European Hospital and Healthcare Federation (HOPE)

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 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.

Artificial Intelligence (AI) is a complex phenomenon interfering with the way medical research is conducted, the biomedical data is used, and the healthcare professions and organisations are regulated. AI use in healthcare would then also requires a specific regulatory approach, in addition to a strong horizontal cross-sector regulation of AI.

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.

The European Hospital and Healthcare Federation (HOPE) welcomes the EHDS legislative proposal and its key objectives as a logical next step in the digital transformation of health and care. However, based on our preliminary analysis, a number of legal and technical clarifications will be required - in particular regarding some of the terminologies, operational requirements and standards, and links with other…

HOPE welcomes this Roadmap as an opportunity to further clarify certain elements in particular as the Commission mentions its priority to reduce inequalities, which are particular important in terms of digital access and digital literacy. Specificities should be recognized instead of being ignored with a one-fits-all approach.

We understand that the proposed Cyber Resilience Act (CRA) Regulation has a horizontal reach and therefore it could be pertinent to various digital networks, IT systems, and Internet of Things (IoT) solutions commonly deployed in hospitals and healthcare environments not covered by other EU legislation.

The legislation on blood and all blood components should stay within the public health framework irrespective of the end use of the project. Blood is not a commodity. We were surprised to read in the roadmap that blood establishments and competent authorities did not know or anticipate the supply and demand in blood an blood products during the Covid-19 crisis. We do not find evidence of this.

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.

The elements of the Directive 2011/7/EU of the European Parliament and of the Council of 16 February 2011 on combating late payment in commercial transactions are more then ever relevant after the consequences of the economic and financial crisis and the COVID19 crisis. The situation of health services in a large number of Member States is still a particular cause for concern in connection with late payment is.

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.