- (Approved on 01/25/2021) as recorded & presented (motion made by John Garguilo, 2nd by Ken Fuchs; approved 30-0-0); refer to Meeting Minutes (September, 2020, Virtual ).
Garguilo walked through the IEEE portion of the September 2020 WG PoCD minutes.
Garguilo asked attendees for any input/edits/changes. None brought forward.
Motion made by John Garguilo to "approve September 2020 IEEE PoCD WG meeting minutes"
Meeting minutes unanimously approved 30-0-0
Goals
Set goals, objectives or some context for this meeting.
Discussion items Agenda and Meeting Minutes (January 2021)
Time
Item
Who
Notes
Agenda Item
(Note checked box indicates topic discussed at WG meetings)
Monday, Q1 & Q2
IEEE EMB 11073 PoCD WG Meeting
(Note checked box indicates topic discussed at WG meetings)
Action item:Konstantinos Makrodimitriscoordinate with MDPINET to provide them interface with IEEE11073 experts on their effort to integrate/map their model(surgical/implant/cardio) to FHIR/HL7 vs 2. Coordinate with Martin Kasparickon leveraging SDC which is relevant(OR surgical). MDEPINET follow up in the next meetings of IEEE11073 this year.
Kosta Makrodimitri noted and recognized the coordination with several standards; and introduced the topics
Dr. James Tcheng
Slides presented entitled: MDEpiNet: The Medical Device Epidemiology Network
Real world evidence (RWE) and medical devices, MDEpiNet (http://mdepinet.net)
Common Approaches across MDEpiNet presented…
Dr. Tcheng noted it all starting with good data!
Common data model - three primary blocks of data: evaluation of patient, management of patient, and outcomes
Questions:
John Garguilo - asked about if only FHIR or if HL7 V2 considered; answer: forward thinking from device but likely information from EHRs to Repositories would continue to be V2…and possibly FHIR in future
Malcolm Clarke - asked about what specific nomenclature…; answer
Todd Cooper - asked about the type of robots, referencing the RASD (Robotic-Assisted Surgical Devices (e.g., classical robots like for surgical assistance vs. autonomous medical robots that can perform tasks with little or no user interaction). Also asked about working with the CIMI group… Dr. Tcheng mentioned they are working on and with the CIMI group
Danica Marinac-Dabic noted the beauty of this work is the tie to formal work, and many of the systems are producing results tied to already approved devices… which attracts folks from many areas - industry, academia, etc…
Kosta Makrodimitris mentioned the anesthesia work (via Paul Schluter) - and also mentioned activity standards designed for emergency rooms or ICU units… perhaps tied to Stefan and Bjorn
Stefan Schlichting mentioned SDC work driving by surgical work and capabilities (perhaps good data for FDA)…
IEEE P11073-40101 and IEEE P11073-40102 Cyber Security Spec Updates (Christoph Fischer) 1:00 PM US ET
PHD/PoCD Cybersecurity overview provided Christoph Fischer
Cybersecurity Task Force is aligned with PoCD/PHD WG
Working on PHD Interface, issue 1 of slide set: No std Plug n Play
11073-40101-2020 - Processes for vulnerability assessment
11073-40402-2020 Part 40102: Cybersecurity - Capabilities for mitigation
Also working on Bluetooth SIG Authorization Control Services (ACS) and Profile (ACP)
Christoph asked, given this work is available, can folks on this call share and use this work and get closer to securing… "take the work and share it"… and also how to dive further into these topics
Stefan mentioned the work with SDC
IHE DEV DPI Program Update (Todd Cooper / Ken Fuchs / Stefan Schlichting)
Under Health IoT, P2933 is under Health IoT in "Clinical Device IoT" - other areas at Clinical Device IoT levels are Consumer/Wellbeing Device IoT…
Sub groups under Clinical Device IoT are "research" Medical Device Iot and "approved" Medical Device IoT…
TIPPSS Update provided by Ken (as part of IEEE-SA, on "imeetcentral" from ieee-sa))
Clinical / Device IoT
~250 members signed up; about 50 active; several WGs: included on Use Cases; Intelligent System Design; AI/ML, Trust and Identity, Privacy, Protection, Security, Safety; Interoperability; and D&D VEVetc…
Officers: Chair: Florence Hudson; Vice Chairs: Mitch Parker and William Harding; Secretary: Ken Fuchs
Hope is for a first draft at end of the year (2021)
ISO/TC 215 WG2, ...JWG7 (Todd Cooper / Ken Fuchs)
Todd Cooper mentioned this is a general overview, tied to what Tom Thompson (IEEE) will provide…
The IEEE 11073 SDC standards are also advanced as ISO & CEN standards once they complete IEEE balloting
ISO/TC 215 has created an Ad Hoc Group #4 for CA Readiness assessment - determining whether and to what degree ISO/TC 215 standards and specifications are organized for conformity assessment (e.g., per ISO 17000 requirements). As part of that AHG4 work, Todd Cooper has applied the assessment template to 11073-20701 and will do the same for additional IEEE standards that will end up at ISO.
AAMI (Ken Fuchs) 3P US ET
Will Vargas (Program manager - no longer w/ AAMI),
2700-2-1 - Forensic Data Log
Standard developed and approved… but not released??
ICE- Julian Goldman and Sandy Weinger
CR511 - Consensus Report for Remote Control of Medical Devices
Used for emergency authorization for Covid use - trying to control devices from outside a room (vs. in the room) - like settings on a ventilator.
Collection of requirements (mainly about the safety focus) - free to download on AAMI site (search on CR511)…
NWIP - Standard for Remote Control of Medical Devices
Working draft for an NWIP based on CR511 (moving forward)…
This work can provide topics to the remote control work… which would hopefully encourage 11073 group.
Note AAMI is under ANSI standards
Could be referenced in Europe but not required - could possibly be brought into IEC at some point…
Also a good topic to brought up in SDC segment tomorrow…
2700-2-1 - Forensic Data LogCR511 - Consensus Report for Remote Control of Medical Devices
NWIP - Standard for Remote Control of Medical Devices
Bakul Patel is the director who led amongst others to the new structure for formal DHCE at FDA
Change the name of the structure; somewhat of a new office - have a strong area in PreCert/Machine Learning-AI/Digital Health areas (and how they relates to standards)… see link ABOVE and read through materials
Proposal to get an expert on one of the topics in one of the next WG meetings…
JHU/APL MDIRA Project Update (Todd Cooper, Steven Griffiths)
Update on project - by Steven of JHU/APL
See slides:
Implementing and adjudication the feedback of Draft 2 on System and Supervisor Requirements
There is the concept of a supervisor like ICE (AAMI 2700-1 Integrated Clinical Environment)
Motivation and Challenges presented
MDIRA Draft 2.0 (Draft 1.0 released about a year ago) - delivered to sponsor in Draft form
What does it mean to be MDIRA compliant?
MDIRA currently funded through June of 2021; hope is to be Open Source by Army
11073 PARs and Projects Update (Tom Thompson) 12:30p US ET
Tom Thompson (IEEE Liason to WG) provided presentation which noted the Current Projects Breakdown and status…
Stay on the books as is, with no intent to re-affirm
No time limit to remain in "inactive reserved"… unless withdrawn
10419 - Insulin Pump
6th recirculation
10442 - Revision Strength Fitness Equipment
10471
Note there are several "expired" standards (inactive after 10 years
8 Active Standards
2 Inactive-Reserved
3 moving to Inactive-Reserved
Ballot Highlights
18 Active Standards
4 Inactive Standards with and Active PAR
-10421 - Peak Flow
-10442 - Strength fitness
-10471 - Independent Living Activity
-10472 - Medication monitor
Device Specializations
ISO Adoptions:
10101 - August 2020
10201 - May 2020
20701 -
MOUs with:
HL7
IHE
LOINC
NIST
?? Missed last one…
See presentation on IEEE iMeet Central site…'
Action item:Tom Thompson provide updates on IEEE analytics and statistics on 11073 standards downloads and adoption from different stakeholders and countries
IEEE 11073 SDC Update(Kathrin Riech, Martin Kasparick, David Gregorczyk)
SDC Organizational Update
(Stefan Schlichting) - Stefan is asking and handing over the SDC subgroup chair to Martin Kasparick (i.e., taking over the responsibility of coordination of SDC work…)
PKP Status (10700, 10701) (David)
SDC Core Status (10207, 20701, 20702)
Discuss and Vote on 10700 PAR Revision
Motion to change the title and scope of PKP Spec
Proposal to change title and scope
Group discussed rewording the scope as there were several questions of the current state.
Motion: To form Ballot Group Start for 10700 (Base PKP)
David asked for input on how to form a ballot group
Tom Thompson (IEEE-SA) suggested getting the title and scope updated before as document needs to go to a MAC review in IEEE…
Ballot Group does take 30 days to form… can the group begin forming the ballot group
After the 30 day period, the ballot has to be initiated within 6 months.
Question if going to MAC and completion before ballot, and that may depend on findings of the MAC review…
Stefan summarized… motion to send
Metric PKP see last slide (of slide set presented)
Ventilator Mode (ISO 19223 & IEEE 11073 & SNOMED alignment)
Action item:Paul Schluter to provide updated slides to the WG including questions/discussion on ISO 19223: 2019 coverage and SNOMED/LOINC mapping progress (2020) of 10101 to integrate with EHRs and clinical real world data/surveillance etc. Provide excel mappings to IEEE-SA 11073 folders repos
Discuss SC and WG tools for Agenda, Listserv, etc.(Ken Fuchs, Steven Dain, Kosta M.)
Locations/Possible separate annual meeting from HL7
Joint meetings with other SDOs
Action item:Konstantinos MakrodimitrisAND Isabel TejeroFDA proposal for 2022 in person annual meeting of IEEE 11073 in US FDA location in Silver Spring MD (in coordination with other FDA and NIST and different SDOs: IEEE EMB, IHE, HL7, LOINC, SNOMED, ISO TC215 ...)
ACOM focus on adoption and a consistent way to express what a device is and how to define the device - not a whole new protocol and specific how to get the semantics (IEEE 10101 Nomenclature Codes) and guidance to implementors - and into for example using FHIR to effecively move device data and leverage modeling of 20601. See Objectives in slides:
Slide on ACOM Conceptually
Key concepts
Not an exchange protocol
Focus is on semantic content and getting a consistent way that models a device (again using 10101 nomenclature and meta data that can be used downstream…
Paul noted Ventilator Mode (ISO 19223 & IEEE 11073 & SNOMED alignment)
LOINC Update (Swapna/NLM & Regenstrief)
Swapna not available for meetings (no discussion or updates provided)
Discuss Meeting Logistics ( Kosta M.)
Locations/Possible separate annual meeting from HL7
Joint meetings with other SDOs in addition to HL7 such as ISO TC215, SNOMED, LOINC, FDA, MSEPINET/SMART, HIMSS,ONC
Discuss SC and WG tools for Agenda, Listserv, etc. (Kosta M., Ken Fuchs)
Ken Fuchs provided a Current 11073 Tools table which provides the 11073 SC, PoCD WG, PoCD SDC SG, PHD WG for the various attributes (Email list, Agenda & Minutes, File Storage, Wiki, Attendance Capture, Track Voting Members, Web Site, Virtual Meetings Tool, Electronic Ballow, and Issue Tracking)
Should we always do the IEEE meetings with HL7. Should there be a IEEE only Virtual Meeting in between or at a certain time each year; or more periodically??
How many times in the year do we and should we meet…??
More discussion needed, likely through emails/chain between now and next WG meetings
Discussion Questions:
Motion to adjourn meeting
First Ken Fuchs, Second John Garguilo, no discussion; Motion passed to adjournment 22-0-0
IEEE meeting Adjourned by chair Stefan Schlichting
Action items Q1 & Q2 highlighted above in RED ...
Type your task here, using "@" to assign to a user and "//" to select a due date
Wednesday Q1&2
HL7 Devices (DEV) WG Meeting
Wednesday Q1 (9:00 - 10:30 AM Pacific)
Welcome, Introductions, and Agenda Review (HL7 Officers)
Confluence / Jira /S3(use of new storage tooling - vs. Gemini GitHub use)
HL7 DoF - focus (Chris Courville / John Rhoads)
PSS review / advancement etc.
PHD / PoCD DoF IG update on status and progress (including publication)
Review of the HL7 FHIR CAT Gemini Devices Isolation PoC Track, including PCIM application to SDPi+FHIR
Tooling & Testing
NIST Tooling Update (Garguilo / Faughn)
John Garguilo provided a verbal update on the V2 Validation Tooling (primarily used by the IHE-DEV Domain)
Updated the known MDC codes to be checked in the OBX fields
Used IGAMT-2 for some of the profiles to generate the profile structure and conformance statement.
Updated/fixed some conformance statements for some.
Added PCD-05 transactions
Some very basic WCTP message schema validation being worked on to put in place in the tool for PCD-07
Updated PIV, ACM and MEMDMC to reflect the changes in the CPs #149,150,151 and 152
Tool update that makes the test cases and test profiles load a bit faster
Added possibility for tool admin to change error classifications (could be useful during the connection if we want to ignore some errors or set them as warnings)
Michael Faughn provided update & status on tooling develop processes (see slide set)
Michael explained the Development process for tooling
RTMMS2 - why?
RTMMS Progress prior to and since Sept 2020 WG meeting
Framework for Device Profiling and Validation (Proposed)
Michael provided demonstration of the RTMMS2 tool (presently on a Prometheus Server, but to be installed on a NIST server over the coming months…
Next Steps discussed by Michael
Malcolm Clarke asked about displaying sub and superscripts…
Michael noted this issue is noted on his "to do list"
https://github.com/HL7/v2-to-fhir - Github version of the project files; the "messages" folder has the spreadsheets for the few mappings that have been done, including ORU
Is a strategy emerging for Use Cases to CA requirements integration? (yes, Gherkin & ReqIF again)
SDPi+FHIR project has sought to raise the level of requirements integration and traceability but how exactly will that work? This briefing explores what exists and how it might be achieved
IHE TF Publications – Accelerating the Evolution
In January 2021, IHE ITI published its Final Text Technical Framework in HTML, marking a major milestone in moving toward a new publication scheme for IHE.
In parallel, the HL7 V2+ project (with some heaving lifting from NIST / Prometheus) is working on an analogous approach for migrating the Word-based V2 specification to an HTML publication that is analogous to FHIR.
Can these two efforts be leveraged in SDPi+FHIR for a more robust authoring and publication approach? Or are we best just sticking to Word with all of its cruft?
Action items Q1 & Q2 highlited above in RED ...
Type your task here, using "@" to assign to a user and "//" to select a due date
Thursday Q1&2
HL7 Devices (DEV) WG Meeting
Thursday Q1 (9:00 - 10:30 AM Pacific)
Welcome, Introductions, and Agenda Review (HL7 Officers)
Agenda Review(HL7 Officers)
Anesthesia - (Martin Hurrell ... sync with GAS Co-Chairs) -coordination TBD
Integration w/ DEV / updating HL7 DEV 3-year plan, charter
Presence on the DEV confluence site...
<listing with the DEV co-chairs ... assumption this is Anne's tasks and will happen auto-magically?>
Projects to pursue - esp. @ Anesthesia constructs in DoF IG...
Other topics??
UDI Implementation Guide Discussion (Kosta)
FHIR - Devices Document linked
Present Efforts?
UCUM (Schluter)
Allowance of 'Lower case' l (for liter -clarity) issue discussion
JOINT OO - Courville to Coordinate (incl. meeting times)
Hosted by OO(see Whova app for access to WGM registrants)
(Scribe: John Garguilo, please review, edit, and update as needed)
Welcome, Introductions, and Agenda Review (HL7 Officers)
Agenda Review (HL7 Officers)
Two new items added
Anesthesia Update (Now, as part of HL7 DEV - Welcome!!) - (Martin Hurrell ... sync with GAS Co-Chairs) - coordination TBD
Integration w/ DEV / updating HL7 DEV 3-year plan, charter
Presence on the DEV confluence site...
<listing with the DEV co-chairs ... assumption this is Anne's tasks and will happen auto-magically?>
Projects to pursue - esp. @ Anesthesia constructs in DoF IG...
Other topics??
Corresponding SNOMED Terms could be known
Kind of detail necessary for patient connected devices are presently not captured - and could be a an activity with IHE-DEV
Main goal…Project Scope Statement FHIR IG
Workplan (May 2021 - May 2024):
Create a second iteration of the Intra-procedural DAM (IP-DAM:I2) to include:
between 10 and 20 additional detailed procedural use cases/DCMs
the specification of a 'clinical note' for each use case (corresponding to fragments of the e-record)
appropriate SNOMED CT term-bindings for each clinical note.
more detailed specification of patient-connected device metrics / parameters
2021 - 2022:
Create a second iteration of the Intra-procedural DAM (IP-DAM:I2) to include:
between 10 and 20 additional detailed procedural use cases/DCMs
the specification of a 'clinical note' for each use case (corresponding to fragments of the e-record)
appropriate SNOMED CT term-bindings for each clinical note.
more detailed specification of patient-connected device metrics / parameters
2022 - 2023:
Create a second iteration of the Intra-procedural DAM (IP-DAM:I2) to include:
between 10 and 20 additional detailed procedural use cases/DCMs
the specification of a 'clinical note' for each use case (corresponding to fragments of the e-record)
appropriate SNOMED CT term-bindings for each clinical note.
more detailed specification of patient-connected device metrics / parameters
Discussion:
Produce PSS for FHIR IG for Intra-procedural Anesthesia
Not called out is the integration with the device interoperability perhaps advanced in parallel (specifically anesthesia)
Term "anesthesia cockpit" kind of a concept…by Todd
Intersection at the operating room with a "workstation" or "anesthesia cockpit" - expoloring the area - e.g., what about SOM
Martin also mentioned another project for displaying and "giving the right information at the right time at the right place"… first work was based on surgical procedures, but could also fit with anesthesia
Martin to connect colleagues working on this with Martin Hurrell
Martin H. responded that at the moment is to simply to define (from the archived AWG) models within the DAM to be realized in the practical IG based on FHIR…
Todd mentioned the PSS (Project Scope Statement) get vetted in both WG, the Steering Division and other WGs can be contributors to or monitoring the project…
E.g., Patient Care WG may be interesting in the procedural parts of the project
Once PSS is moved forward, then there's a move to publish across HL7
What has HL7-DEV published recently?
Todd responded the IG guides are the closest thing…
Kostata mentioned working on Arterial Disease Devices… which has a logical model, and now perhaps groups like Anesthesia Working Group
Martin H. was open to this idea
Martin also mentioned that there's a whole other world which is different to/from Monitors (Todd mentioned similar to why DEV has a close relationship with O&O WG.
Would this need to be a separate work project in HL7
Todd suggested there would multiple parts to this - part will be strictly FHIR; Other part with device connectivity (e.g., external control, and connectivity)
(Martin Kasparick) Within the SDC world, this may not be completely new - for example a "data standard" which to date is not part of the SDC world, but SDC tools provide the tools for logging (which likely would
Kosta M. asked to elaborate on process (specifically for HL7-DEV WG)
Martin H. mentioned the DAM is "somewhere" on the Confluence pages(??)
Todd mentioned it would be good to have all the related materials under the Anesthesia
Latest Published DAM has Suffix "i5"; Martin indicated he will send a copy to Paul Schluter
Kosta M. provided an overview of efforts FDA is looking at
FHIR Release 4
Coordinated through O&O, who are responsible for the "Device" resource and "Device Definition"?…
John Rhoads (and sometimes Chris Courville) represent HL7 DEV at these meetings...
Malcolm asked about UDI, what happens with each of the devices, when several...
Kosta suggested having an informational slide set/wiki on "how and from where do we get to Device Specializations"and mappings HL7/IEEE/LOINC/SNOMED
Perhaps a good way to communicate to the steps to getting to Specializations… is needed...
ACTION ITEM (Konstantinos MakrodimitrisJohn RhoadsTo lead effort to provide more succinct communication on what is being undertaken - item stems from/per Kosta's request ; Todd asked Kosta to provide what target audiences, and help understand that perhaps Kosta can see grappling with these challenges…How we use HL7 Resources to map to? and provide material on how to do this and include nomenclature?…
ACTION ITEM:(Add) Another level to avoid redundancy Todd Cooper
John Rhoads agreed a good point to get the word out… HL7 DEV to IEEE
Todd mentioned that he is the IHE liaison to IEEE
Noted that Gorra Datta and Todd have been working on a statement of understanding on joint activity (e.g. key one being FHIR) with HL7 Leadership (e.g., Wayne)… stay tuned!!
UCUM - reference to represent symbol(s) for Liter (Paul Schluter)
Allowance of 'Lower case' l for 'liter' (for clarity) issue discussion
Goal is to have RTMMS use lower 'l' and upper "L"
Reasoning is because many vendors/manufactures use lower case 'l' so it should be a valid mapping
Note: one could designate a "preferred" (e.g., we use lower 'l' in xyz)
Paul provided a background discussion (see slide)
Paul proposes using lower case 'l' (see liter in below diagram) as is done by and adopted in UCUM
Malcolm noted in producing documentation, one must make a decision.
Noted that use of one or another form of letter l, is not precluded use of capital "L"
Paul noted that in the informative column there is no note for use of lower case presently
Intent is to make alignment
Simply to make things more clear (based on a decision from years ago… so not confused with the number "1").
Paul wants this to be captured in RTMMS and further for validation.
Michael Faughn asked would the lower be used only on base unit or all others like centi-liter
Malcolm asked must one use consistency (e.g. all upper or a mixture of lower and upper)
Action (Paul Schluter ): Paul will update table to use base units of small and/or large "L/l" and create:
An addiontal expansion column listing all possible combinations…
Note: Only for liters (i.e., not for example for "mm" or "cm"
Expansions column list all possibilities
Michael Faughn noted UCUM is listed as "informative" in IEEE Nomenclature
JOINT OO - Chris Courville Report Out
Hosted by OO (see Whova app for access to WGM registrants)
Taking about Substances FMM and passing ownership to BR&R, nothing pertaining to DEV
"DeviceUseStatement Resource Proposal - moving later till Hans can be present"
Was not discussed because Hans was not present. To be taken up later or in weekly calls
"Product Harmonization ("parking lot issues")"
Don't imagine we care about this much in DEV. Its just wording changes on the resource description.
To include ActivityDefinition and potentially PlanDefinition
Shouldn't concern DEV, seems like they are shooting it down anyway
Seems more targeted to drugs or things like drug-eluting stents, not so much DEV devices
That said its all about nesting DeviceDefinition so we need to pay attention.
They seem to not be all that keen on this "Package" proposal.
QUESTION for DEV: Is anyone using DeviceDefinition in a way where they need hierarchy? I assume not but if yes you should start paying attention to this.
FHIR-29800: Proposed changes to support non clinical use cases - DocumentReference
FHIR-29697: Extend Observation.basedOn
FHIR-30503: DeviceDefinition needs a recursive Packaging Backbone element
"Device dispense (Jose)"
Proposing DeviceDispense: not sure DEV would use this, possibly PHD?
"Where are the requirements coming from?": Some regulatory needs to know where the dispense/granting of a device comes from. Would include apps (???really???) as well as physical devices (including PHDish and DME).
"What's the need to track the Function in the Dispense?" There just in case. Most would use Practitioner or PractitionerRole.
"prepareDate makes sense, but not necessarily deliveryDate and receiver" Maybe leave them in to be optional, and we need to figure out how a device dispense workflow works in FHIR (is there a different action on prepare vs delivery?)
"There is currently a system under development in germany where CatalogEntry healthApps"
Team in Germany (Simone Heckmann) uses it, open to dropping it but needs to know where to move to
Seems like this is related to DeviceDefinition
QUESTION FOR DEV: Does anyone in DEV care about/use CatalogEntry, Catalog, or List?
Motion to find persuasive with mod: do not remove, and add note at the top of the resource: There is intent to remove this in R5 – how would this impact implementers – make comments and add link to the catalog IG so folks have the idea that they can review what is in the current build – Francois, Freida Hall
"Discuss and vote on FHIR-30632 Remove CatalogEntry resource"
Addional Notes from Chris Courvillle
O&O's Q2 joint meeting with FHIR-I contains come DeviceDefinition Resource conversations - posting here in case anyone is impacted:
• FHIR Task with History (related to Sample Tracking)
- "Product Harmonization ("parking lot issues"
FHIR•29800: Proposed changes to support non clinical use cases • • Don't imagine we care about this much in DEV. B: just wording changes on the resource description. FHlR.29697: Extend • To include and potentially • Shouldn't concern DEV, Seems like they are shooting it down anyway FHlR-30503; needs a recursive Packaging Backbone element • Seems more targeted to drugs Or things like drug-eluting stents, not so much DEV devices • That said all about nesting DeviceDefinition so we need to pay attention. • They seem to not be all that keen on this "package" proposal. • QUESTION for DEV: Is anvone in a way where they need hierarchy? I assume not but if yes you should start paying attention to this.
Martin Hurrell made note about device being mush more than what is typically thought of (outside of this WG)...
Malcolm mentioned looking at this from a PHD perspective (e.g., using a pulse oximeter - when data comes from the device, it gets mapped to the patient record… might want to look into how FHIR is managed with regard to that…
Chris C. noted DEV needs to keep up with O&O on the development on DeviceDispense work…
Malcolm suggested have a subgroup of DEV be involved to perhaps provide use case and workflow to ensure the proposed resource can handle
Martin H. agrees the process should be to start with use cases
E.g. devices are many things like cathetors with measuring devices… we might have to say "these things are excluded - so the resource doesn't handle them…
Chris noted the above and there was a motion made on "CatalogEntry"
Chris also noted that noticed an upcoming item during Q2 with FHIR-I regarding DeviceDefinition Resource to be discussed with O&O
V2 --> FHIR ORU mapping was not covered, nor UDI…
Kosta asked if the UDI User Guide has a next steps within HL7?
Noted that some WGs(?) is/are working through an IG starting from UDI User Guide… Kosta asked for follow up if possible - Chris mentioned he would ping Daniel Rutz (Epic Colleague)..
Joint w/ FHIR-I Report out (John Rhoads and Martin Rosner)
Topics - This is mostly a listening session with FHIR-I
Martin Rosner and John Rhoads reporting out on FHIR-I meeting
Many process steps!!!
Next steps: Have Brian R. review recording
John Rhoads has (finally!!) been approved to do the submission to both the Vocabulary and Terminology Authority (for nomenclatures which are not managed by HL7)
Martin noted: Lloyd walked through the process to move the IG forward and recorded discussion (so it can be review FMG)
John Rhoads noted that the versions FHIR Release R4b (after R4) due to come out in the next few weeks.. So if anything we'd like to get in (like extensions for example).
John R. noted R6 looks like it will be out in around 2025…
Device resource is owned by O&O, so there are other issues (in addition to what DEV thinks about) with other working groups…
Release R5 with increased number of resources will be started beginning March 30, 2021 (another milestone to getting correction to text and other areas for 'resources'.
ACTION ITEM (John Rhoads ):Outstanding JIRA item that has a "device component" (which is now obsolete) - so needs to be reviewed (and deleted)…
JOINT w/ mHealth (Q2 Thursday; Co-chairs present: Matt Graham, Gorra Datta, and Frank Ploeg) (2 Attendees)
Countries like Finland, Japan, Korea, etc.. That are much more EHR-centric; looking across
EHR + PHR functional models - Gora suggested moving PHR under Mobile Health
PHR: there is relevance with devices…
Can be leveraged from both HL7 DEV and IEEE
Active companies? Used to be Google, Microsoft, etc… shift has been on "Apps"
PHR not accepted in USA, words like Portals, etc. may be more accepted..
Which apps are the out there
Holland - PHR is centered, with subsidies to get PHRs into public areas and big programs to get data from HER to PHRs (so sharing can be enabled with patient/individual and Rx. - about 20-25 PHR vendors - again beacause of subsidies being offered by Gov't
What's the divide with EHR vs. PHR?
PHR more patient driven, vs HER (more clinical)
Attendee noted that Debi Willis is CEO of MyLinks, she is active in the Patient Empowerment HL7 Work Group
Suggest people look at e-Nabiz. This is Turkish system that gives access to all patient information including tests, prescriptions, clinician visits, etc. Also gives personalised notices about availability of vaccines.
SHIFT (see slides)
Mobile Health App - Data Exchange Project Scope - ONC funded
Assessment paper should be coming out in a few weeks…
Keith Boone - participating...
Document release target mentioned Feb of next year (2022)
RCC/MH TR Update (Makrodimitris / Fuchs / Datta)
Several focus presentation given (see slides…)
Outline shown - looking at layers and gaps of care areas as part of overall project such as Home Care, Hospital Care, Post Acute Care and Outpatient Care all within (Safe Effective Secure and …)
Lots of connected care aspects and areas …
Ken Fuchs provied a slide set and background on a project entitled
Gemini HL7 and IEEE and ISO/TC215 WG2 item
Goal is to produce a sound technical report
RCC group meets weekly at 4 PM Tuesday (US Eastern Time)
Will be engaging with and seeking TC215 expertise
Catalyst is the Pandemic… enormous need to allow patients and clinicians
Paper:
Outline shown - looking at layers and gaps of care areas as part of overall project such as Home Care, Hospital Care, Post Acute Care and Outpatient Care all within (Safe Effective Secure and …)
Lots of connected care aspects and areas …
Ken noted shifts in patient care across Hospital, Home Care and Post-Acute, and Outpatient care (see slides)
Kosta presented a virtual series named MDEpiNet
Monday February 1, 2021
Session starting at 3:00 PM Eastern
Kosta will present at 3:40 PM Eastern Time: Remote Connected Care and Mobile Health Solutions in COVID-19 Era for Clincal Practice,RWE, and Trials
Gora presented "FAR: Frontline Analysis & Research Project"
Real-world evidence based Smart Pandemic Management & Care of "Frontline" vulnerability/elderly population
Output: Open source scalable and expandable framework…
Gora presented a "real-world frontline challenge
Practicing physicians: 536,000
486,000 PCPs
Total 1,085,783 Doctors in US
6000 Hospitals
Multiple… multiple EHRs
Reactions and Comments
None
Note Question for DEV - regarding DeviceDefinition
"Where are the requirements coming from?" : Some regulatory needs to know where the dispense/granting of a device comes from. Would include apps (??really??) as well as physical devices (including PHDish and DME).
"What's the need to track the Function in the Dispense?" There just in case. Most would use Practitioner or PractionerRole.
"prepareDate" makes sense, but not necessarily and receiver" Maybe leave them in to be optional, and we need to figure out how a device dispense workflow works in FHIR (is there a different action on prepare vs delivery?)
Action items Q1 & Q2 highlited above in RED ...
Type your task here, using "@" to assign to a user and "//" to select a due date
Device Specific BICEPS sections for Physiologic Monitors, Infusion Pumps, Ventilators and more!
BICEPS Infusion Pump Model Review
Review of a first draft of a comprehensive (all (4) SDC PKPs) BICEPS of an infusion pump (aligned with the MDIRA Ref Implementation)
NOTE: This will fully integrate the current IHE DEV Infusion Pump Group Excel-based terminology / containment tree specification
IHE MDIRA Detailed Profile Proposal Update(Cooper, JHU/APL Team)
Review a first draft of the IHE DEV MDIRA DPP
NOTE: this will leverage constructs from SDPi to define actors such as ICE Supervisor, Data Logger, etc., leveraging technical approaches from the JHU/APL MDIRA SDC-based Reference Implementation
Interoperability levels/definition/scope harmonization (IEEE/HL7/IHE/ISO) and HIMSS
Device Specific BICEPS sections for Physiologic Monitors, Infusion Pumps, Ventilators and more!
BICEPS Infusion Pump Model Review
Review of a first draft of a comprehensive (all (4) SDC PKPs) BICEPS of an infusion pump (aligned with the MDIRA Ref Implementation)
NOTE: This will fully integrate the current IHE DEV Infusion Pump Group Excel-based terminology / containment tree specification
IHE MDIRA Detailed Profile Proposal Update(Cooper, JHU/APL Team)
Review a first draft of the IHE DEV MDIRA DPP
NOTE: this will leverage constructs from SDPi to define actors such as ICE Supervisor, Data Logger, etc., leveraging technical approaches from the JHU/APL MDIRA SDC-based Reference Implementation
Interoperability levels/definition/scope harmonization (IEEE/HL7/IHE/ISO) and HIMSS
other definitions? (AAMI, EU) to adopt for charter and website
Discuss Meeting Logistics/Plans followup 11073 (2021 and 2022 -
VIRTUAL meets in 2021 plan? HL7 registrations? IEEE alternatives
in person meet at US-FDA location-spring 2022 (joint meets with SDOs and FDA/CDRH)
Action Items overview in 2021(HL7/IEEE/ISO) andcoordination with other SDOs
websites/tools volunteers subgroup
Mapping progress
Subgroup on RCC/MH pandemic/COVID19 pilot/project (funding-students)
other WGs SDOs to engage invite
PHR/EHR coordination
educational flowchart to FHIR/VS2 IGs
Meeting Adjournment Notes: (Garguilo)
IEEE PoCD and HL7 DEV Leadership requests attendees provide all presented materials that can be shared be sent to John Garguilo or Konstantinos Makrodimitris
An email will be sent once meeting minutes are posted (Draft) - please take time to visit and review the minutes to provide corrections or clarifications - many thanks :-)
Melvin Reynolds is formally retiring (for good this time!) in March :-:
Look into an IEEE (or other??) award - such as a lifetime achievement award.
Suggestions, thought, ideas on how to celebrate "all things Melvin" appreciated…
HL7 DEVICES WG Meeting Adjourned (Garguilo and Attendees)
Action items Q1 & Q2 highlighted above in RED ...
Type your task here, using "@" to assign to a user and "//" to select a due date
