On 15 January 2025, the European Commission published an action plan on the cybersecurity of hospitals and healthcare providers (the “Action Plan”). The Action Plan sets out a series of EU-level actions that are intended to better protect the healthcare sector from cyber threats. The publication of the Action Plan follows a number of high-profile incidents in recent years where healthcare providers across the European Union have been the target of cyber attacks.
Whilst the Action Plan primarily focuses on healthcare providers including hospitals, clinics, care homes, rehabilitation centres and others, the plan identifies interdependence between those providers and the healthcare industry. Therefore, some of the measures proposed address risks affecting the broader healthcare supply chain and ecosystem, and will potentially have implications for pharmaceutical and biotechnology industry players as well as medical device manufacturers.
The action that will be of most significance for industry is the plan for Member States to request that entities subject to the NIS2 Directive, including healthcare organisations, must report on ransom payments when reporting significant incidents to the competent authority under the NIS2 Directive (section 3.3, p.14). The Action Plan rationalizes this proposal by stating that the collection of further data is needed to understand the effectiveness of measures taken against ransomware attacks, and noting that such reporting would support the effective investigation of incidents. Reporting of ransomware payments is not required by the NIS2 Directive, so this would represent a significant change for in-scope entities. While this is titled a ‘national action’ to be implemented by Q4 2025, it is not immediately clear from the Action Plan if the proposal would take the form of a new EU law that imposes the obligation on Member States or otherwise.
We have highlighted below additional elements of the Action Plan that will be of particular interest to industry:
- The new cybersecurity requirements under the Cyber Resilience Act impact almost all the software and hardware products sold on the EU market. While most medical devices in the EU are already subject to regulation under the Medical Devices Regulation and the Regulation on in-vitro diagnostic medical devices are out of scope of the Cyber Resilience Act, an ongoing evaluation of those regulations is in process that will examine the potential for greater coherence between regulatory frameworks that would guarantee state-of-the-art cybersecurity in the sector. Interestingly, the Action Plan also calls for manufacturers of medical and in vitro diagnostic devices to “voluntarily” report actively exploited vulnerabilities or severe cyber incidents impacting on the security of a medical device as well as other vulnerabilities, incidents, near misses or cyber threats, through the reporting platform to be provided by ENISA under the Cyber Resilience Act, notwithstanding that those manufacturers are expressly out of scope the Cyber Resilience Act (section 3.2, p.12).
- The Action Plan recognizes that managing ICT supply chains for products like connected medical devices and European health records systems is a challenge. To address this, the Action Plan tasks the NIS Cooperation Group, in collaboration with the Medical Device Coordination Group, with conducting a coordinated security risk assessment of medical device supply chains. This assessment will identify both technical and strategic risks and propose mitigating measures (section 3.1, p.10).
- The European Cybersecurity Support Centre for hospitals and healthcare providers (“Support Centre”) within ENISA and to be created as part of the Action Plan will develop new Procurement Guidelines reflecting recent trends such as the ‘cloudification’ of patient data. These guidelines will provide practical tools for hospitals and healthcare providers to track supply chains, including managed security service providers and third-party risk assessments (section 3.1, p.10).
- The Action Plan identifies a need to ensuring that demand across the healthcare sector for qualified cybersecurity professionals is met, including through the promotion of reskilling and upskilling. Exchanges among cybersecurity professionals in the health sector are to be actively encouraged, including through the creation of a European Health CISOs Network, that will enable CISOs to share best practices. The Action Plan calls for industry stakeholders to pledge their support for enhancing cybersecurity support across the sector (section 3.1, p.11).
- The Support Centre is required to support the European Health Information Sharing and Analysis Centre (“European Health ISAC”). The Action Plan calls on the European Health ISAC to bring together healthcare providers with manufacturers to give rise to a joint understanding of cybersecurity threats and to facilitate dialogue about secure design of products (section 3.2, p.13).
- Public-private cooperation is described as essential for the successful implementation of the Action Plan. To assist the work of the Support Centre, the Commission will set up a joint Health Cybersecurity Advisory Board, comprising high-level representatives of the healthcare and cybersecurity fields, which will advise the Commission and Support Centre (section 5, p.16).
While the Action Plan proposes a wide array of different actions to be taken over the course of the next two years, it does not immediately create new obligations for industry. We will continue to monitor the progress of the various proposed actions.
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The Data Privacy and Cybersecurity Practice at Covington has deep experience advising pharmaceutical companies and other healthcare stakeholders on privacy and cybersecurity issues across Europe, and will continue to monitor developments. If you have any questions about the Action Plan, NIS2, and the Cyber Resilience Act, or about developments in the cybersecurity space more broadly, our team would be happy to assist.