Ecosystem of Plug-and-Trust Products - What's the big deal?
First, let's unpack the phrase ...
| ecosystem | System 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. | |
| products | Though 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 ...
| decoupled | Currently, 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:
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 confidence | By 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 81001.org "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 81001.org "life cycle" definition) | |
| MDI | Medical 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. | |
| SES | Safe, 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 81001.org definitions) | |
| SES+MDI | Yes, 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?! | |
| SDPi | Aren'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) | |
| MDIRA | The 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: sdpi-fhir-ecosystem@googlegroups.com (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.
See also .... Gemini 2021 EP Discussions / Formation (archive)
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.
| Overview | General introduction to SES+MDI and the Ecosystem Pathway work stream. | |
| Glossary | Specific terms leveraged and created within the SES+MDI work. EP Glossary. | |
| SES Standards Landscape | SES Standards considered and their relevance and application. | |
| Guidance for Testing & Conformity Assessment | Requirements 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. | |
| References |
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 ...
- SES-Related Presentations
- Brussels Regulatory Affairs Conference March 2022
- "Notified Body Perspective on MDR Conformity Assessement Experience" (Michael Bothe )
- "Regulatory implications for medical devices, used in an interoperable open network ecosystem" ( Matthias Marzinko )
- "Notified Body Perspective on MDR Conformity Assessement Experience" (Michael Bothe )
- Brussels Regulatory Affairs Conference March 2022
- OR.NET Materials
- Relevant Standards / Specification Online Resources
- ISO/IEEE 81001 Online Conceptual Model / Topics Overview (81001.org), including Roles / Responsibilities, Key Properties, Information Technology & Risk Management
- ...
- Gemini (IHE + HL7) Presentations / Documents
- IHE EU Experience 2021.06: IHE & IHE Catalyst: Advancing Interoperable MedTec Solutions with "Regulatory Submission Ready" Conformity Assessment (PDF) (MP4)
- IEEE PKP Standards Update to the IEEE/HL7 Working Group meetings 2021.09
- PKP Overview
- Development update ...
- PKP Overview
- Gemini Project Update (2021.09) to the IEEE/HL7 Working Group meetings - where the SES "Regulatory" initiative was first proposed
- Gemini Project Update (2022.01) to the IEEE/HL7 Working Group meetings - a high-level update on the Ecosystem Pathway initiative
- MDIRA Materials (Medical Device Interoperability Reference Architecture)
- ...
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