Editorial
General Data Protection Regulation. What is new?
Reglamento General de Protección de Datos. ¿Qué novedades presenta?
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A variable-size ROI was manually outlined, including the total uptake area. Maximum counts, pixel number and average counts were obtained for that area.</p>" ] ] ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "Diego F. López Buitrago, Juan M. Muñoz Acosta, Rodrigo A. Cárdenas-Perilla" "autores" => array:3 [ 0 => array:2 [ "nombre" => "Diego F." "apellidos" => "López Buitrago" ] 1 => array:2 [ "nombre" => "Juan M." "apellidos" => "Muñoz Acosta" ] 2 => array:2 [ "nombre" => "Rodrigo A." 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"tieneTextoCompleto" => true "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "69" "paginaFinal" => "71" ] ] "autores" => array:1 [ 0 => array:4 [ "autoresLista" => "M. Milà, F. Abellán" "autores" => array:2 [ 0 => array:4 [ "nombre" => "M." "apellidos" => "Milà" "email" => array:1 [ 0 => "mamila_13@hotmail.com" ] "referencia" => array:2 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] 1 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">*</span>" "identificador" => "cor0005" ] ] ] 1 => array:3 [ "nombre" => "F." "apellidos" => "Abellán" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] ] ] ] "afiliaciones" => array:2 [ 0 => array:3 [ "entidad" => "Servicio Medicina Nuclear IDI, H.U. Joan XXIII, Tarragona, Spain" "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "Derecho Sanitario Asesores, Madrid, Spain" "etiqueta" => "b" "identificador" => "aff0010" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Reglamento General de Protección de Datos. ¿Qué novedades presenta?" ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">In 2018 there was an important change in the regulations applying to our field with the adoption of 2 new European directives. The first is the European Directive 2013/59/EURATOM which was discussed previously in this journal by de Haro del Moral and Barquero<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">1</span></a> with undeniable rigor, and highlighted the significant changes to be addressed with regard to the regulations on radiological protection. The second is the Directive 2016/679 EC of the European Parliament and Commission of 27 April 2016 related to the protection of natural persons and the processing of personal data and free movement of such data. This Directive has replaced Directive 95/46EC (hereafter referred to as the General Data Protection Regulation [GDOR]), having entered into force 25 May 2018, and it is the subject of the present editorial.</p><p id="par0010" class="elsevierStylePara elsevierViewall">The protection of personal data of natural persons was established as a fundamental right of the European Union (EU) (art. 8.1 of the EU Charter of Fundamental Rights and art. 16.1 of the Treaty of the Functioning of the EU [TFEU]). On the other hand, the globalization and development of the digital era has led to an important increase in the storage and exchange of personal data even at an international level, and therefore, also among members countries. In this aspect, medicine is not an exception. Technological advances have transformed health care and day-to-day physician–patient relationships with the digitalization of clinical histories or the use of electronic prescription. With these new challenges for the protection of personal data, the GDPR aims to guarantee the protection of data of natural persons equally and uniformly among all the EU members and guarantee free movement of personal data within the EU as stated in the preface of the GDPR.</p><p id="par0015" class="elsevierStylePara elsevierViewall">It is highly recommendable to have adequate knowledge of the GDPR and obtain specialized counseling on the processing of personal data in order to correctly comply with the regulations and the protection of the right of patients/users in this field as advised by member medical societies.<a class="elsevierStyleCrossRefs" href="#bib0045"><span class="elsevierStyleSup">2,3</span></a> This is especially important if we reflect upon the notable monetary increase of the administrative sanctions imposed for non compliance with obligations related to the protection of personal data in the new GDPR, which are much greater than those established by the Organic Law 15/1999, 13 December, on Personal Data Protection (OLPD).<a class="elsevierStyleCrossRefs" href="#bib0055"><span class="elsevierStyleSup">4,5</span></a> At present, the sanctions for non compliance with the technical and organizational requisites for data processing, or non observance of the delegation of data processing, or the registry of data processing activities, may imply a maximum fine of 10,000,000<span class="elsevierStyleHsp" style=""></span>€ or 2% of the volume of the total annual turnover (art. 83.4 GDPR), and in the case of sanctions for non observance of the regulations in aspects related to the basic principles of treatment, consent, data transfer or non compliance with the resolution of the controlling authority, among others, this fine may ascend to a maximum of 20,000,000<span class="elsevierStyleHsp" style=""></span>€ or 4% of the total annual turnover (art. 83.5 RGPD).</p><p id="par0020" class="elsevierStylePara elsevierViewall">Consequently, what are the most relevant modifications, changes or novelties of the new GDPR which we should know for our daily practice as nuclear medicine physicians?</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">The principle of “Proactive Responsibility”</span><p id="par0025" class="elsevierStylePara elsevierViewall">In the EU regulations on data protection, the GDPR has introduced the principle of “Proactive Responsibility”. This principle establishes that those responsible for data processing are responsible for protecting the obligations and fundamental freedom of natural persons and, especially, their right to data protection, and moreover, should be able to demonstrate this. Therefore, all the measures necessary must be applied to guarantee the protection of personal data, and this must be demonstrated to the competent supervisory authorities.</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Data controller. Notification of personal data breaches</span><p id="par0030" class="elsevierStylePara elsevierViewall">The GDPR describes 2 determinant figures of data processing: the data processor and data controller. The data controller is the natural, legal person or public authority which establishes the objectives and means of data processing. It is mandatory for the controller to apply the most adequate technical and organizational measures to guarantee and demonstrate that the data are controlled in accordance with the GDPR (art. 24 RGPD). On the other hand, the data processor is the natural or legal person or public authority who processes the personal data on behalf of the controller. The controller should provide sufficient guarantees to apply the appropriate technical and organizational measures to ensure that data processing follows the GDPR and gurantees the protection of the rights of the data subject (art. 28 RGPD).</p><p id="par0035" class="elsevierStylePara elsevierViewall">The GDPR introduces the <span class="elsevierStyleItalic">notification of personal data breaches</span>, and under this principle the processor is obliged to notify the controller of the personal data breach within a maximum of 72<span class="elsevierStyleHsp" style=""></span>h (art. 33 RGPD), and even in the likely case that this breach may carry a high risk to the rights and freedom of natural persons, the controller must report the situation to the data subject (art. 34 RGPD).</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Special categories of personal data</span><p id="par0040" class="elsevierStylePara elsevierViewall">The clinical practice of Nuclear Medicine Departments includes the storage and processing of personal data catalogued by the GDPR as <span class="elsevierStyleItalic">special categories of personal data</span> previously known as especially protected data according to the OLPD. Among data which are relevant to our field, these data include personal information revealing ethnic or racial origin, health-related data, sex life or sexual orientation. In addition, however, the new directive adds 2 new categories of special data: the processing of <span class="elsevierStyleItalic">genetic data</span> and <span class="elsevierStyleItalic">biometric data</span> aimed at unequivocally identifying natural persons.</p><p id="par0045" class="elsevierStylePara elsevierViewall">In general, article 9.1 of the GDPR prohibits the processing of special categories of data except in some cases in which it is of public interest to do so. These include when processing personal data is necessary for objectives of preventive or occupational medicine, evaluation of employment capacity, medical diagnosis, provision of health care or health care or social protection or the management of health care and social systems and services, provided that it is guaranteed that the processing of the personal data is performed under professional secrecy according to Union or Member State Law or competent authorities.</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Designation of the data protection officer</span><p id="par0050" class="elsevierStylePara elsevierViewall">Art. 37 of the GDPR includes a substantial new change regarding our practice to date, which specifies that if the core activities of the controller or the processor involve the processing of a large amount of special categories of data, a <span class="elsevierStyleItalic">data protection officer</span> must be designated.</p><p id="par0055" class="elsevierStylePara elsevierViewall">The principal functions of the data protection officer include informing and advising the data controller or processor and the employees, ensure compliance with European and state regulations, cooperate with the controlling authority and carry out the necessary counseling.</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Consent</span><p id="par0060" class="elsevierStylePara elsevierViewall">According to articles 7.7 and 8 of the OLPD, for the processing personal data for health care objectives it is not necessary to obtain consent, although there must be compliance with the established principles of information. In cases in which the personal data are used for objectives other than those related to health, the patient must provide consent.</p><p id="par0065" class="elsevierStylePara elsevierViewall">Besides aspects of health care, the GDPR increases the requirements for obtaining consent, which must be unambiguous, freely given and reversible. Consent should be given with a clearly stated affirmation. <span class="elsevierStyleItalic">Non verbal consent is not admitted</span> since the controller must be able to demonstrate that the data subject consented to the processing of his/her personal data (art. 7 GDPR). This novelty is fundamentally applied to the processing of data with commercial objectives for which it is no longer possible to use large databases for indiscriminantly sending reports.</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0030">New rights</span><p id="par0070" class="elsevierStylePara elsevierViewall">The GDPR has amplified the rights of the patients with respect to the processing of personal data. The right to be forgotten, the right to the restriction of data processing and the right of data portability have been added to the already known rights of access, rectification, cancellation and opposition (ARCO rights).</p><p id="par0075" class="elsevierStylePara elsevierViewall">The right to be forgotten allows the data subject to obtain the erasure of personal data by the controller in cases established by the GDPR. In addition, in cases in which the data have been made public, reasonable measures should be adopted to inform the controllers of the erasure of any link to these data, or any copy or replication of these data (art. 17 GDPR).</p><p id="par0080" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleItalic">Right to the restriction of data processing</span>: The data subject may obtain a restriction of data processing from the controller if they fulfill the conditions established by the GDPR (art. 18 RGPD).</p><p id="par0085" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleItalic">Right of data portability</span>: the data subject will have the right to receive the personal data concerning him/her. It allows him/her to move, copy or transfer personal data across different services without affecting the controller facilitating the transfer. The data subject even has the right to directly transfer the data from one controller to another whenever technically possible (art. 20 RGPD).</p><p id="par0090" class="elsevierStylePara elsevierViewall">The GDPR directive has been directly applicable since May 25, 2018 and does not require internal regulations for transposition. As health care professionals working with personal data from the special categories we must know the application of the European regulations regarding the processing of personal data to ensure the rights of our patient related to the management of their personal data.</p><p id="par0095" class="elsevierStylePara elsevierViewall">Considering the high demands of the European Directives and their complexity, it is recommendable to analyze their application in each organization as well as obtain specialized counseling for correct compliance.</p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">New Spanish law of data protection and important novelties in areas of investigation with health care data</span><p id="par0100" class="elsevierStylePara elsevierViewall">Within a short time the previously mentioned GDPR will bring about the derogation of the internal Spanish laws of protection of personal data (the OLPD and its regulations) and the promotion of a new OLPD, which at the time of writing the present article, is in the final phase of approval in the Spanish Congress, with major consensus from the political parties.<a class="elsevierStyleCrossRefs" href="#bib0065"><span class="elsevierStyleSup">6,7</span></a></p><p id="par0105" class="elsevierStylePara elsevierViewall">The new Spanish law in this area will propose a novel and much more flexible scenario for investigators which can be summarized in the following 3 points:<ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">1.</span><p id="par0110" class="elsevierStylePara elsevierViewall">Consent for the use of data aimed at biomedical investigation will cover categories related to <span class="elsevierStyleItalic">general related areas</span> of a medical or investigative specialty. For example, patient consent will be valid for data to be used in an investigation of a wide area of nuclear medicine without the need for the document to be limited to a specific investigation project.</p></li><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">2.</span><p id="par0115" class="elsevierStylePara elsevierViewall">In addition, reuse of these personal data for the objective of medical and biomedical investigation will be lawful provided that when consent has been obtained for a specific purpose, the data are used for objectives or areas of investigation related to areas in which the initial study was scientifically integrated. In other words, it will not be necessary to obtain further consent from the patient for this purpose.</p></li><li class="elsevierStyleListItem" id="lsti0015"><span class="elsevierStyleLabel">3.</span><p id="par0120" class="elsevierStylePara elsevierViewall">The use of pseudonymized personal data for investigative purposes will be considered lawful without the need to obtain patient consent. In the GDPR, pseudonymization is defined and consists in the processing of data in such a way that the invidual cannot be identified without using additional information, provided that this additional information appears separately and is subject to technical and organizational measures to avoid identification (this system is equivalent to the codification of data). Consequently, it will no longer be necessary for this type of investigation to obtain informed consent or for the data to be previously anonymized, but rather it will be sufficient for the information to be pseudonymized, thereby facilitating the casting of information of clinical histories and availability of the data necessary for their study to investigators.</p></li></ul></p><p id="par0125" class="elsevierStylePara elsevierViewall">Proposals 2 (reuse) and 3 (use of pseudonymized data) mentioned above will require specific conditions which the investigative team must comply with, and these are described in the new bill (following a favorable report from the ethics committee of investigation, etc.). Although the fundamental idea underlying the reform is that consent for investigation with health care data will no longer be the keystone of the system as it has been up to now, it will undoubtedly be an important advance to potentiate investigation with data related to health and to facilitate big data projects in health care.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:8 [ 0 => array:2 [ "identificador" => "sec0005" "titulo" => "The principle of “Proactive Responsibility”" ] 1 => array:2 [ "identificador" => "sec0010" "titulo" => "Data controller. 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Rev Esp Med Nucl Imagen Mol. 2019;38:69–71.</p>" ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0015" "bibliografiaReferencia" => array:7 [ 0 => array:3 [ "identificador" => "bib0040" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "La directiva ya está aquí. ¿Estamos preparados?" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:2 [ 0 => "F.J. de Haro del Moral" 1 => "R. 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