Precision health in Taiwan: A data-driven diagnostic platform for the future of disease prevention.

"Precision medicine" has revolutionized how we respond to diseases by using an individual's genomic data and lifestyle and environment-related information to create an effective personalized treatment. However, issues surrounding regulations, medical insurance payments and the use of patients' medical data, have delayed the development of precision medicine and made it difficult to achieve "true" personalization. We therefore recommend that precision medicine be transformed into precision health: a novel and generalized platform of tools and methods that could prevent, manage, and treat disease at a population level. "Precision health," one of six core strategic industries highlighted in Taiwan's vision for 2030, uses various physiological data, genomic data, and external factors, to develop unique "preventative" solutions or therapeutic strategies. For Taiwan to implement precision health, it has to address three challenges: (1) the high-cost issue of precision health; (2) the harmonization issues surrounding integration and transmission of specimen and data; (3) the legal issue of combining information and communications technology (ICT) with Artificial Intelligence (AI) for medical use. In this paper, we propose an innovative framework with six recommendations for facilitating the development of precision health in Taiwan, including a novel model of precise telemedicine with AI-aided technology. We then describe how these tools can be proactively applied in early response to the COVID-19 crisis. We believe that precision health represents an important shift to more proactive and preventive healthcare that enables people to lead healthier lives.

Transformation of the Taiwan Biobank 3.0: vertical and horizontal integration.

Researchers expect a high quality of biospecimens/data and value-added services from biobanks. Therefore, the concept of "biobank 3.0" was introduced so that biobanks could better meet the needs of stakeholders and maintain sustainable operations. Theoretically, the Taiwan Biobank (TWB) has already gone through the concepts of biobank 1.0 and 2.0. However, three challenges still need to be addressed before it can be transformed into a new generation of the TWB (namely, the TWB 3.0): (1) the difficulty of integrating other biobanks' resources, (2) the efficiency and effectiveness of the release and use of biospecimens/data, and (3) the development of income and revenue models of sustainability. To address these issues, this paper proposes a framework for the TWB 3.0 transformation based on a dual-pillar approach composed of a "physically" vertical integration driven by the TWB and a "virtually" horizontal network led by the National Health Research Institutes (NHRI) of Taiwan. Using prominent biobanks such as the Biobanking and BioMolecular Resources Research Infrastructure-European Research Infrastructure Consortium (BBMRI-ERIC), the UK Biobank, and the National Institutes of Health (NIH)'s All of Us Research Program as models, the TWB can strengthen its on-going TWB 2.0 operations in regional and/or international collaboration, increase the value of data collected and develop closer relationships with biobank participants and users. To these ends, the authors highlight key issues that include, but are not limited to, the harmonization of relevant ELSI standards for various biobanks' integrations; the value-added services and the efficiency of Big Data Era related research and/or precision medicine development, and financial concerns related to biobank sustainability. This paper concludes by discussing how greater participant engagement and the uptake of Information Technology (IT) and Artificial Intelligence (AI) applications can be used in partnership with vertical and horizontal integration as part of a four-pronged approach to promote biobank sustainability, and facilitate the TWB 3.0 transformation.

Managing "incidental findings" in biobank research: Recommendations of the Taiwan biobank.

BACKGROUND: In this article, incidental findings (IF) refer to unforeseen findings made possible through biobanking research and advances in medical diagnostic technologies that raise issues regarding the obligation and/or responsibility of biobank-users and biobanks to return clinically significant information to participants. The World Medical Association (WMA) Declaration of Taipei (2016) highlights the possibility of encountering IF and requires that research on biospecimens address biobank feedback policies in their informed consent process, leaving open the possibility that the policy may be "no return". As clinicians and researchers begin to use these "resources", the possibility of finding clinically significant IF is becoming a reality. DISCUSSION: In line with the WMA's Declaration of Taipei, a pragmatic approach is needed to deal with the issue of returning IF in biobank governance. Indeed, the impacts and concerns associated with the return of IF differ across different stakeholder groups and jurisdictions. Therefore, the framework governing IF return needs to be custom-built, taking into account the nature of each research project and the unique features of biobanks. To this end, in addition to facilitating biobank transparency, establishing an endurable and horizontal connection among biobanks and clinical institutions under a public health system will improve efficiency and effectiveness. Hence, subject to contemporary Taiwanese ethical and/or legal regulations, this article argues for the establishment of an updated framework for imaging-related and genetic-related IF return within the Taiwan Biobank (TWB), mainly based on a limited obligation to disclose life-threatening information revealed by imaging, but not genetic, information. SUMMARY: After discussing some of the ethical, legal and social issues encountered by the TWB and accounting for the experiences of other international biobanks, we propose a systematic framework for returning IF, mainly on a "limited obligation" basis, which offers better and more comprehensive protection for biobank-participants' rights and health.

Next Chapter of the Taiwan Biobank: Sustainability and Perspectives.

The emergence of biobanks has expanded the scope of biomedical research, ushering in an era of "precision medicine" to improve the treatment of disease. However, biobanks also face sustainability challenges comprising three dimensions-"financial," "operational," and "social." The Taiwan Biobank (TWB), as a large-scale national biobank that supplies valuable phenotypic and genetic information to biomedical researchers on an application basis to investigate the relationship among personal health, genes, lifestyle, environment and diseases of the Taiwanese population, has not been sufficiently explored by researchers. Although the TWB has successfully reached a few milestones since its inception, it faces many sustainability challenges. For the next chapter of the TWB, we propose three strategies to improve sustainability. First, the Ministry of Health and Welfare launched the TWB as an infrastructure project under the leadership of Academia Sinica in 2012. We now believe that it is time that the TWB is transformed into a legal entity as a nondepartmental public body. This would not only ensure efficient, effective, and flexible operation, but would also facilitate cooperation with commercial entities. Second, we suggest that the TWB integrates with other Taiwanese biobanks to reduce cost, improve low utilization, and expand specimen collection. Third, self-financing is important if funding is ceased. Besides implementing a cost-recovery model, the commodities developed by the TWB (e.g., TWB 2.0 microarray) will help increase income. After each of these strategies has been discussed in detail, this article will conclude by highlighting how these practices can help improve biobank sustainability.

Taiwan Biobank: making cross-database convergence possible in the Big Data era.

The Taiwan Biobank (TWB) is a biomedical research database of biopsy data from 200 000 participants. Access to this database has been granted to research communities taking part in the development of precision medicines; however, this has raised issues surrounding TWB's access to electronic medical records (EMRs). The Personal Data Protection Act of Taiwan restricts access to EMRs for purposes not covered by patients' original consent. This commentary explores possible legal solutions to help ensure that the access TWB has to EMR abides with legal obligations, and with governance frameworks associated with ethical, legal, and social implications. We suggest utilizing "hash function" algorithms to create nonretrospective, anonymized data for the purpose of cross-transmission and/or linkage with EMR.

Taiwan Regulation of Biobanks.

This paper introduces legal framework and governance structure in relation to the management and development of biobanks in Taiwan. At first, we briefly describe Taiwan's population, political system and health care system. Secondly, this research introduces biobanking framework of Taiwan including 25 biobanks established with the approval of the Ministry of Health and Welfare. In those biobanks, "Taiwan Biobank" is the first and the largest government-supported biobank which comprises population-based cohort study and disease- oriented study. Since the collection of information, data, and biological specimen of biobanks often involve highly sensitive personal information, in the legal framework of Taiwan, there is a specific regulation, "Human Biobank Management Act" (HBMA), which plays an important role in regulating biobanks in Taiwan. HBMA, the Personal Information Act and other regulations constitute a comprehensive legal and regulatory privacy framework of biobanks. Through the introduction and analysis of the current legal framework applicable to biobanks, we found that there are several challenges that need to be solved appropriately that involve duplicate review systems, the obstacles in the international collaboration, and data sharing between biobanks in Taiwan.

Consensus standards for introductory e-learning courses in human participants research ethics.

This paper reports the results of a workshop held in January 2013 to begin the process of establishing standards for e-learning programmes in the ethics of research involving human participants that could serve as the basis of their evaluation by individuals and groups who want to use, recommend or accredit such programmes. The standards that were drafted at the workshop cover the following topics: designer/provider qualifications, learning goals, learning objectives, content, methods, assessment of participants and assessment of the course. The authors invite comments on the draft standards and eventual endorsement of a final version by all stakeholders.

Taiwan Biobank: a project aiming to aid Taiwan's transition into a biomedical island.

Essentially, the term 'biobank' can be defined in different ways. Taking the UK Biobank's experience as the main example, the Taiwan Biobank aims to collect the DNA of a large group of people on the population base and track their health and lifestyle for at least 10 years. It is hoped that the information collected, regarding the mechanisms underlying how genes and environmental factors interact with each other to make us ill, will benefit the society in various ways, including the exploration of a new generation of treatments, support to preventive medicine discovery and also the possible benefits for the promotion of evolving public health-related industries in Taiwan. However, the involvement of large-scale population base gene data collection also triggered serious ethical, legal and social issues. In Taiwan, the challenge is even more serious than for any other biobanking experiences that have occurred previously. Among all the ethical, legal and social issues, the convergence of aboriginal people protection provided under Taiwan's Constitution imposes on the research team an obligation to create an innovative Ethical & Legal Governance Framework adaptable to the unique social background of Taiwan, including a workable public consultation/communication mechanism. In early 2005, the creation of the 'Taiwan Biobank' has been included as a part of Taiwan's strategic development in promoting the country as an island of biomedicine. In this report, the ideology, the goals and special features, government strategy, visions and, in particular, the ethical, legal and social issue planning of the Taiwan Biobank will be briefly introduced and reviewed.

Impact of development of population-based study in biomedical field on laws and regulations: a cross-strait experience on biobank development.

Together with the completion of the Human Genome Project, biomedical research has marched into the "Post-Genomic Era." In order to take advantage of these extracted gene related information extensively and precisely so as to realize the human being's biological phenomena as well as the mechanism of pathogenesis, consequentially, large scale sample collection of different geological areas and/or ethic group becomes necessary for the future population based genetic research of a country and, in turn, the construction of population-based genetic database (Biobank). In recent years, both mainland China & Taiwan have not only made great progress in information & computation technologies but have also gradually taken a close look into the quality of medicine delivery. Thus, it becomes unavoidable for both sides to create each one's population-based genetic databases (Biobank). Theoretically speaking, the Biobank development shall benefit the study on the correlation between genes and disease and, also, the solution for disease treatment. At the same time, medical diagnosis technology has also been significantly improved. It is believable that the population-based genetic database might be utilized to promote medical quality and to reduce the cost of public health delivery. Furthermore, in the near future, it might become the "raw materials" for medical research application. However, when taking the public welfare promotion as the premises for a Biobank development, severe and multi challenges occurred against traditional legal rules in terms of the privacy protection, public trust development, the compliance of informed consent principle, the implementation of a benefit-sharing doctrine and the possible discrimination concern on the population/participants selection and some other ELSI issues. In this paper, the major legal issues encountered by the Biobank development will be firstly reviewed accompanied with the background information concerning the Biobank development scenario crossing the Taiwan Strait. Also, mainly following the realm of comparative policy or legal approaches, the paper, learning from the fruits of this comparative study, tries to propose some recommendations for future legislative consideration by both mainland China & Taiwan. It's been this author's wish that, when establishing a large scale population based Biobank, the promotion of public trust shall be placed as the primary goal together with the emphasis on the supporting publicity and transparency on the administrative practices, so as to encourage the public participation in observing the principle of altruism and, in turns, benefit the future biomedicine development.