Table 3 Overview of HTA Requirements Across Established European Frameworks and Convergence Outlook for HTA Core Model® Domains Beyond Rapid Relative Effectiveness Assessment (REA)
From: Comprehensive policies for scaling systemic and equitable integration of digital health technologies
HTA Core Model® Domains Beyond the Scope of REA | Established HTA Requirements for Digital Medical Devices (DMDs) in the EU and Convergence Outlook | Current Cross-Country Convergence | Opportunity for Future Convergence |
|---|---|---|---|
Costs and Economic Evaluation | ■ Economic evaluation requirements for DMDs vary. Belgium and England require cost-effectiveness analysis. England’s NICE has also proposed a strategic transformation of its HealthTech program, removing the cost-saving requirement for medical technologies and allowing broader cost-effectiveness assessments that weigh patient and system benefits, to expand NHS adoption of medical devices, digital and AI-based innovations. Germany and France do not require economic analysis, though it is often considered in pricing and reimbursement decisions. ■ While convergence remains limited, alignment on fit-for-purpose frameworks and principles for economic analysis of DMDs, which reflect their broader value dimensions could progressively support greater alignment while preserving flexibility for local cost structures, resource valuations, and healthcare priorities. | Low | Medium |
Ethical Analysis | ■ Ethical, fairness, equity, and environmental considerations are increasingly acknowledged in DMD assessments, but systematic evaluation remains inconsistent. ■ While recognition of their importance is growing, shared principles, metrics, and data collection frameworks are still lacking. Defining common approaches at the EU level—while allowing flexibility to reflect local societal values (e.g. by applying different weights to ethical and equity considerations)—could progressively support alignment. | Medium | High |
Organisational Aspects | ■ Organisational impacts of DMDs are increasingly acknowledged, but structured evaluation remains inconsistent across Member States. Germany’s DiGA pathway accepts evidence of positive patient-relevant structural and procedural improvements for DMDs certified under the MDR as Class I or IIa; France’s HAS guidance also recommends reporting on organisational outcomes. Shared evaluation standards are lacking. ■ While convergence is limited, alignment on key domains—such as workflow integration, resource use, workforce readiness, and access to care—could enhance the assessment of DMDs’ systemic value across countries, while preserving flexibility for national delivery models. | Medium | Medium |
Social Aspects | ■ Social aspects—such as patient empowerment, digital equity, and health literacy—are increasingly acknowledged in DMD evaluations, though they are not mandated and standardised assessments remain limited. ■ While recognition of social impact is growing, the development of shared metrics for empowerment, equity, and patient-reported experience outcomes could support greater alignment across the EU Member States, while preserving flexibility to reflect national contexts (e.g. by weighting these dimensions differently). | Medium | High |
