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BALEARIC ISLANDS HEALTH INFORMATION RESEARCH (PRISIB)

Introduction

Since 1999, the Health Service of the Balearic Islands (IBSalut) has been incorporating computerised information and communication tools in healthcare. In addition to the multiple advantages that these systems have in citizen care, they represent an opportunity for the generation of knowledge and for the improvement of health.

Data analysis provides insight into the clinical and care reality of the population and can provide valid information to answer research questions that generate predictive models, study behavioural patterns or lead to the discovery of new needs and strategies for risk reduction and the provision of more personalised services.

In order to take advantage of these opportunities, IdISBA and IBSalut agreed to create a specific structure for research to make these data available to researchers and to promote clinical and health research with real world healthcare data.

Objectives

Accordingly, the objectives of PRISIB are:

Support research by providing valid and reliable data from IBSALUT's computerised medical records and other complementary sources.
Contribute to the generation of knowledge, training and innovation in the field of health data research.
Collaborate with care structures to respond to information needs that are essential for management.

To meet these objectives we offer various services aimed at secondary use of healthcare data, participation in federated research structures and training the research community in so-called Data Science

Services

PRISIB offers the following services:

Extraction of data from the electronic medical record for research projects. The project requesting data from PRISIB must respond to a protocol duly drawn up by the research team developing it. This protocol must have been approved by the corresponding research committee, the Ethics Committee and the PRISIB Scientific-Technical Committee.

This service includes the creation of the project's data model, the identification of data sources, the mapping of variables, the creation of extraction algorithms, the scheduling of periodic extractions, the anonymised georeferencing of data and the analysis of data quality, descriptive statistics and anonymity.

Consultations for feasibility studies or exploratory studies. A consultation service is offered for feasibility studies that provides approximate data, without quality control and whose objective is to have a first approximation of the problem in order to assess whether it is subsequently worthwhile to develop a more ambitious study. These are studies in which you want to know the N that exists in the databases of a certain problem or how certain information of interest is registered. These consultations are offered free of charge as they are used to develop the protocols for subsequent studies.
Visualisation of data linked to research projects. These visualisations can range from the generation of vector maps or statistical graphs to the implementation of interactive reports in web format.
Implementation of systems for research data collection, case randomisation and pseudonymisation.
Custody of research data, which would be stored in the Platform's data repository at the Health Service's data processing centre.
Advice on drafting research project applications, interoperability plans, data management plans and other documentation related to the use of data in health research.

Sources of data

It collects the clinical information of nearly 1,300,000 active users, distributed among 59 Health Centres, 103 Basic Health Units, 38 Primary Care Emergency Services, 47 Women's Care Units and 7 hospitals of the Health Service of the Balearic Islands.

Ethical principles

The platform respects the fundamental bioethical principles inherent to all health activities (beneficence, non-maleficence, autonomy and justice), with special attention to those that protect the privacy and safety of users.

Researchers applying for the platform's services shall sign an agreement to respect the principles and to comply with the conditions of access laid down.

Protection of personal data

In addition to ethical principles, this platform will implement security measures to ensure privacy and strengthen the protection of personal data.

In case of authorisation for data extraction, the data provided will be pseudonymised.

The prior signature of an informed consent by the study subjects will be required for the access and use of their data that cannot be de-identified by their nature, such as genomic data or personal data (address, telephone number, etc.).

The platform operates in accordance with the regulations in force, highlighting, but not excluding others:

EU Regulation 2016/679 of the European Parliament and of the Council of 27 April 2016 (EU's GDPR)
The Organic Law 3/2018 on the protection of personal data and guarantee of digital rights (LOPDGDD)
Basic Law 41/2002 regulating patient autonomy and the rights and obligations regarding clinical information and documentation.
Royal Decree 957/2020 regulating observational studies involving medicinal products for human use

Governance

PRISIB Steering Committee: In charge of defining and approving the guidelines, requirements and regulations of the platform.
PRISIB Delegate Commission: With the task of implementing the decisions of the Steering Committee, proposing the work plan, monitoring, ensuring compliance with regulations and resolving problems and contingencies that may arise during the platform's activity.
PRISIB's Scientific-Technical Committee: With the functions of evaluating the applications that reach the platform, ensuring the scientific and technical quality of the platform's work and proposing improvements to the platform's procedures.
- Composition:
  - Scientific Director of IdISBa or person delegated by him/her.
    - Miquel Fiol
  - Head of Innovation at IdISBa or person delegated by him
    - Carlos Enrique
  - Head of the IdISBa Methodological Support Platform or person delegated by him/her.
    - Guillem Frontera (substitute Aina Millán).
  - Head of the Health Data Observatory or person delegated by him/her.
    - Noemí Pérez
  - President of the Research Ethics Committee of the Balearic Islands (CEI-IB) or person she or he may delegate
    - Francisco Campoamor
  - Data Protection Delegate of the Health Service of the Balearic Islands or person delegated by him/her.
    - Miguel Ángel Benito
  - Researcher proposed by the Research Commission of the Primary Care Management Department.
    - Oana Bulilete (substitute Joana Ripoll)
  - Researcher proposed by the Son Espases Research Commission
    - Francisco Fanjul (substitute Borja G. Cosío).
  - Researcher proposed by the Son Llàtzer Research Commission.
    - Fiorella Sarubbo (substitute Mónica Sanz).
  - Researcher proposed by the Research Commission of the Health Area of Eivissa and Formentera.
    - Maria Costa (substitute Aranzazu López).
  - Researcher proposed by the Research Commission of the Menorca Health Area.
    - Matías Torrent (substitute Fèlix Vinent).
  - Researcher proposed by the IUNICS
    - Aina Yáñez (substitute Josep Tur).
  - Head of the PRISIB platform, who will act as secretary of the committee and will not have the right to vote.
    - Pau Pericàs

Evaluation criteria

The criteria to be taken into account when assessing projects requesting the use of PRISIB data are as follows:

Feasibility (possibility to obtain data from PRISIB)
Scientific quality and relevance of the project
Degree of interference with existing projects by IdISBa groups.
Compatibility with IBSalut's clinical strategy
Extent to which the project can be financed

Platform resources and location

The platform has an IT technician with the capacity to extract data from electronic medical records and a manager with health and technical training for the analysis, validation and implementation of projects.

The platform staff is located in Building S of the Hospital Universitari Son Espases in Palma.

Impact

PRISIB has contributed data for more than 30 research studies and participates in the following health data science projects and structures.

IMPaCT-Data: is the Data Science Programme of the Infrastructure for Precision Medicine associated with Science and Technology promoted by the Carlos III Institute, which aims to support the development of a common, interoperable and integrated system for the collection and analysis of clinical data.
EHDEN: is the European Health Data & Evidence Network, promoted by Horizon 2020 and EFPIA to create a federated network of health data research centres using the same data models and coding (OMOP CDM) with the intention of generating robust and reliable scientific evidence quickly and efficiently.
OHDSI: the Observational Health Data Sciences and Informatics programme is an international collaboration for the development of large-scale health information analysis tools using open source and the federated data model.
EOSC-A: The European Open Science Cloud Association is the legal entity created by the European Commission to govern the European portal to data and services for scientific research.
REGIC: Red de Entidades Gestoras de Investigación Clínica is an association created with the aim of sharing experiences and creating a space for interaction and training in the management of R&D&I in healthcare.