Terms of Use

1.General and subject matter of the contract

1. Una Health GmbH, Katharinenstraße 30a, 20457 Hamburg ("UNAHEALTH") offers its users (hereinafter: "Users") an app-based programme to support patients with type 2 diabetes in self-managing their disease so that they can improve their blood glucose control and alleviate the symptoms associated with type 2 diabetes (hereinafter: "UNAHEALTH Services"). UNAHEALTH emphasises the inclusion of all genders. Exclusively for better readability, the masculine form is chosen in texts.

2. UNAHEALTH services are offered via smartphone app ("Una-App"), which can be downloaded from a dedicated platform (Google Play and Apple App Store) as a digital application. 

3. UNAHEALTH is continuously developing the UNAHEALTH services. New functions can be introduced and existing ones replaced by new ones or removed without replacement.

2. Scope

1. These General Terms and Conditions ("GTC") apply in the version valid at the time of conclusion of the contract to the entire range of services offered by UNAHEALTH. By agreeing to the validity of these GTC, the user makes the GTC an integral part of the contract for the services offered by UNAHEALTH. Agreement to these GTC is a prerequisite for the use of the UNAHEALTH services.

2. The details of the services to be provided by UNAHEALTH also result from the individual service descriptions and documentation for the software, such as manuals and operating aids.

3. Any agreements and ancillary agreements made prior to the conclusion of the contract shall only become part of the contract if UNAHEALTH expressly confirms them again in writing. No verbal subsidiary agreements have been made. Conflicting GTC of the user are hereby expressly contradicted.

3. Details of the user and information obligations

1. The user of these GTC is
   Una Health GmbH

   Katharinenstraße 30a, Contor

   20457 Hamburg

   Commercial register: HRB 176343

   Register court:: Hamburg

   Represented by: Pascal Grimm, Dominic Steele, Matthew Fenech

2. The user can contact the user service at the e-mail address programm@unahealth.de with questions about services.

3. The language available for the conclusion of the contract is German.

4. There is no out-of-court complaint or redress procedure to which UNAHEALTH is subject. UNAHEALTH has not subjected itself to any special code of conduct (set of rules).

5. The user can access, copy, save and print out the GTC at any time on the website https://unahealth.de/app/tou/v1/de. UNAHEALTH saves the GTC and sends them by e-mail on request.

6. As an online company, UNAHEALTH is obliged to refer the user as a consumer to the online dispute resolution platform (ODR platform) of the European Commission. The OS platform can be reached via the following link https://webgate.ec.europa.eu/odr. It applies to the out-of-court settlement of disputes about contractual obligations arising, among other things, from online service contracts between consumers and online companies and aims to achieve a high level of consumer protection in the European internal market. The possibility of online dispute resolution (ODR) is intended to provide a simple, efficient, fast and inexpensive out-of-court solution to disputes. The ODR platform forwards duly filed complaints to the competent out-of-court dispute resolution bodies (ADR entities) under national law. The use of the ODR platform itself is free of charge; in proceedings before the ADR entities, the consumer may incur costs of up to EUR 30.00 if his or her request is in abuse of rights.

7. UNAHEALTH does not participate in dispute resolution proceedings before a consumer arbitration board.

4. Use of UNAHEALTH services

1. Registration is required for the UNAHEALTH services. In doing so, users must observe and accept the manufacturer's specifications within the framework of the instructions for use.

2. The use of UNAHEALTH services takes place using exclusively telecommunications media (online, telephone). Registration requires a valid e-mail address and internet access as well as the use of a smartphone to use the UNAHEALTH app. 

3. UNAHEALTH services represent a personalised programme designed to help users self-manage their condition with the aim of improving blood glucose control. The digital application is a CE-certified Class I medical device according to the Medical Device Regulation (MDR) 2017/745, registered with the German Medical Device Information and Database System (DMIDS) under registration number DE/CA05/ 00189808.

4. The UNAHEALTH services are not intended to support or make diagnostic or treatment decisions. The specific conditions for use and the costs of using the individual UNAHEALTH services are determined by UNAHEALTH in the respective product conditions. 

5. The costs for the UNAHEALTH services are displayed to the user when the order is placed. Insofar as UNAHEALTH services are used in accordance with § 33 a SGB V as a digital health application in accordance with a doctor's prescription or with the approval of the health insurance fund for a certain period of time, the costs of use are generally borne by the health insurance fund. Insofar as functions or areas of application go beyond the digital health applications included in the list for digital health applications according to § 139e SGB or their costs exceed the remuneration amounts according to § 134 SGB V, the users must bear these additional costs themselves.

6. UNAHEALTH services do not constitute a medical or therapeutic diagnosis, recommendation or medical treatment.

7. UNAHEALTH is entitled to make the use of the services offered dependent on suitable proof of the user's identity or ability to use the services. The use of the service offer requires that the user is at least 18 years of age and has unlimited legal capacity and is not under care, unless a legally valid representation is actively proven. Furthermore, the truthful and complete provision of the data to be entered by the user in the respective input mask is a prerequisite for the provision of services. Registration in the name of a legally competent third party - irrespective of the latter's consent - as well as multiple registrations of a user under different names or e-mail addresses are not permitted. UNAHEALTH expressly reserves the right to verify the data provided by taking appropriate measures.

8. Access to the contents of the service offer is only possible during the term of the respective user relationship.

9. When booking or requesting services, it may be necessary for the user to provide payment information if the service in question is not reimbursed by cost units. Only in the event that UNAHEALTH confirms the booking shall a contract be concluded between UNAHEALTH and the user for the use of the UNAHEALTH services in accordance with the respective product conditions.

10. In the case of use as a digital health application in accordance with § 33a SGB V, the possibility of using the UNAHEALTH services ends with the expiry of the prescribed or approved period of use after 14 days, without the need for termination.

11. The possibility of use also ends if the user revokes his/her consent to the processing of health-related data, as the use requires the processing of health-related data by UNAHEALTH.

5. User obligations and blocking of access

1. Insofar as the use of the services of UNAHEALTH requires a user profile, the user undertakes to keep his access data for the user profile, in particular but not exclusively the password for access, secret and to protect it from access by third parties and neither to tolerate nor enable third parties to gain knowledge of it. In the event of misuse or loss of the password or a corresponding suspicion, the user must inform UNAHEALTH immediately. The user is liable for any misuse.

2. The user is obliged to provide correct, complete and truthful information when registering the user profile and booking the individual services offered by UNAHEALTH.

3. The user is obliged to refrain from actions which are likely to impair and/or place an excessive load on the UNAHEALTH services or the technical infrastructure behind them. This includes, in particular, the use of software, scripts, viruses or other computer codes, data or programmes which are intended to interrupt, destroy and/or restrict the UNAHEALTH services, the functionality of software or hardware or other equipment.

4. The UNAHEALTH services are intended exclusively for the personal use of the user. Use for commercial purposes or assignment or transfer of the rights of use in any other way to third parties that has not been expressly agreed is not permitted.

5. UNAHEALTH reserves the right to block the user's access in the event of justified suspicion of misuse, a material breach of contract or repeated breach of user obligations. The user may then contact UNAHEALTH. If the suspicion can be dispelled, the blocking will be lifted again, otherwise UNAHEALTH is entitled to an extraordinary right of termination.

6. If the contract ends in the case of a service with several betsand parts due to the extraordinary termination before the expiry of the contract term, the user of the pro rata amount remains obligated for the period of use.

6.Protection of intellectual property and prohibition of reproduction

1. All texts, software, images, graphics, videos, audio documents, etc. provided on the website https://unahealth.de/, the UNA app, e-mails and within the scope of all other services offered by UNAHEALTH are protected by trademark, copyright or other protective rights and any rights to the content of the respective range of services and additional information, in particular the rights of use and exploitation, are either the exclusive property of UNAHEALTH or have been granted to UNAHEALTH on the basis of licences for use in accordance with the contract.

2. Saving or archiving the content and information provided outside the website or the app, as well as passing on or offering the content of the respective range of services to third parties, is not permitted. The user is not permitted to change, remove, suppress or otherwise impair protected content of UNAHEALTH. The user is not permitted to reproduce, modify, edit, publish, sell, license or otherwise exploit content of the website or the app without the prior written consent of UNAHEALTH. Any infringement will be pursued with legal action.

7. Basic regulations for UNAHEALTH services

1. The agreed UNAHEALTH services shall be made available by UNAHEALTH immediately after conclusion of the contract by making them accessible via download or virtual installation.  If UNAHEALTH fails to provide the UNAHEALTH services without delay or within an agreed period of time, the user shall be entitled to terminate the contract after a reasonable period of time has been set in advance.

2. The UNAHEALTH services comply with the manufacturer's instructions and terms of use listed in the instructions for use with regard to content, quantity and quality, functionality, compatibility, interoperability and other features. Furthermore, UNAHEALTH does not guarantee the correctness and completeness or the constant and uninterrupted availability of the UNAHEALTH services or the complete and error-free reproduction of the posted content.

3. The UNAHEALTH services are suitable for the purpose intended by the user within the scope of the intended purpose of the medical device according to the instructions for use and the manufacturer's instructions and conditions of use. In this respect, a medical benefit has been demonstrated for the UNAHEALTH services as part of the conformity assessment procedure in accordance with the Medical Device Regulation (MDR) (EU) 2017/745. A promise of efficacy or guaranteed success in connection with the use of the UNAHEALTH services is therefore not made.

4. The characteristics of the UNAHEALTH Services, in particular with regard to functionality, compatibility, accessibility, continuity and security, correspond to the requirements that are usual for digital services ("healthcare apps") and that the user can reasonably expect.

5. The UNA app is regularly updated (updates) and UNAHEALTH ensures that the user is informed about (security) updates and that these are provided to the user as long as the user can use the UNAHEALTH services.

6. In connection with updates, UNAHEALTH shall inform the user of the availability of the update and of the consequences if the user does not install it. If the user does not install the update within a reasonable period of time, UNAHEALTH shall not be liable for any resulting lack of conformity of the UNAHEALTH services.

7. The UNAHEALTH services shall be made available to the user for the entire term of the contract in the latest available version at the time of conclusion of the contract.

8. UNAHEALTH shall only be liable for a lack of conformity resulting from improper integration of the UNAHEALTH services into the user's digital environment if the UNAHEALTH services were integrated under UNAHEALTH's responsibility or the UNAHEALTH services were to be integrated by the user and the improper integration was due to inadequate instructions from UNAHEALTH.

9. UNAHEALTH's liability for breach of contract shall expire two years after the provision of the UNAHEALTH Services. UNAHEALTH shall bear the burden of proof for the contractual condition of the UNAHEALTH Services during the period of provision, unless UNAHEALTH can prove that the user's digital environment is incompatible with regard to the technical requirements of the UNAHEALTH Services and UNAHEALTH has informed the user of this prior to the conclusion of the contract. The user shall cooperate with UNAHEALTH to the extent reasonably necessary and possible to determine whether the cause of the lack of conformity lay in the consumer's digital environment.

10. In the event of a lack of conformity, the user shall be entitled to have the UNAHEALTH services restored to their contractual condition, unless this would be impossible or would cause UNAHEALTH to incur costs that would be disproportionate taking into account all the circumstances of the individual case. These circumstances include the value that the content or digital services would have if there were no lack of conformity and the materiality of the lack of conformity.

11. The user shall be entitled either to a pro rata reduction of the price if the UNAHEALTH services are provided against payment of a price, or to termination of the contract if one of the following cases exists: it is impossible or disproportionate to bring the Digital Content or Digital Services into the condition required by the contract in accordance with clause 6.11; UNAHEALTH has failed to bring the UNAHEALTH Services into the condition required by the contract; a lack of conformity occurs despite UNAHEALTH's attempt to bring the UNAHEALTH Services into the condition required by the contract; the lack of conformity is so serious that an immediate price reduction or termination of the contract is justified; or UNAHEALTH has stated or it is clear from the circumstances that UNAHEALTH will not restore the digital content or digital services to their contractual condition within a reasonable period of time or without considerable inconvenience to the user.

12. In the event of termination of the contract, UNAHEALTH shall refund the portion of the price paid corresponding to the period during which the UNAHEALTH services were not in a condition in accordance with the contract and, if applicable, the portion of the price paid in advance by the user for the remaining period of the contract - if it had not been terminated.

13. After termination of the contract, the user must refrain from using the UNAHEALTH services.

8. Liability regulations for damages

The following applies to damages incurred by the user in connection with the use of the UNAHEALTH services:

1. In the event of intent or gross negligence, the liability of UNAHEALTH and its legal representatives or vicarious agents shall be unlimited.

2.  In the event of a slightly negligent breach of material contractual obligations, liability shall be limited to damage to property and pecuniary loss attributable thereto in the amount of the foreseeable, typically occurring damage, the occurrence of which the parties had to expect at the time of conclusion of the contract on the basis of the circumstances known to them at that time. Material contractual obligations are those whose fulfilment characterises the contract and on which the user regularly relies and may also rely. In the event of a simple negligent breach of an essential contractual obligation, UNAHEALTH shall not be liable for any loss of profit.

3.  Any further liability for damages is excluded - except for claims in tort - and the above limitations of liability do not apply to injuries to life, limb or health culpably caused by UNAHEALTH.

4.  The liability provisions do not involve any change in the burden of proof to the detriment of the user, nor do they exclude any claims granted in these GTC.

5. UNAHEALTH shall not be liable for loss of data as well as costs of useless data entry within the framework of the aforementioned provisions.

9. Data protection

UNAHEALTH processes personal data and in particular also health data of the user in connection with the use of the UNAHEALTH services. The data protection provisions apply here, which can be accessed by the user at any time via the website https://unahealth.de/datenschutz.

10. Cancellation policy

1. Right of withdrawal

Users have the right to withdraw from this contract within fourteen days without giving any reason. The withdrawal period is fourteen days from the date on which the user or a third party other than the carrier designated by the user has received or taken possession of the UNAHEALTH services. To exercise the right of withdrawal, the user must notify UNAHEALTH:

UNAHEALTH GmbH

Katharinenstraße 30a, Contor

20457 Hamburg

programm@unahealth.io

by means of a clear declaration (e.g. a letter sent by post or e-mail) of the decision to revoke this contract. A model withdrawal form (clause 10.3.) may be used for this purpose, but is not mandatory. To comply with the withdrawal period, it is sufficient that the notification of the exercise of the right of withdrawal is sent before the expiry of the withdrawal period. UNAHEALTH will send confirmation of receipt of a revocation without delay (e.g. by e-mail).

2. Consequences of revocation

In the event of cancellation, UNAHEALTH will repay all payments received by UNAHEALTH from the user, including the delivery costs (with the exception of additional costs resulting from the fact that the user has chosen a type of delivery other than the cheapest standard delivery offered by UNAHEALTH), without undue delay and at the latest within fourteen days from the day on which UNAHEALTH receives the notification of your cancellation of this contract. For this repayment, UNAHEALTH will use the same means of payment that the user used for the original transaction, unless expressly agreed otherwise; in no case will the user be charged any fees due to this repayment. UNAHEALTH may refuse the repayment until UNAHEALTH has received the goods back or until the user has provided proof that he has returned the goods, whichever is the earlier.

The user must return or hand over the goods to UNAHEALTH without delay and in any case no later than fourteen days from the day on which he notifies us of the revocation of this contract. The deadline is met if the user sends the goods before the end of the period of fourteen days.

The user shall bear the direct costs of returning the goods. The user shall only be liable for any loss in value of the goods if this loss in value is due to handling of the goods that is not necessary for testing the condition, properties and functioning of the goods.

- End of the cancellation policy-

3. Sample cancellation form

To exercise the right of withdrawal, users can use the following model withdrawal form:

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 consumer(s
Address of
Signature of consumer(s) (only for communication on paper)
Date

(*) Delete as applicable

11. Changes to the GTC

1. UNAHEALTH reserves the right to amend and adapt the GTC at any time without stating reasons with effect for the future. An intended change will be sent to the user at the email address last provided to UNAHEALTH or communicated via an announcement on the website.

2. If the user does not object to the amended GTC within two weeks, they shall be deemed accepted and the amended GTC shall become effective. The date of dispatch of the objection shall be decisive for compliance with the deadline.

3. In the event of an objection within the period, UNAHEALTH may terminate the contractual relationship with the user without notice, whereby payments already made shall be refunded proportionately to the remaining term. If UNAHEALTH does not terminate the previous contractual relationship after the effective objection, the previous GTC shall continue to apply unchanged in relation to the corresponding user.

12. Applicable law and place of jurisdiction

1. 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. If the user has placed the order as a consumer and has his habitual residence in another country at the time of the order, the application of mandatory legal provisions of that country shall remain unaffected by the choice of law made in sentence 1.

2. If the user is an entrepreneur or merchant and has his registered office in Germany at the time of the order, the exclusive place of jurisdiction is Hamburg. The same applies to users who do not have a general place of jurisdiction in Germany or another EU member state or who have moved their place of residence abroad after conclusion of the contract or whose place of residence or habitual abode is unknown at the time the action is brought. Otherwise, the applicable statutory provisions shall apply to the local and international jurisdiction.

13. Final provisions

1. The user can print or save these GTC via the browser function.

2. Should individual provisions of these GTC be invalid or unenforceable or become invalid or unenforceable after conclusion of the contract, this shall not affect the validity of the remainder of the contract. The respective statutory provisions shall take the place of the unenforceable or ineffective provision. If statutory law is not available in the respective case, the invalid or unenforceable provision shall be replaced by the valid or enforceable provision whose effects come closest to the economic objective pursued by UNAHEALTH and the user with the invalid or unenforceable provision. This shall apply accordingly in the event that one or more of the terms and conditions prove to be incomplete.