Germany’s Digital Health Fast-Track Scheme: What Manufacturers Need To Know

Understanding the German reimbursement system is crucial for any medtech firm eyeing the European market, and healthtech innovators in particular may benefit from its fast-track digital health app scheme. But how does the scheme work, and who can apply?

Germany Digital — • Source: Shutterstock

The value of digital healthtech is being increasingly recognized by payers and health technology assessment (HTA) bodies in Europe. A multinational EU working group is currently developing recommendations on how best to assess digital medical devices, while the UK’s regulator recently received a funding boost for use in creating a regulatory framework for mental health apps.

Germany has been ahead of the trend for some time, which is not surprising given it has the largest medtech...

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