June 23. 2024. 1:12

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Czech stakeholders: Secondary use of health data still needs fine-tuning


Some EU countries such as Czechia are already making ‘secondary use’ of health data, ahead of the set-up of the new EU-wide framework to boost the digitalisation of the sector.

Re-using health data for ‘secondary use’ is a crucial component of the European Health Data Space (EHDS), the proposed legislative framework to govern health data across the bloc.

Secondary use includes health records, public registries, clinical studies, research questionnaires, and social, administrative, genetic, genomic or biomedical data such as biobanks.

For its advocates, secondary use of health data could make it easier to develop new drugs, set policy goals, manage epidemics or improve healthcare quality. However, concerns remain over patients’ consent and access.

This form of ‘data recycling’ is already up and running in the Czech Republic.

One example is the ‘Vitakarta’ project of the Czech Occupational health insurance company (OZP) which uses an app and a smartwatch to help insured people collect their health data and use it for various purposes.

“The app monitors prevention, allows us to check the reported care and reward the quality of care. It automatically watches for inappropriate drug interactions and can identify chronic conditions,” said Eva Švecová, head of the OZP’s strategies department, during a recent debate.

Secondary use of health data is already ‘in full swing’ at the national level, according to Jaroslav Dušek, director of the Institute of Health Information and Statistics of the Czech Republic (IHIS).

He added that anyone who meets the conditions can apply for available statistical data, i.e. research centres, companies and other entities.

Dušek also emphasised that the Czech Republic is said to be the most advanced in sharing laboratory data on COVID-19.

But many things have yet to be fine-tuned, especially the completion of the National Health Information System (NHIS) and the lack of usable data remains a significant challenge.

“We are talking about data sharing, and we are located in a country that can share only 30% of the data because it has no more than that collected centrally in a parametric way,” Dušek pointed out.

Council hashes out secondary use of data in EU health data space

The EU Council has found common ground on the secondary use of data, one of the most crucial aspects for gaining citizens’ trust in the European Health Data Space (EHDS), according to a draft position obtained by EURACTIV.

EHDS comes in handy

Paper documentation is still prevalent in Czech clinics, for instance, leaving room for more efficient standardisation and data collection in the country’s healthcare sector.

According to Ladislav Švec, director of the Health Insurance Office, the EU’s initiative focusing on data – the EHDS – could “push” the Czech Republic forward and grow its IT sector.

Moreover, EU funds could support the creation of the necessary infrastructure. The EHDS is backed by a budget of €800 million coming from different EU funding programmes such as the EU4Health, Digital Europe, and Horizon Europe.

The advantage of pan-European data sharing is noticeable – more data from more countries means a better picture of overall trends.

While the Commission presented the EHDS proposal in May 2022, talks between EU ministers and MEPs have yet to start.

There are several points on which the states have different views, according to Petr Čermák, who has been involved in the negotiations since the beginning on behalf of the Czech Permanent Representation to the EU.

Neither the breadth of the categories of data provided nor the degree of harmonisation is apparent. It also needs to be clarified whether the EU will make the data available to interested third countries.

The nature and extent of the powers of the Health Data Access Body, which will grant and control access to the data, has not been decided yet.

Medical devices to lead way in using health data ‘goldmine’

The revolutionary EU health data space has been hailed as the dawn of a new era for medical devices but its proper implementation presents the sector with some challenges on regulatory aspects and on confidentiality of business information.

Patients’ consent and access to data

Data for secondary use would only be shared in aggregated, anonymised and pseudonymised forms. Still, lively debate has ensued about patients’ power to influence where their data goes.

For liberal Czech MEP Ondřej Knotek (ANO, Renew Europe) some lawmakers in the European Parliament are “opportunistically calling, in the name of fighting for freedom” for some amendment where the patients are supposed to give their consent before sharing data.

Debate speakers responded that this would limit the volume of data collected, and as such risk undermining the point of secondary uses.

Another outstanding issue is who should have access to the data, apart from researchers.

Manufacturers of novel drugs, represented in the Czech Republic by the Association of Innovative Pharmaceutical Industry (AIFP), argue that their data from clinical trials is no longer enough and that without access to other statistical data, they will lose out in the global competition.

But the industry is not the only one interested in data. Jakub Dvořáček, Czech deputy health minister, believes that no one should be barred from accessing the data, whether it is academics, patients, hospitals, insurers or industry – once the purpose of using the data is made clear.

However, even secure data sharing is not without risk regarding misinterpretation of such data. According to Dvořáček, raw data without a verified interpretation can be misused, which he cautioned is something to watch out for in the EHDS.