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
Compositionand 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
Libraryresource) 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.
- Focusing Flows: The four defined methods for invoking the focusing process based on how the ePI and IPS/PV data are provided (e.g., ePI ID and IPS ID; ePI JSON and IPS JSON).
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).