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According to Article 6 of the Medical Director of Health and Public Health Act, the operation of health services and/or changes in the operation of health services must be notified to the Directorate of Health. The Directorate of Health then has to confirm whether the operation meets the professional requirements and other conditions in the health legislation. Because the same professional requirements apply to the provision of telehealth services as other health services, such operations must be notified to the office.
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Operators in health services must meet certain minimum professional requirements to be allowed to start operating in health services, and there must be a confirmation from the Directorate of Health to that effect before the operation begins. This is according to IV. chapter in the regulation on the Medical Director of Health´s supervision of health services operations and minimum professional requirements (Icelandic) but instructions that the Medical Director of Health may issue with authorization in Article 12. IV. section of the regulation should also be followed.
Information in the notification about the planned operation of health services and/or changes in the operation of health services are prerequisites for the Directorate of Health to be able to assess whether it is possible to confirm that the operation is considered to meet the minimum professional requirements.
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An operator is a person responsible for the operation of the health service, regardless of whether the person has an independent operation under his identification number or an operating company (hf., ehf., or slf.)
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The responsible party is the person who is responsible for the health service that will be provided.
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In the Health Services Act (Icelandic), health services are classified and defined as follows:
Primary health care: Health care, health protection and prevention, emergency and accident reception, and other health services provided by primary health care. Services and care in nursing homes, residential facilities, and in daycare.
Secondary health care: Health care provided in hospitals, health care institutions, and premises of self-employed healthcare professionals. Other services that are normally not provided at health centers.
Tertiary health care: Health care provided in a hospital that requires special skills, advanced technology, expensive and problematic drugs, and access to intensive care.
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A healthcare practitioner who intends to provide health service must describe how the activity will be carried out and what special treatment the person intends to provide.
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Each healthcare practitioner must familiarize themselves with the laws on patients' right to know how to communicate with patients. This Act aims to guarantee patients certain rights in accordance with human rights and dignity, thus strengthening their legal position concerning health services and supporting the confidentiality that should exist between patients and healthcare practitioners.
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With reference to the law on medical records (Icelandic), the healthcare practitioner is obliged to keep a medical record, see a detailed description of the registration points in Article 6 of the law. Only healthcare practitioners are permitted to enter information in medical records. Medical records must be kept securely so that no medical record information is lost and that it is accessible.
There are two types of registration in medical records, one is electronic registration and the other is registration in paper form.
Electronic registration includes the use of software that stores and works with medical records. An example is the software Gagni used by physiotherapists. Larger units such as medical offices or health institutions use Saga or Profdoc Medical Office.
If there is uncertainty as to whether the medical record system that a healthcare practitioner plans to use meets the requirements of the Directorate of Health, it is welcome to contact the National Center for E-Health at the Directorate of Health.
In the case of medical records in paper form, then information on how the data is stored must be available so that unauthorized persons cannot access the medical records. Here we are talking about filing cabinets that are fire and waterproof and are locked.
According to the law on medical records no. 55/2009, the patient has the right to receive a copy of the medical records as long as it serves the patient's interests.
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According to the law on medical records (Icelandic), it is not permitted to delete original data from medical records. If personally identifiable data is deleted, it must be described how this will be done.
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It is always necessary to inform who is the central host of the medical record system. Examples: Sensa and TM Software.
If the operation of the medical records system is entrusted to a third party, it must be ensured that the host has either a certified quality system or meets the requirements of ISO ÍST 27001. All operations must meet the requirements according to the Act on Personal Protection and Processing of Personal Information (Icelandic) in addition to the rules no. 299/2001 on the security of personal information. If a third party is asked to handle the processing of personal information from the medical record, this shall be done in accordance with Article 13 of the Act on Personal Protection and Processing of Personal Information.
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The responsible party and supervisor of medical records must be specified. It is not required that the responsible party is a certified healthcare professional, on the other hand, the supervisor must always be a healthcare professional.
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Access to sensitive information in an electronic medical system must be in accordance with the procedures defined for the institution. Access to medical records is managed in accordance with the basic principles of personal protection, confidentiality, and privacy.
Healthcare professionals shall have access to the medical records necessary for their work. An employee shall only search for necessary information about their patients which will be of benefit to them.
It must always be ensured that all employees sign a declaration of confidentiality and that they are aware of the rules that apply to looking up medical records.
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Self-employed specialists must submit information on their activities (Icelandic) to monitor the service, ensure its quality, and evaluate its effectiveness. The Register of Contacts with Medical Specialists in Private Practice is useful for monitoring the extent and use of the service, and the frequency of diseases and treatments.
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In accordance with the Healthcare Practitioners Act 34/2012, there are regulations in force for each healthcare profession regarding education, rights, and obligations. Here you can access information about each health profession (Icelandic). Furthermore, it is important to point out the regulation on the recognition of the professional education and qualification of healthcare workers from other EEA countries or Switzerland to work in this country (Icelandic).
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If a healthcare practitioner is self-employed, only he/she should be registered. However, in the case of a company, information on the full-time equivalent unit of the healthcare practitioners and the number of contractors must be provided along with information on the names of those for whom he/the company/institution is responsible.
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A copy of a license to practice from the municipal health authority must be submitted where information about the validity period is provided, or a copy of the audit (if applicable), a confirmation from the Icelandic Radiation Safety Authority (if applicable), and a copy of the confirmation e-mail from the Icelandic Medicines Agency (if applicable).
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The main equipment and instruments that will be used in connection with the services that will be provided, for registration, storage of medicinal products, disinfection, sterilization, etc., must be described. Furthermore, the description of the procedures regarding communicable disease prevention, the internal and external controls on sterilization equipment, cf. requirements for disinfection and sterilization of utensils used in healthcare (Icelandic), and the rules to be followed regarding the disposal of contaminated waste cf. regulation no. 737/2003 on waste management (Icelandic).
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When providing services, the Health Service Act no. 40/2007 must be respected as well as the Patients' Rights Act no. 74/1997, healthcare practitioners' ethical rules, guidelines from the Directorate of Health on good medical practices (Icelandic), and other laws and government orders as appropriate.
Quality indicators are numerical measures, which provide evidence of quality, safety, and performance in healthcare cf. plan for quality development in healthcare 2019-2030 (Icelandic).
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According to the law, healthcare institutions, self-employed healthcare practitioners, and others who provide health services must send a regular summary of all unexpected incidents and serious incidents to the Directorate of Health. The recording of incidents and attitude towards them is an important part of improving safety in health institutions, but it is estimated that about 10% of patients in hospitals experience some kind of accident or mistake that can be classified as an unexpected incident.
It is therefore important that healthcare practitioners familiarize themselves with their responsibilities and which forms need to be submitted.
The forms can be found at the Directorate of Health's web.
Service provider
Directorate of Health