August 2021, Rev #6
General, Consent, and Application.
1.5.1. “Client” — patient (the “Patient”), subject (the “Subject”), physician (the “Physician”), including the Patient’s or Subject’s health care provider or any geneticist, clinical geneticist pharmacist, genetic counselor and specialist, genetic institute (as defined in the Israeli Genetic Information Law), genetic testing laboratory, including medical laboratories that have been granted a license to perform genetic testing (pursuant to the Israeli Genetic Information Law).
1.5.2. “Associates” — additional individuals in respect of whom the Client provides information to Taliaz.
1.5.3. “User” — a visitor and/or user of the Platform, including a Client.
1.5.4. “Services” — conducting the Digital Test or the Genetic Test (as defined hereunder), granting and accessing the Test Reports (as defined hereunder).
1.5.5. “Products” — products that Taliaz provides, which include the questionnaire, the Test Reports, the Digital Test, the Genetic Test, and the test results.
1.5.7 “Taliaz”— Taliaz Ltd.
1.5.7. “The Digital Test”— the Predictix test, aimed at recommending a medicinal treatment to a Subject’s Physician, in light of the clinical, demographic, and behavioral information of the Subject using the Predictix System.
1.5.8. “The Genetic Test”— the Predictix test, utilizing a sample of the Subject’s saliva for DNA analysis, aimed at recommending a medicinal treatment to a Subject’s Physician in light of the clinical, demographic, behavioral and/or genetic information of the Subject using the Predictix System.
1.5.9. “Tests”— the Digital Test and the Genetic Test.
1.5.10. “Test Report”— the output of the Predictix System, which gives the Physician an indication about a possible match for the medications detailed in it, which may assist the Physician in the prescription of the treatment, while maintaining the ability to exercise independent review of the entirety of the data (including the clinical data) related to the Subject.
1.5.11. “The Predictix System” or the “System”— Taliaz’s system for processing clinical, demographic, behavioral, and/or when utilized as part of the Genetic Test, genetic information, in order to recommend medicinal treatment.
- Using the Platform and the Services
2.3. Taliaz may, at any time, according to its sole and absolute discretion, change and/or terminate the provisions of the Services using the Platform and/or any part thereof, and this, without being obligated to give the User any notice about it.
2.6. The use of the Platform and the information available on it (including the Test Report) does not constitute any medical recommendation and/or counseling (including genetic counseling). The use of the Tests, and the information available on the Platform (the Test Report) is strictly at the User’s own risk, and Taliaz shall not be responsible for any damage or loss, whether direct or consequential, related to the use of the System and/or the Platform and/or the information found on it (including the Test Report) and/or the use of the Services and/or the relying on any of them. Taliaz shall not be liable or responsible for any failure of the Physician to procure the right health care. Taliaz is not a health service provider or a medical organization and therefore is unable to provide medical advice. . User shall always seek the advice of a healthcare professional for any medical questions User may have.
2.7. The Genetic Test
2.7.1. The Subject must provide Taliaz with the appropriate sample according to the type of Genetic Test as detailed in the Predictix System, along with (a) a Consent Form, approved by him; and (b) the questionnaire found on the Platform. It is hereby clarified that Taliaz shall only deal with saliva samples that it receives following the approval of the Consent Form and a questionnaire completed to Taliaz’s satisfaction, and this, at Taliaz’s discretion.
2.7.2. Taliaz shall sequence DNA from the sample provided by the Subject, on its own or using an external laboratory (“the External Laboratory”). The DNA shall be analyzed, and when the results of the DNA test are received, its data shall be entered into the Predictix System and, with the data from the questionnaire, the Test Report shall be produced.
2.7.3. If there is any fault in the saliva sample provided by the Subject, and it is impossible to produce a DNA analysis from it for any reason whatsoever, the Subject shall have to repeat the process.
2.7.4. Taliaz shall provide to the Physician of the Subject access to the Test Results.
2.8. The Tests
2.8.1. The Test Report produced as the result of Subject’s or Patient’s use of either of the Tests is intended solely for use by Subject’s or Patient’s Physician for the purpose of supporting or providing recommendations to the Physician about treatment of the Subject’s or Patient’s existing disease or condition. The Physician is not intended to rely primarily on any of such recommendations of the Test Report to make a clinical diagnosis or treatment decision regarding an individual Subject or Patient.
2.8.2. The Tests are intended solely for Subjects or Patients with prior diagnoses of Major Depressive Disorder.
28.3. The Test are not intended for Subjects or Patients with psychiatric conditions where the underlying psychiatric condition may require an urgent or immediate clinical intervention and the delay of the intervention may pose significant harm to the Subject or Patient, including, but not limited to, the treatment of suicidality.
- Declarations and Undertakings
3.1. The Physician, declares and undertakes as follows:
3.1.1. That the Subject has authorized him to take a DNA sample using a DNA collection tube, to fill out the Test questionnaire, to send the DNA sample to Taliaz and/or an external laboratory (as per Taliaz’s instructions) using a DNA collection tube, and to receive the Test Results from Taliaz. The Physician further confirms that the Genetic Test is conducted in connection to full medical services;
3.1.2. That he has given the Patient a detailed explanation regarding the meaning of the Genetic Test (including pursuant to the Consent Form), the collection of a genetic sample and the conducting of researches (as it appears on the Consent Form), and that after he gave the Subject the legally required explanations, including an explanation that the Consent Form includes a written informed consent according to any applicable law, including the Genetic Information Law, 5761-2000 and GDPR, and approve that the Subject has signed the Consent Form;
3.1.3. That he understands and has explained to the Subject the rest of the provisions of these Terms, and that (a) the Physician, and him alone, is the only one who determines the proper medicinal treatment, while examining the entirety of the Subject’s clinical data, and that the Subject has undertaken before him not to make any use of the Test Results, in whole or in part, unless pursuant to the Physician’s advice, and at his own risk; (b) the limits of the Genetic Test (as hereinafter detailed and on the Consent Form); (c) sometimes, due to the performance of a certain genetic test, there may occur a situation where a disorder or any other condition, which were not initially intended to be detected, shall be identified; (d) it is possible that certain samples and additional information received from the Test shall be kept for the purpose of improvement processes, internal checks and validation, teaching and/or research purposes, and that this shall only be done after any identifying details have been detached from the DNA samples in a manner that shall not enable the re-identification of the Subject. Moreover, it is possible that non-identifiable information (which has been stripped of details that enable the identification of the Subject) shall be transferred to research databases; (e) Subject to his consent on the Consent Form, following the performance of the Genetic Test and with the expiration of the time period required by law for the preservation of the DNA sample, the DNA sample shall be preserved when it is identified for the purpose of any research approved by law if the Subject has checked on the Consent Form that he agrees to the preservation of the DNA sample when it is identified; in any other case, the DNA sample shall be preserved when it is non-identifiable (DNA samples that are preserved over time lose their quality, and it is possible that they cannot be used).
3.2. The Subject confirms by his/her signature that s/he is not one of the following: pregnant, a minor under the age of eighteen (18) years old, a person for whom a guardian was appointed, legally incompetent.
3.2.1. S/he is aware of the limits of the Tests, including that—
(a) The Tests are performed within the context of full medical services, and are not designated to provide information regarding diseases or syndromes the Patient carries and does not perform any medical diagnosis; (b) due to the complexity of genetic tests, a certain rate of erroneous results, which may distort the test results, is possible; (c) the Tests do not supersede the Physician’s decision, but serves as a decision-supporting tool that assists the Physician in personalizing the treatment for the Patient; (d) both Tests are not used to diagnose depression or any other mental condition; (c) the proper interpretation of the Test Report and its use for the purpose of providing medical service depends on many factors, which Taliaz is not responsible for, such as (1) a full and accurate report about the Subject’s health condition and/or the health condition of the Subject’s family, (2) the reliability of the answers to the questionnaire, (3) the reliable results of the genetic test performed by the laboratory, (4) additional background diseases, and (5) life events, and more; (e) the Tests are, inter alia, statistical analyses that rely on probabilistic tools in order to assist the Physician in determining the suitable medicinal treatment; (f) the performance of the Tests does not guarantee that the Services shall yield the desired or optimal results for the Subject, and nothing in the performance of the Tests guarantees that the forecast given in the framework of the Services shall indeed be accurate. The Tests are not intended for the aforesaid in Section 3.2.
3.3. The Subject agrees, declares, and undertakes as follows:
3.3.1. That the Genetic Test is for investigational use only. The performance characteristics of the Genetic Test have not been established. In the event that he is using the Genetic Test, he has signed the Consent Form;
3.3.3. To take sole and complete responsibility, including for any risk stemming from any use made of the Platform and/or Products and/or Services and/or the Test Results (including with regard to the User information and including with respect to the Associates about whom he gives information);
3.3.4. That he himself is the Subject (as defined in the Genetic Information Law of his country) in respect of whom the genetic information is provided to Taliaz;
3.3.7. That the Physician, and him alone, is the only one who determines the proper medicinal treatment, while independently examining the entire clinical data of the Subject.
3.3.8. That the Subject is at least 18 years old and is not pregnant.
3.4. The User (including the Patient and the Physician) declares and undertakes:
3.4.1. That he is aware that nothing in the Tests and the Test Report constitutes any suggestion or consultation, neither general or such that considers the Patient’s personal needs, and that the Physician, and him alone, is the only one who determines the proper medicinal treatment, when examining the Subject’s entire clinical (and other) data.
4.1. As a subcontractor within the meaning of the laws and regulations applicable to it with regard to the protection of personal data, Taliaz undertakes to:
4.1.1. process the Subject’s personal data only for the purpose (s) pursued by the Doctor, with the exception of the possible reuse by Taliaz of only anonymized data for statistical purposes for the needs of improving the quality of the System;
4.1.2. process personal data in accordance with the documented instructions of the Doctor in his capacity as data controller. If Taliaz, as a subcontractor, considers that an instruction constitutes a violation of the applicable regulations, he immediately informs the Doctor.
4.2.1. not to communicate or transfer personal data to unauthorized third parties;
4.2.3. to the extent possible, help the Doctor, as data controller, to fulfill his obligation to respond to requests for the exercise of the rights of data subjects;
4.2.4. collaborate with the Doctor in carrying out any analysis of the impact on data protection relating to the processing of personal data decided by the Doctor and, where applicable, any prior consultation of the competent national data protection authority ;
4.2.5. notify as soon as possible to the Doctor, in his capacity as data controller, any violation of personal data processed within the framework of the Predictix System of which Taliaz is aware;
4.2.6. implement the appropriate technical and organizational security measures, in particular by means of pseudonymization devices by default, in order to guarantee the anonymity of the Subjects and a level of security of personal data adapted to the identified risks, in particular by proceeding in storage of these data with an approved health data host within the meaning of the regulations in force, so as to prevent destruction, loss, alteration, deformation or other modification, pirating, misappropriation, damage, access by unauthorized persons or disclosure of personal data that Taliaz processes, in any way, on behalf of the Doctor.
4.4. The Doctor may have an audit carried out, at his exclusive expense once a year and subject to prior information 2 months before the start of operations, to ensure that Taliaz fulfills its obligations as a as a subcontractor of the Doctor with regard to the applicable laws and regulations.
4.5. Taliaz undertakes to only transfer personal data outside the European Union on the basis of an adequacy decision like that granted by the European Commission to the State of Israel. either of appropriate guarantees, such as standard contractual clauses, and – in the latter case – after having carried out an assessment of the respect by the national law of the third State of the rights granted to the Subject in accordance with the applicable protection regulations personal data.
4.6. Under the terms hereof, the Doctor declares and acknowledges Taliaz authorized to use any subsequent subcontractor, provided that the latter undertakes to comply with the same conditions as those provided for the processing of personal data under the Conditions of use.
- Intellectual Property
Among the parties, Taliaz holds the full rights (exclusively) in respect of the Tests, the Test Report, the Services, the Platform, including the components, features and models of any of them, the updates, changes, improvements and upgrades of any of them, and for any future development of any of them (even if done on the basis of insights provided by any User), the data available on any of them (excluding the User information) and all other rights, including any right of patent, trademark, design, copyright and any other intellectual property rights related to the aforesaid, whether listed or not (the “Trademarks”). All of the rights not conferred within the framework of the license are reserved for Taliaz. Nothing hereunder shall be construed as granting, by implication, estoppel, or otherwise, any license or right to use the Trademarks, without Taliaz prior written permission specific for each such use. Use of the Trademarks as part of a link to or from any site is prohibited unless establishment of such a link is approved in advance by us in writing. All goodwill generated from the use of the Trademarks inures to Taliaz’s benefit. If User provides suggestions, ideas, or other feedback to Taliaz about the System and/or Platform, Taliaz will be free to exercise all rights in such feedback without restriction and without compensating User.
Liability and Indemnification
6.3. The User is aware and consents to the fact that the use of the Platform is conditioned upon an available internet connection, and the inexistence of an internet connection and/or the termination of the connection shall prevent the use of the Platform. The User agrees that he alone shall bear all of the various charges of the communications service provider, which may be collected for the necessity of an internet connection in order to use the Platform. Taliaz shall not bear any responsibility whatsoever for any damage that may be caused due to the termination of the Services or the availability of the Platform, including due to maintenance work, whether or not the User received notice about them. The User understands and agrees that any responsibility and/or risk with regard to the aforesaid shall solely apply to the User.
- Governing Law, Jurisdiction, and Miscellaneous
7.4. No partnership, agency relationship or joint venture exists between Taliaz and the User.