ethernet Converter
Not much happens with device data
Greatly oversimplified
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49. NETSPECTIVE
Next Gen Gateway Architecture
Patient
Manager
Secure
Social
Messagi
Network
ng
s
Single sign on (LDAP, SAML)
HCP
Directorie
s
Target multiple devices like
PC, SmartPhone, Tablet,
Voice
HIE/NHIN
Integratio
n
EHR
Integratio
n
NLP &
Patterns
Med
Device
Integratio
n
Med Device Tethering
Security &
Auditing
App Store
EHR Modules
Alerting
Themes
Documents
Dashboards
IM / E-mail
Forms
Reporting
Content Management System
Biz Intel
EII
Metadata
Gateway
Data Mining
Notifications
ETL
OLAP
Process Mgmt
HIPAA Encryption & RBAC
Provisioning & Auditing
Legacy App Connectivity
Rules Engine
Analytics
Integration
Mobility Stack
Secure, HIPAA-Compliant, Web Server
HL7
X.12
CCR DDS
Enterprise Service Bus
Data Integration Stack
Web Application Stack
Secure, MU- and HIPAA-Compliant, Clinical Data Repository (CDR) and Master Patient Index (MPI)
Relational Database
Graph DB (RDF)
Content Repository
Taxonomy
Full Text Search
LDAP
Data Services and Persistence Stack
On-Premise Appliance or Cloud Deployment
As defined
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by Netspective Medigy Platform
49
50. NETSPECTIVE
Ensure transport flexibility
Hospital or Cloud
Development
TCP, HTTPS, SOAP, REST
HTTP, SFTP, SCP, MLLP
SMTP, XMPP
Vendors & Partners
VPN
Services
Remote
Center
Apps
Apps
Registry
MQs
Services
HTTPS, REST, SOAP
SFTP, SCP, MLLP
SMTP, XMPP, TCP
Embeddable Integration Backbone
Central
DB
Security
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Service
DB
Management
Services
Firewall
App
DB
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51. NETSPECTIVE
Make data available early
Proactive
Responsiveness
Reactive
Scheduled Reports
HIS / EHR
Manual Analysis
CPOE
Operations
Financial
Automated
Analysis
Alerts
Response
Labs
Meds
Time Elapsed
?
Minutes
1 Day/Week
1 Month
Source: Informatica Corporation
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52. NETSPECTIVE
Don’t limit the format types
HL7
HL7 RIM
CDISC
Excel, CSV
Access,
SQL
SEND
CCD
CCR
RDF, RDFa
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ATOM Pub
X.12
52
53. NETSPECTIVE
Choose tools that can do it all
Connect
Collect &
Cleanse
Exchange
Standardize
(Map & Link)
Federate
Store
Analyze
Report
Secure
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Audit
Guarantee
HIPAA
Compliance
53
54. NETSPECTIVE
Structured Data Format Suggestions
Item
In general
Follow requirements stipulated by NIST in MU
guidance
Patient Summary Record
HL7 CDA Release 2 CCD or ASTM CCR
Electronic Prescribing
NCPDP SCRIPT Version 8.1 or 10.6
Electronic Submission of
Lab Results to Public
Agencies
HL7 2.3.1 or HL7 2.5.1
Electronic submission to
immunization registries
HL7 2.3.1 or HL7 2.5.1
Quality Reporting
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Standard
The CMS Physician Quality Reporting Initiative (PQRI)
2009 Registry XML Specification
54
55. NETSPECTIVE
Coded Vocabulary Suggestions
Item
In general
Follow requirements stipulated by NIST in MU
guidance
Problem List
ICD9-CM / ICD10 or SNOMED CT 2009
Procedures
CPT-4 / CPT-5
Laboratory test results
LOINC 2.27+
Medications
Any source vocabulary that is included in RxNorm
Immunizations
HL7 Standard Code Set CVX - Vaccines Administered,
July 30, 2009 version
Race and Ethnicity
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Standard
OMB Statistical Policy Directive No. 15
55
56. NETSPECTIVE
Privacy and Security Standards
Item
In general
Follow NIST 800-53 and related standards
Encryption and decryption of
electronic health information
SSL/TLS Certificates, NIST FIPS 140-2
Record actions related to
electronic health information
The date, time, patient identification, and user identification
must be recorded when electronic health information is
created, modified, accessed, or deleted; and an indication of
which action(s) occurred and by whom must also be recorded
Verification that electronic
health information has not
been altered in transit
SHA-1 or higher (NIST FIPS PUB 180-3)
Record treatment, payment,
and health care operations
disclosures
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Standard
The date, time, patient identification, user identification, and a
description of the disclosure must be recorded for disclosures
for treatment, payment, and health care operations, as these
terms are defined at 45 CFR 164.501
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