- PADRIS (Public Data Analysis for Health Research and Innovation Program) will be managed by the Catalan Department of Health-Agency for Health Quality and Assessment of Catalonia (AQuAS).
- The new program joins the Catalan Strategic Plan for Health Research and Innovation (PERIS) to promote people-centred health research.
- PADRIS aims to help improve Catalonia’s international positioning in the area of scientific research.
Minister of Health of Catalonia, Antoni Comín, presented last January 12th, the Public Data Analysis for Health Research and Innovation Program (PADRIS), which aims to provide the scientific community with big data, in an effort to foster health research, innovation. This goal can be achieved through providing access to the reuse and cross referencing of the health data generated by the SISCAT (Integrated Public Use Healthcare System of Catalonia) for research, according to the legal and regulatory framework, ethical principles and public transparency.
The reuse and cross-referencing of big data related to healthcare can facilitate studies such as, for example, the monitoring and supervision of recently implemented drugs, medical devices and implants; the detection of interactions and side effects which have not been detected by clinical studies; the development of comparative studies of effectiveness; monitoring patient cohorts; and extending our knowledge of rare diseases.
PADRIS is also an initiative to help improve the positioning of Catalonia on the international stage as a region of reference in the information society and one that is moving towards a new model of country that specializes in high value-added services and promotes innovation as a catalyst for improving the health of citizens and the competitiveness of its production model.
PADRIS will be administered and managed by the Catalan Department of Health agency, Agency for Health Quality Research and Assessment of Catalonia (AQuAS). To accomplish this mission, AQuAS will be provided with all the necessary governing and controlling bodies, and the technological and human resources to fulfil the functions of strategic management, monitoring, assessment and operational implementation, anonymization and indexing of the SISCAT data set for the purposes of research, innovation and evaluation.
The anonymized and de-identified data is will be accessible by researchers from research centres which have been certified by the Research Centres of Catalonia (CERCA), SISCAT representatives and public university research centres, as well as the health administration itself (i.e. research groups under the auspices of the Health Strategic Plan of Catalonia).
Interested parties can only access data in compliance with the criteria established to ensure safeguarding of PADRIS ethical, safety and risk analysis principles and only after approval from a Research Ethics Committee (REC) has been secured. Ethical principles established by the program include respect for people, patient to patient solidarity, fairness, efficiency, transparency, responsible research and personal data protection.
To ensure the benefits to citizens and the public health system of using the data, data requests must be accompanied by a description of the research project, detailed justification of the study’s scientific interest, its alignment with strategic plans, and a description of the potential benefit to the health of citizens and the health system. Moreover, data users undertake to publish the resulting scientific results and AQuAS will be responsible for communication and support activities for the implementation of the scientific results.
PADRIS will be implemented in three stages.
- Definition and foundations (2017). During the first six months of PADRIS, the program will be provided with the agreed governance bodies and all procedures for the timely processing of applications will be outlined.
- Deployment and consolidation (2017-2018).
- Full operation and evaluation (2019-2020). The program will be fully operational, while ensuring quality control and accountability to facilitate the achievement of its objective with the necessary ethical guarantees.
The PADRIS program joins forces with the 2016-2020 Strategic Plan for Research and Innovation in Health (PERIS) approved last July to develop fresh knowledge to combat disease and provide better health care.
The health data of individuals is the inalienable property of each person. However, each person has a moral duty to contribute to the common good and at the same time the right to benefit from it, when necessary, through access to the care network and research results. The program also provides individuals with the choice to opt-out of the use of their personal data.
In recent years, the health system in Catalonia has benefited from major transformation due to the implementation of large-scale digital and technological projects, such as the Shared Medical History or the Electronic Prescription. This deployment has led to improvements in healthcare processes and, in turn, has generated a significant volume of data and information.
In March 2016, in order to get PADRIS underway, the Plenary Session of the Parliament of Catalonia urged the government to organize a participatory process "concerning the management of healthcare big data in the area of health" and to promote the creation of a public health big data program. This was followed by a motion to develop the content of the resolution passed in March. The parliament urged the Government to commission AQuAS to hold a public consultation process to pool contributions from the public and experts in the associated scientific, technical and ethical issues. Once this phase was completed, AQuAS was to invite contributions, assess these initiatives and which were subsequently incorporated into the PADRIS program which was unveiled during today’s presentation.
Programa públic d’analítica de dades per a la recerca i la innovació en salut a Catalunya –PADRIS– [1,43 MB ]
PADRIS Report. Available in Catalan.