Policy gaps, standards and equity challenges in digital health interoperability

Fragmented regulations, lack of national strategies, and insufficient alignment between domestic and cross-border frameworks continue to impede the adoption of open standards. In LMICs, these gaps are often compounded by resource constraints, siloed donor-driven projects, and underdeveloped IT infrastructure.

A new scoping review highlights the pivotal role of interoperability in transforming digital health systems and enabling equitable, patient-centered care across diverse health environments. The research is presented in the paper “Interoperability as a Catalyst for Digital Health and Therapeutics: A Scoping Review of Emerging Technologies and Standards (2015–2025)” published in the International Journal of Environmental Research and Public Health.

The review brings together findings from 255 studies, with a detailed analysis of a representative 26 papers, to assess how technological innovation, global standards, and governance frameworks are shaping efforts to achieve seamless data exchange. The authors stress that while technical solutions have advanced rapidly, persistent barriers in governance, equity, and implementation limit the transformative potential of interoperability, particularly in low- and middle-income countries (LMICs).

Addressing policy and governance gaps

Governance and policy fragmentation remain the single largest obstacle to building interoperable digital health ecosystems. Despite widespread recognition of interoperability’s importance for scaling digital health tools and integrating digital therapeutics, progress has been uneven.

Fragmented regulations, lack of national strategies, and insufficient alignment between domestic and cross-border frameworks continue to impede the adoption of open standards. In LMICs, these gaps are often compounded by resource constraints, siloed donor-driven projects, and underdeveloped IT infrastructure.

The review notes that regional and global initiatives such as the Trusted Exchange Framework and Common Agreement (TEFCA) have gained traction in some countries, but scaling these models requires significant political commitment and investment. The authors emphasize that achieving sustainable interoperability demands strong, coordinated governance that bridges public, private, and donor-led efforts.

Standards, emerging technologies, and infrastructure challenges

The paper highlights substantial progress in the adoption of global data standards such as HL7’s Fast Healthcare Interoperability Resources (FHIR), SNOMED CT, LOINC, and OMOP CDM. These standards are critical for enabling structured data exchange across health platforms. However, semantic mismatches, legacy health information systems, and the coexistence of proprietary solutions continue to pose integration challenges.

The study examines how emerging technologies are reshaping the interoperability landscape. Blockchain is recognized for its ability to enhance data integrity and security, while AI-driven tools are increasingly applied to predictive analytics, disease surveillance, and chronic care management. Federated learning is highlighted for its potential to enable collaborative research without compromising patient privacy.

Despite these advances, practical deployment often remains limited, particularly in LMICs. Barriers include inadequate infrastructure, workforce capacity gaps, and insufficient adaptation of tools to local needs. The authors argue that successful implementation depends on building robust foundational infrastructure, including digital registries, connectivity, and secure data-sharing protocols.

Equity and the path to inclusive digital health

The study theme revolves around the persistent inequity in digital health systems, especially in regions with limited resources. Only nine of the studies examined explicitly addressed equity issues such as language barriers, digital divides, and the inclusion of marginalized populations. The authors stress that ignoring these dimensions risks widening health disparities, even as technical solutions become more sophisticated.

The study focuses on the importance of designing equity-conscious digital health policies and interoperability frameworks. This includes supporting multi-language interfaces, local data stewardship models, and participatory approaches that integrate the perspectives of underserved communities.

The authors advocate for interoperability maturity models tailored to LMIC contexts, combining technical and organizational readiness assessments with clear pathways for staged improvements. They call for aligning investments in emerging technologies with equitable access goals to ensure that the benefits of digital health transformation reach all populations.

A roadmap for the next decade

Interoperability is not merely a technical requirement but a strategic enabler of sustainable and equitable health systems. Emerging technologies offer significant promise but require shared governance, policy harmonization, and infrastructure investment to scale effectively.

The authors highlight that future success depends on:

• Strengthening global collaboration on standards and policies to avoid fragmented solutions.
• Building interoperability readiness frameworks that combine technology deployment with workforce training and stakeholder engagement.
• Ensuring that equity considerations are embedded into the design and evaluation of digital health initiatives.
• Supporting evidence-based investments that prioritize high-impact, context-appropriate solutions over fragmented pilot projects.

This comprehensive roadmap offers a way forward for countries striving to harness digital health and therapeutics for stronger, more resilient, and inclusive health systems.