HL7 Healthcare Devices/IEEE 11073 Working Group Meetings
2014.05.04 – 2014.05.09 – Phoenix, Arizona
See meeting documents posted @ http://www.hl7.org/Special/committees/healthcaredevices/docs.cfm?
Monday – Q3 May 5, 2014
Participants
- John Garguilo (NIST)
- John Rhoads (Philips)
- Stan Wiley (Draeger)
- Stefan Schlichting (Draeger)
- Kathryn Bennett (IEEE)
- Janek Schumann (GS corpuls)
- Jan Wittenber (Center for Medical Interoperability)
- Todd Cooper (Center for Medical Interoperability)
- Ken Fuchs (Center for Medical Interoperability)
- Jing Li (Center for Medical Interoperability) jli @center4mi.org
- Allen Hobbs (KP) [TBD]
Other Participants Pool (note – use for future Qs if present)
- Paul Schluter (GE)
- Masato Tanaka (Nihon Kohden)
- Gora Datta (Cal2Cal)
- Stephan Poehlsen (Draeger)
- Kathryn Bennett (IEEE)
- John Roberts (GS-1-US)
- Jeff Rinda (Hospira)
· Barry Brown (Mortara Instruments)
· Leslie Tompkins (FDA CDRH UDI)
- Nicholas Crouzier (Prometheus Computing)
- Scott Denis (Center for Medical Interoperability)
- Kevin MacDowell (Center for Medical Interoperability)
· John Walsh (Partners Healthcare)
· Martin Hurrell (Anesthesia WG)
· Andrew Norton (United Lincolnshire Hospitals)
· William Goosen (PC WG)
· Paul Knapp (ITS , Chair of UDI Task Force)
· Terri Monk (APSF)
· Chi Tran (Center for Medical Interoperability)
· Michael Faughn (Prometheus Computing)
· Art Greisser (Prometheus Computing)
· Russell Ott (Deloitte/DoD DHA)
· Joe Good (Center for Medical Interoperability)
· Darryl Mellott (Center for Medical Interoperability)
· Paul Spadafora (Center for Medical Interoperability)
· Greg Staudenmaier (VA)
· Kevin Brady (NIST)
· Sean Moore (Epic)
· Larry Gay (Sevocity)
· David Hay (FMG)
· Galen Mulrooney (JP Systems)
· David Rein Wertheim (Furore)
· Jackie Mulrooney (JP Systems)
· Josh Mandel (Boston Children’s Hospital) TBD
· Grahame Grieve (Health Intersections Pty Ltd) TBD
· Tracy Rausch (DocBox/MDPnP)
· Kai Hassing (Philips)
· Sadamu Takasaka (HL7 Japan)
· Zachary Huynh (Kaiser Permanete)
Minutes for Q3
- The Patent Policy, IP Policy, and the Anti-Trust Policy of the IEEE were reviewed with attendees.
- Agenda revision 1.4 was reviewed. Motion by S. Wiley and seconded by J. Rhoads; motion was amended by T. Cooper to add to the agenda an update on Tuesday of the HL7 Co-Chairs Meeting that would be held on Monday evening. Amended agenda was approved.
- Minutes and action items from the January 2014 Committee Meeting were reviewed. John Rhoads reported that efforts to discontinue HCD DEV Project #s 513 and 595 were in process. Motion to approve minutes as presented was advanced (T. Cooper), seconded (J. Garguilo), and approved.
- HL7/HCD Status Report
o A. Hobbs’ new role as an independent consultant and in private practice in California. Expect to clarify the co-chair position at the September, 2014 HL7 Working Group Meeting. J. Rhoads standing for re-election as an HL7 Co-Chair,
o Project 595 – discontinue as an HL7 project; FHIR is the successor to this project.
o Project 850 – still active; interest expressed by Dr. John Walsh at MGH.
o HL7 Terminology Authority – HL7 and IHTSDO (owner of SNOMED CT) created a single authority for terminology and manage the vetting process. Group met in January; similar discussion in CIMI (clinical information model interface), and agreeing to integrate with the HL7 and IHTSDO groups.
o HL7 Conformance Testing – HL7 initiated a conformance testing program approximately 4 months ago. Had a pilot project around registries for immunizations (HL7), done in conjunction with CDC. Aegis is driving this testing initiative.
Monday – Q4
Participants
· Attendees from Q3 on Monday
- Stephan Poehlsen
- Kathryn Bennett
- Jeff Rinda
- John Roberts
Minutes for Q4
· Agenda adjustments:
o HL7 3 year plan - deferred to Friday
o HL7 Terminology Authority – covered in Q3 on Monday
o HL7 Conformance Testing – covered in Q3 on Monday
- DEV Projects
o #850 IG CDAr3 Vital Signs X73 Representation (proposed for discontinuation to enable resource availability for FHIR resource project development)
o #595 IG HCD Comm. Messaging
- FHIR PSS & Status Update
o HL7 Device Alert and Control Resources – draft PSS for review : device alert report, device control operation, device service control: proposed DEVWG FHIR resources.
o Resource availability – Aug/Sep 2014; Content for inclusion in FHIR DSTU ballot - Jan 2015; ballot content published as part of next DSTU – Mar 2015
o Proposed minor edits to draft to update prior to the presentation to the Domain Experts Steering Division.
- TC215 Proposed Olympic Games Demo
o “EHR Interoperability at the Olympic Games” – proposal for a “demo” during the Olympic Games supporting interoperability across multiple EHRs (athlete medical triage, Olympic Village medical Center, host city Hospital)
Tuesday – Q1 May 6, 2014
Participants
· Attendees from Q3 on Monday
· John Roberts
· Masato Tanaka
· Paul Schluter
Minutes from Q1
· The Patent Policy, IP Policy, and the Anti-Trust Policy of the IEEE were reviewed with attendees.
· HL7 Co-Chairs Meeting (T. Cooper/J. Rhoads/J. Garguilo)
o No significant results
o DEV PSS for FHIR project was approved (coordinate with FHIR on final wording; questions about schedule, including commitment to do a profile; also clinical decision support)
o Doing pilot with Conformance Testing (Aegis) on immunization work
o DEV WG assessment was rated as “Green”
· IEEE Updates
o Elections (K. Fuchs)
§ Melvin Reynolds (UK) has left medical device area; co-chair role is now open
§ Last election: J. Wittenber (Upper Layer Co-Chair); K. Fuchs (Committee Chair); S. Wiley (Secretariat)
o IEEE+ICUCare & Other Agreements (K. Fuchs)
§ ICUCare dissolved the MoU with IEEE
§ Discussions between IEEE (Todd Cooper) and ITSDO (Jane Millar): Discussing the relationship of IEEE nomenclature with the SNOMED CT nomenclature.
o Projects (K. Bennett)
§ Reference presentation from IEEE posted on HCD HL7 website
§ 27 PARs Open; 5 PARs due to expire by 31 Dec. 2014
· P10101
· P10201 – no further extension possible
· P10413
· P10419 – further extension will be difficult
· P20101
· Decision to defer actions on this topic to Friday, 9 May 2014.
§ Ballot Highlights
· P10101a – ballot group to close by 17 May 2014; ballot group is currently unbalanced (producer category is at 37.5%; must be at 33.3% or lower)
· P10419 – still in ballot; due to expire
· P10422 – in comment resolution
· P20601 – in 2nd recirculation until 8 May 2014
· Others…. Reference presentation from K. Bennett
§ SASB Actions Since January 2014
· 4 approved withdrawals
· 5 Approved PARs
§ ISO Adoption Status
· 4 Approved by TC215 (10103, 10102, 10408, 10417)
· Queued (30200a, 20601a, 00103, 10441)
§ Agreements
· IEEE/HL7 SoU – due to expire 7 August 2014
· IHE MoU – auto renew in August
· IHTSDO MoU – under negotiation
· NIST Royalty Free Agreement: Kathryn B and John G to review in this meeting
· Continua Collaboration Agreement
§ 2014 Conferences/Meetings…reference presentation from K. Bennett
§ Alternative Publications
· Nomenclature (10101)
· DIM (10201) – implications to PAR expiration
§ eHealth Strategy
· Seeking instructors (standards education) from 11073 community (Oct. 2014) for Innovation Point-of-Care Technology Conference
· Need advocacy speaker on behalf of PHD for mHealth Summit (Dec. 2014)
§ PR & Sales
· Evangelization via IEEE-SA Facebook, Twitter, etc.
· Subscription for Health for sale in Q3 2014
o IEEE P&P (K. Bennett)
§ Sponsor – current approved expires 31 Dec. 2014
§ Work Group
o Sponsor Change (K. Bennett)
§ Advantages and Disadvantages of EMBS sponsorship
§ Potential alternatives with better fit
§ Key decision factors
§ Next steps – briefing document being prepared for IEEE SA; meeting scheduled with Chair of EMBS next week; propose group discussion/decision at next 11073 Committee Meeting
· Motion to endorse Kathryn’s review of the current situation with the Executive Director and Chair of EMBS. Seconded and approved.
· Motion to endorse Kathryn’s engagement of the IEEE Communications Society and the IEEE Computer Society. Seconded and approved.
o IEEE News & Tools (K. Bennett) reference presentation from K. Bennett
Tuesday – Q2
Participants
· Attendees from Q3 on Monday
· John Roberts
· Masato Tanaka
· Paul Schluter
· Jeff Rinda
· Barry Brown
· Leslie Tompkins
Minutes from Q2
· US FDASIA (T. Cooper)
o FDA Safety and Innovation Act – report published in April 2014. 3 days of meetings next week
o Creation of HIT Safety Center
o Updated agenda now available: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm392877.htm#agenda
· AAMI-UL JC2800 (S. Wiley)
o Open meetings on June 2, 3 @ AAMI Standards Week
o Vertical Standards and Horizontal Standards for initial exemplar of ICS PCA-Patient Monitoring
o List of artifacts which support the creation of the standards to be discussed at the June F2F meeting
· 11073-10101a Amendment
o Review Draft Document
i. Updates to the 10101a nomenclature extensions (see presentation by P. Schluter)
ii. Draft ready by end of May 2014; 5 remaining gating action items
iii. Reconciling vent terms with ISO/TC121/SC4 – anticipated full synchronization in 10101b;
iv. Now awaiting inclusion of infusion terms and enumerations
v. Decision to make WCM attributes “wave general” (not ECG-specific)
vi. Review Pump Terms
vii. Review Vent Terms
o PHD Terminology
o Finalize Set for Ballot
o 11073-10101 Revision (documents, database, tooling)
o Work Planning
o Barry Brown’s Request
i. Just balloted an updated implementation guide for aECG standard (continuous ECG waveforms for up to 48 hours in recognized file structures)
ii. Using HL7 V3 messaging; encapsulated data type (ED)
iii. Needed to add a control structure; additional MDC codes to define structure within the files (sensitivity, time skew, filter values, etc. ~12 new terms)
iv. Jan/Paul: requested presentation on proposed control variables and how they will be used; semi-formal definition for interleaving methods (meta information for describing data format)
o Jeff Rinda’s Request – Deferred to Q3 on Tuesday
Tuesday – Q3
Participants
· Attendees from Q3 on Monday
· Scott Denis
· John Roberts
· Masato Tanaka
· Paul Schluter
Minutes from Q3
· 11073-10101a Amendment
o Review Draft Document
· Updates to the 10101a nomenclature extensions (see presentation by P. Schluter)
§ Draft ready by end of May 2014; 5 remaining gating action items
§ Reconciling vent terms with ISO/TC121/SC4 – anticipated full synchronization in 10101b;
§ Now awaiting inclusion of infusion terms and enumerations
§ Decision to make WCM attributes “wave general” (not ECG-specific)
§ Consensus from group that there are no major “Showstoppers” to move forward to start the ballot (authorization to go directly to ballot without performing in-Committee Review)
§ The amendment PAR expires by end of Dec. 2014; ballot should therefore start by mid-June to ensure availability for Rev-Con Meeting in Dec. 2014.
· Review Pump Terms
· Review Vent Terms
o PHD Terminology – included in P. Schluter presentation update
o Finalize Set for Ballot – targeting mid-June 2014
· 11073-10101 Revision (documents, database, tooling) – reference presentation given to IHE PCD F2F (J. Garguilo): Adding to the Rosetta terminology, a simple tagging mechanism. Adding audit capabilities of when new terms are added. Proposing to begin automated build into standard quality standard quality documentation approved by IEEE. Will add appropriate columns (set of attributes to support versioning and tagging) to database to enable interim ballot reports – these will provide status of terminology progress.
· Work Planning – not discussed in detail - loosely estimated for end of May 2014.
· Jeff Rinda’s Request (T. Cooper) – Pump Update
o Overview of work since Jan. 2014
· Update MDC Fluid Flow
· Genericized term “reservoir” to “container” in REFID and DESCRIPTION
· Added new terms to program PCA Pumps
· Missing PCA terms
· Terms without the “total” discriminator
· Others….
· ISO 8003 (K. Fuchs/J. Wittenber)
o Nomenclature standardization effort in ISO TC12; ISO TC215 reviewing
o Meetings next week in Europe to better understand scope and need
o Proposed standard has terminology in WORD tables; defined significant parts of the standard
· IHE USA MDPRI Project Update (w/ MU III) (P. Schluter)
o Series of weekly telecons on Monday for purposes of promoting IEEE 11073 terminology in requirements for Meaningful Use (ONC); Alex Lippett from HIMSS taking lead.
o Progress is slow.
o Plan is to build this on top of RTMSS.
o Would require contract expertise to perform this mapping.
o Mapping could be store at both the NLM and at NIST.
· Mapping 11073/LOINC/SCT (per VA/IHE POI & IHE USA Project requirements)
o See above
· x73 and IHE-PCD Containment Tree
o OBX-4 within and across OBRs: is the containment tree static or dynamic? Should this be mandatory? Intent is to discuss tomorrow morning at the IHE PCD Technical Committee.
Tuesday – Q4
Participants
· Attendees from Q3 on Monday
· Scott Denis
· John Roberts
· Masato Tanaka
· Paul Schluter
· Leslie Tompkins
· John Walsh
· Martin Hurrell
· Andrew Norton
· William Goosen
· Paul Knapp
· Terri Monk
Minutes from Q4
· Hosting HL7 Anesthesia WG (GAS)
o Joint GAS-HCD Projects
§ All collaborative projects are covered by DEV
§ Potential collaboration in 10101 for “ventilator mode” and mapping with SNOMED CT
o #513 CDA Anesthesia Record (J. Rhoads)
§ Believe there is a need of incorporating “encapsulated” data with streaming data (HL7 ORU messages) from PoC gateway.
§ 10101 (Nomenclature), 10201 (DIM), CDA, CCD, and PHMGuide are relevant building blocks
§ Will initiate regular teleconferences to adapt CDA within the next 3 weeks; participants are encouraged (solicitations will be sent out via the HL7 ListServer)
§ Will collaborate further with GAS for additional use case material
o #850 VS in CDA (J. Rhoads)
§ Tied to #513
o #661 DCM4MD Update
§ No discussion
· UDI Discussion
o FDA Update (Leslie Tompkins, PhD)
§ 21 CFR801.20 readable labeling; 21 CFR 830.xx
§ FDASIA requirement incorporate for 2015; Class 2 devices 2015