Terms and conditions for MRI scans

By signing, the undersigned service recipient confirms that he or she has read, understood and accepted these terms and conditions on his or her own behalf or as a legal guardian on behalf of a minor who is represented, cf. the provisions of the Legal Capacity Act, No. 71/1997, in particular Chapter V of the Act.

These terms and conditions apply to magnetic resonance imaging examinations by Intuens segullómskoðun ehf., and to the evaluation and analysis of images taken during such examinations.

The terms and conditions explain, among other things, the benefits, risks and limitations of undergoing an MRI examination at Intuens segullómskoðun ehf. (hereinafter “Intuens”) and receiving the imaging services provided as further described on the company’s website, www.intuens.is. The terms and conditions also explain how information about you will be stored and used after the screening has been performed and your rights. Before a service recipient signs these terms, the person concerned may request further information from Intuens or seek external advice of any kind.

I. Intuens Segulómun ehf.

IIntuens provides services that include magnetic resonance imaging examinations and the evaluation and analysis of images taken. This is a healthcare service within the meaning of Act No. 40/2007 and the activities are carried out under the license and supervision of the Directory of Health, cf. the Act on the Directory of Health and Public Health, No. 41/2007. The activities are also subject to various other laws and regulations issued pursuant to them, including the Act on Medical Records, No. 55/2009, the Act on Healthcare Professionals, No. 34/2012, the Act on Patients' Rights, No. 74/1997, the Act on Medical Devices, No. 16/2001 and the Act on Privacy and Data Processing, No. 90/2018. Intuens' services are provided by radiologists, physicians or other healthcare professionals who work for or with Intuens. The company provides further information about its operations on its website www.intuens.is, and further information can be requested.

II. Because of MRI scan

A doctor will send a referral for an MRI scan if he or she considers the screening appropriate for you. The booking process also requires you to answer important questions, which is part of ensuring that the screening is safe and that it can be prepared adequately. Your answers to such information will be stored in accordance with the Act on the Protection of Personal Data and Processing of Personal Data, No. 90/2018.

An MRI scan at Intuens involves taking cross-sectional images of the service recipient's body using magnetic resonance imaging technology. The images are stored and then evaluated and analyzed, and the results are presented in a report. Services are provided by doctors or other healthcare professionals who work for and or with Intuens. A report with the results of the MRI scan and images will be made available to you and the referring doctor who ordered the MRI scan. The doctor who sent the referral for the examination is responsible for following up on the case and thereby explaining the report to the client.

III. Benefit

An MRI scan can reveal diseases or other abnormalities in the physical condition. The scan can detect over 400 different diseases, blood clots and inflammations. An examination performed early enough can lead to a diagnosis before symptoms appear, e.g. in the case of cancer, but this can affect both the possibilities for treatment and the results that may result from it. The results can also show changes that are not necessarily malignant, and knowledge of this can prevent incorrect diagnosis in the future. The results can shed light on precursors to diseases or risk factors, and knowledge of this can help you make a more informed decision afterwards, e.g. regarding lifestyle changes, etc. Information obtained with the MRI scan should be able to help you and your healthcare professional make more informed decisions about healthcare.

IV. Risk

MRI is a medical screening that does not involve X-ray radiation. Intuens does not perform MRI scans unless a checklist has been completed because in exceptional cases, it may not be possible to perform the scan without risk, e.g. if the person has a pacemaker. In this case, knowledge of, for example, prosthetic joints or implants may give reason to gather further information before the scan can be performed. MRI can reveal a disease or condition that exists, but cannot be treated for some reason, and such information may also affect the person's obligation to disclose information to an insurance company in connection with taking out life and health insurance.

False positive results. The scan can give false positive results and unexpected results can lead to further tests for diseases that are not actually diseases. However, there is always a risk of false positive results in imaging studies, whether it is an MRI scan or other research methods. With technological advances, the number of such cases has decreased significantly.

False negative results: the study can give false negative results, i.e., indicate that a disease is not present when it is present and thus even lead to symptoms being ignored. However, as the devices have better diagnostic capabilities, the risk of this decreases.

V. Limitations of an full body MRI scan

MRI is intended to diagnose certain diseases or changes under the best possible conditions. Despite the latest technology and accuracy in image analysis, as in the case of other medical examinations, various factors can lead to a disease or symptom of some kind not being diagnosed due to factors that cannot be observed. This can be, for example, due to inadequate body position or movement, due to the stage of the disease or due to other physiological factors. The above or other factors can also lead to, for example, a tumor or other condition not being detected if the extent is below certain limits, even if this may be detected during an examination performed later. MRI can also indicate the presence of diseases, but further examination reveals that this is not the case. Intuens is not responsible if the results of an MRI scan do not reveal a specific condition or if further testing is performed unnecessarily because a test incorrectly indicates a condition.

The following limitations also apply to whole-body MRI scans:

  1. They may support but are not intended to prevent or replace specific screenings for certain conditions (including but not limited to colonoscopy, mammography, cervical cancer screening, and lung screening).

  2. They are effective in staging lesions that are 1 cm in diameter or larger in the head, neck, chest, abdomen, and hip, but may not detect all abnormalities and diseases.

  3. They are limited to aneurysms that are 3 mm in diameter or larger.

  4. They do not assess the condition of the heart or cardiovascular system.

  5. They are not a complete examination of the vascular system.

  6. They are not a primary examination of the lungs, and they do not detect all lung diseases. CT scans are the most appropriate method for diagnosing the lungs.

  7. They diagnose a limited number of joints in a way that the screening does not provide a detailed diagnosis of joints (including but not limited to osteoarthritis, spondylosis, and hip labrum).

  8. They are not intended to diagnose skin conditions.

  9. They are not intended to replace specialized screening and imaging of individual body parts for specific diagnoses.

  10. Images of the hands and arms are not taken in a full-body MRI.

VI. Potential results

The goal of MRI scans at Intuens is to detect diseases early, thereby increasing the chances of curing them. Intuens sends those who undergo an examination at the company a report in computerized form outlining the results. If the results indicate something serious, the referring physician should also be contacted to review the results. It is important to note that even if a disease is not detected, this does not guarantee that the person who underwent the MRI scan does not suffer from any disease, and Intuens recommends that everyone make decisions regarding their own health in consultation with a healthcare professional.

VII. Privacy, data security, waiver of financial benefits for data

Information on the retention of health information of service recipients and the company's privacy policy, including rights regarding such information, can be found at https://www.intuens.is/fridhelgisseftenva or will be made available to you upon request by sending an email to intuens@intuens.is.

The personal information that Intuens receives from service recipients or third parties in connection with an MRI scan is used to fulfill a contract and provide the agreed-upon service. Part of providing the service is to share information with the company's analysts. This is authorized in Section 2, Paragraph 1, Article 9 of the Act on the Protection of Personal Data and the Processing of Personal Data, No. 90/2018. The collection of personal data and its processing by Intuens is governed by the Act on the Protection of Personal Data and the Processing of Personal Data, No. 90/2018.

Intuens also uses personal information for the purpose of fulfilling the legal obligation of the healthcare provider to maintain a medical record of the treatment, cf. Act No. 55/2009 and Regulation No. 550/2015. This is authorized in Section 3, Paragraph 1, Article 9 of the Personal Data Protection Act. Intuens may also use personal information about service recipients for marketing purposes, such as to increase or improve services and product offerings, provided that the provisions of the Personal Data Protection Act are observed. Intuens reserves the right to prepare non-personal statistical summaries related to the use of the service. This is authorized in Section 6, Paragraph 1, Article 9 of the Personal Data Protection Act. However, the service recipient may request that the information not be used for marketing purposes. The service recipient waives any claims for financial gain that may arise from the research or the storage and processing of the data to Intuens.

According to the Health Records Act, No. 55/2009, it is not permitted to delete information from the health record without the consent of the Director of Health. Other information that we store about you is stored for as long as is necessary for the purpose for which it was collected. Individual information may be stored longer if special rules apply, e.g. tax or accounting laws.

VIII. Liability and indemnity

ATo the extent not otherwise provided by law, Intuens, its employees, directors or partners shall not be liable for any damage or costs, by whatever name such damage or costs may be called, incurred by the Service Recipient, whether such damage or costs are direct or indirect and arise from Intuens' services to the Service Recipient. This applies unless it is proven that the damage or costs were caused by intent or gross negligence on the part of Intuens, its employees or parties with whom the Company collaborates to provide its services. The same applies to any damage or costs that a third party may suffer in connection with Intuens or services under this Agreement.

IX. Communication and information provision

The Service Recipient agrees that notifications, information and other communications with Intuens will be made by email and through the company's website. In this regard, notices sent by Intuens will be deemed to have been received on the same day that Intuens sends notifications, information or other electronic means. such electronic communications as described in this section.

X. X. Use of information

The Service Recipient agrees that Intuens may use and collect non-personally identifiable information from the MRI scan and results for research and development purposes. Your information will otherwise only be used to explain the results in a report that will be made available to you and your referring physician.

XI. Defence Assembly and laws

These terms and conditions are governed by Icelandic law.

If a dispute arises between the parties regarding the content of these terms and conditions or the services provided by Intuens, the dispute shall be submitted to the Reykjavík District Court for resolution.

By booking a scan I understand confirm and understand that:

By signing, I confirm that I am 18 years of age and have read and understood these terms and conditions and that I have been provided with adequate information about the MRI scan provided by Intuens, including the purpose, nature and risks of the study. I have been given the opportunity to ask questions in more detail about issues that were not clear to me and have received satisfactory answers to my questions. I understand that the Icelandic Health Insurance will not pay for the MRI scan in any way.

I also confirm by signing that I am not advised to make decisions regarding my health based on the results of the study without consulting a healthcare professional. I understand that the results of the MRI scan are based on information that I have provided to Intuens and that the screening will therefore not provide correct results unless the information provided is accurate and correct.

I understand that unforeseen issues may arise during the study and agree that they will be addressed as needed, provided that this is done in a well-reasoned and evidence-based manner.

I confirm that Intuens may use and collect non-personally identifiable information from the MRI scan analysis and results for research and development purposes.