Interoperability Frameworks for uHealth and Digital Therapeutics: Standards, Governance, and Emerging Technologies for Scalable Health Data Integration

Background:Ubiquitous health (uHealth) and digital therapeutics require interoperable digital ecosystems to achieve an effective and scalable implementation. Alignment between technical standards and regulations is crucial to ensure the secure and patient-centric exchange of data as these technologies continue to evolve. Objective: This narrative review examines the existing interoperability frameworks that support uHealth and digital therapeutics. Technical standards and governance models were evaluated to identify barriers and recommend future directions for the universally scalable integration of these frameworks. Method: The authors conducted a systematic narrative synthesis to review existing interoperability standards, such as HL7 FHIR and TEFCA, as well as prominent regulations, including HIPAA and the GDPR. Real-world deployments, including those by the U.S. Department of Veterans Affairs, were examined to derive practical lessons. Emerging technologies, including AI, blockchain, and federated learning, were also considered, along with their potential contributions to interoperability. Results: This review highlights ongoing difficulties, including uneven standard implementation, disjointed regulatory regimes, sparse digital infrastructure, and semantic discrepancies among systems. These problems are particularly prevalent in low-income and middle-income nations. New technologies represent promising, yet untapped, remedies. Conclusion: Achieving sustainable interoperability requires reforming governance, adopting modular and standards-based architectures, and fostering widespread stakeholder engagement. Bridging the divide between policy and technology is crucial for building resilient digital health ecosystems that can support equitable, personalized, and globally integrated care delivery.