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Data access from health registries, health studies and biobanks

Access to data from the Norwegian Prescription Database

Guidelines for applying for data from the Norwegian Prescription Database.

Illustrasjonsfoto: Colourbox.com
Illustrasjonsfoto: Colourbox.com

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The Norwegian Prescription Database (NorPD) contains information about the use of prescription drugs dispensed in Norwegian pharmacies. You can obtain information about the number of users of a particular drug or drug category.

The database only contains information about drugs dispensed by prescription. Over-the-counter drugs are not included.

Application for data

NorPD may disclose detailed information in accordance with the regulation for NorPD. All applications for data from NorPD must have a description for what purpose the data will be used. All applications are evaluated by the NorPD Data Access Evaluation Group.

Types of data that may be delivered after application

Statistiscal data (table data)

We publish statistical data regularly on http://www.norpd.no. Application for access to other statistical data (aggregated data/tabular data) on drug consumption must include a precise description of the requested data, including metrics, time period, drugs (ATC codes) etc. An empty table (shell table) showing the desired table layout (with only row and column names) should be attached. Statistical data from the NorPD are generally presented in excel format.

Research data (research dataset)

In a research dataset, each drug dispensed to each individual is presented on one row. A completed list of required variables from the NorPD must be attached to the application (see below). Only apply for variables that are necessary and justified by the research project's purpose. Data from the NorPD are generally delivered as a txt.file delimited by semicolons. For datasets including data from NorPD linked to one or several other health registries or other data sources, the applicant should also choose the application form 'Application for access to data’, see below.

Linkage to other data sources

Data from the NorPD can be linked to data from other health registries and other data sources with access to the full identity of the individuals in the study population, provided legal permission has been granted. The data linkage will follow a standard procedure for linkage of data with the NorPD.

Application

It is important that applicants tick variables that are necessary and relevant for the project objectives only. This includes variables from other health registries that will be linked to NorPD.

Legal requirements

Legal requirements for the delivery of data (only NorPD)

Disclosure of tabular data does not require any special legal permission.

Ensuring the anonymity of a research dataset from the NorPD is difficult. An anonymous dataset will need to have few and roughly categorised variables, usually resulting in limited value for research and health analysis. Research datasets from NorPD are therefore normally indirectly identifiable personal data, and lawfulness of processing must be justified by applicants, cf. the NorPD regulation § 5-2. Legal basis for access and processing may be:

  • Approval from the Regional Committee for Medical and Health Research Ethics (cf. Health Research Act § 33) 

A confidentiality exemption from a Committee for Medical and Health Research Ethics (cf. Health Research Act § 35) or the Directorate of Health (cf. Health Personnel Act § 29b) is also required.

Legal requirements for the delivery of research datasets from NorPD linked to other data sources

Data from the NorPD can be linked to data from other health registries defined by the Health Register Act § 11 cf. the NorPD regulation § 5-3 first paragraph. The linkage must be performed so that individuals cannot be recognised in the linked dataset. If an indirectly identifiable dataset is requested, a licence from the Norwegian Data Inspectorate is required.

Ensuring the anonymity of  research datasets based on linked data from different health registries is difficult. An anonymous dataset will need to have few and roughly categorised variables, usually resulting in limited value for research and health analyses. This implies that applicants should apply for an approval from the Data Protection Authority. A confidentiality exemption from a Committee for Medical and Health Research Ethics or the Directorate of Health is also required in the absence of consent from the individuals to be included in the project. For health research projects it is also required to get an approval from a Committee for Medical and Health Research Ethics.

Linkage of data from the NorPD and other data sources than the health registries defined by the Health Register Act § 11, requires a licence from the Data Inspectorate, cf. the NorPD Regulation § 5-3 second paragraph. A confidentiality exemption from a Committee for Medical and Health Research Ethics or the Directorate of Health is also required in the absence of consent from the individuals to be included in the project. For health research projects it is also required to get an approval from a Committee for Medical and Health Research Ethics.

Please note that the NorPD is a pseudonymous registry, and data from the NorPD cannot be linked to data from other datasources that can easily lead to identification of individuals via the linked dataset. Only  request variables that are relevant for the research project’s purpose. This applies both to variables from the NorPD and to variables requested from other data sources to be linked with NorPD.

About the implementation of the General Data Protection Regulation in Norway

The Ministry of Justice and Public Security in Norway issued a hearing on 6 July 2017 on a new Personal Information Act. The proposal entails that the General Data Protection Regulation (GDPR), which applies from 25 May 2018, is made applicable in Norwegian law. It is proposed to abandon the requirement of prior approval (licence from the Data Inspectorate), but it is currently unclear which solutions will be chosen and how long existing licences and approvals will be valid. Further information on how the new regulations will affect access to data from the NorPD will be made available on our website as soon as we have more information.

Delivery deadlines

According to the regulations, the NorPD has a 30 day delivery deadline for uncoupled data and a 60 day delivery deadline for coupled data when data from all sources are available and legal permission is in place.

Price

The current cost of obtaining information from the Norwegian Prescription Database is NOK 875 per hour’s work, excluding VAT.

Appeals

According to Norwegian legislation, a decision about data delivery can be challenged. Any complaints should be sent to the Norwegian Institute of Public Health. If the institute does not respond satisfactorily, the appeal can be sent further to the Ministry of Health and Care Services for a final decision.

Acknowledgements

All publications and presentations that use data from the Norwegian Prescription Database must refer to it as the source.

If acronyms or abbreviations are required, please refer to NorPD (in both English and Norwegian).

All publications should include "The Norwegian Prescription Database" in the title or abstract text to highlight the register in PubMed searches.

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