Patient Data Accessibility for Biotech and Medicine Industry Start-ups in Taiwan

生物科技與醫藥新創產業社群中的病患資料近用性

10.6182/jlis.202112_19(2).025

鄭瑋(Wei Jeng)；王姿涵(Zih-Han Wang)；張維庭(Wayland Chang)

Health Data ； Data Accessibility and Reusability ； Data Infrastructure ； Biotech and Medicine Industry Startups ； 健康資料 ； 資料近用與資料再用 ； 資料基礎建設 ； 生物科技與醫藥新創產業

圖書資訊學刊

19卷2期（2021 / 12 / 01）

25 - 41

英文

In Taiwan's current biotechnology and medicine industry (BMI) landscape, there exists a data accessibility-ethical dilemma that might lead to an overall health data accessibility and availability supply-demand gap. Focusing on Taiwanese BMI startups' perceived data accessibility, this article-with a qualitative approach-altogether analyzed such startups' current challenges and circumstances. We conducted semi-structured interviews with 17 participants as different stakeholders, including 4 physicians, 5 BMI startup workers, and 8 with both roles. Also analyzed were several actual data accessibility issues that Taiwan's BMI startup community often encounters during data acquisition. Ultimately, this study confirms a rather inconvenient truth that data acquisition costs are rather very high - not only in monetary-wise, but also perceived efforts-wise in response to Taiwan's rather rigid biotechnology regulatory regime. Also found were that many of the interviewed BMI startups had voiced hopes for more regulatory transparency plus well-roundedness than those of more regulatory relaxations. With an interview approach, we found still more rooms of improvement in the realms of the startup itself, BMI startup accelerators, and government in Taiwan. Thus, this study has three recommendations: First, better startup's data literacy to better respond to relevant data requests. Second, better governmental transparency and well-informed regulations. Third, about the aforesaid complex regulations, better mentorship by such startup accelerators. Also observed were startups' various proactive attempts to strike a strong ethics-development growth ethics. Thus, this study provides deeper insights into building more mutually beneficial approaches in the data accessibility issues realm for Taiwanese BMI startup communities' different stakeholders. Namely as such startups are often at the crossroads of burgeoning expansionary visions and sometimes stifling regulatory regimes.

臺灣生物科技與醫藥產業環境中，病患資料的近用性（patient data accessibility）涉及倫理與法規上的考量，攸關資料釋出與取用上的供需平衡。本研究透過質化方法，對17位受訪者進行半結構式訪談（包含4位醫師、5位BMI新創公司人員，餘8位身兼上述兩種角色），以探索臺灣BMI新創社群在病患資料取得過程中，產生的可近用性需求與感知的困難。本研究發現，臺灣BMI新創產業環境中，病患資料取得成本相當高：除貨幣（金錢）成本之外，尚包括相關從業者因應生技法規之存在，而感知到必須付出的勞力與心力（perceived efforts）。研究結果亦顯示，臺灣的BMI從業者傾向期待政府能為醫患資料的取用建立更為完善、嚴明（而非放寬）的監管制度。

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