Letter to the editor
Preliminary analysis of the healthcare data management process in Spain
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management process in Spain" "tieneTextoCompleto" => true "saludo" => "Dear Editor," "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "232" "paginaFinal" => "233" ] ] "autores" => array:1 [ 0 => array:4 [ "autoresLista" => "V Tíscar-González, J Cayón-De las Cuevas" "autores" => array:2 [ 0 => array:4 [ "nombre" => "V" "apellidos" => "Tíscar-González" "email" => array:1 [ 0 => "veronica.tiscargonzalez@osakidetza.eus" ] "referencia" => array:3 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] 1 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] 2 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">*</span>" "identificador" => "cor0005" ] ] ] 1 => array:3 [ "nombre" => "J" "apellidos" => "Cayón-De las Cuevas" "referencia" => array:2 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] 1 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] ] ] ] "afiliaciones" => array:2 [ 0 => array:3 [ "entidad" => "Responsable de Investigación e Innovación de la OSI Bilbao Basurto, IIS Biobizkaia. Presidenta de la Academia de Ciencias de Enfermería de Bizkaia" "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "Director del grupo de Investigación en derecho sanitario y bioética. IDIVAL-Universidad de Cantabria" "etiqueta" => "b" "identificador" => "aff0010" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">As a preliminary analysis, a descriptive observational study has been undertaken as part of the Project within the Master's Degree in Health Innovation Management (MINDS) organised by the University of Nebrija and the IDIVAL Health Research Institute with the aim of establishing what the situation is at state level of the use of secondary data for research purposes and the performance of Data Protection Impact Assessments (DPIAs) through an ad hoc questionnaire that is sent out by email to all Research Ethics Committees (CEIms) in Spain.</p><p id="par0010" class="elsevierStylePara elsevierViewall">In this study, a total of 36 CEIms (out of a total of 82) responded, representing a response rate of 43.9%. In relation to the Data Protection Impact Assessment (DPIA), 55.6% reported using a self-completed checklist and subsequent assessment by the corresponding research and medicines ethics committee; 16.7% reported that the risk was assessed in a specific impact assessment committee; 11.1% reported that the risk assessment was entrusted to an audit by an external company; and finally, 16.7% used other methods of impact assessment.</p><p id="par0015" class="elsevierStylePara elsevierViewall">In relation to the time that participants estimated that it usually took for their organisation to approve an impact assessment for the secondary use of data for research purposes, the average time was 2 months, but with significant variability between the different autonomous communities. The time to obtain a favourable report from the DPIA, according to the participants, ranged from 2 weeks in the autonomous community that needed the least time, to between 6 months and more than 1 year in the autonomous communities where this process took longer. Differences were observed even within the same autonomous community. Eight (22.2%) people were unaware of the time it took for their institution to approve a DPIA and two regional CEIm committees reported that there was no clearly defined structure or procedure for the Data Protection Impact Assessment in their Autonomous Community.</p><p id="par0020" class="elsevierStylePara elsevierViewall">Regarding the service in charge of data mining for research purposes, in 52.8% of the cases this was the IT service in charge of data mining, followed by clinical documentation services in 41.7%. Finally, the remaining 5.5% was mined by the Epidemiology unit or similar. In relation to the estimated time required for data mining in their organisations, there were again notable differences between the different regions. The time to obtain the data, according to the participants, ranged from 1 month in the autonomous community that needed the least time to between 6 months and 1 year in the autonomous communities where this process took longer. This means that in some cases, around 16 months couldd elapse between an application, presentation of the project by the research team, and finally obtaining the data. Five participants did not know the time required for data collection at their institution.</p><p id="par0025" class="elsevierStylePara elsevierViewall">Regarding the new European data protection regulation, 66.7% said they were aware of this European regulation. Although in general the participants considered that the new European regulations will facilitate the secondary use of data for research purposes; 40.9% (9) of the 22 professionals who answered this question were less optimistic, waiting to see how the Spanish regulations will be adapted for its interpretation and application by the autonomous communities and organisations themselves.</p><p id="par0030" class="elsevierStylePara elsevierViewall">There is no doubt that data is currently the cornerstone of research and opens up interesting opportunities for the future at the clinical and management level. In spite of this, there are a series of ethical-legal difficulties in this country that make it difficult to access data and manage it for its use in research.<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">1–3</span></a></p><p id="par0035" class="elsevierStylePara elsevierViewall">This preliminary analysis presents a first approximation to working out how data is processed for research purposes in the different regions, evidencing the differences that currently exist.</p><p id="par0040" class="elsevierStylePara elsevierViewall">In this country, the decisions over Data Protection Impact Assessments can range from a few weeks to more than a year, which may be a consequence of varying interpretations and application of the current regulations depending on the region. Even within the same autonomous community differences can be observed in the process depending on the CEIm and the mechanism used for decisions over impact assessments (the Impact Assessment Committee, checklist, audit by external company or others). Therefore, as highlighted by other authors such as Lalova-Spinks et al.,<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a> the lack of legal harmonisation continues to constitute one of the main challenges in complying with the General Data Protection Regulation (GDPR) as regards research, highlighting the differences in its interpretation at local, regional and even institutional levels.</p><p id="par0045" class="elsevierStylePara elsevierViewall">For all the above reasons, it would be advisable to standardise the protocols for action in order to reduce possible inequality. As some authors<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a> have stated, it is necessary for the systems and processes created to ensure that research safety is fast-moving and flexible, and to be able to adapt as emerging methodologies and technologies evolve.</p></span>" "pdfFichero" => "main.pdf" "tienePdf" => true "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:5 [ 0 => array:3 [ "identificador" => "bib0005" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Primary, secondary, and meta-analysis of research" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:1 [ 0 => "G. 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