Background: Healthcare data interoperability faces significant barriers, including regulatory compliance complexities, institutional trust deficits, and technical integration challenges. Current centralized architectures demonstrate inadequate mechanisms for balancing data accessibility requirements with patient privacy protection, as mandated by HIPAA and GDPR frameworks. Traditional compliance approaches rely on manual policy implementation and periodic auditing, which are insufficient for dynamic, multi-organizational healthcare data-sharing scenarios. Objective: This study develops and proposes a blockchain-based healthcare data management framework that leverages Hyperledger Fabric, IPFS, and the HL7 FHIR standard and incorporates automated regulatory compliance mechanisms via smart contract implementation to meet HIPAA and GDPR requirements. It assesses the theoretical system architecture, security characteristics, and scalability considerations. Methods: We developed a permissioned blockchain architecture that employs smart contracts for privacy policy enforcement and for patient consent management. The proposed system incorporates multiple certification authorities for patients, hospitals, and research facilities. Architectural evaluation uses theoretical modeling and system design analysis to assess a system’s security, compliance, and scalability. Results: The proposed framework demonstrated enhanced security through decentralized control mechanisms and cryptographic protection protocols. Smart contract-based compliance verification can automate routine regulatory tasks while maintaining human oversight in complex scenarios. The architecture supports multi-organizational collaboration with attribute-based access control and comprehensive audit-trail capabilities. Conclusions: Blockchain-based healthcare data-sharing systems provide enhanced security and decentralized control compared with traditional architectures. The proposed framework offers a promising solution for automating regulatory compliance. However, implementation considerations—including organizational readiness, technical complexity, and scalability requirements—must be addressed for practical deployment in healthcare settings.

Background: Healthcare 5.0 represents a shift toward intelligent, human-centric care systems. Intensive care units generate vast amounts of data that require real-time decisions, but current decision support systems lack comprehensive frameworks for safe integration of artificial intelligence. Objective: We developed and validated the Learn–Predict–Monitor–Detect–Correct (LPMDC) framework as a methodology for systematic artificial intelligence integration across the critical care workflow. The framework improves predictive analytics, continuous patient monitoring, intelligent alerting, and therapeutic decision support while maintaining essential human clinical oversight. Methods: Framework development employed systematic theoretical modeling integrating Healthcare 5.0 principles, comprehensive literature synthesis covering 2020–2024, clinical workflow analysis across 15 international ICU sites, technology assessment of mature and emerging AI applications, and multi-round expert validation by 24 intensive care physicians and medical informaticists. Each LPMDC phase was designed with specific integration requirements, performance metrics, and safety protocols. Results: LPMDC implementation and aggregated evidence from prior studies demonstrated significant clinical improvements: 30% mortality reduction, 18% ICU length-of-stay decrease (7.5 to 6.1 days), 45% clinician cognitive load reduction, and 85% sepsis bundle compliance improvement. Machine learning algorithms achieved an 80% sensitivity for sepsis prediction three hours before clinical onset, with false-positive rates below 15%. Additional applications demonstrated effectiveness in predicting respiratory failure, preventing cardiovascular crises, and automating ventilator management. Digital twins technology enabled personalized treatment simulations, while the integration of the Internet of Medical Things provided comprehensive patient and environmental surveillance. Implementation challenges were systematically addressed through phased deployment strategies, staff training programs, and regulatory compliance frameworks. Conclusions: The Healthcare 5.0-enabled LPMDC framework provides the first comprehensive theoretical foundation for systematic AI integration in critical care while preserving human oversight and clinical safety. The cyclical five-phase architecture enables processing beyond traditional cognitive limits through continuous feedback loops and system optimization. Clinical validation demonstrates measurable improvements in patient outcomes, operational efficiency, and clinician satisfaction. Future developments incorporating quantum computing, federated learning, and explainable AI technologies offer additional advancement opportunities for next-generation critical care systems.

The sharing of medical data between different healthcare organizations in Europe must comply with the legislation of the Member State where the data were originally collected. These legal requirements may differ from one state to another. Privacy requirements such as patient consent may be subject to conflicting conditions between different national frameworks as well as between different legal and ethical frameworks within a single Member State. These circumstances have made the compliance management process in European healthgrids very challenging. In this paper, we present an approach to tackle these issues by relying on several technologies in the semantic Web stack. Our work suggests a direct mapping from high-level legislation on privacy and data protection to operational-level privacy-aware controls. Additionally, we suggest an architecture for the enforcement of these controls on access control models adopted in healthgrid security infrastructures.

Summary: Objectives: Clinical practitioners and medical researchers often have to share health data with other colleagues across Europe. Privacy compliance in this context is very important but challenging. Automated privacy guidelines are a practical way of increasing users’ awareness of privacy obligations and help eliminating unintentional breaches of privacy. In this paper we present an ontology-plus-rules based approach to privacy decision support for the sharing of patient data across European platforms.Methods: We use ontologies to model the required domain and context information about data sharing and privacy requirements. In addition, we use a set of Semantic Web Rule Language rules to reason about legal privacy requirements that are applicable to a specific context of data disclosure. We make the complete set invocable through the use of a semantic web application acting as an interactive privacy guideline system can then invoke the full model in order to provide decision support.Results: When asked, the system will generate privacy reports applicable to a specific case of data disclosure described by the user. Also reports showing guidelines per Member State may be obtained.Conclusion: The advantage of this approach lies in the expressiveness and extensibility of the modelling and inference languages adopted and the ability they confer to reason with complex requirements interpreted from high level regulations. However, the system cannot at this stage fully simulate the role of an ethics committee or review board.

The integration of different European medical systems by means of grid technologies will continue to be challenging if technology does not intervene to enhance interoperability between national regulatory frameworks on data protection. Achieving compliance in European healthgrid domains is crucial but challenging because of the diversity and complexity of Member State legislation across Europe. Lack of automation and inconsistency of processes across healthcare organizations increase the complexity of the compliance task. In the absence of automation, the compliance task entails human intervention. In this paper we present an approach to automate privacy requirements for the sharing of patient data between Member States across Europe in a healthgrid domain and ensure its enforcement internally and within external domains where the data might travel. This approach is based on the semantic modelling of privacy obligations that are of legal, ethical or cultural nature. Our model reflects both similarities and conflicts, if any, between the different Member States. This will allow us to reason on the safeguards a data controller should demand from an organization belonging to another Member State before disclosing medical data to them. The system will also generate the relevant set of policies to be enforced at the process level of the grid to ensure privacy compliance before allowing access to the data.

Background: Anatomopathological reports are largely unstructured, which limits automated data extraction, interoperability, and large-scale research. Manual extraction and standardization are costly and difficult to scale. Objective: We developed and evaluated an automated pipeline for entity extraction and multi-ontology normalization of anatomopathological reports. Methods: A corpus of 560 reports from the Military Hospital of Tunis, Tunisia, was manually annotated for three entity types: sample type, test performed, and finding. The entity extraction utilized BioBERT v1.1, while the normalization combined BioClinicalBERT multi-label classification with retrieval-augmented generation, incorporating both dense and BM25 sparse retrieval over SNOMED CT, LOINC, and ICD-11. The performance was measured using precision, recall, F1-score, and statistical tests. Results: BioBERT achieved high extraction performance (F1: 0.97 for the sample type, 0.98 for the test performed, and 0.93 for the finding; overall 0.963, 95% CI: 0.933–0.982), with low absolute errors. For terminology mapping, the combination of BioClinicalBERT and dense retrieval outperformed the standalone and BM25-based approaches (macro-F1: 0.6159 for SNOMED CT, 0.9294 for LOINC, and 0.7201 for ICD-11). Cohen’s Kappa ranged from 0.7829 to 0.9773, indicating substantial to near-perfect agreement. Conclusions: The pipeline provides robust automated extraction and multi-ontology coding of anatomopathological entities, supporting transformer-based named entity recognition with retrieval-augmented generation. However, given the limitations of this study, multi-institutional validation is needed before clinical deployment.