EU Health Data Space to support patients and research

 

EU Health Data Space to support patients and research

Press Releases

·   Citizens will be able to access prescriptions, imagery and lab tests electronically, also from different EU countries

·   Aggregated health data can be shared for research purposes e.g. into cancer and rare diseases

·   Strong privacy safeguards on the manner and the purpose of the sharing of sensitive data

EP and Council negotiators agreed on the creation of a European Health Data Space to ease access to personal health data and to boost secure sharing for the public interest.

The provisional political agreement on a European Health Data Space (EHDS), reached early on Friday by Parliament and the Belgian Presidency of the Council, outlines that patients will be able to access their personal health data electronically across the EU’s different healthcare systems. The bill also gives health professionals access to their patients’ data, based strictly on what is necessary for a given treatment, and patients will also be able to download their health record free of charge.

Electronic health records (EHR) would include patient summaries, electronic prescriptions, medical imagery and laboratory results (so-called primary use).

Each country would establish national health data access services based on the MyHealth@EU platform. The law would also create a European electronic health record exchange format, and outline rules on data quality, security and the interoperability of EHR systems that will be monitored by national market surveillance authorities.

Data-sharing for the common good with safeguards

The EHDS would allow anonymised or pseudonymised health data, including health records, clinical trials, pathogens, health claims and reimbursements, genetic data, public health registry information, wellness data and information on healthcare resources, expenditure and financing, to be shared for public interest purposes (so-called secondary use). These reasons would include research, innovation, policy-making, education and patient safety purposes.

The sharing of data for advertising or assessing insurance requests will be prohibited. During negotiations, MEPs ensured that secondary use would not be allowed concerning decisions on labour markets (including job offers), lending conditions and other types of discrimination or profiling.

Stronger safeguards for sensitive data

The law ensures patients will have a say in how their data is used and accessed. They must be informed each time their data is accessed, and they will have the right to request or correct incorrect data. Patients will also be able to object to healthcare professionals accessing their data for primary use, except where this is necessary for protecting the vital interests of the data subject or another person. MEPs secured the right for patients to opt out of secondary use, with certain exceptions for public-interest, policy-making or statistics purposes, and protections for intellectual property rights and trade secrets when relevant data is shared for secondary use.

National data protection authorities will monitor the enforcement of health data access rights and will be empowered to issue fines in the event of shortcomings.

Quotes

Tomislav Sokol (EPP, Croatia), Environment Committee co-rapporteur, said: “The European Health Data Space will put citizens in control of their health data by providing a safe framework for storing and accessing their personal health records that will be accessible anywhere in the EU - enhancing healthcare at a national and cross-border level. the EHDS will also facilitate the responsible sharing of health data to researchers - boosting research and innovation in the EU, and ensuring the development of new treatments.”

Annalisa Tardino (ID, Italy), Civil Liberties Committee co-rapporteur, said: “The EHDS will contribute to providing state-of-the-art healthcare to patients everywhere in the EU. We have succeeded in including in the text significant reinforcements regarding the protection of sensitive personal data, in particular with the possibility for patients to opt-out both for primary and secondary use of their health data. In that regard, Parliament’s mandate was stronger and provided even more safeguards, but the majority of LIBE political groups considers that the final agreement strikes a balance between exchanging health data for treatment and for life-saving research, and protecting the privacy of our citizens.”

Next steps

The provisional agreement still needs to be formally adopted by both institutions before it can enter into law.

Παραβιάσεις δικαίου της ΕΕ - Μάρτιος 2024

 https://ec.europa.eu/commission/presscorner/detail/en/inf_24_663

1 The Commission calls on CYPRUS to properly assess projects that may have a significant impact on Natura 2000 sites

Today, the European Commission decided to send a reasoned opinion to Cyprus (INFR(2019)2303) for failing to properly assess projects that may have a significant impact on Natura 2000 sites as required by the Habitats Directive (Directive 92/43/EEC). The Directive is one of Europe's primary tools for protecting biodiversity. The Habitats Directive requires that plans and projects that are likely to have a significant impact on a Natura 2000 site undergo an assessment of their effects on the site before their authorisation. Plans and projects can only be authorised, subject to certain exemptions, if they do not harm the integrity of the site. The Commission sent a letter of formal notice to Cyprus in November 2019. Since then, the Commission has continued to receive complaints by citizens concerning the authorisation of new projects and has further monitored the situation. The Commission has found that the structural and persistent practice of authorising economic activities in Natura 2000 sites without complying with the Habitats Directive continues. Therefore, the Commission has decided to send a reasoned opinion to Cyprus, which now has two months to respond and take the necessary measures. Otherwise, the Commission may decide to refer the case to the Court of Justice of the European Union.

2 The Commission decides to refer CYPRUS to the Court of Justice of the European Union for failure to take the necessary steps to protect and manage its Natura 2000 sites

Today, the European Commission decided to refer Cyprus (INFR(2021)2064) to the Court of Justice of the European Union for failure to comply with the Habitats Directive (Directive 92/43/EEC). Under the Habitats Directive, Cyprus has formally designated 37 sites as Special Areas of Conservation but has yet to establish the necessary conservation measures for 28 of those sites. Moreover, the conservation objectives for 5 sites are not adequate, meaning that the species and habitats in these sites are not properly protected. The Commission sent a letter of formal notice to Cyprus in June 2021, followed by a reasoned opinion in April 2022. Despite some progress on the designation of Special Areas of Conservation, the Cypriot authorities have not fully addressed the grievances. The Commission considers that efforts by the Cypriot authorities have, to date, been insufficient and is therefore referring Cyprus to the Court of Justice of the European Union. More information is in the press release.

3 The Commission calls on BULGARIA, CYPRUS, and SLOVENIA to fulfil the obligations of the Regulation on dissemination of terrorist content online  

Today, the European Commission decided to send reasoned opinions to  Bulgaria (INFR(2022)2113), Cyprus (INFR(2022)2114) and Slovenia (INFR(2022)2132) for failing to comply with certain obligations of the Regulation on the dissemination of terrorist content online (TCO, Regulation (EU) 2021/784).The TCO Regulation, which entered into application on 7 June 2022, requires that terrorist content in the EU is taken down by online platforms within one hour upon receipt of a removal order issued by Member States' authorities. This helps to counter the spread of extremist ideologies online – which is key for preventing attacks and addressing radicalisation – while safeguarding fundamental rights. The Commission launched a set of infringements in January 2023, by sending letters of formal notice to 22 Member States. The Commission considers that Bulgaria, Cyprus, and Slovenia have failed to comply with one or more obligations under the TCO Regulation. Therefore, the Commission has decided to send a reasoned opinion to Bulgaria, Cyprus and Slovenia, which now have two months to respond and take the necessary measures.  Otherwise, the Commission may decide to refer the cases to the Court of Justice of the European Union.    

4 The Commission calls on SPAIN, ITALY, CYPRUS, LUXEMBOURG and POLAND to fully transpose the EU rules on procedural safeguards for children in criminal proceedings  

The European Commission decided to open infringement procedures by sending letters of formal notice to Spain (INFR(2023)2176), Italy (INFR(2023)2090), Luxembourg (INFR(2024)2002) and Poland (INFR(2023)2127), and to issue an additional reasoned opinion to Cyprus (INFR(2019)0175), for failing to fully transpose into their national law the Directive on procedural safeguards for children who are suspects or accused persons in criminal proceedings (Directive (EU) 2016/800). This Directive is part of the EU's comprehensive strategy to establish common minimum standards to guarantee the right to a fair trial and the rights of suspects or accused persons in criminal proceedings across the EU. It establishes common rules on the protection of procedural safeguards for children such as the right to an individual assessment, to specific treatment in case of deprivation of liberty (such as separation from adult detainees and access to training and education) and to be accompanied by the holder of parental responsibility during the proceedings. The Commission considers that Poland failed to fully transpose the scope of the Directive and certain substantive requirements, for instance, with regards to the right to an individual assessment and the assistance of the child by a lawyer. In the cases of Italy, Luxembourg and Spain, completeness issues were identified, for instance, with regards to the right to information of the child and the right to a medical examination. Cyprus received a first reasoned opinion in May 2020 for failing to communicate to the Commission the measures transposing the Directive. Following Cyprus' reply, the Commission concluded that the notified measures fall short of the requirement of the Directive to ensure specific treatment of children in case of deprivation of liberty. Therefore, the Commission has decided to send letters of formal notice to Spain, Italy, Luxembourg and Poland and an additional reasoned opinion to Cyprus. The Member States now have two months to respond and address the shortcomings raised by the Commission. In the absence of a satisfactory response, the Commission may decide to send Spain, Italy, Luxembourg, and Poland a reasoned opinion and refer Cyprus to the Court of Justice of the European Union.  

5 The Commission calls on SPAIN, CROATIA, CYPRUS, LUXEMBOURG, POLAND and SLOVENIA to transpose EU rules on use of vehicles hired without drivers for carriage of goods by road 
The European Commission today decided to send a reasoned opinion to Spain (INFR(2023)0213), Croatia (INFR(2023)0221), Cyprus (INFR(2023)0196) Luxembourg (INFR(2023)0229), Poland (INFR(2023)0236) and Slovenia (INFR(2023)0246) for failing to communicate to the Commission any national measures to transpose EU rules on the use of vehicles hired without drivers for the carriage of goods by road (Directive (EU) 2022/738). This Directive aims to help companies to benefit from the advantages of using hired vehicles, for example by allowing the use of vehicles hired in another Member State. Such a possibility can, in particular, make it easier for companies to meet short-term, seasonal or temporary peaks in demand or to replace defective or damaged vehicles, while ensuring compliance with the necessary safety requirements and ensuring adequate working conditions for drivers. Member States needed to adopt the measures by 6 August 2023 to comply with EU legislation. Therefore, the Commission has decided to send a reasoned opinion to these Member States, which now have two months to respond and take the necessary measures. Otherwise, the Commission may decide to refer the case to the Court of Justice of the European Union. 

6 The Commission calls on SPAIN, PORTUGAL, ROMANIA, SLOVENIA, SLOVAKIA, SWEDEN and FINLAND to fully and correctly transpose the provisions of the Seasonal Workers Directive  
The European Commission has opened an infringement procedure by sending a letter to Spain (INFR(2024)2004), Portugal (INFR(2024)2006), Romania (INFR(2024)2007), Slovenia (INFR(2024)2009), Slovakia (INFR(2024)2010), Sweden (INFR(2024)2008) and Finland (INFR(2024)2005) for failing to fully transpose all provisions of the Seasonal Workers Directive (Directive 2014/36/EU). The Directive aims to ensure fair and transparent rules for the admission of non-EU seasonal workers to the EU, with guarantees for decent working and living conditions, equal rights, and sufficient protection from exploitation across the EU. Ensuring the full respect of the Seasonal Workers Directive is an important prerequisite for attracting the workers needed for seasonal work to the EU and it could also contribute to reducing irregular migration. The Commission is monitoring its transposition into national law by Member States.  The Commission launched the first set of infringements in April 2023, by sending letters of formal notice respectively to Belgium, Bulgaria, Germany, Estonia, Greece, Italy, Cyprus, Latvia, Lithuania, and Luxembourg. A second set of infringements was launched in December 2023, by sending letters of formal notice to Czechia, France, Croatia, Hungary, Malta, the Netherlands, Austria, and Poland. The Commission considers that Spain, Portugal, Romania, Slovenia, Slovakia, Finland, and Sweden, have incorrectly transposed and/or implemented some obligations under the Directive. The Commission is therefore sending a letter of formal notice to Spain, Portugal, Romania, Slovenia, Slovakia, Sweden and Finland, which now have two months to respond and address the shortcomings raised by the Commission. . In the absence of a satisfactory response, the European Commission may decide to send them a reasoned opinion.