Ministry Ministry of Health and Care Services
Last amended: LOV-2021-05-07-31 of 01.07.2021
Entry into force: 15.06.2018, 01.05.2019
Amends: LOV-1999-07-02-61, LOV-1999-07-02-64
Corrected: 23.03.2022 (punctuation in lists adapted to universal design)
Short title: Act relating to the Norwegian Healthcare Investigation Board
Act relating to the Norwegian Healthcare Investigation Board
Section 1. Purpose
The purpose of the Act is to improve patient and user safety in the health and care services through investigations of serious adverse events and other serious matters.
Section 2. Scope
The Act applies to health and care services provided in the realm.
The Ministry may lay down regulations stipulating that the Act and regulations pursuant to the Act shall apply in whole or in part to Svalbard and Jan Mayen and may establish special rules taking local conditions into account.
The Ministry may lay down regulations stipulating that the Act and regulations pursuant to the Act shall apply in whole or in part to Norwegian ships engaged in foreign trade, to Norwegian civil aircraft engaged in international traffic, to installations and vessels at work on the Norwegian continental shelf and within the Norwegian search and rescue region.
Section 3. Definitions
For the purposes of this Act, the following definitions apply:
a. serious adverse event: death or very serious injury to the patient or user where the outcome is unexpected based on foreseeable risk.
b. serious matters: circumstances or contexts that are assumed to lead to serious adverse events.
0 Amended by Act of 7 May 2021 No. 31 (entry into force 1 July 2021 pursuant to Decree of 7 May 2021 No. 1444).
Section 4. The Norwegian Healthcare Investigation Board
The Norwegian Healthcare Investigation Board (the investigation board) is an administrative body administratively subordinate to the Ministry. It shall perform its duties in an autonomous and independent manner, and it cannot be instructed in professional matters.
The investigation board is headed by a director who is appointed by the King.
The Ministry may in regulations lay down further provisions concerning the organisation of the investigation board.
Section 5. Duties of the investigation board
The investigation board shall investigate serious adverse events and other serious matters to improve patient and user safety in the health and care services. The purpose of the investigations is to investigate the course of events, causal factors and causal relationships in order to contribute to learning and prevention of serious adverse events.
The investigation board shall not assess civil or criminal liability or culpability.
The investigation board decides for itself which serious adverse events or serious matters to investigate, the timing and scope of the investigation, and how it shall be executed.
The Ministry may in regulations lay down further provisions concerning the work of the investigation board.
Section 6. Annual reporting
The investigation board shall report annually to the Ministry on its activities and results.
Section 7. Notification to the investigation board of serious adverse events
An undertaking that provides health and care services shall immediately notify the Norwegian Healthcare Investigation Board of the death or very serious injury to a patient or user as a result of the provision of the service or when one patient or user injures another. The duty to notify applies if the outcome is unexpected based on foreseeable risk.
Patients, users or next of kin may notify the investigation board of events as described in the first paragraph.
Once the investigation board has received notice pursuant to the first or second paragraph, it shall decide without undue delay whether an investigation shall be initiated.
0 Amended by Act of 7 May 2021 No. 31 (entry into force 1 July 2021 pursuant to Decree of 7 May 2021 No. 1444).
Section 8. Notification and right to make a statement
Once the investigation board has initiated an investigation, it shall, as far as possible, inform service providers, patients or users, next of kin or others to whom the investigation relates. Such notification shall be given as soon as possible, and it shall disclose the rights under the second paragraph and pursuant to Section 16.
Before the investigation is concluded, the persons and service providers referred to in the first paragraph shall be allowed to make a statement on the serious adverse event or matter. They also have the right to familiarise themselves with the documents with the limitations imposed by the duty of confidentiality in Section 12.
Section 9. Measures to obtain information
The investigation board may demand to investigate the location where the serious adverse event or serious matter took place and take possession of items, including medical equipment. It shall also be given access to documents and results of investigations carried out by other authorities in connection with the serious adverse event or serious matter, including investigations of persons involved and autopsies of the deceased.
The investigation board may order health personnel to participate in or submit to a breath test, blood test and clinical medical examination.
The investigation board may request information and assistance from other public authorities, as well as use necessary expert assistance.
Measures under this provision may only be carried out to the extent necessary for the investigation board to carry out its duties and the measure is reasonably proportionate to the objective sought to be achieved.
The Ministry may in regulations lay down further provisions concerning the investigation board’s measures to obtain information.
Section 10. Duty to give evidence
Everyone has, irrespective of the duty of confidentiality, a duty to give evidence before the investigation board about information that may be of importance to the investigation.
Anyone who gives evidence before the investigation board has the right to be assisted while giving evidence unless this significantly delays the case.
Section 11. Securing of evidence
The investigation board may demand the securing of evidence outside of legal proceedings pursuant to the provisions of Sections 28-3 and 28-4of the Dispute Act. Claims for securing evidence are brought before the district court in the jurisdiction where the persons to be questioned live or are present, or where real evidence is to be examined.
Section 12. Duty of confidentiality
Anyone who performs work or services for the investigation board has a duty of confidentiality under the Public Administration Act regarding what he or she becomes aware of during the performance of their work. However, Public Administration Act
Section 13 (b) (6).
When persons as described in the first paragraph receive information that is subject to a stricter duty of confidentiality than what ensues from the Public Administration Act, a correspondingly strict duty of confidentiality shall apply unless weighty public considerations indicate that the information should be passed on or the information is necessary to explain the cause of the incident.
Persons as described in the first paragraph also have a duty of confidentiality regarding all information that has emerged during evidence giving before the investigation board pursuant to Section 10, unless significant public considerations indicate that the information should be passed on or the information is necessary to explain the cause of the incident.
The duty of confidentiality as described in the second and third paragraphs does not prevent the information from being passed on to the extent that the person entitled to confidentiality consents, if the information is in statistical form, or if it is generally available elsewhere.
Section 13. Public disclosure
Draft investigation reports and statements to the report pursuant to Section 16 may be exempted from public disclosure.
Refusal of access requests may be appealed pursuant to the provisions of the Freedom of Information Act. Anyone who performs work or services for the appellate body has a duty of confidentiality in accordance with Section 12 of this Act for information they become aware of in connection with the appeal case.
Section 14. Information to the relevant public body
The investigation board shall, within the framework of the duty of confidentiality pursuant to Section 12, keep the relevant public body informed of serious matters uncovered during the investigation and its preliminary assessments thereof, to the extent that this is considered critical to patient and user safety.
Section 15. Investigation report
The investigation board shall prepare a report after it has investigated a serious adverse event. The investigation board shall decide for itself whether it is necessary to prepare a report in other cases. If investigations are concluded without a report, the investigations shall be documented in another appropriate manner.
The report shall explain the sequence of events in the case and contain the investigation board's assessment of the causal factors. The report shall also contain any recommendations from the investigation board on measures that should be taken or considered to prevent similar incidents in the future.
The report must not contain references to the names and addresses of individuals. The investigation board shall publish the report when it has been completed.
The Ministry may in regulations lay down more detailed provisions on the circumstances in which investigation reports are to be prepared, how investigation reports are to be formulated and applied, as well as time limits for preparing investigation reports.
Section 16. Submission of a draft investigation report
Before the investigation board completes the report, a draft report shall, upon request, be submitted to persons referred to in Section 8, with a reasonable period for the person concerned to make a statement, unless special circumstances indicate that this should not be done. The first sentence applies only to those parts of the draft report on which the person concerned has special qualifications to make a statement because of his or her connection to the case or the investigation.
Section 17. Prohibition against use as evidence in criminal proceedings
Information received by the investigation board pursuant to Section 10 cannot be used as evidence in subsequent criminal proceedings against the person who provided the information.
Section 18. Prohibition against sanctions by employers
An employee who gives evidence pursuant to Section 10 shall not, as a result, be subjected to any form of sanctions on the part of the employer.
The first paragraph does not apply to
a. measures taken by the employer with the primary purpose of improving the qualifications of the employee
b. if the information received shows that the employee does not meet the health requirements to hold his or her position
c. if the information received shows that the employee has personally acted with gross negligence in connection with the serious adverse event or serious matter
d. if circumstances relating to the employee or his or her actions or omissions have become known in any other way than through the employee's giving of evidence pursuant to Section 10.
Section 19. Relationship to the Personal Health Data Filing System Act
The Personal Health Data Filing System Act applies insofar as this Act does not provide otherwise from this Act.
Section 20. Entry into force
This Act enters into force on the date1 determined by the King. The King may put the individual provisions of the Act into force at different times.
1 Sections 1, 2,4 and 20 enter into force on 15 June 2018 pursuant to Decree 15 May 2018 No. 878. Section 3, Section 5 to Section 19 and Section 21 enter into force on 1 May 2019 pursuant to Decree of 26 April 2019 No. 541.
Section 21. Amendments to other acts
The following amendments to other acts shall apply as from the date on which this Act enters into force: –