作者：Futoshi Iwata, Ryoko Hatanaka
出版年月：202409
關鍵詞：Medical Accident Investigation；Professional Autonomy；Medical Safety；Unexpected Death；Root Cause Analysis；Legal Liability

英文摘要
This paper argues that Japan’s 2015 Medical Accident Investigation Scheme, which places great emphasis on professional autonomy, has fatal flaws.
After nearly two decades of discussions on how to establish a transparent and thorough medical accident investigation scheme and improve medical safety. Japan implemented the Medical Accident Investigation Scheme in 2015 (the 2015 Scheme). Under its scheme, (1) each hospital and clinic is required to report to the third-party organization approved by the Ministry of Health, Labour and Welfare (MHLW) when any“unexpected death”of a patient occurs in the course of medical treatment, regardless of any negligence. (2) Then, each hospital and clinic must conduct a transparent and thorough root cause analysis of how and why such death occurred and submit the final investigation report with a new safety measure to the third-party organization and the patients’families. (The investigation committee may include at least one member from outside the institution, but that is not required.) (3) The third-party organization analyses the final reports of reported cases and provides feedback on safety issues to hospitals and clinics.
MHLW predicted about 3,000 reports each year based on the medical records review for accidental deaths in hospitals several years ago. However, the number of reported cases has been much lower than previously predicted, around 350-400 cases per year (only about one report per day). And so, by not reporting, professional autonomy–the very foundation of the current scheme–is being shaken.
To explore what barriers prevent the reporting of unexpected deaths and what benefits of such reporting there are in reality after the implementation of the 2015 Scheme, we conducted online interviews with 20 medical safety experts (doctors, nurses, and families of medical accident victims). Each interview lasted a minimum of 60 minutes for each interviewee.
There are some positive results of the 2015 scheme, such as that (1) some hospitals have significantly increased their efforts to report accidents and analyse the causes of accidents scientifically and objectively; (2) bereaved families are often satisfied with the results; (3) the medical community’s initial concerns about the 2015 Scheme’s possible effect of promoting conflicts with victims’families and litigation were largely unfounded; and (4) external review committee members have often proven effective.
But our conclusion is that many challenges remain. The single undeniable problem is that many medical institutions neither report medical accidents nor conduct in-hospital accident investigations. Ironically, the 2015 Scheme’s structure is based on trust of professional independence, yet that trust has been undermined by the professionals themselves. In order to regain the societal expectations of medical professionals, the 2015 Scheme should be thoroughly reexamined.
 

Analysing the Role of State and Non-State Actors in the Protection of Data in the Southeast Asian Nations with Special Reference to the Existing Legal Regime in India
作者：Priyanka Dhar
出版年月：202409
關鍵詞：Data Protection；Data Sharing；State Actors；Personal Data；Sensitive Information；Data Breach

英文摘要
In the era of information technology, where data emerges as a critical asset and a potent tool for extracting valuable insights, privacy is progressively evolving into a paramount global concern. The primary driver of this global unease stems from the escalating number of individuals willingly divulging their sensitive information on the internet. Furthermore, a significant portion of the population is compelled to share sensitive data due to the necessity of engaging in online transactions. Despite the diverse motives behind sharing personal data on online platforms, individuals worldwide share a collective apprehension about the storage, processing, and third-party control of their private data. The inability to access one’s data, coupled with numerous incidents of data breaches and privacy violations, intensifies the sense of insecurity among individuals, heightening the fear of becoming victims of such privacy breaches.
As a result, safeguarding data in digital form has emerged as a global issue demanding special attention within a legal context. In the Western world, the European Union (EU) implemented specific provisions for databases through the EU Data Protection Directive of 1995 (DPD), subsequently replaced by the General Data Protection Regulation (GDPR) in May 2018. Widely regarded as an exemplary demonstration of assurance to guarding the sensitive and personal data of data subjects, the GDPR sets a benchmark for data protection.
Southeast Asian democracies, experiencing rapid development and outperforming Western democracies in terms of GDP, are crucial players in the global business landscape. Given their engagements with EU members, many Southeast Asian nations have established data protection regimes that align with or are GDPR-compliant. Notably, India enacted the Digital Personal Data Protection Act, 2023 on August 11, 2023, marking a significant legislative milestone dedicated to data protection.
This article aims to analyse the provisions of the Digital Personal Data Protection Act, 2023, specifically focusing on the existing legal frameworks related to data protection in Southeast Asian democracies such as Singapore and Taiwan. The examination will centre on the responsibilities of state and non-state actors. Lastly, a comparative analysis of these jurisdictions will be conducted to identify vulnerabilities and best practices in the existing legal mechanisms.

Analysis of the National Intellectual Property Protection Strategy of the United States from a Geopolitical Perspective: Focusing on the“Joint Intellectual Property Enforcement Strategic Plan”
作者：黃孝怡
出版年月：202409
關鍵字：美國國家智財保護戰略；智慧財產執法聯合戰略計畫；地緣政治；國家智財戰略；智慧財產權保護；United States’National Intellectual Property Protection Strategy；Joint Intellectual Property Enforcement Strategic Plan；Geopolitics；National Intellectual Property Strategy；Intellectual Property Rights Protection

中文摘要
美國國家智財戰略並非單一的國家戰略，而是包括法律、政策與戰略，其涉及廣泛的行政機構和部門，以確保政府的努力集中且協調一致。而國家智財保護戰略主要的目的在保護美國境內與海外的智慧財產權。以往美政府各部門各有不同的智慧財產權政策與執法行動，但在2008年美國國會通過的「智慧財產資源及機構優先法案」（Prioritizing Resources and Organization for Intellectual Property Act）規定下制定了「智慧財產執法聯合戰略計畫」（Joint Strategic Plan on Intellectual Property Enforcement）。「智慧財產執法聯合戰略計畫」主要目的重點是協調和發展美國的整體智慧財產執法政策和戰略，促進創新和創造力，並確保國內外有效的智慧產權保護和執法。由於海外智慧財產權的保護不免會受到國際地緣政治因素的影響；因此在最近三位美國總統任內，「聯合戰略計畫」的內容與方向也有所轉變。本文將從美國智慧財產權保護政策與國際地緣政治兩個面向，分析「聯合戰略計畫」的內容與轉變。研究顯示，美國的國家智財權保護戰略，其主要目的在持續強化美國國內外智慧財產權的保護，以及防止來自境外的智慧財產權侵害；但該計畫較其他國家的智財戰略更具有國內外執法的功效，也會因地緣政治變化而進行方向與強度的調整。

英文摘要
The United States’intellectual property strategy is not a separate national strategy, but includes laws, policies and strategies. It involves a broad range of executive branch agencies and departments to ensure that the government’s efforts are focused and well coordinated. The main purpose of the Intellectual Property Protection Strategy is to protect intellectual property rights within the United States and abroad. In the past, various departments of the U.S. government had different intellectual property policies and enforcement actions. However, under the“Prioritizing Resources and Organization for Intellectual Property Act”passed by the U.S. Congress in 2008, the“Joint Strategic Plan on Intellectual Property Enforcement”was formulated. The main purpose of the“Joint Strategic Plan for Intellectual Property Enforcement”is focused on coordinating and developing the United States’overall intellectual property enforcement policy and strategy, to promote innovation and creativity, and to ensure effective intellectual property protection and enforcement domestically and abroad. The protection of international intellectual property rights will inevitably be affected by geopolitical factors; therefore, during the terms of the last three US presidents, the content and direction of the“Joint Strategic Plan”have also changed in different years. This article analyzes the content and changes of the“Joint Strategic Plan”in different years from the two aspects of intellectual property rights protection policies and geopolitics. The results show that the“Joint Strategic Plan”will be adjusted its directions and intensity due to geopolitical changes.

A Study on the Protection of Trade Secrets in the Electronic Equipment Industry—Focusing on Judicial Practice in Taiwan
作者：蘇柏樺；林志潔
出版年月：202409
關鍵詞：營業秘密；電子設備；經濟間諜；國家安全；智慧財產；Trade Secret；Electronic Equipment；Economic Espionage；National Security；Intellectual Property

中文摘要
電子設備產業的智慧財產權有其獨特性，就是被侵權時極難取證。電子設備業以B2B（Business to Business，企業對企業）模式銷售生產製程設備或輔助生產設備，當設備被銷售到一個工廠，就算侵害了競爭對手的智慧財產權，競爭對手也無法自由進出該工廠並進行取證，更何況是對鏡頭與記憶體有高度入廠管制的高科技製造產業。彙整臺灣2017年到2023年8月9間電子設備業公司營業秘密相關判決，判決結果只有兩個依照營業秘密法第13條之1第一項第一款和第二款裡的洩漏營業秘密判處有罪，其他民刑事判決皆為無罪、駁回、和解等結果。其中兩個判決提出被使用智慧財產權的證據，都被法官以無法確認其所有權、或是舉證不足等原因不被採納。國家安全法在2022年有修法，但僅將極少數電子設備業定義為國家核心技術範圍，故多數電子設備業暫時不適用。美國經濟間諜法是針對外國政府或其代理人之經濟間諜行為，但沒有針對使用營業秘密行為處罰。加州的電腦資料存取與詐欺罪立法不是為了外國政府的經濟間諜行為，不過卻協助全球最大曝光機設備商阻止中國公司竊取其營業秘密後進行競爭。

英文摘要
The intellectual property rights of the electronics device industry are uniquely characterized by the extreme difficulty of evidence collection in infringement cases. Sales in this industry often occur in a B2B (Business to Business) model, involving the sale of production or auxiliary production equipment. Once equipment is sold to a factory, even if it infringes upon a competitor’s intellectual property rights, the competitor cannot freely enter the factory to collect evidence, especially in high-tech manufacturing with strict controls over cameras and memory access. Reviewing Taiwan’s 9 companies of electronic device industry’s trade secret-related judgments from 2017 to August in 2023, only two cases resulted in convictions based on the leakage of trade secrets under specific provisions of the Trade Secrets Act. Most other civil and criminal judgments resulted in acquittal, dismissal, or settlement. Additionally, two judgments that presented evidence of used intellectual property rights were not accepted by judges due to insufficient evidence or unclear ownership. The National Security Law was amended in 2022, but it defined only a minimal portion of the electronics industry as within the scope of national core technologies, thus excluding most of the industry. The U.S. Economic Espionage Act targets espionage by foreign governments or their agents without addressing the misuse of trade secrets. California’s laws against computer data access and fraud were not designed for economic espionage by foreign governments but have helped the world’s largest photolithography equipment manufacturer prevent Chinese companies from stealing its trade secrets for competition.