Data is arguably the most valuable coin of our time and it’s set to become more relevant as we progress through the 21st century. Data governs our world, governments and companies around the globe leverage personalized data for diverse purposes, but essentially taking your data footprint – from online purchases to the amount of time spent scrolling certain websites or your last reservations at hotels and restaurants – to build your digital profile. These profiles are constantly being developed and enhanced through additional data, and this practice is here to stay.
But what is the situation for the healthcare industry and how can data be used to improve the lives of EU citizens?
The latest development in the data world is the ambitious proposal by the European Commission to start harnessing and unleashing the full potential of health data across the EU. With more than 500 million Europeans, diverse healthcare systems, and arguably the biggest health database in the world, the potential is massive and very exciting.
Before getting too hyped about the idea of the European Health Data Space (EHDS), however, let’s take a look at the current EU landscape and rationalize our excitement. Health data collection in the EU is extremely fragmented and diverse throughout Member States, from the Finnish or French systems which are nearly fully digitalized to countries still working with paper and creating non-interoperable written archives, in Eastern Europe. The absence of a common exchange format facilitating the portability and interoperability of Electronic Health Records (EHRs) across borders significantly hampers the potential of health data. This is precisely what the European Commission seeks to solve with the ambitious EHDS.
Ideally, by 2025, citizens will have access to their EHRs and be able to share them with healthcare professionals cross-borders. In practice, this translates into medical records issued in a common exchange format, interoperability becoming a compulsory requirement for manufacturers and health data becoming more available for secondary purposes such as research and innovation, policymaking, and official statistic creation among others.
Debates to watch
- The EHDS should consider current international interoperability standards to avoid processes becoming more complicated for the industry.
There are already international interoperability standards and processes. While some new standards are deemed useful, there should be added value. For the industry, it will be important to make sure that the additional standards are consistent with current frameworks to ensure a smooth transition.
- It is not yet clear how the EHDS will interplay with other data legislation, with opportunities to solidify the legal basis for research not sufficiently addressed.
Legislation such as GDPR was deemed to make medical research with data more difficult in the EU, deterring international investment. There is an opportunity for the EHDS to clear up some of the uncertainty by clarifying the legal basis for data use, but this is another part of the proposal which will be addressed at a later stage. It will be key for stakeholders to emphasise the importance of having a clear legal basis for the use of health data in a way that is coherent with other files, such as the Data Act, Medical Device Regulation and AI Act.
- The Commission has not sufficiently clarified how secondary data can be shared with third parties, which could impact innovation and development of new treatments.
There is support from the industry, if the use of this data is effectively limited to R&D purposes. Clarification is needed on the type of data companies will have to share and with whom it can be shared, with innovation and development of new treatments highly dependent on it. In addition, both the cost and monetary retribution for data is uncertain. With this policy set to be determined further down the line in the implementation of the policy, it will be important that industry concerns are clarified in the relevant feedback processes.
The legislative proposal is now going to go to the European Parliament and the European Council. We can expect the legislation to be highly political with extensive input from Member States seeking to retain health competencies at the national level. Likewise, adoption will probably be a long and challenging process due to an extremely busy healthcare legislative pipeline and upcoming EU Parliament elections in 2024, threatening to slowdown the revision and amendments timeline.
The current proposal leaves room for the Commission to introduce concrete aspects of the EHDS at later stages and through national legislation. Experience from previous legislative processes suggests that this could create an uneven playing field between different Member State positions, risking fragmentation and further delaying implementation
It is an exciting time for European healthcare and the EHDS could drastically change the lives of millions across Europe. Inevitably, however, the implementation of something so monumental across the whole of the EU is not going to be straight forward. We will watch and monitor developments closely and look forward to bringing you updates in the years to come.
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September 21, 2022
August 30, 2022