EU heads of state and government negotiated late into the night at the extraordinary summit and agreed in principle on the EU Commission’s compromise proposal for an oil embargo. Hungary, the Czech Republic, and Slovakia, however, insisted on guarantees that still need to be worked out in detail over the next few days, as Stephan Israel and Eric Bonse report from Brussels.
At the beginning of May, the Commission presented the draft regulation on the European Health Data Space. It was supposed to be a “milestone in the history of European medicine”. However, since then, the topic of data protection and confidentiality of patient data, in particular, has been hotly debated. Who will get access to health data? How will access be regulated? And what steps does Germany still need to take to be ready both digitally and legally by the time the regulation comes into force? Eugenie Ankowitsch has analyzed the various positions and arguments.
Staying on the subject of health, those who have survived cancer often face financial obstacles for decades to come. EU Health Commissioner Stella Kyriakides now wants to create a code of conduct on the right to be forgotten. Read more about this in the News.
How is data changing society? To address this question, David Schönwerth from Stuttgart works as a consultant for Data Economy in the field of AI and Big Data at the digital association Bitkom. There, he argues for a meaningful exchange of data, as he explains in the Profile.
Another personnel development in EU politics: Manfred Weber will in all likelihood be elected today as chairman of Europe’s largest party family, the EPP. The 49-year-old CSU politician is the only candidate in the running and hopes to succeed former EU Council President and Polish head of government Donald Tusk.
EU Council President Charles Michel announced the political agreement on the oil embargo via Twitter shortly before midnight. The import ban affects “two-thirds of oil imports from Russia”. With this, the EU is cutting an important source of revenue to finance the Russian war machine, Charles Michel later said, calling it a big step. “The EU is united,” German Chancellor Olaf Scholz wrote on Twitter, “We have agreed on drastic sanctions against Russia.”
The basis for the agreement is the compromise proposal that the EU Commission put on the table before the start of the extraordinary summit on Monday. Thus, the EU wants to end the import of Russian oil by sea by the end of the year. Oil that comes via the Druzhba pipeline, on the other hand, is exempt from the embargo for the time being.
The discussion recently dragged on because, in addition to Hungary, the Czech Republic and Slovakia also made new demands in addition to the “temporary exemption”. The three countries are almost exclusively dependent on the Druzhba pipeline and also have refineries, some of which can currently only process Russian oil. When the leaders arrived in the afternoon, an agreement still seemed very uncertain. While Prime Minister Viktor Orbán spoke of a “good solution for Hungary”, he suddenly demanded guarantees in the event that Ukraine disrupts the Druzhba pipeline.
Specifically, Hungary should now be able to purchase Russian oil via the Adriatic pipeline in an emergency to supply its refineries. This is at least until the switch to other types of oil is made, which will take some time. Russian oil is even to be supplied by sea as part of the exemption. The Adriatic pipeline starts on the Croatian island of Krk.
The problems in the Czech Republic are similarly specific. If the Druzhba pipeline were to fail, the country would be short two million tons of diesel or one-third of its annual demand from domestic refineries. At the summit, Czech Prime Minister Petr Fiala also called for pledges of help from neighboring countries and guarantees that the capacities of the Transalpine oil pipeline could be expanded quickly. This pipeline runs from the port of Trieste to Germany, but already has a side branch to the Czech Republic.
German Chancellor Olaf Scholz had already expressed optimism upon arrival, saying, “From what I hear, it sounds like there could be a consensus.” Scholz also made it clear that Germany, like Poland, did not want to benefit from the exemption for the Druzhba pipeline. The two countries want to stop importing Russian oil by the end of the year anyway. Commission President Ursula von der Leyen, on the other hand, did not want to believe in an agreement upon arrival. She said the embargo should not unfairly burden any country in the EU: “And this is precisely the issue we have not yet resolved.”
The reluctance, however, was probably also tactically justified. Ursula von der Leyen recently had to listen to some criticism of the preparation of the sixth sanctions package with the oil embargo as the sticking point. The Commission had not prepared the package correctly with the member states, Viktor Orbán spoke of “irresponsible behavior”. Austria’s Karl Nehammer also criticized the way the EU Commission had prepared the “difficult issue”. Instead of talking to the member states individually, the discussion had been held “on the big stage”.
Commission President Ursula von der Leyen had presented the sixth sanctions package at the beginning of May, perhaps somewhat prematurely. Originally, imports of Russian crude oil were to be ended within six months, regardless of the transport route, and those for oil products such as diesel and gasoline within eight months. Transition periods until the end of 2023 were planned for Hungary and Slovakia. How should the compromise be assessed?
The summit will come back to the “temporary exception” for Hungary, Ursula von der Leyen defended the concession to Viktor Orbán. The Czech Republic, on the other hand, is said to have agreed to a transitional period of 18 months.
Prime Minister Mark Rutte also defended the deal. “We have not watered down anything,” the Dutchman said. The punitive measures would, after all, affect two-thirds of Russian oil exports. Since Germany and Poland also want to stop buying Russian oil from the end of the year, the embargo would de facto cover as much as 90 percent of previous Russian oil exports to the EU.
Rutte showed understanding for the concerns of some Eastern European states. At the same time, the Netherlands and Belgium were among the states that warned against unfair competition at the end and insisted on guarantees for a level playing field. Hungary, the Czech Republic, and Slovakia should not be allowed to resell cheaper Russian oil and compete with seaports in Belgium or the Netherlands.
Russia earns significantly more from oil exports than from gas. However, Moscow is about to turn off the gas tap itself. Dutch gas trader GasTerra reported on Monday that it had not complied with Russia’s demand that it settle its invoices in rubles: “In response to GasTerra’s decision, Gazprom has declared that it will cease gas deliveries as of May 31,” the company said in a statement. However, the Dutch company’s contract would have expired on October 1 anyway.
GasTerra reports that it is prepared for the situation and has procured additional gas from other suppliers. Denmark is also preparing for the end of deliveries. The next invoice is due this week, and they do not intend to pay in rubles, writes the Danish energy company Ørsted. There is a risk that Gazprom will stop supplying gas. But the Danish energy company does not expect any problems with the supply of households and companies either. Gazprom has already stopped gas supplies to Bulgaria and Poland along the same lines.
The dispute over the oil embargo has held up the entire sixth sanctions package. The package also includes other drastic measures, such as the exclusion of Sberbank, Russia’s largest financial institution, from the Swift payment service provider, Charles Michel wrote on Twitter. Russian tanker operators will no longer be able to sign contracts with European insurers and reinsurers. The ban on other services related to Russian oil exports also remained part of the package.
The EU Council president confirmed that the ban on three more Russian state propaganda broadcasters is also coming. In addition, more individuals believed responsible for war crimes will be subject to entry and account bans. The sanctions package will be formally approved by EU ambassadors on Wednesday, Charles Michel said. It will enter into force shortly thereafter with publication in the EU’s Official Journal.
Ukrainian President Volodymyr Zelenskiy has called on EU leaders to quickly grant his country candidate status. Without Ukraine, there will never be a “full-fledged European power”, he said in a video address at the EU summit in Brussels. “We have to be like you. We want Ukraine to get candidate status,” Zelenskiy said. By June at the latest, it must be done.
Zelenskiy’s demand was in response to the EU’s decision to examine the membership application first. “The European Council takes note of the preparation of the Commission’s opinions on the applications for EU membership of Ukraine, as well as Moldova and Georgia, and will return to them at its June meeting,” the summit statement said. In addition, the leaders expressed their intention to provide Ukraine with exceptional financial assistance of up to €9 billion this year.
The EU Commission wants to make a recommendation on candidate status in time for the regular EU summit at the end of June. It is not yet clear what the outcome will be, said an EU diplomat, adding that there are still debates within the Brussels authority. France’s leader Emmanuel Macron had proposed that Ukraine and other countries first join a new “political community”. However, Zelenskiy rejects this.
The Ukrainian president also called on the EU to quickly impose further sanctions on Russia. “Why is Russia still able to earn almost a billion euros a day by selling energy?” Zelenskiy asked. He said the EU must stand together and not allow itself to be blackmailed by Russia. “Europe must show strength. Because Russia only takes power seriously as an argument,” Zelenskiy said.
In contrast to earlier speeches, he did not call the brakemen by name this time. However, it was also clear that the main issue was Hungary. Zelenskiy expressly thanked the EU for its efforts to reach compromises. These are intended to revive the negotiations on an oil embargo, which have been deadlocked for four weeks.
At the beginning of May, the European Commission presented a draft regulation for a European Health Data Space (EHDS). Already during the presentation of the proposal, it became clear which topics will play the main role in the discussions surrounding the EHDS in the coming months. Right at the forefront were data protection and the confidentiality of patient data. Both Commission Vice President Margaritis Schinas and EU Health Commissioner Stella Kyriakides never tired of emphasizing that they were aware of the importance of data protection in the healthcare sector and that all regulations in the regulation absolutely had to comply with the General Data Protection Regulation.
In the European Parliament, in particular, data protection and the issues surrounding the procedures for secure anonymization and pseudonymization of health data are likely to be at the center of the debates. This is also indicated by the fact that the Committee on Civil Liberties (LIBE) has now been proposed as the lead committee. The Committees for the Budget (BUDG), Internal Market (IMCO), Environment and Health (ENVI), and Industry and Research (ITRE) are also to be consulted. As yet, this allocation is not final, as the co-advisory committees could and very likely will claim a greater role for themselves. For the ENVI Committee, in particular, this could be the case. In the ITRE Committee, the dossier has already been assigned to the European People’s Party (EPP).
However, the draft regulation has met with broad approval, especially from industry, but also from the research community and consumer and patient associations. At the same time, it is becoming apparent that the private sector’s access to health data will be the subject of heated debate. In some EU countries, industry is not currently eligible to apply for access to health data.
It is no surprise that the affected industries, such as pharma and medtech, rushed to claim a seat at the table. MedTech Europe, for example, called for equal access to data in its initial reaction to the Commission’s proposal. Bitkom, the trade association for the German information and telecommunications industry, also stressed that the EU project should grant private research “a right to apply for the use of voluntarily provided, pseudonymized health data”.
The European Patients’ Forum (EPF), umbrella organization of European patients’ associations, welcomed the Commission’s proposal but called for a concrete and meaningful involvement of patients in the planned EHDS Committee. This is to ensure that their needs are fully taken into account, and that patient safety is guaranteed at all levels. Furthermore, the participation of patients and patient representatives in the committee’s meetings should not be made dependent on the topics discussed and their sensitivity.
As expected, the medical profession reacted cautiously to the draft regulation, pointing to the risks of using health data. The Standing Committee of European Doctors (CPME) called for ethically sound rules for the exchange of health data. Medical research is indeed essential for the development of new treatments and medicines, it said. However, the possibilities of research with “Big Data” should not lead to a softening of current ethical standards. Patient autonomy, dignity, privacy, and the right to self-determination must always be guaranteed.
The German Association of Contractual Psychotherapists (bvvp) was particularly concerned about the Commission’s proposal. The superficially good idea that all EU citizens should be able to access their health data at any time in the EU area harbors the risk, on closer inspection, of a development in the direction of a “transparent citizen”, criticized the association.
According to the bvvp, a European electronic patient file will create an unprecedented volume of data. It has not yet been precisely defined who, when and what data may, should or even must be entered into these files. The association is particularly critical of the plan to release blanket pseudonymized health data for research without a precise definition of the pseudonymization procedure.
Just on the day that the Commission presented its EHDS proposal, the Society for Civil Liberties in Germany filed a lawsuit against this form of data use. From October, according to the Digital Health Care Act of 2019, health data from all 73 million people with statutory health insurance are to be collected pseudonymously and made available for research. The civil rights activists want to prevent this with the lawsuit.
In his expert opinion commissioned by the civil rights activists, cryptographer Dominique Schröder concludes that the envisaged pseudonymization is not sufficient to protect patient data. Even with publicly accessible data sets, patients could easily be re-identified. The expert also criticizes the central collection of data at the Central Association of Health Insurance Funds as “superfluous and dangerous”. Because of the fundamental legal questions, the plaintiffs are also aiming for clarification of the legal situation by the European Court of Justice.
Electronic prescriptions and patient records, emergency data records, and data use for research purposes: One German health minister after another has failed to digitize the German healthcare system in recent years. The umbrella organization of the statutory health insurance funds (GKV) recently warned against automatically activating the ePA in the short term. In a resolution a few days ago, the National Association of Statutory Health Insurance Physicians (KBV) called for more support and incentives for e-prescribing. Otherwise, they want to opt out of corresponding Gematik processes, which is tantamount to a boycott. This raises the question of the feasibility and practicability of the ambitious EHDS project, which the Commission wants to start in 2025.
For Germany in particular, external pressure from EU legislation is eminently important, said Henrik Matthies, founder and CEO of Honic (Health Data Technologies GmbH), at an event in Berlin. “Because otherwise, nothing will move here,” was his conclusion, which some players in the German healthcare system would likely agree with. Until a few months ago, Matthies was Managing Director of the Health Innovation Hub (HIH). The HIH was an interdisciplinary expert think tank and sparring partner for the German Federal Ministry of Health with a focus on the topic of digitization in the healthcare sector and expired with the change of government at the end of 2021. The digital transformation process in Germany, which has been painstakingly started in recent years, would have to be continued “at an impressive speed” to be able to meet the requirements of the EHDS as early as 2024 or by 2025 at the latest, says the digitization expert.
To ensure that the EHDS regulation does not catch Germany unprepared, a health data utilization law, as announced in the coalition agreement, is therefore indispensable. Currently, there is a lack of legal certainty and uniform legal bases for the secondary use of medical data in this country, especially for research. “We need permissions and not these vague ‘non-definitions’ that we are currently working with,” Matthies said.
A legal framework for the use of health data was also demanded a few days ago by 14 top representatives of the health wise, including CEO of the AOK Federal Association Carola Reimann, CEO of Techniker Krankenkasse Jens Bass, President of the German Hospital Association Gerald Gaß and Managing Director of Gematik Markus Leyck Dieken, in a joint letter. The Health Data Use Act (GDNG) requires a change in perspective, the letter states. In addition to the protection of health data from misuse as a “right of defense“, a “positive right of citizens to the best possible use” of health data should be anchored on an equal footing.
“In a health care system based on solidarity and the principle of subsidiarity,” say the signatories, “the general availability of health information in digital form also gives rise to a solidarity-based responsibility on the part of the individual to support the community, insofar as no personal disadvantages are to be feared as a result.” A conclusion that contains social dynamite, as the discussions during the COVID pandemic impressively demonstrated. The risks, such as invasion of privacy, stigmatization, discrimination, or disadvantage due to data misuse, could be counteracted “by appropriate information technology, organizational and, if necessary, also by tightened (criminal) legal measures”.
In the authors’ view, the law should create a uniform federal basis for the processing of health data, “ensuring the most uniform possible interpretation and application of data protection law by the current 18 data protection authorities at federal and state level”. The role and function of research data centers should be defined, “with clear rules for access and use in the interest of public benefit research questions.” In addition, health care providers should be required to make health data available to patients as soon as possible after it is generated.
David Schönwerth lived most of his life in Stuttgart, less than 100 kilometers from the French border. But the first time he really came to France – apart from a day trip to Strasbourg – was for his master’s degree in public policy at Sciences Po in Paris. Schönwerth, who is also a member of the Young Liberals, had previously studied business informatics in Stuttgart and Hohenheim, but he became interested in how data changes society.
Since 2021, the 25-year-old has been a Data Economy Policy Officer for AI and Big Data at the digital association Bitkom. In 2017, Bitkom received the mocking “Big Brother Award” from the Digitalcourage association for, as it was called at the time, “uncritical promotion of Big Data, its penetrating lobbying against data protection and because it is de facto a front for large American corporations.”
Schönwerth rejects the accusations: “80 percent of the companies we represent have their headquarters in Germany, and about 8 percent come from Europe. Bitkom’s list of members is transparent and open for all to see on our website. When it comes to data protection, our line is clear, and it’s good that the General Data Protection Regulation is now in place.” However, it was important to strike a balance between data economy and data availability.
“Data protection is important, but the solution can’t be that we have data protection at home and then buy the data we need somewhere else.” And data sharing would not only benefit the economy but also the population: In pandemic response, cancer screening, and in a crisis, where data sharing could help solve problems.
The Data Act was a step in the right direction, but some companies were still concerned that corporate secrets would be endangered by the exchange of data. A Bitkom survey published in early May 2022 attests that German companies are becoming increasingly aware of data-driven business models, but three-quarters of companies have some catching up to do in this regard.
Some 63 percent of companies surveyed do not share data, which Schönwerth believes plays an “immensely important role” in keeping pace with the economy. However, this requires staff who can evaluate the data. This already needs to start with school education, he explains. “Otherwise, in a way, you’re not as competent as you want to be.”
Another problem is “an ever-evolving regulatory maze” of national and EU data-related requirements. Schönwerth lists: numerous data initiatives in the German coalition agreement, GDPR, in perspective the ePrivacy Regulation, Data Governance Act, Data Act, and the AI Act. “This can create uncertainty, especially in medium-sized businesses. If I can’t figure out what I’m allowed to do and what I’m not allowed to do – then when in doubt, I won’t do it. And that’s an innovation inhibitor.” Gabriel Bub
EU heads of state and government negotiated late into the night at the extraordinary summit and agreed in principle on the EU Commission’s compromise proposal for an oil embargo. Hungary, the Czech Republic, and Slovakia, however, insisted on guarantees that still need to be worked out in detail over the next few days, as Stephan Israel and Eric Bonse report from Brussels.
At the beginning of May, the Commission presented the draft regulation on the European Health Data Space. It was supposed to be a “milestone in the history of European medicine”. However, since then, the topic of data protection and confidentiality of patient data, in particular, has been hotly debated. Who will get access to health data? How will access be regulated? And what steps does Germany still need to take to be ready both digitally and legally by the time the regulation comes into force? Eugenie Ankowitsch has analyzed the various positions and arguments.
Staying on the subject of health, those who have survived cancer often face financial obstacles for decades to come. EU Health Commissioner Stella Kyriakides now wants to create a code of conduct on the right to be forgotten. Read more about this in the News.
How is data changing society? To address this question, David Schönwerth from Stuttgart works as a consultant for Data Economy in the field of AI and Big Data at the digital association Bitkom. There, he argues for a meaningful exchange of data, as he explains in the Profile.
Another personnel development in EU politics: Manfred Weber will in all likelihood be elected today as chairman of Europe’s largest party family, the EPP. The 49-year-old CSU politician is the only candidate in the running and hopes to succeed former EU Council President and Polish head of government Donald Tusk.
EU Council President Charles Michel announced the political agreement on the oil embargo via Twitter shortly before midnight. The import ban affects “two-thirds of oil imports from Russia”. With this, the EU is cutting an important source of revenue to finance the Russian war machine, Charles Michel later said, calling it a big step. “The EU is united,” German Chancellor Olaf Scholz wrote on Twitter, “We have agreed on drastic sanctions against Russia.”
The basis for the agreement is the compromise proposal that the EU Commission put on the table before the start of the extraordinary summit on Monday. Thus, the EU wants to end the import of Russian oil by sea by the end of the year. Oil that comes via the Druzhba pipeline, on the other hand, is exempt from the embargo for the time being.
The discussion recently dragged on because, in addition to Hungary, the Czech Republic and Slovakia also made new demands in addition to the “temporary exemption”. The three countries are almost exclusively dependent on the Druzhba pipeline and also have refineries, some of which can currently only process Russian oil. When the leaders arrived in the afternoon, an agreement still seemed very uncertain. While Prime Minister Viktor Orbán spoke of a “good solution for Hungary”, he suddenly demanded guarantees in the event that Ukraine disrupts the Druzhba pipeline.
Specifically, Hungary should now be able to purchase Russian oil via the Adriatic pipeline in an emergency to supply its refineries. This is at least until the switch to other types of oil is made, which will take some time. Russian oil is even to be supplied by sea as part of the exemption. The Adriatic pipeline starts on the Croatian island of Krk.
The problems in the Czech Republic are similarly specific. If the Druzhba pipeline were to fail, the country would be short two million tons of diesel or one-third of its annual demand from domestic refineries. At the summit, Czech Prime Minister Petr Fiala also called for pledges of help from neighboring countries and guarantees that the capacities of the Transalpine oil pipeline could be expanded quickly. This pipeline runs from the port of Trieste to Germany, but already has a side branch to the Czech Republic.
German Chancellor Olaf Scholz had already expressed optimism upon arrival, saying, “From what I hear, it sounds like there could be a consensus.” Scholz also made it clear that Germany, like Poland, did not want to benefit from the exemption for the Druzhba pipeline. The two countries want to stop importing Russian oil by the end of the year anyway. Commission President Ursula von der Leyen, on the other hand, did not want to believe in an agreement upon arrival. She said the embargo should not unfairly burden any country in the EU: “And this is precisely the issue we have not yet resolved.”
The reluctance, however, was probably also tactically justified. Ursula von der Leyen recently had to listen to some criticism of the preparation of the sixth sanctions package with the oil embargo as the sticking point. The Commission had not prepared the package correctly with the member states, Viktor Orbán spoke of “irresponsible behavior”. Austria’s Karl Nehammer also criticized the way the EU Commission had prepared the “difficult issue”. Instead of talking to the member states individually, the discussion had been held “on the big stage”.
Commission President Ursula von der Leyen had presented the sixth sanctions package at the beginning of May, perhaps somewhat prematurely. Originally, imports of Russian crude oil were to be ended within six months, regardless of the transport route, and those for oil products such as diesel and gasoline within eight months. Transition periods until the end of 2023 were planned for Hungary and Slovakia. How should the compromise be assessed?
The summit will come back to the “temporary exception” for Hungary, Ursula von der Leyen defended the concession to Viktor Orbán. The Czech Republic, on the other hand, is said to have agreed to a transitional period of 18 months.
Prime Minister Mark Rutte also defended the deal. “We have not watered down anything,” the Dutchman said. The punitive measures would, after all, affect two-thirds of Russian oil exports. Since Germany and Poland also want to stop buying Russian oil from the end of the year, the embargo would de facto cover as much as 90 percent of previous Russian oil exports to the EU.
Rutte showed understanding for the concerns of some Eastern European states. At the same time, the Netherlands and Belgium were among the states that warned against unfair competition at the end and insisted on guarantees for a level playing field. Hungary, the Czech Republic, and Slovakia should not be allowed to resell cheaper Russian oil and compete with seaports in Belgium or the Netherlands.
Russia earns significantly more from oil exports than from gas. However, Moscow is about to turn off the gas tap itself. Dutch gas trader GasTerra reported on Monday that it had not complied with Russia’s demand that it settle its invoices in rubles: “In response to GasTerra’s decision, Gazprom has declared that it will cease gas deliveries as of May 31,” the company said in a statement. However, the Dutch company’s contract would have expired on October 1 anyway.
GasTerra reports that it is prepared for the situation and has procured additional gas from other suppliers. Denmark is also preparing for the end of deliveries. The next invoice is due this week, and they do not intend to pay in rubles, writes the Danish energy company Ørsted. There is a risk that Gazprom will stop supplying gas. But the Danish energy company does not expect any problems with the supply of households and companies either. Gazprom has already stopped gas supplies to Bulgaria and Poland along the same lines.
The dispute over the oil embargo has held up the entire sixth sanctions package. The package also includes other drastic measures, such as the exclusion of Sberbank, Russia’s largest financial institution, from the Swift payment service provider, Charles Michel wrote on Twitter. Russian tanker operators will no longer be able to sign contracts with European insurers and reinsurers. The ban on other services related to Russian oil exports also remained part of the package.
The EU Council president confirmed that the ban on three more Russian state propaganda broadcasters is also coming. In addition, more individuals believed responsible for war crimes will be subject to entry and account bans. The sanctions package will be formally approved by EU ambassadors on Wednesday, Charles Michel said. It will enter into force shortly thereafter with publication in the EU’s Official Journal.
Ukrainian President Volodymyr Zelenskiy has called on EU leaders to quickly grant his country candidate status. Without Ukraine, there will never be a “full-fledged European power”, he said in a video address at the EU summit in Brussels. “We have to be like you. We want Ukraine to get candidate status,” Zelenskiy said. By June at the latest, it must be done.
Zelenskiy’s demand was in response to the EU’s decision to examine the membership application first. “The European Council takes note of the preparation of the Commission’s opinions on the applications for EU membership of Ukraine, as well as Moldova and Georgia, and will return to them at its June meeting,” the summit statement said. In addition, the leaders expressed their intention to provide Ukraine with exceptional financial assistance of up to €9 billion this year.
The EU Commission wants to make a recommendation on candidate status in time for the regular EU summit at the end of June. It is not yet clear what the outcome will be, said an EU diplomat, adding that there are still debates within the Brussels authority. France’s leader Emmanuel Macron had proposed that Ukraine and other countries first join a new “political community”. However, Zelenskiy rejects this.
The Ukrainian president also called on the EU to quickly impose further sanctions on Russia. “Why is Russia still able to earn almost a billion euros a day by selling energy?” Zelenskiy asked. He said the EU must stand together and not allow itself to be blackmailed by Russia. “Europe must show strength. Because Russia only takes power seriously as an argument,” Zelenskiy said.
In contrast to earlier speeches, he did not call the brakemen by name this time. However, it was also clear that the main issue was Hungary. Zelenskiy expressly thanked the EU for its efforts to reach compromises. These are intended to revive the negotiations on an oil embargo, which have been deadlocked for four weeks.
At the beginning of May, the European Commission presented a draft regulation for a European Health Data Space (EHDS). Already during the presentation of the proposal, it became clear which topics will play the main role in the discussions surrounding the EHDS in the coming months. Right at the forefront were data protection and the confidentiality of patient data. Both Commission Vice President Margaritis Schinas and EU Health Commissioner Stella Kyriakides never tired of emphasizing that they were aware of the importance of data protection in the healthcare sector and that all regulations in the regulation absolutely had to comply with the General Data Protection Regulation.
In the European Parliament, in particular, data protection and the issues surrounding the procedures for secure anonymization and pseudonymization of health data are likely to be at the center of the debates. This is also indicated by the fact that the Committee on Civil Liberties (LIBE) has now been proposed as the lead committee. The Committees for the Budget (BUDG), Internal Market (IMCO), Environment and Health (ENVI), and Industry and Research (ITRE) are also to be consulted. As yet, this allocation is not final, as the co-advisory committees could and very likely will claim a greater role for themselves. For the ENVI Committee, in particular, this could be the case. In the ITRE Committee, the dossier has already been assigned to the European People’s Party (EPP).
However, the draft regulation has met with broad approval, especially from industry, but also from the research community and consumer and patient associations. At the same time, it is becoming apparent that the private sector’s access to health data will be the subject of heated debate. In some EU countries, industry is not currently eligible to apply for access to health data.
It is no surprise that the affected industries, such as pharma and medtech, rushed to claim a seat at the table. MedTech Europe, for example, called for equal access to data in its initial reaction to the Commission’s proposal. Bitkom, the trade association for the German information and telecommunications industry, also stressed that the EU project should grant private research “a right to apply for the use of voluntarily provided, pseudonymized health data”.
The European Patients’ Forum (EPF), umbrella organization of European patients’ associations, welcomed the Commission’s proposal but called for a concrete and meaningful involvement of patients in the planned EHDS Committee. This is to ensure that their needs are fully taken into account, and that patient safety is guaranteed at all levels. Furthermore, the participation of patients and patient representatives in the committee’s meetings should not be made dependent on the topics discussed and their sensitivity.
As expected, the medical profession reacted cautiously to the draft regulation, pointing to the risks of using health data. The Standing Committee of European Doctors (CPME) called for ethically sound rules for the exchange of health data. Medical research is indeed essential for the development of new treatments and medicines, it said. However, the possibilities of research with “Big Data” should not lead to a softening of current ethical standards. Patient autonomy, dignity, privacy, and the right to self-determination must always be guaranteed.
The German Association of Contractual Psychotherapists (bvvp) was particularly concerned about the Commission’s proposal. The superficially good idea that all EU citizens should be able to access their health data at any time in the EU area harbors the risk, on closer inspection, of a development in the direction of a “transparent citizen”, criticized the association.
According to the bvvp, a European electronic patient file will create an unprecedented volume of data. It has not yet been precisely defined who, when and what data may, should or even must be entered into these files. The association is particularly critical of the plan to release blanket pseudonymized health data for research without a precise definition of the pseudonymization procedure.
Just on the day that the Commission presented its EHDS proposal, the Society for Civil Liberties in Germany filed a lawsuit against this form of data use. From October, according to the Digital Health Care Act of 2019, health data from all 73 million people with statutory health insurance are to be collected pseudonymously and made available for research. The civil rights activists want to prevent this with the lawsuit.
In his expert opinion commissioned by the civil rights activists, cryptographer Dominique Schröder concludes that the envisaged pseudonymization is not sufficient to protect patient data. Even with publicly accessible data sets, patients could easily be re-identified. The expert also criticizes the central collection of data at the Central Association of Health Insurance Funds as “superfluous and dangerous”. Because of the fundamental legal questions, the plaintiffs are also aiming for clarification of the legal situation by the European Court of Justice.
Electronic prescriptions and patient records, emergency data records, and data use for research purposes: One German health minister after another has failed to digitize the German healthcare system in recent years. The umbrella organization of the statutory health insurance funds (GKV) recently warned against automatically activating the ePA in the short term. In a resolution a few days ago, the National Association of Statutory Health Insurance Physicians (KBV) called for more support and incentives for e-prescribing. Otherwise, they want to opt out of corresponding Gematik processes, which is tantamount to a boycott. This raises the question of the feasibility and practicability of the ambitious EHDS project, which the Commission wants to start in 2025.
For Germany in particular, external pressure from EU legislation is eminently important, said Henrik Matthies, founder and CEO of Honic (Health Data Technologies GmbH), at an event in Berlin. “Because otherwise, nothing will move here,” was his conclusion, which some players in the German healthcare system would likely agree with. Until a few months ago, Matthies was Managing Director of the Health Innovation Hub (HIH). The HIH was an interdisciplinary expert think tank and sparring partner for the German Federal Ministry of Health with a focus on the topic of digitization in the healthcare sector and expired with the change of government at the end of 2021. The digital transformation process in Germany, which has been painstakingly started in recent years, would have to be continued “at an impressive speed” to be able to meet the requirements of the EHDS as early as 2024 or by 2025 at the latest, says the digitization expert.
To ensure that the EHDS regulation does not catch Germany unprepared, a health data utilization law, as announced in the coalition agreement, is therefore indispensable. Currently, there is a lack of legal certainty and uniform legal bases for the secondary use of medical data in this country, especially for research. “We need permissions and not these vague ‘non-definitions’ that we are currently working with,” Matthies said.
A legal framework for the use of health data was also demanded a few days ago by 14 top representatives of the health wise, including CEO of the AOK Federal Association Carola Reimann, CEO of Techniker Krankenkasse Jens Bass, President of the German Hospital Association Gerald Gaß and Managing Director of Gematik Markus Leyck Dieken, in a joint letter. The Health Data Use Act (GDNG) requires a change in perspective, the letter states. In addition to the protection of health data from misuse as a “right of defense“, a “positive right of citizens to the best possible use” of health data should be anchored on an equal footing.
“In a health care system based on solidarity and the principle of subsidiarity,” say the signatories, “the general availability of health information in digital form also gives rise to a solidarity-based responsibility on the part of the individual to support the community, insofar as no personal disadvantages are to be feared as a result.” A conclusion that contains social dynamite, as the discussions during the COVID pandemic impressively demonstrated. The risks, such as invasion of privacy, stigmatization, discrimination, or disadvantage due to data misuse, could be counteracted “by appropriate information technology, organizational and, if necessary, also by tightened (criminal) legal measures”.
In the authors’ view, the law should create a uniform federal basis for the processing of health data, “ensuring the most uniform possible interpretation and application of data protection law by the current 18 data protection authorities at federal and state level”. The role and function of research data centers should be defined, “with clear rules for access and use in the interest of public benefit research questions.” In addition, health care providers should be required to make health data available to patients as soon as possible after it is generated.
David Schönwerth lived most of his life in Stuttgart, less than 100 kilometers from the French border. But the first time he really came to France – apart from a day trip to Strasbourg – was for his master’s degree in public policy at Sciences Po in Paris. Schönwerth, who is also a member of the Young Liberals, had previously studied business informatics in Stuttgart and Hohenheim, but he became interested in how data changes society.
Since 2021, the 25-year-old has been a Data Economy Policy Officer for AI and Big Data at the digital association Bitkom. In 2017, Bitkom received the mocking “Big Brother Award” from the Digitalcourage association for, as it was called at the time, “uncritical promotion of Big Data, its penetrating lobbying against data protection and because it is de facto a front for large American corporations.”
Schönwerth rejects the accusations: “80 percent of the companies we represent have their headquarters in Germany, and about 8 percent come from Europe. Bitkom’s list of members is transparent and open for all to see on our website. When it comes to data protection, our line is clear, and it’s good that the General Data Protection Regulation is now in place.” However, it was important to strike a balance between data economy and data availability.
“Data protection is important, but the solution can’t be that we have data protection at home and then buy the data we need somewhere else.” And data sharing would not only benefit the economy but also the population: In pandemic response, cancer screening, and in a crisis, where data sharing could help solve problems.
The Data Act was a step in the right direction, but some companies were still concerned that corporate secrets would be endangered by the exchange of data. A Bitkom survey published in early May 2022 attests that German companies are becoming increasingly aware of data-driven business models, but three-quarters of companies have some catching up to do in this regard.
Some 63 percent of companies surveyed do not share data, which Schönwerth believes plays an “immensely important role” in keeping pace with the economy. However, this requires staff who can evaluate the data. This already needs to start with school education, he explains. “Otherwise, in a way, you’re not as competent as you want to be.”
Another problem is “an ever-evolving regulatory maze” of national and EU data-related requirements. Schönwerth lists: numerous data initiatives in the German coalition agreement, GDPR, in perspective the ePrivacy Regulation, Data Governance Act, Data Act, and the AI Act. “This can create uncertainty, especially in medium-sized businesses. If I can’t figure out what I’m allowed to do and what I’m not allowed to do – then when in doubt, I won’t do it. And that’s an innovation inhibitor.” Gabriel Bub
