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>

For more background information, see "References" section below, the  Narrative: MDIRA / ICE page, as well as the JHU/APL MDIRA Project web site


What Lays 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: 

  1. 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 Platform actor, but in the model above the actual MDIRA Medical Apps are brought into the profile vs. the SDPi-P Smart Apps actor which is currently (not necessarily forever) outside the profile's boundaries.


IHE MDIRA Road to "Regulatory Submission Ready" Product Conformity Assessment

<to do:

  1. Add discussion about the IHE CA process in general and how that would apply to the MDIRA profile specifications
  2. Include IHE graphic ...
  3. Craft a graphic showing the various aspects of this w/ sequence (incl. Supplement appendix w/ ICS tables linking to 2.0 document & profile specifications)
  4. Link to the FDA ASCA Pilot discussion page
  5. 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:


MDIRA Profile TF-1  Interoperability Profiles

MDIRA Profile TF-2  Transactions 

MDIRA Profile TF-3  Content Modules

Document or Model + Github Repository?

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 formalized either 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

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.  


Agenda

No agenda published in advance

Participants

Todd Cooper Jan Rizzuto Hinrich Althoff Kenneth Fuchs John J. Garguilo    Steven Griffiths

Discussion Notes

A general update discussion by the participants – no advance agenda published ...

  1. MDIRA Discussions at Gemini SDC/SDPi+FHIR Meetings 
    1. Last week the HL7 WGM were in Phoenix and included device standards discussions
    2. MDIRA was mentioned in the context of regulatory challenges around how to identify responsible vendors when there is a safety event
    3. 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!
    4. 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
  2. Topic:  PQC for SES MDI & Gemini SDPi Security Operationalization Roadmap
    1. 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 
    2. NIST has recently updated their PQC related publications (FIPS 423 - 425)
    3. JTC1/SC27 & the European PQCRYPTO groups have some joint standardization work afoot (though it looks a bit stale)  
    4. 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
    5. 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.
    6. 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.
  3. Next Meetings
    1. Due to travel in October & November, the normal 3rd Wednesday dates do not work for the MDIRA calls
    2. Change the next calls to:
      1.   at 0700 Pacific 
      2. 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)

Agenda

No agenda published in advance

Participants

Todd Cooper Jan Rizzuto Hinrich Althoff Kenneth Fuchs John J. Garguilo  

Discussion Notes

A general update discussion by the participants – no advance agenda published ...

  1. MDIRA Profile Outlook for 2023 (Todd Cooper
    1. Todd briefed the group on recent discussions and a general (possible) outlook for MDIRA Profile in 2023
    2. It was noted that especially in the FDA-related discussions around advancing SDPi Supplement, "ICE" and "MDIDS" (see below) have been mentioned as topics
    3. 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
    4. 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
    5. 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
    6. 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" 
  2. APL Perspective (Jan Rizzuto )
    1. Jan mentioned that the topic comes up occasionally in discussions and presentations, but there is no clear funded project work on the horizon
    2. They did give a briefing to FDA personnel, but no follow-up to that at this point
    3. Noted that for APL, MDIRA is seen as an enabling technology to be used on other projects that require MDI (vs. advancing MDIRA specifically) 
  3. SES RCC/MH Tech Report (Kenneth Fuchs
    1. 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
    2. 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.
  4. ICE / MDIDS / AAMI WG / NIST ... Discussion (Kenneth Fuchs  & group)
    1. 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 
      1. There was a recent survey in the AAMI WG to look at uptake + interest in revision ... results are not known
      2. 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 
      3. MDIDS is mentioned occasionally, randomly, but there is no known development / use activity and no clear examples 
    2. MDIDS → IHE SDPi TF-3 Specializations
      1. In IHE DEV TF, the analog of MDIDS are the TF-3 Content Module specifications for device specializations (e.g., ventilator, infusion pump, ...)
      2. 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
        1. These xml files are roughly analogous to MDIDS, only with considerably more information + usable for conformity assessment activities
        2. 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)
      3. NIST's device profiler tool could be used to generate the device specialization files ...
        1. BUT the current version only supports 11073-10201 Classic DIM, not BICEPS
        2. IF there is interest and demand for a BICEPS-enabled version of the tool, then that task could be evaluated and possibly pursued
        3. 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
  5. Near Term (2022 → 2023) Profile plans:
    1. Given the 2023 outlook provided in (1) and (2) above ...
    2. Include references to MDIRA in the SDPi 1.0 specification (both references and content in TF-1 Appendix A)
    3. Include mention of MDIRA in the EP 2023 Considerations & Strategy Report (to be published March 2023)
    4. Include references to MDIRA (and ICE) in EP & FDA related discussions ... to keep it on the radar
    5. 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!)

Action Items / Tasks

No new action items.


Agenda (proposed)

  1. General Updates
  2. ...
  3. Any Other Business

Participants

Todd Cooper   John J. Garguilo  Jan Rizzuto  Kenneth Fuchs  

Discussion Notes

  1. General Updates 
    1. Ecosystem Pathway Group Updates 
      1. EP group continues to work through a large list of issues 
      2. MDIRA consideration is on the EP list ... but not a high priority - may be addressed in 2023, perhaps earlier than later-er in the year 
    2. Gemini SES+MDI Program - General Updates
      1. Current focus is on the SDPi 1.0 specification, which may include a "future" focused reference to MDIRA
      2. CA strategy is also included which will support the MDIRA ICS support as well 
    3. APL Update
      1. Virtual Hospital support task ends  
      2. labs continue looking for opportunities that leverage the MDIRA work 
  2. ...
  3. Any Other Business
    1. Next Meeting: 
      1. Cancel August? Yes
      2. September?  During HL7 WGM - can include MDIRA as a topic

Action Items / Tasks

No additional action items.


Agenda (proposed)

  1. General Updates
  2. ...
  3. Any Other Business

Participants

Todd Cooper   Hinrich Althoff   Kenneth Fuchs  Okan Yilmaz  Jan Rizzuto  Steven Griffiths  John J. Garguilo  

Discussion Notes

  1. General Updates
    1. Gemini program May '22 updates posted on the Library confluence page 
    2. DMEA '22 (Berlin conference) 
      1. Okan provided a brief report out from the recent DMEA conference held in Berlin ...
        1. The OR.NET booth was well situated outside a conference venue - so great traffic in the booth!  
        2. Here is a news brief about the event ...
        3. And some pic's!  
          1. and
        4. 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
      2. Hinrich also reported that ...
        1. 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
  2.  APL Exploring Potential Project Opportunities 
    1. For example, FDA DH CoE interest in MDIRA-related ... interested in potential standards that apply to "SES+MDI" 
      1. Note:  the FDA Digital Health CoE MDI page
    2. "MDIDS" (Medical Device Interoperability Data Sheet) leveraging may be a potential area of interest
      1. Note the pulse-ox MDIDS was linked to the related 80601/60601-2-x standard 
    3. 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) 
  3. Any Other Business 
    1. June 15 Meeting?  
      1. Hinrich Althoff  & Todd Cooper  cannot join the call due to travel 
      2. Cancel or schedule for a different time in June?
      3. DECISION:  Cancel June 15th, reconvene on July 20

Action Items / Tasks

No new action items


Agenda (proposed)

  1. General Updates
  2. HIMSS'23 Showcase Considerations
  3. Topics of Interest - MDIRA Review
  4. Any Other Business

Participants

Todd Cooper   Jan Rizzuto  Hinrich Althoff  John J. Garguilo   Kenneth Fuchs   Steven Griffiths 

Discussion Notes

  1. General Updates
    1. Gemini Ecosystem Pathway Update
      1. The EP group continues to form and focus on specific topics as captured in the EP Topics of Interest Table
      2. 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
      3. All EP meeting notes and other artifacts are on Pathway to an Ecosystem of Plug-and-Trust Products
    2. APL Update
      1. 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;
      2. Internal discussions continue for identifying project proposal opportunities that may include a MDIRA component
      3. 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
    3. Factoid of the Day:  310M CDA Docs / month  in the U.S. a la Sequoia Project ... images are next 
      1. Note that this group, funded by the ONC, is also highly aware and supportive of the 
    4. HL7 PSS-2005 SES+MDI in Review
      1. today the HL7 Devices WG approved PSS-1980 to be submitted for HL7 Consensus review (e.g., all co-chairs across all work groups)
      2. 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
      3. Note that the MDIRA Profile is fully approved on the IHE Devices side
  2. HIMSS'23 Showcase Demonstrations
    1. HIMSS'22 report out  ( Hinrich Althoff  Kenneth Fuchs )
      1. Devices not key focus but good conversations, especially infusion pump vendors!  
      2. At the NETCCN / TIDE session, a very positive presentation was made of the work accomplished to date (including by Matt Quinn/TATRIC)
        1. The ventilator remote  control demo (from last December; see Goldman et al) was highlighted
        2. 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 
        3. Note:  The "interoperability" being demonstrated was not standards based, but via vendors like DocBox 
        4. 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
      3. 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
    2. HIMSS'23 Showcase: 
      1. Gemini SES+MDI program participants are focusing on a demo around the Silent ICU use cases
      2. Example scenarios are detailed on the related Topic:  DAS + Smart Alerting Challenges (especially the slides referenced at the top of the confluence page)
      3. Companies considering participation include Dräger, Philips,  a number of infusion pump vendors
      4. MDIRA at HIMSS'23?
        1. Consider:  Supervisor "events" or "alarms" for MDIRA/SOMDS Health indications 
        2. These could be integrated into the story easily
      5. Note:  Showcase planning finalization is generally in the August / September ... October / November contracting is finalized with HIMSS
  3. Any Other Business
    1. Next Meeting:  May 18

Action Items / Tasks

None identified.


Agenda (proposed)

  1. General Updates
  2. Ecosystem Pathway Coordination
  3. MDIRA Project Advancement Activities
  4. Additional Topics

Participants

Todd Cooper  Jan Rizzuto  Kathleen Perrino

Regrets:  Hinrich Althoff  Kenneth Fuchs  

NOTE:  Many were at the HIMSS'22 conference in Orlando Florida this week

Discussion Notes

  1. General Updates
    1. HIMSS'22 Updates
      1. Isolation Point-of-Care (SDC) demo at the HIMSS'22 Interoperability Showcase
        1. See HIMSS'22 Interoperability Demonstrations Use Case Descriptions (page 4)
      2. NETCCN/TiDE is also present at HIMSS'22
      3. FDA March 25 Interoperability 
        1. The FDA is conducting a virtual workshop on Interoperable Medical Device Systems & Standards (IMDSS), March 25 
        2. Many of the device interoperability standards leaders will be involved in various capacities, including Kenneth Fuchs , Todd Cooper  
        3. It isn't clear what is motivating the conference, though possibilities include 
          1. "ticking the box" to show that the FDA is working to advance patient safety and quality of care in the MDSS arena 
          2. 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)
  2. Ecosystem Pathway Coordination
    1. A key venue within the Gemini SES+MDI program to build the value proposition for the MDIRA profile is the Pathway to an Ecosystem of Plug-and-Trust Products 
    2. 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
      1. ACTION( Todd Cooper  ) Add APL (Jan Rizzuto ) as an interested party to this topic
    3. APL (Jan Rizzuto ) should consider adding someone to the bi-weekly EP group call (Tuesday's at 11:00 Eastern).  Next call is  
  3. HIMSS'23 Showcase Discussions
    1. 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)
    2. This demonstration could include support not only for physiological and technical (e.g., "leads off") patient alarms / alerts, but also operational health advisories
    3. 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
  4. Any Other Business
    1. Gemini RI+MC+RR 2022 Strategy + SysML 2.0 Support
      1. 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 
      2. 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
      3. QUESTION:  Does anyone at APL know anyone (anywhere) who could identify if / when such support would be provided?

Action Items / Tasks




Agenda (proposed)

  1. General Updates
  2. Coordination with Gemini Ecosystem Pathway Group
  3. Funding Opportunities for MDIRA Profile Development
  4. Additional Topics

Participants

Todd Cooper   Kenneth Fuchs   Steven Griffiths  Jan Rizzuto   Page layout

Regrets:  Hinrich Althoff  

Discussion Notes

  1. General Updates
    1. Question:  (Hinrich Althoff ) Current "MDIRA" sightings in the wild?
      1. 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; 
      2. 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
    2. Engagement with agencies within DHA, MDRC, TATRIC etc. continue but no clear path has been identified to pursue; 
    3. NOTE: there have been significant organizational changes between these agencies resulting in continued engagement challenges 
  2. Coordination with Gemini Ecosystem Pathway Group
    1. Reviewed EP home page and relevant slides from overview presentation 
    2. Discussion:
      1. The MDIRA-related topics in the EP group discussions will "build the need" for the profile capabilities and actors 
      2. BUT in a review of the EP Topics of Interest table and the EP home confluence page, there were no references to MDIRA.  
      3. 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
  3. Funding Opportunities for MDIRA Profile Development
    1. Todd reviewed recent discussions around an AAMI grant group that might provide opportunity to advance MDIRA Profile development
      1. AAMI Foundation Mary K. Logan Research Grant
      2. "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."
      3. Previous Grant Recipients 
      4. Submission deadline:  2022.03.11 
    2. These grants were pointed out to me by Elliot Sloane a good friend and long term colleague of Ken Fuchs and myself
    3. Thoughts were to try and propose a research project that integrated various threads including:
      1. SES+MDI & MDIRA - device interoperability ... safe effective & secure ... real-world evidence ... clinical algorithms etc.
      2. Isolation Point-of-Care or SMART Alarming use cases
      3. Pediatric care scenarios
      4. COVID related care - including home/remote care settings (Isolation Point-of-Care at Home!) 
      5. ... (others, Elliot is always a good source for 1,000 ideas per minute!
    4. For MDIRA and APL, 
      1. Would there be a role for participating or supporting this kind of grant project?
      2. Though $80K is not significant ... would it open the door to other "match" kind of funding or help kick-start other related efforts
      3. What are the options and processes for APL interest / engagement / participation / support etc.?
    5. For MDIRA, APL and Brian Haberman's TECH Focus
      1. 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)
      2. 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.
    6. ACTION( Steven Griffiths  Jan 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
  4. Additional Topics
    1. 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 Griffiths  Jan 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.

Agenda (proposed)

  1. General Updates
  2. Topics of Interest - MDIRA Review & Discussion
  3. 2022 MDIRA Profile - Roadmap Planning
  4. Additional Topics
    1. December Meeting Date?
    2. January Meeting Dates & '22 Cadence?

Participants

Todd Cooper  Steven Griffiths Jan Rizzuto   Kenneth Fuchs   Michael Faughn  Hinrich Althoff   

Regrets:  Okan Yilmaz  

Discussion Notes

  1. General Updates
    1. MDIRA RI "Open Source" - Status Update
      1. 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
      2. 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
      3. A key issue is that there is no way to provide support for the open source repository, responding to questions, etc.
      4. Software would be provided "as is", licensing requirements?  Agreement / acknowledgement only of terms of use
      5. 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?
      6. Next Steps:  Technology Transfer office working on answers to these questions
      7. This may prove important in 2022 for advancing prototyping of the MDIRA profile 
    2. IHE DEV Domain Board Report & "apps"
      1. Presented earlier in November, the question of "SAMD" and "What is a device?" was raised during the Board meeting 
      2. 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. 
      3. 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
    3. "Ecosystem Pathway" Cohort Forming & will address the "SES" elements of the Gemini SDC/SDPi+FHIR program
      1. 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
      2. 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.
    4. SDC DataLogger Research Implementation  
      1. At RWTH Aachen University, Okan Yilmaz is part of a research team that has implemented a "data logger" for SDC networks
      2. 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.
      3. 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
  2. Topics of Interest - MDIRA Review & Discussion
    1. No new updates / issues
  3. 2022 MDIRA Profile - Roadmap Planning
    1. Priorities & realities for 2022?
      1. Keep discussion going - for example in various Gemini SES MDI program groups (monthly MDRIA profile, Ecosystem Pathway, ... 
      2. Identify and secure funding - with a prioritized list of possible projects that might be perused 
        1. ACTION( Jan Rizzuto  & Todd Cooper ) Discuss planning around advancing MDIRA profile development 
    2. Coordination with SDPi Roadmap?
      1. 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.
      2. 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).
      3. 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
    3. 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?
      1. FDA focused?  Military?  Veterans?  ???
      2. 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;  
        1. 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)
      3. 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?  
    4. 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?
      1.  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
  4. Additional Topics
    1. December Meeting Date?  
      1. Same but joint with IHE Devices monthly "all hands" meeting
      2. MDIRA profile will get the opportunity to report out to a broader audience! (including TBD the provision of MDIRA RI source code)
      3. NOTE:  Different Zoom information for this joint meeting ... to be emailed to the group
    2. January Meeting Dates & '22 Cadence?
      1. Keep current meeting sequence 
      2. 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



Agenda (proposed)

  1. General Updates
  2. Topics of Interest - MDIRA Review & Discussion
  3. Additional Topics

Participants

Todd Cooper   Hinrich Althoff  Jan Rizzuto   Steven Griffiths   Tobias Klotz   

Kathleen Perrino

Discussion Notes

  1. General Updates
    1. Gemini SES/"Regulatory" Group Formation 
      1. A new group is launching in the Gemini SES MDI program with a name (TBD) of SES/Quality & Regulatory Trust (or something similar)
      2. 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
      3. 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
    2. MDIRA RI - How to make available?
      1. Any challenges with publishing on a public APL site that includes the SDC library from Dräger?
        1. IF it is the version that is published on github (Jan thinks this is the case) ... then there should be no issue
        2. 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
      2. Would APL include licensing terms?  What would those be?  
        1. Good question!  Stay tuned ...
    3. HIMSS'22 Interoperability Showcase - APL going to conference?
      1. APL has talked about it as a possibility .. but funding is TBD
      2. Dräger incl. Hinrich & Tobias - will be there with an Isolation Point-of-Care (IPoC) use case demo showing SDC-enabled components
  2. Gemini SDPi Infusion Pump "Demo" & Modeling Discussion 
    1. 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
    2. 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
    3. Discussion focused on how Tobias used the pump model, along with other tools and libraries.
    4. 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; 
      1. 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.
      2. The "gold standard" for the infusion pump nomenclature - and that is publicly accessible - is the NIST RTMMS tool
      3. 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.  
  3. Topics of Interest - MDIRA Review & Discussion
    1. Group reviewed the items on the MDIRA ToI page and added priorities for the newest items
    2. 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.
    3. 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.
  4. Additional Topics
    1. Confirmed next meting:  November 17th

Action Items / Tasks

No new action items.



Agenda (proposed)

  1. General Updates
    1. JHU/APL Programs Updates
    2. Gemini SDPi+FHIR Program Update
  2. Review Confluence Pages Updates (see list in previous meeting below)
  3. Topics of Interest - MDIRA Review 
  4. MDIRA Profile Development Planning Review
  5. Additional Topics
    1. 2021 Meeting Planning

Participants

Todd Cooper Kenneth Fuchs Jan Rizzuto  John J. Garguilo  

Kathleen Perrino 

Discussion Notes

  1. General Updates
    1. JHU/APL Program Update
      1. Recent meetings with project sponsor and others included MDIRA RI demonstration; positive responses but also acknowledgement that much more work remains
      2. MDIRA follow-on (funded) projects remains in discussion; however, it will most likely not be in the near future (e.g., weeks or months)
    2. Gemini SDPi+FHIR Program Updates
      1. 3+ year roadmap discussions underway; should be ready to publish detailed version in August
      2. 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)
      3. HIMSS showcases  are included in that roadmap ... Question:  Would APL be interested in participating in the '22 showcase?
        1. Note:  The HIMSS'22 event is scheduled for March 15-17, 2022 in Orlando, Florida
        2. Interoperability Showcases typically have a U.S. government area, and at times an academic / research area too
        3. TBD what will be available in March '22 ... but we can start the conversation now 
        4. For example, APL could have a kiosk that highlighted MDIRA, Virtual Hospital and other related research ... promoting APL
        5. ACTIONJan Rizzuto) will investigate and see if there is enough interest to begin the discussion directly with HIMSS
      4. Regulatory related discussions re. MDIRA 
        1. In recent discussions around advancing SDC/SDPi enabled products through a regulatory process, the potential value of MDIRA profile implementations was mentioned
        2. 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
    3. JHU/APL IHE International Membership Status?
      1. Still under legal review within APL;  Jan will check on the status
  2. MDIRA Profile Development Roadmap
    1. 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?
    2. Indicate current, regular project team activities:
      1. Monthly web meetings, with a focus on ...
        1. Updates from team members (see above "Updates" section
        2. Extending, discussing and resolving the items included in the Topics of Interest - MDIRA page 
      2. Ensuring connection with related Gemini SES MDI efforts, such as the SDPi profiles development
    3. MDIRA Roadmap could target (for strawman purposes) :
      1. Technical discussion / resolutions NOW ('21 2H) (per 
      2. Publish MDIRA supplement 1.0 summer '22
      3. Participate in NA CAT January '23
      4. PAT's in '22
      5. vCAT's in '22
    4. ACTION(  Todd Cooper ) Update Gemini roadmap w/ MDIRA section per the above
  3. Topics of Interest
    1. See updates made directly on the Topics of Interest - MDIRA page
  4. Additional Topics
    1. Next meeting:  3rd Wednesday at 0800 Pacific, August 18 

Action Items / Topics

  • Jan Rizzuto) will investigate and see if there is enough interest to begin the discussion directly with HIMSS
  • (  Todd Cooper ) Update Gemini roadmap w/ MDIRA section per the above 



Agenda (Proposed)

  1. General Updates
    1. JHU/APL MDIRA Project Updates
      1. Reference Implementation Update
      2. Open Source plans 
      3. MDIRA 2.1 specification comment plans
      4. MDIRA 2.1 MBSE/SysML modeling update
      5. IHE International membership update (for JHU/APL) 
    2. SDPi+FHIR Project Updates
  2. MDIRA Confluence Review
    1. Narrative: MDIRA / ICE 
    2. Library with EVERYTHING you ever wanted to know ... 
    3. Specifications: MDIRA / ICE Profile (this page!)
  3. Topics of Interest - MDIRA Review
  4. Profile Development Planning 
  5. Additional Topics
    1. Schedule & Agenda for July / August Meetings
    2. 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  

Participants

Todd Cooper Wouter Peeters Jan Rizzuto Steven Griffiths Kenneth Fuchs 

Discussion Notes

  1. General Updates
    1. JHU/APL MDIRA Project Updates
      1. Reference Implementation Update
        1. Finalizing last parts of the reference implementation demonstration system
        2. RI has been able to successfully identify & register components, request & share data, and enable Supervisor "authorization" for inter-device control 
        3. Goal:  Craft a video showing the final RI demonstration
      2. Open Source plans 
        1. No current plans in place BUT
        2. Continuing to work to identify how to make RI software available to an public community
      3. MDIRA 2.1 specification comment plans
        1. Use the MDIRA "Feedback" web page to submit any questions about the specification or related to the overall program
      4. MDIRA 2.1 MBSE/SysML modeling update
        1. Updated model in process but not yet complete
        2. Primary focus would be on capturing the MDIRA 2.1 requirements in a SysML Requirements Model
        3. TBD – when the updated model will be completed 
        4. NOTE:  The discussion will be included with the Gemini CA & Tooling discussions as part of the MBSE/SysML/Cameo Pilot Projects 
        5. ACTION (Todd Cooper) Add Wouter & Steve & Jan to the sdpi-fhir-ca email list & meeting invites
      5. IHE International membership update (for JHU/APL)
        1. JHU/APL advancing the process; possibly later in 2021
    2. SDPi+FHIR Project Updates
      1. Finalizing 3+ year milestones & specification phasing (e.g., what has to be in Version 1.0 of the SDPi supplement)
      2. Note:  Current draft supplement is available at the GitHub repo for the SDPi Supplement  
      3. MDIRA Profile folders created in SDPi-FHIR Github Repo
  2. MDIRA Confluence Review
    1. Narrative: MDIRA / ICE 
    2. Library with EVERYTHING you ever wanted to know ... 
    3. Specifications: MDIRA / ICE Profile (this page!)
  3. Topics of Interest - MDIRA Review
    1. 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
  4. Profile Development Planning 
    1. Monthly MDIRA profile meetings will advance the discussion, BUT
    2. SDPi 1.0 needs to be published / finalized before the MDIRA profile spec can be significantly completed (e.g., with referenced transactions)
    3. ACTIONTodd Cooper) migrate content from MDIRA DPP to this page, including "Breakdown of tasks..." section
    4. ACTIONTodd Cooper) Add planning review as a standard topic for the monthly calls
  5. Additional Topics
    1. Schedule & Agenda for July / August Meetings
      1. DECISION:  Change monthly meeting time to 0800 Pacific / 1700 CET
      2. DECISION:   Schedule   at 0800 Pacific & CANCEL  meeting only
    2. 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



The following report is generated for Gemini confluence pages that contain INCOMPLETE action items are tagged: sdpi-fhir-mdira.

...

DescriptionDue dateAssigneeTask 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
Todd CooperSpecifications: MDIRA / ICE Profile
  • ( Steven Griffiths  Jan 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
Steven GriffithsSpecifications: MDIRA / ICE 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
Okan YilmazSpecifications: MDIRA / ICE Profile
  • ( Todd Cooper  ) add a "place holder" section now for the MDIRA conformance requirements, indicating linkage to the MDIRA profile and the MDIRA specifications
Todd CooperSpecifications: MDIRA / ICE Profile
  • ( Todd Cooper  )  Ensure that the currently scheduled meetings will continue into 2022
Todd CooperSpecifications: MDIRA / ICE Profile
Jan RizzutoSpecifications: MDIRA / ICE Profile
  • (Todd Cooper) Migrate content from MDIRA DPP to this page, including "Breakdown of tasks ..." section

Todd CooperSpecifications: MDIRA / ICE Profile
  • (Todd Cooper) Add planning review as a standard topic for the monthly calls

Todd CooperSpecifications: MDIRA / ICE Profile
  • (  Todd Cooper ) Update Gemini roadmap w/ MDIRA section per the above 
Todd CooperSpecifications: MDIRA / ICE Profile
  • Jan Rizzuto) will investigate and see if there is enough interest to begin the discussion directly with HIMSS
Jan RizzutoSpecifications: MDIRA / ICE Profile

References

  1. MDIRA documents (for latest versions!):
    1. See JHU/APL MDIRA Program web page for complete information
    2. MDIRA Specification Document
      1. Latest Draft:  MDIRA Version 2.1 (2021-June).pdf
      2. MDIRA Specification Document Version 1.0.pdf
    3. MDIRA FAQ 2021-04-21A.pdf 
    4. MDIRA Reference Implementation Video (New as of 2021-05-03) 
  2. IHE DEV MDIRA profile proposal documents (both approved by IHE DEV):
    1. IHE DEV Profile Proposal - Brief MDIRA 2020.09.25B.pdf
    2. IHE DEV Profile Proposal - Detailed MDIRA 2021.02.19A.pdf 
  3. Update Presentations to HL7 / IEEE / IHE Devices Groups
    1. See "library" presentations in MDIRA Profile section
    2. APL MDIRA Update to IEEE HL7 WGM_01252021.pdf
    3. JHU-APL MDI - Update to 2020-09 Joint HL7-IEEE-IHE WGM_09212020_Update.pdf
  4. Gemini SES MDI / MDIRA Profile References
    1. IHE SDPi-FHIR Github Repository for the MDIRA Profile 
    2. Narrative: MDIRA / ICE 
    3. IHE Service-oriented Device Point-of-care Interoperability (SDPi) White Paper (2019-11-01), section 10.1.1.2 Example: MDI Reference Architecture & Autonomous Medical Systems
    4. IHE Compendium of Medical Device Oriented Use Cases (2019-11-01; Companion to SDPi White Paper), section B Integrated Clinical Environment (ICE) Clinical Scenarios, and section F NITRD - Medical Device Scenario & Use Cases
    5. ...
  5. Standards/Specifications Specific for the Profile Specification
    1. <TBD:  ISO/IEEE 11073 SDC standards link>
    2. <TBD:  AAMI 2700 ICE standards link>
    3. <TBD:  list from the MDIRA 2.1 specification>
    4. <TBD:  any from the MDIRA RI ?? e.g., OAUTH> 
    5. ...
  6. ...