Regional healthcare data

Sweden's 21 regions are responsible for large amounts of data generated in the health and medical care sector. Private healthcare providers also produce comprehensive data. In addition to healthcare needs, this information can also be used for research.

Medical records and other healthcare information systems

A medical record must be kept for each healthcare episode. The main purpose is to ensure good and safe healthcare for the patient. Information in medical records can also be used for research, among other things.

Data from medical records and healthcare administrative systems are themselves sources for registers held by other holders, such as the health data registers at the National Board of Health and Welfare and Swedish National Quality Registers managed by the regions

Information in medical records

A patient’s medical record contains information that is necessary to ensure good and safe healthcare and to fulfil documentation obligations and administrative needs. Examples of information that always must be included in a medical record:

• the patient's identity
• background details pertaining to the healthcare
• diagnosis
• reason for more significant measures
• measures taken and planned
• decisions on the choice of treatment options and the possibility of a renewed medical assessment
• whether the patient has decided to refrain from certain healthcare or treatment.

There is also information that is not recorded in medical records but in other healthcare information or administrative systems, for example:

• appointments
• waiting times
• healthcare costs.

How healthcare data is documented and classified

There is no comprehensive overview in the form of metadata, variable lists, or similar, of data in medical records or other healthcare information systems of each region or other healthcare providers. The systems and the way in which information is documented can vary greatly, both between regions and between different healthcare providers within the regions. Information in medical records is documented both in text and as structured information. The use of standardised terms varies.

Common classifications and codes used in record-keeping are:

• ICD-10-SE - International Statistical Classification of Diseases and Related Health Problems: for medical diagnoses and certain treatments.
• ICF - International Classification of Functioning, Disability and Health: mainly for physiotherapy and occupational therapy.
• ICNP - International Classification for Nursing Practice: for nursing diagnoses, goals and interventions.
• - Classification of healthcare interventions: one version for medical interventions and one for surgical interventions in healthcare.

To find out what data is available in a particular system and how it is documented, the respective region needs to be contacted.

Archived data from older medical record systems

Some data from older medical record systems is only stored in digital archives and is not always sufficiently structured or documented to be useful in research. When new medical record systems are introduced, comprehensive archiving is also carried out. In order to determine the most appropriate time intervals when requesting archived data, dialogue with the region/individual healthcare provider is required.

Local registers and data collections

Locally, there may also be information collections and registers containing healthcare data. However, there is no national compilation of these.

Some local registers enable national-level data and comparisons. For example, PrimärvårdsKvalitet (primary care quality) supports quality improvement and follow up in primary care. For more information, contact the respective region or regional register centre organisation.

Order data from regions and other healthcare providers

As data holders, each region or other healthcare provider is responsible for its own process for the disclosure of data from medical records and other healthcare information systems. Therefore, the process for handling data requests may differ between regions and even between different healthcare providers within the same region.

How the information is documented, and what the technical infrastructure surrounding electronic health record systems and other healthcare information systems looks like, also varies. This that the complexity involved in disclosing the same type of data may differ between regions, and that data may be released in different ways. However, several regions have a coordinated process for ordering data from different data sources.

Some regions have set an upper limit on the amount of working time that may be used to carry out a disclosure. This means that an application may be rejected if it is deemed too complex and time-consuming.

Ordering medical record copies

When analysing more complex data, it may sometimes be necessary to apply for access to complete medical records. Some regions have the same processes for ordering copies of medical records as for other data extracts, while others handle medical record orders in a separate process. Sometimes it is necessary to contact the individual healthcare provider or the relevant department/clinic.

Applying for a sample size calculation

Before a clinical study, a sample size calculation is often performed to get an idea of how many potential research subjects there are. This requires the healthcare provider to process personal data from patient medical records or quality register. The result of a sample size calculation only includes the number of people who meet the pre-set criteria and is stated as an exact number or as a range.

In several regions, applications for sample size calculations can be made using the same processes as applications for the disclosure of data. Count calculations can normally be made without the need for an approved application for ethical review.

Ordering statistics

In several regions, aggregated statistics can be ordered from medical records and other healthcare information systems using the regions' data disclosure functions.

Applying for data from medical records from private healthcare providers

Contact the private healthcare provider for more information. In some cases, data from private healthcare providers can be requested via the region.

Quality registers in healthcare

Quality registers are structured collections of personal data established to systematically and continuously develop and ensure the quality of healthcare. They are often structured around individual diagnoses or interventions and are intended to enable comparisons within healthcare at national and regional level. Quality registers contain individual data on diagnoses, treatment and outcomes for various diseases or conditions within general healthcare and municipal healthcare.

For national and regional quality registers, there is a central data controller authority, known as a CPUA authority. Only healthcare authorities may be data controllers for the processing of personal data in a national or regional quality register.

Swedish national quality registers

Swedish national quality registers have often been established through voluntary initiatives by medical specialty societies to be used as support for quality development in clinical work. Over the years, just over 90 registers have been financed through a joint effort by the state and the regions. In addition to these Swedish national quality registers, there are also around 30 other national and regional quality registers.

For most quality registers, statistics, comparisons and annual reports are published.

Regional quality registers

Regional quality registers are run by healthcare providers in one of Sweden's six healthcare regions or within a region. There is no national summary of existing regional quality registers.

Reporting to quality registers

Reporting to quality registers is voluntary, which means that the connection rate can vary. The connection rate shows the proportion of clinics or practices that report the diagnosis or measure covered by the quality register.

The National Board of Health and Welfare regularly compiles coverage rates for the national quality registers by comparing data reported to national quality registers with data reported to the National Board of Health and Welfare's health data register. Coverage rates refer to the proportion of the quality register's intended register population that has been registered, i.e. how well the data in the quality register covers what it is intended to cover.

Ordering data from a quality register

Data in quality registers may be used for research in healthcare, calculating numbers for clinical research and producing statistics, among other things.

Anyone who wishes to submit an application for the disclosure of data from a quality register should do so to the CPUA authority in responsibility for the data, which in turn will decide on disclosure.

SALAR's support function for Swedish national quality registers

Swedish Association of Local Authorities and Regions (SALAR; SKR in Swedish) has a support function for Swedish National Quality Registers. The SALAR website kunskapsstyrningvard.se includes:

• guidance describing the regulations and the various steps in the disclosure process for researchers who wish to use quality register data
• a form that can be used to apply for data extracts from quality registers when the data holder does not provide its own form
• a description of the legal conditions for transferring personal data to a third country for research purposes
• a guide for collaboration between industry and quality registers, with a description of the disclosure process in research projects and templates for necessary agreements.

Register Centre support for quality registers

Each healthcare region has a register centre and a regional cancer centre, which together form a register centre organisation, RCO. The register centres' mission is, among other things, to support quality registers in their operation, improvement work and results analysis. Each register centre is responsible for a number of quality registers.

The register centres provide support to Swedish national quality registers and have expertise in areas such as law, IT and statistics. Researchers can also turn to them for help and support with research projects, including:

• variable lists for quality registers
• forms and support in preparing applications for data extraction
• advice and support in planning and conducting statistical analyses
• methodological support, for example in relation to register-based randomised controlled trials (R-RCTs).

Data and follow-ups from SALAR

Swedish Association of Local Authorities and Regions (SALAR) implements surveys and other data collection, follow-ups and analyses in the healthcare sector, for example, the healthcare barometer, regional activity statistics and cost per patient (KPP). Aggregated data and reports are available on SALAR's website. Contact the respective data controller, i.e. the region or specific healthcare provider, for more detailed data.

Patient-reported data collection

The National Form Collection is a library of quality-assured digital forms for collecting patient data. The service is provided by SALAR and Inera via 1177's e-services. It can be integrated with the regions' electronic health record systems and includes forms that can be used before and during patient visits, as well as for follow-up of healthcare and treatment. The forms include patient-reported outcome measures (PROM), which measure how patients themselves experience their illness and health, often linked to treatment or other interventions. The responses become part of the patient's medical records.