Yesterday evening, the EU Commission was still planning to submit its proposal for a sixth sanctions package against Russia to the member states of the European Union. In all likelihood, it will be presented today by Commission President Ursula von der Leyen in the EU Parliament. As EU chief diplomat Josep Borrell announced, the proposal will include new punitive measures against actors who deliberately spread misinformation. Furthermore, in addition to action against oil imports from Russia, the exclusion of further banks from the international communication network Swift is also planned. We will of course keep you up to date.
Green hydrogen and its derivatives play an important role in the REPowerEU plan, with which the Commission aims to make Europe less dependent on Russian energy supplies. The German funding project H2Global is dedicated to the import of hydrogen, which is vital for the industry. Kirsten Westphal heads the analysis department of the H2Global Foundation. In an interview by Manuel Berkel, she talks about the first shiploads, highly complex supply chains and Ukraine as a partner.
It is a huge undertaking: Since yesterday, the EU Commission’s proposal for the European Health Data Space has been on the table. It is intended to give European citizens digital access to their medical data and allow them to decide on its use. In addition, the data is to be made available for research purposes. Eugenie Ankowitsch took a closer look at the plans and identified first pitfalls.
Manuel Berkel: The industry wants to invest billions in climate-friendly plants and switch its production to green hydrogen. When will the first green gas come to Europe via H2Global?
Kirsten Westphal: In the first funding window, we are not yet talking about pure hydrogen, but about derivatives – i.e. green ammonia, methanol, and fuel for aircraft. Our subsidiary HINT.CO is currently preparing the tenders for these three lots. We want to start the auction procedures in the summer and sign the contracts by the end of the year. The first shipments can then be expected between the end of 2024 and the beginning of 2025.
Green hydrogen and its derivatives also play an important role in the REPowerEU plan, with which the Commission wants to make Europe less dependent on Russian energy supplies. What is the significance of H2Global as a German funding instrument for the European plans?
Although the initiative was set up by the German government, H2Global does not see itself as a purely German instrument. The delivery point is defined as the region between the ports of Antwerp, Zeebrugge, Rotterdam, and Hamburg to Rostock and Duisburg as a major inland port. This northwestern European industrial region is predestined. The H2Global Foundation is also becoming more European when you look at who is involved with us. H2Global can become a pioneer for a European hydrogen accelerator as described by REPowerEU.
So what quantities of hydrogen derivatives will H2Global be able to procure? The Commission wants to quadruple the targets for green H2 by 2030 – to 20 million tons per year.
In the first funding window, we have €900 million available until 2033. This will be used to buy the derivatives, which will also cover the expected difference between the bid prices for delivery and for offtake. It is difficult to estimate at present what quantities we will be able to obtain for this. Globally, there have been virtually no price signals as to what green ammonia costs. H2Global can provide transparency on the prices of hydrogen derivatives, and for the industry, this will be an important added value. But the question is fair. H2Global will not be able to procure large quantities in the first round of funding. First, it’s an important pilot. The crucial point is to get going and find hydrogen projects that can be scaled up. And H2Global will be the first instrument across Europe to test the entire supply and value chain for green hydrogen.
What do you mean by that?
Up to now, people have been looking very closely at the production and customers of green hydrogen and believing that everything in between will work out somehow. Yet the supply chains are also highly complex: means of transport, transport routes, storage. The logistics of hydrogen imports have become even more urgent because of the war in Ukraine. We will need a larger number of different derivatives faster. H2Global creates a protective umbrella so that supply chains can be established and companies can position themselves accordingly. Bidders will have to make sure the logistics work. That will be factored into the bids, so the tenders will also provide transparency on transportation costs. Another big factor that is still missing is the regulatory framework. Only when the regulatory framework has been clarified can companies really add value to green hydrogen and its downstream products – keyword delegated act on RED II.
The amendment of the entire Renewable Energies Directive RED II and the gas package are also being negotiated in Brussels. Does all this have to be decided before you can certify your hydrogen derivatives as “green”?
In fact, there is still a lot to be done on the certification and creditability issues. The standards for our first funding window will be defined by the German Federal Ministry of Economics by the start of the auctions. The challenge will be to set the standards for H2Global high enough so that the products purchased are considered green throughout the contract period. This is already part of our lessons learned: Europe’s first climate-neutral hydrogen must still be able to be sold as green in ten years’ time. H2 pilot projects would need grandfathering in European regulation.
The switch from natural gas to hydrogen is seen as an opportunity to break dangerous dependencies. How can supplier diversification be ensured?
Building a hydrogen world will be a generational task. In order to stimulate the market, we will perhaps experience structures similar to those in the natural gas industry for a transitional period – large pipelines, at the end of which producers and customers scale. But in the long term, we don’t want to fall into similar traps again. That’s why H2Global was designed to be flexible from the start. The instrument allows new production windows to be adapted to political goals. People are now looking a lot to the Middle East, Australia, and Chile. There are front-runners there that have capital and are quite far along in the projects. Yet, in the second or third round of funding windows, we could, for example, expand Europe’s partnership with more African countries to diversify. I’m thinking very much of interconnectors to Egypt, from where you could create further infrastructure links into the continent. These could be underpinned with H2Global.
Will H2Global last that long or will it soon be merged into a European platform?
The coalition agreement already states that the German government wants to further develop H2Global on a European scale and provide it with appropriate funding. That’s also good, so that investors don’t have to keep adjusting to different national rules and the projects don’t compete with each other. H2Global can help the EU speak to the world with one face – something that has long been lacking in the natural gas world. Thinking further ahead, we can identify several regionally defined supply regions. Hydrogen could enter Europe via Trieste, Barcelona, Marseille, or other Mediterranean ports.
Before the war, Ukraine was also considered a promising partner for hydrogen partnerships. Does this vision still exist?
In view of the frightening images from Ukraine, it is unfortunately still far too early for such plans. However, stakeholders in the EU have rightly always considered Ukraine in the development of a European hydrogen economy, as in the European Hydrogen Backbone and the 2×40 gigawatt strategy. In the long term, it remains very sensible to include Ukraine in the EU’s hydrogen plans. In the case of electricity and gas networks, we are already seeing the importance of European operators working with their Ukrainian partners. When it comes to reconstruction, interconnectors will play an essential role in both electricity and hydrogen.
After a series of delays, the EU Commission yesterday presented a draft regulation for the European Health Data Space (EHDS). The regulation aims to improve healthcare in the EU, strengthen patients’ rights to their electronic health data, and promote scientific research.
“The European Health Data Space is a game-changer in the digital transformation of healthcare in the EU,” said Health Commissioner Stella Kyriakides when presenting the proposal in Strasbourg. The EU was taking a “truly historic step” on the road to digital healthcare. “Revolutionary,” agreed EU Commission Vice President Margaritis Schinas.
Contrary to many speculations that have been circulating since the postponement of the original April 5 release, there have been no fundamental changes to the EHDS infrastructure compared to the leaked version from March (Europe.Table reported). However, that does not mean there is no need for discussion. There are likely to be many obstacles to overcome before the regulation is finally adopted – the Commission is quite optimistically assuming one and a half to two years of negotiations.
“For patients, the EHDS means that they have direct digital control over their health data and can share it with doctors across the Union when needed,” said S&D MEP Tiemo Wölken. For research, too, better data means huge potential, especially in the research and development of new medicines and therapies for rare diseases, for which there is often insufficient data in individual member states. “In the coming weeks, it is now important to examine whether the Commission’s proposal meets these important objectives,” Wölken said.
The Commission proposes two separate health data infrastructures. On the one hand, people should be able to access their own treatment data digitally and decide on their use – including cross-border use – (primary use). On the other hand, health data should be made available for research purposes (secondary use).
Under primary use, the Commission grants everyone the right to “immediate access, free of charge, to their personal electronic health records in an easily readable and accessible form.” Patients can share their data, limit access or revoke it. With this entitlement, the EU Commission hopes to strengthen patients’ right to control their health data.
Member states will be required to make key data, such as patient records, electronic prescriptions, medical images, lab results, and discharge reports, available in a common European format. National stakeholders in many a member state are likely to breathe a sigh of relief on one point: personal health data that was not collected electronically prior to the application of the regulation does not have to be converted to an electronic format by decision of the national governments.
According to the draft regulation, each member state must create a national body that, among other things, provides the necessary eHealth services. In Germany, such an institution exists in the form of Gematik as the national agency for digital medicine. According to Gematik, it bears overall responsibility for the telematics infrastructure (TI), the central platform for digital applications in the German healthcare system.
To enable patients to exchange their health data across borders with healthcare providers in other member states, and to do so in their own language, the participation of member states in the digital infrastructure MyHealth@EU is to be mandatory. This is likely to cause quite a stir in the Council, as many member states have so far taken their time to connect to the platform, which has been in existence for more than ten years.
Currently, only ten EU countries use MyHealth@EU, and to an extremely limited extent. According to the Commission, most countries had previously planned to join this platform by 2025. Now this is to become binding. For countries like Germany, which is still struggling with the introduction of e-prescribing, this target is likely to be ambitious.
“For Germany, this means that we must now accelerate the digitization of our healthcare system,” said Achim Berg, president of the digital association Bitkom. “We must therefore push ahead with the expansion of electronic patient records, digital infrastructure for the use of health data or interoperability.” In this context it is important that the German Health Data Use Act planned in the coalition agreement be launched quickly and in line with European regulations.
With the draft regulation, however, the Commission also regulates the so-called secondary use of health data. For this purpose, each member state is to designate one or more bodies to provide access to health data. Only one, however, is to act as coordinator and national contact point and be responsible, among other things, for making electronic health data available for secondary use – also across borders. The national bodies will be integrated into the new decentralized EU infrastructure for secondary use HealthData@EU. This infrastructure will be tested from 2022 as part of an EU4Health project (Europe.Table reported).
The processing of the data must take place in a secure environment. To this end, the Commission defines a number of security requirements: for example, unauthorized persons should not have access to the secure processing environment. Unauthorized reading, copying, modification, or removal of electronic health data must also be prevented. All-access must be logged.
The data centers must also ensure transparency. For example, they should disclose information about requests for data access. In addition, data users must publish the results of their data use and inform health data access bodies of any important findings relevant to an individual’s health.
In Germany, the Research Data Center Health (FDZ Gesundheit) will act as a national contact point, although it is still being established. It is located at the Federal Institute for Drugs and Medical Devices (BfArM). The FDZ Gesundheit was initiated by the legislature in 2019 through the Digital Care Act. According to the BfArM, the legal, technical, and organizational measures are currently being defined and implemented. Applications for data use are expected to be possible from fall 2022.
In the present draft regulation, the Commission defines a number of data categories for secondary use. Accordingly, it includes data from electronic health records, public registries and clinical trials, genetic and genomic data, and also social data that have an impact on health. In addition, there is administrative data, including claims and reimbursement data.
The list of permissible uses includes, but is not limited to, public health research, assisting government agencies in carrying out their duties, educational purposes, scientific research, and training algorithms for medical applications. It is prohibited to use data to make decisions that are detrimental to individuals, to increase insurance premiums, to market health products to health professionals or patients, or develop harmful products or services.
One of the sticking points is likely to be data protection. Health data is considered particularly sensitive. There are likely to be many discussions about this, especially in the EU Parliament. Tiemo Wölken, a Social Democrat, also emphasizes the outstanding importance of data protection and data security: “Patients must be able to trust the digital exchange of data without restriction; highly sensitive personal health data must not fall into the wrong hands.” MEPs could also insist on particularly high standards in supervision.
The Commission knows that, too. Data protection and security standards should always be respected, Kyriakides stressed several times when presenting the draft regulation. Citizens should have control over their data and decide for themselves what information they share. Researchers would also need permission from national authorities to work with the data.
In order to realize the European Health Data Space, investments must be made in electronic health records, telemedicine, interoperability, but also data quality, institutions, and solutions for the secondary use of health data. At the same time, interoperable EU-wide infrastructures are needed to enable the cross-border use of health data in the EU.
The Commission has budgeted over €800 million for the development of the EHDS. The money is to come from several EU funding programs, including EU4Health, Digital Europe Programme, Connecting Europe Facility, and Horizon Europe. In addition, member states would have the option of receiving funds from the Recovery and Resilience Facility. €12 billion was earmarked for investment in health, including digital health and secondary use of health data, according to the Commission.
The European Regional Development Fund and the InvestEU program would provide complementary opportunities for additional investment in digital health based on national needs. The Commission also intends to support member states in developing and implementing strategies and action plans to improve the interoperability of health systems, if requested.
Apart from the technical challenges and high investment requirements, however, the success of the EHDS depends heavily on whether all stakeholders, from physicians in practices and clinics to hospital managers and politicians at all levels, can be persuaded to participate in the EHDS.
“Whoever leads in AI also leads the world. That is why we cannot afford to lag behind,” says Axel Voss (59), rapporteur in the Special Committee on Artificial Intelligence in the Digital Age (AIDA) in the EU Parliament.
The report of the AIDA Special Committee was adopted yesterday in the European Parliament with a large majority. The report focuses on the EU’s competitiveness in digital markets and how it can be promoted. For example, it identifies policy options that could unleash the potential of AI in the areas of health, environment, and climate change to fight pandemics and world hunger and improve people’s quality of life through personalized medicine.
AI, when combined with the necessary support infrastructure, education, and training, can boost capital and labor productivity, innovation, sustainable growth, and job creation, the report says.
In the plenary session of the EU Parliament, Voss was not completely satisfied with the finished report. This is because many of his original demands were weakened, in some cases considerably, in the compromise version that was adopted. “We have achieved a lot,” said Voss during the debate in the plenary. However, “We could have been bolder or even revolutionary.”
AI is the key technology of the future and of high strategic relevance. Europe must ask itself how it intends to keep up with other regions of the world “that are advancing research and development far more consistently and in a more targeted manner, that are training talent, that are putting a lot of money into it, and that can react more flexibly to new developments.” Voss issued an urgent warning against Europe becoming a “digital colony” of such regions whose values it does not share.
Voss describes Europe’s task in the field of AI as follows: “It’s a major challenge to integrate values and remain competitive.” He generally believes that the potential of AI is not being exploited enough: “We are now too intimidated by data protection, because no one wants to be accused of not handling data properly. And that leads to a lot of things not being done that would make sense.”
In his private life, he uses facial recognition on his iPhone. However, Voss doesn’t want to put Amazon’s Alexa or similar Home Spots in his living room: “I’ll hold back a bit on that. I’d maybe take something from Telekom.”
Voss would have liked to discuss the planned regulation on AI (AI Act) in the Legal Affairs Committee as the lead committee. However, responsibility for this regulation was given to the Committees for Civil Liberties, Justice and Home Affairs (LIBE) and Internal Market (IMCO). “The AI Act answers the question of how we as a society want to deal with algorithms.” That has nothing specifically to do with either fundamental rights or the internal market, but is “something ethical, and that’s just up to the Legal Affairs Committee,” Voss said.
He has been a Member of the European Parliament since 2009. In 2017, he became coordinator of the EPP Group in the Legal Affairs Committee. In his parliamentary work, the focus is on digital issues. “It wasn’t planned that way at all,” he says. His curiosity was piqued in the course of the discussion on data protection law: “I wanted to approach things in a more practical way.”
For the General Data Protection Regulation, Voss was shadow rapporteur for the EPP Group. Later, he was the rapporteur for the Copyright Directive. And suddenly the name “Axel Voss” was a well-known name to young people. The discussion about upload filters in the context of Article 13 (later Article 17) caused protest on the net and in the streets at the beginning of 2019. “I didn’t foresee this wave of outrage at all,” Voss recalls. He had perceived copyright as a niche for experts. “I was surprised by the hatred that came, even though you’re actually just balancing fundamental rights against each other.”
As a lawyer, he knows his way around the law. He studied law in Trier, Freiburg, and Munich. He doesn’t see the fact that he has a legal background and not a technical one as a problem: “Of course, you have to look at the effects of what you’re doing differently in a digital world than in a non-digital world. You need an understanding of problems, but you don’t necessarily have to know what’s going on technically.”
Voss commutes between Bonn and Brussels. During the pandemic, he travels the distance by car, but otherwise, he also likes to take the train. Why he is convinced of the relevance of decisions about the digital realm? “Realities manifest themselves through technology. You get that over time.” Paula Faul/Eugenie Ankowitsch
Yesterday evening, the EU Commission was still planning to submit its proposal for a sixth sanctions package against Russia to the member states of the European Union. In all likelihood, it will be presented today by Commission President Ursula von der Leyen in the EU Parliament. As EU chief diplomat Josep Borrell announced, the proposal will include new punitive measures against actors who deliberately spread misinformation. Furthermore, in addition to action against oil imports from Russia, the exclusion of further banks from the international communication network Swift is also planned. We will of course keep you up to date.
Green hydrogen and its derivatives play an important role in the REPowerEU plan, with which the Commission aims to make Europe less dependent on Russian energy supplies. The German funding project H2Global is dedicated to the import of hydrogen, which is vital for the industry. Kirsten Westphal heads the analysis department of the H2Global Foundation. In an interview by Manuel Berkel, she talks about the first shiploads, highly complex supply chains and Ukraine as a partner.
It is a huge undertaking: Since yesterday, the EU Commission’s proposal for the European Health Data Space has been on the table. It is intended to give European citizens digital access to their medical data and allow them to decide on its use. In addition, the data is to be made available for research purposes. Eugenie Ankowitsch took a closer look at the plans and identified first pitfalls.
Manuel Berkel: The industry wants to invest billions in climate-friendly plants and switch its production to green hydrogen. When will the first green gas come to Europe via H2Global?
Kirsten Westphal: In the first funding window, we are not yet talking about pure hydrogen, but about derivatives – i.e. green ammonia, methanol, and fuel for aircraft. Our subsidiary HINT.CO is currently preparing the tenders for these three lots. We want to start the auction procedures in the summer and sign the contracts by the end of the year. The first shipments can then be expected between the end of 2024 and the beginning of 2025.
Green hydrogen and its derivatives also play an important role in the REPowerEU plan, with which the Commission wants to make Europe less dependent on Russian energy supplies. What is the significance of H2Global as a German funding instrument for the European plans?
Although the initiative was set up by the German government, H2Global does not see itself as a purely German instrument. The delivery point is defined as the region between the ports of Antwerp, Zeebrugge, Rotterdam, and Hamburg to Rostock and Duisburg as a major inland port. This northwestern European industrial region is predestined. The H2Global Foundation is also becoming more European when you look at who is involved with us. H2Global can become a pioneer for a European hydrogen accelerator as described by REPowerEU.
So what quantities of hydrogen derivatives will H2Global be able to procure? The Commission wants to quadruple the targets for green H2 by 2030 – to 20 million tons per year.
In the first funding window, we have €900 million available until 2033. This will be used to buy the derivatives, which will also cover the expected difference between the bid prices for delivery and for offtake. It is difficult to estimate at present what quantities we will be able to obtain for this. Globally, there have been virtually no price signals as to what green ammonia costs. H2Global can provide transparency on the prices of hydrogen derivatives, and for the industry, this will be an important added value. But the question is fair. H2Global will not be able to procure large quantities in the first round of funding. First, it’s an important pilot. The crucial point is to get going and find hydrogen projects that can be scaled up. And H2Global will be the first instrument across Europe to test the entire supply and value chain for green hydrogen.
What do you mean by that?
Up to now, people have been looking very closely at the production and customers of green hydrogen and believing that everything in between will work out somehow. Yet the supply chains are also highly complex: means of transport, transport routes, storage. The logistics of hydrogen imports have become even more urgent because of the war in Ukraine. We will need a larger number of different derivatives faster. H2Global creates a protective umbrella so that supply chains can be established and companies can position themselves accordingly. Bidders will have to make sure the logistics work. That will be factored into the bids, so the tenders will also provide transparency on transportation costs. Another big factor that is still missing is the regulatory framework. Only when the regulatory framework has been clarified can companies really add value to green hydrogen and its downstream products – keyword delegated act on RED II.
The amendment of the entire Renewable Energies Directive RED II and the gas package are also being negotiated in Brussels. Does all this have to be decided before you can certify your hydrogen derivatives as “green”?
In fact, there is still a lot to be done on the certification and creditability issues. The standards for our first funding window will be defined by the German Federal Ministry of Economics by the start of the auctions. The challenge will be to set the standards for H2Global high enough so that the products purchased are considered green throughout the contract period. This is already part of our lessons learned: Europe’s first climate-neutral hydrogen must still be able to be sold as green in ten years’ time. H2 pilot projects would need grandfathering in European regulation.
The switch from natural gas to hydrogen is seen as an opportunity to break dangerous dependencies. How can supplier diversification be ensured?
Building a hydrogen world will be a generational task. In order to stimulate the market, we will perhaps experience structures similar to those in the natural gas industry for a transitional period – large pipelines, at the end of which producers and customers scale. But in the long term, we don’t want to fall into similar traps again. That’s why H2Global was designed to be flexible from the start. The instrument allows new production windows to be adapted to political goals. People are now looking a lot to the Middle East, Australia, and Chile. There are front-runners there that have capital and are quite far along in the projects. Yet, in the second or third round of funding windows, we could, for example, expand Europe’s partnership with more African countries to diversify. I’m thinking very much of interconnectors to Egypt, from where you could create further infrastructure links into the continent. These could be underpinned with H2Global.
Will H2Global last that long or will it soon be merged into a European platform?
The coalition agreement already states that the German government wants to further develop H2Global on a European scale and provide it with appropriate funding. That’s also good, so that investors don’t have to keep adjusting to different national rules and the projects don’t compete with each other. H2Global can help the EU speak to the world with one face – something that has long been lacking in the natural gas world. Thinking further ahead, we can identify several regionally defined supply regions. Hydrogen could enter Europe via Trieste, Barcelona, Marseille, or other Mediterranean ports.
Before the war, Ukraine was also considered a promising partner for hydrogen partnerships. Does this vision still exist?
In view of the frightening images from Ukraine, it is unfortunately still far too early for such plans. However, stakeholders in the EU have rightly always considered Ukraine in the development of a European hydrogen economy, as in the European Hydrogen Backbone and the 2×40 gigawatt strategy. In the long term, it remains very sensible to include Ukraine in the EU’s hydrogen plans. In the case of electricity and gas networks, we are already seeing the importance of European operators working with their Ukrainian partners. When it comes to reconstruction, interconnectors will play an essential role in both electricity and hydrogen.
After a series of delays, the EU Commission yesterday presented a draft regulation for the European Health Data Space (EHDS). The regulation aims to improve healthcare in the EU, strengthen patients’ rights to their electronic health data, and promote scientific research.
“The European Health Data Space is a game-changer in the digital transformation of healthcare in the EU,” said Health Commissioner Stella Kyriakides when presenting the proposal in Strasbourg. The EU was taking a “truly historic step” on the road to digital healthcare. “Revolutionary,” agreed EU Commission Vice President Margaritis Schinas.
Contrary to many speculations that have been circulating since the postponement of the original April 5 release, there have been no fundamental changes to the EHDS infrastructure compared to the leaked version from March (Europe.Table reported). However, that does not mean there is no need for discussion. There are likely to be many obstacles to overcome before the regulation is finally adopted – the Commission is quite optimistically assuming one and a half to two years of negotiations.
“For patients, the EHDS means that they have direct digital control over their health data and can share it with doctors across the Union when needed,” said S&D MEP Tiemo Wölken. For research, too, better data means huge potential, especially in the research and development of new medicines and therapies for rare diseases, for which there is often insufficient data in individual member states. “In the coming weeks, it is now important to examine whether the Commission’s proposal meets these important objectives,” Wölken said.
The Commission proposes two separate health data infrastructures. On the one hand, people should be able to access their own treatment data digitally and decide on their use – including cross-border use – (primary use). On the other hand, health data should be made available for research purposes (secondary use).
Under primary use, the Commission grants everyone the right to “immediate access, free of charge, to their personal electronic health records in an easily readable and accessible form.” Patients can share their data, limit access or revoke it. With this entitlement, the EU Commission hopes to strengthen patients’ right to control their health data.
Member states will be required to make key data, such as patient records, electronic prescriptions, medical images, lab results, and discharge reports, available in a common European format. National stakeholders in many a member state are likely to breathe a sigh of relief on one point: personal health data that was not collected electronically prior to the application of the regulation does not have to be converted to an electronic format by decision of the national governments.
According to the draft regulation, each member state must create a national body that, among other things, provides the necessary eHealth services. In Germany, such an institution exists in the form of Gematik as the national agency for digital medicine. According to Gematik, it bears overall responsibility for the telematics infrastructure (TI), the central platform for digital applications in the German healthcare system.
To enable patients to exchange their health data across borders with healthcare providers in other member states, and to do so in their own language, the participation of member states in the digital infrastructure MyHealth@EU is to be mandatory. This is likely to cause quite a stir in the Council, as many member states have so far taken their time to connect to the platform, which has been in existence for more than ten years.
Currently, only ten EU countries use MyHealth@EU, and to an extremely limited extent. According to the Commission, most countries had previously planned to join this platform by 2025. Now this is to become binding. For countries like Germany, which is still struggling with the introduction of e-prescribing, this target is likely to be ambitious.
“For Germany, this means that we must now accelerate the digitization of our healthcare system,” said Achim Berg, president of the digital association Bitkom. “We must therefore push ahead with the expansion of electronic patient records, digital infrastructure for the use of health data or interoperability.” In this context it is important that the German Health Data Use Act planned in the coalition agreement be launched quickly and in line with European regulations.
With the draft regulation, however, the Commission also regulates the so-called secondary use of health data. For this purpose, each member state is to designate one or more bodies to provide access to health data. Only one, however, is to act as coordinator and national contact point and be responsible, among other things, for making electronic health data available for secondary use – also across borders. The national bodies will be integrated into the new decentralized EU infrastructure for secondary use HealthData@EU. This infrastructure will be tested from 2022 as part of an EU4Health project (Europe.Table reported).
The processing of the data must take place in a secure environment. To this end, the Commission defines a number of security requirements: for example, unauthorized persons should not have access to the secure processing environment. Unauthorized reading, copying, modification, or removal of electronic health data must also be prevented. All-access must be logged.
The data centers must also ensure transparency. For example, they should disclose information about requests for data access. In addition, data users must publish the results of their data use and inform health data access bodies of any important findings relevant to an individual’s health.
In Germany, the Research Data Center Health (FDZ Gesundheit) will act as a national contact point, although it is still being established. It is located at the Federal Institute for Drugs and Medical Devices (BfArM). The FDZ Gesundheit was initiated by the legislature in 2019 through the Digital Care Act. According to the BfArM, the legal, technical, and organizational measures are currently being defined and implemented. Applications for data use are expected to be possible from fall 2022.
In the present draft regulation, the Commission defines a number of data categories for secondary use. Accordingly, it includes data from electronic health records, public registries and clinical trials, genetic and genomic data, and also social data that have an impact on health. In addition, there is administrative data, including claims and reimbursement data.
The list of permissible uses includes, but is not limited to, public health research, assisting government agencies in carrying out their duties, educational purposes, scientific research, and training algorithms for medical applications. It is prohibited to use data to make decisions that are detrimental to individuals, to increase insurance premiums, to market health products to health professionals or patients, or develop harmful products or services.
One of the sticking points is likely to be data protection. Health data is considered particularly sensitive. There are likely to be many discussions about this, especially in the EU Parliament. Tiemo Wölken, a Social Democrat, also emphasizes the outstanding importance of data protection and data security: “Patients must be able to trust the digital exchange of data without restriction; highly sensitive personal health data must not fall into the wrong hands.” MEPs could also insist on particularly high standards in supervision.
The Commission knows that, too. Data protection and security standards should always be respected, Kyriakides stressed several times when presenting the draft regulation. Citizens should have control over their data and decide for themselves what information they share. Researchers would also need permission from national authorities to work with the data.
In order to realize the European Health Data Space, investments must be made in electronic health records, telemedicine, interoperability, but also data quality, institutions, and solutions for the secondary use of health data. At the same time, interoperable EU-wide infrastructures are needed to enable the cross-border use of health data in the EU.
The Commission has budgeted over €800 million for the development of the EHDS. The money is to come from several EU funding programs, including EU4Health, Digital Europe Programme, Connecting Europe Facility, and Horizon Europe. In addition, member states would have the option of receiving funds from the Recovery and Resilience Facility. €12 billion was earmarked for investment in health, including digital health and secondary use of health data, according to the Commission.
The European Regional Development Fund and the InvestEU program would provide complementary opportunities for additional investment in digital health based on national needs. The Commission also intends to support member states in developing and implementing strategies and action plans to improve the interoperability of health systems, if requested.
Apart from the technical challenges and high investment requirements, however, the success of the EHDS depends heavily on whether all stakeholders, from physicians in practices and clinics to hospital managers and politicians at all levels, can be persuaded to participate in the EHDS.
“Whoever leads in AI also leads the world. That is why we cannot afford to lag behind,” says Axel Voss (59), rapporteur in the Special Committee on Artificial Intelligence in the Digital Age (AIDA) in the EU Parliament.
The report of the AIDA Special Committee was adopted yesterday in the European Parliament with a large majority. The report focuses on the EU’s competitiveness in digital markets and how it can be promoted. For example, it identifies policy options that could unleash the potential of AI in the areas of health, environment, and climate change to fight pandemics and world hunger and improve people’s quality of life through personalized medicine.
AI, when combined with the necessary support infrastructure, education, and training, can boost capital and labor productivity, innovation, sustainable growth, and job creation, the report says.
In the plenary session of the EU Parliament, Voss was not completely satisfied with the finished report. This is because many of his original demands were weakened, in some cases considerably, in the compromise version that was adopted. “We have achieved a lot,” said Voss during the debate in the plenary. However, “We could have been bolder or even revolutionary.”
AI is the key technology of the future and of high strategic relevance. Europe must ask itself how it intends to keep up with other regions of the world “that are advancing research and development far more consistently and in a more targeted manner, that are training talent, that are putting a lot of money into it, and that can react more flexibly to new developments.” Voss issued an urgent warning against Europe becoming a “digital colony” of such regions whose values it does not share.
Voss describes Europe’s task in the field of AI as follows: “It’s a major challenge to integrate values and remain competitive.” He generally believes that the potential of AI is not being exploited enough: “We are now too intimidated by data protection, because no one wants to be accused of not handling data properly. And that leads to a lot of things not being done that would make sense.”
In his private life, he uses facial recognition on his iPhone. However, Voss doesn’t want to put Amazon’s Alexa or similar Home Spots in his living room: “I’ll hold back a bit on that. I’d maybe take something from Telekom.”
Voss would have liked to discuss the planned regulation on AI (AI Act) in the Legal Affairs Committee as the lead committee. However, responsibility for this regulation was given to the Committees for Civil Liberties, Justice and Home Affairs (LIBE) and Internal Market (IMCO). “The AI Act answers the question of how we as a society want to deal with algorithms.” That has nothing specifically to do with either fundamental rights or the internal market, but is “something ethical, and that’s just up to the Legal Affairs Committee,” Voss said.
He has been a Member of the European Parliament since 2009. In 2017, he became coordinator of the EPP Group in the Legal Affairs Committee. In his parliamentary work, the focus is on digital issues. “It wasn’t planned that way at all,” he says. His curiosity was piqued in the course of the discussion on data protection law: “I wanted to approach things in a more practical way.”
For the General Data Protection Regulation, Voss was shadow rapporteur for the EPP Group. Later, he was the rapporteur for the Copyright Directive. And suddenly the name “Axel Voss” was a well-known name to young people. The discussion about upload filters in the context of Article 13 (later Article 17) caused protest on the net and in the streets at the beginning of 2019. “I didn’t foresee this wave of outrage at all,” Voss recalls. He had perceived copyright as a niche for experts. “I was surprised by the hatred that came, even though you’re actually just balancing fundamental rights against each other.”
As a lawyer, he knows his way around the law. He studied law in Trier, Freiburg, and Munich. He doesn’t see the fact that he has a legal background and not a technical one as a problem: “Of course, you have to look at the effects of what you’re doing differently in a digital world than in a non-digital world. You need an understanding of problems, but you don’t necessarily have to know what’s going on technically.”
Voss commutes between Bonn and Brussels. During the pandemic, he travels the distance by car, but otherwise, he also likes to take the train. Why he is convinced of the relevance of decisions about the digital realm? “Realities manifest themselves through technology. You get that over time.” Paula Faul/Eugenie Ankowitsch
