Helsedataservice takes over authority to process applications and grant access to health data
Since 15 March, Helsedataservice has had the authority to make decisions about making health information available and granting exemptions from confidentiality.
Helsedataservice at The Directorate for e-health takes over the authority to process applications and grant access to health data from eleven central health registers, and the authority to grant exemption from confidentiality. Until March of this year, the authority was placed with the Norwegian Directorate of Health and Regional Committees for Medical and Health Research Ethics (REC).
The change applies to health information for use in statistics, health analyses, research, quality improvement, planning, management and preparedness (see Regulations on national solutions for making health data available (In Norwegian only)).
According to Helsedata.no, the goal is simpler, faster and more secure access to health data.
The eleven registers are:
- Cause of death registry
- Cancer Registry of Norway
- Medical Birth Registry of Norway (MBRN)
- Norway Surveillance System for Communicable Diseases (MSIS)
- Norwegian Adverse Drug Reaction Registry
- Norwegian Cardiovascular Disease Registry
- Norwegian Health Archives Registry
- Norwegian Immunisation Registry (SYSVAK)
- Norwegian Patient Registry (NPR)
- Norwegian Prescribed Drug Registry (NorPD)
- Norwegian Registry for Primary Health Care (KPR)
If data from these registers are to be combined with other health registers, treatment-oriented or others, applications for access to health data or exempt from confidentiality from these registers should also be submitted through the helsedataservice website.
Authority with the Norwegian Directorate of Health
When the purpose of the project is statistics, health analyses, quality improvement, planning, management and preparedness and the development and use of clinical decision support tools, the Norwegian Directorate of Health has authority to grant exemption from confidentiality in certain cases. Read more on the directorates website (application form at the bottom of the page).
Some exemtions still granted by REC
The Regional Committees for Medical and Health Research Ethics (REC) still has the authority to grant exemption from confidentiality in certain cases.
When the purpose is research, REK can grant exepmtion from confidentiality for access to:
1. Health information exclusively from treatment-oriented health registers (patient record systems)
2. Health information exclusively from health registers that are not covered by the Directorate for e-Health's decision-making authority.
3. Compilation of health information from treatment-oriented health registers (patient record systems) and health registers that are not covered by the Directorate for e-Health's decision-making authority.
Applications are sent by logging into rekportalen.no.