Making primary use of health data and electronic health records work for citizens and patients
A fundamental belief of the medical technology sector is that the great potential of emerging technologies must be harnessed through a patient-centred approach. The main objective is to deliver high-quality patient care and provide transparent information that builds trust between patients, healthcare professionals, and regulators.
With this in mind, we are pleased to witness the EU Institutions’ determination and commitment to create the European Data Health Space (EDHS). A long-awaited initiative, the legislation promises to revolutionise healthcare provision across the EU. It aims to empower patients to manage and access their electronic health data without compromising information security or accuracy, improve between member states, and facilitate research.
For electronic health data to benefit all stakeholders across the healthcare pathway, it is crucial to clarify its definition in the legislation by including only data directly related to patient care or health management. Excluding raw data and technical parameters from the scope of the definition would give stakeholders access to data they are interested in without being overloaded with too much information. Similarly, we believe patients should have access to truly actionable data that is meaningful, relevant and appropriate.
A streamlined approach to Electronic Health Record (EHR) systems
As an indispensable component of the health data ecosystem, medical technologies are increasingly integrated across multiple electronic platforms and systems. Therefore, they are situated at the very core of the EHDS proposal. Legal clarity and consistency must be ensured to continue supporting medical technology manufacturers to innovate and produce high-quality solutions for patients. The definition of EHR systems should not be overly broad. Further clarifications are needed on how the rules would apply if a product or service falls under differing definitions across different regulations.
Indeed, medical technologies are complex in nature and their modular design does not always allow for such an easy distinction. Furthermore, it is essential to maintain, where relevant, a single conformity assessment process under the framework of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). This would ensure legal clarity for all the actors involved, which is paramount to ensure continued access for patients and healthcare professionals.
Consider industry’s best practices in terms of interoperability and cybersecurity
Achieving technical and semantic interoperability and seamless exchange of data and information is critical to the success of the EHDS. To this end, we firmly believe that the EHDS should consider existing international standards for interoperability and cybersecurity as well as best practices. Setting out common specifications instead of harmonised standards may lead to using outdated data formats that may no longer be secure and therefore restrictive. The development of appropriate and international standards is a collaborative effort and requires input from the industry and other stakeholders, digital health authorities at national and regional levels, as well as relevant Standard Developing Organisations.
The medical technology sector remains committed to partnering with the EU institutions and relevant stakeholders to inform future-proof legislation that works for all.