The focus of this subproject is to respond to the changing environment of science and technology law and applied ethics, and to propose prudent planning, balance the interests of multiple parties, and forward-looking legal strategy recommendations.
This project constructs the whole picture of institutional infrastructure for AI medicine development, by connecting three dimensions, that is, research ethics, data governance, and clinical ethics. In light of the emerging new pattern for medical technology, a paradigm-shift for medical law should be anticipated.
1. Aspects of Research Ethics: recommend a revised version of Human Subjects Research Act in Taiwan
The theme of this subproject is how to implement the new research methods by the existing research ethics model framework. On the other hand, it simultaneously examines the reform of foreign models of research ethics systems and proposes institutional reforms that Taiwan should carry out.
2. Aspects of Data governance: establish an international data quality inspection mechanism
Under this subproject, we will explore the quality inspection mechanism required by foreign countries for the training materials of medical artificial intelligence to ensure that our team’s research confronts international standards from the most basic data set.
3. Aspects of Application model: build a legal system of community-based chronic disease care network
Under this subproject, the supervision sandbox will be investigated as an experimental model for innovative experiments. The reversal of the medical care system is also the focus, including how to break through the regulatory barriers faced by the community medical network, and the reallocation and re-specialization of the medical care workforce, which are all necessary supporting links.
4. Discussion on the strategy of international legal system integration
From the above three aspects, there are corresponding institutional trends internationally. Taiwan's legal system is based on the necessity of international harmony. Based on the previous research on the legal system of International AI competition, this subproject will continue to pay attention to the legal development in this field for reference to Taiwan's policy and industry.
Research Ethics, Data Governance, eHealth and Medical Devices, Regulatory Sandbox, Community Medical Network