ACT on Patient Insurance no. 111/2000

Patients, as defined in Article 2 of the Act on Patients' Rights, who suffer physical or mental damage in Iceland in connection with examination or medical treatment in a hospital, health-care centre or other health institution, during medical transport, or in the care of a self-employed health-service worker certified as such by the Minister of Health and Social Security, are entitled to compensation pursuant to this Act. The same applies to those who lose their principal provider upon the death of such patients.
Patients who urgently require hospitalisation in a foreign hospital or other health institution abroad, pursuant to Article 35 of the Social Security Act, and suffer physical or mental damage as a result of examination or medical treatment in the institution in question are entitled to compensation under this Act, following deduction of any compensation to which they may be entitled in the foreign state.
People participating in medical experiments that are not part of the diagnosis or treatment of the illness of the party concerned shall have the same rights as patients under this Act, unless otherwise specified.
Donors of tissue, organs, blood or other body fluids shall have the same rights as patients under this Act, unless otherwise specified.

Compensation shall be paid irrespective of whether anyone may be liable for damages according to rules of tort, provided that the damage suffered can in all probability be traced to any of the following incidents:
1. It may be assumed that damage could have been avoided if the examination or treatment under the circumstances in question had been conducted in the best possible manner and based on existing knowledge and experience in the relevant field.
2. Damage results from a malfunction or defect in instruments, tools or other equipment used during examination or medical treatment.
3. Subsequent evaluation reveals that damage could have been avoided by employing a different available treatment method or technique, which would from a medical point of view have been equally useful in the treatment of the patient.
4. Damage results from treatment or examination, including operations conducted for diagnostic purposes, and the damage is suffered from infections or other side effects which are more extensive than the patient should reasonably be expected to endure without compensation. On the one hand, account shall be taken of the extent of the damage, and on the other hand the illness and general health of the patient. It shall also be taken into consideration whether it is common for damage to result from treatment of the type received by the patient, and whether or to what extent the risk of such damage could have been anticipated.

Compensation shall be paid for damage resulting from incorrect diagnosis in instances described in Sub-paragraphs 1 and 2 of Article 2. However, this does not apply to instances falling under Sub-paragraphs 3 and 4 of Article 2.
In the event that a patient is injured from causes other than those described in Sub-paragraph 2 of Article 2, compensation shall be paid only if the patient was undergoing examination or treatment at the hands of an institution or other party covered by this Act, and if the accident occurred in such a manner that such institution or other party must be regarded as liable for damages pursuant to the general rules of tort.
Compensation under this Act shall not be paid if the damage can be traced to the characteristics of a medical product used in examination or medical treatment.

Compensation shall be paid to individuals referred to in Paragraphs 3 and 4 of Article 1 if they suffer damage as a possible result of a medical experiment, removal of tissue, etc., unless all the indications are that the damage can be traced to another cause.
The provisions of Paragraph 1 do not apply to damage that can be traced to the characteristics of a medical product used in examination or treatment, cf. Paragraph 3 of Article 3.

The determination of the amount of compensation under this Act shall be conducted in accordance with the law of tort, subject, however, to Paragraph 2 of Article 10 hereof.
Compensation pursuant to Paragraph 1 shall be paid if the damage suffered is assessed at ISK 50,000 or more. However, the maximum amount of compensation accorded for a single incident of damage shall be ISK 5,000,000. These amounts shall be adjusted as of 1 January each year according to the credit-term index.
The provisions of Paragraph 2 do not apply to damage described in Paragraph 1 of Article 4, cf. Paragraphs 3 and 4 of Article 1.
Compensation shall not be paid pursuant to this Act for the satisfaction of reimbursement claims.

Compensation may be reduced or cancelled if a patient is involved in causing the damage, intentionally or as a result of gross negligence.

No claim for damages shall be made on any party subject to liability under the rules of tort, unless the damage in question has not been fully compensated in accordance with Article 5, and then only for the residual amount due.

In the event that a liable party pursuant to Article 9, or an employee or former employee of such party, is liable to pay damages to a patient pursuant to the rules of tort, no reimbursement claims shall be made against the liable party for payment pursuant to Article 5, unless the damage in question was caused intentionally.

All providers of health service, in institutions and otherwise, are liable for damage by this Act. These are:
a. Health care centres, whether run by the state, municipalities or other parties,
b. Hospitals, whether run by the state, municipalities or other parties,
c. Other health institutions, regardless of the parties responsible for their operation,
d. Self-employed health service workers who have been certified for such work by the Minister of Health and Social Security, regardless of whether the health care service they provide is paid for in full by the patient or by sickness insurance in accordance with an agreement with the State Social Security Institute,
e. The State Social Security Institute, in respect of patients who urgently require hospitalisation in a foreign hospital or other health institution abroad, cf. Paragraph 2 of Article 1, and
f. Parties operating medical transport.

Liable parties pursuant to Article 9 shall be insured (patient insurance) with an in-sur-ance company holding an operating licence in Iceland, subject, however, to Article 11.
The Minister of Health and Social Security shall issue a regulation regarding, e.g., the minimum insurance amount in each insurance year and the implementation of the obligation to carry insurance. The Minister may subject the operating licenses of health institutions not covered by Article 11 and work permits of self-employed health service workers to the condition of full compliance with the insurance obligations pursuant to this Act.

Health-care centres, hospitals and other health institutions owned or partly owned by the State are exempted from the insurance obligation pursuant to Article 10. The same applies to the State Social Security Institute and parties operating medical transport for the state. However, such parties may take out insurance pursuant to Article 10.

Claims for compensation under this Act in respect of damage suffered by parties other than the parties listed in Article 11 shall be addressed to the insurance company of the liable party.
Employees of insurance companies responsible for the cases of patients or other injured parties shall maintain full confidentiality regarding all personal data which may come to their knowledge in the course of their work or in connection therewith.

Claims for compensation under this Act in respect of damage suffered by parties that have exercised their right not to purchase insurance, cf. Article 11, shall be addressed to the State Social Security Institute.

The State Social Security Institute shall provide patient insurance in respect of parties that have exercised their right not to purchase insurance, cf. Article 11.
The Minister shall issue a regulation regarding the State Social Security Institute's operation and processing of patient insurance cases

The State Social Security Institute shall gather data as necessary and may, e.g., obtain depositions before the District Court where the deponent is resident. The Institute may require health care centres, hospitals, other health institutions, self-employed health service workers certified by the Minister of Health and Social Security, and parties operating medical transport, to surrender documents of any kind, including clinical records that the Institute regards as relevant to the processing of a case pursuant to this Act.
Following data gathering, the State Social Security Institute shall decide on liability and establish the amount of compensation.
Employees of the Institute responsible for the cases of patients or other injured parties shall maintain full confidentiality regarding all personal data which may come to their knowledge in the course of their work or in connection therewith

The State Social Security Institute shall notify all parties concerned of its conclusion in each case. The Institute's findings may be referred to the Social Security Ruling Committee in accordance with the Social Security Act.

The State Social Security Institute shall annually prepare a report for the Minister of Health and Social Security describing activities in respect of patient insurance and the cases processed by the Institute. The Institute's annual report shall furthermore describe, to the extent possible, the processing by insurance companies of cases of compensation claims based on patient insurance. The annual report shall be accessible to the general public.

The State Social Security Institute is under obligation to inform the general public of the provisions of this Act on Patient Insurance. Such information shall reveal, inter alia, that in cases involving self-employed health service workers, claims shall be addressed to insurance companies.

Claims for compensation pursuant to this Act shall lapse when four years have elapsed from the time that the injured party was informed of or could have been informed of his/her damage.
However, in any case, claims shall lapse when ten years have elapsed from the incident resulting in the damage.

Violations of Paragraph 1 of Article 10 of this Act, subject, however, to Article 11 hereof, are punishable by fine.
Violations of Paragraph 2 of Article 12 and Paragraph 3 of Article 15 of this Act are punishable by fine or imprisonment.
In the event that a punishable offence is committed in the course of employment with a company, institution, or other non-natural entity, such entity shall be held responsible for payment of the consequent fine.

The Minister may issue a regulation for the further implementation of this Act. Such regu-lation shall include further definition of what shall constitute medical treatment, cf. Article 1, and what shall constitute a medical experiment, cf. Paragraph 3 of the same Article.

This Act shall enter into force on 1 January 2001, and shall apply to instances of damage occurring subsequent to that date. This Act shall be reviewed within four years of its entry into force.

On the enforcement date of this Act the following amendments of the Social Security Act No. 117 of 20 December 1993 shall take effect:
a. Sub-paragraph (f) of Paragraph 1 of Article 24 of the Act shall be deleted.
b. The second clause of the final paragraph of Article 29 of the Act shall be deleted.
c. The words "Sub-paragraphs (e) and (f)" in the final sentence of Paragraph 1 of Article 31 of the Act shall be replaced with the words "Sub-paragraph (e)".
d. Sub-paragraph (d) of Paragraph 2 of Article 43 of the Act shall be deleted.
e. The following new Sub-paragraph shall be added to the Transitional Provisions of the Act:

Patients entitled to benefits in accordance with Sub-Paragraph (f) of Paragraph 1 of Article 24 prior to 1 January 2001 shall retain their rights pursuant to Chapter III of the Act.
In the event that a claim is made subsequent to 1 January 2001 regarding an incident which occurred prior to that date, the provisions of Sub-Paragraph (f) of Paragraph 1 of Article 24 and those of Sub-Paragraph (d) of Paragraph 2 of Article 43 of the Social Security Act shall apply, notwithstanding the provisions of Paragraph 1.

On the enforcement date of this Act, the following amendments of the Torts Act No. 50 of 19 May 1993 shall take effect:
a. Paragraph 2 of Article 3 of the Act shall be as follows:
Payments from a third party shall be governed by the provisions of the first, third, fourth and fifth sentences of Paragraph 4 of Article 5.
b. The following new sentence shall be added after the second sentence of Paragraph 4 of Article 5 of the Act: Compensation pursuant to the Patient Insurance Act shall also be deducted from the amount of damages claimed.