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Integrating the Healthcare EnterpriseInternational
Free Educational Webinar Series 2011
Learn More: www.ihe.net/events/webinars2011.cfm
www.ihe.net
Planning Committee Ken Fuchs / Steve Merritt
Technical Committee John Garguilo / John Rhoads
Patient Care Device Domain Update (PCD)
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
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On the Road to Interoperability:From Standards to Profiles
Profile Development
Base Standards eHealth Projects
IHTSDO
IETF
Specific Extensions
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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
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.
IHE PCD Charter
www.ihe.net
Trial
IHE Profiles Drafted & Revised
6-13 mos.
Implementation Posted
Install Interoperable
products in Clinical Settings
worldwide
Install Interoperable
products in Clinical Settings
worldwide
Demonstrate at aDemonstrate at a
IHE Improves, Safety, Quality
and Efficiency in Clinical Settings.
14-18 mos.
Publish in IHE’s Product Registry
Test at IHE Connectathons
PublishedFor PublicComment
IHE Technical Framework Developed
IHE Call for Proposals Opens
IHE Call for Proposals Opens
Profile Selection by Committees
1-5 mos.
IHE Development Process
www.ihe.net
2011-2012 CycleIHE Profile Cycle Stages
Participation Status
Open Date Close Date Learn More
Call for Proposal Completed July 2010 September 2010
Examples of Brief Proposals: ftp://ftp.ihe.net/Patient_Care_Devices/IHEPCDyr5-2009-2011/Cycle_5_Proposals/
Profile Selection Completed October 2010
November 2010
Examples of Detailed Proposals: ftp://ftp.ihe.net/Patient_Care_Devices/IHEPCDyr5-2009-2011/Cycle_5_Proposals/
IHE Profiles drafted in IHE Committees
Completed February 20101
May 2011
Public Comment 1 Completed May 2011 June 2011 IHE.net- Documents now in PCIHE’s Wiki- PC Process explained
Trial Implementation Published
Completed July 2011 ftp://ftp.ihe.net/Patient_Care_Devices/TechnicalFrameworkforTrialImplementation/
IHE N.A. Connectathon Registration
Open August 22, 2011
September 30, 2011
www.iheusa.org/connectathon_participant.aspx
IHE N.A. Connectathon Dates
January 9-14, 2012
www.iheusa.org/connectathon_participant.aspx
IHE ConnectathonEuropean Dates
May 21-25, 2012
www.ihe-europe.net
www.ihe.net
2012-2013 CycleIHE Profile Cycle Stages
Participation Status
Open Date Close Date Learn More
Call for Proposal Open July 20, 2011 Sept 5, 2011 Examples of Brief Proposals: ftp://ftp.ihe.net/Patient_Care_Devices/IHEPCDyr5-2009-2011/Cycle_5_Proposals/
Profile Selection Closed October 2011
December 2011
Examples of Detailed Proposals: ftp://ftp.ihe.net/Patient_Care_Devices/IHEPCDyr5-2009-2011/Cycle_5_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 PCIHE’s Wiki- PC Process explained
Trial Implementation Published
Open N/A August 2012 ftp://ftp.ihe.net/Patient_Care_Devices/TechnicalFrameworkforTrialImplementation/
IHE N.A. Connectathon Registration
Open August 2012 September 2012
IHE N.A. Connectathon Dates
Open January 2013
IHE ConnectathonEuropean Dates
Open Spring 2013
www.ihe.net
CPOE/ Pharmacy System
FuturePCD
CurrentPCD
Infusion Pump
Barcode Medication
Administration System
Other Devices
EquipmentManagement
System
Future Non- PCD
Clinical Decision Support System
Implantable Device
IDCO
ACM, DEC, WCM, ADQ,
PCIM
ACM, MEM
ACM: Alarm Communication ManagementADQ: Asychronous Device Query
DEC: Device Enterprise CommunicationIDCO: Implantable Device – Cardiac – Observation
MEM: Medical Equipment ManagementPCIM: Point-of-Care Identity Management
PIV: Point-of-Care Infusion VerificationWCM: Waveform Communication Management
Home BasedSystem
Ventilation/Anesthesia
System
EMR/EHR
CIS
Physiologic Monitoring
System
DEC
ACM, DEC
ACM, DEC, WCM
PIV
IHE PCD - Profiles
EMR/EHR
ACM, DEC, WCM, ADQ,
PCIM
ACM, DEC, WCM, ADQ
www.ihe.net
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
IHE PCD - Profiles
www.ihe.net
[WCM]Waveform Content Message
MobileAccess
Continuous WaveformData
Alarm Evidentiary Data
WCM WCM encodedwaveform
In-HospitalAccess
RemoteAccess
WaveformEvents
WaveformFilter Descr.
WaveformDisplay Attr
.•{1..1} Filter Freq/Type•{0..1} Filter Order•{0..1} Filter String
•{0..1} Sweep Speed•{0..1} Grid•{0..1} Color •{0..1} Scale•{0..1} Phys. Range
•{0..*} Annotations / Events
{0..*}
WaveformData Attr.
•{1..*} Technical Cond. Map•{1..1} Sample Rate•{1..1} Wave Count•{0..1} Encoding•{0..1} Resolution•{0..1} Range
{0..1}{0..*}{1..1}
WaveformGroup
Waveform Attributes
Waveform Data
•{1..*} Data {Num Array}
{1..*}
MobileAccess
Continuous WaveformData
Alarm Evidentiary Data
WCM WCM encodedwaveform
In-HospitalAccess
RemoteAccess
WaveformEvents
WaveformFilter Descr.
WaveformDisplay Attr
.•{1..1} Filter Freq/Type•{0..1} Filter Order•{0..1} Filter String
•{0..1} Sweep Speed•{0..1} Grid•{0..1} Color •{0..1} Scale•{0..1} Phys. Range
•{0..*} Annotations / Events
{0..*}
WaveformData Attr.
•{1..*} Technical Cond. Map•{1..1} Sample Rate•{1..1} Wave Count•{0..1} Encoding•{0..1} Resolution•{0..1} Range
{0..1}{0..*}{1..1}
WaveformGroup
Waveform Attributes
Waveform Data
•{1..*} Data {Num Array}
{1..*}
www.ihe.net
[ACM]Alarm Communication Management
HL7 Messagesper ACM andWCM profiles
HL7 Messagesper ACM andWCM profiles
Parameters, waveforms, etc.as evidentiary data items
Parameters, waveforms, etc.as evidentiary data items
DeviceSpecificgraphics
DeviceSpecificgraphics
Alarm InformationSource, Phase, State, Priority
PatientLocationInstance
Alarm textCallback
TimestampEvidentiary data
Dissemination StatusInstance
Accepted by ACUndeliverable
DeliveredRead
AcceptedRejectedCancelled
Callback start/stop
AlarmCommunicator
AC
AlarmCommunicator
AC
AlarmManager
AM
AlarmManager
AM
AlarmReporter
AR
AlarmReporter
AR
Report AlarmPCD-04 →← PCD-05
Report AlarmStatus
Disseminate AlarmPCD-06 →← PCD-07
DisseminateAlarm Status
AlarmSource
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.
EMR,CDSS,CIS,Etc.
Data QueryPCD-12
Data ResponsePCD-13
Data QueryPCD-12
Data ResponsePCD-13
Data RequestersData Servers
FullDisclosure
Data Serverand/or
Data Requester
Data QueryPCD-12
Data ResponsePCD-13
www.ihe.net
[MEM]Medical Equipment Management
Patch ManagementPending patchesPatch history
Location ServicesCurrent locationPrevious locations (Trending)Boundary controls (Alarm when
device leaves area)
Device Configuration Management
Recall ManagementUnique device identificationHardware configuration (serial numbers, etc)Software configuration (revision numbers, etc)
Device ReconfigurationUse profiles (NICU vs. CICU)
Operational Status and Monitoring
Is the device currently in useUsage historyAlarms – which are active, what the trigger
levels, how long has the alarm been on
Day/time of last self check and its resultEvent log recordingPreventative Maintanence
Last PMNext scheduled PMLast repair time/date
Battery ManagementOn A/C or D/C? Charge level (% of full)/Est.
operating time left. Charging / Discharging historyBattery type and installation date Est. battery life
Risk ManagementRisk analysisRisk evaluationVerification of risk control measuresResidual risks
www.ihe.net
[MEM]Medical Device Security & Mgmnt.
HIPAA
HITECH
FDA:• 21 CFR 801, 803,
807, 812, 814, 820 • MDDS
IEC 80001
IHE PCD
MDS2
MedicalDevice
AccessControl Privacy
CE/IT Manage
mentSecurity
ConfigurationManagement
Asset Discovery
Cyber Protection
Network Access Control
Lifecycle Mgmt.
Encryption
ePHIBreach Risk
Key ManagementAuthenti-cation
www.ihe.net
Profiles & Technical Frameworks
• 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
Overview
www.ihe.net
Trial
IHE Profiles Drafted & Revised
6-13 mos.
Implementation Posted
Install Interoperable
products in Clinical Settings
worldwide
Install Interoperable
products in Clinical Settings
worldwide
Demonstrate at aDemonstrate at a
IHE Improves, Safety, Quality
and Efficiency in Clinical Settings.
14-18 mos.
Publish in IHE’s Product Registry
Test at IHE Connectathons
PublishedFor PublicComment
IHE Technical Framework Developed
IHE Call for Proposals Opens
IHE Call for Proposals Opens
Profile Selection by Committees
1-5 mos.
IHE Development Process
www.ihe.net
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
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
www.ihe.net
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
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
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
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 SYSTEM SYSTEM TYPE PCD PROFILESAmcom Commtech Messenger Event Notification Middleware ACM
BIOTRONIK SE & Co. KG Home Monitoring Service CenterImplantable Cardiac Device Observer System IDCO
B Braun Outlook Infusion Pump Infusion Pumps DEC, ACM, PIV B Braun Space Infusion System Infusion Pumps DEC, ACM, PIV
B BraunDoseTrac Infusion Management Software "Gateway" software DEC, ACM, PIV
Capsule Datacaptor Interface System DECCerner CareAware iBus Interface System PIV, DEC, ACM
EpicEpicCare Inpatient and associated modules EMR/EHR DEC, PIV,ICDO
MedtronicMedtronic Mainspring Connected System Gateway
Implantable Device Follow-up System IDCO
Mindray DS USA, Inc. eGateway Integration Manager HL7 Gateway ACM, DECMindray DS USA, Inc. A5 Anesthesia machine ACM, DECNuvon VEGA™ Interface System DECOZ Systems eScreener Plus Interface DECPhilips Emergin Alarm Manager ACMPhilips HL7 Gateway DEC
St. Jude Medical, Inc. Merlin.net MN5000Implantable Cardiac Device Observer System IDCO
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
www.ihe.net
How to Participate in IHE PCD?
• 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
IHE International Membership is Free.
www.ihe.net
Learn More about IHE International
• 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
Important Links and Information
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