Wendy Lloyd-Goodwin, Founder of Life Science Law, looks at the implications of a new EU-wide framework for health data, including for research and clinical trials.

The EU is hoping to achieve a quantum leap forward in the way healthcare is provided to people across Europe. It wants to empower people to control and utilise their health data in their home country or in other Member States while also providing a framework to use health data for research, innovation, policy-making and regulatory activities.

The European Commission recently launched its European Health Data Space initiative aiming to give citizens access to their e-prescriptions and health records online. This system, to start by 2025, will be connected with all 27 EU member states, meaning people can travel around the EU and still access their health information. Researchers and pharma companies will also get access to anonymised data to improve the development of medicines, including making personalised cancer treatments or using artificial intelligence. Regulators and policymakers could also get access to improve health policy decisions.

“With the European Health Data Space, we can harness the power of health data and stronger health research, with citizens in control of their data at all times,” stated Health Commissioner Stella Kyriakides. “It will be a game changer for how we deliver healthcare and health solutions, always for the benefit of citizens and patients.”

The European Health Data Space is just one of many new initiatives designed to improve healthcare across Europe. Another is the EU Clinical Trials Directive (EU-CTR) which was brought in to harmonise and simplify the processes for the application and supervision of clinical trials throughout the European Union. The Regulation enables sponsors to submit one online application via the CTIS for approval to run a clinical trial in several European countries, making it more efficient to carry out such multinational trials.

The new Regulation will improve information-sharing and collective decision making on clinical trials and increase transparency of information as EU-CTR requires transparency throughout the development process. Protocols, for example, are subject to EU-CTR’s public disclosure rules. Sponsors will need to consider their options for deferring publication of specific details, including the study protocol, and the onus is on them to protect patient confidentiality at the point of submission. The new transparency rules intend to promote greater public awareness and understanding of clinical trials.

Health data and data privacy laws

While it is clear to see that health data sharing is a major priority for the EU Commission and to remove obstacles to the smooth functions of the data economy, it does prove challenging when it comes to patient confidentiality. There is potential conflict between the confidentiality of individuals and their healthcare versus the desire to share data widely to support improvements in healthcare.

Under current data privacy laws, consent is required for any personal data to be shared at all. Yet a recent Assessment of the EU Member States’ rules on health data, in light of GDPR, found that a number of legal and operational issues need to be addressed to ensure that European healthcare systems can make best possible use of health data. The evidence gathered through the study showed that there is a strong interest in the prospect of a European Health Data Space, but that it would require a sound level of legal and operational governance. The need for operational governance embracing the FAIR data principles1 was highlighted, which in turn emphasised the need for wide-spread implementation of technical standards to ensure data interoperability and to build trust in data governance amongst EU citizens.

In addition, incidents of data misuse by commercial parties, including those based outside the EU, increase the awareness that compliance with data protection rules must be ensured. The challenge for Member States and the EU as a whole is therefore to strike a balance between data security and data sharing, also as the latter is seen as a key requisite for establishing medical innovations, e.g. for vulnerable patient groups such as in specific rare diseases. While policies and regulations might be regarded as very permissive in some countries, the rules for processing health data in other countries are considered as very stringent, thus impeding information-sharing between healthcare professionals as well as for secondary purposes such as scientific research.

The research concluded that Member States must find a balance between autonomy of citizens and the challenges of their sustainable and safe health care system. It will be interesting to see if in practice member state authorities can achieve full anonymity for health-related data while still keeping the data useful for research.

www.lslaw.co.uk  |  wendylg@lslaw.co.uk