活動名稱
Legal Trends in the Commercial Use of Health Data Forum
Legal Trends in the Commercial Use of Health Data Forum
【2023/07/05】
Director Lee Po-chang of the Health and Welfare Policy Research Center expressed that the theme of this forum is “Exploring Legal Trends in the Commercial Use of Health Data.” It focuses on the legal aspects of the commercial use of health data. He pointed out that striking a balance between using health data and protecting patient privacy is a critically important issue. In this data-driven era, health data has become a crucial element in the fields of healthcare, research, and business. However, the use of this data must be accompanied by strict legal and ethical regulations to ensure patient privacy and data security. He encouraged participants to actively engage in discussions and share their insights.
Mr. Lee Ke-wen, Legal Counsel of Taiwan Nova Corporation, stated that health data plays a vital role in medical science and business innovation. He mentioned that de-identified health data in large quantities holds a pivotal position in drug research, efficacy assessment, and precision medicine. Regulations should provide more incentives and flexibility to facilitate the legal use of health data. He emphasized the challenging balance between safeguarding patient privacy and enabling data-driven innovation. Taiwan Nova Corporation is eager to collaborate with Taipei Medical University and contribute to discussions on legal trends in health data.
Mr. Salah Mostafa, Legal Counsel for the Asia-Pacific, Middle East, and Africa regions of Nova, expressed that Taiwan’s national health insurance system and medical market prospects have attracted Nova’s attention, making it an ideal investment choice. He pointed out that health data is a key element for personalized treatment and drug development. He expressed confidence in Taiwan’s active development and looked forward to collaborative efforts in this age of big data to find ways to balance patient privacy rights and promote advancements in medical science and business innovation.
Mr. Chen Chuan-wen, Secretary-General of the Developmental Pharmaceutical Research Association of the Republic of China, stated that the application of medical big data is a worthwhile investment area that can enhance the level of personalized disease prevention and treatment, ushering in a new era for the people of Taiwan. He shared the importance of medical big data in drug development and called for legal frameworks to evolve in order to promote further applications of health data.
Director Wang Tzu-hsiung, Institute for Information Industry Digital Transformation Center
Director Wang discussed the topic of “The Gray Area of Health Data: A Legal Perspective and Solutions in Taiwan.” He emphasized the use and release of health data and how to achieve balance within the legal framework. He mentioned that Taiwan can learn from legal frameworks abroad and introduced the sources, types, and potential legal regulations of health data. Director Wang also discussed the balance between individual autonomy and the interests of the group, as well as how different countries handle this issue.
Dean Chen Ching-hsiung, College of Technology Law at National Yang Ming Chiao Tung University
Dean Chen emphasized that the legal system in the United States, particularly regarding personal data protection, is worth Taiwan’s consideration. He explored the development of commercial use in different countries and mentioned the differences in reviewing authorities, such as the European Union having national agencies for review, while the United States uses Institutional Review Boards (IRBs). He also shared a case involving the balance between personal privacy rights and ownership of personal data, emphasizing that these issues should be addressed by the legislature. Dean Chen highlighted the need for transparency and independent oversight mechanisms.
Mr. Lee Chung-hsi, Associate Director, Health and Welfare Policy Research Center
Professor Lee discussed the value of health data, emphasizing that aggregated data holds research value. He explored the definition of health data and its relationship with individual rights. He stressed the importance of a value balance and data exit mechanisms.
Minister Sun Ting-ting, Clinical Research Department, Taiwan Nova Global Drug Development Center
Minister Sun emphasized the importance of protecting the privacy of trial subjects and discussed the benefits of digitization tools and data in clinical trials. She talked about the importance of electronic informed consent, direct extraction of electronic source data, and electronic patient self-reported questionnaires. Minister Sun mentioned the potential benefits of data reuse and feedback to patients. She emphasized the importance of digitization tools and data in clinical trials, as collecting sufficient health data can improve trial efficiency, data quality, and progress in new drug development.
Vice Dean Hsu Ming-hui, College of Management at Taipei Medical University
Vice Dean Hsu expressed his position on the management of the commercial use of health data, emphasizing his opposition to including the commercial use of health data in Institutional Review Board (IRB) regulations. He also thanked Associate Director Lee Chung-hsi and Dean Chen for their public welfare perspectives. Vice Dean Hsu stressed that biomedical research requires substantial databases and urged greater attention to the value of “Health.”
Mr. Lee Chung-hsi, Associate Director, Health and Welfare Policy Research Center
Associate Director Lee Chung-hsi emphasized the importance of Taiwan actively seeking to join the World Health Organization (WHO). He pointed out that the core concept of the WHO is human rights, including privacy rights, individual autonomy, and the right to health. He advocated achieving this goal through cooperation with businesses and training institutions, viewing the right to health as a manifestation of equality rights, as defined by the WHO.
Associate Director Lee further mentioned that Taiwan’s pride, its National Health Insurance, is a crucial part of health infrastructure and represents a commitment to health equality. He believed that health expenditure is not just consumption but an investment that can enhance work capacity, drive industrial development, and increase national revenue. Finally, Associate Director Lee also brought up the relatively inadequate investment in the medical and health field in Taiwan, including issues with the salaries of medical personnel and whether more medical products should be included in national health insurance. He called on the government to provide more financial support and handle these issues from an equality perspective to achieve the goals of health equality and universal health.
Ms. Tseng Hui-chin, Honorary Vice Director, Tsai Chen & Associates, CPAs
Vice Director Tseng pointed out that Taiwan is undergoing a revolution in the convergence of technology and healthcare, changing our lives. Science fiction stories have always inspired limitless imagination about the future, but in reality, many of the technologies from such stories have become reality. Some Taiwanese companies have also introduced similar products, such as non-contact physiological signal measurement technology by FaceHeart Inc., which has received FDA certification in the United States. Additionally, Quantum Hi-Tech developed a magnetically controlled capsule endoscope for upper gastrointestinal examination. The FDA certification of these innovative technologies signifies that science fiction has become reality and is changing the lives of people in Taiwan. AI has made significant advancements in fields like image processing, big data analysis, and disease detection, making Taiwan a participant in the global health technology sector.
Secretary-General Hou Yi-hsiu, Taiwan Artificial Intelligence School Foundation
Secretary-General Hou emphasized the criticality of training in artificial intelligence (AI). She mentioned that the Taiwan AI School Foundation has trained over 10,000 students, with approximately 15% being doctors. She pointed out that understanding the fundamentals of AI is essential because AI applications require relevant infrastructure. With the emergence of generative AI technology, new challenges arise, with the constant need to generate new data to train models, attracting students from various fields. The Taiwan AI School Foundation is committed to meeting the growing demand for AI learning, providing the latest training and resources to adapt to the rapid development of AI technology.
Director Li Yi-min, Taiwan Nova Pharmaceutical Academic Departmen
Director Li Yimin, emphasized the critical importance of feasibility in pharmaceutical research and development. Traditional methods of selecting institutions and estimating the number of patients are time-consuming and inaccurate. He proposed the establishment of a hospital data interoperability platform that offers more accurate assessments through information sharing while saving time and human resources. He stressed that the integration of health data is highly beneficial for pharmaceutical companies. Mentioning that multinational pharmaceutical companies have adopted some data platforms, but Taiwan’s data is often not included, leading to the need for additional Asian trials or reliance on Taiwan’s National Health Insurance (NHI) database. However, this process requires more time and costs and must comply with Taiwanese regulations. These factors may make Taiwan not the first choice for pharmaceutical companies.
This forum brought together professional insights from experts, scholars, industry representatives, and government departments to discuss the legal trends in the commercial use of health data. They also discussed how to promote both medical science and business innovation while safeguarding privacy rights. The forum provided valuable insights and collaborative opportunities for Taiwan’s future development in the field of health data utilization law.