Artificial Intelligence (AI) has become a key technology in the digitalisation of health – from transforming the delivery of care to expanding precision medicine. Startups have been at the forefront of the development and deployment of AI in health, pioneering life-changing innovations in the global market. While there have been discussions about improving conditions for AI startups in health, the reality is that in recent years numerous legislations have added to a more complicated regulatory framework. Although regulation and certification standards are key, the regulatory complexity has become a barrier for digital health and AI innovators, curbing the potential of the European AI and digital health market. 

The HealthTech Charter aims to spotlight policies and measures across Europe that empower innovators in digital health to scale. The fourth best practice zooms into Artificial Intelligence in health, taking the Croatian case as an example of what works – and what we need more of across the Block. As one of Croatia’s Digital Innovation Hub candidates, the AI4Health.Cro public-private consortium provides a platform for AI startups in health to test, learn, collaborate and fund their innovations, paving the way for MDR compliant, trustworthy AI technologies to come to the market. AI4Health.Cro aims to foster the growth and success of digital companies by providing the necessary space for experimentation, testing, funding, and technical expertise. It empowers digital health entrepreneurs with a sandbox to ‘test before investing,’ and stimulate the European uptake of artificial intelligence, among other areas, in health. 

Initiatives such as AI4Health.Cro provide startups with a sandbox and to navigate AI legislation and test their innovations. According to Nina Sesto, CEO of Megi, creating these forms of sandboxes are “…fundamental in bringing clinicians and innovators together, enabling lean development, evaluating clinical relevance and safety and implementing compliance with MDR expectations of new technologies early in their development. We strongly believe such hubs will enable the European Union to pave the way towards trustworthy digital healthcare and long term sustainability of healthcare worldwide.” 

The AI4Health.Cro serves as an example of what works – a blueprint for European Member States in creating sandboxes for AI and health. Let’s push the conversation forward as we continue building Europe into a leading hub for digital health innovation. 

Interested in having a conversation or collaborating in the HealthTechCharter project? Don’t hesitate to reach out to us here!