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FOSPS Reference Concepts List

I. Platform Architecture and Components​

These concepts define the structure and foundational technology of the Federated Open-Source Platform and Services (FOSPS):

  • FOSPS (Federated Open-Source Platform and Services): The overall software platform designed using a microservices-based, three-layer architecture.
  • G-lens Solution/System: The pioneering solution supported by FOSPS that empowers patients to access trustworthy, personalized Electronic Product Information (ePI).
  • Architectural Layers (App, Service, Data): The fundamental three layers used to structure the FOSPS components.
  • FHIR Server: The internal component often implemented using the HAPI FHIR JPA Server Starter, responsible for managing FHIR resources like cached ePIs and Provenance records.
  • Connectors (FHIR/ePI/IPS Connector): Modules responsible for modularizing access to external Trusted Sources of Information (TSI) and performing necessary format transformations into FHIR format.
  • Kubernetes (k8s) Deployment & Helm Charts: The underlying orchestration technology and packaging system used for deploying FOSPS components.
  • Istio (Service Mesh): The mechanism used for network management, providing traffic control, security, and acting as the Service Mesh and Gateway.
  • OpenAPI Specification (OAS) & Swagger UI: The standard used for API documentation, exposed through the Swagger deployment, allowing developers to understand service endpoints.

II. Core Data Models and Inputs​

These concepts represent the key information assets handled, retrieved, or created by the FOSPS.

  • Electronic Product Information (ePI): The digital document, standardized in a FHIR format (FHIR ePI IG), which contains regulated and scientifically validated medicinal product information, including the Patient Information Leaflet (PIL).
  • ePI Bundle (FHIR Resource): The container resource used to group the Composition and other related resources to reproduce the local label template in a semi-structured format.
  • International Patient Summary (IPS): An electronic health record extract containing essential healthcare information about a patient, used as context for personalization.
  • Persona Vector (PV): A standardization element designed to codify and standardize the context and preferences of the user, supplementing the IPS for use in the focusing mechanism.
  • Supporting Material (SM): A broad term encompassing both regulated Additional Risk Minimization Measures (aRMM) and non-regulated Health Education Material (HEM), intended to complement the ePI.
  • Additional Support Material Profile: The FHIR resource (based on DocumentReference) used to store the metadata for Supporting Material, including source, language, and associated terminology codes.
  • Standard Terminologies (SNOMED-CT, ICPC-2, etc.): The common language used within FOSPS to semantically annotate content and ensure interoperability across services (e.g., used for preprocessing and matchmaking).

III. Focusing Mechanism and Workflow​

These concepts describe the core process of personalizing the ePI content for the end-user.

  • Focusing: The process defined as "Adapting information to the context of the end user for effective and optimal understanding of the information" without modifying the regulated content itself.
  • Focusing Manager: The central orchestration component of the focusing module that coordinates Preprocessors, Lens Selectors, the Lens Execution Environment (LEE), and data retrieval to generate the focused ePI.
  • Preprocessor: A pluggable service that semantically annotates raw ePIs using standard terminologies (like SNOMED-CT or ICPC-2) to generate a Preprocessed ePI (p(ePI)).
  • Preprocessed ePI (p(ePI)): The intermediate state of the ePI after semantic annotations have been embedded, preparing it for lens execution.
  • Lens: A conceptual piece of code (packaged as a FHIR Library resource) that encodes clinical or context-specific knowledge, applying transformation rules (highlighting, collapsing, supplementing) based on the IPS and PV.
  • Lens Execution Environment (LEE): The service that executes the lens logic on the p(ePI) using the patient's contextual data (IPS/PV) to produce the final outcome.
  • Focused ePI (f(ePI)): The final personalized output of the focusing process, adapted for a specific patient's context.
  • Attention Detail Modification: The specific non-content changes applied by lenses, categorized by "highlight" (increased attention) and "collapse" (decreased attention) CSS classes.

IV. Trust, Security, and Quality Components​

These modules enforce security, traceability, and monitoring within the platform.

  • Content Trust Framework (CTF): The module responsible for digitally certifying and signing content (FHIR resources) to maintain trustworthiness, integrity, and traceability across the production chain.
  • Provenance Statements (FHIR Resource): A FHIR record that describes Agents (actors), Entities (resources), and Activities (processes) involved in creating, transforming, or influencing a resource, used as the basis for the CTF.
  • Audit Log: A trust component that provides granular auditability for system logs with immutable proofs, enhancing security and log authenticity throughout the platform's lifecycle.
  • Trust Function (TF): A serverless function that consumes the provenance tree of a resource and translates the accumulated metadata into a quantifiable trust level for the user or system.
  • Keycloak: The open-source identity and access management (IAM) tool used by FOSPS to handle Authorization and Authentication (OIDC/OAuth protocols).
  • Metric Management System (Grafana/Prometheus/Loki Stack): The subsystem used for collecting, storing, processing, and monitoring technical Key Performance Indicators (KPIs) and logs in real-time to ensure system health.
  • Metric Management System (Grafana/Prometheus/Loki Stack): The subsystem used for collecting, storing, processing, and monitoring technical Key Performance Indicators (KPIs) and logs in real-time to ensure system health.

V. Tools and Specialized Services​

These are the user-facing interfaces or specialized services built on top of the core FOSPS platform.

  • Focusing Inspector: A proposed tool for professional stakeholders (developers, etc.) providing a user interface to check the results of pre-processed ePIs and the application of lenses, supporting both programmer and end-user views.
  • Supporting Material Tool (SM Tool): A proposed tool designed to facilitate the management, curation, and matchmaking of Supporting Material (SM/aRMM/HEM) to patient profiles/IPS.
  • Content Trust Framework Inspector (CTF Inspector): A proposed tool allowing users to inspect, verify, and create provenance statements and analyze the validity of resources, especially for Trust Function developers.
  • Annotation Tool: A proposed tool to allow experts to semantically annotate free text in ePIs with standard terminology labels, serving as manual pre-processing or generating data for training NLP models.
  • Supporting Material Matchmaking: The process enabled by an API that takes ePI, IPS, and PV as input and returns composed material that matches the terms, conditions, and languages present in the input data.
  • Natural Language Processing (NLP) Services: Proposed Artificial Intelligence services, potentially including automatic ePI preprocessors, SM topic extractors, and Summary Lenses, using models like Name Entity Recognition (NER).
  • Natural Language Processing (NLP) Services: Proposed Artificial Intelligence services, potentially including automatic ePI preprocessors, SM topic extractors, and Summary Lenses, using models like Name Entity Recognition (NER).