Balancing between the Cross-border Data Flows and Privacy Protection

학위논문(석사) -- 서울대학교대학원 : 국제대학원 국제학과(국제통상전공), 2023. 8. 이영섭.데이터는 오늘날 상호 연결된 디지털 경제에서 경제 및 사회적 거래의 기반이 되는 귀중한 자원이다. 하지만 데이터, 특히 개인정보의 공유가 증가함에 따라 국경 간 이동하는 데이터의 적절한 사용 및 착취에 대한 우려를 낳으며 개인정보보호를 촉구하는 여론이 해를 거듭할수록 강렬해지고 있다. 이에 대응하여 여러 국가에서 데이터 규제를 강화하여 국경 간 데이터 이동을 제한하거나 특정 위치 내에서 데이터 저장 및 처리를 의무화하는 조치를 시행하고 있다. 그러나 다양한 규제의 확산은 국가 간 규제 환경의 세분화를 초래하여, 개인정보보호 및 데이터 보호와 같은 공공 정책 목표를 효과적으로 시행하는 데 상당한 어려움을 야기하고 있다. 이러한 상황은 상당수 기업이 원활하게 여러 관할권에서 운영하는데 큰 장애물로 작용하여 기업의 글로벌 확장 가능성이 제한되고 디지털화의 이점을 충분히 이용하지 못한다는 우려가 제기된다. 따라서 본 연구는 국경 간 데이터 이동과 개인정보보호를 둘러싼 정책 환경을 이해하고 여러 국가 간 세분화된 규제 체제에 대응할 수 있는 실용적인 접근 방식과 메커니즘을 제시하는데 의의가 있다. 이를 위해 본 연구는 기존 규제 메커니즘을 검토하고 프라이버시와 개인정보보호를 위한 포괄적인 글로벌 메커니즘을 구축하기 위해 지역 및 국제 데이터 보호 규정의 효율성과 상호 운용성 및 호환성을 향상시킬 수 있는 방법을 모색하고자 한다.Data constitute a valuable resource for economic and social transactions in todays interconnected, data-driven digital economy. However, the widespread sharing of data, particularly personal data, has raised concerns regarding appropriate data usage and possible exploitation across borders, thereby escalating concerns regarding privacy and personal data protection. In response, countries have implemented and modified data regulations, enforcing measures restricting data transfer across borders or mandating data storage and processing within specific locations. Owing to the absence of an international legal framework at the multilateral level, the proliferation of diverse regulations has resulted in a fragmented regulatory landscape, posing significant challenges in effectively enforcing public policy objectives such as privacy and data protection. Consequently, businesses encounter obstacles in operating seamlessly across different jurisdictions, limiting their potential for global expansion and hampering the anticipated benefits of digitalization. In this regard, this study aims to enhance the understanding of the policy landscape surrounding cross-border data flows and privacy protection and contribute to ongoing discussions on practical approaches and mechanisms that countries can adopt to reconcile increasingly complicated and fragmented regulatory regimes. This study examines three existing regulatory mechanisms and explores avenues for enhancing their effectiveness and the interoperability of regional and international data protection regulations to establish a comprehensive global mechanism for privacy protection. Furthermore, this study recommends two-sided efforts: first, a vertical approach of developing a compatibility mechanism built on the two pillars of the APEC CBPR and European Union GDPR, which could elevate the level of privacy protection regulation; and second, a horizontal approach of fostering consensus on cross-border data flows and privacy protection through preferential trade agreements to increase inclusiveness. Such a compatibility mechanism, along with PTAs, can serve as an experimental domain for governance, thereby paving the way for a more effective and harmonious international regulatory framework for digital trade and the potential establishment of a global privacy protection mechanism.Introduction 1 I. The Role of Data and the Need for Data Governance 5 1. Definition of Key Terms 7 2. Rationale Behind Data Protection Regulations 9 II. Construction and Evolutionary Trend of Data Regulations 12 1. Absence of a Legal Framework at the Multilateral Level 12 2. Growing Number of Data Regulations 13 3. Proliferation of PTAs with Data Regulations 16 4. Issues Raised by Emerging Data Regulations 18 III. Personal Data Protection in Transnational Rules 20 1. OECD 20 2. APEC 21 3. GDPR 24 IV. Personal Data Protection in Trade Rules 30 1. GATS 30 2. CPTPP 33 3. USMCA 36 V. Toward a Global Privacy Protection Mechanism 39 1. Accountability Mechanisms 39 2. Unilateral Approach 42 3. PTAs 44 Conclusion 47 Bibliography 48 Abstract in Korean 53석

Optimal Duration of Dual Antiplatelet Therapy after Stent- Assisted Coil Embolization of Unruptured Intracranial Aneurysms : A Prospective Randomized Multicenter Trial

Objective: Stent-assisted coil embolization (SAC) has been increasingly used to treat various types of intracranial aneurysms. Delayed thromboembolic complications are major concerns regarding this procedure, so dual antiplatelet therapy with aspirin and clopidogrel is needed. However, clinicians vary the duration of dual antiplatelet therapy after SAC, and no randomized study has been performed. This study aims to compare the safety and efficacy of long-term (12 months) dual antiplatelet therapy and shortterm dual antiplatelet therapy (6 months) after SAC for patients with unruptured intracranial aneurysms (UIAs). Methods: This is a prospective, randomized and multicenter trial to investigate the optimal duration of dual antiplatelet therapy after SAC in patients with UIAs. Subjects will receive dual antiplatelet therapy for 6 months (short-term group) or 12 months (longterm group) after SAC. The primary endpoint is the assessment of thromboembolic complications between 1 and 18 months after SAC. We will enroll 528 subjects (264 subjects in each group) and perform 1 : 1 randomization. This study will involve 14 topperforming, high-volume Korean institutions specializing in coil embolization. Results: The trial will begin enrollment in 2022, and clinical data will be available after enrollment and follow-up. Conclusion: This article describes that the aim of this prospective randomized multicenter trial is to compare the effect of short-term (6 months) and long-term (12 months) dual antiplatelet therapy on UIAs in patients undergoing SAC, and to find the optimal duration.ope

External Ventricular Drainage before Endovascular Treatment in Patients with Aneurysmal Subarachnoid Hemorrhage in Acute Period: Its Relation to Hemorrhagic Complications

PURPOSE: The purpose of this study was to report the authors' experience with external ventricular drainage (EVD) before endovascular treatment (EVT) in patients with acute aneurysmal subarachnoid hemorrhage (aSAH) and to investigate its relation to hemorrhagic complications. MATERIALS AND METHODS: Between March 2010 and December 2017, a total of 122 patients were recruited who had an aSAH, underwent EVT to secure the ruptured aneurysm, and had EVD performed within 72 hours of rupture. The pre-embo EVD group (n=67) comprised patients who underwent EVD before EVT, and the post-embo EVD group (n=55) comprised those who underwent EVD after EVT. RESULTS: Overall, EVD-related hemorrhage occurred in 18 patients (14.8%): six (8.9%) in the pre-embo EVD group and 12 (21.8%) in the post-embo EVD group (P=0.065). No rebleeding occurred between EVD and EVT in the pre-embo EVD group. Clinical outcomes at discharge did not differ significantly between groups (P=0.384). At discharge, the final modified Rankin Scale score in patients who experienced pre-embo rebleeding was better in the pre-embo EVD group than in the post-embo EVD group (P=0.041). Current use of an antiplatelet agent or anticoagulant on admission (odds ratio [OR], 2.928; 95% confidence interval [CI], 1.234-7.439; P=0.042) and stent use (OR, 2.430; 95% CI, 1.524-7.613; P=0.047) remained independent risk factors for EVD-related hemorrhagic complications. CONCLUSION: EVD before EVT in patients with aSAH in acute period did not increase the rate of rebleeding as well as EVD-related hemorrhagic complications. Thus, performing EVD before EVT may be beneficial by normalizing increased intracranial pressure. Especially in patients with rebleeding before the ruptured aneurysm is secured, pre-embo EVD may improve clinical outcomes at discharge.ope

Comparison Between Balloon-Assisted and Stent-Assisted Technique for Treatment of Unruptured Internal Carotid Artery Aneurysms

Purpose : To compare clinical and angiographic outcomes between balloon-assisted (BAC) and stent-assisted coiling for internal carotid artery unruptured aneurysms (ICA-UA). Materials and Methods : A total of 227 ICA-UA in 190 patients were treated with BAC (120 patients, 141 ICA-UA) or SAC (70 patients, 86 ICA-UA. We compared characteristics of patients and ICA-UA, and clinical and angiographic outcomes between groups. Results : Aneurysm size and neck diameter were greater for SAC than in BAC, but aneurysm volume and coil packing density were not different between groups. Immediate angiographic occlusion grade was better for BAC than for SAC. Periprocedural thromboembolic events were more frequent during SAC (11.6%) than BAC (2.4%) per aneurysm, but hemorrhagic events were the opposite (2.4% for BAC and none for SAC per aneurysm) (p < 0.05). At discharge, treatment-related morbi-mortality rates were 1.6% for BAC and 1.4% per patient for SAC. At clinical follow-up (BAC, 118 patients [98.3%] for a mean of 48.4 months; SAC, 69 patients [98.6%], for a mean of 37.4 months), 1 additional treatment-related infarction occurred during SAC, resulting in a modified Rankin scale score of 4. Thus, overall treatment-related morbi-mortality rates were 1.7% in BAC and 2.9% in SAC. At imaging follow-up (BAC, 135 aneurysms [95.7%] for 28.3 months; SAC, 81 aneurysms [94.1%] for 23.9 months), BAC and SAC showed stable or improved occlusion in 94.1% and 95.0%, minor recurrence in 4.4% and 2.5%, and major recurrence in 1.5% and 2.5%, respectively. Conclusion : Both BAC and SAC were safe and effective techniques for ICA-UA. There were no differences in morbi-mortality and recurrence rates between groups.ope

Orbital Venous Malformation Accompanied by Arteriovenous Fistula

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Preoperative Coiling of Coexisting Intracranial Aneurysm and Subsequent Brain Tumor Surgery

OBJECTIVE: Few studies have investigated treatment strategies for brain tumor with a coexisting unruptured intracranial aneurysm (cUIA). The purpose of this study was to evaluate the safety and efficacy of preoperative coiling for cUIA, and subsequent brain tumor surgery. MATERIALS AND METHODS: A total of 19 patients (mean age, 55.2 years; M:F = 4:15) underwent preoperative coiling for 23 cUIAs and subsequent brain tumor surgery. Primary brain tumors were meningiomas (n = 7, 36.8%), pituitary adenomas (n = 7, 36.8%), gliomas (n = 3, 15.8%), vestibular schwannoma (n = 1, 5.3%), and Rathke's cleft cyst (n = 1, 5.3%). cUIAs were located at the distal internal carotid artery (n = 9, 39.1%), anterior cerebral artery (n = 8, 34.8%), middle cerebral artery (n = 4, 17.4%), basilar artery top (n = 1, 4.3%), and posterior cerebral artery, P1 segment (n = 1, 4.3%). The outcomes of preoperative coiling of cUIA and subsequent brain tumor surgery were retrospectively evaluated. RESULTS: Single-microcatheter technique was used in 13 cases (56.5%), balloon-assisted in 4 cases (17.4%), double-microcatheter in 4 cases (17.4%), and stent-assisted in 2 cases (8.7%). Complete cUIA occlusion was achieved in 18 cases (78.3%), while residual neck occurred in 5 cases (21.7%). The only coiling-related complication was 1 transient ischemic attack (5.3%). Neurological deterioration did not occur in any patient during the period between coiling and tumor surgery. At the latest clinical follow-up (mean, 29 months; range, 2-120 months), 15 patients (78.9%) had favorable outcomes (modified Rankin Scale, 0-2), while 4 patients (21.1%) had unfavorable outcomes due to consequences of brain tumor surgery. CONCLUSION: Preoperative coiling and subsequent tumor surgery was safe and effective, making it a reasonable treatment option for patients with brain tumor and cUIA.ope

Pipeline Embolization Device for Large/Giant or Fusiform Aneurysms: An Initial Multi-Center Experience in Korea

PURPOSE: The purpose of this study was to assess the safety and early outcomes of the Pipeline device for large/giant or fusiform aneurysms. MATERIALS AND METHODS: The Pipeline was implanted in a total of 45 patients (mean age, 58 years; M:F=10:35) with 47 large/giant or fusiform aneurysms. We retrospectively evaluated the characteristics of the treated aneurysms, the periprocedural events, morbidity and mortality, and the early outcomes after Pipeline implantation. RESULTS: The aneurysms were located in the internal carotid artery (ICA) cavernous segment (n=25), ICA intradural segment (n=11), vertebrobasilar trunk (n=8), and middle cerebral artery (n=3). Procedure-related events occurred in 18 cases, consisting of incomplete expansion (n=8), shortening-migration (n=5), transient occlusion of a jailed branch (n=3), and in-stent thrombosis (n=2). Treatment-related morbidity occurred in two patients, but without mortality. Both patients had modified Rankin scale (mRS) scores of 2, but had an improved mRS score of 0 at 1-month follow-up. Of the 19 patients presenting with mass effect, 16 improved but three showed no changes in their presenting symptoms. All patients had excellent outcomes (mRS, 0 or 1) during the follow-up period (median, 6 months; range, 2-30 months). Vascular imaging follow-up (n=31, 65.9%; median, 3 months, range, 1-25 months) showed complete or near occlusion of the aneurysm in 24 patients (77.4%) and decreased sac size in seven patients (22.6%). CONCLUSION: In this initial multicenter study in Korea, the Pipeline seemed to be safe and effective for large/giant or fusiform aneurysms. However, a learning period may be required to alleviate device-related events.ope

Comparative Analysis of Feasibility of the Retrograde Suction Decompression Technique for Microsurgical Treatment of Large and Giant Internal Carotid Artery Aneury는

Objective: Retrograde suction decompression (RSD) is an adjuvant technique used for the microsurgical treatment of large and giant internal carotid artery (ICA) aneurysms. In this study, we analyzed the efficacy and safety of the RSD technique for the treatment of large and giant ICA aneurysms relative to other conventional microsurgical techniques. Methods: The aneurysms were classified into two groups depending on whether the RSD method was used (21 in the RSD group vs. 43 in the non-RSD group). Baseline characteristics, details of the surgical procedure, angiographic outcomes, clinical outcomes, and procedure-related complications of each group were reviewed retrospectively. Results: There was no significant difference in the rates of complete neck-clipping between the RSD (57.1%) and non-RSD (67.4%) groups. Similarly, there was no difference in the rates of good clinical outcomes (modified Rankin Scale score, 0-2) between the RSD (85.7%) and non-RSD (81.4%) groups. Considering the initial functional status, 19 of 21 (90.5%) patients in the RSD group and 35 of 43 (81.4%) patients in the non-RSD group showed an improvement or no change in functional status, which did not reach statistical significance. Conclusion: In this study, the microsurgical treatment of large and giant intracranial ICA aneurysms using the RSD technique obtained competitive angiographic and clinical outcomes without increasing the risk of procedure-related complications. The RSD technique might be a useful technical option for the microsurgical treatment of large and giant intracranial ICA aneurysms.ope

Localization and Treatment of Unruptured Paraclinoid Aneurysms: A Proton Density MRI-based Study

OBJECTIVE: The purpose of this study was to evaluate the usefulness of proton density magnetic resonance (PD MR) imaging for localization of paraclinoid internal carotid artery aneurysms. MATERIALS AND METHODS: From April 2014 to April 2015, 76 unruptured paraclinoid aneurysms in 66 patients were evaluated using PD MR and angiography (CT/MR angiography or digital subtraction angiography). The locations (extradural, transdural, intradural) in relation to the distal dural ring (DDR) and projection (superior, inferior/posterior, medial, lateral) of the aneurysms were assessed and compared. RESULTS: The most common location of paraclinoid aneurysms was extradural (n = 48, 63.2%), followed by intradural (n = 18, 23.7%), and transdural (n = 10, 13.2%). In the medial projection group (n = 49, 64.5%), 31 were extradural (63.3%), 5 were transdural (10.2%), and 13 were intradural (26.5%). In the inferior/posterior projection group (n = 19, 25.0%), there were 14 extradural (73.7%), 4 transdural (21.0%), and 1 intradural (5.3%). In the superior (n = 4, 5.3%)/lateral (n = 4, 5.3%) projection groups, there were 0/3 extradural (0/75.0%), 1/0 transdural (25.0/0%), and 3/1 intradural (75.0/25.0%). CONCLUSION: PD MR showed sufficient contrast difference to distinguish paraclinoid aneurysms from surrounding dural structures.ope

Intraventricular hemorrhage clot clearance rate as an outcome predictor in patients with aneurysmal subarachnoid hemorrhage: A retrospective study

Background: The development of intraventricular hemorrhage (IVH) in aneurysmal subarachnoid hemorrhage (aSAH) is linked with higher mortality and poor neurological recovery. Previous studies have investigated the effect of the amount and distribution of the initial IVH on the prognosis of aSAH. However, no studies have assessed the relationship between the changes in IVH over time and the prognosis of aSAH. The aim of this study was to analyze the effect of the clearance rate of IVH, which can be represented by the IVH clot clearance rate (CCR), on the outcomes of aSAH. Methods: The IVH CCR was calculated based on the difference between the initial and follow-up modified Graeb scores (mGS), which were assessed by initial and 7-day follow-up brain computed tomography, respectively. Poor functional outcome was defined as a modified Rankin Scale score of 3-6. Univariate and multivariable analyses were performed to assess the relationships between IVH CCR and other risk factors and the prognosis of patients. Receiver operating characteristic curve analysis was performed to identify cut-off values of IVH CCR for predicting poor functional outcome. Results: In total, 196 consecutive patients were diagnosed with aSAH between January 2014 and March 2018. According to the inclusion and exclusion criteria, 67 patients were finally included in the study. The univariate analysis revealed that a lower IVH CCR (p<0.001), higher initial mGS (p<0.001), older age (p<0.001), higher initial Hunt and Hess grade (p<0.001), presence of delayed infarction (p=0.03), and presence of shunt-dependent hydrocephalus (p=0.004) were significantly related to poor functional outcome. The multivariable analysis revealed that IVH CCR (odds ratio [OR] 0.941; p=0.029), initial mGS (OR 1.632; p=0.043), age (OR 1.561; p=0.007), initial Hunt and Hess grade (OR 227.296; p=0.030), and delayed infarction (OR 5310.632; p=0.023) were independent predictors of poor functional outcome. Optimal cut-off values of IVH CCR and mGS for poor outcome were 36.27%, and 13.5, respectively (all p< 0.001). Conclusions: The IVH CCR might have an important predictive value on poor functional outcome in patients with aSAH and IVH, along with initial mGS, age, initial Hunt and Hess grade, and delayed infarction.ope