We are proud to share that together with members of the Association’s Policy and Advocacy Working Group, the Holomedicine® Association developed and submitted feedback to the European Health Data Space last month.

European Health Data Space (EHDS)

The European Commission presented a regulation to set up the European Health Data Space on 3 May 2022.

The proposal is based on two pillars and introduces two different infrastructures that aim to:

1. Allow individuals to control and utilise their health data in their country of residence or in other Member States (primary use of data).
2. Provide researchers and other stakeholders with a thorough, reliable, and effective framework to utilise health data for research, innovation, policy, and other regulation activities while fulfilling the high EU standards of data protection (secondary use of data). 

The proposal is an ambitious framework through which the Commission aims to harness the power of EU data that could support the development of new treatments, improve patient outcomes, and ultimately contribute to better-functioning health systems. The aims of the EHDS are closely aligned with those of the Association, and we are glad to have had the chance to provide our own feedback.

You will find the feedback we submitted below:

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The Holomedicine® Association is the first global association for holographic technology used in medicine, comprised of individual experts from medicine, science, technology, and policy. The Association warmly welcomes the EHDS initiative as well as the European Commission's efforts towards a streamlined approach to the primary and secondary use of patient data.

Holographic technology allows the projection of 3D holograms generated from MRI and CT images and enables healthcare professionals to control the images from different angles to fully understand the complexities of a patient’s anatomy. The technology provides high-resolution and interactive 3D visualisations of scanned data and has great potential to enhance patient safety and improve patient outcomes. In addition to its applicability in the clinical setting, the technology can also be useful in education.

EHDS can address challenges that holographic technology faces in its wide-spread adoption, especially regarding data sharing, patient safety and public trust. To enable this, the technology needs a solid backend infrastructure: adequate space for data storage, robust encryption standards and high-speed data transfer. Due to the large volume of data processing needed in innovative technologies, latency could prove a problem for its functionality.

The Association believes that simple, safe and secure access and sharing of patient data between healthcare services must be a key pillar of the regulation, and strongly agrees that health data shall be provided only through a secure processing environment. The adoption of the regulation in practice will require prior assessment of its impact on daily medical routines and the advancement of medicine through global cooperation.

The secondary use of health data provides researchers secure access to quality data, an aspect highly anticipated by many. The Association notes that to share good quality data between European Health Record systems as well as to ensure interoperability of EHRs with digital technologies, the required connectivity needs must be met.

To realise its full potential, the technology shall be integrated within high-capacity networks (such as 5G infrastructure), providing real-time transfer of data. This is key, both when it comes to using the technology within the institutions, during teleconsultations, two collaborating institutions (example: referral/regional hospital) and/or during cross-border consultations. As such, adequate synergies must be ensured with funding mechanisms to support the implementation of 5G infrastructure in healthcare settings, and securely interconnect cloud infrastructures.

With the sheer amount of data transmitted between devices, favourable conditions must be met to enable safe and secure data sharing: all transmitted data must be well-secured and encrypted. While the approach taken by the Commission to establish a secure processing environment (Art. 50) is welcomed, the Association notes that further measures should be set through implementing acts to provide for the technical, information security, and interoperability requirements for the secure processing environments and looks forward to contributing to the development of the requirements.

As the EHDS builds upon legislations such as GDPR, the proposed AI Act, and the Medical Devices Regulation, the Association notes that:

• Uneven implementation/interpretation of the GDPR rules related to health data in the EU shall be tackled through this proposal,
• The current broad definition of AI systems, as outlined in the proposed AI Act should be further defined,
• Interoperability of EHR systems with medical devices and high-risk AI systems should be ensured.

With the rapidly growing use for advanced visualisation solutions in the medical field, it is imperative for EHDS to reflect the potential of holographic technology and maximise the availability of high quality and interoperability healthcare services for better patient outcomes.

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