美國食品藥物管理局更新新型醫療與數位裝置的安全規範
FDA updates safety rules for new medical and digital devices
美國食品藥物管理局（FDA）宣布其數位健康監管策略發生重大轉變。
The U.S.
為了促進創新，該機構正在簡化低風險數位健康工具的規範。
Food and Drug Administration (FDA) has announced a significant shift in its regulatory strategy for digital health.
這種「親創新（ㄑㄧㄣ ㄔㄨㄤˋ ㄒㄧㄣ）」的轉向，旨在減少消費者科技開發者的行政繁文縟節（ㄈㄢˊ ㄨㄣˊ ㄖㄨˋ ㄐㄧㄝˊ）。
As of early 2026, software providing clinical decision support and general wellness wearables face fewer hurdles, provided they avoid medical-grade diagnostic claims.
然而，FDA 同時對網路安全採取了更嚴格的「安全第一」方針。
This "pro-innovation" pivot aims to cut red tape for developers of consumer technology.
根據新規定，任何軟體驅動型醫療器材的製造商，現在必須提供詳細的軟體物料清單（SBOM），並在產品生命週期內證明其網路安全性。
However, the FDA is simultaneously taking a stricter "safety-first" approach regarding cybersecurity.
這些規則將漏洞視為對病患安全的重大威脅。
Under new mandates, manufacturers of any software-enabled medical device must now provide a detailed Software Bill of Materials (SBOM) and prove cybersecurity throughout the product lifecycle.
