DECISIO: clinical intelligence and interoperability ecosystem

The DECISIO platform stands as the definitive evolution in clinical data management, functioning as an essential middleware engineered for data retrieval, harmonization, and advanced analysis across heterogeneous healthcare systems. Built on a highly scalable, multi-tenant microservices architecture, DECISIO is designed for both shared Cloud environments (SaaS) and dedicated On-Premise installations for major institutions like public hospitals or university laboratories.

This strategic solution offers unparalleled capabilities across three primary domains:

I. Universal Interoperability and Standardization

DECISIO resolves the critical challenge of data fragmentation by adhering to global clinical standards, ensuring seamless exchange and structured data integrity:

• OMOP Common Data Model: The platform harmonizes and normalizes incoming data according to the OMOP (Observational Medical Outcomes Partnership) standard. It exposes OMOP-compatible APIs to facilitate structured reading and writing of clinical data, enabling integration with third-party software and academic research platforms.

• HL7 FHIR Integration: A core module manages bi-directional data exchange conforming to the HL7 FHIR standard, essential for real-time communication with Hospital Information Systems (HIS), Electronic Health Records (EHR), and telemedicine platforms.

II. Integrated Clinical Intelligence (AI/ML)

The integrated Artificial Intelligence microservice (developed in collaboration with Artea SRL) transforms raw data into clinical insights, providing fundamental diagnostic and analytical support.

• Clinical Decision Support (CDSS): The AI engine delivers high-value functionalities, including automated synthesis of clinical documents (reports, letters) by extracting key concepts, providing contextual diagnostic suggestions, and automatically identifying clinical patterns for risk assessment.

• Advanced Data Normalization: The system leverages AI, specifically utilizing Retrieval Augmented Generation (RAG) techniques and standardized dictionaries (like SNOMED CT), to automate the semantic transcoding and validation of structured files (CSV, JSON, XML) from external systems, ensuring data quality and OMOP compatibility.

III. Specialized Data Acquisition and Analysis Modules

DECISIO integrates optional, cutting-edge modules to address emerging data sources:

• Wearable and IoT Integration: This innovative microservice collects real-time biometric and physiological data (e.g., heart rate, sleep cycles) from major wearables (Apple Watch, Fitbit, Android Health). Crucially, the patient retains explicit control, authorizing or revoking data sharing at any time via their personal area.

• Genetic Analysis (VCF): A dedicated, optional module supports specialized laboratories (such as those involved in collaborations with the University of Bergamo) in managing and consulting genetic "cases" based on VCF files. It enables phenotypic search, variant annotation, and analysis of familial relationships (probando, mother, father). This includes an specialized AI Parser for structured extraction of phenotypes and diagnoses from clinical and genetic reports.

IV. Security and Operational Excellence

The platform is underpinned by robust security and compliance guarantees:

• Security by Design: DECISIO implements Role-Based Access Control (RBAC) across profiles (Global Admin, Tenant Admin, Doctor, Patient), supports Two-Factor Authentication (2FA), and ensures data encryption both in transit (HTTPS) and at rest (AES-256).

• GDPR Compliance: Full adherence to GDPR, including traceable digital consent mechanisms, complete audit logs for all sensitive operations, and features allowing for selective data deletion upon request.

• Flexible Billing: The system supports diverse monetization models (subscription, one-time payment) and integrates with major payment gateways (PayPal, optional Stripe) and automated accounting tools.

• Native Multilingual Support: Designed for international adoption, the platform supports the complete translation of the user interface (initially Italian and English), configurable per tenant.