Market Pathways’ Post

Germany's Pioneering DIGA Act Spurs Digital Health Innovation, With Limits While the RCTs required to meet DiGA’s standards are not as onerous as traditional pharmaceutical pivotal trials, they are still time-consuming, and the statue allows manufacturers to get an extendable one-year listing based on preliminary evidence, which enables them to generate revenue while they complete the more rigorous studies required for a permanent listing (see Figure 1 below). Germany’s high-profile DiGA legislation has successfully encouraged digital therapeutics innovation, according to two new studies, although critics say it still leaves room for improvement. The US company Enovis, which embraces digital therapeutics as a promising business, and its German start-up partner Orthopy Health GmbH are testing the DiGA waters in what Enovis considers to be an important ex-US market opportunity: https://bit.ly/4eWlwj6 #digitaltherapeutics #digitalhealth #medtechinnovation #digitalhealthinnovation #Germany #medtech

  • Germany's Pioneering DIGA Act Spurs Digital Health Innovation, With Limits



While the RCTs required to meet DiGA’s standards are not as onerous as traditional pharmaceutical pivotal trials, they are still time-consuming, and the statue allows manufacturers to get an extendable one-year listing based on preliminary evidence, which enables them to generate revenue while they complete the more rigorous studies required for a permanent listing (see Figure 1 below).



Germany’s high-profile DiGA legislation has successfully encouraged digital therapeutics innovation, according to two new studies, although critics say it still leaves room for improvement. 



The US company Enovis, which embraces digital therapeutics as a promising business, and its German start-up partner Orthopy Health GmbH are testing the DiGA waters in what Enovis considers to be an important ex-US market opportunity: https://bit.ly/4eWlwj6



#digitaltherapeutics #digitalhealth #medtechinnovation #digitalhealthinnova

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