General Terms and Conditions SCQM
This is a translation of the original document in German. In case of conflict, the German version shall prevail.
Version 2.0
1. Preamble
The SCQM Foundation (Swiss Clinical Quality Management in Rheumatic Diseases) (hereinafter "SCQM ") is a tax-exempt foundation in accordance with Art. 80 ff of the Swiss Civil Code (ZGB) based in Zurich, which uses digital tools and real-world data to support people with rheumatic diseases and medical professionals in improving the quality of treatment for rheumatic diseases. At the same time, the SCQM promotes medical research in this field.
Services of SCQM (hereinafter "Services") are:
- the SCQM Patient Register (hereinafter "Patient Register");
- the web-based application mySCQM (hereinafter "mySCQM"); and
- the Online Reporting Dashboard (hereinafter "ORD").
2. Scope of application
The subject of these General Terms and Conditions (hereinafter "GTC") is the relationship between SCQM and the users of SCQM services.
These GTCs are binding for all users of services.
By using the services of SCQM, users accept these GTC and the guidelines for use contained therein. These GTC are also an integral part of every contract concluded between the user and the SCQM, unless otherwise agreed between the parties.
3. Definitions
"Users”:Refers to all natural and legal persons who use the services.
Users of the Patient Register are
- "Healthcare institutions";
- "Authorised employees"
Users of mySCQM are exclusively “affected persons”.
Users of the ORD are exclusively "partners".
"Authorised employees”:Refers to medical specialists (employees or attending physicians) working at a healthcare institution for rheumatology, physical medicine & rehabilitation and allergology & clinical immunology, assistant physicians and other healthcare professionals.
"Affected persons”:Refers to persons who suffer from a rheumatic disease and who have read the SCQM patient information and signed the associated SCQM consent forms.
"Patient Register”:Refers to the register in which authorised employees and patients can enter data relating to rheumatic diseases in accordance with certain specifications defined by the SCQM.
"mySCQM": Refers to the web-based application associated with the Patient Register, with which patients can access their own data in the Patient Register and complete questionnaires.
"Healthcare institution”:Refers to institutions such as university hospitals, hospitals and doctors' surgeries that treat people with rheumatic diseases and have concluded a cooperation agreement with the SCQM regarding the use of the Patient Register.
"ORD": Refers to the online reporting dashboard created by the SCQM, which is a separate database from the Patient Register. It contains SCQM reports that the SCQM has created based on a scientific analysis of the anonymised data from the Patient Register. The ORD does not contain any personal data.
"Partners": Designates legal entities that have signed the document "Contract with partners" .
Members of the data and quality management of the SCQM office Refers to employees of the SCQM office who have been trained in the SCQM Patient Register and are subject to confidentiality obligations.
"Services": Designates the services according to the preamble.
"SCQM": Designates the SCQM Foundation (Swiss Clinical Quality Management in Rheumatic Diseases).
4. Access to the services
Patient Register:Healthcare institutions and their authorised employees are granted access to the Patient Register after concluding a cooperation agreement with the SCQM. Healthcare institutions only have access to the data in the patient registry that
- was entered by authorised employees of their own healthcare institution.
- was released to the healthcare institution by means of access authorisation for data viewing and processing.
- was entered into the Patient Register via mySCQM.
mySCQM:Affected persons receive access to mySCQM via their healthcare institution after they have signed the SCQM patient information and the associated SCQM declaration of consent. They have access to their own data registered in the Patient Register via mySCQM.
ORD:Partners receive access to the ORD or to the SCQM reports designated therein after they have signed the "Contract with Partners" document.
Access to Patient Register, mySCQM and ORD:Members of the data and quality management team at the SCQM office have access to the Patient Register, mySCQM and the ORD as well as to the data contained in the Patient Register and the ORD.
Usage guidelines:Access to the Patient Register, mySCQM and the ORD is personalised and takes place via two-factor authentication. In order to grant users access to SCQM services, the SCQM (or the healthcare institution in the case of mySCQM users) may request authentication details from users. The SCQM will specify to the respective user which authentication details are required.
All users are obliged to keep their access data secure and confidential. They are required to change their personal passwords on a regular basis. For security reasons, passwords must be chosen that cannot be linked to the user. Users may not pass on their access data and may only access the Patient Register, mySCQM and the ORD via their personalised access. Exceptions require the prior written consent of the SCQM in individual cases. When users leave the Patient Register, mySCQM or the ORD, they must log out or lock the device.
If there are indications that users are using their access contrary to the contractual provisions of the SCQM or that unauthorised third parties know the authentication details or have access to the Patient Register, mySCQM or the ORD, users are obliged to inform the SCQM immediately. The loss of access hardware or a personal authentication factor provided by the SCQM must also be reported to the SCQM office immediately.
All users are responsible for their own internet access and the hardware and/or software components (including configuration) required for access. They must ensure that their systems are adequately protected against malware (viruses, malware, etc.) and unauthorised access.
All users shall ensure that the systems and devices used for the patient registry, mySCQM and ORD are protected against unauthorised access and manipulation.
5. Use of the Patient Register, mySCQM and the ORD
The users of the Patient Register, mySCQM and the ORD may not use the services of the SCQM in a manner contrary to the intended purpose or in breach of contract or feed in data in a manner contrary to the intended purpose or in breach of contract.
Users are responsible for their own activities in connection with the use of the patient registry, mySCQM and the ORD, in particular for the data uploaded, recorded, stored, made available for retrieval and/or transmitted by them.
Users ensure and are responsible for ensuring that all data entered by them is correct, up-to-date and complete and that they have all necessary authorisations, consents and approvals for the entries they make.
The Patient Register, mySCQM and the ORD contain general data, reports and information provided by the SCQM on health law topics (e.g. on specific studies). The SCQM itself does not provide medical diagnoses and does not offer patient-specific advice on treatment. The information provided by the SCQM is for information purposes only. The SCQM excludes any liability in connection with this information.
The data and information in the patient registry, in mySCQM and in the ORD relating to medicinal products refer to medicinal products authorised by Swissmedic for specified indications. If a medicinal product or indication is not yet authorised (off-label use) and the corresponding entry regarding an off-label use is nevertheless made by users in the patient registry and/or is mentioned in an SCQM report available in the ORD, full responsibility for this off-label use lies with the treating healthcare professional. The SCQM accepts no liability for any side effects or other consequences resulting from the use or mention of such or other medicinal products. The SCQM makes no recommendations regarding the use of medicinal products, particularly in the context of off-label use.
Access to the services does not exempt users from complying with their professional duties and duties of care.
6. Data protection, confidentiality and protection of interests
Users shall ensure compliance with the applicable data protection regulations in their area of responsibility. They guarantee the permissibility of the processing of personal data that they or, where relevant, their authorised employees upload to the Patient Register, mySCQM or the ORD, as well as all other personal data that is processed in connection with the services (in particular the transfer of personal data about authorised employees and other employees to, and the processing of such personal data by, SCQM).
All information contained in the Patient Register, in mySCQM and in the ORD is confidential. Information may only be passed on to third parties with the prior written consent of SCQM and only in compliance with any other applicable confidentiality obligations (in particular medical confidentiality). The confidentiality obligation also applies during the cancellation phase and after termination of the contracts concluded between SCQM and the users.
Users shall ensure that any employees, authorised representatives, auxiliary persons or other persons working in the area of responsibility of the respective user are obliged to comply with the applicable data protection regulations and to maintain confidentiality.
All users undertake to protect the interests of the SCQM in good faith at all times. In particular, in the event of differences of opinion, they shall refrain from any actions that could damage the reputation of the SCQM in the public eye.
7. Rights and obligations of the SCQM
Blocking access and combating abuseThe SCQM is authorised to block users' access to the Patient Register, mySCQM or the ORD without prior notice and without incurring costs if users violate the contractual rules agreed with the SCQM or statutory obligations, if there is a suspicion of misuse, if the security of the systems is at risk or if this is necessary to protect their interests. The SCQM may also take further measures to prevent or combat misuse. The SCQM is also authorised to block users' access without notice and without incurring any costs if inactivity (no use of the login) is detected for more than six months. Users must contact the SCQM office (Aargauerstrasse 250, 8048 Zurich, by e-mail at scqm@hin.ch or by telephone on +41 43 268 55 77) and must identify themselves upon request if they wish to unblock their access.
SecuritySCQM takes appropriate precautions to ensure the availability and functionality of the patient registry, mySCQM and the ORD. SCQM will keep interruptions to rectify faults, carry out maintenance windows, introduce new technologies, etc. as short as possible and, wherever possible, schedule them during low-traffic periods. The SCQM protects its infrastructure and user data by taking appropriate measures and treats the personal data entrusted to it as strictly confidential. The infrastructure relevant to the patient registry, mySCQM and the ORD (e.g. architecture, network, systems) and the processes relevant to the patient registry, mySCQM and the ORD are regularly reviewed both internally and externally; any deficiencies are rectified promptly. The infrastructure is located exclusively in data centres in Switzerland.
Checks and adjustments to the data The SCQM is not responsible for checking or adjusting the content of the information stored in the Patient Register (e.g. on the basis of feedback from data subjects). Reviews or adjustments of data stored in the patient registry are the sole responsibility of the entering user. If data is changed by members of the SCQM Data and Quality Management Office, the healthcare institutions concerned will be informed of changes or adjustments in an appropriate manner, where relevant.
8. Costs
If users of the patient registry, mySCQM and the ODR incur costs for the data connection (i.e. contract costs of the mobile phone provider, connection costs and access to the internet as well as any additional costs charged for loading the data), these costs will be borne solely by the users themselves.
9. Guidelines, rules and regulations
The SCQM may at any time and without prior notice issue, cancel or amend further guidelines, regulations and/or provisions concerning the use or other handling of the patient registry, mySCQM or the ORD. The most current versions published on the patient registry, in mySCQM and in the ORD apply. In the event of an update, users will be informed of the change in an appropriate manner.
10. Intellectual property and other rights
The SCQM is the owner of the patient registry, mySCQM and the ORD. All trademarks, names, titles, logos, images, designs, texts and other materials used in this context belong to the SCQM or a contractual partner of the SCQM . No rights are acquired or transferred by accessing, downloading, receiving or copying information or by granting access to the Patient Register, the ORD or mySCQM. The complete or partial reproduction, transmission, modification, linking or use of the Patient Register and the information contained therein for public or commercial purposes is prohibited without the prior written consent of the SCQM.
At the request of the SCQM, users must immediately return all documents and information (including copies thereof) that they have received in connection with the services or, if requested by the SCQM, destroy them. Healthcare institutions and partners shall ensure that all their employees also comply with this obligation.
11. Duration of the agreements; termination
Agreements covered by these GTC shall enter into force upon acceptance by the parties. They shall apply for an indefinite period.
Agreements between users of mySCQM (data subjects) and the SCQM are concluded with the successfully completed registration of the mySCQM profile through the acceptance of the necessary documents (e.g. Privacy Policy) and are valid for an indefinite period of time.
Agreements between authorised employees of healthcare institutions and the SCQM are concluded upon acceptance of the necessary documents (e.g. SCQM General Terms and Conditions, Privacy Policy).
The SCQM, users of mySCQM (data subjects) and authorised employees may terminate the agreements in writing or verbally at any time with immediate effect. Users must send written notices of cancellation to the SCQM office (Aargauerstrasse 250, 8048 Zurich, by e-mail at scqm@hin.ch, or by telephone on +41 43 268 55 77).
The respective parties reserve the right to make additional agreements deviating from this section 11.
12. Disclaimer of warranty and liability of SCQM, liability of the users; indemnification
The SCQM assumes no liability for the availability of the Patient Register, mySCQM or the ORD or for the topicality, correctness or completeness of the data contained therein. Responsibility for the accuracy and completeness of the data entered by users lies exclusively with them or, in the case of authorised employees, with the healthcare institution, to which these authorised employees belong. It is also the sole responsibility of the users to ensure that only data of data subjects as defined and intended by these GTC are entered in the Patient Register or mySCQM.
The liability of SCQM and that of auxiliary persons, substitutes or agents acting on behalf of SCQM, in particular, but not limited to, any direct and/or indirect damages, consequential damages and/or lost profits, is excluded to the maximum extent permitted by law.
If users or their employees, auxiliary persons or persons acting on their behalf in any other way are responsible for damages, the users undertake to indemnify SCQM immediately and in full and to hold SCQM harmless from any claims by third parties.
13. Transmission
The user may only transfer or assign rights and obligations arising from these GTC and from related agreements to third parties with the prior written consent of SCQM.
14. Prohibition of offsetting
The user waives the right to offset any claims against SCQM against any obligations under these GTC or related agreements.
15. Notifications
All notifications from one party to the other under these GTC and any related agreements must be made in writing.
16. Written form
If written form is required, the requirement of written form is also fulfilled if the notification is demonstrably made by text via the Patient Register or by e-mail to scqm@hin.ch, whereby the notifying party bears the burden of proof for the delivery of the notification. The parties may use electronic signatures, even if these do not fulfil the requirements for qualified electronic signatures in accordance with the Federal Act on Electronic Signatures (ZertES). Subject to any differing legal requirements or provisions.
17. Changes to these GTC
The SCQM may amend or adapt these GTC and the services at any time. It is the responsibility of SCQM to announce the changes in advance and in a suitable manner (e.g. by means of a notice when logging in). In the absence of a written objection within one month, but in any case, with the first use of the affected service, the changes are deemed to have been approved. In the event of an objection, SCQM and/or the respective user are free to terminate the contractual relationship with immediate effect in accordance with section 11. Special agreements remain reserved.
18. Independence
The SCQM and the user work autonomously and independently in their respective areas. Neither party is authorised to represent the other party externally on the basis of these GTC or related agreements.
There is no corporate relationship between the SCQM and the user.
19. Partial invalidity
Should a provision of these GTC or of a related agreement be ineffective, void, invalid, unenforceable or contain a loophole, the legal effectiveness of the remaining provisions of these GTC and/or the related agreement shall remain unaffected. In place of the ineffective, void, invalid or unenforceable provision, the parties shall agree on a provision that best corresponds to the intentions of the parties and their economic objective. This shall also apply in the event of a contractual loophole.
20. Forfeiture
If SCQM waives its right to enforce a contractual right in an individual case, this shall not constitute a waiver of this right.
21. Applicable law and place of jurisdiction
Swiss law shall apply exclusively to the contracts concluded with SCQM and to the services provided by SCQM, excluding conflict-of-law provisions.
For all disputes arising from the contracts concluded with the SCQM (including their validity) or in connection with the use of the services, the competent courts in Zurich 1 shall have exclusive jurisdiction.
Zurich, November 2024