Last changed: 01.09.2022
TERMS OF SERVICE OF OÜ ANTEGENES
Current terms and conditions of service provision (Terms of Service) concern the rights and obligations of OÜ Antegenes (registry code 14489312, address Raatuse 21, Tartu 50603) (“Antegenes”, “We”, “Service Provider”) and the person (hereinafter referred as User) using the services (services related to ordered tests, services in Antegenes information system, account management, genetic consultations, related to participation in the research or other services provided).
BY ORDERING AND USING ANTEGENES SERVICES, I ACKNOWLEDGE THAT I HAVE READ, UNDERSTAND, AND AGREE TO THE TERMS AND CONDITIONS OF THE SERVICES, WHICH INCLUDE CURRENT TERMS OF SERVICE, PRIVACY POLICIES AND APPLICABLE FORMS OF CONSENT.
1. Scope of the Terms of Service
1.1 The Terms of Service lay down the rights, obligations, and liabilities to the Service Provider and User during service provision.
1.2 The Service Agreement consists of the Terms of Service and any other additional terms and conditions agreed with the User orally or in writing. In addition to the above, the relations between the parties are regulated by the internal rules notified to the User (eg Service Provider’s internal procedures, good practice) and relevant legislation of the Republic of Estonia and the European Union (incl. the Law of Obligations Act, Health Care Services Act, Health Insurance Act, EU General Data Protection Regulation).
1.3 In the event of a conflict between the TCoS and supplementary terms specifically designed to regulate the relationships between the parties, the specifically given terms and conditions in the latter shall apply.
2. Content of the Service and Consent to provide the Service
2.1 Health care services or any other services provided by the Service Provider, which include the provision of genetic risk tests, medical consultations, and other products and services offered are considered services. The list of services may change over time and TCoS in effect at the time also applies to the provision of new services.
2.2 If health care service is provided to the User, the Service Provider is a healthcare service provider. In that case, by accepting the Terms of Service, the User consents to the provision of the service as a healthcare service by the Service Provider.
2.3 If the User purchases services directly from Antegenes, Antegenes will provide healthcare services to the User. Antegenes may offer its services as both healthcare and non-healthcare services.
2.4 If the services are provided through Antegenes Partners (third parties), the service type will depend on the third party and their service provider licenses.
2.5 Antegenes offers its services to Partners as healthcare services if the partner is registered as a healthcare provider in its jurisdiction.
2.6 Antegenes offers its services to its Partners as services, but not as healthcare services, if the partner to whom the service is provided is not registered as a healthcare provider in its jurisdiction.
2.7 If during service provision through third parties the User orders any additional services directly from Antegenes the User becomes an Antegenes patient and Antegenes provides healthcare services to the extent of those ordered.
2.8 If the service is provided as a health care service The Terms of Service are considered to be standard terms for health care services as represented in the Law of Obligations Act in force in the Republic of Estonia.
2.9 As part of the service provision, the User or Antegenes opens an account for the User in the Antegenes information system, which is used to manage the service processes. The service is in effect until the account is active.
2.10 The results of services provided as health care services are also entered into the Estonian Health Information System (digilugu.ee), the chief processor of which is the Health and Welfare Information Systems Centre (registry code 70009770, address Uus-Tatari tn 25, 10134 Tallinn). In case of questions, the person can contact the Health and Welfare Information Systems Support Centre by phone +372 794 3943 or e-mail firstname.lastname@example.org. The User has access to the data in the information system and the User has all the rights arising from the Personal Data Protection Act with regard to the data stored in the Health Information System, including closing the data so that it is not accessible to anyone.
2.11 The Service Provider has the right to change the Terms of Service by publishing the updated Terms of Service on the website. Amendments to the Terms of Service apply whenever the User continues to use the Antegenes services or after 30 days from the posting of the amended Terms of Service on the website, or if the User has not made a written statement of disagreement with the Terms of Service. Upon submission of a corresponding written application, the service is considered terminated for the respective User.
3. Consent to provide the Service
3.1 User consent is required for providing the services. By law, there may be additional consents required, such as test specific informed consent forms. When the User arrives at the service provider to receive the service, when ordering the service via the website or third parties, the User’s consent to receive the service is required. If necessary and/or required by law, the User must accept (sign) an informed consent form on paper or electronically.
3.2 Antegenes services are not intended for persons under 18 years of age. Also, to order services, agree to the Terms of Service, and approve any other forms of consent, the User or his/her representative must be at least 18 years old, and any services requiring the processing of genetic data or health data can also be ordered by persons at least 18 years old.
3.3 In the case of receiving the service as part of the research, the service is intended for a specific target group of the research, one of the criteria of which may be age.
3.4 In the case of a User with limited active legal capacity, consent to receive the service can be approved by his/her legal representative unless the User is able to responsibly consider the pros and cons of the service. The Service Provider is not obligated to follow the decision of the legal representative if it obviously damages the interests of the User.
3.5 Partners who offer Antegenes services (including healthcare providers) ensure that they have the legal right to provide Antegenes services and that the User’s awareness of the limitations and benefits of the services is ensured, and the necessary consents are collected.
3.6 Data submitted for genetic testing can be used for secondary testing. A new consent form is required to perform any additional tests.
4. Ordering the Service and Payment
4.1 Antegenes services may be subject to a fee. The service fee depends on the Antegenes price list that is valid at the time of purchase. The Service Provider may change the price list.
4.2 To order a service, the User or an authorized partner selects a suitable service, and the User pays for the ordered service either electronically or at the location of the service provider in cash or with a bank card. There is no payment for participation in the free research.
4.3 The partners shall forward the collected orders to Antegenes via the agreed electronic or other channels together with the contractually agreed data necessary for the fulfillment of the order.
4.4 Placing a paid order electronically at our website – the user adds the selected services into the shopping cart and fills in the required fields for placing an order. The payment methods of the service include LHV, Swedbank, SEB, PayPal and payment by invoice. Payments will be accepted in euros. After receiving the payment, the User will receive a purchase confirmation e-mail.
4.5 In the case of free research services, the User will be shown the instructions corresponding to the research process for obtaining the service for free.
4.6 If the service has been ordered directly from Antegenes and significant steps have not yet been performed during the ordered service (laboratory procedures or consultations have not been performed or results of services have not been issued) and no more than 14 days have passed since placing the order, the User can cancel the ordered by sending a withdrawal request to the Service Provider via e-mail email@example.com.
4.7 If the User returns the ordered service in accordance with section 4.6 of the Terms of Service, the fee paid by the User shall be refunded within 14 days from the receipt of the return request specified in clause 4.6 of the Terms of Service by the Service Provider. If the service order included a DNA testing kit and its shipment, the amount paid will be refunded, from which we deduct the logistics costs and costs of the sampling tools.
4.8 If the service has been ordered from the Service Provider’s partners, refund requests will be submitted to the representative of the respective authority.
4.9 In the case of a service received in research, withdrawal is in accordance with the provisions of the research consent form.
4.10 The DNA sample must be returned to the return address as soon as possible, but no later than 12 months after the arrival of a DNA testing kit to the User.
5. Service Processes
5.1 As part of the service, an account will be created for Users to Antegenes information system, through which the service processes will be managed.
5.2 If the User orders services from Antegenes directly via Antegenes or via a Partner mediating these services, the User can manage his orders through the User portal MyAntegenes related to the Antegenes information system.
5.3 Antegenes never asks its Users for passwords for their accounts. Users can log in to the MyAntegenes environment either with an e-mail and password or via eID personal identification tools. The e-mail and password are confidential, and the User is responsible for securing them. If the password is lost, it can be recovered via the MyAntegenes environment.
5.4 If the Users contact the customer service, genetic counselors, or other representatives of the Service Provider, the User may be asked to identify himself/herself. Antegenes cannot guarantee the complete confidentiality of the information sent by the User if the information exchange takes place through information channels, not in the possession of the Service Provider (eg public wi-fi, unsecured data traffic). The user is responsible for his account and the activities under his control and security.
5.5 For all MyAntegenes Users, the User’s personal identification is required (Antegenes uses the personal identification services of Veriff OÜ or Dokobit UAB), adding the personal data necessary for performing the test and filling in the consent forms related to the ordered tests. Analyzes of the genetic data will not be performed until identity is verified and test-specific consents have been given.
5.6 If the MyAntegenes User service includes laboratory services and genotyping of DNA material, the User may need to register the sent DNA sample code, which can be found on the box or/and on the sample collection kit according to the instructions in the box.
5.7 If the services ordered by the User do not include laboratory services, these may require uploading DNA data from external sources to the information system through MyAntegenes. We currently support data from 23andMe, MyHeritage, AncestryDNA, FamilyTreeDNA, Genes for Good, or the Estonian Gene Bank.
5.8 If the MyAntegenes User has also ordered a genetic consultation as an additional service, it is possible to voluntarily answer the questions related to the respective test, which will provide the consultant with additional information about the User’s health condition.
5.9 Registration for the consultation is done via eKliinik’s online booking system. This option opens to Users with the respective access rights after the reports are visible.
5.10 During the various process steps, Antegenes may send e-mails to the User giving updates about the service process.
5.11. Antegenes services may be provided without access to the MyAntegenes environment, where the respective processes are managed by an external partner.
5.12 Genetic test results reports may be made available to the Patient either directly through the MyAntegenes User Environment and/or a User-approved Partner and/or in some other agreed secure and lawful pathway. When the reports are completed, the Users will be sent an e-mail for each completed report.
5.13 In cases where Antegenes is responsible for genotyping, but DNA genotyping is not successful and there is no reason to suspect knowingly malicious behavior (sending inappropriate biological material or contamination of the sample), the service may try to extract DNA from previously unused sample material or send a new DNA extraction kit to the User free of charge.
6. Genetic Consultation
6.1. Genetic consultation (Consultation) is a health care service during which the medical professional explains to the User the results of the genetic risk tests performed on him or her.
6.2 It is possible to register for the Consultation after receiving the risk score test reports either through the MyAntegenes portal or other agreed means. In case of participation in the research, if necessary, a consultation will take place in accordance with the research conditions, which the User will be informed about by the research provider.
6.3 The Consultation is usually done online but may also be done over the phone if requested.
6.4 After registering for the Consultation, the Service Provider will send the User a Consultation invitation to the e-mail address entered by the User, which includes both a link and a password to join the video consultation, as well as Consultation instructions. The link and password sent to the User are meant only for the authorized person, ie the User who has registered for the Consultation and received the link. The User undertakes not to share the sent link and password with other persons.
6.5 At the request of the User, it is possible to receive a Consultation at the Service Provider’s medical institution at the address (Raatuse 21, 50603 Tartu or Linnamäe tee 3, 13912 Tallinn). The time and place of the Consultation will be agreed with the User and the User will arrive at the location of the Consultation at the agreed time.
6.6 The Service Provider has the right to postpone the Consultation if, due to an unforeseen organizational problem, such as the employee’s illness or a failure of the medical device, it is not possible to provide the service at the agreed time. In this case, the Service Provider notifies the User of the postponement of Consultation as soon as possible and offers a new free Consultation time.
7. User Declarations
7.1 By using the services of Antegenes, the User confirms that he has read, understands, and agrees with the following clauses about himself.
7.2 The User always provides true information when receiving Antegenes services. The personal data and samples submitted in the course of the service come from the User or have been mediated to the extent necessary by his/her legal representative to receive the service. The User confirms that the DNA sample and/or data come from the same person who is identified during the service and who confirms the consent form.
7.3 The User authorizes Antegenes and its authorized processors to process their genetic data and to disclose the results of the analyzes to themselves and to third parties authorized by them. The User takes full responsibility in all related circumstances.
7.4 The User confirms that he or she understands that the Antegenes genetic tests are not used to diagnose diseases but to provide a probabilistic risk assessment for the development of tested tumor types. Very high-risk assessments do not indicate that a disease would surely develop nor do very low-risk assessments rule it out.
7.5 The User understands that each service that contains genetic testing has a recommended age group where its expected benefits are the greatest.
7.6 The User understands that Antegenes processes personal data on servers located in Estonia (European Union) and that the User’s DNA sample and its results may be processed outside the User’s country of location.
7.8 The User understands that the performance of the Antegenes tests has mainly been evaluated on populations with European ancestry.
7.9 The User is responsible for sharing his data with third parties.
8. Refusal to provide the Service
8.1 The Service Provider has the right to refuse to provide the service to the User or to apply other proportional measures, incl. legal action if:
8.1.1 the User wishes to receive a service, the provision of which would pose a greater risk to the User’s health than not providing the service;
8.1.2 the User wishes to receive a service that may endanger the health of an employee of the Service Provider or a third party;
8.1.3 according to an active license, the Service Provider does not have the right to provide the desired service to the User or there is temporarily no professional competence available to provide a specific service;
8.1.4 the User violates his / her obligations arising from the conditions or legislation agreed upon orally or in writing for the provision of the service;
8.1.5 the User does not disclose the information necessary for the provision of the service to the Service Provider;
8.1.6 the User violates the obligation to aid the Service Provider in providing the service, incl. does not agree with the services accompanying the provision of the basic service, without which the provision of the basic service is not expedient;
8.1.7 the employee of the Service Provider is not able to communicate with the User in a language he or she understands and the User is not able to involve an interpreter, which may make the service unsuitable for the User or dangerous to his/her health;
8.1.8 According to the employee of the Service Provider, the user has signs of intoxication upon arrival at the Consultation;
8.1.9 the User treats the employee of the Service Provider rudely;
8.1.10 the User violates the obligation to pay a fee to the Service Provider for the provision of the service.
8.1.11 the User requests the provision of the service to him or her on terms and conditions that conflict with the Terms of Service;
8.1.12 in the course of the service, the User has submitted false information to the Service Provider or submitted samples that do not belong to him;
8.1.13 arbitrary and non-targeted use of Antegenes intellectual property or use / brokering of services by the User;
8.1.14 the User makes malicious attempts to prevent the provision of the service.
9. Termination of Service
9.1 The Terms of Service apply to the User and are valid until the termination of the service and/or the closure of the account by the User or Antegenes.
9.2 The service can be terminated by submitting a request to Antegenes to close the User account, terminate the service, and delete the data. After submitting the request, a second contact will be sent an e-mail asking for confirmation, after which the service will be terminated.
9.3 The procedure for terminating the service may take up to 30 days from the beginning of the respective procedure. In this case, the consent given to other forms of Antegenes consent (incl. consents to send information materials and to participate in cooperation projects) will be automatically terminated.
9.4 Upon request to terminate the service, all pending service processes will be suspended.
9.5 Upon deletion of the account, Antegenes may, in accordance with applicable law, retain some of the data used, which may result from the obligation to retain healthcare data or for other legal reasons.
9.7 Antegenes may, in accordance with applicable law, terminate the service with the User at any time and restrict access if the User has violated or indicated an intention to violate the Terms of Service, termination of the service is required by law or its offer is illegal or Antegenes can no longer offer its services in the User’s country.
10. What to look for when using Antegenes Services
10.1 The Service Provider confirms that it takes the necessary measures to ensure the quality of the services provided. The Service Provider makes every reasonable effort to ensure that the results of the service are accurate and true. Despite the efforts of the Service Provider, it cannot be completely ruled out that the information provided by the Service Provider on the Patient’s state of health in the course of providing the service is inaccurate or untrue.
10.2 Interpretations of genetic data provided by Antegenes services may give rise to all sorts of negative and positive feelings and changes in psychological status.
10.3 Laboratory and bioinformatic analyses may fail to process the User’s sample for a variety of reasons, and there may be some random variability in the result of the analysis sample.
10.4 Different polygenic risk scores for the same trait may give different results depending on the genetic variants included in the risk score and their weights.
10.5 Antegenes risk models are based on rapidly evolving science that may provide future data to supplement, heal, or change. This may add to and change the clinical recommendations over time.
10.6 Antegenes services are not the same as for the analysis of pathogenic monogenic variants. In such assays, individual genetic variants have a very high impact on the likelihood of the disease, such as the analysis of BRCA gene variants in breast cancer. Antigenes tests do not analyze these rare pathogenic monogenic variants.
10.7 In addition to the User’s personal data, the absolute disease risks issued in the Antegenes services also take into account the epidemiological disease indicators (age and sex incidence, mortality) of the country that issued the document used as the basis for identification provided by the User.
11. Dispute Settlement and Liability
11.1 Disputes arising from the Terms of Service and in the course of providing the service shall be settled by negotiations between the parties. The jurisdiction of disputes arising from this is the Tartu County Court, Estonia. The law of the Republic of Estonia shall apply to the contract.
11.2 The Service Provider is not responsible for the negative consequences of the provision of the service if the employee of the Service Provider has informed the User about the possible risks and consequences and the User has given consent to the provision of the service.
11.3 The ordered service is considered reviewed and accepted if the User does not submit a claim regarding the results of the service to the Service Provider within a reasonable time from the time the service results are made available to the User. The user can submit complaints to the Service Provider together with the reasons at firstname.lastname@example.org.
11.4 The Service Provider is not responsible for the consequences arising from the fact that the Service User has not followed the instructions given to him.
11.5 When providing the service, the Service Provider is also liable for the activities of other legal entities providing the service to it and for defects in the equipment used for the provision of the service.
11.6 According to the law, the fact on which liability of the Service Provider and the health care provider directly providing the health care service must be proved by the service User, ie the patient, unless the provision of health care to the patient has not been properly documented.
11.7 The expiration date of a claim for compensation for damage by a health care service to a User is five years from the time when he or she became aware or should have become aware of the breach of the Service Provider’s obligation and the occurrence of the damage.
11.8 The Service Provider is liable for breach of its obligations in the provision of health care services based on an authorization agreement articles of the Law of Obligations Act. The Service Provider is liable only for direct property damage caused by the breach of his obligation in the provision of health care service, and up to ten times the fee for the service provided. The Service Provider is not liable for indirect or non-pecuniary damage caused by the breach of its obligation in the provision of health care service.
11.9 The Health Board, register number 70008799, Paldiski mnt 81, 10619, Tallinn, phone +3726943500, e-mail email@example.com, supervises the provision of health care services. In case of claims against the Service Provider, the Patient has the right to submit a corresponding complaint or application to the Health Board. More detailed information on submitting a complaint or application can be found on the Health Board’s website (terviseamet.ee).