HOPE (EUROPEAN HOSPITAL AND HEALTHCARE FEDERATION)

HOPE welcomes the proposed revision that aims to simplify the EU regulatory framework, reduce unnecessary administrative burden and support timely access to products. However, those efforts should not weaken the patient protection. The proposed revision of the Medical Devices Regulation (MDR) concerning artificial intelligence in Recital 23 and in article 4 of should be deleted.

The core aim of the revision of the Public Procurement directives should be to reducing the administrative burden by simplifying the current rules. HOPE advocates for clear and simple rules with a reduction in the level of detail and greater reliance upon the general principles of transparency, equal treatment and non-discrimination. 1.

HOPE welcomes the CSA2 proposal in light of a changed cybersecurity threat landscape, with new threats and uncertain future developments faced by hospitals and health services. A flexible, needs-focused, horizontal cybersecurity framework is important at a time when AI-enabled automated attacks and social engineering, refocused ransomware attacks (including state-sponsored) and advances in quantum computing are…

HOPE acknowledges the proposal for a Directive amending Directive (EU) 2022/2555 (NIS2) as regards simplification measures and alignment with the proposal for the Cybersecurity Act 2. The delays experienced in the national NIS2 transposition demonstrated that its implementation is challenging, including in the hospital sector where financial, human, and operational resources are insufficient for adapting to…

Given the continuously evolving nature of cyber-threats affecting the hospital and healthcare sector, HOPE is generally in favour of targeted European coordination and measures that improve resilience, lend support national, regional and institutional stakeholders cybersecurity actions, and enhance the protection of fundamental rights.

HOPE welcomes the publication of the draft Commission guidance on the application of the Cyber Resilience Act (CRA) as an indispensable reference document addressed to economic operators and supporting the activities of market surveillance authorities, notifying authorities and notified bodies.

The European Hospital and Healthcare Federation (HOPE), representing national hospital associations and healthcare providers across Europe, welcomes the European Commissions initiative to prepare a legislative proposal for an ERA Act. Hospitals, as key actors in Europes research and innovation ecosystem, are directly concerned by this process..

HOPE thinks that great care must be taken that simplification measures, primarily requested by technology companies to reduce administrative and cost burdens, do not generate detrimental effects (privacy, liability, safety, security, uncertainty) for the institutions and individuals charged with overseeing and using advanced digital tools in healthcare, including hospital staff, healthcare workers, and patients.

HOPE agrees with the Commission that the rise in foundational AI technologies and associated threats affecting critical sectors, including cyber-attacks, disinformation, algorithmic manipulation and deep fakes, coupled with geopolitical uncertainties, are serious developments that must be considered in the Digital Decade Policy Programme (DDPP).

HOPE welcomes the Commissions commitment to enhance labour mobility. However, there are already a wide range of tools in place at EU-level, to build on in an appropriate way, with full respect for the principles of subsidiarity and proportionality. In this context, voluntary adoption, real-world testing with employers, and interoperability with national systems must guide all EU-level initiatives.

HOPE appreciates the opportunity to comment on the draft Implementing Regulation setting out measures on the establishment and operations of the EHDS Board. Recognising its key function as a forum for cooperation and exchange of information between the Member States and the Commission, HOPE backs its swift inception to steer the EHDS implementation.