Why Measuring The Value Of AI In Medtech Is Complex, And Where Solutions Lie
The increased development of AI-enabled medtech means HTA bodies have a complex task on their hands. One set of researchers show how a multipronged approach is needed to assess the value of AI in medical imaging.
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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?
MHRA Says UK Approach To AI Regulation ‘Legislatively Light’, Unlike EU Proposals
The UK’s medtech regulator is “going big on guidance” when it comes to artificial intelligence and software as a medical device, an expert from the agency has said, while legislation will be light in comparison to the EU’s planned AI Act.
Europe’s ‘Regulatory Lasagna’: Commission Facing Yet More AI Act Criticism
Is regulating artificial intelligence a good idea? A lawyer questions whether the European Commission’s proposed AI Act is appropriate for medtech, where a growing “regulatory lasagna” could compound notified body capacity issues and SME workload.