你有下載過App商店內的醫療相關App嗎? 一項最新的研究回顧發現，在Google Play和Apple App Store裡，被歸類為「醫療器材軟體（Software medical device likely, SaMD-like）」的App，竟然有高達 95%都「不合規」！ 沒有公開聲明擁有歐盟CE標誌或美國FDA的許可證明。 難道App商店是SaMD的「野蠻西部(Wild West)」!! 這不僅對「公共健康有很大的風險」，也讓人擔憂App商店是否正淪為一個「廉價的行銷平台」，讓不合規的醫療器材軟體得以輕易推向市場。 內容參考: Rudolf Wagner. Analysis of Software as a Medical Device (SaMD) Compliance in App Store Applications: A Critical Review of Regulatory Oversight and App Store Accountability DOI: 10.70317/2025.08rw01 *「Wild West」野蠻西部: 這個名詞片語指的是 19 世紀美國西部拓荒時期，那時候治安鬆散、規範不足、充滿機會但也混亂危險。 留言告訴我你對這一集的想法： https://open.firstory.me/user/ckssiau1vq5ic082295g8on9d/comments ✎ 留言: podcast.biomeder.com/contact-us 📧 Email: [email protected] 《生醫人生旅歷》podcast.biomeder.com 《BioMeder生醫人網摘》biomeder.com Powered by Firstory Hosting
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