The Gemini Medical Device Interoperability Reference Architecture (MDIRA) Profile leverages the requirements and guidance <include scope / overview content from the DPP and other MDIRA documents>, the MDIRA Reference Implementation research <add more here>, and the SES MDI profiles and standards <as part of the Gemini project ... add content here> ...
<provide background for the history of this MDIRA Profile ...and link to sections below>
MDIRA Waterfall Feature in the Gemini Hanging Gardens
The Gemini Hanging Gardens Framework includes a Reference Architectures / Frameworks Garden that not only provides place for the ISO/IEEE 11073 SDC Service Oriented Architecture (SOA - BICEPS & SOMDA) or the AAMI Integrated Clinical Environment (ICE) framework but also anticipated the inclusion of the MDIRA specification. The following MDIRA "Requirements Waterfall" diagram has been annotated to the progression from the high-level requirements and guidance document to the standards and profiles and ultimately prototype & product implementations that are anticipated by this Gemini MDIRA Profile project.
Note: The annotations on this diagram are for examples only and not exhaustive. See the Hanging Gardens Framework for examples of other standards & profiles that will be leveraged.
Source: JHU/APL MDIRA Requirements Waterfall Model (annotated)
<add explanation of above diagram and annotations>
The MDIRA specification (ver 2.0) identified above includes the following diagram identifies the core components of the architecture specification.
<add explanation of the elements in the above diagram>
Note that the above system components model directly informs the IHE MDIRA Profile actor model included below.
Building on the MDIRA Reference Implementation Using 11073 SDC
<add content from the DPP document>
See the MDIRA RI Overview Video for an overview of how the JHU/APL MDIRA team used ISO/IEEE 11073 SDC and other standards (e.g., OAUTH) for their reference implementation.
Gemini MDIRA Profile Technical Approach
<content from the DPP such as the actor model, SDPi-P model & others, etc.>
The following MDIRA profile actor diagram is based on the foundational IHE SDPi-Plug-and-Trust profile model and adapted to support the MDIRA system components model above:
<add tour of the above actor diagram>
Note:
The MDIRA system components diagram includes a Patient Care Manager (PCM) that would be mapped to the MDIRA Patient Care Platform + MDIRA Medical Apps above. That MDIRA Patient Care Platform actor in turn leverages the SDPi-P SOMDS Smart App Platformactor, but in the model above the actual MDIRA Medical Apps are brought into the profile vs. the SDPi-P Smart Appsactor which is currently (not necessarily forever) outside the profile's boundaries.
IHE MDIRA Road to "Regulatory Submission Ready" Product Conformity Assessment
<to do:
Add discussion about the IHE CA process in general and how that would apply to the MDIRA profile specifications
Include IHE graphic ...
Craft a graphic showing the various aspects of this w/ sequence (incl. Supplement appendix w/ ICS tables linking to 2.0 document & profile specifications)
Link to the FDA ASCA Pilot discussion page
Objectives: MDIRA conformant products that can be included in RFP language, etc.
>
Profile Development
MDIRA Supplement Content
The following subpages capture the core content that will be formalized in the MDIRA Profile specification (note discussions in subsequent sections). The organization of the pages are in accordance with the general layout of an IHE technical framework:
The MBSE / SysML for MedTech Solutions Pilot project is evaluating whether the SDPi specification can be model centric with an exported "document" view, or if it will be document-centric (current IHE publication approach) as a Word document that is then PDF'd and analyzed and prototyped by implementers (yech!), or if it will use an emerging IHE technical framework publication approach that is analogous to HL7 FHIR's HTML-based specifications using FHIR IG Builder.
As a result, this page will capture the core content that will ultimately be formalizedeither in an MBSE/SysML model OR in an IHE Word profile supplement document.
Either way, github repository folders have been created to persist the content regardless of the path ultimately chosen: <add link here once pushed to the master>
See also the MBSE / SysML for MedTech Solutions Pilot pages for more information regarding the model-centric approaching being advanced, as well as example models for SDPi+FHIR and MDIRA, as well as others.
Topics of Interest - MDIRA Profile
As was done for the SDPI+FHIR development (see Topics of Interest), a Topics of Interest - MDIRA page provides a home for key implementation-focused discussions around the MDIRA specification and the MDIRA Profile implementation. Ultimately, the resolution of these topics will result in github repo "issue" tags and will provide the content for the Open/Closed Issues section in the IHE MDIRA Profile supplement document.
Discussion Notes & Action Items / Tasks
MDIRA Profile Meeting Discussion Notes
Note: Most recent (or future) meetings first.
2023 MDIRA Meetings
NOTE: Generally the MDIRA group has been meeting the 3rd Wednesday of each month at 0800 Pacific to catch-up everyone on the SDPi project + MDIRA-related topics BUT notes are not generally needed given the lack of action items, etc.
A general update discussion by the participants – no advance agenda published ...
MDIRA Discussions at Gemini SDC/SDPi+FHIR Meetings
Last week the HL7 WGM were in Phoenix and included device standards discussions
MDIRA was mentioned in the context of regulatory challenges around how to identify responsible vendors when there is a safety event
This always relates back to how to manage and track the "health" of a plug-and-trust ecosystem of medical device component products which always leads back to MDIRA on SDPi!
As the visibility and implementation community for SDC/SDPi+FHIR grows, so will these challenges and the need to implement a network health layer such as provided by MDIRA
Topic: PQC for SES MDI & Gemini SDPi Security Operationalization Roadmap
Next generation security utilizing post-quantum cryptography (PQC) is of interest to many government agencies across the world, including how to apply it to the health informatics field
NIST has recently updated their PQC related publications (FIPS 423 - 425)
JTC1/SC27 & the European PQCRYPTO groups have some joint standardization work afoot (though it looks a bit stale)
This topic is of strong interest to various government agencies, including DHS and HHS/FDA; it has broad application not only for military assets throughout the healthcare infrastructure as well
The Gemini SDPi Security Operationalization group is building out a roadmap to determine the path from the current approach standardized in 11073-20702 using WS-Security + TLS 1.3 or greater, to something that is more easily deployable at scale (1,000's of devices per site), and across geographies and regulatory jurisdictions. Addressing PQC as an end point in that roadmap, and understanding how it might fit into an SDPi/MDIRA world might be a good research project topic, especially building on the security aspects of the APL MDIRA project.
DECISION: Schedule a focused discussion with experts from APL (e.g., Brian Haberman) and NIST (TBD) to join the MDIRA time on the next call 25 October.
Next Meetings
Due to travel in October & November, the normal 3rd Wednesday dates do not work for the MDIRA calls
Change the next calls to:
at 0700 Pacific
at 0800 Pacific (normal time
August / September 2022 Meetings:
2022.08.17 meeting canceled due to summer holidays
2022.09.21 meeting is during the HL7 WGM / DEV WG - the MDIRA topic / report out will be included as part of that agenda (hopefully in the same time slot but with different Zoom info)
Todd briefed the group on recent discussions and a general (possible) outlook for MDIRA Profile in 2023
It was noted that especially in the FDA-related discussions around advancing SDPi Supplement, "ICE" and "MDIDS" (see below) have been mentioned as topics
Keeping ICE/MDIRA on the radar gives us a story to tell (and bring up), especially in contexts where the idea of a DataLogger or Supervisor or general PnT network "health" is brought up
As SDPi 1.0 is published early February for Trial Implementation, and as it is related to HIMSS'23 Interoperability Showcase demonstrations + the EP 2023 Considerations & Strategy Report due out before HIMSS in April 2023, discussions around SDPi will increase significantly, providing opportunity in discussions to include MDIRA Profile references
Note: MDIRA Profile is built on-top of SDPi ... so once SDPi 1.0 (and the 1.x / 2.0) is published, it clears the way to seriously look at MDIRA, when the need arises
Will demand for MDIRA capabilities surface in 2023 or beyond? Has MDIRA's "shelf life" already expired?! The group's sense was a definite MAYBE and "Not Yet"
Ken mentioned that MDIRA and a graphic is included in the SES Remote Connected Care / Mobile Health technical report that is in the final stages of development
Co-edited by Kosta at the FDA (Konstantinos Makrodimitris ) this paper will provide visibility to MDIRA, in both IHE-HL7 and especially ISO/TC 215.
General discussion about the status (update and maintenance) of the AAMI 2700-1 ICE standard (and related documents + any MDIDS (Medical Device Interoperability Data Sheet) sightings
There was a recent survey in the AAMI WG to look at uptake + interest in revision ... results are not known
Focus of that AAMI work group is currently on Remote Connected Care (or Remote Control?), with a focus on risk management and User Interface requirements
MDIDS is mentioned occasionally, randomly, but there is no known development / use activity and no clear examples
MDIDS → IHE SDPi TF-3 Specializations
In IHE DEV TF, the analog of MDIDS are the TF-3 Content Module specifications for device specializations (e.g., ventilator, infusion pump, ...)
SDPi Supplement TF-3 will include BICEPS overview sections + point to xml specification files that include a BICEPS MDIB xml specification that can be used for CA purposes
These xml files are roughly analogous to MDIDS, only with considerably more information + usable for conformity assessment activities
These xml files will be referenced from the appropriate TF-3 sections and included in the published SDPi Supplement (in the SDPi_Supplement/referenced-artifacts folder)
NIST's device profiler tool could be used to generate the device specialization files ...
BUT the current version only supports 11073-10201 Classic DIM, not BICEPS
IF there is interest and demand for a BICEPS-enabled version of the tool, then that task could be evaluated and possibly pursued
NOTE: Another alternative is to use a model-based (SysML 2.0) version that can be used to model the specialization and then create the xml file; this would be similar to what Stefan Schlichting did for the infusion pump prototype
Near Term (2022 → 2023) Profile plans:
Given the 2023 outlook provided in (1) and (2) above ...
Include references to MDIRA in the SDPi 1.0 specification (both references and content in TF-1 Appendix A)
Include mention of MDIRA in the EP 2023 Considerations & Strategy Report (to be published March 2023)
Include references to MDIRA (and ICE) in EP & FDA related discussions ... to keep it on the radar
No focused development of the profile will be advanced until after SDPi 2.0 is published for TI + Interest from the ecosystem is realized (i.e., contributors!)
As can be seen in the pictures, there was an Isolation Point-of-Care "SDC" demo component to the OR.NET booth, which was a mini version of what was shown at HIMSS
Hinrich also reported that ...
Dräger had a separate booth about a 5-minute walk away from the OR.NET booth, and when asked "What's coming next?" they would send them to the Isolation Point-of-Care demo in OR.NET
APL Exploring Potential Project Opportunities
For example, FDA DH CoE interest in MDIRA-related ... interested in potential standards that apply to "SES+MDI"
"MDIDS" (Medical Device Interoperability Data Sheet) leveraging may be a potential area of interest
Note the pulse-ox MDIDS was linked to the related 80601/60601-2-x standard
Note: APL has a new program manager (Jonathan Thornhill) who is actively assessing the landscape in groups that are stakeholders with the MDI world (esp. security)
Note that requirements for the implementation and use of MDIRA profile actors and capabilities will most likely be rooted in the discussions of this EP group
The NETCCN "virtual hospital" program continues (indirectly) to look at use of MDIRA/DDS (e.g., via DocBox) but potentially utilizing BICEPS/SDC-over-DDS;
Internal discussions continue for identifying project proposal opportunities that may include a MDIRA component
Some use / evaluation of the MDIRA RI within other projects; not to advance the MDIRA work but to utilize the RI to address connectivity requirements
Factoid of the Day: 310M CDA Docs / month in the U.S. a la Sequoia Project ... images are next
Note that this group, funded by the ONC, is also highly aware and supportive of the
HL7 PSS-2005 SES+MDI in Review
today the HL7 Devices WG approved PSS-1980 to be submitted for HL7 Consensus review (e.g., all co-chairs across all work groups)
Note that though this project scope statement does not directly mention MDIRA, it can be updated in the future or a separate PSS advanced to obtain formal approval (and recognition) of MDIRA within HL7
Note that the MDIRA Profile is fully approved on the IHE Devices side
Devices not key focus but good conversations, especially infusion pump vendors!
At the NETCCN / TIDE session, a very positive presentation was made of the work accomplished to date (including by Matt Quinn/TATRIC)
The ventilator remote control demo (from last December; see Goldman et al) was highlighted
The "remote consultancy" aspect of the project has truly helped patients (e.g., helping patient-local caregivers set up a ventilator on a patient); however, the ventilator remote control demonstrated in the presentation was "demo only" and though the perception was that patient use was next, no real patient treatment was involved
Note: The "interoperability" being demonstrated was not standards based, but via vendors like DocBox
Observation: From a functional perspective, there was no advancement from what was demonstrated betwen Dräger and MDPnP in 2014 using a tablet and a ventilator, supporting external control
MITRE is a primary contractor for the NETCCN "virtual hospital" program, for example, providing overall contract management services; MITRE is also contracted to ONC for various tooling projects including INFERNO for FHIR-based testing
HIMSS'23 Showcase:
Gemini SES+MDI program participants are focusing on a demo around the Silent ICU use cases
Example scenarios are detailed on the related Topic: DAS + Smart Alerting Challenges (especially the slides referenced at the top of the confluence page)
Companies considering participation include Dräger, Philips, a number of infusion pump vendors
MDIRA at HIMSS'23?
Consider: Supervisor "events" or "alarms" for MDIRA/SOMDS Health indications
These could be integrated into the story easily
Note: Showcase planning finalization is generally in the August / September ... October / November contracting is finalized with HIMSS
The FDA is conducting a virtual workshop on Interoperable Medical Device Systems & Standards (IMDSS), March 25
Many of the device interoperability standards leaders will be involved in various capacities, including Kenneth Fuchs , Todd Cooper
It isn't clear what is motivating the conference, though possibilities include
"ticking the box" to show that the FDA is working to advance patient safety and quality of care in the MDSS arena
Motivate the creation of "a new FDA digital health advisory committee" to "facilitate private sector coordination and gather stakeholder input" (from JAMA Health Forum, "The Case for Medical Device Interoperability, 2022.01.14)
One of the EP Topics of Interest items includes "Topic: Use of MDIRA to Improve PnT Ecosystem Operational Health" was added to the table in recent weeks
APL (Jan Rizzuto ) should consider adding someone to the bi-weekly EP group call (Tuesday's at 11:00 Eastern). Next call is
HIMSS'23 Showcase Discussions
The Gemini SES+MDI group is actively working on the HIMSS'23 showcase approach, built around the Silent ICU (e.g., use of SDC alert delegation)
This demonstration could include support not only for physiological and technical (e.g., "leads off") patient alarms / alerts, but also operational health advisories
APL could play a role in utilizing the MDIRA system components to monitor SDPi Plug-and-Trust ecosystem "health" and issue advisories to appropriate stakeholders
Any Other Business
Gemini RI+MC+RR 2022 Strategy + SysML 2.0 Support
Over the last month, concerted effort has been made to determine a 2022 strategy for realistically doing what we can to advance Requirements Interoperability + Model Centric + Regulatory Ready
For MC, the ultimate approach is to leverage MBSE/SysML 2.0 utilizing some tool chain BUT even those vendors who were instrumental in developing SysML 2.0 are not disclosing when they will have tool support for the new constructs
QUESTION: Does anyone at APL know anyone (anywhere) who could identify if / when such support would be provided?
Question: (Hinrich Althoff ) Current "MDIRA" sightings in the wild?
Virtual Hospital project (NETCCN) still active and leverages some MDIRA know-how; See demonstration ventilator from 2021 December; but solution is based on DocBox / DDS and interoperability is of a minor focus;
Now considering what is related to Virtual Hospital but more MDIRA over DDS; what is the same & what is different; what can be learned from VH to potential future MDRIA-related efforts
Engagement with agencies within DHA, MDRC, TATRIC etc. continue but no clear path has been identified to pursue;
NOTE: there have been significant organizational changes between these agencies resulting in continued engagement challenges
Reviewed EP home page and relevant slides from overview presentation
Discussion:
The MDIRA-related topics in the EP group discussions will "build the need" for the profile capabilities and actors
BUT in a review of the EP Topics of Interest table and the EP home confluence page, there were no references to MDIRA.
ACTION( Todd Cooper ) Add references to MDIRA both on the EP confluence home page (incl. links in the Reference Materials section) and in the Topics of Interest table
Funding Opportunities for MDIRA Profile Development
Todd reviewed recent discussions around an AAMI grant group that might provide opportunity to advance MDIRA Profile development
"The Mary K. Logan Research Awards is a grant program aimed at supporting research that enhances the safe adoption and safe use of health technology. The program awards up to $80,000 in grants annually."
Isolation Point-of-Care or SMART Alarming use cases
Pediatric care scenarios
COVID related care - including home/remote care settings (Isolation Point-of-Care at Home!)
... (others, Elliot is always a good source for 1,000 ideas per minute!
For MDIRA and APL,
Would there be a role for participating or supporting this kind of grant project?
Though $80K is not significant ... would it open the door to other "match" kind of funding or help kick-start other related efforts
What are the options and processes for APL interest / engagement / participation / support etc.?
For MDIRA, APL and Brian Haberman's TECH Focus
Though the focus of this research grant is "safe adoption and safe use of health technology", there could be a related TECHNICAL project as well (or as a separate grant initiative)
For example, the SDC/SDPi work is now including a gRPC/protobuf transport option (to the current MDPWS WS* transport) – see protoSDC.org – This could be coupled with the Topic: Precision Time Protocol Option that includes emerging standards[-based technology that Brian has been advancing.
ACTION( Steven GriffithsJan Rizzuto ) Investigate the options and possible approaches that we might take within APL in regard to the AAMI and other grants to advance work on the MDIRA profile
Additional Topics
No additional topics identified
Action Items / Tasks
( Todd Cooper ) Add references to MDIRA both on the EP confluence home page (incl. links in the Reference Materials section) and in the Topics of Interest table
( Steven GriffithsJan Rizzuto ) Investigate the options and possible approaches that we might take within APL in regard to the AAMI and other grants to advance work on the MDIRA profile
NOTE: 15 December 2021 meeting will be joint with the IHE Devices "all hands" meeting that has been moved to that time slot.
Discussions continue w/ APL's office of tech transfer; has provided the "means and mechanism" for how to provide the code via the web site
NOTE: The source code will not be "open" in the sense that anyone can simply download but a means for making it available upon request
A key issue is that there is no way to provide support for the open source repository, responding to questions, etc.
Software would be provided "as is", licensing requirements? Agreement / acknowledgement only of terms of use
Question: What if someone downloaded & posted to a different public repo? Or made extensions / enhancements and wanted to provide it back ot the open community?
Next Steps: Technology Transfer office working on answers to these questions
This may prove important in 2022 for advancing prototyping of the MDIRA profile
IHE DEV Domain Board Report & "apps"
Presented earlier in November, the question of "SAMD" and "What is a device?" was raised during the Board meeting
Pointed to the inclusion of "clinical therapeutic apps" a la MDIRA and SDPi, as well as DTx and Dx which are outside of MDIRA, etc.
Very well received along with the Gemini "Ecosystem Pathway" group being formed to engage the quality / regulatory affairs / legal risk management "SES" side of the effort; MDIRA's focus on monitoring and managing the "health" of a plug-and-trust ecosystem of decoupled component products will play a key role
"Ecosystem Pathway" Cohort Forming & will address the "SES" elements of the Gemini SDC/SDPi+FHIR program
As this group works through various aspects of the challenges related to advancing products through a defined "pathway" (including regulatory clearance) to market, implementation & use, the need for MDIRA capabilities will be identified and evaluated
At some point, it might be good for someone from the APL team (Steven Griffiths & Jan Rizzuto ) to join those calls (once they get started) and provide connection with the JHU/APL work as well as using it to engage APL program management around emerging opportunities.
SDC DataLogger Research Implementation
At RWTH Aachen University, Okan Yilmaz is part of a research team that has implemented a "data logger" for SDC networks
The research will be presented at a conference in 2022 and Okan would like to review that work with this group, including determination if it could serve as the basis for the MDIRA profile's DataLogger actor.
ACTION( Okan Yilmaz ) Join us for one of the MDIRA monthly meetings in 2022 and provide an overview of the research and discuss how this might be utilized within the Gemini SES MDI / MDIRA Profile efforts
Keep discussion going - for example in various Gemini SES MDI program groups (monthly MDRIA profile, Ecosystem Pathway, ...
Identify and secure funding - with a prioritized list of possible projects that might be perused
ACTION( Jan Rizzuto & Todd Cooper ) Discuss planning around advancing MDIRA profile development
Coordination with SDPi Roadmap?
A 3+ year SDPi Roadmap has been developed that charts a course for the capabilities that will be included in SDPi 1.0, 2.0, 3.0 etc.
Though there is no mention of integration with MDIRA Profile in the roadmap, since the profile is built upon the capabilities provided in the SDPi profiles, at some point it should be integrated (perhaps into a Gemini Roadmap).
As an added advantage, as we work to stand up a funded program for roadmap execution, having MDRIA in the mix will provide a possible place to advance the profile, implementations and conformity assessment
How might APL ( a trusted advisor for government agencies, especially on issues of systems engineering) leverage MDIRA program expertise / knowledge to provide this information to government agencies?
FDA focused? Military? Veterans? ???
NETCCN already includes some aspects of this work, includes TeleICU focus ... how to do remote control safely! also consider the Unity (SSch) study and the (Remote) Isolation PoC use case;
QUESTION: Can APL capitalize on opportunities in that arena? (answer: probably, but that's something that APL will have to determine, having all the contacts with those who manage those programs)
What is "next"? If the MDIRA Profile gets published and products are developed to that specification (including CA & regulatory clearance), and integrators and users deploy or are ready to deploy - wouldn't this be "sufficient" for FDA / Regulatory clearance? Focus on post-market surveillance?
Include section / reference in SDPi TF-1 Appendix B to mention conformance to MDIRA spec OR let that only be part of the MDIRA profile supplement and added to the SDPi profile only and IF needed?
Answer: Yes, ACTION( Todd Cooper ) add a "place holder" section now for the MDIRA conformance requirements, indicating linkage to the MDIRA profile and the MDIRA specifications
Additional Topics
December Meeting Date?
Same but joint with IHE Devices monthly "all hands" meeting
MDIRA profile will get the opportunity to report out to a broader audience! (including TBD the provision of MDIRA RI source code)
NOTE: Different Zoom information for this joint meeting ... to be emailed to the group
January Meeting Dates & '22 Cadence?
Keep current meeting sequence
ACTION( Todd Cooper ) Ensure that the currently scheduled meetings will continue into 2022
Action Items / Tasks
( Okan Yilmaz ) Join us for one of the MDIRA monthly meetings in 2022 and provide an overview of the research and discuss how this might be utilized within the Gemini SES MDI / MDIRA Profile efforts
( Jan Rizzuto & Todd Cooper ) Discuss planning around advancing MDIRA profile development
( Todd Cooper ) add a "place holder" section now for the MDIRA conformance requirements, indicating linkage to the MDIRA profile and the MDIRA specifications
( Todd Cooper ) Ensure that the currently scheduled meetings will continue into 2022
A new group is launching in the Gemini SES MDI program with a name (TBD) of SES/Quality & Regulatory Trust (or something similar)
The Gemini group to date has been primarily technically focused by technical guys; this group will engage the quality, regulatory affairs, risk management stakeholders to address the "SES" questions that we need to resolve early '22 in order to achieve the goal of "regulatory submission ready" 17025 CA Test Report summaries
This is of interest to the MDIRA group in that a key focus of the architecture is to facilitate the "health" of interoperable plug-and-trust medical devices - especially with actors such as a Supervisor or DataLogger; as part of the discussions in this new group, MDIRA Profile capabilities will be advanced
MDIRA RI - How to make available?
Any challenges with publishing on a public APL site that includes the SDC library from Dräger?
IF it is the version that is published on github (Jan thinks this is the case) ... then there should be no issue
Hinrich says it is a "MIT" open source license ... thus anything published has to to include the notice BUT what is added by APL can be under other license as well
Would APL include licensing terms? What would those be?
Good question! Stay tuned ...
HIMSS'22 Interoperability Showcase - APL going to conference?
APL has talked about it as a possibility .. but funding is TBD
Dräger incl. Hinrich & Tobias - will be there with an Isolation Point-of-Care (IPoC) use case demo showing SDC-enabled components
In recent APL work on the "virtual hospital", there has been discussion around the use of Stefan Schlichting's BICEPS Infusion Pump model (MBSE/SysML/Cameo); Todd answered a number of questions from Kathleen on the general topic of the current use and future status of this model, including the fact that it was utilized by Tobias in the SDC infusion pump demo that he is giving Thursday to the IHE Devices "Fall" meeting participants
Tobias gave a demo of an infusion pump that utilizes the BICEPS Infusion Pump model (MBSE/SysML/Cameo (Magicdraw) that Stefan Schlichting created as part of the MDIRA project work
Discussion focused on how Tobias used the pump model, along with other tools and libraries.
A key topic was the status and use of the ISO/IEEE 11073 Infusion Pump nomenclature, that is integrated into the model and the pump demo;
The containment model and related nomenclature is that which has been formalized in the 11073 nomenclature standards, is being extended by the IHE DEV Infusion Pump group, and is in prevalent use today by every infusion pump gateway to exchange information with enterprise systems, such as EHRs.
The "gold standard" for the infusion pump nomenclature - and that is publicly accessible - is the NIST RTMMS tool
RTMMS v2.0 tooling is getting closer to completion and will include an API that will allow dynamic access to the nomenclature database and value sets.
Group reviewed the items on the MDIRA ToI page and added priorities for the newest items
Note that the two high priorities emphasize the use of MDIRA to advance the health and resiliency of interoperable devices + to define therapy actors that include closed-loop control System Function capabilities.
Todd noted that the infusion pump demo (above) included some limited controls that will be needed for the HIMSS '22 Showcase IPoC demo (e.g., silencing the alarm) BUT that CLC capabilities will most likely need to be driven by non-pump companies given the value propositions involved and the regulatory / risk management challenges.
Additional Topics
Confirmed next meting: November 17th
Action Items / Tasks
No new action items.
2021-07-14 MDIRA Wednesday Web Meeting
Agenda (proposed)
General Updates
JHU/APL Programs Updates
Gemini SDPi+FHIR Program Update
Review Confluence Pages Updates (see list in previous meeting below)
Recent meetings with project sponsor and others included MDIRA RI demonstration; positive responses but also acknowledgement that much more work remains
MDIRA follow-on (funded) projects remains in discussion; however, it will most likely not be in the near future (e.g., weeks or months)
Gemini SDPi+FHIR Program Updates
3+ year roadmap discussions underway; should be ready to publish detailed version in August
Note that the MDIRA profile is not currently part of the roadmap - it is focused on SDC/SDPi+FHIR - however, will add a section on that (see discussion below)
HIMSS showcases are included in that roadmap ... Question: Would APL be interested in participating in the '22 showcase?
Note: The HIMSS'22 event is scheduled for March 15-17, 2022 in Orlando, Florida
Interoperability Showcases typically have a U.S. government area, and at times an academic / research area too
TBD what will be available in March '22 ... but we can start the conversation now
For example, APL could have a kiosk that highlighted MDIRA, Virtual Hospital and other related research ... promoting APL
ACTION( Jan Rizzuto) will investigate and see if there is enough interest to begin the discussion directly with HIMSS
Regulatory related discussions re. MDIRA
In recent discussions around advancing SDC/SDPi enabled products through a regulatory process, the potential value of MDIRA profile implementations was mentioned
These related discussions help keep the potential value of MDIRA as part of the SES MDI discussion, while the primary focus is on completing the SDPi supplement and moving into formal IHE CAT testing
JHU/APL IHE International Membership Status?
Still under legal review within APL; Jan will check on the status
MDIRA Profile Development Roadmap
The notional profile development roadmap included in the MDIRA Detailed Profile Proposal (DPP) was based on the pre-approval plans September 2020; much has happened since, though, including the completion of the MDIRA project; as the Gemini SDPi+FHIR Roadmap is updated, there will be MDIRA profile content included; Question: What should that look like given the current landscape and that of the foreseeable future?
Indicate current, regular project team activities:
Monthly web meetings, with a focus on ...
Updates from team members (see above "Updates" section
Quick review of the pages and the intent to connect the topics of interest to Github issues to the TF-1 open/closed issues lists
Profile Development Planning
Monthly MDIRA profile meetings will advance the discussion, BUT
SDPi 1.0 needs to be published / finalized before the MDIRA profile spec can be significantly completed (e.g., with referenced transactions)
ACTION( Todd Cooper) migrate content from MDIRA DPP to this page, including "Breakdown of tasks..." section
ACTION( Todd Cooper) Add planning review as a standard topic for the monthly calls
Additional Topics
Schedule & Agenda for July / August Meetings
DECISION: Change monthly meeting time to 0800 Pacific / 1700 CET
DECISION: Schedule at 0800 Pacific & CANCEL meeting only
NOTE: Todd Cooper will be on holiday July 17 through August 3; Consider whether to move the July meeting to or cancel July and have the next meeting
Action Items / Tasks
(Todd Cooper) Create a MDIRA Topics of Interest page ( )
(Todd Cooper) Create Google group for the MDIRA profiling team ( )
(Todd Cooper) Schedule WebEx meetings 4th Wednesday of each month at 0730 Pacific
(Todd Cooper) Migrate content from MDIRA DPP to this page, including "Breakdown of tasks ..." section
(Todd Cooper) Add planning review as a standard topic for the monthly calls
MDIRA Action Items / Tasks
The following report is generated for Gemini confluence pages that contain INCOMPLETE action items are tagged: sdpi-fhir-mdira.
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Gemini MDIRA Tasks Report
Description
Due date
Assignee
Task appears on
( Todd Cooper ) Add references to MDIRA both on the EP confluence home page (incl. links in the Reference Materials section) and in the Topics of Interest table
( Steven GriffithsJan Rizzuto ) Investigate the options and possible approaches that we might take within APL in regard to the AAMI and other grants to advance work on the MDIRA profile
( Okan Yilmaz ) Join us for one of the MDIRA monthly meetings in 2022 and provide an overview of the research and discuss how this might be utilized within the Gemini SES MDI / MDIRA Profile efforts
( Todd Cooper ) add a "place holder" section now for the MDIRA conformance requirements, indicating linkage to the MDIRA profile and the MDIRA specifications
