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.

The type-2 variant of human cytomegalovirus glycoprotein N (gN-2) is not the rarest in the Chinese population of Taiwan: influence of primer design.

Studies of the human cytomegalovirus (HCMV) glycoprotein N (gpUL73-gN) showed that genotypic variations exist in different geographic areas, with gN-2 unidentified in Chinese population. The purpose of this study was to determine the HCMV gN variants in the Chinese population of Taiwan. Primers were designed and a polymerase chain reaction (PCR) was carried out on the UL73 gene. The PCR products were subjected to restriction fragment length polymorphism (RFLP) analysis. The same PCR-RFLP assay was repeated using primers published previously to demonstrate the influence of primer design. Of the 48 clinical HCMV isolates, 33 were positive for PCR products by both primer sets. Fifteen were positive only by the "in-house" PCR. The distribution of gN-1, gN-2, gN-3, and gN-4 by RFLP analysis was 14:11:7:17, with one isolate positive for both gN-1 and gN-2. The published primers detected the four genotypes with the number of 14:0:2:17. The under-representation of gN-2 and gN-3 by the method published previously may be due to inappropriate primer design when re-examining the sequences. On the basis of the results of this study, gN-2 is not the rarest gN genotype in the Chinese population of Taiwan. The design of primers used for PCR-RFLP genotyping may have a great influence on the frequency distribution of HCMV genomic variants.

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.

Criminal liability research in vaccine administration by public health nurse: a case study of the Nantou vaccine administration case.

Immunization is recognized as a powerful public health tool in disease control and eradication. Registered nurses (RNs) are the principal health professionals responsible for administering vaccines, not only in terms of childhood immunization but also increasingly in administering travel vaccines and annual influenza vaccinations. The RN often provides leadership in developing and maintaining a high quality program. The legal position of nurses when administering a vaccine conflicts with their role as care providers, and nurses must be aware of their legal position when administering a vaccine that has not been individually prescribed by a doctor. A recent case involving a baby who died after receiving a vaccine administered by a public health nurse without a doctor's prescription resulted in the prosecutor initiating a prosecution against the nurse and chief of Health Bureau for a violation of Article 28 of the Physician's Act and the criminal law. Although the nurse and Bureau Chief were judged not guilty, the first trial court pointed out that the behavior of this nurse still violated Article 28. This reflects the conflict that exists between empirical practice and legal regulations. In order to guarantee that prophylactic inoculation is implemented properly under legitimate and effective conditions (specially in remote districts), in May 23, 2006, Legislative Yuan passed an amendment to Article 4 of the Communicable Disease Control Act, which specified that no public health nurse can be prosecuted for violations of Article 28 of the Physician's Act as a result of vaccine administration. In the future, nurses in clinics located in remote districts may conduct prophylactic inoculation work without fear of the terms of Article 28 and focus on implementing public prophylactic inoculation responsibilities. However, a public health nurse can still be liable for the malpractice in criminal law during the vaccination. Therefore, following procedure is still necessary in the conduct of vaccination duties.