The Electronic Health Record (EHR): Legal framework and issues about personal data protection

2018 ◽  
Vol 19 (3-4) ◽  
pp. 141-159
Author(s):  
Licia Califano
2016 ◽  
Vol 23 (3) ◽  
pp. 265-277
Author(s):  
Silvio Bologna ◽  
Alessandro Bellavista ◽  
Pietro Paolo Corso ◽  
Gianluca Zangara

The present article deals with the Italian Electronic Health Record (hereinafter ehr), recently introduced by Act 221/2012, with a specific focus on personal data protection. Privacy issues — e.g., informed consent, data processing, patients’ rights and minors’ will — are discussed within the framework of recent e-Health legislation, national Data Protection Code, the related Data Protection Authority pronouncements and eu law. The paper is aimed at discussing the problems arising from a complex, fragmentary and sometimes uncertain legal framework on e-Health.


2020 ◽  
Vol 7 (1) ◽  
Author(s):  
Karl Stoeger ◽  
Martina Schmidhuber

Abstract National electronic health record systems controlled (at least in parts) by the patient are becoming increasingly common. During a pandemic, data stored in such records could be used by health authorities to identify persons with a particular health risk. In this contribution, the authors focus-from the perspective of law and medical ethics-on the question whether such state access to data could, under certain circumstances, be disadvantageous to a person’s state of health in the long run. This may be the case if the data extracted is not only used for the purpose of informing persons, but serves as a basis for measures taken against the will of the individual concerned. This might be perceived as a “breach of trust” and could result in persons opting out of or not opting into an electronic health record system. Such unintended consequences raise concerns from an ethical and a legal point of view. It follows that, even in times of a pandemic, access to personal data stored in patient-controlled health records should be used as a last resort only. While this contribution deals with the legal framework within the EU, its considerations are transferable to other national electronic health record systems.


Author(s):  
Rita De Sousa Costa

[PT]No presente texto, apresentamos as grandes linhas de aplicação do direito europeu da protecção de dados conforme gizadas pela jurisprudência do TJUE, com o objectivo de demonstrar como e em que medida este Tribunal modelou – e continua a modelar – o quadro jurídico em vigor, na certeza de que aquela jurisprudência impõe um conjunto de desafios determinantes para a realização material do direito europeu da protecção de dados pessoais. [ESP]Este texto presenta las líneas generales de la aplicación de la legislación europea de protección de datos tal como se establece en la jurisprudencia del TJUE, con el objetivo de demostrar cómo y en qué medida este Tribunal ha configurado -y sigue configurando- el marco jurídico vigente, con la certeza de que la dicha jurisprudencia plantea una serie de retos cruciales para la aplicación material del derecho europeo de la protección de datos personales. [ENG]This text outlines the implementation of the European data protection law as laid down in the case-law of the Court of Justice of the European Union, with the aim of demonstrating how and to what extent the Court has shaped – and continues to shape – the current legal framework. The case-law analysed points out a plethora of challenges which are key to the implementation of the European personal data protection law.


Author(s):  
Olympia Giannakopoulou ◽  
Petros Toumpaniaris ◽  
Ioannis Kouris ◽  
Konstantia Moirogiorgou ◽  
Nansy Karanasiou ◽  
...  

eMass project aims to digitalize the medical examination procedure of recruitment phase of conscripts in the Hellenic Navy. eMass integrates recruits’ Electronic Health Record (EHR), while allows a pre-screening test, through portable telemedicine equipment. The data will be exploited to assess the individual’s cardiovascular risk through appropriate digital tools and algorithms. The eMass digital platform, will be accessible to health experts involved in the recruitment procedure for further assessment and processing. Recruits’ personal data is stored in the database encrypted using Advanced Encryption Standard (AES). eMass solution contributes to beneficial management and medical data analysis, preventing inessential physical or medical examinations minimizing danger of possible errors and reducing time-consuming processes. Moreover, eMass exploits Electronic Health Record data through a machine-learning based cardiovascular risk assessment tool.


Author(s):  
Alexander Gurkov

AbstractThis chapter considers the legal framework of data protection in Russia. The adoption of the Yarovaya laws, data localization requirement, and enactment of sovereign Runet regulations allowing for isolation of the internet in Russia paint a grim representation of state control over data flows in Russia. Upon closer examination, it can be seen that the development of data protection in Russia follows many of the steps taken at the EU level, although some EU measures violated fundamental rights and were invalidated. Specific rules in this sphere in Russia are similar to the European General Data Protection Regulation. This chapter shows the special role of Roskomnadzor in forming data protection regulations by construing vaguely defined rules of legislation.


Author(s):  
Maria Casoria ◽  
Eman Mahmood AlSarraf

The chapter discusses the influence of the General Data Protection Regulation (GDPR) on legal systems extra-EU and particularly the Kingdom of Bahrain, country member to a regional organisation located in the Arabian Gulf denominated Gulf Cooperation Council (GCC), which is exclusive to six states (i.e., Saudi Arabia, United Arab Emirates, Oman, Qatar, and Kuwait in addition to Bahrain). Amongst these countries, Bahrain is the only one that has recently enacted its own separate Personal Data Protection Law (PDPL) mostly resembling the GDPR due to the ever-increasing commercial relationship with business undertakings in Europe. Moreover, the adoption of the data protection law counts as a huge leap forward taken by the kingdom in reforming its legal framework, since it is the state's striving strategy to grow into a midpoint for data centre, just on time for the launch of data centres opening in Bahrain that are endorsed by Amazon Web Services.


Author(s):  
A. G. Barabashev ◽  
D. V. Ponomareva

Legal regulation of the use of personal data is essential in ensuring the quality of scientific research. Regulation of the European Parliament and of the Council of the European Union No. 2016/679 of April 27, 2016 «On the protection of natural persons with regard to the processing of personal data and on the free movement of such data», repealing Directive 95/46/EC, aims to unify the standards governing the protection of human rights to privacy, certain conditions beyond. This novel, introduced by the Regulation in the EU legal framework, complements and updates the acquis communautaire achieved within the framework of Directive 95/46/EC on personal data protection. The Regulation establishes both general rules applicable to any type of personal data processing and special rules applicable to the analysis of certain categories of personal data, such as information obtained during clinical trials. This paper provides an overview of new standards (in force since May 2018) that regulate aspects of personal data processing in the context of research activities (personal health data, genetic, biometric information, etc.)


BMJ ◽  
2004 ◽  
Vol 328 (7444) ◽  
pp. 871-874 ◽  
Author(s):  
Trina Adams ◽  
Martin Budden ◽  
Chris Hoare ◽  
Hugh Sanderson

2008 ◽  
Vol 12 (1) ◽  
pp. 63-74
Author(s):  
Calin Veghes

Protection of personal data represents a relatively recent concern for all the entities consumers, organizations and public institutions involved in the development of the direct marketing industry and the overall Romanian market. Noteworthy growth of the direct marketing campaigns, increase in the consumer demands and expectations and the background provided by the countrys adhesion to the European Union, have determined a strong necessity to build up a legal framework for protection of the personal data. Important steps have been made when laws no. 677 (on the protection of the personal data in terms of their processing and free circulation - 2001), no. 506 (on the processing of personal data and protection of privacy in the electronic communications sector - 2004) and no. 102 (regarding the setting up, organization and functioning of the National Supervisory Authority for Personal Data Processing - 2005) have been issued. Adoption of the Directive no. 95/46/EC has connected Romanian and European Union legal framework of the personal data protection. Enforcement of the existing legal background has revealed several problems that have affected activities conducted mainly by the direct marketing and marketing research companies. Relatively unclear definition of the content of personal data to be protected appeared to be one of the most important. From this point, at least the following questions should be answered:what is the specific meaning of the personal data? What data is personal and must be protected through dedicated laws and regulations?are public initiatives best ways and public institutions sole entities to handle the development of an effective legal background for the personal data protection?how important is the voice of the consumers in the process of development of a regulatory environment in this area? Should those to be protected represent the main source of initiating and building the related legal framework?An exploratory survey on a sample including 96 Romanian urban consumers aged 18 to 45 has been conducted aiming to provide information on the: importance of the data protection for the consumers, main characteristics of the data protection legal environment (area of protection, public-private, respectively national-international relationships in terms of the data protection, need for national or international laws and regulations), content of the personal data to be protected by a more precisely defined object of the law, consumer preferences regarding the opt-in and opt-out mechanisms, knowledge associated to the legal rights of consumers related to the personal data protection as they are granted through the existing law, major risks associated with the absence or improper personal data protection mechanisms, consumers exposure to the personal communication media, preferences for personal sources of information and perceived importance of personalization as potential factors to be considered for the development of the personal data protection legal framework, opportunity to develop and implement a Robinson list.Results of the survey may serve as a starting point for a future research conducted at the level of a national representative sample and the Romanian experience may be considered for the upcoming effort to develop a legal framework of the personal data protection in the European Union based on the consumers views, needs and expectations.


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