數字醫學協會

2023年8月14日,

2023年8月14日出版的讚助內容到秋天來了,所以對數字的健康管理產品。今年春天,CDC正式結束美國流行“突發公共衛生事件,”這意味著公司接受緊急異常對其產品將不得不刪除它們從市場如果他們不讓他們fda在11月初。這不是抽象的威脅:今年夏天早些時候,FDA發出了嚴厲的警告給iRhythm誇大的範圍使用一個可穿戴的心髒監測器。行動導致iRhythm股價暴跌,表明即使是市場領導者像他們會有麻煩如果他們不勤於呆在合規。一般來說,最近的數字醫療爆炸——從smart-trackers決策支持係統,在很大程度上已經超過了監管框架需要確保這些工具是安全,有效,並適當地使用。公司的空間,一個強大的監管策略是至關重要的,以確保電子健康產品滿足必要的監管要求,為市場準入盡快清除,並優化定位報銷。當前的挑戰是監管環境難以駕馭的飛速發展管理科學和需求程度。創新者很難知道如何與監管機構、哪些,當。這是一個新的教育課程從數字醫學協會(硬幣)。數字健康產品開發人員”“成功解鎖監管產品旨在幫助開發人員構建定製的監管策略,加強他們的組織的業務策略,區分和建立信任他們的產品。 The six-lesson course from DiMe helps learners identify the regulatory requirements applicable to their particular work, as well as build regulatory strategies for their product portfolios. After completion of the course, learners will be able to identify whether their digital health products are likely to be regulated and through which mechanisms. They will be equipped with the skills to build and implement a regulatory strategy, and positioned to advance the success of their digital health product portfolios. And they will be empowered to build high-quality evidence-based products without having to pay for expensive consulting services. “For anyone developing new digital-health products, optimizing your regulatory strategy will save you valuable time, energy, resources, money, and frustration,” said DiMe CEO Jennifer Goldsack. “It is due time that all of us in the field have clear knowledge of the regulatory requirements and pathways that apply to us and the safety of our products and services.” The strategy course includes modules on the “why”, “what” and “how” of digital health regulation, outlining the components of a fit-for-purpose regulatory strategy and ways to optimize it for success over time. This includes: Identifying target markets