Statement on regulatory pain points for startups in healthcare
Ahead of a high-level meeting where we bring together startups and Members of the European Parliament, we are preparing a short statement on the regulatory issues that European digital health startups face and how to move forward. Our goal is to widely share this statement to raise awareness among key EU policymakers and broader healthcare stakeholders.

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What are the most common regulatory problems that startups in digital healthcare face (e.g. regulatory complexity, over-regulation, funding, partnership, talent/talent drain)? Which regulations in particular affect your startup?
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What policy changes would help overcome regulatory hurdles (e.g. a guideline/digest demonstrating the regulatory steps necessary for digital health products, regulatory sandboxes, more regulatory harmonisation/unified requirements at the EU level)? Why?
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What are the opportunities of the digital health ecosystem in Europe?
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What should be the European Union’s policy priorities in healthcare in the next 5 years?
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