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A Europe fit for Digital Healthcare

Small steps towards the creation of The Common European Health Data Space (EHDS)

The current pandemic has exposed the growing need of the global society to strengthen its readiness for management capabilities of cross-border health threats. In Europe, whilst the focus continues to be on ensuring that countries contain the spread of the virus and reduce the social and economic impact of the pandemic, the Member States are starting to draw their first lessons on their ability to have a coordinated response in the face of wide-spread health risks. But what actions will the European authorities take to make a common shield of protection for the entire population against health, pharma and life science issues?

Designing the EHDS – a silver lining of the pandemic

Digital healthcare has taken a leap forward due to COVID-19. According to some public sources, since the pandemic began, 58% of countries are using telemedicine to replace face-to-face consultations. The global outbreak of COVID-19 demonstrates that digital technologies can be very helpful in care delivery and disease prevention. COVID-19 also highlights the need for effective data sharing between countries. This crisis has shown all the importance of having access to vital health data to track the disease, because it has also a serious negative impact on the delivery of care to deal with other diseases, for example, by delaying surgeries. Just like the Data Governance Act, this proposal is based on the use and re-use of data, being an extension of it in the health and medicine sector.

However, the need to create a European Health Data Space is not created but only accelerated by the COVID-19 pandemic. Medicines, whether generic or innovative, come with (i) different regulatory systems for their introduction and distribution on the market, (ii) various reimbursement systems and/or (iii) specific local protocols in some countries, hence the numerous obstacles that the population faces in order to have access to them. On these accounts, a joint effort at EU level is required, so that all this vital information can be included in a common database for easier monitoring.

Given these circumstances, creating a common space for health data with the participation of all Member States could prove to be a life-saving solution.

The Commission’s forecast: a Europe that needs to be united in the field of health

 At the beginning of 2020, as part of the European Digital Strategy, the European Commission announced a Digital Services Act package aimed at strengthening the Single Market for digital services and fostering innovation and competitiveness of the European online environment across all sectors. At the same time, the EC published its European strategy for specific data in which the digital health sector, including healthcare and medical devices, was specifically addressed.

On December 23, 2020, the European Commission published its “Inception Impact Assessment[1] of policy options for establishing a European Health Data Space. The Inception Impact Assessment was opened for consultation until February 4, 2021, encouraging citizens and stakeholders to provide views on the Commission’s understanding of the current situation, problem and possible solutions.

Following the public consultation, several opinions were expressed by the public, but an official document from the European Commission is yet to be issued.

What are the advantages and scope of the EHDS?

 Firstly, the EHDS will decrease the fragmentation between the Member States in the health sector, as well as encourage the idea of a single market for health data. Moreover, the EHDS can also bring huge economic benefits for those at the forefront of innovation, and by creating this digital space, Europe could be the first economic area or market in the world which has an ethically-driven, ethically-sound and democratically-produced rule-base for using data, including health and welfare data.

On top of that, the EHDS would harmonise the reimbursement systems, which may have to be adapted to incentivize data collection, which in turn could be a great benefit for patients in urgent need of limited medicines for rare diseases.

Lastly, this common space data could help the industry identify new drug candidates. For example, the data gathered thus far in the COVID-19 outbreak has helped understand new uses of existing treatments, speed-up clinical trials, and provide much better targeting, monitoring and identification of safety issues. In close connection with the ongoing pandemic, the EC expressed its hope that “by 2025, patients from all Member States should be able to share their data with healthcare professionals of their choice when travelling abroad. Together, we can empower millions of citizens, to digitally increase their access to healthcare, and improve their well-being”. This project also paves the way for the participation of the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC) in the future European Health Data Space infrastructure, along with research institutes, public health bodies, and data permit authorities in the Member States.

Which are the potential obstacles in establishing the EHDS?

 Unfortunately, not all Member States are prepared or have the necessary infrastructure to make the leap to a common digital space in the field of health data. Whilst the EU has made some progress, interoperability between the healthcare systems and the standardization of the diversity of data sources remains problematic.

Needless to say, Europe must have a uniform legal framework for privacy and use of data. Although the interpretation of the General Data Protection Regulation (GDPR) is many years away from being harmonised across the EU and a common code of conduct could be a reliable solution, it is difficult to imagine that all Member States will comply with this obligation within a reasonable time. The potential risks posed by the EHDS are significant, especially because health data is classified as a “special category” of personal data under the GDPR, as use of such data may pose significant risks to the data subject’s fundamental rights and freedoms. Furthermore, the data protection issues that the EHDS might give rise to, must be considered and analysed by the EDPS, the EU’s independent data protection authority. In any case, there are many stumbling blocks that need to be removed before the EHDS sees the light of day.

When will we have the EHDS?

We are still in the early stages of having any sort of implementation. However, the Commission’s agenda for 2021 includes the EHDS as well, the roadmap showing that the proposal for a regulation is planned for Q4. Until then, there are plenty of activities that would hopefully make things easier for all the relevant actors and stakeholders, including:

a joint action of the EC with 22 Member States to propose options on governance, infrastructure, data quality and data solidarity, as well as to empower citizens with regards to secondary use of healthcare data in the EU;

investments to support the European Health Data Space under the EU4Health programme;

engagement with the appropriate players on the market to develop targeted Codes of Conduct for secondary use of patient data;

a pilot project, to demonstrate the feasibility of cross border analysis for healthcare improvement, regulation and innovation etc.

Preliminary “diagnosis”

These ambitious objectives need to be followed by concrete actions, especially from the Member States, so that we may all have a Europe that fully embraces the new digital age in the field of health, pharma and life science. Yet, one thing is sure: the future of European digital health looks bright!

 

[1] https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12663-A-European-Health-Data-Space

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