All articles by Eugenie Ankowitsch

IPCEI Health: Germany opts out for now
16 EU countries want to participate in the new IPCEI in the healthcare sector. In doing so, they want to strengthen Europe's sovereignty in this area and promote their own economic position. Germany is not participating for now, while France does not want to lose any time. continue reading →
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by Eugenie Ankowitsch
EU Health Data Space: Megaproject gets underway
The EU Commission's draft regulation seeks to balance data protection and innovation. The project is to be in place by 2025. At the same time, it is seen as a kind of test run for other sectoral data spaces. continue reading →
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by Eugenie Ankowitsch
EU Health Data Space: Commission proposal on the table
It is the first sector-specific data space in the Union: the European Health Data Space. In early April, the EU Commission planned to present its proposed regulation for the European Health Data Space (EHDS). The draft, which the French news portal Contexte has already made public, contains rules, common standards and practices, and a governance […] continue reading →
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by Eugenie Ankowitsch
AI: ITRE rapporteur wants to weaken requirements
The AI law must strike a balance between freedom and control. This is emphasized by the responsible rapporteur in the Industry Committee (ITRE) Eva Maydell (EPP) in the draft of her opinion on the AI law available to Europe.Table. Therefore, further provisions would have to find their way into the regulation, which would enable not […] continue reading →
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by Eugenie Ankowitsch
Russia sanctions also affect healthcare industry
The export of medical or pharmaceutical goods is largely exempt from EU sanctions. Nevertheless, manufacturers are directly or indirectly affected. The consequences of the conflict could also be far-reaching for clinical trials. continue reading →
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by Eugenie Ankowitsch
Health data: legal interpretation and data governance biggest problems
Different legal interpretations and data management practices in Europe cause most of the problems in health data exchange. This is the conclusion reached by the Towards the European Health Data Space (TEHDAS) project in its latest report. Contrary to popular belief, technical problems were among the least cited challenges to data exchange. In total, the […] continue reading →
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by Eugenie Ankowitsch
Sanctions in Russia: ‘Nothing has happened yet!’
A battle over interpretive sovereignty has broken out in the Russian media not only over the war but also over the sanctions imposed by the West. While the pro-government press is trying to appease citizens and thus keep them away from the ATMs, independent media paint a gloomy picture. continue reading →
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by Eugenie Ankowitsch
Council: further requirements for high-risk AI systems
The French Council Presidency wants to extend the conformity assessment requirements for high-risk AI systems. This emerges from a compromise proposal on Articles 40 to 52 of the AI Regulation published by Contexte. It contains a list of criteria that are to be binding for the standards institutes as specifications for their assessment processes. Only […] continue reading →
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by Eugenie Ankowitsch
EU Health Data Space: consortium tinkering with test version
The EU Commission's draft regulation for the European Health Data Space (EHDS) is eagerly awaited. It will be the first of its kind within the framework of the European data strategy. A consortium is to start work on a kind of beta version of the EHDS this year. continue reading →
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by Eugenie Ankowitsch
EU Parliament votes on own-initiative report on cancer prevention
Fair access to cancer screening, diagnosis, and treatment, the promotion of cross-border research, stricter measures against tobacco, new regulations on e-cigarettes, and warning labels on alcoholic beverages: These are the key demands in the report of the Special Committee on Beating Cancer (BECA), which the EU Parliament discussed and voted on yesterday. The chances of surviving cancer in […] continue reading →
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by Eugenie Ankowitsch
AI regulation: study calls for coherence
Regulation in the digital sector in Europe lacks coherence. This is shown by a study commissioned by the AI Special Committee (AIDA). In the search for a balance between protecting fundamental rights on the one hand and promoting innovation on the other, coherence and simplicity have been partially disregarded, the authors said when presenting the […] continue reading →
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by Eugenie Ankowitsch
Health data: ethics before profit
The European Health Data Space (EHDS) is to be created by 2025. The French EU Council Presidency has presented guiding principles in advance as an ethical framework for digitization in healthcare. In February 2020, the EU Commission adopted the European Data Strategy. The health data space envisaged as part of this strategy is intended to […] continue reading →
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by Eugenie Ankowitsch
Health data: ethics framework initiative launched
The French Council Presidency wants to develop an ethical framework as the basis for the planned European Health Data Space. The initiative was launched at the “Citizenship, Ethics and Health Data” conference. The goals pursued with the creation of the European Health Data Space (EHDS) cannot be achieved without the trust of citizens, stressed French […] continue reading →
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by Eugenie Ankowitsch
Product liability and AI: Commission working on new rules
The Product Liability Directive has been in force since 1985. Since then, the product landscape has changed significantly, especially due to digitalization. It is questionable whether the directive still offers sufficient legal certainty and consumer protection in the age of intelligent and AI-based products and services. The Commission wants to tighten things up. continue reading →
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by Eugenie Ankowitsch
Health data: Finland as a blueprint?
By 2025, the European Health Data Space (EHDS) is to promote new digital health services and enable GDPR-compliant access to health data. The EU Commission intends to present a regulation proposal in April. Given the very different starting points and degrees of digitization among individual member states, the magnitude of the task quickly becomes clear. continue reading →
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by Eugenie Ankowitsch
Liese: no supply contracts for COVID drug Paxlovid
It is expected that on Thursday, the European Medicines Agency (EMA) will decide whether to approve Pfizer’s COVID drug Paxlovid. This was said by Peter Liese, a member of the EU Parliament, in an interview with journalists. He expects that after a positive EMA vote, the EU Commission will formally approve the drug on the […] continue reading →
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by Eugenie Ankowitsch
COVID: Most EU countries back partial vaccine mandate
Austria was the first EU country to adopt a general COVID-19 vaccination requirement. In other countries, however, a partial vaccine mandate for certain occupational and/or age groups is much more likely. In Germany, the discussion about a general vaccine requirement recently picked up steam again. However, the outcome is uncertain. continue reading →
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by Eugenie Ankowitsch
E-prescription: Germany remains EU laggard
For electronic prescriptions to become a reality, industry, physicians, pharmacists, health insurers, and insured persons must all pull together. Whether they are willing to do so, however, is questionable. Many EU countries have already made much more progress with electronic prescriptions. continue reading →
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by Eugenie Ankowitsch