New EU assessment framework for digital health on the horizon?

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New EU assessment framework for digital health on the horizon?

Photo: peshkov/Getty Images A harmonised European Health Technology Assessment Regulation (HTAR) is set to come into force in 2025, but the mandatory application of the regulation does not cover digital health technologies. The EDiHTA Project aims to address that. Health technology assessment (HTA) is a formidable task across drug development, medical device innovation, and digital health solutions. To help with this task, the European HTA Regulation entered into force in January 2022 and will apply in January 2025. For some medical device and pharmaceutical industry players, this is a heavily anticipated change, since at the moment, they need to adapt their health technology assessment documentation to different country-specific regulatory bodies. Article 23 of HTAR does foresee voluntary cooperation of HTA agencies in many member states. Until now, there has been a lack of shared and harmonised methodological guidance for digital health technologies. By 2028, the European Digital Health …

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