Dedalus Group

Dedalus welcomes the opportunity to provide input to the European Commissions Digital Omnibus proposal. As a European leader in Software as a Medical Device (SaMD) and AIenabled medical devices (MDAI), serving large hospital networks across the Union, Dedalus strongly supports the objective of creating a predictable, innovationfriendly, and clinically safe digital regulatory environment.

Dedalus, a European medical software manufacturer, welcomes the Digital Omnibus initiative and urges the EU to simplify and harmonize digital regulations. The current landscape (GDPR, MDR, IVDR, NIS2, CRA, AI Act, etc.) is complex, with overlapping and sometimes conflicting requirements that increase compliance risks and administrative burden.

MDR/IVDR Targeted Revision (COM(2025) 1023): Dedalus, a European healthcare software group (7,000+ employees, standalone software medical devices used by hospitals across the EU), welcomes the Commission proposal as a strong basis for restoring proportionality, predictability and international competitiveness while maintaining patient safety.

Dedalus is a well-established European-based medical software manufacturer regulated under MDR and IVDR. Our portfolio spans primary care, hospital systems, diagnostics, emergency care, and population health management.

Health IT applications have mission-critical components that directly support clinical decision-making, patient identification, medication management, diagnostics, care coordination, and continuity of operations.

Dedalus welcomes the opportunity to provide input to the Cybersecurity Act 2 and NIS2 Simplification Measures proposals. As a European leader in Software as a Medical Device (SaMD) and AIenabled medical devices (MDAI), serving large hospital networks across the Union, Dedalus strongly supports the objective of creating a predictable, innovationfriendly, and clinically safe digital regulatory environment.

1. Quantum-safe protection of sensitive health data. The Act should explicitly support the transition to post-quantum cryptography (PQC) for electronic health records, communications, digital signatures, and authentication systems, in coordination with ENISA, ETSI, EuroQCI and national cybersecurity authorities. 2. Quantum-ready interoperability and standards.

In the attached working paper Dedalus Group responds to the European Commissions consultation on the Digital Decade Policy Programme (DDPP) 2030, offering our perspective as a leading innovator in digital healthcare.

Dedalus S.p.A., as a group developing and distributing medical software within the European Union, would like to express our sincere appreciation for the European Commission's efforts in advancing cybersecurity through the Cyber Resilience Act (CRA). We welcome the orientation, clarity, and strategic foresight demonstrated by the CRA.

Dedalus outlines the following core industrial priorities for the European implementation framework for Secondary Use of data: Valuing the Role of Qualified "Service Providers" (Article 9): The draft law allows national hubs (NCPs/HDABs) to hire external technology partners. Private tech companies are ready to cooperate in building and running such network.

Dedalus Group welcomes the publication of the draft implementing regulation on the European Health Data Space (EHDS) Board and appreciates the effort to establish a governance framework that promotes coordination and transparency. In this context, we would like to offer some recommendations aimed at strengthening inclusiveness, clarity, and moving to effective implementations.

The European Interoperability Framework should continue to play a central role in enabling the effective functioning of cross-border digital public services. Its core principlesmultilayer interoperability, reuse, openness and interoperability by designremain valid and should be further strengthened.