The European patient | In Principle

The European Union is preparing a shared health data space. It is designed to facilitate treatment for Europeans (within the EU) and to consolidate a high standard of medical products and services across all member states. It is also a method for meeting European aspirations for patients’ rights and ensuring more effective treatment and research.

The creation of a uniform data market, alongside efforts to develop artificial intelligence solutions, is one of the two pillars of the digital transformation policy which the European Commission has defined for the upcoming years. The data strategy is intended to ensure Europe sovereignty and competitiveness on a global scale. This is mainly an economic challenge, as the goal is for all data generated or collected within Europe to be processed first and foremost to benefit Europeans. The strategy refers to common European data spaces, in which data can be freely and securely shared, and citizens and businesses will be able to better control their data.

This will require more efficient, secure and scaled infrastructure for data processing centres, including cloud solutions.

It also requires a legal framework. In the area of personal data protection, uniform legal rules were launched by the General Data Protection Regulation. In the flow of data, protection of consumers and competition is to be ensured through the proposed Data Governance Act (draft COM(2020)767). These are accompanied by the proposed Digital Markets Act (COM(2020)842) and Digital Services Act (COM(2020)825). These are being hotly debated, mainly in connection with the competition between internet platforms and guarantees of civil liberties, but they are also significant for the overall data infrastructure in Europe.

Valuable medical data

The concept of a European health data space is a special area within the context of the global battle over valuable data. Implementing it will require further interpretation of the GDPR. The amendment to the eIDAS Regulation now being debated, governing identification systems, digital identity and trust services, will also help. In addition, we should also rethink issues of cross-border transfer of data, cybersecurity, application of decision support systems, AI, entitlements to medical insurance and benefits, risk assessment, payments for services, and regulated prices.

Existing provisions for the healthcare sector can be used (such as the Cross-Border Healthcare Directive (2011/24/EU), Commission Implementing Decision 2019/1765 on the eHealth network, and provisions on COVID passports, in the final phase of agreement). But entirely new legal frameworks will also be required. The European Commission has just announced consultations on the European health data space, which will continue through July.

Healthcare has undeniably become one of the key priorities for EU policy, and the pandemic has only highlighted its importance even further. Healthcare projects are now found in nearly all EU programmes for financing the digital transformation. They are indicated in the Recovery and Resilience Facility, which in Poland will be implemented through the National Reconstruction Plan. They are reflected in the European Fund for Regional Development, the European Social Fund Plus, Invest EU, EU4Health, and the Digital Europe Programme, and widely covered by the new edition of the Horizon Europe scientific research programme.

These projects differ greatly from those connected for example with industrial data. This is because the European health data space is designed to promote the development of services within the EU itself, rather than strengthen competitiveness with data processors outside Europe.

Setting challenges

The European health data space sets strategic aims that are clearly defined but not necessarily easy to achieve:

• Ensuring access, sharing and optimal use of health data for healthcare delivery purposes as well as reuse for research and innovation, policy-making and regulatory activities, in a privacy-preserving, secure, timely, transparent and trustworthy way, and with appropriate institutional governance, seeking to achieve coordination and interoperability throughout the EU
• Fostering a genuine single market in digital health, covering health services and products, including tele-health, tele-monitoring and mobile health
• Enhancing the development, deployment and application of digital health products and services, including those incorporating artificial intelligence and other emerging technologies.

These aims are set for the short-and mid-term perspectives. The European health data space is intended to provide:

• A solid system for managing data, with regulations governing data sharing
• A guarantee of the quality of data
• Appropriate infrastructure and an interoperative set of services and applications.

The planned legal measures to lower technical and regulatory barriers to the use of medical data should ensure patients and citizens access to and control over their own data, regardless of their location in the EU. The actions to enable this will cover:

• Infrastructure and standardisation issues
• Issues connected with medical documentation
• Issues connected with the use abroad of tools and applications already available to patients in many countries (including Poland), such as e-prescriptions, patient accounts, e-referrals, data from patient registers, and genome data
• Review and further unification of regulations on patients’ rights.

Access to data for research purposes is to be expanded, as well as for purposes of adopting policies and regulations in the healthcare system, large-scale analysis of prevention, therapy, environmental factors contributing to illness, early detection of epidemiological threats, and so on.

The anticipated market effects of creating a European health data space are fairly obvious:

• Improved effectiveness and productivity of healthcare systems, including through shortening of diagnosis times
• Optimisation of treatment options
• Avoiding duplicative research
• Reducing errors
• Facilitating the growth of personalised medicine
• Increased effectiveness of prevention programmes
• Improved monitoring of the efficacy and safety of medicinal products and medical devices.

This is line with pan-European programmes planned or already in operation for which economies or statistics of scale are relevant, such as the battle against cancer, genetic testing, prevention of chronic illnesses, and treatment of rare diseases.

More than data

Considering the differences between healthcare systems in European countries, organising a European health data space is a challenge as tempting as it is complex. Due to the pandemic, probably more digital innovations have been introduced in the last year than in the whole preceding decade. But this has also revealed new challenges.

Many of these solutions have been makeshift, and often quite conservative, technically and in terms of the possibilities promised by the debate on new technologies, such as digital identity. An example is the draft regulation on the COVID passport. It is supposed to facilitate travel for Europeans even prior to the 2021 summer holidays. The COVID passport is referred to as a “digital green certificate,” but the occasion was not used to agree on a uniform technical solutions ensuring that the system would be airtight. For example, blockchain technology, which has already been proven on the market for payment instruments and financial instruments, could have been used.

The introduction of digital healthcare products and services using breakthrough technologies is not an end in itself. First we must know what needs they are intended to fill. Online platforms may be a response to a shortage of specialists, helping patients deal themselves with chronic illness, high blood pressure or circulatory problems. They can also foster a healthy lifestyle, eldercare, and addiction therapy. Many ideas are appearing for services that not only provide access to data, but also allow the data to be collated, analysed and diagnosed. Mobile devices enable the integration of data obtained from various sensors. Personalised applications can engage the patient, for example in games with preventive or therapeutic action.

It is apparent that market opportunities of this type bring together two different cultures. On one hand there are the rigours to which medical devices are typically submitted, and on the other hand the speed demanded by the unregulated market for online applications. It will be interesting to see what emerges from their collision.

Piotr Rutkowski, Wardyński & Partners