數位健康時代下健康軟體之上市管制策略初探

Towards a Regulatory Framework for Health Software in the Digital Health Age

本研究探討數位健康時代下健康軟體的上市管制策略。在資通　訊以及人工智慧等新興等技術快速發展的背景下，隨著數位健康生　態圈的成形與演進，健康軟體在醫療體系中扮演日益重要的角色，　但同時也帶來了管制上的挑戰。研究從健康軟體的去中心化（decentralization）、整合（integration）及精準化（precision）特徵出發，分析了現行醫療器材管理框架在應對健康軟體時的不足，特別是在處理醫療器材和一般消費品邊界產品時的困難。文章詳細探討了健康軟體的潛在風險，包括單獨使用的風險、產品型態挪移帶來的風險，以及多元健康資料整合與應用可能引發的風險等三個面向。
通過比較美國、歐盟和臺灣的管制策略，本研究提出了「可信賴的協作治理機制」作為解決方案。這一機制強調公私協作，在政府主動引導下鼓勵業者自主管理，並透過動態調整確保管制效能。研究建議建立適應性管理框架，採取差異化的管理策略。
本研究強調，在健康軟體發展初期，應採取公私協力的方式建立以信賴為核心的管理框架。這種框架不僅要確保公眾健康安全，還要為創新留下空間。研究提出了具體建議，包括明確低風險健康軟體的定義、採用自願性標準、強化資訊透明度，以及建立持續監測機制。這些策略旨在建立一個能夠因應科技快速發展、平衡安全、效能與創新的健康軟體管理體系，期望為數位健康時代的發展提供有力支持。

This study investigates regulatory strategies for health software in the digital health era, focusing on market entry control mechanisms. With the rapid advancement of AI and emerging technologies, health software has become an integral component of modern healthcare systems, presenting unprecedented regulatory challenges. The research examines how the distinctive characteristics of health software – decentralization, integration, and precision (DIP) – challenge current medical device regulatory frameworks. The research identifies the limitations of existing medical device regulatory frameworks in addressing the unique characteristics of health software, particularly highlighting the regulatory ambiguities surrounding products that blur the line between medical devices and general consumer goods.
Through detailed analysis, this study identifies three major concerns: risks from standalone use, risks of “skating the line”, and risks associated with the integration and utilization of diverse health data. These findings serve as a foundation for developing a more responsive regulatory framework.
Through a comparative analysis of regulatory strategies employed in the United States, European Union, and Taiwan, the research proposes a novel “Trustworthy Collaborative Governance Mechanism” as a potential solution to the identified regulatory challenges. This mechanism emphasizes dynamic public-private collaboration, featuring proactive government guidance while maintaining flexibility for industry self-regulation.
To implement an adaptive regulatory framework, this research recommends a balanced approach that promotes public-private collaboration while providing space for innovation in health software development while ensuring public safety. Specific regulatory recommendations are presented, including establishing clear definitions for low-risk health software, promoting the adoption of voluntary industry standards, enhancing information transparency requirements, and implementing robust, continuous monitoring mechanisms.
This research contributes to the development of a comprehensive regulatory strategy for health software. The proposed approach aims to create a regulatory system that can balance safety, efficacy and innovation, thereby providing a solid foundation for the governance of health software in the evolving digital health landscape.