Commission calls for risk assessment across critical technologies As part of the broader European Economic Security Strategy, the European Commission has adopted a recommendation advocating for collective risk assessments in four critical technology areas. These include advanced semiconductors, artificial intelligence, quantum computing and biotechnologies. Based on their potential to transform the future of technology; risk of civil-military fusion; and risk of misuse in violation of human rights, these areas were found to face particularly strong risks in relation to technology security and technology...

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The U.S. Food and Drug Administration (FDA) is making efforts to modernize both the 510(k) approval process for medical devices and study designs for drugs and biologics. On September 7, 2023, the FDA Center for Devices and Radiological Health (CDRH) issued three draft device guidances: 1) Best Practices for Selecting a Predicate Device to Support a Premarket Notification Submission; 2) Recommendations for the Use of Clinical Data in Premarket Notification Submissions; and 3) Evidentiary Expectations for 510(k) Implant Devices. On...

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After releasing a model treaty provision in July, the OECD has published a multilateral convention to facilitate the implementation of the Pillar Two Subject to Tax Rule (Convention) on 3 October 2023. Similar to the Multilateral Instrument (MLI) that enabled faster implementation of several BEPS measures, the Convention aims at accelerating the implementation of the Subject to Tax Rule (STTR), which is part of the OECD's Pillar Two measures. Similar to the MLI, the STTR only impacts an existing bilateral...

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In February 2023, Portugal proposed a “Mais Habitação” or “More Housing” bill that would, in part, suspend the entire Golden Visa immigrant investor program in an effort to address housing availability in the country, as discussed in an earlier blog post. Since that writing, there have been significant updates. Legislative Progress In July 2023, Portugal’s Assembly of the Republic approved a version of the bill that ended the Golden Visa program’s real estate-based investment options. This marked a substantial restructuring, mitigating the possibility...

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As ESG continues to evolve as a global area of focus, companies in the private sector are not necessarily exempt from ESG reporting requirements.  Here’s a checklist to gauge if having a conversation sooner vs. later makes sense from a strategic planning perspective. Do any of these apply to your enterprise? The company is doing business with publicly traded companies. The company sells to non-US entities in Europe and is subject to EU sustainability reporting requirements starting in 2024. The...

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The EU State aid rules continue to cause significant uncertainty for taxpayers as to the correct application of tax rulings and transfer pricing rules within the European Union. These judgements are one of many steps in providing further clarity and guidance on the application of the State aid rules.Companies should continue to track state aid developments and assess the potential impact of recent judgements. State Aid remains a dynamic area and we expect to see more interesting judgements delivered. EU...

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