A study project with IHE Catalyst to detail how and who and when with what ... for SDC/SDPi CA & Tooling over the next 3 years is going forward
First report should be done late November and initial results ready for report out to this group in the December meetings
This will answer questions like "How exactly do you interface a test application with Gazelle?"
IHE T&T October Meeting Report Out
Todd reported out on the SDC/SDPi+FHIR work (esp. CA & Tooling) to the monthly IHE Testing & Tools meeting yesterday (2021.10/20), including the successful PAT #5, planning for PAT #6, Gemini SES/Quality & Regulatory Trust group launching, and the Catalyst study ... very well received by this "high level" IHE T&T team
Report outs included the increasing demand for FHIR support and testing ... driving roadmaps for '22 to be updated to provide these capabilities
NIST Asbestos tool (initially for XDS.b to FHIR-based MHD testing) was also detailed and will be demo'd in the November T&T meeting; SDC/SDPi-P::FHIR Gateway may use this tool
IHE DEV Infusion Pump Demo Today
Note that Tobias will provide a LIVE!!! demonstration today of an SDC-enabled infusion pump along with the development & test tooling
A recorded version will provided in the next week for those who cannot participate
PAT #5 Report Out
Tobias provided an update on IHE DE PAT #5 earlier this month
Virtual testing infrastructure (VPN) worked very well
"Real" devices are increasingly being used in the testing (vs. application - to - application testing)
Poll out for a F2F ... and response has been 50% "yes"!!!
RI+MC+RR for SDPi 1.0 Report Out
Todd reviewed a few of the slides on the current effort to define a baseline RI approach for SDPi 1.0; a broader demonstration will be part of the IHE DEV F2F meetings later today
QUESTION: How will test assertions be formalized and linked from test cases / scripts into the RI chains that identify the requirements that they meet?
This question will need to be resolved by the end of '21 and will be informed by the result of the Catalyst Study project.
Additional Items
No additional topics identified
Action Items / Tasks
No new tasks
NOTE: 2021.10.07 Meeting CANCELED due to concurrent IHE DE PAT #5
ACTION (Todd Cooper & John Rhoads ) Coordinate with Sarah Bell re. IHE Calendar invite list + send Zoom info blast to CA & Tooling List
PAT #5 Update - Full steam ahead ...
Tooling development update - still looking for developer to work on testing tool (supporting transaction level testing)
IHE T&T Monthly Report + HIMSS Showcase Briefing report out -
<T&T agenda & participation for SDPi >
Both Showcase '22 (March/Orlando) & NA CAT (late January/Chicago) - focus is on in-person ONLY for both ... maybe hybrid if it is necessary
IHE Catalyst discussions update
Advancing a "study" project <... scope ...>
John noted that <...relevance ...>
Related question: Is Gazelle the best long term tool for our test management? especially with virtualized 24/7 testing / CA support
Consider the Stella Story & identification of gaps for using Gazelle for formal independent CA purposes
ACTION( John Donnelly ) Provide the short list of "gaps" for using Gazelle in support of product CA using ISO 17000
Kicking off an "SES/Regulatory Group" next week to focus on the strategy / roadmap and elements needed to build competence & confidence toward achieving "regulatory submission ready" product CA test reports
Discussion: Can we build sufficient regulatory confidence through virtualized 24/7 testing including product CA?
Given the challenges of in-person around the same table testing events (including CAT), a primary SDPi CA focus will be virtualized 24/7 testing, including CAT & product CA ...
Given the challenges of needing to establish SES / regulatory confidence and trustworthiness in "regulatorily decoupled" component products ...
IOW when you cannot do combinatorial testing of all possible
NOTE: See OR.NET Conformance Principles white paper
QUESTION: What "mix" of CA & Tooling capabilities & events & implementation / pilot projects & demonstrations will be needed?
Discussion:
<... crosscuts with other stakeholders / experts esp. SES/Regulatory >
< ... the sooner we start directly supporting vCAT and vCA ...> ( at a quarterly basis)
< ... will the FDA/NB require in-person D2D testing? How much? Will pilots/demos + in-hospital examples be sufficient? How much? ...>
< ... CAT has two deliverables: (1) Systems that demonstrate conformity + (2) tool maturity leading to CA process ... where the tool version gets locked down as part of the test package ...>
< ... see ONC's testing certification program (excludes devices) that includes now a requirement for real world testing of products that are annually certified, need to submit a plan & test results for every criteria of certified product WITH A CUSTOMER ... in the implemented / in use of those products ...>
< NOTE ONC Tech Forum last Friday w/ "devices" session ... ACTION( Todd & John D. ) to find slides and possibly recording of event ...>
< ...Authority demanding / requiring CA ... Scheme owner & recognition of specifications (requirements & quality) + test plans / cases (completeness) & test tooling & how evidence captured and persisted ....>
< ... need a focused plan & execution for all stakeholders for specifications => CA test plans / cases => CA process ... etc.>
See ASCA Pilot as well ...
< ... in Catalyst discussions ... how to integrate SDC/SDPi testing (incl. test cases) is included but provided by this Gemini SES MDI community ... >
< ... note differences between ONC and FDA in terms of business driver & needed rigor for CA of med tech ...>
Additional Topics
Schedule / cancel next meeting (during PAT #5) ?
DECISION: Cancel meeting due to PAT #5 & vacation schedules
NOTE: Todd to send out written update on October 7th to CA & Tooling list
Watch for new Zoom web call info + new calendar invites from an "IHE International" calendar
Watch for Sarah Bell emails ... she is providing administrative support for the IHE Devices domain
FDA SDC/SDPi+FHIR Discussions Continue
Stefan Schlichting, Konstantinos Makrodimitris, Sajjad Syed & Todd Cooper are advancing some general discussions around how to ensure that regulatory stakeholders both understand the SDC/SDPi+FHIR technology (especially the SES MDI construct) as well as the CA and regulatory submission documents that implementers will provide.
Note: similar discussions have been conducted in the EU with Notified Bodies; however, like the FDA discussions, they are somewhat ad hoc or "as needed"
Intent is to move these discussions to a more regular schedule and to build SDC/SDPi+FHIR (SES MDI) competency across all regulatory stakeholders
Updates from these discussions will be posted to the FDA ASCA & IHE CA Pilot confluence page and then expanded to other pages when appropriate
First presentation regarding the FDA ASCA meetings IHE CA "pilot" will be given at the upcoming IEEE/IHE/HL7 Devices WGM's
PAT / CAT Planning
CAT '22 Discussion in IEEE SDC Tuesday call
Challenge is which companies would participate in a late January NA CAT?
ACTION( Todd CooperJohn Rhoads ) Ensure that Sara Bell has the SDPi CAT Roadmap on her "radar" (CC Amit)
PAT #5 for early October for 3 days - everything moving forward
PAT/CAT Tooling
Actively working to get a developer onboard who can focus on transaction testing tooling
HL7 FHIR CAT 2021-09
No DoF Gemini track this time due to PoCD FHIR IG ballot consuming available resources!
...
Additional Topics
None identified
Action Items / Tasks
( Todd CooperJohn Rhoads ) Ensure that Sara Bell has the SDPi CAT Roadmap on her "radar" (CC Amit)
Need to expand and integrate into a Test Case plan that can then be integrated with Gazelle
Additional Topics
Pilot Projects Update
"RI"Requirements Interoperability Pilot
Primary focus in coming weeks will be to craft a basic SysML model that would link with Word styles that would enable ReqIF specification extration by NIST "V2plus" tooling
"MC"Model Centric - MBSE / SysML / Cameo Pilot
Future ('22)_ : MBSE/SysML Test Case & coverage w/ traceability to requirements
Now: BICEPS Infusion Pump will be leveraged in near term for TF-3 + basic RI modeling + basic models for TF-1 & TF-3
"RR" Regulatory submission Ready Pilot
Target a report out on this during the September WGM
CA will require some "user" involvement - not 100% automation
"user" involvement may include an observer / tester (individual) on site or camera etc.
System Function => System Function Contribution (a la participant) => preconfiguration steps (a la participant configuration) => SystemContext & other MDIB verification
ASCA Pilot will be key ASAP
Establishing the process pathway (e.g., a la the ASCA process) will be a key step in gaining regulatory approval for SDPi-compliant products and systems
MDIRA Profile actors may play a key role in addressing a strategy for establishing confidence in the SES of a deployed system of decoupled component products
Also Stefan Schlichting 's MBSE/SysML BICEPS Infusion Pump model tour video now "public"
IHE CA & IHE Catalyst Updates
Direct discussions begun to explore how IHE Catalyst can support the Gemini SES MDI program (tooling & testing services)
These will continue for the next 2 months (especially with August being a European "holiday" month) and should be finalized late September
IHE NA CAT Planning
Note that the next IHE NA CAT '22 is (unofficially!) planned for last week of January in Atlanta, as a hybrid event
DTx and Interoperability Standards / Testing?
Digital Therapeutics (DTx) has been a recent topic of discussion, including in IHE (e.g., PCH Program)
Quality related standards being advanced in ISO/TC 215 WG11 & JWG7, but: Interoperability standards?
Considerations for applying IHE CA for SDPi SAMD (per the SDPi and MDIRA actor models) to DTx applications?
Participants were not familiar with these apps or kinds of testing
Test Tooling Strategy - Continued Discussion from previous call
CONSUMER System Testing Strategy (see discussion from )
David reviewed an extended set of slides on this topic with two scenarios; find it here
Current Gazelle test cases include setup (precondition), test steps, and final result (success criteria)
Monitors may have to verify that a system actually processed the information - but not specifically how
Can be a display screen (may be screen captured)
Log file
...
Question is how to achieve the rigor needed for RR CA? + Achieving full automation for CA of products?
"Man in the Middle" tool (e.g., SDccc) will support this approach, but in the nearer term the JTest approach
Hybrid approach may be where we land: full/partial automation, manual inspection, log files, etc.
Note SDC Log files are not thoroughly defined (in terms of their contents) - perhaps we should add PAT/CAT/CA testing detail requirements for log files
Discussion included the challenges in earlier IHE CA of device related profiles (e.g., DEC or ACM) and the challenges that resulted in the profiles not being included in subsequent version of the IHE CAS-2 Scheme
Primary challenges were how difficult it was to cover testing "gaps" (as discussed above) and thus to lock down the CA test tooling and environment
The problem was not intractable - clearly vendors take regulated products to market that include DEC & ACM interfaces - BUT there were limited time & resources and insufficient market demand complete the needed work
OBSERVATION: SDPi CA will also have to surmount these same challenges, but there are many more business drivers and control "levers" to significantly increase the success factor
Note: Since the IHE CA of DEC & ACM, recently the Continua Test Tooling has been integrated with Gazelle (in 2020) for the IHE POU (FHIR-based) profile testing. Though the underlying technologies are different, this should help inform the work ahead with SDPi CA
vCAT Testing / Tooling Strategies
Virtualized CAT events for single profiles (e.g., an SDPi vCAT) is a key objective of this program and in discussions with Catalyst, appeared to be very much a likely reality
2020 CAT virtual events + other projectathon testing events drove the competency for deploying Gazelle for these configurations
Helping this discussion was recent vCAT support for IVD profiles
It was also noted that this can be done in a way to lower the cost barriers for small companies and in emerging markets (where the testing value is too nascent to motivate traditional IHE CAT cost structures)
SDC Transactions across cloud infrastructure is a key challenge for SDPi CA
VPN infrastructure used in PAT events will directly support the vCAT testing
NOTE: This is as opposed to the typical SDC PoC subnet around a bed
Challenges would include
How / where to capture test information
Probes/Hello's across a VPN needs a multicast simulation simulation, such as what is done for the PAT
MBSE Pilot Update (Deferred)
QUESTION: Representing IHE TF constructs in the MBSE Model
No additional updates - see Community Events for basic information
Will engage participants for who will actually plan on showing up - given that it is summer in the north .... expectations are not high!
IHE Catalyst Update Update
TBD when IHE EU will publish recorded IHE EU Experience videos re. Gemini project & IHE Catalyst & IHE Testing Continuum
Discussions between Gemini SDPi+FHIR group & IHE Catalyst leadership underway
MDIRA Project Updates
JHU/APL MDIRA program completed its Period of Performance (POP) and is actively working on follow-up project funding especially regarding MDIRA Profile advancement
MDIRA profile group had their first monthly meeting ... notes and all MDIRA profile related discussions are anchored at Specifications: MDIRA / ICE Profile
Group is working on updating their MBSE Model (based on an early version of the MDIRA specification ... see Github models repo folder; focus is only on updating the Requirements Model and TBD when now that the POP has expired
NOTE: APL is actively working to join IHE International + will try to actively participate in these Gemini CA & Tooling calls
Video Library Update (David G. will star!!!)
Will post today the recording and presentation of the last PAT David Gregorczyk gave a couple weeks ago
Investigating moving recordings to an OR.NET YouTube stream vs. Todd's personal channel!
SDC PROVIDER (test system) can easily confirm SDC CONSUMER (SUT) proper message sequencing, well formedness (e.g., syntactic and semantic interoperability) of received messages and confirmation of sent messages
BUT NOT "Did the consumer properly interpret the content received?" and similar questions
CONSUMER could generate a report separately providing evidence of its processing of interactions with a PROVIDER system
This CONSUMER report could then be correlated with the PROVIDER repot to tie the ends together
This "Backchannel" approach (e.g., CONSUMER sends PROVIDER (or Test Entity) via a different means / protocol etc.
Acceptance Criteria per test easy for Provider vs. Consumer ... ???
NOTE:
Many systems will not be purely PROVIDER or CONSUMER but
PROVIDER/CONSUMER's ... and this may further add "System of Products" challenges when a test scenario includes an ensemble of component products
Noted that though this is a starting point in lieu of having a fully functional test system tooling set BUT ...
The goal is to decisively move toward IHE 'regulatory submission ready" CA at the product level
Device specialization profiles (starting with TF3 specifications and MBSE models) will help inform specific test cases and sequences
QUESTION: Test Proxy needed? Either now or in 2022?
Approach for "Lean" JUnit test app
David Gregorczyk setting up a JUnit app that will act as an SDC CONSUMER that will be able to perform basic connectivity testing
TBD – Timing ... it is summer! ... but goal is to have it ready by fall
MBSE / SysML / Cameo Pilot Discussion
Cameo tooling activities ...
John Rhoads now has a version of the Cameo tool up and running
Todd Cooper also does BUT needs to update it to the latest service pack in order to load SSch's infusion pump model
Future Topic: How best to represent the IHE TF constructs & SDPi Transactions to SDC Message Sequence mappings in the SysML Model
FDA ASCA / IHE CA Pilot Discussion
No specific progress in last month ... due to priorities
This was the primary topic for the IHE EU Experience presentation by Stefan Schlichting and Todd Cooper and will be the topic of discussion with IHE Catalyst
Additional Topics
No additional topics identified
Action Items / Tasks
No new action items identified.
NOTE: June 17th meeting canceled to participate in the IHE Europe Experience sessions (part of IHE EU CAT event).
NOTE: Today is a holiday in parts of Europe (incl. southern Germany) - shocker!
Discussion Notes
General Updates
IHE DE SDC/SDPi PAT #3 Update
Successfully concluded the June 1-2 virtual Plug-a-thon and "expanded the interoperability matrix"
Dates identified for PAT #4 & PAT #5
REPORT OUT scheduled for the 2021.06.11 Friday SDPi Meeting (per David Gregorczyk)
MBSE / SysML / Cameo Pilot Update
Briefing from Stefan Schlichting on the BICEPS Infusion Pump MBSE / SysML / Cameo model
Stefan reviewed a BICEPS infusion pump that was created as part of the MDIRA project, but that has very broad applicability to the entire SDC/SDPi+FHIR work and the MDIRA Profile now underway
Key features realized in this model include:
BICEPS SysML Model (from which the pump model was crafted)
Capabilities include metric reporting, alerting and external control
In the case of control, this is a major requirement of the MDIRA that supports closed-loop control, for example, and it is not enough to allow an infusion pump to be programed but then require a person to push "go"!
Integration of the RTMMS Nomenclature into a table in the Cameo tool
Python script that can traverse the BICEPS device specialization model (looking for the top level MDS) and export it to an IEEE BICEPS XSD conformant specification
Starting point to realize a truly model-based specification for SDC/SDPi/MDIRA profiles
Establishes a UML (SysML is a strict profile of UML) BICEPS model that can serve as the basis for a revision of the 11073-10207 BICEPS standard, which per recent expert discussions, has a "disconnect" between the UML diagrams in the document and the "source of truth" constructs in the IEEE BICEPS xsd file.
Status?
This is a very comprehensive and impressive model BUT there is a backlog of possible updates (e.g., modeling some dimensions more extensively)
That will be the work of this pilot group as it moves the discussion forward and finds value in such modifications
Video of the previous "MBSE / SysML Pitch" has been posted and linked to the Education & MBSE pages; video of today's demo will also be posted
The SDPi TF3 BICEPS infusion pump content will be linked to and generated from this model (see the forthcoming Specifications: Device Specializations pages)
Discussion
Question: Are all units of measurement modeled in a given metric or only one?
For expediency, generally only a single UoM was included in the model to show how it would work, BUT
YES, sets of units particular for a specific semantic can be included in the model
NOTE: These data element semantics are rooted in what is provided in the RTMMS-based nomencature table
Question: Is this a model of an infusion pump INSTANCE or can it be used for a specialization specification ("Dev Spec")?
For expediency, this infusion pump model is more of an INSTANCE vs. TYPE ( ), but
yes, it can be used to craft a general / generic device specialization specification
NOTE: This is precisely what we intended to do for the SDPi TF-3 BICEPS Infusion Pump section
Question: Could you also IMPORT from xml to the tool?
YES, but why?
If the model is the "source of truth" for all other artifacts, then exporting from the model ensures cohesiveness
BUT if you already have an xml-based device specification, then yes, you could use that to "jump start" the modeling
Question: What is the "value add" for using SysML vs. xml-based tools?
Benefits identified included ...
Ease of use (vs. an XML editor ... though Altova and similar provide good options)
Full support for MBSE (method) and the entire R+ALP modeling
Integration from a requirements model to CA test scripts
Traceability from tests to requirements (and coverage)
Profiling is "easier"
Supports simulation and other capabilities as well (i.e., SysML can be an "executable" system (of systems) specification
NOTE: SysML 2.0 (forthcoming later 2021) includes an API specification that should enable true tool "interoperability" (vs. using xml & ReqIF for example)
BUT as one might expect, XML capabilities & SysML capabilities are often two sides of the same coin (e.g., utilization of schematron for constraint logic)
Question: How hard is it to leverage this infusion pump model for other device specializations (e.g., physiologic monitor)?
Very easy ...
Can start with this model, add what you need new, update the elements (e.g., MDS fields) for the new specialization, and delete the pump specific stuff
It also starts with an export from the RTMMS tool of a value set for the specialization ... this table in the SysML specification will guide the BICEPS model components that are needed
NOTE: Stefan indicated that he generally (mostly) worked with tables and then rendered the graphics that were needed. This is a general MBSE / SysML principle: the model has everything, "views" (e.g., diagrams) have some subset as appropriate for the needs
Question: How extensively can you model requirements in SysML?
Basically any kind of constraints (constraint logic)
OMG SysML Chapter 16 covers the requirements modeling constructs
NOTE: That the Cameo requirements modeler tool includes export to ReqIF
...
Follow-up Actions
Create a starter "tool chain" discussion / graphic that shows the current inter-relatedness between CAMEO, BICEPS xsd, VSCode, NIST RTMMS ... ReqIF ... etc.
Post session recording on Education pages and link to MBSE page discussion
Update / create infusion pump device specialization pages to capture content from this model
Craft "how to" guides (starter versions) for various topics, including
Using this model to profile new device specializations
Path from RTMMS device value set export (JSON) and Cameo nomenclature table importing
How to run the Python script to export the device specialization and then validate it against the IEEE BICEPS xsd specification
Discussions continue with IHE CASC (final ecosystem model coming soon) & IHE Testing & Tools
Discussions about to begin with IHE Catalyst regarding integration with Gazelle etc.
NOTE: PCHA/Continua tool integration to Gazelle (phase 1) took about a man month; Phase 2 planned at a man month
Note that the phases (if memory is correct) for the Gazelle integration of the Continua Conformity Test Tooling ...
Phase 1 - being able to launch the test tool from a Gazelle test instance, maybe with test instance metadata; test results are copy & paste into the appropriate test step
Phase 2 - auto incorporation of the test results into the test instance
Phase 3 - more seamless integration at the test step level
RI-TF-CA Update
Requirements Interoperability Pilot Update
Moving ahead slowly with tooling configuration (e.g., Todd Cooper now has license for the 3DS Cameo Systems Modeler w/ Requirements Modeling Tool) necessary for the pilot project
Note: that the need for multi inter-standard requirements interoperability specifications is increasingly (daily) clear
"BICEPS vs. UML" discussion thread ...
Discussion thread grew out of review of proposed alert nomenclature terms and the relationship between the BICEPS descriptor model & state model
Observation: Not clear that BICEPS UML does not necessary sync with the "standardized" XML schemas per the BICEPS
Note: There is no comprehensive BICEPS model ... from the IEEE 11073 SDC group
NOTE: JHU/APL MBSE / SysML expert was planned to do a demo of his approach to an early version of the MDIRA specification; will try to get queued up for the next meeting
See related BICEPS vs UML discussion above
Recent "device specializations" discussion also resulted in initial crafting of a Confluence Gemini SES MDI discussion work area (Specifications: Device Specializations) that will include MBSE / SysML modeling for each of the TF-3 device specializations.
Noted that Stefan Schlichting has created an infusion pump model for the JHU/APL work that includes a Cameo SysML model, that he uses a Python script to search and export a BICEPS compatible XML specification.
Hope to demonstrate that in the next CA meeting
Confluence page under development
FDA ASCA & IHE CA Pilot Update
IHE "Accreditation" topic: Relevance? Strategy?
Discussions on this topic are queued up with both NIST and ANSI staff ... today and tomorrow
Confluence page under development
Additional Topics
None mentioned
Action Items / Tasks
ACTION( David Gregorczyk ) confirm June 2-3 dates due to German holidays ("Pentecost")
Need to engage with IHE Catalyst re. integration of SDC / SDPi testing support + use at virtual SDPi CAT late 2021
Ditto for getting DEV SDPi into the IHE CA Scheme in '22 (late)
NOTE: Now that the HIMSS/PCHA/Continua testing platform integration is complete, precedence has been set for this kind of device-focused integration; question is $$$ and process and ..."who"!
ACTION( John DonnellyTodd Cooper ) Engage IHE Catalyst leadership to begin a dialog regarding the SDC/SDPi+FHIR testing pathway in 2021 and beyond
PATs include the development of test sequences for SDC capabilities to be leveraged for SDPi CAT testing
NOTE; intent is map from current SDC exchanges to SDPi transactions and content for SDPi CAT testing; based on the current draft of the SDPi Supplement with its actors and transactions models, no significant issue is anticipated
IHE CASC Model Updates (see notes from last Friday <link>)
An "IHE Ecosystem" diagram with broader detail is also in development and will hopefully ready to review next call May
"Implementationathon" is an other phrase being used by some U.S. entities running - similar to Projectathons (e.g., HL7 for CDA, Blue Cross / Blue Shield for Da Vinci project)
FDA ASCA Program Update
An initial ROUGH confluence page (FDA ASCA & IHE CA Pilot) was reviewed that will establish a pilot project to investigate the possibility of establishing a mapping between the IHE CA approach to be applied to SDC / SDPi+FHIR assessment and the requirements emerging from the FDA ASCA pilot program
Note that the "screen shots" will be replaced with the webinar presentation links once they are published publicly
After general discussion, it was recognized that this is potentially a major opportunity to add "teeth" to the SDC / SDPi CA objective of "regulatory submission ready" CA test reports
Note: This will be a standing discussion topic for this CA + Tooling group
MF: Especially once you get to ReqIF / XMI content, morphing it into needed forms is pretty straightfoward (if you've done it 100 times before!)
MO: (who had seen the slides previously)
"Excited about where the MBSE community of practice can take these initiatives."
Regarding use of Magicdraw Cameo Systems Modeler, other tools have been used (e.g., Vitech GENESIS and CORE) but the Cameo has tended to work best for large projects
JD: Moving IHE in this direction has been a long term discussion - perhaps finally this is a path forward!
Piero
Regarding tooling: In healthcare, Cameo doesn't seem to be the most used (e.g., vs. Sparx Enterprise Architect, which has been advanced in HL7 for example for decades) however this is not as much about the tooling than the application of systems engineering to healthcare ...
Regarding SysML Interoperability - version 2.0 due out later this year includes an API capability that will make models (esp. in different tools) interoperable
NOTE: No one was on the call who could speak to the status and plans for the Dräger compliance check tooling that is anticipated to be used to support SDPi CAT testing later in 2021
IHE CASC "CA Model" update still in process ... should be aligned with what is scoped out for Gemini SES MDI but is not "public" yet
Investigation is underway to understand the relationship between the two and how to ensure that IHE CA test labs and test reports can "automatically" meet the requirements for this FDA program
There is a public webinar by the FDA on April 13th (see the links above)
NOTE: NIST / Amy Phelps is actively involved in the team and has worked in the same department as John J. Garguilo and Lisa Carnahan - so is familar with our focus area; also Konstantinos Makrodimitris (FDA) is actively involved as well
An update is planed for the next call 4/15
Focus on MBSE/SysML for IHE SES MDI MedTech (regulated!) profiles
As reported in recent weeks, advancing the tool chain needed to enable "requirements interoperability" included a quick evaluation of whether MBSE / SysML (e.g,. using Magicdraw Cameo SysML) would be a good option for our purposes, especially since that tool generates ReqIF representation of the SysML modeled requirements
Determination the (Todd going solo) was that there was promise but descending into the SysML rabbit hole might be a terminal decision ... never to rise to the surface again!
Susbsequently, though others have expressed interest and expertise for MBSE/SysML including
JHU/APL MDIRA team that created a system model in the early days of that project and have SMEs who use Magicdraw Cameo for similar projects throughout APL
Stefan Schlichting helped present a MBSE webinar 3/25 that included application of the technologies to a "ventilator challenge" contest that they won in 2020
It is clear that there is both interest & willingness of at least a few to see how far we can get in this area AS WELL AS value to try and move Gemini SES MDI (and IHE especially) from a document centric approach to one that is model centricand that provides a whole new level of value to implementers
ACTION( Todd Cooper ) Update the Tooling & Conformity Asssment page + a new "home" section under that for "MBSE/SysML for MedTech Solutions"
Action Items / Tasks
Todd Cooper Update CA & Tooling WebPages to reflect current RI-TF-CA strategy & MBSE/SysML dialogue
NOTE: IHE NA CAT is this week ... impacting some normally on this call ... and the call was shortened to 30 minutes due to NA CAT T&T Summit scheduled for the same time
John Donnelly updated the group on his efforts to inform the IHE CA Business Model (in development by the IHE CASC) to ensure it supports the SDPi+FHIR CA strategy we have been advancing
Almost all of the recommendations were agreed by the CASC and should be reflected in the forthcoming model
NOTE: The model isn't public yet but should be available later this month or early next;
Review of RI-TF-CA Efforts
Todd Cooper provided an update of his work-in-progress to take the Year 3 Update Presentation and advance the three core components to the next level of detail
Note: current efforts are focused on three lines of activity ... in priority:
RI - Requirements Interoperability / Management
TF - Technical Framework management from content creation, development management (github) and publication (incl. HTML)
CA - Conformity Assessment including requirements traceability and "regulatory submission ready" CA test reports
Current focus is primarily on the requirements management part, including how to formally represent and link capabilities & needs from various standards to capabilities that would be V&V'd at an interface.
Part of that discussion included a review of Michael Faughn's musings model (DEFINITELY WIP!) ...
Discussion focused around where to start, namely with "human crafted" content and linkages BUT with a desired FUTURE state where RI could be automated via assembling components
The RI "Paper Airplane" Pilot effort will demonstrate the feasibility of RI in the Hanging Gardens model and hopefully a pathway to future automation
Group reviewed "publication" section of slides being finalized ...
View file
name
Gemini SDPi-FHIR Project Update 2021-02-18A.pdf
height
150
Slides 17-29 (IHE TF Publication section) were presented during the IHE T&T meeting yesterday, providing participants with a more detailed understanding of the HL7 V2+ project and the play for SDPi Supplement development and publication
One question that was raised was whether NIST's IGAMT/TCAMT V2 management tools would be integrated with the V2+ tools
Discussion confirmed that there has been coordinated discussions with key tool builders including Robert Snelick and Frank Oemig, but that details for how these tools might be integrated is "future" work, but is also not anticipated to be a major challenge
ACTION( John J. Garguilo ) Craft a few slides that show how the V2+ tooling could integrate with other V2 Management tools such as IGAMT/TCAMT
Final updates were made to the SDPi Supplement authoring / management / publications slide #29 reflecting discussion and review during this meeting
IHE CA Models Update
IHE CASC (Conformity Assessment Steering Committee) has been developing a detailed (though high-level) model of how requirements and CA + tooling are managed in IHE processes.
NOTE: This was also mentioned during the IHE T&T call discussed in (2.b.) above
Question is how the proposed Gemini MDI SDPi+FHIR CA / requirements traceability strategy (slide 29 and following) would integrate with this emerging CASC model
ACTION( John DonnellyTodd Cooper) Craft an initial crosswalk between the draft CASC model and the SDPi+FHIR Requirements Traceability & CA model to ensure coordination and identify any potential disconnects; try to complete the initial analysis before the next CASC and IHE International Board meetings
ACTION( Todd Cooper ) Circulate the Doodle poll link to the SDPi+FHIR list AND update the Community Events page
Action Items / Tasks
( John J. Garguilo ) Craft a few slides that show how the V2+ tooling could integrate with other V2 Management tools such as IGAMT/TCAMT
( John DonnellyTodd Cooper) Craft an initial crosswalk between the draft CASC model and the SDPi+FHIR Requirements Traceability & CA model to ensure coordination and identify any potential disconnects; try to complete the initial analysis before the next CASC and IHE International Board meetings
NOTE: This meeting originally scheduled for 2021.01.21 - not sure if we actually had a discussion then! No reminder sent for today's meeting ...
2021 PAT/CAT Planning Update
Todd Cooper still trying to determine what the "process" looks like for advancing a virtual SDPi-focused IHE CAT this year; this includes platform requirements, Gazelle tool usage (and instance), monitors, etc.
David Gregorczyk & Team are looking at OR.NET supported IHE PAT events this year, including the sequence of topics that might be proposed; intent is to try to have a testing event nominally every 6 weeks (+/- 2 weeks)
Engagement in the IHE Europe June 2021 Connectathon & Conference for anything related to SDC/SDPi is being undertaken by OR.NET & IHE DE
Gemini SDPi+FHIR Update for IEEE/IHE/HL7 WGM meetings last week - Review
Todd Cooper reviewed the update presentation made during the Devices WGM last week
Discussion included a detailed review of the IHE TF to HTML Publication section related to leveraging work done by NIST / Prometheus (Michael Faughn) for the HL7 V2+ project, which is also a Word-to-HTML publication effort.
IHE CA - Use Cases to CA Report Discussion
Todd Cooper reviewed the final section (still being drafted) from the above Gemini update - related to requirements management from use case specifications to CA test scripts and test reports
Section should be finalized today and posted on the WGM site
John Donnelly reported work in the IHE CASC to craft an updated model for IHE CA that clearly traces the path from use case requirements to test reports;
This would fit nicely into the detailed reqirements management section mentioned above
Hopefully we can see a version of the CA model in the next meeting
Action Items / Tasks
No new action items identified.
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2021-01-07 Thursday Web Meeting
Agenda
Review Action Items from December 17th meeting and before (below)
NOTE: First meeting of the year ... amazed anyone actually showed up!
Discussion Notes
NOTE: Agenda above was mostly pushed to the next meeting.
Review open action items
IHE USA / Amit related topics - still waiting to hear back; hopefully by the next meeting in two weeks
Update on "IHE Supplements in Word or HTML" action items
Reviewed exchanges between John Donnelly & Todd Cooper w/ John Moehrke regarding the questions of how to advance use of HTML and related for the SDPi+FHIR specifications
Moehrke's response to the questions (see action items from previous meeting) was that for now, we should use the IHE Word template - everything else is very much in its infancy
Lengthy discussion included:
Need to advance IHE specification development and publication to the same "level" as the FHIR spec, namely HTML publication and a development process that supports that work
Noted that the current HL7 FHIR specification tooling / process is challenging - as Moehrke stated 10-20 times harder than simple Word documents (at leat in the front end authoring side
The approach that David Gregorczykprovided for tagging and extracting test assertions / requirements from the Word document may be a good "hack" but Michael Faughn made it clear that at best, it was a "hack"!!!
...
John Donnelly will continue to advance the need for moving forward with a new on-line specification publication approach for IHE Supplements vs. traditional Word approach; report out at next meeting
ACTION( Todd Cooper ) Ask Steve Moore / Lynn Felhoffer about status / use of the Gazelle Assertion Tool
IHE Gazelle vCAT in 2021 - How would that work for SDPi CAT Event Uses?
Still underdiscussion by CAT managers for NA CAT & IHE Services, etc.
ACTION( John Donnelly ) Ask Amit / IHE USA regarding approach for Gazelle test management for 2021 CAT event(s) + cost basis for a CAT instance for a virtual SDPi CAT using Gazelle (similar to IHE Brazil or Eyecare)
Will this require a Gazelle VM for the specific event?
Note that this was done for IHE Korea CAT events but that the overhead of setting up and managing the VM for a single event of a small size (5-10 systems) didn't make sense
IHE USA has a 24/7 instance of the Gazelle environment used for NA CATs and that includes specialized CAT instances for IHE Brazil and IHE Eyecare
Will the "new" IHE Gazelle virtualized test environment / server (via IHE Services) provide the same? Associated costs (if any)?
Integration of Requirements into SDPi Word Document
Leverage the same / similar approach to the IEEE 11073 PKP standards utilizing ReqIF embedded in the Word document
David Gregorczyk showed an example of using Word Bookmarks to capture "requirements"
AND if IHE is moving toward HTML-based publishing (vs. PDFs of Word documents), should SPDPi Supplement be in HTML NOW vs. Word and then HTML?
ACTION( Todd Cooper ) Ask Mary Jungers / John Moehrke whether SDPi Supplement should be in HTML now
How would Gherkin (TF-1 Appendix C) be leveraged?
Is this limited to Use Case requirements to terst tooling or from the core document as well?
OR from the core document in Use Case sections?
ACTION( Todd CooperJohn Donnelly) Query IHE Gherkin-istas re. current intent; intehgrate IHE Gherkin discussion page
Use of HTML for IHE Profile specification / publication
Question: Would requirements / testable assertions be directly integrated?
ACTION( Todd / John D. ) Ask Moehrke to confirm & identify "how"
Next Meeting Agenda:
Report out on action items below
Firm up the 2021 SDPi+FHIR CA & Tooling roadmap & "issues" list
Action Items / Tasks
Todd Cooper Ask Steve Moore / Lynn Felhoffer about status / use of the Gazelle Assertion Tool
John Donnelly Ask Amit / IHE USA regarding approach for Gazelle test management for 2021 CAT event(s) + cost basis for a CAT instance for a virtual SDPi CAT using Gazelle (similar to IHE Brazil or Eyecare)
Todd CooperJohn Donnelly Ask Mary Jungers / John Moehrke whether SDPi Supplement should be in HTML now
Todd CooperJohn Donnelly Ask Moehrke to confirm & identify "how" testable assertions / requirements etc. integrated into the HTML TF documents
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2020-12-17 Thursday Web Meeting
Agenda
General Updates
Review 2020 Roadmap
General Review
2021 March NA CAT Track?
FHIR CAT 2021-01 Track Review
Use Case Test Scripting Discussion
Tooling Stastus / Planniing Review
Additional Topics
Participants
<TBD>
Discussion Notes
Action Items / Tasks
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2020-11-19 Thursday Web Meeting
Agenda
General Updates / Action Item Review
SDPi+FHIR CAT Track for 2021-01
Road Mapping 2020 - 2021: IHE SDPi Test Tooling Strategy for CAT / PAT Discussion
ACTION( Todd ) Sync with John J. Garguilo re. future development and use of the above tool to add an SDC connector and support SDPi+FHIR integration & SDPi & XDS etc.
FHIR DevDays Today & Tomorrow ... presentations / content will inform what we do in 2021, especially FHIR 2021-01 CAT event
NOTE that this use case will be one of primary focus in 2021 esp. given its relevant topic & use of all SDPi profiles; this may also be proposed for demonstration videos & events such as HIMSS'21 Interoperability Showcase
Engagement for this FHIR CAT 2021-01 Track + Use Case marketing "ACTION" all ...
ACTION( Todd ) Add a Gemini SDC / SDPi+FHIR "Track" to the 2021 roadmap
ACTION( John ) Engage HIMSS / NA CAT leadership to understand where to position this item :
Plug-a-thon for Gemini SDPi+FHIR?
Standards Accelarator Track?
It is also important to understand WHERE this fits in the "Testing Continuum" from IHE PAT to CAT to CA, including FHIR CAT events + relationship to other more informal hackathongs such as those historically advanced by OR.NET
Review Initial SDPi Use Cases / Scenarios to Test Scripts Exercise
Deferred to next meeting ...
Other Discussion Topics
Next Meeting: December 17th!!!
Action Items / Tasks
Todd CooperSync with John J. Garguilo re. future development and use of the above tool to add an SDC connector and support SDPi+FHIR integration & SDPi & XDS etc.
Todd Cooper Engage AAMI re. participation in Gemini SDPi+FHIR & Isolation Bed use case & 2021-01 FHIR CAT & etc.
Todd Cooper Engage ACCE & IFMBE / CED around the use case
Todd Cooper Engage Derek Ritz re. use case & WHO engagement
Todd Cooper Engage FHIR DevDays team + Zulip community around FHIR CAT 2021-01 participation
Todd Cooper Add a Gemini SDC / SDPi+FHIR "Track" to the 2021 roadmap
John Donnelly Engage IHE NA CAT'21 Leadership around Gemini SDPi+FHIR Track, isolation bed use case, and '21 August Showcase etc.
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2020-11-05 Thursday Web Meeting
Agenda
General Updates
Action Item Review
IHE DE PAT - "Takeaways" & Building on the Success!
Road Mapping 2020 - 2021: IHE SDPi Test Tooling Strategy for CAT / PAT Discussion
Reviewed the main takeaways including having proved out the key components that will be needed for future PAT / CAT events (VPN, MS Teams, SDC Discovery Proxy, etc.) +
Challenges around CAT $$$ and intent to schedule multiple focused PAT / CAT events in 2021 that are formally recognized & approved by IHE T&T and Board
SDC Test Tooling Update
Anna Feiler provided a short update on the focus and status of the SDC conformance test tooling (note earlier related / background updates in previous web meetings)
Focus on the current compliance check tool is "core" SDC capabilities primarily at the MDPWS standard level (that builds on BICEPS & SOMDA standards as well).
Noted that this is similar to the HL7 V2 validation tooling that simply confirms adherence to the core syntax and messaging sequences, but not specific application content or profiled components
This tool would be perfect for a Pre-Connectathon test, like we have today for other protocols and IHE profiles
A PKP test tool is pushed into 2021 at some time, primarily because the first of the PKP standards (11073-10700) has yet to go to IEEE ballot.
Note that this Base PKP standard is nearing ballot group formation, but there are still a number of issues being resolved.
TBD how these tools might be utilzied and integrated into an SDPi PAT / CAT event - that is for the FUTURE discussion of this group
Road Mapping 2020 - 2021: IHE SDPi Test Tooling Strategy for CAT / PAT Discussion
Confirmed the intent to hold regular (monthly?) Plug-a-thon events to test out various elements of the SDPi+FHIR profiles
Schedule (see below) multiple 2021 CAT events that also focus on specific profiles (e.g., one for SDPi-P, one for SDPi-A, etc.) or specific use case scenarios
How to "bootstrap" test scripting?
DECISION: Take the detailed use cases / scenarios that we are currently building into the SDPi Supplement document and begin an exercise of test script development to be presented at the next CA & Tooling call
Pre-CAT tooling vs. CAT tooling -
Inventory for what we have TODAY that can be leveraged for both PAT and CAT and pre-CAT testing
Inventory of current IHE Tooling that might be utilized / adapted / integrated into ....
Note that there are other tools that may be leveraged as well, such as NIST's Asbestos tool set (under development) that could have an SDC Connector added for SDC/SDPi-to-FHIR testing
Develop a strategy for how 1:1 and multi-way SDC/SDPi SOMDS testing might be accomplished in pre-CAT and CAT events, including
How and where and how many messages are grabbed?
How will security be managed for (1) above?
How will person identity be managed (e.g., patient identifiers and PHI)?
What might a PHASED roadmap look like as we enter 2021?
Start simple with what we have, taking the same early approaches for PCD-01 (DEV-01) transaction testing or CDA document validation
Start small with Excel spreadsheets and monitor checking vs. Gazelle integration & full test automation
Chart a roadmap from today to a fully automated future tooling architecture
Other Discussion Topics
Engagement of the IHE T&T Committee
IF the SDPi+FHIR community is going to advance focused PAT and (official/formal) IHE CAT events in 2021,
THEN IHE T&T has to review and approve the proposal(s) and the IHE Board has to ratify the events
Note that this is required in order to have the CAT results officially recognized and recorded as they are for other events (e.g., IHE EU & NA CAT)
To do this, the T&T must ...
Be educated as to the basics of SDC & SDPi+FHIR so they understand the kinds of capabilities and challenges that are represented
Be briefed on the tooling and testing approach being advanced by this group
Be presented with CAT proposal(s) for review and approval
Questions include ...
Timing of T&T engagement (esp. given everything else that is of an equal or higher priority ... as the end of 2020 approaches!)
Who and what should be briefed and when?
What (if anything) is done in 2020 and what can be done early in 2021?
Action Items / Tasks
Todd CooperTake the detailed use cases / scenarios that we are currently building into the SDPi Supplement document and begin an exercise of test script development to be presented at the next CA & Tooling call
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2020-10-15 Thursday Web Meeting
Agenda
General Updates on SDC / SDPI CA & Tolling Topics
IHE DE SDC / SDPI PAT 2020 OCT 21 - 22 Review / Planning
Tool Chain Discussion: Computable Device Specialization Specification to Simulation to CA & Tooling
(DEFERRED) OR.NET and member org plans for open sourcing / licensing SDC CA tooling for use in IHE PAT / CAT / CA
(DEFERRED) Related discussions from recent IHE / HL7 / IEEE joint meetings
IHE DE SDC / SDPI PAT 2020 OCT 21 - 22 Review / Planning
Status update (participants, logistics, etc.)
Brief discussion ...
Separately: Logistics are still being worked out between in-person and a conference call / video feed; also still working out the intended use case and testing / "hacking" objectives
Test Infrastructure Plans - TBD
Schedule / scenarios
Formal agenda / schedule is still being finalized
Initial concept is to have a use case / scenarios around an isolation ICU room
NOTE: Todd Cooper is working on some SDC=>SDPi=>PAT/CAT/CA slides that will provide background for next week's IHE PAT in Lübeck as well as going forward for reviewing and using the supplement
ACTION( John Donnelly ) John will see if he has any updated graphics around the IHE PAT / CAT / CA and Projectathon etc. concepts
Tool Chain Discussion: Computable Device Specialization Specification to Simulation to CA & Tooling
Soon we will have device specialization specificsations (e.g., from PoCSpeC and others), joined with the Base PKP standard, joined with the core SDC standards, all profiled by SDPi ...
NOTE: This topic was not directly addressed today ... will be picked up in a future session
Question: What specification format(s) and what device profiling tooling can we use to get to a computable spec that leads us all the way to CA of SDC/SDPi conformant SOMDS Participant systems?
Initial discussion around what can be done NOW vs. where we want to go in the future but will require more time & resources than currently available
Todd Cooper recounted some recent discussions with David Gregorczyk about possibly just "tagging" formal requirements in the SDPi Supplement Word document and then extracting them for subsequent requirements management / testing / tooling etc.
Michael Faughn indicated that (sadly) he has a lot of experience pulling requirements from a Word .docx file, it isn't pretty but it is doped
For example, you could define a Word Style that could be applied to these requirements; however, you will also need to include some contextual metadata to help understand, for example, whether the requirement applies to an actor, transaction, option, SDC message, etc.
ACTION( Todd CooperMichael Faughn) Todd will create a few examples of what a ReqIF "ready" requirement might look like in the SDPi Supplement document and have Michael review and "fix". Report back in the next CA & Tooling call November 5th
Question: What SDC testing tools are currently being advanced for general "open" conformity assessment use?
(Anna) There are two tools currently being developed:
SDC Test Tool - Rigorous testing of conformance to the core SDC standards (11073-10207/-20701/-20702)
PKP Test Tool - focused on establishing conformity to the Participant Key Purposes standards (11073-1070x)
The SDC Test Tool will be available for use in CAT testing next year, but the PKP tool will have to wait publication of the related standards, targeted for later in 2021
Other Discussion Topics
How rigorous (and repetitive) will CAT testing of SDPi profiles be over SDC testing?
For example, the SDC testing tool supports fully automated checking of all core SDC capabilities and usually runs "over night"; though this level of rigor is mandatory for conformant systems, it shouldn't be required for the interoperability multi-vendor system testing at CAT; but where to draw the line between the two?
IHE CAT events require all systems to first pass "pre-connectathon" testing:
This testing ensures that the vendors have fully complied to the technical capabilities that will be utilized during the CAT testing
For example, that they use the right BICEPS schema, security, MDPWS messages, etc. etc. etc.
This is the detailed level of testing that would be supported by the SDC Test Tool (see above) for the required SDC capabilities based on the SDPi CAT testing to be performed
In the SDPi CAT Testing ...
The exchanges will have to be verified at basic message syntax level, but will assume that the vendor has 100% passed pre-CAT testing
NOTE: This is necessary to ensure the integrity of the test results and to facilitate debugging, especially given that software is often modified frequently during the CAT event based on issues that are identified during connection with other vendors (decoupled) systems.
The test SCENARIOS are much more limited than full core SDC functionality and are focused on actor / profile / option / transaction testing ..
What scenarios will be tested for IHE CAT?
This is TBDby those who join the SDPi CAT testing group (including this group) to identify the scenarios and the test that should be performed to provide the desired interoperability confidence.
This SDPi CAT test development will begin in earnest once the SDPi Supplement 1.0 drafting / publication is completed.
These tests will be captured in the IHE Gazelle test management system, which will guide and document (including independent reviewer / monitor evaluation) each of the tests
For CAT testing, full automation is not the intent, but it will leverage the SDC Test Tooling and its integration with Gazelle and the logging of message exanges between each test participant
How will test participant exchanges / messages be logged (especially if encrypted)?
(See next for the "encrypted" part of this question)
Vendor logging of each exchange for CAT tests is very important, in that it provides the evidence that the exchange actually happened (time stamps included) and that it was successful (e.g., pasting logged message instances into Gazelle so as to let the Monitor run validation testing).
This can be faciliated by network monitoring tools (incl. Wireshark and similar), but is a key part of creating the evidence.
Again, for debugging of test problems, logging is a key tooling capability
(Anna) How will secure connections be supported by IHE PAT / CAT / CA test tooling?
There are numerous ways of accomplishing this, including utilization of a middle-man participant appliance that captures and forwards the message exchanges between two participants
Question is what is the best way of accomplishing this in an IHE / Gazelle CAT testing environment
Discussion recognized that this challenge has been dealt with many times in IHE testing, especially ITI profiles, and that we should understand and leverage that work
ACTION( John J. Garguilo ) Discuss with Bill M. & Rob S. at NIST about strategies that have been used in IHE Gazelle-based CAT testing for secure communications.
<Note: there were undoubtably other questions but ...>
Action Items / Tasks
Todd CooperMichael Faughn Todd will do a few examples of what a requirement might look like in the SDPi Supplement document and have Michael review and "fix". Report back in the next CA & Tooling call
John J. Garguilo Discuss with Bill M. & Rob S. at NIST about strategies that have been used in IHE Gazelle-based CAT testing for secure communications. to report back to the group no later than
John Donnelly Provide updated graphics (if any) for IHE PAT / CAT / CA etc. to use to brief those starting to work with
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2020-10-01 Thursday Web Meeting
Agenda
General Updates
Action Items Review
Tool Chain (requirements to test scripts to test execution / documentation) Discussion
IHE Germany & OR.NET have scheduled anSDC/SDPi Plug-a-thon (PAT)for October 21 & 22 at Dräger in Lübek, Germany
PAT objectives under consideration include ...
Exploring a virtual (or hybrid) CAT / PAT event for SDC / SDPi testing - this would set the foundations for subsequent PAT/CAT events
Utilization of a "discovery proxy" concept, that could then possibly be supported by a MDIRA/ICE Supervisor / Network Controller actor (see below)
Validation and consideration of the current SDPi Actors & Transactions (at an abstract level) and their mapping to MDPWS messages and message sequences
SDPi Transaction Test Scripting & Tooling (see below detail)
SDPi Supplement Update
Actor Models & Transactions & options have been created for all four SDPi Profiles
Detailed drafts of these should be provided in the 10/02 Friday supplement release +
Ready for consideration at the upcoming IHE Germany PAT (per above)
IHE DEV MDIRA Profile Proposal
Proposal for an IHE DEV MDIRA Profile proposal was advanced two weeks ago, reviewed last week during the joint HL7 / IHE / IEEE WGM and is out for approval by the IHE Devcies domain
This profile proposal would build on the foundation of the four SDPi profiles, but add actors and transactions supporting the MDIRA Reference Implementation (see the JHU/APL MDIRA Update to the September WGM last week)
Note that Gemini MDI CA & Tooling would directly support this emerging profile ... if we get everything "right"!
Michael pointed out that Cucumber (incl. Studio) and Gherkin are primarily intended to drive test tooling; whereas here we are using it as a stepping stone from use case / scenarios to ReqIF
John Donnelly will try to provide an update on IHE-based discussions as well (e.g., HIE white paper work)
Updating SDC / SDPi Test Tooling diagrams (David Gregorczyk & Anna Feiler)
NOTE: Both David & Anna are on PTO for another week or two
Per previous discussions, the intent is to provide more up-to-date tool diagrams; here are those from the white paper:
..
Tool Chain Discussion
Requirements Capture
Discussions will continue with how to capture (e.g., using ReqIF) requirements from JWG7 standards (such as 80001-1 2nd edition) for mapping to PKP (e.g., 11073-10700) and to SFC (see above) and testing
Test Scripting
Now that the initial complete set of transactions for the four SDPi profiles has been established, work (at least at the conceptual level) can begin for test scripts ... starting with the upcoming IHE DE PAT
To date this has been mostly applied to the OpenHIE initiative & some IHE test tooling considerations (e.g., possibly for future FHIR-based testing of QEDm)
Can it be utilized for IHE DEV DPI SDPi Use Case analysis purposes? (e.g., see Peter K's QH/Silent ICU Gherkin examples)
Discussion ...
Prometheus & Dräger have experience with Cucumber / Gherkin ... but not necessarily this Studio tool
"BDD" (Behaviour-Driven Development) Experience? (None on the call)
ACTION( David & Todd ) Ask for experience with Dräger & Prometheus stakeholders (incl. BDD use)
ACTION( Todd ) Create Silent ICU project & invite Ken Fuchs & Peter Kranich as members to test out
Virtual CAT Testing for SDC/SDPi?
Some have said, "You can't test SDC-based interoperability virtually ... the whole point is tight integration around a patient!" To what degree is that statement true?
Discussion ...
(David) SDC is a local area network focus, so virtualization requires a virtual LAN w/ WS multi-cast support; So ... "not easy" but also very doable - with the Right Smart Guy!
VLAN's utilized with some testing (incl. cross Atlantic sessions in virtual environment) ... so there is some experience
Utilized a "discovery proxy" to facilitate discovery w/o UDP multi-cast requirements; but this is not formally defined (in standards) & currently Dräger internal only
CONSIDER profiling discovery proxy in SDPi as an option & backfill to the ISO / IEEE 11073 SDC standards when / as needed & appropriate
(John D.) All U.S. ONC testing has been virtualized, but not for devices! This effort may support future adoption & integration
ACTION( David ) Consider the 2020 IHE Germany SDC/SDPi Plug-a-thon to test out virtualized testing approaches
NOTE: This was the first meeting moving to IHE WebEx web call info ...
September WGM Agenda - updates in progress
Draft IEEE 11073-10700 Base "Common" PKP w.r.t. Hanging Gardens Model
David GregorczykProvided a tour of a draft 11073-10700 standard (pre ballot)
(Todd Cooper) provided an orientation of the positioning of -10700 to the Hanging Gardens model + how to be integrated into the SDPi Supplement document
NOTE: The early draft of the -10700 standard was circulated to the meeting participants NOT TO BE FURTHER DISTRIBUTED OR POSTED ANYWHERE!
(David Gregorczyk) Provided a high-level review of the document's content
Section 6 is focused on the quality / regulatory / legal affairs stakeholders
Section 7 is focused on the MDI R&D technical stakeholders
Discussion
(John Donnelly) Would be good to keep sync of titles & graphics to reduce confusion for those just coming to the party
CONSIDER: Changing 11073-1070x PAR titles and / or Cathedral window titling; also audiences from the IEC/SC 62A & 60601-xyz standards community
Sources of requirements (at least topics) for the document? Standards-based sources?
Relationship to a "shared" (across SDC products ecosystem) risk management / RCMeasures requirements? Supporting interoperability of decoupled products? What's missing?
NOTE: Ran out of time ...
Open Discussion / Topics
(John Donnelly) Questions regarding Home-sourced to Cloud Info
Home device to "home hub" => FHIR (a la IHE POU)
For example, for remote patient monitoring / disease management applications
NOTE: Not typically acute care medical devices deployed at home settings
Should include device status info (e.g., device failure)
What should we tell device manufacturers for terminology, for connectivity standards, etc. etc. etc.
ISO/IEEE 11073 General Info Sources? (per (i) above)
New players(e.g., from LTC per COVID challenges / post-acute) looking at home-based care technologies ... not steeped in health informatics and definitely not in device informatics
"Remote Patient Monitoring" and similar hot topics today ...
IHE T&T: IHE Europe & IHE Services continue to finalize the approach for November's IHE EU Connectathon, including F2F / Remoted / Hybrid; IHE USA has indicated January's event will be 100% virtual;
David Gregorczyk provided a quick review of the 11073-10700 Base PKP standard, including the use of ReqIF.
Word document will be available mid-next week for review
The Word document was created from a ReqIF based specification that was exported from DOORS.
Goal is to be able to transform the ReqIF XML spec (e.g., using "ReqIF Studio" or similar tooling) into the Hanging Gardens ReqIF Integration spec
SDPi Supplement & Readiness for Test Tooling
Todd Cooper reviewed the SDC tooling descriptions in the 2019 IHE SDPi White Paper
Anna indicated that these are quite dated - tooling strategy has evolved over the last year! - and does not reflect what is planned for release into the public domain later in 2019
ACTION( Anna) To craft some tool diagrams that will reflect the current planning
Other Business
(Anna) updated the group on a PKP regulatory focused white paper that is being developed
Paper will be put on a public drive early next week for review and contributions;
Paper completion deadline will be set in the coming weeks when the next meeting with European regulators is set
Action Items / Tasks
(Anna / David Gregorczyk) Update tool diagrams reflecting what is planned for public release later this year
NOTE: July 16th meeting didn't capture any notes here ... but the focus was on the development of the SES MDI Framework slides as discussed today in (2) below
Reviewed Topics from 7/2 session (see above & below)
NOTE: The EU CAT'20 in November in Brussels is still TBD whether it is F2F / Virtualized / Hybrid event; to be finalized & announced around September 15
Framework Slides review
General discussion and review of the current draft of the slide deck
Question: Is the current Hanging Gardens Conceptual Model about right - worth drilling down on more detail - or is it off track in some way?
Consensus is that it has evolved to a generally good place ... BIG scope / vision ... but needed
Yes, drilling down on the next level of detail and then using to present to "layers" communities / stakeholders is appropriate
Next Steps:
Create a UML model of the constructs both for horizontal layer characterization + integration across layers
Update the layer-specific pages to illustrate the artifacts / components etc. that comprise that subject matter and the linkages to the Big 6 Formalization technologies (e.g., ReqIF)
ACTION (Todd CooperMichael Faughn) Get MagicDraw up and working for this UML file (note MagicDraw is also used by Dräger and many others)
CA - Tooling Topic Updates
(2.a) Gherkin & ReqIF Update -
no progress at this point - but see (2.b)
Kenneth Fuchs has been extending the detail around audible alert management - at which point we will be able to
(2.b) PKP & ReqIF Update
David Gregorczyk working on PKP standards using ReqIF but for Word version of standards documents
Hopefully will have a version of these by next meeting of this group 8/20th? Consider how to extract / migrate those requirements to a Gemini SDPi+FHIR ReqIF format
(2.c) Inter-layer Mapping
Todd Cooper is first addressing this in the SES MDI Framework slide deck ... then can focus on more specifics of the mappings
(2.g) CA Strategy
No significant work since the last meeting - but completing the slide deck will help lay the foundation for the strategy
John J. Garguilo provided a Reality Check regarding the fact that specifications are still in development, DPE tool is in work but a ways off ... resources are highly constrained ...
AND this is a very very complex set of profiles - perhaps the most in IHE - Strategy vs. near term Starting Point will have to factor all this together
(2.h) Tool Identification / Collection
Still an open To Do item
Note that Dräger put the Python sdc11073 library in the public domain and Todd Cooper & David Gregorczyk are working to integrate sample messages and links to the library in the TF-2 SDC messages appendix.
The OR.NET, Dräger and others also have test tooling that will be contributed for CAT testing and that leverage the sdc11073 lib, etc.
Other Business
John J. Garguilo led a discussion of the upcoming HL7 / IEEE / IHE WGM's (virtualized) and the schedule that we should use.
Agreement was that scheduling 2x 90 minute sessions daily should be sufficient: 0600-0730 Pacific & 0800-0930 Pacific
Action Items / Task Lists
Todd CooperMichael Faughn Get MagicDraw up and going on Todd's platform for creation of the UML diagrams for the slide deck
ACTION (Todd) Post Michael F's Ghirkin for SDPi presentation
ACTION (Todd) update slide deck (to SES MDI) version, including fixing the PKP on the SDPi profiles model
Topics / Issues
Requirements Capture: Scenarios to Gherkin to ReqIF (Ken & Michael)
Includes a few example scenarios example (simple but representative)
Use of ReqIF by the PKP Standards (David & Michael)
Use of ReqIF for SDPi inter-layer mapping (Todd)
<Target report out for 2020.07.16 call>
Update of an SDC/SDPi Device Profile Editor (DPE)
Is the current "SDC DPE" from PoCSpeC project to/from Prometheus ... usable? (probably ... not)
Scope of the DPE tool?
What layers from the SDPi layers model?
Integration of ReqIF?
Generation of SFC specifications?
Inventory of tooling that is or will soon be available (Anna, John/Michael)
See white paper + list for IHE CAT below.
Target: Update of tooling approach on meeting 2020.08.06 call
CA Strategy - Narratives to PnT using IHE CA for SDPi (Todd + John & Anna)
"strategy" - Need to define approach
(Garguilo) Challenge is today vs. 2-3 years "strategic" objective
NOTE: CA is much more rigorous than CAT integration & interoperability testing
Target: Initial update on 2020.07.16 ca..
IHE Connectathon Support Tooling & Testing Processes (work that has to be done to plan for planned '20 & 21 IHE CAT events) (John & Todd)
Use of existing NIST tooling?
Leveraging the V2 test framework?
Potential use of NIST FHIR Toolkit (e.g., XDS.b & MHD profiles testing)?
IHE Devices tooling (RTMMS, DPE)
Integration with Gazelle (& IHE Services ...)
Use of existing & emerging SDC / OR.NET tooling (+ MoVE project, Martin K's university tooling, etc.)
NOTE: Whether future IHE CAT events are F2F, remoted or a hybrid is TBD - should be able to report out at next call (based on IHE T&T call the day before)
ACTION (Todd) Create a similar "topics" table / pages like used on the Topics of Interest page & add action items for the team members
Team Discussion Prioritization
Topics: 2.a + 2.b + 2.c grouped and initial report out at next call (Ken, David, Michael)
Topics: 2.g initial report out on next call (Anna, John, Todd)
Topics: 2.h begin to collect
Defer: 2.e until after 2.f & 2.f until August (after German vacation / holiday season)
Action Items / Task Lists
Todd CooperPost Michael F's Ghirkin for SDPi presentation
Todd Cooper update slide deck (to SES MDI) version, including fixing the PKP on the SDPi profiles model
Todd Cooper Create a similar "topics" table / pages like used on the Topics of Interest page & add action items for the team members
), but
