In spring 2020 the Norwegian Government suggested to amend the existing Health Registry Act and other relevant data regulations to establish a single portal for all secondary use of health data with a common system of governance. The reform builds on the work undertaken under the National Health Data Programme, which was established in 2017 by the Directorate for e-Health (NDE), and the Health Registries for Research project (2014-2019), which was aimed at improving access to existing health data for health care improvement, monitoring, management and research purposes (see section 2.6 in the online HiT). The reform was further enabled by the recent (2019) changes in the Statistics Act that allowed for a limited set of demographic and socioeconomic variables to be linked to health data from the registries for the purpose of health care improvement, monitoring and management and not only for research purposes as before.
The suggested amendments were approved by the parliament in December 2020 and enacted from January 2021. As part of the reform, the Prescription Database (NorPD) will be transformed from a pseudo-based registry into a registry with unique patient identification (regulations detailing this were passed in the Parliament in April 2021). A new organisational unit, the National Data Service, will be established in 2021 within the NDE. The new unit will be responsible for granting access to health data that is available through the portal helsedata.no. The portal was established in autumn 2020 and contains information about various data sources, variables, electronic application forms and guidance on the process of requesting access to health data. The National Data Service will be co-located with the National Health Archives at Tynset - a rural location in the Eastern part of Norway.
The detailed regulation for National Data Service will be subject to a public hearing in spring 2021. The unit is expected to be operational - with delegated authority to authorize access to health data - from September 2021, when production of datasets may start. A dashboard of process and outcomes indicators have been established to monitor the implementation of the reform. The rural location of the unit is posing some challenges with regards to transfer of personnel from current urban settings.
The reform supports the ‘Health, Demography and Quality of Life’ programme of the Nordic councils of Ministers, whose action areas include finding solutions on how to bridge Nordic health data and personal data for utilization in the Nordic health ecosystems. Finland and Denmark have both recently established national health data portals in support of this programme.