The device industry has yet to weigh in on the potential impacts of the Medicare reforms raised by the Republican presidential campaign. In the meantime, “The Gray Sheet” spoke to former Medicare administrators Gail Wilensky and Donald Berwick, who have differing takes about some broader implications.
The topic of Medicare reform has picked up steam as a core issue of the presidential campaign, particularly since Mitt Romney selected Rep. Paul Ryan, D-Wis., as his running mate.
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A New South Korean law, the Digital Medical Products Act, enhances regulation for digital health products. Medical devices in the country are categorized both by risk and by similarity to already authorized devices. The approval process may stretch to 515 days for new manufacturers.
Its move comes as the Swiss recognize the need to ensure adequate supplies on medical devices in its country.
Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.
