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In May 2022, the European Commission published a proposal to establish a European Health Data Space (“EHDS”). The Commission’s EHDS proposal aims to improve access by individuals to their health data (primary use) and facilitate the re-use of health data for societal good across the European Union (secondary use). The European Commission’s aim is to adopt the EHDS by the end of its current mandate (October 31, 2024). The European Commission expressed its hope that the provisions of the regulation will enter into force across all EU member states in 2025. Businesses operating in the health and pharma sectors should therefore carefully consider how the EHDS might affect them.…

Continue Reading Health Data: European Commission Proposes new Rules on Access and Use

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On 28 September 2022, the European Commission adopted proposals for two directives adapting non-contractual civil liability rules to artificial intelligence (“AI”). The proposed AI Liability Directive aims at targeted harmonization measures on civil liability for AI among the EU member states. The revised Product Liability Directive proposes adaptations to the producer’s no-fault (strict) liability for defective products that have caused damage to health or property or loss or corruption of data.

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Continue Reading EU Commission Proposes New Liability Rules on Products and AI

On 21 April 2021, the European Commission proposed a new, transformative legal framework to govern the use of artificial intelligence (AI) in the European Union. The proposal adopts a risk-based approach whereby the uses of artificial intelligence are categorised and restricted according to whether they pose an unacceptable, high, or low risk to human safety and fundamental rights. The policy is widely considered to be one of the first of its kind in the world which would, if passed, have profound and far-reaching consequences for organisations that develop or use technologies incorporating artificial intelligence.
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Continue Reading The European Union Proposes New Legal Framework for Artificial Intelligence

On 23 January 2019, the European Commission (the “EU Commission”) authorized the free flow of personal data to Japan. This “adequacy decision,” issued jointly with a mirroring decision by the Japanese government, allows personal data to transfer between the European Union (the “EU”) and Japan freely and under strong guarantees of protection. The outcome of lengthy negotiations resulting in Japan strengthening its privacy rules to follow EU standards, …
Continue Reading Free Flow of Personal Data Between the European Union and Japan Starts Now

A political agreement was reached between the European Parliament, the Council of the European Union (EU) and the European Commission on the EU Cybersecurity Act (Act) and announced on December 10, 2018. The pace of the adoption of the Act (with less than three months of discussions among the EU institutions) confirms that cybersecurity is high on the EU political agenda.
Continue Reading The EU Cybersecurity Act is (Almost) There

On 18 November 2016, the European Commission published a notice on the application of certain key provisions within Regulation (EC) No. 141/2000 on orphan medicinal products (the “Orphan Regulation”). Orphan medicinal products are medicinal products that are used for the diagnosis, prevention or treatment of rare diseases. An orphan designation allows a pharmaceutical company to benefit from EU incentives to develop a medicinal product, such as fee waivers for the regulatory procedures or a ten year market exclusivity.
Continue Reading European Commission Publishes Revised Guidelines on Criteria for Orphan Designations of Medicinal Products

On 15 December 2015, the European Council and representatives of the European Parliament reached a consensus on the European Commission’s proposed Directive on “the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure.” The Commission’s original proposal …
Continue Reading The New European Directive on the Protection of Trade Secrets

On 9 December 2015, the European Commission has proposed new rules concerning content portability across the so-called Digital Single Market. Under the first set of proposals, which will need to be discussed with and endorsed by the European Parliament and the Council of the European Union, Europeans will be able to access online services they…
Continue Reading The Digital Single Market – Commission Announces Plans to Ensure Wider Access to Online Content Across Europe

In its judgment of 6 October 2015 (C-362/14), the Court of Justice of the European Union (“CJEU”) held that transfers of personal data of European citizens to the United States made under the so-called Safe Harbor scheme are subject to significant risks, and declared the corresponding decision of the European Commission to be invalid. As a consequence, EU entities of U.S. companies so far relying on Safe Harbor will need to revise their practice of submitting personal data to the U.S. to comply with EU data protection law.
Continue Reading Redefining Data Protection? Court of Justice of the European Union Strikes Down the Commissions “Safe Harbor” Decision

On 26 March 2015, the EU Commissioner in charge of competition policy, Margrethe Vestager, announced plans to inquiry into the e-commerce sector. The possibility of conducting sector inquiries is provided for in Art. 12 of Council Regulation 17/62 which allows the commission to conduct a general investigation into an economic sector “[i]f  in any sector of the economy the trend of trade between Member States, price movements, inflexibility of prices or other circumstances suggest that in the economic sector concerned competition is being restricted or distorted within the common market”.
Continue Reading Commission Announces E-Commerce Sector Inquiry