Transcript N0346_IHE_Webinar_2011-PCD_Domain_rev1.0

Integrating the Healthcare Enterprise
International
Free Educational Webinar Series 2011
Learn More: www.ihe.net/events/webinars2011.cfm
www.ihe.net
Patient Care Device
Domain Update (PCD)
Planning Committee
Ken Fuchs / Steve Merritt
Technical Committee
John Garguilo / John Rhoads
www.ihe.net
PCD Domain Webinar Agenda
• Domain & Committee Overview
• Domain Profiles & Technical Frameworks
– Overview Profiles developed
– New Profiles developed in 2010-2011 year
• How to Participate?
– IHE International Membership
– Planning & Technical Committees
• Q&A Session
3
www.ihe.net
Domain & Committee
Overview
www.ihe.net
On the Road to Interoperability:
From Standards to Profiles
Base Standards
eHealth
Projects
Profile
Development
IETF
IHTSDO
Specific Extensions
www.ihe.net
Role of IHE PCD
• IHE PCD was formed in 2005 to address issues
related to integration of Point-of-Care medical
devices:
– With each other
– With enterprise systems
• IHE PCD wants to “raise the bar” from the
current state of integration projects to out of
the box interoperable solutions.
• IHE PCD’s co-sponsors are HIMSS, ACCE and
AAMI.
www.ihe.net
IHE PCD Charter
The Patient Care Device Domain is
concerned with use cases in which at least
one actor is a patient-centric point-of-care
medical device. The PCD coordinates with
other IHE clinical specialty based domains
such as medical imaging and lab to ensure
consistency of medical device integration
solutions across all IHE technical
frameworks.
www.ihe.net
IHE Development Process
IHE Profiles Drafted & Revised
Test at IHE Connectathons
Trial
Implementation
Published Posted
For Public
Comment
IHE Technical
Framework
Developed
Profile Selection by
Committees
IHE Call for Proposals
Opens
1-5 mos.
Publish in IHE’s
Product Registry
14-18 mos.
Demonstrate at a
6-13 mos.
IHE Improves,
Safety, Quality
and Efficiency in
Clinical Settings.
Install
Interoperable
products in
Clinical
Settings
worldwide
www.ihe.net
2011-2012 Cycle
IHE Profile Cycle
Stages
Participation
Status
Call for Proposal
Completed
Profile Selection
Completed
Open Date
Close Date
Learn More
September
2010
Examples of Brief Proposals:
October
2010
November
2010
Examples of Detailed Proposals:
July 2010
IHE Profiles drafted in
IHE Committees
Completed
February
20101
May 2011
Public Comment 1
Completed
May 2011
June 2011
Trial Implementation
Published
Completed
July 2011
IHE N.A. Connectathon
Registration
Open
August 22,
2011
ftp://ftp.ihe.net/Patient_Care_Devices/IH
EPCDyr5-2009-2011/Cycle_5_Proposals/
ftp://ftp.ihe.net/Patient_Care_Devices/IH
EPCDyr5-2009-2011/Cycle_5_Proposals/
IHE.net- Documents now in PC
IHE’s Wiki- PC Process explained
ftp://ftp.ihe.net/Patient_Care_Devices/Te
chnicalFrameworkforTrialImplementation/
September
30, 2011
www.iheusa.org/connectathon_part
icipant.aspx
IHE N.A. Connectathon
Dates
January 914, 2012
www.iheusa.org/connectathon_part
icipant.aspx
IHE Connectathon
European Dates
May 21-25,
2012
www.ihe-europe.net
www.ihe.net
2012-2013 Cycle
IHE Profile Cycle
Stages
Participation
Status
Open Date
Close Date
Call for Proposal
Learn More
Open
July 20, 2011
Sept 5, 2011
Examples of Brief Proposals:
Profile Selection
Closed
October
2011
December
2011
Examples of Detailed Proposals:
IHE Profiles drafted in
IHE Committees
Closed
February
2012
May 2012
Public Comment 1
Open
June 2012
June 2012
IHE.net- Documents now in PC
IHE’s Wiki- PC Process explained
Trial Implementation
Published
Open
N/A
August 2012
ftp://ftp.ihe.net/Patient_Care_Devi
ces/TechnicalFrameworkforTrialImpl
ementation/
IHE N.A. Connectathon
Registration
Open
August 2012
September
2012
IHE N.A. Connectathon
Dates
Open
January 2013
IHE Connectathon
European Dates
Open
Spring 2013
ftp://ftp.ihe.net/Patient_Care_Devices/IHEPC
Dyr5-2009-2011/Cycle_5_Proposals/
ftp://ftp.ihe.net/Patient_Care_Devices/IHEPC
Dyr5-2009-2011/Cycle_5_Proposals/
www.ihe.net
Domain Profiles
Developed
www.ihe.net
IHE PCD - Profiles
CPOE/ Pharmacy
System
Physiologic
Monitoring
System
Ventilation/
Anesthesia
System
ACM,
DEC,
WCM
Barcode
Medication
Administration
System
PIV
Infusion
Pump
ACM,
DEC
DEC
Home Based
System
Current
PCD
Future
PCD
Future
Non- PCD
ACM, DEC,
WCM, ADQ,
PCIM
EMR/EHR
EMR/EHR
Clinical Decision
Support System
ACM, DEC,
WCM, ADQ
IDCO
CIS
ACM, DEC,
WCM, ADQ,
PCIM
Other
Devices
ACM,
MEM
Implantable
Device
Equipment
Management
System
ACM: Alarm Communication Management
ADQ: Asychronous Device Query
DEC: Device Enterprise Communication
IDCO: Implantable Device – Cardiac – Observation
MEM: Medical Equipment Management
PCIM: Point-of-Care Identity Management
PIV: Point-of-Care Infusion Verification
www.ihe.net
WCM: Waveform
Communication Management
IHE PCD - Profiles
 Completed Workitems:




Rosetta Terminology Management (RTM)
Enterprise sharing of Patient Care Data (DEC)
PCD Alarm Communication Management (ACM)
Point-of-care Infusion Verification (PIV)
Implantable Device – Cardiac Observation (IDCO)
Waveform Content Message (WCM)
 Work in Process:




Event Communication (EVT)
Point-of-Care Identity Management (PCIM)
Device Point-of-care Integration (DPI)
Medical Equipment Management (MEM)
+ Location Services
+ Cyber Security Management
www.ihe.net
[RTM]
Rosetta Terminology Mgmnt.
www.ihe.net
[DEC]
Device to Enterprise Communication
www.ihe.net
[WCM]
Waveform Content Message
www.ihe.net
[ACM]
Alarm Communication Management
HL7 Messages
per ACM and
WCM profiles
Alarm
Source
Alarm
Reporter
AR
Device
Specific
graphics
Parameters, waveforms, etc.
as evidentiary data items
Report Alarm
PCD-04 →
← PCD-05
Report Alarm
Status
Alarm
Manager
AM
Disseminate Alarm
PCD-06 →
← PCD-07
Disseminate
Alarm Status
Alarm
Communicator
AC
Alarm Information
Dissemination Status
Source, Phase, State, Priority
Patient
Location
Instance
Alarm text
Callback
Timestamp
Evidentiary data
Instance
Accepted by AC
Undeliverable
Delivered
Read
Accepted
Rejected
Cancelled
Callback start/stop
www.ihe.net
[PIV]
Point of Care Infusion Verification
www.ihe.net
[IDCO]
Implantable Device – Cardiac Observ.
www.ihe.net
Domain Profiles
Under Development
www.ihe.net
[PCIM]
Point-of-Care Identity Management
www.ihe.net
[ADQ]
Asynchronous Data Query
Supports retrospective query of PCD data from databases.
Supports Use Cases such as Clinical Decision Support,
back-filling of EMR databases, etc.
Data Query
PCD-12
Data Query
PCD-12
Data Response
PCD-13
Data Response
Full
PCD-13
Disclosure
EMR,
CDSS,
CIS,
Etc.
Data Server
and/or
Data Requester
Data Query
PCD-12
Data Response
PCD-13
Data Servers
Data Requesters
www.ihe.net
[MEM]
Medical Equipment Management
Location Services
Current location
Previous locations (Trending)
Boundary controls (Alarm when
device leaves area)
Operational Status and
Monitoring
Is the device currently in use
Usage history
Alarms – which are active, what the trigger
levels, how long has the alarm been on
Day/time of last self check and its result
Event log recording
Preventative Maintanence
Patch Management
Last PM
Next scheduled PM
Last repair time/date
Pending patches
Patch history
Device Configuration
Management
Battery Management
On A/C or D/C?
Charge level (% of full)/Est.
operating time left.
Charging / Discharging history
Battery type and installation date
Est. battery life
Recall Management
Unique device identification
Hardware configuration (serial
numbers, etc)
Software configuration (revision
numbers, etc)
Device Reconfiguration
Use profiles (NICU vs. CICU)
Risk Management
Risk analysis
Risk evaluation
Verification of risk control measures
Residual risks
www.ihe.net
[MEM]
Location Services
www.ihe.net
[MEM]
Medical Device Security & Mgmnt.
HIPAA
Cyber
Protection
HITECH
IEC 80001
Network
Access
Control
IHE PCD
Authentication
Lifecycle
Mgmt.
Medical
Device
Access
Control
MDS2
Asset
Discovery
CE/IT
Manage
ment
Security
FDA:
• 21 CFR 801, 803,
807, 812, 814, 820
• MDDS
Configuration
Management
ePHI
Breach Risk
Privacy
Key Management
Encryption
www.ihe.net
[MEM]
Medical Device Security & Mgmnt.
www.ihe.net
Profiles & Technical Frameworks
Overview
• IHE Technical Frameworks
– Introductory information on the various Patient Care Device Technical Frameworks,
Profiles, White Papers and User Guides can be found at:
http://wiki.ihe.net/index.php?title=Profiles#IHE_Patient_Care_Device_Profiles
– Links to the Patient Care Device Technical Framework documents can be found on
IHE.NET at:
http://www.ihe.net/Technical_Framework/index.cfm#pcd
• Learn More
– Previous versions of the IHE PCD Webinar for the IHE Educational Webinar Series can
be found at:
• 2010 Webinar Series- http://www.ihe.net/Events/webinars2010.cfm
• 2009 Webinar Series- http://www.ihe.net/Events/webinars2009.cfm
• 2008 Webinar Series- http://www.ihe.net/Events/webinars2008.cfm
• Handouts or other helpful materials/links
www.ihe.net
IHE Development Process
IHE Profiles Drafted & Revised
Test at IHE Connectathons
Trial
Implementation
Published Posted
For Public
Comment
IHE Technical
Framework
Developed
Profile Selection by
Committees
IHE Call for Proposals
Opens
1-5 mos.
Publish in IHE’s
Product Registry
14-18 mos.
Demonstrate at a
6-13 mos.
IHE Improves,
Safety, Quality
and Efficiency in
Clinical Settings.
Install
Interoperable
products in
Clinical
Settings
worldwide
www.ihe.net
NIST Testing Tools
www.ihe.net
NIST Testing Tools
www.ihe.net
Connectathon – in the dungeon…
www.ihe.net
@ HIMSS
2010
PCD –PCD
HIMSS
Interoperability
Showcase 2011
www.ihe.net
IHE PCD
–
HIMSS
’10
Wall
1
PCD – HIMSS 2011
www.ihe.net
PCD – HIMSS 2011
www.ihe.net
IHE PCD
–
HIMSS
’10
Wall
2
PCD – HIMSS 2011
www.ihe.net
How to Participate
www.ihe.net
PCD PC Committee Responsibilities
Planning Committee
• Recruitment
• Education
• Presentations
• White Papers
• Review IHE Profile Proposals
• Identifies committee
priorities and problems
• Meets every 2 weeks
alternating with TC
Contact Information
• Project Mgr: Manny Furst
– [email protected]
• Co-Chair: Ken Fuchs
– Mindray North America
• Co-Chair: Steve Merritt
– Baystate Health
• Google Group
– [email protected]
• Committee’s Wiki
– http://wiki.ihe.net/index.php?title
=PCD_Planning_Committee
www.ihe.net
PCD TC Committee Responsibilities
Technical Committee
• Recruitment
• Development of IHE Profiles
• Maintenance of IHE
Technical Frameworks
• Development of test scripts
• Work with NIST on
automated testing
• Meets every 2 weeks
alternating with PC
Contact Information
• Project Mgr: Manny Furst
– [email protected]
• Co-Chair: John Garguilo
– NIST
• Co-Chair: John Rhoads
– Philips Healthcare
• Google Group email
– [email protected]
• Committee’s Wiki
– http://wiki.ihe.net/index.php?title
=PCD_Technical_Committee
www.ihe.net
PCD User Handbook 2011 Edition
•
•
•
•
•
Overview of IHE-PCD
Value Propositions for medical device interoperability
Advice on how to specify IHE in technology assessment
Tools to find IHE-PCD compliant products
Guidance on installation testing to confirm that IHE capabilities are
functioning properly
• Issues to consider when installing and configuring IHE-compliant system
• Identifying and addressing potential problems in order to maximize your
benefit despite existing “legacy” systems
• To be posted for comment shortly, meanwhile the draft is here
– wiki.ihe.net/index.php?title=PCD_User_Handbook
•
2011 Changes include
– Appendix H Mapping Clinical Requirements to Purchasing Requirements
– Consolidation of the 2 major sections into 1 section
– Incorporation of public comments from 2010 edition
www.ihe.net
RFP Guidance
www.ihe.net
We are Seeing Green Shoots!!
• Vendors are starting to release IHE compliant
products…
– ~20 devices/systems announced so far
– We expect ~30 devices by end of ’11
• Typically a search of Integration Statements on
the IHE web site will give you a list…
– http://product-registry.ihe.net
– Some vendors are having internal issues getting
the appropriate web sites set up.
www.ihe.net
Let’s Go Shopping!!
COMPANY
Amcom
PCD PROFILES
ACM
St. Jude Medical, Inc.
SYSTEM TYPE
Event Notification Middleware
Implantable Cardiac Device
Home Monitoring Service Center Observer System
Outlook Infusion Pump
Infusion Pumps
Space Infusion System
Infusion Pumps
DoseTrac Infusion Management
Software
"Gateway" software
Datacaptor
Interface System
CareAware iBus
Interface System
EpicCare Inpatient and
associated modules
EMR/EHR
Medtronic Mainspring
Implantable Device Follow-up
Connected System Gateway
System
eGateway Integration Manager HL7 Gateway
A5
Anesthesia machine
VEGA™
Interface System
eScreener Plus
Interface
Emergin
Alarm Manager
HL7 Gateway
Implantable Cardiac Device
Merlin.net MN5000
Observer System
Surgical Information Systems
SIS Periop
Periop CIS
ACM, DEC
Surgical Information Systems
SIS Anesthesia
Anesthesia CIS
ACM, DEC
Welch Allyn
Connex VM
VSM HL7 Gateway
DEC
BIOTRONIK SE & Co. KG
B Braun
B Braun
B Braun
Capsule
Cerner
Epic
Medtronic
Mindray DS USA, Inc.
Mindray DS USA, Inc.
Nuvon
OZ Systems
Philips
Philips
SYSTEM
Commtech Messenger
IDCO
DEC, ACM, PIV
DEC, ACM, PIV
DEC, ACM, PIV
DEC
PIV, DEC, ACM
DEC, PIV,ICDO
IDCO
ACM, DEC
ACM, DEC
DEC
DEC
ACM
DEC
IDCO
www.ihe.net
How to Participate in IHE PCD?
IHE International Membership is Free.
• Apply for IHE International Organizational Membership
– Visit: www.ihe.net/apply
– Approved monthly by IHE International Board
– Review IHE's 400+ Organizational Members
• Participate in IHE Domains & Committees
– IHE Organizational Members only
– 12 Clinical and Operational Domains
– Each Domain has one planning and one technical committee
• Non-members participate in comment periods and
implement IHE Technical Frameworks
www.ihe.net
Learn More about IHE International
Important Links and Information
• IHE Webinar Series runs June-September 2011
– Visit www.ihe.net for the full list of webinars
– Registration is free!
• All webinar recordings and slide decks will be posted
online at: www.ihe.net/Events/webinars2011.cfm
• Sign up for the IHE International News
– Email [email protected]
– Sign up for the IHE Webinar Series listserv
• Apply for IHE International’s Free Membership
– Visit: www.ihe.net/apply
www.ihe.net
Thank you for your attention
Questions?
www.ihe.net