Commissioner for Health and Food Safety Olivér Várhelyi, in a written answer on 28 July 2026, defended the European Health Data Space (EHDS) as a framework that lowers barriers for small and medium-sized enterprises (SMEs) and protects EU citizens' health data from non-democratic third countries. The answer responds to a question from Polish ECR MEP Piotr Müller, who had raised concerns about certification costs, market concentration by global tech firms, and digital exclusion of older people.
Várhelyi pointed to the EHDS Regulation (EU 2025/327), adopted on 11 February 2025, which introduces a self-certification procedure for electronic health record (EHR) systems, limiting administrative burdens and costs for manufacturers of all sizes, including SMEs. On data protection, he cited the Regulation's reciprocal access mechanism (Articles 75(5) and 91) that allows only entities from third countries with equivalent data protection rules to apply for access to EU health data, alongside the GDPR's Chapter V conditions for transfers. Regarding digital exclusion, Várhelyi noted that the EHDS promotes inclusive design usable for all, including older adults.
The answer contains concrete references to existing legal instruments but offers no new financial instruments or procedural simplifications beyond the self-certification already enshrined in the Regulation. The policy orientation is firmly pro-integration and pro-SME, emphasising harmonisation as a cost-reduction tool. Institutional follow-up is limited to implementation of the already-adopted Regulation, with no indication of further legislative proposals or monitoring mechanisms beyond existing GDPR and EHDS provisions.