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Policy

DTX Innovation Policy Uncategorized September 28, 2023 Exploring the Path to Medical Device Regulation Compliance

A medical device, such as a thermometer or pacemaker, is a tool designed for healthcare purposes, including diagnosis, treatment, monitoring, and prevention of medical conditions. As technology continues to advance at an unprecedented pace, medical devices have become synonymous with cutting-edge healthcare solutions, offering the potential of significantly improved patient outcomes.  The Medical Device Regulation …

Artificial Intelligence Innovation Policy Uncategorized September 18, 2023 Navigating the landscape of the EU’s voluntary AI initiatives

Now that the AI Act, originally proposed in April 2021, is on its way to be adopted by the end of 2023, one may think that the topic of artificial intelligence will incrementally cease to make the headlines in the EU. On the contrary, in the months to come after the adoption of the AI …

Innovation Policy September 7, 2023 How can the Product Liability Directive best support the startup ecosystem?

Context Since the European Commission proposed a revision of the Product Liability Directive (PLD) on 28 September 2022, both the Council of the EU and the European Parliament started their respective work on the file. Now that the Council has reached a general approach on 14 June 2023, all eyes are on the Members of …

DTX Policy September 4, 2023 The European Health Data Space: Where Are We At

Just over one year ago, the European Commission proposed the first EU-wide framework for data sharing: the European Health Data Space (EHDS). With stark ambitions to unleash the potential of health data for stakeholders across the care continuum, the EHDS promises to lay the ground-rules for harmonisation and accessing cross-border health data. European co-legislators have …

Innovation Policy July 12, 2023 Open source software: Empowering startups in the global market

Open source software (OSS) has become a critical tool for startups seeking to thrive in today’s competitive landscape. Its affordability, flexibility, and ability to facilitate global scalability have positioned it as an invaluable asset for emerging businesses. Interestingly, the European Union recognises the significance of open source software and its role in fostering innovation. In …

Data Policy July 6, 2023 Assessing The Data Act: How Startup-Friendly Is It?

On the 27th of June, after three months of trilogue negotiations, EU policymakers came to an agreement on the Data Act, which mandates requirements to facilitate the sharing of non-personal data. Before the beginning of the trilogues, Allied for Startups and its Members approached policymakers with an open letter in which we suggested three key …

Latest News Policy June 2, 2023 Where are we in the encryption debate?

Startups benefit from using encryption in their everyday operations, as it allows them to store and send information across the Internet securely at a relatively low cost. Many startups use encryption to provide secure communication channels for their employees and customers, which in turn helps to build trust and credibility around their businesses and, ultimately, …

Data Latest News Policy May 25, 2023 ‘Back to Basics for Startups’ – International Data Transfers

Any entrepreneur is just an idea and the right data set away from a startup. As global actors, startups benefit from transferring data across borders to expand their customer base and scale their businesses. The General Data Protection Regulation (GDPR), the Data Governance Act (DGA) and the Data Act are three key policies that contain …

Latest News Policy May 17, 2023 ‘Back to Basics for Startups’ – The revision of the EU Product Liability Directive

What’s proposed? The European Commission proposed on 28 September 2022 a revision of the Product Liability Directive (PLD), originally adopted in 1985. The main goal of the proposed revision is to modernise the existing Directive to reflect technological advances, changes in consumer behaviour, and evolving business practices. In this regard, the latest revision of the …

Artificial Intelligence Latest News Policy May 3, 2023 ‘Back to Basics for Startups’ – AI Regulation in the EU

What’s proposed? The European Commission has proposed a new Artificial Intelligence Act (AI Act) to regulate the development and use of AI systems in the European Union. The proposed legislation outlines a risk-based approach to AI, with four levels of risk categorisation: unacceptable risk AI, high-risk AI, limited risk AI, and minimal risk AI. If …