| 摘要: | 若將資料類比為數位經濟時代的石油，那麼對於生技醫藥產業而言，健康資料便是這極具開發價值的石油；健康資料的研究利用不僅是生技醫藥產業研發新藥、新技術，以及促進醫學知識進步的基石，其最終的研究結果也能提升全民的健康福祉。
然而，按我國現行法制，生技醫藥業者僅能透過研究計畫，經資料主體同意後收案，才能利用資料主體的健康資料；惟實務上難免遇到客觀上難以取得資料主體同意的情況，進而，目的外研究利用資料的需求與重要性便油然而生。另外，觀諸各國與健康資料利用相關的法制，不見如我國禁止生技醫藥業者目的外研究利用資料，卻允許公共機關或學術研究機構申請目的外利用做研究的罕見規定。
顯然，針對健康資料的治理，我國現行法制尚有不周全以及與實務脫節之處；因此為回應我國現行法制的問題，本文先從在我國制度下，商業研究利用健康資料之困境談起。進一步，整理美國、歐盟與英國與健康資料利用相關的法制，從中汲取值得我國參考之內容。並且說明生技醫藥業者研究利用健康資料的重要性。最後，以衛生福利資料管理條例草案為中心，提出我國在制定健康資料商業研究利用的法制時，應考慮的面向。
展望未來，在大數據浪潮席捲而來之時，期待我國的態度並非退縮，而是乘浪而上；透過更完善的健康資料法制，能夠提升民眾的數位信任以及為生技醫藥業者創造友善的科學研究環境，提升全民的健康福祉。
Comparing data to the oil of the digital economy era, then health data in the biomedical industry is valuable oil. The research use of health data is not only the cornerstone for the biomedical industry in developing new drugs, new technologies, and advancing medical knowledge, but the research outcomes can also enhance the health and well-being of the entire population.
However, under the current legal system in Taiwan, biotech and pharmaceutical companies can only use health data through research projects with the consent of the data subjects. Yet, under certain circumstances, it is often challenging to obtain the consent of data subjects. Consequently, the necessity and importance of secondary use of health data naturally arise. Additionally, compared to other countries' legal systems regarding the use of health data, it is rare to see regulations prohibiting biotech and pharmaceutical companies from secondary data while allowing public authorities or academic research institutions to apply for such use for research purposes.
The current legal system in Taiwan regarding the governance of health data is inadequate and disconnected from practical needs. Therefore, to address the issues of our current legal system, this article begins by discussing the challenges of commercial research use of health data under our system. It further organizes and examines the legal systems related to the use of health data in the United States, the European Union, and the United Kingdom, extracting content worthy of Taiwan’s reference. Additionally, it explains the importance of biotech and pharmaceutical companies using health data for research purposes. Finally, it proposes the aspects that should be considered when formulating laws for the commercial research use of health data in Taiwan.
Looking ahead, as the wave of big data sweeps in, we hope that our country's attitude will not be to retreat but to ride the wave. Through a more comprehensive health data legal system, we can enhance the public's digital trust and create a friendly scientific research environment for biotech and pharmaceutical companies, thereby improving the health and well-being of the entire population. |
