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BioWorld - Thursday, July 16, 2026
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Home » EU legislation and coverage issues prompting industry to ask whether AI is worth the trouble
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EU legislation and coverage issues prompting industry to ask whether AI is worth the trouble

May 18, 2023
By Mark McCarty
The EU’s Artificial Intelligence (AI) Act is still in the thick of the legislative process, which seems likely to ladle even more regulatory liabilities onto AI software used for medical purposes. Bodo Wiegand, senior advisory at Viopsy, told attendees at a May 18 webinar that between the promise of yet more regulation along with existing coverage and reimbursement hurdles in the EU, developers of medical software are considering whether they should steer clear of developments that qualify as AI simply because of the extraordinary time and expense associated with generating revenues for these projects.
Medical technology Regulatory Europe

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