International experience with performance-based risk-sharing arrangements: implications for the Chinese innovative pharmaceutical market

2020 ◽  
Vol 36 (5) ◽  
pp. 486-491
Author(s):  
Weiwei Xu ◽  
Jing Wu
Keyword(s):  
Risk Sharing ◽  
Grey Literature ◽  
Personal Data ◽  
International Experience ◽  
Successful Implementation ◽  
Personal Data Protection ◽  
Implementation Costs ◽  
Government Websites ◽  
And Performance ◽  
Feasible Outcome

ObjectivesVarious forms of outcomes-based or risk-sharing agreements have been implemented since early 2000s as a way of access to innovative medicinal products. This study aims to summarize the international experience of performance-based risk-sharing arrangements (PBRSAs) and identify the preconditions for a successful implementation of such schemes. Their implications for the Chinese healthcare market are discussed.MethodsA systematic literature review (in PubMed) was conducted to review the evidence on the nature and performance of PBRSAs in the past 10 years. Grey literature was searched for reports in government websites of the countries in scope.ResultsThe search identifies 463 records from PubMed and 3 additional records from other sources. Thirty-one publications are included in the final review. The following preconditions were identified to support a successful implementation of PBRSAs: (1) Identify meaningful and feasible outcome measurements; (2) Establish an effective and efficient data collection infrastructure; (3) Control of the implementation costs; (4) Develop governance and administrative infrastructure to allow delisting and rebate/refund; (5) Clarify personal data protection issues.ConclusionsThe implementation of PBRSAs has proven to be challenging. Although the Chinese healthcare system is not yet well equipped to implement such schemes, some recent changes may pave the way to successful PBRSAs for particular innovative products.

scholarly journals International experience in personal data protection

2020 ◽  
Vol 16 (1) ◽  
Author(s):  
Alla Andreevna Neznamova ◽  
Georgyi Nickolaevich Kuleshov ◽  
Mikhail Mikhailovich Turkin
Keyword(s):  
Personal Data ◽  
International Experience ◽  
The European Union ◽  
Council Of Europe ◽  
Personal Data Protection ◽  
Eu Directive ◽  
Mandatory Notification ◽  
General Scientific ◽  
Definition Of ◽  
The Right

The article is devoted to the analysis of various approaches to the protection of personal data in Russia and the European Union. In order to determine the importance of observing the right to protection of personal data, a number of documents of the European Commission adopted over the past few years have been analyzed. General scientific and special legal methods of cognition allowed for a comparative analysis of Regulation 2016/679 on the Protection of Individuals in the Processing of Personal Data and Their Free Movement (2018) and EU Directive 2016/680. Although Russia has ratified the Council of Europe Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data (1981), it has not been able to solve a number of problems related to the mandatory notification about personal data leaks, protection of personal data during their processing and against unauthorized access, etc. As a result, conclusions are drawn regarding the prevailing approaches to the definition of personal data and a unified conceptual and categorical apparatus in the field of personal data. Proposals for the modernization of Russian legislation based on international experience are made as well.

Importance of Personal Data Protection Law for Commercial Air Transport

2017 ◽  
Vol 2017 (1) ◽  
pp. 35-44
Author(s):  
Dawid Zadura
Keyword(s):  
Data Protection ◽  
Public Information ◽  
Personal Data ◽  
Air Transport ◽  
Civil Aviation ◽  
Aviation Industry ◽  
Personal Data Protection ◽  
It Systems ◽  
Data Protection Law ◽  
The Law

Abstract In the review below the author presents a general overview of the selected contemporary legal issues related to the present growth of the aviation industry and the development of aviation technologies. The review is focused on the questions at the intersection of aviation law and personal data protection law. Massive processing of passenger data (Passenger Name Record, PNR) in IT systems is a daily activity for the contemporary aviation industry. Simultaneously, since the mid- 1990s we can observe the rapid growth of personal data protection law as a very new branch of the law. The importance of this new branch of the law for the aviation industry is however still questionable and unclear. This article includes the summary of the author’s own research conducted between 2011 and 2017, in particular his audits in LOT Polish Airlines (June 2011-April 2013) and Lublin Airport (July - September 2013) and the author’s analyses of public information shared by International Civil Aviation Organization (ICAO), International Air Transport Association (IATA), Association of European Airlines (AEA), Civil Aviation Authority (ULC) and (GIODO). The purpose of the author’s research was to determine the applicability of the implementation of technical and organizational measures established by personal data protection law in aviation industry entities.

Problems of establishment and development of the Institution of personal data protection in the Russian Federation: historical-legal aspect

2020 ◽  
pp. 28-35
Author(s):  
Yanis Arturovich Sekste ◽  
Anna Sergeevna Markevich
Keyword(s):  
Russian Federation ◽  
Data Protection ◽  
Information Technologies ◽  
Legal Aspect ◽  
Personal Data ◽  
Legal Regulation ◽  
Private Life ◽  
Russian Society ◽  
Personal Data Protection ◽  
The Russian Federation

The subject of this research is the problems emerging in the process of establishment and development of the Institution of personal data protection in the Russian Federation. Special attention is turned to the comparison of Soviet and Western models of protection of private life and personal data. The authors used interdisciplinary approach, as comprehensive and coherent understanding of socio-legal institution of personal data protection in the Russian Federation is only possible in inseparable connection with examination of peculiarities of the key historical stages in legal regulation of private life of the citizen. After dissolution of the Soviet political and legal system, the primary task of Russian law consisted in development and legal formalization of the institution of protection of human and civil rights and freedoms, first and foremost by means of restricting invasion of privacy by the state and enjoyment of personal freedom. It is concluded that the peculiarities of development of the new Russian political and legal model significantly impacted the formation of the institution of personal data protection in the Russian Federation. The authors believe that the Russian legislator and competent government branches are not always capable to manage the entire information flow of personal data; therefore, one of the priority tasks in modern Russian society is the permanent analysis and constant monitoring of the development of information technologies.

Sign in / Sign up

Export Citation Format

Share Document