Ecosystem Pathway Workstream

The IHE-HL7 Gemini SES+MDI (Safe, Effective, Secure Medical Device Interoperability) program has primarily focused on the technical "MDI" aspects of the program, but not the "SES" aspects that are arguably as important – more important! – than the technical aspects:  Why bother coming up with a consensus technical solution if a clear parallel approach is not established that addresses the quality, risk management and public/private oversight (government/regulatory) - process aspects of product development?  

"Pathway to an ecosystem of Plug-and-Trust Products" (Ecosystem Pathway / EP) workstream evaluates those systems engineering lifecycle processes (Total Product Lifecycle) that will need to be applied consistently across the Gemini SES MDI implementation community to ensure that products that are developed independently ("decoupled") by different manufacturers are trustworthy and when they are connected "plugged" together, will interoperate effectively, safely and securely.  

This is not an abstract "what if" exercise, nor creation of yet more SES standards.  Rather, the EP group will identify and apply specific standards (e.g., 80001-1:2021) and processes, to specific product implementations of the SDC/SDPi+FHIR technical interoperability specifications, for specific real-world acute care use cases (e.g., silent ICU or isolation point-of-care).   

NOTE:  The joint IHE-HL7 Gemini SES+MDI program leverages specific technical interoperability standards including ISO/IEEE 11073 Service-oriented Device Connectivity (SDC), IHE Service-oriented Device Point-of-care Interoperability (SDPi) profile specifications, and HL7 Devices on FHIR (DoF) implementation guides.  Thus "SDC/SDPi+FHIR" references the combined technical specifications context in which the EP group will apply the related SES process standards and requirements.

As is the case for the foundational technical MDI standards mentioned above (e.g., from ISO/IEEE or HL7), the EP work also leverages its own set of foundational process / quality standards, such as ISO/IEC 80001-1:2021 or 81001-1, and determines how to apply them to the technical implementations envisioned by the MDI SDC/SDPi+FHIR specifications.   Similarly, there are Conformity Assessment (CA) processes and programs that the EP effort will integrate and adapt as needed.

Ecosystem Pathway stakeholders are primarily those SES quality, risk management, public (regulatory) & private governance affairs experts who are concerned with the product development, implementation and use aspects of establishing an ecosystem of trusted products.   Open consensus will always be the goal for determining agreed guidance on how to achieve the SES aspects of the SES+MDI program.

The subsequent sections of this page present overviews on some of the primary topics facing the EP work group (e.g., challenge of establishing mutual trust - between ALL stakeholders ... internationally!) as well as specific sections capturing discussion notes, reference materials and the various "deliverables" of the group that constitute guidance on how to achieve an ecosystem of plug-and-trust decoupled acute care medical device products.

Note:  An  IHE sdpi-fhir "Ecosystem Pathway" github repository folder has also been created to persist key artifacts of this work stream.

What Lays Below ...

Ecosystem of Plug-and-Trust Products - What's the big deal?

First, let's unpack the phrase ...

ecosystemSystem of systems, where health & medical devices (including health software and "apps") are components of an overall ecosystem that shares a common architectural, technical and "trust" foundations, that together provide integrated clinical system functions.  Think:  Vendor neutral.

plug-and-trust (PnT)Plug-and-play is well known, implementing some level of "pre-coordination" such that discovery / connection / operation / disconnection happens seamlessly - without operator intervention.  "trust" in this context is used in the broadest sense of the term - confidence on the part of ALL stakeholders:  manufacturers, users, integrators, regulators, ... patients!  Yes it does include fundamental cybersecurity capabilities, but it also covers the quality processes and risk management elements that all component product stakeholders adhere to.

productsThough modalities, for example, may be thought of in the abstract, the focus here is on how to advance specific bundles of capability from concept to production production to patient use.  And how these deployed products can provide the intended system functions safely, effectively and securely.  

Pathway defines a consensus way (set of solutions/approaches and actions/processes) that those stakeholders who play a role in the realization of an ecosystem of PnT products agree to follow.

Consider some of the challenges involved ...

decoupledCurrently, medical systems that are intended to interoperate when placed into patient use must be tested combinatorially (Vendor A System X with Vendor B System Y etc.).  Decoupled indicates that  system component products that have been developed independently (by different vendors), but are conformant to the SES+MDI pathway requirements (both technical & quality requirements), will be able to plug-and-trust at implementation & deployment time, only requiring integration testing.  

System Function (Contribution)An ecosystem of products provide some set of clinical system functions, with each component product supporting its specified contribution (SFC) to this overall capability.  

(4) Key Interoperability Purposes

Functionally, there are (4) primary classes of services supported by system component products: 

  1. Plug-and-Trust - Basic connectivity within a healthcare / acute medical care use context
  2. Reporting - Exchange of metrics and other information (for charting or a consolidated dashboard)
  3. Alerting - Risk control measures that notify others of both physiological and technical conditions that pose risk of harm (e.g., communicating an infusion pump air-in-line condition to a clinician)
  4. Controlling - External control services between participant products (e.g., adjusting a devices alert limit from another system)

These (4) provide organization to much of the MDI and SES work.  For example, there are (4) IHE SDPi profiles (for PRACtical interoperability).  There are also (4) IEEE 11073-1070x Participant Key Purposes (PKP) standards under development.

shared risk / shared confidenceBy definition, medical device technology presents some level of risk (harm) which must be managed.  When a given product provides only a slice of functionality (SFC) that must be relied upon by the other system component products, then there must be a model to support shared confidence that each component will perform as expected when expected, and that any shared risk between each component will be managed in a consistent and competent manner such that the overall systems of systems will operate in a safe, effective and secure manner.  (See "risk management" definitions)

Total Product Lifecycle (TPL)Interoperability, like security and other capabilities, can only be designed-in to a certain level at the product production and market introduction point.  Ongoing monitoring and configuration / management - coupled with real-world operational oversight - must be performed to ensure no only MDI+SES at technology implementation, but then through use, re-configuration and decommissioning.  See ISO/IEC 81001-1 for more. (See also "life cycle" definition)

MDIMedical Device Interoperability - used here to focus on the technical aspects of how an ecosystem of component products work together to provide the intended SFC.  Here it specifically includes the ISO/IEEE 11073 SDC standards, the IHE SDPi profiles, and the HL7 V2& FHIR standards. (SDC/SDPi+FHIR)  Yes there are other technologies and standards, but for this EP effort, these are the focus.

SESSafe, Effective & Secure - a short hand for the process aspects and related standards related to developing and deploying medical technology and health software across shared infrastructure.  The "SES" moniker comes from the joint ISO/TC215 & IEC/SC62A working group (JWG7) that developed the 80001-1, 82304-1/-2, 81001-1, and other standards; however, when used in this context is is not limited to that group's standards.  For example, ISO 14971 or IEC 60601-x would be included when appropriate. (See also definitions)

SES+MDIYes, that "+" sign means something!  Typically, MDI and SES standards are developed independently and product implementers must rise to the challenge of how to integrate the disparate sets of requirements and ensure that they are addressed and V&V tested.  The Gemini SES+MDI project, especially this Ecosystem Pathway workstream, seeks to create a shared (multi-stakeholder) approach for integrating both the technical and process / quality requirements from core standards into a single cohesive whole.  How hard can that be?!

SDPiAren't the ISO/IEEE 11073 SDC standards for plug-and-trust interoperability sufficient?  Well, not really!  In order to achieve multi-vendor / vendor neutral interoperable PnT products, you need to remove as many options as possible (that are in the base standards) and add additional capabilities that may be beyond the scope of the various SDC standards.  The IHE Service-oriented Device Point-of-care Interoperability (SDPi) profile specifications do just that, including the full integration standards from both SES+MDI.  (See the related EP overview slides above)

MDIRAThe Medical Device Interoperability Reference Architecture (MDIRA) developed by Johns Hopkins University / Applied Research Lab (JHU/APL) is the subject of a Gemini SES+MDI MDIRA profile specification that is built on top of the SDPi profile specification that adds capabilities and system components / actors that can monitor and manage the overall health of an ecosystem of plug-and-trust component products.  (See MDIRA Materials references below)

Big deal?  Well ... only in that for the both the SES (quality) and MDI (techie) communities, this level of integration, this "wholistic" approach utilizing open consensus standards has not been attempted before in the same way.  

Pathway Construction

Creating a product pathway represents a significant undertaking HOWEVER it doesn't happen in a vacuum or a "blank piece of paper".  Rather the EP work BUILDS on a wealth of SES standards and community experience.  The questions being asked are how to best leverage this knowhow to chart a clear and deterministic course toward the establishment of an ecosystem of plug-and-trust products.  How hard can that be?! 

As a starting point, consider the following presentation that provides an overview of the EP initiative's scope of work (including anticipated deliverables), foundational principles, and operational approach, review the following presentation:

Note:  This presentation is being updated based on EP group feedback.  This is the most recent version (Updated:  2022.02.15):  Gemini SES+MDI EP Operation LATEST DRAFT.pdf

Here is the recorded version of the presentation:

IHE-HL7 Gemini SES+MDI – Ecosystem Pathway – Foundations & Operationalization (2022-02-11) Recordings

Section 1 – Introduction & Operationalization (13 minutes; MP4, audio)

Section 2 – SES Standards Landscape (13 minutes; MP4, audio)

Section 3 – Deliverables / Artifacts (18 minutes; MP4, audio)

Section 4 – Focus:  11073 PKP Integration (15 minutes; MP4, audio)

Real World "Concrete" Clinical System Functions 

Though the primary target of the EP work is concerned with standards and processes around Gemini SES+MDI, the top-level requirements are always rooted in real-world clinical scenarios and use cases.  A recent study by Unity Consulting identified a number of high-value use cases for advancing the state-of-the-art of interoperable medical device care. 


Key use cases for the EP initiative will include:  Silent ICU and Isolation Point-of-Care, among others.

For the IHE SDPi technical framework specification, detailed use cases are captured in Volume 1, Appendix C, with requirements from these specifications driving the MDI capabilities that are provided elsewhere in the technical specification.   These use cases will also act as a real-world source of SES requirements - "What could go wrong?!" - also driving the content of the SDPi supplement, as well as other pathway requirements, principles and guidance.  

It should be noted that the Gemini SES+MDI Hanging Gardens framework calls out "User Narratives / Use Cases / Requirements" at the top level, impacting every layer down the stack.  This includes a general application / implementation requirement that all solutions perform safely, effectively and securely (SES).

Note:  A valuable overview of applicable use cases is provided in the IHE document:  IHE PCD Compendium of Medical Device Oriented Use Cases, with some examples detailed in the IHE SDPi White Paper.

CA for an Ecosystem of Plug-and-Trust Products

Robust Conformity Assessment (CA) of all plug-and-trust component products in an ecosystem is crucial to establishing and maintaining confidence on the part of all stakeholders that all connected technologies will perform safely, securely and effectively.  This includes detailed requirements, both SES and MDI, that include test assertions and test plans / cases / scenarios that support robust verification testing, along with tooling and CA processes.  

The "trust" in Plug-and-Trust is only as good as the CA that is applied to each component product.

The Gemini SES+MDI program leverages IHE International's testing and product Conformity Assessment, as illustrated in the following diagram:

The Gemini program has already completed numerous plugathon testing events, building the implementation community, test scripts and tooling.  In 2022, the first IHE Connectathons of the SDPi specifications (ver 1.0) should be performed, with formal product CA being available within the next 2-3 years after the core capabilities are in production ready "final text".  

EP & Gemini Program CA & Tooling Workstream

Though CA is a core aspect of charting a path to an ecosystem of plug-and-trust component products, including the additional SES standards, principles, requirements, guidelines, etc. that will be part of any comprehensive and rigorous testing and conformity assessment capability – the technical details of conducting testing events (including plugathons and connectathons), as well as the tooling and open source implementations, will be addressed by the Gemini program Conformity Assessment & Tooling group.  Coordination between the EP and CA & Tooling groups will require collaborative meetings and shared documents, to be arranged when appropriate.  

"Regulatory Ready" Initiative

One of the innovations of the Gemini SES MDI program is to advance RI+MC+RR capabilities.  The last item "Regulatory (submission) Ready" is a key part of new value for all stakeholders, including both product developers as well as public/government "regulators" whose charter is to ensure public safety of all medical technology that is allowed to be used within the region of jurisdiction.  Ensuring "RR" will be a key aspect of the EP work program.

See related information in the Reference Materials section below, as well as the EP IHE CA Alignment with FDA ASCA  initiative.

Ecosystem Topics of Interest

As topics of interest surface during community exchanges, they are recorded in a table, sub-pages created to capture the discussions and resolution, and then updates applied to Gemini MDI+SES artifacts as appropriate.   Note that the table acts as an anchor for each topic, with a confluence page created for each as the discussion begins.  Ultimately, once they are fully discussed, IF they impact other artifacts in SDPi+FHIR (e.g., content in one of the profile specifications), then that is linked in the right column, and a github repo Issue item is created to persist and link the resolution.

See the list of topics at EP Topics of Interest.

Team Collaboration

An email list has been created for this group:   (send a request to Todd Cooper  / Todd Cooper to be added to the list)

Starting February 1, 2022, the EP group meets bi-weekly (every other Tuesday).  Notes for those meetings are below.

Gemini EP Discussion Notes

See also .... Gemini 2021 EP Discussions / Formation  (archive)

DescriptionDue dateAssigneeTask appears on
  • ( Todd Cooper  ) Create a CA & Tooling Summit confluence page
Todd CooperGemini 2023-09-19 EP Web Meeting
  • ( Todd Cooper  Michael Bothe ) Craft an initial "roadmap" based on Michael Bothe 's models to show the pathway from vendor implementation of SES SDC/SDPi to product CA by a NB and CE marking
Todd CooperGemini 2022-08-30 EP Web Meeting
Monica da SilvaGemini 2022-07-05 EP Web Meeting
  • ( Michael Bothe )  Provide an initial set of principles or criteria for including a term in the glossary, identifying its relevance to the SES+MDI discussion
Michael BotheGemini 2022-05-24 EP Web Meeting
  • (Monica da Silva ) Move FDA Design Considerations for Interoperability Tracing to 510(k) content to the topic's confluence page
Monica da SilvaGemini 2022-03-29 EP Web Meeting
Todd CooperGemini 2022-03-01 EP Web Meeting

Pathway Guidance 

As the pathway to an ecosystem of plug-and-trust component products is crafted, various artifacts will be created capturing the guidance and requirements agreed to by the group.  The sections below capture this information and will serve as a basis for an "Ecosystem Pathway Guidance" document.  The following sections form an initial Table of Contents for such a document.

OverviewGeneral introduction to SES+MDI and the Ecosystem Pathway work stream.


Specific terms leveraged and created within the SES+MDI work. EP Glossary.  

SES Standards LandscapeSES Standards considered and their relevance and application.

Guidance for Testing & Conformity AssessmentRequirements and principles from creating test scripts & plans to product conformity assessment and "regulatory submission ready" test reports.

Guidance for ... <something use case based here?>

Guidance for ... <ICS tables>

Guidance for ... <traceability & coverage support>

Guidance for ... <SES+MDI Assurance Case>

Template for ... <CA test report>Conformity Assessment test reports that are "regulatory submission ready" should conform to a baseline, vendor neutral content template, ensuring consistency and efficiency for all stakeholders.

Template for ... <IFU>Consistent consensus vendor neutral "instructions for use" (IFU) template will greatly facilitate the implementation and use of networks of plug-and-trust component products.


Gemini SES+MDI Conformity Assessment - Overview & Ecosystem Pathway Plan 

A document is under construction to capture the challenges, strategy and plans for a comprehensive conformity assessment program that will fully support SDC/SDPi+FHIR product implementers and the triple goal of RI+MC+RR.  Note that this document is intended to be complimentary to the general EP document above, and will provide clear guidance to the Gemini CA & Tooling group, which will focus on "how" to accomplish what is specified in this SES+MDI CA plan document.

Content will be crafted on the CA Overview and Ecosystem Pathway Plan Document confluence pages and ultimately moved to a document in the sdpi-fhir repository, the same as with other program documents such as the SDPi supplement specification.

Reference Materials

Materials below include publications and media that are of particular value for the discussions of the Gemini Ecosystem Pathway group.

Note:  Additional SDC/SDPi+FHIR materials are available at Library with EVERYTHING you ever wanted to know ... 

  1. SES-Related Presentations 
    1. Brussels Regulatory Affairs Conference March 2022
      1. "Notified Body Perspective on MDR Conformity Assessement Experience" (Michael Bothe
      2. "Regulatory implications for medical devices, used in an interoperable open network ecosystem" ( Matthias Marzinko )
  2. OR.NET Materials
    1. SDC Conformance Principles (PDF)
    2. Technical report:  Medical device approval based on the SDC Participant Key Purpose standards for safe interoperability (PDF)
  3. Relevant Standards / Specification Online Resources
    1. ISO/IEEE 81001 Online Conceptual Model / Topics Overview (, including Roles / Responsibilities, Key Properties, Information Technology & Risk Management
    2. ...
  4. Gemini (IHE + HL7) Presentations / Documents
    1. IHE EU Experience 2021.06:  IHE & IHE Catalyst: Advancing Interoperable MedTec Solutions with "Regulatory Submission Ready" Conformity Assessment (PDF) (MP4
    2. IEEE PKP Standards Update to the IEEE/HL7 Working Group meetings 2021.09
      1. PKP Overview                 
      2. Development update ...        
    3. Gemini Project Update (2021.09) to the IEEE/HL7 Working Group meetings - where the SES "Regulatory" initiative was first proposed
    4. Gemini Project Update (2022.01) to the IEEE/HL7 Working Group meetings - a high-level update on the Ecosystem Pathway initiative
  5. MDIRA Materials (Medical Device Interoperability Reference Architecture)
    1. Gemini project home page:  Specifications: MDIRA / ICE Profile 
    2. JHU/APL MDIRA Project Home
    3. Gemini MDIRA Update Presentations (In the Library)
  6. ...

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