A national HTA organisation/body is a legal entity having a clearly defined, often formally supported through legislative acts, role in the national HTA production process to inform decision-making on reimbursement, pricing and/or provision of health technologies in the country.

HTA processes differ significantly across countries, shaped by their healthcare systems’ structure, with national or regional implementations sometimes causing duplication of clinical benefit assessments, particularly in decentralised systems. Most HTA recommendations are non-binding, but their impact on coverage decisions varies; in some countries non-binding recommendations are de facto mandatory for reimbursement. EU cooperation could streamline HTA activities, reduce duplication of clinical evidence assessments, and harmonise methodologies, especially for medical devices, where evaluation processes are fragmented and less advanced. Stakeholder engagement, including patients and healthcare experts, varies widely, influencing transparency and uptake of HTA outcomes.

HTA agencies are integral to the EDiHTA project, contributing their expertise from the outset to shape a scientifically robust and practically applicable framework. Their active involvement in pilot testing and validation ensures the framework remains relevant to the evolving digital health landscape while meeting high assessment standards.