Terms of use - elona therapy (for patients)

Preamble

These Terms of Use apply to the contractual relationship between Elona Health GmbH, Schirmerstraße 61, 40211 Düsseldorf, Germany, and the users* of its smartphone app elona therapy to support the therapeutic treatment of mental illnesses (depression, anxiety/panic disorders, somatoform disorders).

§ 1 General

(1) The subject of these Terms of Use is the provision of the elona therapy app (hereinafter "App") by Elona Health GmbH (hereinafter "Provider"). The contractual partner (hereinafter "User") is granted the use of the functionalities of the App by Elona Health GmbH against payment of the agreed fee. The User can download the App via the Google Play Store or the Apple App Store.

(2) The app is used together with the web-based application "elona therapy für Therapeut:innen" and forms a CE-marked medical device of class I according to MDD.

(3) The app is aimed exclusively at natural persons of legal age. Registration or use of the app is not permitted for users under the age of 18.

(4) Use of the app is only possible after the user has agreed to these terms of use and consented to the processing of his/her personal data and in particular his/her health data.

(5) Any agreements deviating from these Terms of Use must be made in writing. Any general terms and conditions of the user shall not apply.

(6) To register for the use of the app, a valid e-mail address is required. After entering an email address, the user receives an email with a confirmation code. Only when this code has been entered by the user is a contract with the provider concluded and use of the app is possible.

(7) The app is not intended for users over 65 years of age or who have one or more of the exclusion criteria or contraindications postulated by the manufacturer. A complete list of exclusion criteria, contraindications and warnings can be found in the applicable instructions for use.

§ 2 Subject matter of the contract

(1) The provider provides the app to the user for the purpose of supporting outpatient psychotherapeutic treatment. The app contains functions such as psychoeducational content, multimedia and interactive exercises, mood protocols, questionnaires and a note function. These functions and contents are intelligently provided to users based on their therapy progress. Users edit these independently. The provider reserves the right to change or expand the functions offered or to discontinue certain services. Services already bindingly booked are not affected by subsequent changes during the term of the contract.

(2) The source code of the app is not part of the subject matter of the contract.

(3) The App and its documentation shall remain the property of the Provider. The Provider shall remain the sole owner of all right, title and interest in and to the App and the intellectual property rights associated with the App, including, without limitation, copyrights, any patents, trade secrets, trademarks and other intangible rights.

(4) There is no entitlement to the conclusion of a contract for the use of the app. The provider is free to automatically or manually reject an application for use of the app without giving reasons. A rejection shall be made in particular if there has already been reasonable suspicion in the past of misuse or use that is substantially contrary to the contract (in particular with regard to breaches of the obligations specified in § 5 of these Terms of Use).

(5) The provider is responsible for the maintenance of the app. This includes, in particular, the adaptation to changing legal regulations, provided that this does not involve work that is unreasonable for the provider.

§ 3 Use

(1) The app can only be used with an Android smartphone or an Apple iPhone (hereinafter referred to as "end devices"). The app can only be obtained via the above-mentioned app stores. The Provider reserves the right to offer the App for other end devices in the future. The information on compatibility in the instructions for use shall always be authoritative.

(2) The use of all functions of the app is only possible if the user's therapist uses the web-based application module "elona therapy für Therapeut:innen" in connection with the user's therapy. Registration then takes place via a QR code of the therapist, which the user scans with the camera of his end device. To scan the QR code, the one-time use of the camera of the user's end device is mandatory.

(3) The user is not obliged to connect the information entered in the app with his therapist and thus make it accessible to him. However, the use of all functionalities of the app to support psychotherapeutic therapy is not possible in this case.

(4) Provided that the user allows local notifications by the app on his end device, he can be reminded by the app to use the content offered.

§ 4 Costs

(1) Use of the app is subject to a charge and is billed quarterly. The prices stated in the app at the time of the conclusion of the contract shall apply. All prices include the statutory value added tax and must be paid in advance.

(2) The costs for the use of the app can in principle be covered by the user's health insurance in the case of a therapeutic prescription. In this case, registration takes place via an access code or a QR code that the user receives from his/her health insurer after the therapist has issued a prescription for the use of the app. Provided that the user has successfully entered the code or scanned the QR code for authentication, billing with the health insurer will take place automatically. The user will not use any access codes for the purpose of reimbursement by the health insurer that he/she has not been authorised to use by the health insurer.

(3) Costs incurred by the Provider due to incorrect information provided by the User or insufficient account coverage shall be borne by the User.

§ 5 Rights and duties of the user

(1) The use of the app is voluntary. However, if a therapy has been started using the app, it is recommended not to discontinue the use of the app during the treatment, unless there is a therapeutic recommendation to discontinue. The user is permitted to use the app exclusively within the framework of psychotherapeutic treatment and for the aftercare of the therapy ("relapse prophylaxis") after consultation with the therapist.

(2) The user is granted a simple and revocable right to use the app, which is limited in time to the term of this contract. Transfer or sub-licensing of the granted right of use is excluded. Furthermore, the user is prohibited from any distribution, modification or reproduction of the materials made available via the app.

(3) The app and all content published via the provider's website are fundamentally protected by copyright. Reproduction, editing, redesign, distribution, making available to the public as well as the removal, suppression or manipulation of legal notices are prohibited unless the provider gives its express written consent in advance. This also applies to the use of bots, scripts, plug-ins or other means for the automated false representation of user activities or storage of contents of the app.

(4) Exploitation or spying out of the database provided by means of the app using other software is not permitted. This applies in particular to automated access to the app or the content provided in the app.

(5) The User is not permitted to modify, translate, examine for functionality or decompile the source code of the App unless this right is expressly granted to him/her by law or by the Provider.

(6) The user shall ensure that all information which he provides within the scope of the use of the app and which is required for proper line provision by the provider is complete and correct. He shall also keep this information up to date during the entire term of the contract.

(7) Illegal actions and violations of applicable law are prohibited when using the app. Furthermore, the storage, publication, dissemination and making available of harassing, manipulated, youth-endangering (e.g. pornographic or glorifying violence), defamatory, discriminatory, inciting hatred, illegal, confidential or otherwise infringing the rights of third parties (e.g. personal rights or copyrights) is prohibited. This also includes the sending of abusive messages (spam) and the distribution of malware.

(8) The user must create individual login data and a password before starting to use the service. Further mandatory details are marked accordingly during registration, if applicable. He is obliged to protect the login and password and to protect them from unauthorised access by third parties. If misuse by a third party is suspected, the user shall inform the provider of this immediately. As soon as the provider becomes aware of the unauthorised use, the provider will take the necessary steps to protect the user account. The provider reserves the right to change the user's login and password in the event of justified suspicion of misuse; in such a case, the provider will inform the user of this without delay.

(9) The user is also obliged to cooperate in the clarification of attacks by third parties on the app, insofar as this cooperation is necessary.

(10) The user is responsible for using an end device that is suitable for the use of the app and that meets the minimum requirements for the installation of the app as specified in the app store. He/she must also provide suitable secure internet access suitable for the secure transmission of his/her sensitive health data. Possible costs for internet use depend on the respective tariffs of the user's internet provider.

(11) The user undertakes to refrain from all measures that endanger or disrupt the functioning of the app and not to access data to which he is not entitled. Furthermore, the user must ensure that the information and data transmitted via the app are not infected with viruses, worms or other malware. The user undertakes to compensate the provider for all damages resulting from the user's failure to comply with these obligations and, in addition, to indemnify the provider against all claims by third parties, including lawyers' fees and court costs, which they assert against the provider due to the user's failure to comply with these obligations.

(12) The user is given the option to additionally protect the app by using Face ID, Touch ID or comparable technologies, provided that the end device used has a corresponding function available. If the user does not select this option, the provider is not responsible for unauthorised access to the processed data that could have been prevented by using Face ID / Touch ID technology.

(13) Updates to the App offered via the App Store must be installed by the User without delay and the App must always be kept up to date.

§ 6 Availability

(1) The app is generally available to the user around the clock. Technical work (such as troubleshooting, software maintenance or data backup), however, may lead to temporary restrictions. Technical work is usually carried out on weekdays between 21:00-06:00 or on weekends, unless this is not possible due to the particular relevance or urgency of the work. If this is possible, any troubleshooting work will be announced to the user with a reasonable period of notice in the app or in text form.

(2) In addition, availability still exists if the essential functions of the app can be carried out without prejudice to minor disruptions. Availability is only not present if essential functions of the app cannot be used.

(3) Downtimes in which the availability of the app is suspended are not the responsibility of the Provider, in particular in the following cases:

(a) Downtime due to incorrect operation or use of the App by the User;

(b) if the user does not comply with his obligations to cooperate in the elimination of faults;

(c) Downtimes that are due to circumstances beyond the control of the Provider. These include, in particular, disruptions at third parties who are not acting as vicarious agents of the Provider, unlawful attacks on the Provider's infrastructure (e.g. DoS attacks, attacks by malware and hackers), natural disasters, war or other forms of force majeure.

(4) The Provider offers online support and telephone support. The online support can be reached via the e-mail address support@elona.app. The telephone support can be reached within the support hours (Monday-Friday 9:00-18:00) at 0211-8226866-0. The support is only responsible for advising on technical difficulties or questions when using the app. It does not provide medical advice and is also not a contact for inquiries, suggestions or complaints in connection with the user's therapeutic treatment. A response to support requests will be provided within 24 hours of receipt of the request.

(5) Support by the Provider shall not be offered if the User has modified, adapted or supplemented the App himself/herself or through third parties without consultation with the Provider.

§ 7 Use for therapeutic purposes

(1) It is possible that the use of certain functions and the performance of exercises in the app may be therapeutically ordered by the user. Proper use of the diagnostic and prognostic functions by the user's therapist is only possible if the user uses the respective functions of the app to the full extent and truthfully provides the required information. The user shall notify the provider of any changes to his/her data, including payment data, without delay. The provider reserves the right to block the user if the user intentionally or grossly negligently provides false information.

(2) The user will in particular answer questions in the app concerning his/her mental state truthfully, complete progress regularly and perform the exercises carefully.

(3) Insofar as the user's therapist is provided with prognoses and risk assessments as a result of using the app, their medical-therapeutic classification is carried out exclusively by the therapist. The provider is not responsible for therapeutic decisions made by the therapist based on the information and prognoses provided by the app. The app alone is not a substitute for psychotherapeutic diagnosis and treatment.

(4) The app mainly provides psychoeducational content. This does not replace psychotherapeutic treatment, but can support it. The content provided via the app is not suitable for self-diagnosis or self-treatment without therapeutic support.

(5) If the user's therapist advises against the use of the app, the user will not continue to use it.

(6) The provider is entitled to temporarily block the user's access if there is sufficient suspicion that the user is using a code to access the app or to pay costs without authorisation or is otherwise abusively violating obligations arising from these terms of use. The user may avert this measure by submitting suitable evidence at his own expense. In the event of a proven violation in the use of access codes, permanent blocking of access is also possible.

§ 8 Data protection

(1) Data processing by the Provider shall be carried out exclusively on the basis of the data protection information for users, the current version of which is available in the app or at http://www.elona.health. The Provider shall treat all information of the User received in connection with the use of the App as confidential.

(2) For optimal use of all functions of the app, it is necessary that information on progress, checkups and therapy reflection is shared with the therapist. However, the therapist receives this information only after the user has given his or her express consent, which the user can revoke at any time under the app settings. However, the app can also be used without the user's consent. Under no circumstances will the therapist have access to free text entered by the user.

(3) The user shall not enter any third-party personal data into the app or collect, store, use or transmit such data via other users unless the consent of the persons concerned has been obtained.

(4) The provider undertakes to treat all data relating to the user as well as all personal data of third parties which have been transmitted to it by the user and which are marked as confidential by the user as confidential and to use them only in accordance with these terms of use. The provider reserves the right to deviate from this if he is obliged to disclose such data due to legal or official orders.

(5) The obligations under this § 8 shall apply beyond the end of the contract and shall also be imposed on the employees and other vicarious agents of the Provider.

§ 9 Right of withdrawal

Consumers within the meaning of § 13 of the German Civil Code (BGB) have a statutory right of withdrawal when concluding distance contracts, which is explained below. The user is a consumer insofar as the purpose of the ordered deliveries and services cannot be attributed predominantly to his commercial or independent professional activity.

Cancellation policy

You have the right to cancel this contract within fourteen days without giving any reason.

The withdrawal period is fourteen days from the day of the conclusion of the contract.

To exercise your right of withdrawal, you must inform us (Elona Health GmbH, Schirmerstraße 61, 40211 Düsseldorf, Tel.: 0211-8226866-0, e-mail: info@elona.health) of your decision to withdraw from this contract by means of a clear declaration (e.g. a letter sent by post, fax or e-mail). You can use the enclosed model withdrawal form for this purpose, which is, however, not mandatory.

In order to comply with the withdrawal period, it is sufficient that you send the notification of the exercise of the right of withdrawal before the expiry of the withdrawal period.

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Consequences of revocation

If you withdraw from this contract, we must repay you all payments that we have received from you, including the delivery costs (with the exception of the additional costs resulting from the fact that you have chosen a type of delivery other than the cheapest standard delivery offered by us), without delay and at the latest within fourteen days from the day on which we received the notification of your withdrawal from this contract. For this repayment, we will use the same means of payment that you used for the original transaction, unless expressly agreed otherwise with you; in no case will you be charged for this repayment.

If you have requested that the services begin during the withdrawal period, you must pay us a reasonable amount corresponding to the proportion of the services already provided up to the time you notify us of the exercise of the right of withdrawal in respect of this contract compared to the total scope of the services provided for in the contract

Cancellation form

(If you wish to revoke the contract, please complete and return this form).

- To:

Elona Health GmbH

Schirmerstraße 6140211

Düsseldorf

E-mail: info@elona.health

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- I/we (*) hereby revoke the contract concluded by me/us (*) for the purchase of the following goods (*)/the provision of the following service (*)

- Ordered on (*)/received on (*)

- Name of the consumer(s)

- Address of the consumer(s)

- Signature of the consumer(s) (only in the case of notification on paper)

- Date

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(*) Delete as applicable

End of withdrawal form

§ 10 Liability

(1) The provider shall be liable for intent and gross negligence without limitation, but for slight negligence only in the event of a breach of material contractual obligations. Liability in the event of a breach of such an essential contractual obligation is limited to the amount of the damage that was foreseeable and typical for the contract at the time of the conclusion of the contract. Material contractual obligations are those whose fulfilment characterises the contract and on which the user may rely. The above limitation of liability does not apply to liability for personal injury or liability under the Product Liability Act.

(2) The Provider shall not be liable for disruptions within the line network for which it is not responsible.

(3) The Provider shall only be liable for the loss of data in accordance with the above paragraphs if such a loss could not have been avoided by reasonable data backup measures on the part of the User.

(4) Liability does not extend to impairments of the contractual use of the provider's services caused by improper or incorrect use by the user.

(5) The above limitations of liability shall also apply mutatis mutandis in favour of the Provider's vicarious agents.

(6) The Provider shall not be liable for the legality, correctness, completeness, up-to-dateness, etc. of data entered by therapists in the "elona therapy für Therapeut:innen" application belonging to the app.

(7) The user undertakes to compensate the provider for all damages incurred because actions of the user or data posted by the user violate statutory provisions or the rights of third parties and, in addition, to indemnify the provider against all claims of third parties, including lawyers' fees and court costs, which such third parties assert against the provider due to the user's failure to comply with these obligations.

§ 11 Warranty for defects

(1) The user is aware that it is not possible to create software applications completely free of errors. Thus, the Provider does not owe complete freedom from errors, but only from errors that impair the use of the app in a significant way.

(2) If an error occurs during the use of the app, the user shall report this to the provider immediately via the support service (see § 6 para. 5). Such an error exists if the app does not work in accordance with the service description or does not function properly in another way, so that the use of the app is not possible or is restricted. Errors and faults will generally be rectified within a reasonable period of time. The Provider is entitled to provide the User with a substitute or workaround solution in the event of the necessity of extensive error elimination measures.

(3) In all other respects, the statutory warranty claims shall apply.

§ 12 Term of contract and termination

(1) The contract on the use of the app is concluded for an indefinite period of time and can be terminated by the user at any time (e.g. by deleting the user account) and by the provider with two weeks' notice. However, the period of use is in any case limited to the prescription period.

(2) Each party has the right to terminate the contract for good cause without notice. An important reason for the provider are in particular violations of the provisions of these terms of use by the user, which are not remedied even after setting a deadline, or tortious acts by the user.

(3) Any notice of termination must be in writing. Notices of termination by e-mail shall comply with the written form requirement.

§ 13 Final provisions

(1) The user is only entitled to set-off against the provider with undisputed or legally binding counterclaims.

(2) Claims for services against the provider are exclusively due to the user who has received an access code according to § 3 para. 2 and are not transferable.

(3) The law of the Federal Republic of Germany shall apply to the exclusion of the UN Convention on Contracts for the International Sale of Goods. The mandatory provisions of the state in which the user has his habitual residence remain unaffected.

(4) Should individual provisions of these Terms of Use be or become invalid and/or contradict the statutory provisions, this shall not affect the validity of the remaining provisions of the Terms of Use. The ineffective provision shall be replaced by the contracting parties by mutual agreement with a provision that comes as close as possible to the economic purpose of the ineffective provision in a legally effective manner. The above provision shall apply mutatis mutandis in the event of loopholes.

(5) The EU Commission has created an online dispute resolution platform to provide consumers and online businesses with an out-of-court solution to disputes. The platform is available at http://ec.europa.eu/cosumers/odr accessible. However, the provider is neither willing nor obliged to participate in a dispute resolution procedure before a consumer arbitration board.