On June 23, 2022, the German Federal Office for Information Security (“Office”) published technical guidelines on security requirements for healthcare apps, including mobile apps, web apps, and background systems. Although the technical guidelines are aimed at healthcare app developers, they contain useful guidance for developers of any app that processes or stores sensitive
Anna Oberschelp de Meneses
Anna Sophia Oberschelp de Meneses is an associate in the Data Privacy and Cybersecurity Practice Group. Anna is a qualified Portuguese lawyer, but is both a native Portuguese and German speaker. Anna advises companies on European data protection law and helps clients coordinate international data protection law projects. She has obtained a certificate for "corporate data protection officer" by the German Association for Data Protection and Data Security ("Gesellschaft für Datenschutz und Datensicherheit e.V."). She is also Certified Information Privacy Professional Europe (CIPPE/EU) by the International Association of Privacy Professionals (IAPP). Anna also advises companies in the field of EU consumer law and has been closely tracking the developments in this area. Her extensive language skills allow her to monitor developments and help clients tackle EU Data Privacy, Cybersecurity and Consumer Law issues in various EU and ROW jurisdictions.
European Commission Conducts Further Consultation on the European Health Data Space Initiative
On May 3, 2021, the European Commission (the “Commission”) opened a further public consultation (“Consultation”) on the European Health Data Space (“EHDS”).
This follows a consultation earlier in the year, on the Commission’s “Inception Impact Assessment” in relation to the EHDS. (For further information on the earlier consultation and an overview of the EHDS, please see our blog post available here).…
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European Commission Conducts Open Consultation on the European Health Data Space Initiative
On December 23, 2020, the European Commission (the “Commission”) published its inception impact assessment (“Inception Impact Assessment”) of policy options for establishing a European Health Data Space (“EHDS”). The Inception Impact Assessment is open for consultation until February 3, 2021, encouraging “citizens and stakeholders” to “provide views on the Commission’s understanding of the current situation, problem and possible solutions”.
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European Commission’s White Paper on Artificial Intelligence (Part 2 of 4)
The European Commission, as part of the launch of its digital strategy for the next five years, published on 19 February 2020 a White Paper On Artificial Intelligence – A European approach to excellence and trust (the “White Paper”). (See our previous blog here for a summary of all four of the main papers published by the Commission.) The White Paper recognizes the opportunities AI presents to Europe’s digital economy, and presents the Commission’s vision for a coordinated approach to promoting the uptake of AI in the EU and addressing the risks associated with certain uses of AI. The White Paper is open for public consultation until 19 May 2020.
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European Commission Presents Strategies for Data and AI (Part 1 of 4)
On 19 February 2020, the European Commission presented its long-awaited strategies for data and AI. These follow Commission President Ursula von der Leyen’s commitment upon taking office to put forward legislative proposals for a “coordinated European approach to the human and ethical implications of AI” within the new Commission’s first 100 days. Although the papers published this week do not set out a comprehensive EU legal framework for AI, they do give a clear indication of the Commission’s key priorities and anticipated next steps.
The Commission strategies are set out in four separate papers—two on AI, and one each on Europe’s digital future and the data economy. Read together, it is clear that the Commission seeks to position the EU as a digital leader, both in terms of trustworthy AI and the wider data economy.…
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Germany Publishes Draft Regulation on the Reimbursement of Digital Health Applications
Germany recently enacted a law that enables state health insurance schemes to reimburse costs related to the use of digital health applications (“health apps”), but the law requires the Federal Ministry of Health to first develop the reimbursement process for such apps. Accordingly, on January 15, 2020, the German government published a draft regulation setting…