Revolutionizing respiratory care with AI-driven compliance and data insights
Coach Name
EU Organization
Sosteco
Members
- Roberto Medina Bujalance
- Sandra Lohnes
- Victor González Toledo ( advisor )
US Organization
Sonoma State University
Members
- Dr. Farid Farhamand
Project Overview
SmartBreathAI is a digital health project designed to modernize respiratory rehabilitation by transforming incentive spirometry into an intelligent, connected therapy tool. The platform provides real-time feedback to patients, monitors adherence, and supports clinicians with data-driven insights to improve recovery and reduce postoperative complications.
Developed entirely with open-source technologies, SmartBreathAI integrates a patient- and clinician-facing interface, a secure backend, and an anonymized data analytics pipeline, all compliant with HIPAA and GDPR standards. The project also produced an open-access GitHub repository, a comprehensive compliance roadmap, and a scientific paper summarizing the methodology and outcomes.
With registered trademarks in both the EU and the USA, SmartBreathAI establishes a strong foundation for future clinical validation and the potential creation of a dedicated startup focused on AI-powered respiratory care.
Methods and approaches
Human-Centered Design Framework
Co-created the patient and clinician interfaces through iterative feedback with healthcare professionals in surgery, pulmonology, and internal medicine departments.
AI and Machine Learning Pipeline
Developed an explainable AI model using anonymized spirometry data for adherence classification and recovery prediction, following reproducible ML workflows.
Secure Data Infrastructure
Implemented a local private server with AES-256 encryption, JWT authentication, and HIPAA/GDPR-compliant data management for privacy and integrity.
Open-Source Development
Built the platform entirely with open-source technologies (React, Node.js, TypeScript, SQLite) and released the repository publicly on GitHub to ensure transparency and reproducibility.
Compliance and Ethical AI Design
Integrated privacy, fairness, and transparency principles into every development stage through a dedicated compliance roadmap and responsible data governance.
Participatory Validation and Knowledge Transfer
Validated the prototype through structured pilot feedback, internal workshops, and documentation in the Knowledge Transfer Handbook to ensure sustainability and reproducibility.
Key Achievements
Developed a functional digital spirometry prototype
Integrated real-time patient feedback, clinician dashboards, and AI-based adherence tracking into a unified secure platform.
Ensured full data protection compliance
Implemented HIPAA and GDPR standards with encrypted data storage, secure authentication, and role-based access control.
Created an open-source repository
Published the SmartBreathAI code, anonymized datasets, and documentation on GitHub to support reproducibility and transparency.
Produced a scientific paper and compliance report
Submitted the research paper “Design, Implementation, and Evaluation of a Digital Incentive Spirometry Application for Respiratory Therapy” and finalized a complete HIPAA/GDPR compliance roadmap.
Strengthened international collaboration
Maintained active cooperation between EU, US, and Canadian partners through mentoring sessions, data exchange, and continuous feedback.
Established the foundation for startup creation
Registered trademarks in the EU and USA, defining a roadmap toward clinical validation, commercialization, and future company formation.
Impact & Results
Scientific Impact
Advanced the field of digital respiratory monitoring by demonstrating how AI and real-time feedback can improve patient adherence and clinical decision-making.
Industrial Impact
Provided a scalable model for healthcare technology integration using open-source tools, enabling hospitals and startups to adopt cost-effective and compliant digital health systems.
Economic Impact
Showed potential for reducing hospital readmissions and clinician workload, creating measurable efficiency gains and laying the foundation for future startup-driven job creation.
Social Impact
Empowered patients through accessible, user-friendly design and continuous motivation, promoting better self-care and improved recovery outcomes.
Policy and Compliance Impact
Aligned with HIPAA and GDPR frameworks, setting a benchmark for ethical, privacy-preserving AI applications in healthcare and reinforcing trust in digital medical systems.
Publications and Open-Source Contributions
Project web : https://smartbreath.ai/
Research article: “Design, Implementation, and Evaluation of a Digital Incentive Spirometry Application for Respiratory Therapy” (to be published)
GitHub Repository: https://github.com/SmartBreathAI/SmartBreathAI
Workshop materials and stakeholder input summaries (referenced in report)
Future directions
Clinical Validation
Expand pilot testing with partner hospitals to validate SmartBreathAI’s effectiveness in real-world postoperative and rehabilitation settings.
Regulatory Pathway
Initiate steps toward medical device certification and formal clinical trial design in alignment with EU MDR and FDA frameworks.
AI Model Expansion
Refine and retrain the AI algorithms using larger, more diverse datasets and publish enhanced models on Hugging Face for community validation.
Startup Development
Establish the SmartBreathAI startup to support deployment, maintenance, and commercialization, building the foundation for sustainable growth.
EHR Integration
Implement interoperability with hospital Electronic Health Record systems using FHIR standards for seamless clinical data exchange.
International Collaboration
Continue the strong EU–US and EU–Canada partnerships to co-develop new research projects focused on AI ethics, data governance, and health innovation.