Table 1 Priority areas and critical factors in the RD field highlighted by the experts
Priority area | Critical factor |
|---|---|
Clinical work | - Envisaged benefits and potentials of RD registries for clinical work with patients, designing standards, and research |
-Monitoring the effects of patient treatment and planning further procedures | |
-Effective work and access to all relevant patient information in one place | |
Patient treatment perspective | - Better coordination and monitoring of the treatment process |
- Higher quality, safer medical treatment and better treatment results (better quality of life) | |
-An effective communication channel and secure exchange of information | |
- Evidence-based allocation of resources for patients with rare diseases | |
ICT infrastructure and solutions | - Effective and user-friendly ICT solutions (RD registry) |
- Ensuring interoperability despite the heterogenity of the information systems | |
- Definition of the rules of operation, information flows, and organizational processes | |
-The role of eHealth (the Central Registry of Patient Data (CRPD)) | |
Normative framework | - Adequate legal basis |
-Protection of personal data (application of the safe-by-design principle) | |
-Personal Data Protection Act / General Data Protection Regulation (GDPR) | |
Development of the PRDR and conceptualization of the RD ecosystem in Slovenia | - Strategic documents and development directions |
-Research and pilot projects | |
-Adequate funding, engagement of stakeholders, and healthcare policy support | |
-Selection of the appropriate approach for the development of the PRDR (and subsequently the national RD registry) and the establishment of the RD ecosystem in Slovenia |