1.1. This website, its features and services (the “Website”) are controlled and operated by Smart Blood Analytics Swiss SA, whose principal place of business is at Höschgasse 25, CH-8008 Zürich, Switzerland and its affiliates (“SBAS”, “we”, “us” and “our”). Please read the following terms and conditions (the “Terms and Conditions”) carefully as they set out the basis upon which we will grant you access to the Website and permit you to avail of the services via the Website. By using our Website, you agree to our Terms and Conditions, so please review all these documents carefully.
1.2. These Terms and Conditions are the legal equivalent of a signed, written contract between you and SBAS. These Terms and Conditions, if not contractually agreed otherwise, apply to the Tool (as defined below), regardless of whether it has been accessed and used via the Website or an API incorporated in a Customer Information System platform (“API”).
1.3. SBAS will request for specific groups to conclude a separate Service agreement in relation to the use of the Tool (as defined below). In such case the Service agreement as individually agreed between the user and SBAS shall prevail over these Terms and Conditions, to the extent relevant matters are regulated in both legal documents. For matters which are not governed in the Service agreement, but are regulated in the Terms and Conditions, the latter shall equally apply.
1.4. In cases where a legal entity concludes a Service agreement with SBAS in relation to the use of the Tool (as defined below), it is obliged to inform individual users of the Tool (as defined below) that they are bound with the Service agreement as well as these Terms and Conditions.
2. Description of the service
2.1. SBAS has developed SBAS Software. SBAS Software is a clinical decision support system (CDSS) that interprets blood test results and expands differential diagnostics. It provides a physician with a list of the ten most probable diseases or medical conditions based only on blood test results, biological sex, and age. SBAS Software does not make a final diagnosis and is not meant to be a substitute for physicians but instead aims to empower and guide them to make faster and more accurate decisions, resulting in better patient outcomes. It is accessible either via the Website or via an API (the “Tool”).
2.2. The Tool falls within the scope of medical devices in accordance with applicable laws in countries where the Tool is accessible and is CE marked. The Tool conforms, inter alia, to the following standards: ISO 13485:2016, ISO 14971:2019, EC 62304:2006/AMD 1:2015, IEC 62366-1:2015/AMD 1:2020, EN 13612:2002, and ISO 15223-1:2021.
2.3. Based on international diagnostics procedures, a physician determines the scope of the blood analysis and required parameters before using the Tool. Summarizing the patient's anamnesis, symptoms, and signs and having obtained the blood test results, the physician decides which model (covering the known group of diseases) can be used to interpret blood test results, expanding the patient's differential diagnosis:
• Internal medicine
2.4. Based on the blood test results and the chosen model, the Tool provides a physician with a list of the ten most probable diseases or medical conditions for a specific patient. For every disease or medical condition, the Tool provides a "Ranking factor" and a "Parameter evidence" that helps a physician evaluate the likelihood of each resulting disease.
2.5. The final patient's diagnosis shall always be determined by the responsible physician based on all available physical findings, patients' anamneses, symptoms, and results of other diagnostic tests. The information provided by the Tool is only intended to support the diagnosis decision.
2.6. The following special warnings and precautions for the use of the Tool shall be observed:
a) Using the Tool is not advised without considering the patient's symptoms and medical history. The Tool shall not be used for screening purposes;
b) the Tool can only be used if a minimum of 30 blood test parameters from Annex 1 Available list of parameters (disclosed in the Instructions for Use) are available and inserted;
c) the Tool can only predict a disease that is available in the Tool's database. Available diseases are listed in Annex 2 Groups of disease in the Instructions for Use;
d) the Tool is not designed to be used on healthy patients. The use on healthy patients may provide non-relevant information.
2.7. SBAS is not a healthcare provider, and the results pursuant to the Tool are not a substitute for a diagnostic test used to confirm or ascertain diagnosis that meets applicable healthcare regulations. The Website or the results pursuant to the Tool do not constitute medical advice, nor are they a substitute for medical advice from a qualified healthcare provider.
2.8. By filling up the sign-up form and agreeing to these Terms and Conditions, as well as separately also to a Service agreement, if so requested by SBAS, you confirm you intend to use the Tool for assistance in the interpretation of blood test results within your healthcare organization, and SBAS is willing to grant you access to use the Tool based on the signed Service agreement and these Terms and Conditions.
3. Acceptance of Terms and Conditions
3.1. Your use of the Tool is subject to these Terms and Conditions and the signed Service agreement (if applicable). Except as specified herein, these Terms and Conditions apply to any use of the Tool, results pursuant to the Tool, including but not limited to:
a) Entering/sending anonymous information regarding the patient biological sex and age. It is not permitted to enter/send any personal identity information of the patients into the application (e.g., health care registration number, first name, last name, address, etc.);
b) Entering/sending parameters and values of existing blood test results in selected units;
c) selecting the Tool model provided and creating a report providing ten most likely diseases;
d) use of the Tool;
e) interpretation of the results pursuant to the Tool and use thereof.
3.2. To use the Website and the Tool, you must first agree to these Terms and Conditions. You shall not use the Website and the Tool if you do not agree with the Terms and Conditions. By continued use of the Website and the Tool, it is deemed that you agree with the Terms and Conditions.
3.3. Prior to using the Tool, you are obliged to thoroughly review the Instructions for Use for the Tool and the video presentation (training) of Tool report interpretation, which will be accessible when accessing the web application. The Instructions for Use represent a vital part of these Terms and Conditions and are incorporated into these Terms and Conditions. You are obliged to consider the Instructions for Use before and during the use of the Tool, especially section 3.10 Instructions for Use of the Instructions for Use. If at any time you discover any inconsistency between the Instructions for Use and best medical practice, you shall immediately inform SBAS.
3.4. SBAS may, from time to time, publish guidelines or rules applicable to any of its services. Such guidelines and rules shall be deemed part of these Terms and Conditions and directly applicable to the user. You are obliged to consider such guidelines and rules when using the Tool.
3.5. SBAS may offer other or additional services from time to time that could be governed by different terms of service or a specific contract, which shall prevail over these Terms and Conditions.
4. Intended user profile
4.1. The Tool shall only be used by physicians holding a Doctor of Medicine degree and completed residency, licensed to practice medicine in the competent country.
4.2. The Tool may be used by other healthcare professionals, but only under direct and strict supervision by a licensed physician.
4.3. Users of the Tool shall have an average level of computer skills and shall, prior to the use of the Tool, complete the SBAS’ Tool training.
5. Intended patient profile
5.1. The use of the Tool is currently evaluated and therefore possible for interpreting blood results of Caucasian adult patients (older than 18 years), either female or male, with acute and/or chronic conditions in the fields pursuant to Instructions for Use.
5.2. The Tool is especially contraindicated for use in children, pregnant women, and patients taking drugs that interfere with the laboratory blood test results (consistent with the clinical information on the therapy described in the SmPC).
6. Web sign-up process
6.1. Prior to accessing the Tool, Service agreement shall be signed, if so requested by SBAS.
6.2. The sign-up process starts at our healthcare professional Sign Up page at the following link https://app.smartbloodanalytics.com/SignUp where you, according to these Terms and Conditions, agree to enter your correct personal data which are requested.
6.3. You may only use your work-related e-mail address (with your employer's or professional email account).
6.4. A confirmative response e-mail will follow the e-mail address entered in the sign-up form to confirm your contact information. When confirming this, a member of our onboarding team will evaluate your request. If the request meets the criteria pursuant to these Terms and Conditions and Service agreement (if applicable), you will receive an email with an invite link, and you will be able to log in at our login page.
6.5. The SBAS onboarding team has the right to decide at its own discretion not to reply to your request in any way if they decide it does not meet the criteria pursuant to these Terms and Conditions. SBAS decides upon the sign-up and onboarding process of the user which Tool models will be enabled for the user.
7. Purchase of Tool reports
7.1. Tool's interface via the Website enables you to enter patients' blood tests and create Tool reports which will be charged a fee according to the signed Service agreement (if applicable) and internal pricelist as will be valid from time to time and notified. SBAS reserves the right to change its prices at any time, upon prior notification.
7.2. An invoice will be generated and delivered periodically for the use of the Tool in accordance with Service agreement and applicable laws.
8. Right of order cancellation and refunds
8.1. Any order placed by the user is final and non-refundable.
8.2. . If the Tool would not be accessible due to reasons within the control of SBAS for more than ten consecutive days, the user is entitled to claim a refund of any positive balance on the user's account in relation to the Website by making such request via: .
9. User representations and warranties
9.1. You confirm that you are a licensed physician or other healthcare profession who may, in accordance with these Terms and Conditions and Service agreement (if applicable), use the Tool.
9.2. You warrant that you are using the Tool in relation to healthcare services, and you have all required legal authorizations to use the patient data in such manner, and it is for healthcare reasons only.
9.3. You acknowledge and agree that you use the Tool at your own risk and that you are solely responsible for the use of the Tool within your organization.
9.4. You are responsible for all the consequences resulting from sharing or disclosing any Tool result information with others.
9.6. You acknowledge that by inserting blood test results, you do not have any proprietary or other rights in any research or products that might be developed by SBAS or our partners. You understand that you will not benefit in any way from research or from products resulting from the input information.
9.7. You acknowledge that the Tool is not a substitute for competent medical advice, independent medical decisions, and human intervention.
9.8. You confirm you are aware that the quality of the Tool reports is, inter alia, dependent upon the completeness, accuracy, and quality of the submitted data. You shall, therefore:
a) enter any data in the Tool accurately and completely;
b) read any information displayed in the Tool accurately and completely;
c) independently confirm the accuracy of any medical data and medical diagnosis, including the Tool report, in the same manner that such medical data and diagnosis would be confirmed if it were not obtained through the Tool; and
d) use the Tool only in accordance with good medical practice;
e) fully consider the Instructions for Use for the Tool;
f) complete the training for the use of the Tool.
9.9. You are responsible for obtaining any consent or authorizations from patients, which might be required under the applicable law of your country for using the Tool, and you are solely responsible for complying with the applicable data protection laws.
9.10. As a condition of your use of the Website and the Tool, you warrant to SBAS that you will not use the Website and the Tool for any purpose that is unlawful or prohibited by these Terms and Conditions, applicable legislation, or notices. You may not use the Website and the Tool in any manner that could damage, disable, overburden, or impair the services or interfere with any other party's use and enjoyment of the services. You may not obtain or attempt to obtain any materials or information through any means not intentionally made available or provided for through the Website and the Tool.
9.11. In case you break any of these representations and warranties or breach these Terms and Conditions and Service agreement (if applicable) in any manner, SBAS has the right to suspend, pause and/or terminate your account and refuse the future use of SBAS' services, claim damages, and/or request indemnification.
10. Limitation of liability
10.1. SBAS will not be liable for any misdiagnosis or mistreatment towards any patient and any adverse consequences following such action. Any medical data and/or medical diagnosis, including the Tool report, is provided to you under the condition that it is only made available to healthcare professionals in accordance with section Intended User Profile of these Terms and Conditions, who have sufficient medical training, know-how, and expertise to verify and independently assess such medical data and/or medical diagnosis.
10.2. SBAS does not guarantee the interference-free functionality of the Tool. It will not be liable for any indirect or consequential damages, e.g. such as loss of profits, loss of savings, loss of data caused by simple negligence or other adverse consequences due to unavailability (temporary or longer) of the Tool.
10.3. We do not guarantee the effectiveness of any specific course of action, procedures, opinions, or other information that may be mentioned in any of our reports or other materials. If we provide guidance on what might work for you based on blood tests, this is intended only for use in accordance with these Terms and Conditions. In relation to the efficacy of the Tool, please refer to section Performance of the SBAS Software of the Instruction for Use.
10.4. The limitations and exclusions in this clause shall apply to the fullest extent permitted by law. If for any reason, the exclusion of our liability is not permitted under the mandatory laws, our total liability to you arising in connection with an order will be limited to the price you have paid us so that you can get some or all of your money back. In particular, we are not liable for any loss, delay, inconvenience, or damage you suffer as a result of:
a) incorrect data provided by you within the Tool;
b) inaccessibility of the Website and the Tool;
c) any use you choose to make of the findings of the results report (including any healthcare comment which may accompany the results report). The results report will set out the measurements that have been conducted on your behalf, based upon blood data, so any reliance you make on those measurements is at your own risk. Results report and any healthcare comment (if provided) is intended for informational purposes only and do not constitute medical advice, and are not a substitute for a medical diagnosis conducted.
10.5. We will not be liable or responsible for any failure to perform or delay in performance of any of our obligations under an order caused by an event outside our control (force majeure). An event outside our control means any act or event beyond our reasonable control, including without limitation strikes, lock-outs or other industrial action by third parties, civil commotion, riot, invasion, terrorist attack or threat of terrorist attack, war (whether declared or not) or threat or preparation for war, fire, explosion, storm, flood, earthquake, subsidence, epidemic or other natural disasters, or failure of public or private telecommunications networks or impossibility of the use of railways, shipping, aircraft, motor transport or other means of public or private transport.
10.6. You agree to indemnify, defend and hold SBAS and its directors, officers, employees, agents, and contractors harmless from and against any and all claims, damages, losses, costs (including without limitation reasonable attorneys' fees), or other expenses that arise directly or indirectly out of or from (i) your breach of any provision of these Terms and Conditions and Service agreement (if applicable); or (ii) your activities in connection with the use of the Tool and Website.
11. Data privacy, security, and confidentiality
11.2. All data transmitted from you by means of the Tool must be anonymized and shall not allow the identification of individuals from which the data has been obtained. Other than for automatic generation of the Tool report, SBAS does not willingly collect, process, and/or store any patient-related data. The user may not insert any information in the Tool, or its interface pursuant to which a patient would become identifiable.
11.3. You shall keep confidential and shall not use for your own purposes, nor without the prior written consent of SBAS disclose to any third party (except your professional advisors or as may be required by any law or any legal or regulatory authority), any confidential information, including any information relating to SBAS or any of its affiliates (i) which is marked as confidential; or (ii) the confidential character of which can reasonably be inferred from the circumstances, in both cases unless such information (a) has lawfully become public knowledge; (b) is already known to you at the time of disclosure; or (c) subsequent to the disclosure, comes lawfully into your possession from a third party (the “Confidential Information”). You shall use your reasonable endeavors to prevent the unauthorized disclosure of any Confidential Information and may disclose Confidential Information to your employees if and to the extent such employee has a need to know the Confidential Information.
12. Intellectual Property Rights and no resale of services
12.1. SBAS grants to the registered and approved user a non-exclusive license (without the right to grant sub-licenses) to use the Tool or a third-party software solution enabling the Tool within its organization in the territory of your seat/residence (the “License”).
12.2. The information (including the Tool report), content graphics, text, sounds, images, buttons, trademarks, service marks, trade names, and logos (the “Materials”) contained on the Website and in the Tool, as well as its reports, are protected by copyright and other intellectual property laws. Reports may be used for individual professional purposes (in line with the License and these Terms and Conditions and Service agreement, if applicable), which means for reading, viewing and/or printing of one available copy of the Materials, as long as all copyright, trademark, and other proprietary notices are left intact. Any other use of the contents of the analysis, such as the reproduction, modification, distribution, transmission, re-publication, or use of content, is prohibited. Any other use of your printed results and the Website and the Tool, its contents, and its underlying software, including the reproduction, modification, distribution, transmission, republication, display, or performance of the content on the Website and the Tool, are strictly prohibited.
12.3. By agreeing to these Terms and Conditions, you are not allowed to distribute, license, publish, reproduce, duplicate, copy, create derivative works from, modify, sell, resell, exploit, transfer, or transmit for any commercial purposes, all or any portion of the information from the Tool.
12.4. Use of the materials or trademarks in a way not permitted by these Terms and Conditions constitutes a violation of your agreement with us and may also be a violation of copyright, trademark, and other laws. The title to the Materials remains with us. We reserve all rights not expressly granted to you.
13.1. The Website provides, and third parties may provide, links to other sites and resources on the internet. Because SBAS has no control over such sites and resources, you acknowledge and agree that SBAS is not responsible for the availability of such external sites or resources and does not endorse and is not responsible or liable for any content, advertising, products, or other materials on or available from such sites or resources. You further acknowledge and agree that SBAS shall not be responsible or liable, directly or indirectly, for any damage or loss caused or alleged to be caused by or in connection with the use of or reliance on any such content, goods, or services available on or through any such hyperlinked site or resource.
14. Modifications and severability
14.1. SBAS may revise these Terms and Conditions at any time and for any reason. Such changes, revisions, or modifications shall be effective after five days upon notice to the users at large, which may be given by any means, including, without limitation, posting on the SBAS website. You are solely responsible for ensuring your review of the most up-to-date version of these Terms and Conditions. If you disagree with these Terms and Conditions, your sole remedy is to discontinue your use of the Website and the Tool. Any use of them by you after such notice shall be deemed to constitute acceptance of the changes.
14.2. If any portion of these Terms and Conditions is found to be unenforceable or null and void, the remaining portion will remain in full force and effect, whereas the unenforceable or null and void portions shall be replaced with enforceable and valid portions closest to the economic interest of SBAS.
15.1. You acknowledge and agree that the form and nature of the services SBAS provides may change from time to time without prior notice provided to you. As part of this continuing innovation, you acknowledge and agree that SBAS may stop (permanently or temporarily) providing some services (or any features within the services) to you or to users generally at SBAS' sole discretion, without prior notice to you. SBAS has the right to delete some registered users who were inactive for a relatively long period as determined by SBAS, if their amount balance is zero and according to the signed Service agreement (if applicable).
15.2. You may decide at any point of time to disable your account and thus terminate your relationship with SBAS according to signed Service agreement. You may disable your account by sending an email to . Following such action, any data and any SBAS Software reports will be permanently deleted without the possibility of recovery. A confirmation email of such deletion will be sent to you.
15.3. When these Terms and Conditions and Service agreement (if applicable) come to an end, either by termination or you not using the Website and/or the Tool anymore, all of the legal rights, obligations, and liabilities that you and SBAS have benefited from, been subject to (or which have accrued over time while these Terms and Conditions and/or Service agreement have been in force) or which are expressed to continue indefinitely, shall be unaffected by this cessation, and the provisions of those sections, which shall survive such termination by its nature, including but not limited to user's warranties and representations, limitation of liability, intellectual property rights and no resale of services and similar, shall continue to apply to such rights, obligations, and liabilities indefinitely.
16. Governing law and jurisdiction
16.1. Any dispute or claim arising out of or in connection with these Terms and Conditions shall be governed by, and construed in accordance with, the laws of Switzerland. Any dispute, controversy, or claim arising out of or in relation to these Terms and Conditions shall be resolved by the ordinary courts of the Canton of Zürich, Switzerland.
Effective Date: October 21, 2022