The mySmartBlood smartphone application and all its features, services and related webpages (the “mySmartBlood”) are 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 mySmartBlood and permit you to avail of mySmartBlood.
To use mySmartBlood (as defined in point 2 of these Terms and Conditions), you must be a natural person and be at least 18 years old. By using mySmartBlood you agree and accept our Terms and Conditions, so please review all these documents carefully. These Terms and Conditions are the legal equivalent of a signed, written contract between you and SBAS.
We may modify these Terms and Conditions at any time. If you do not accept these updated Terms and Conditions or do not wish to be bound by changes following posted notices you must discontinue use of mySmartBlood.
SBAS has developed mySmartBlood, through use of which blood test results are interpreted by way of advanced machine learning algorithms with medical intended purpose.
mySmartBlood falls within the scope of the Swiss Medical Devices Ordinance (MedDO) and the Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, as amended. SBAS has ascertained compliance with the essential requirements of the aforementioned regulation and notified Swissmedic as the Competent Authority No. CH/CA01). mySmartBlood is classified as IVD Other (GMDN / EDMS Code 38442) and is CE marked and it conforms, inter alia, to the following standards: ISO 14971:2019, IEC 62304:2006/AMD 1:2015, EN 13612:2002 and EN ISO 13485:2016.
mySmartBlood is an in vitro medical device, intended to provide information concerning medical conditions or diseases and respective physiological or pathological states using results of in vitro examination of blood. It provides a ranking of potential diseases to be used by healthcare professionals in the advanced differential diagnosis in the fields of internal medicine (Toxicology, Endocrinology, Gastroenterology, Cardiology, Hematology, Nephrology, Pulmonology, Rheumatology). mySmartBlood operates by using machine learning algorithms trained on clinical cases.
mySmartBlood is available in Switzerland, European countries covered by CE regulation, countries that observe CE regulation and some additional countries where SBAS obtained required regulatory approvals and/or may be lawfully offered. These countries will be listed on www.mysmartblood.com and will be updated regularly. Please note that the list of countries may change from time to time and therefore you are advised to regularly check for any updates.
If you wish to use mySmartBlood, you will be required to enter results of specifically requested blood test parameters, which you may obtain from a local medical laboratory. Based on the blood test results, mySmartBlood lists a group(s) of most likely diseases or medical conditions. For every such group, mySmartBlood provides the most likely diseases, blood parameter contribution and field of medicine.
Please note that mySmartBlood is not a diagnostic medical device and you are not allowed, and you should not make any decisions based only on the results obtained by mySmartBlood, without consulting a healthcare professional. You shall never disregard healthcare`s professional advice or cancel an appointment with a healthcare professional because you are relying only on information read in the mySmartBlood. You assume full risk and responsibility for the use of information obtained from or through mySmartBlood.
Your 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 software is only intended for informational and awareness purposes, to guide you to consult the appropriate healthcare professional.
SBAS is not a healthcare provider and the results provided by mySmartBlood are not a substitute for a diagnostic test used to confirm or ascertain diagnosis that meet applicable healthcare regulations. mySmartBlood does not constitute medical advice, nor are a substitute for medical advice from a qualified healthcare provider.
If you think you may have a medical emergency, please contact your physician or emergency services immediately.
The following special warnings and precautions for use of mySmartBlood shall be observed:
mySmartBlood was clinically evaluated on data of Caucasian adult patients. The performance of mySmartBlood, when used in/on unintended population can be lower than specified;
your diagnosis shall always be determined by the responsible physician based on all available physical findings, patients’ anamneses, symptoms and results of other diagnostic tests;
mySmartBlood can only be used if 56 blood test parameters from the list of parameters (disclosed in the Instructions for Use) are available and correctly inserted;
mySmartBlood can only provide information on a group of diseases which are available in the mySmartBlood’s database. Available groups of diseases are listed in the Instructions for Use;
mySmartBlood is not designed to be used on healthy persons. The use on healthy persons may provide non-relevant information.
Your use of mySmartBlood, in its widest sense, is subject to these Terms and Conditions. Except as specified herein, these Terms and Conditions apply to any use of mySmartBlood, including but not limited to:
registration of the user;
input of mandatory blood test parameters and other relevant health data or other relevant information;
generation, review and share of mySmartBlood reports;
review and use of any information provided within or through mySmartBlood;
By using mySmartBlood you agree and accept our Terms and Conditions. These Terms and Conditions are the legal equivalent of a signed, written contract between you and SBAS. You shall not use mySmartBlood if you do not agree with the Terms and Conditions. By continued use of mySmartBlood it is deemed that you agree with the Terms and Conditions.
Prior to using mySmartBlood you are obliged to thoroughly review the Instructions for Use. The Instructions for Use represent a vital part of these Terms and Conditions and is incorporated into these Terms and Conditions. You are obliged to consider the Instructions for Use before and during the use of the mySmartBlood.
SBAS may from time to time publish guidelines or rules applicable to any of its services and products. 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 mySmartBlood.
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.
The use of mySmartBlood is currently evaluated and therefore possible for interpreting blood results of Caucasian adult patients (older than 18 years), being either a female or male, with acute and/or chronic conditions in the fields of internal medicine (Toxicology, Endocrinology, Gastroenterology, Cardiology, Hematology, Nephrology, Pulmonology, Rheumatology).
mySmartBlood may not be used for the use concerning children, pregnant women. Certain kinds of medication therapy can affect mySmartBlood reports. When consulting with a healthcare professional, please inform them regarding this.
In order to use mySmartBlood, you need to create a personal account (“Account”) by providing personal data (i.e. name, birth date, biological sex). You need to provide your email address as a username and create a password to protect your data.
Creation of the Account is free of charge, however the Account itself does not provide you with full functionalities pursuant to mySmartBlood. Provision of mySmartBlood reports is subject to payment, as described below.
By accepting the Terms and Conditions and after you have completed the registration procedure you expressly confirm that you have access to the intended use of mySmartBlood as set out in the present Terms and Conditions.
mySmartBlood enables you to enter relevant blood test parameters and to create mySmartBlood report which will be charged a fee as listed in mySmartBlood. SBAS reserves the right to change its prices at any time. Depending on the platform used, you might have the opportunity to purchase the mySmartBlood report via credit card (through In-App Payment).
Before you perform any payment, you will have the opportunity to review and accept the fees that will be charged. Please note that in order to use the envisaged functionalities provided by mySmartBlood, you will need to obtain the requested mandatory blood parameter results, which may be subject to additional charge by your local healthcare provider or laboratory.
Payments will be processed through the relevant app store from which you originally downloaded mySmartBlood. You acknowledge and agree that all payment transactions are handled by the relevant app store provider from whose platform you downloaded mySmartBlood. The relevant app store provider’s terms and conditions (with regard to your payment transaction and billing information) shall apply and prevail over the in-app payment terms and conditions of these Terms and Conditions. If you have any payment related issues with your in-app payments then you need to contact the app store provider directly.
SBAS retains its right to enable from time to time, entirely pursuant to its own discretion, promotional or special use periods during which mySmartBlood payable services or products may be provided free of charge or with discounts ascertained by SBAS.
Any purchase order placed by the user is final. All fees are non-refundable, to the fullest extent permitted under applicable law. You will not receive a refund of any fees already paid for the purchased service within mySmartBlood.
Prior to your use of mySmartBlood, you represent and warrant that you understand and will comply with the following:
you have the authority to enter into this binding agreement personally;
you have entered any User Content (as defined in clause 11.5) accurately and truthfully;
you will review the Instructions for Use accessible within mySmartBlood application available in the Disclaimer page and under Settings – Instructions For Use;
you have obtained all mandatory blood parameters from an accredited medical laboratory, and you have entered the requested parameters in mySmartBlood correctly;
you are an adult (18 years and above);
no limitations for the use of mySmartBlood, as described in clauses 2 and 4 of these Terms and Conditions, are present;
you are aware the SBAS is not a healthcare provider, and mySmartBlood is not intended as a diagnostic medical device. For that reason, you will not rely solely on the results provided by mySmartBlood and you will consult appropriate healthcare professional in relation to any diagnosis;
the results provided through the use of mySmartBlood are based on artificial intelligence and no human person reviews the results prior to being delivered to you. mySmartBlood is not a substitute for competent medical advice, independent medical decisions and human intervention;
you are using mySmartBlood for your personal, non-commercial, use. You agree to provide us with the required mandatory blood parameters results, as well as the required personal information and you consent to such use. You will not enter any personal information for which you do not consent to being processed or you have not obtained such a valid explicit consent from a third person, if applicable in certain circumstances (e.g. joint custody, etc.);
mySmartBlood is provided upon your voluntary request and you agree to use it at your own risk. You are wholly responsible for all activities carried on by you under your Account;
you are obliged to uphold the confidentiality and security of the login data of your Account, such as your password or other credentials, as well as the device on which mySmartBlood is installed.
In order to use all functionalities of mySmartBlood, you will need Wi-Fi on your mobile device or mobile Internet connection. Access to Wi-Fi or a mobile internet connection is your own responsibility.
If your mobile device does not support application installation, we are unable to ensure that mySmartBlood will work properly. SBAS declines all and any liability for loss or damage due to the fact that you failed to comply with the aforesaid requirements.
You accept to immediately notify SBAS of any unauthorized use of your Account or of any other security breaches. SBAS declines all and any liability for loss or damage due to the fact that you failed to comply with the aforesaid requirements.
As a condition of your use of mySmartBlood, you warrant to SBAS that you will not use mySmartBlood for any purpose that is unlawful or prohibited by these Terms and Conditions, applicable legislation or notices. You may not use mySmartBlood 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 mySmartBlood.
In case you violate any of the representations and warranties or breach these Terms and Conditions in any manner, SBAS has the right to suspend, pause and/or terminate your account and refuse the future use of SBAS’ services, including mySmartBlood, claim damages and/or request indemnification.
Except as expressly provided in this clause and to the maximum extent permitted by applicable law, mySmartBlood, including the interpretation of your blood parameters by mySmartBlood are provided on "AS IS" basis and we make no other warranties, covenants or representations, or conditions, whether written, oral, express or implied including, without limitation, any implied warranties of satisfactory quality, course of dealing, trade usage or practice, merchantability, suitability, availability, title, noninfringement, or fitness for a particular use or purpose, with respect to the use, misuse, or inability to use mySmartBlood. We do not warrant that:
all errors can be corrected, or that access to or operation of mySmartBlood shall be uninterrupted, secure, or error-free, and
the information, including but not limited to the analysis of your measurements by our algorithm, available on or transmitted by mySmartBlood, is true, complete or accurate.
You specifically acknowledge and agree that we cannot be held liable for any healthcare or related decisions made by you or your physician based upon the interpretation of your blood parameters by mySmartBlood, transmitted or displayed by or on mySmartBlood whether such data is accurate or inaccurate.
You acknowledge and agree that your physician, and not we, is solely responsible for the interpretation of your blood parameters or other healthcare information related to you. You expressly acknowledge and agree that your use of mySmartBlood including the analysis of your health data, is at your sole risk. You acknowledge and agree that there are risks inherent to transmitting information over and storing information on the internet and that we are not responsible for any cybersecurity incidents and/or losses of your data, including but not limited to the analysis of the health data and any User Content (as defined in clause 11.5), in connection therewith.
SBAS will not be liable for any misdiagnosis or mistreatment, if you, against our specific warning, relied on the information provided by mySmartBlood, as well as for any adverse consequences following such action.
We do not guarantee the effectiveness of any specific course of action, procedures, opinions, or other information that may be mentioned within mySmartBlood, its reports or other materials. If we provide guidance on what might work for you based on blood tests, this is intended only for the use in accordance with these Terms and Conditions. In relation to efficacy of mySmartBlood please refer to Instructions for Use.
To the maximum extent permitted under applicable law, our liability arising out of or in connection with mySmartBlood under these Terms and Conditions whether in contract, warranty, tort or otherwise, shall not exceed the price paid by a user for the use of mySmartBlood. Nothing in these Term of Use shall limit or exclude our liability for (i) gross negligence; (ii) wilful misconduct, (iii) fraud or personal injury.
To the extent legally permitted under applicable law, we shall not be liable to you or any third party, for any special, indirect, exemplary, punitive, incidental or consequential damages of any nature including, but not limited to damages or costs due to loss of profits, data, revenue, goodwill, production of use, procurement of substitute services, or property damage arising out of or in connection with mySmartBlood under these Terms and Conditions, including but not limited to any miscalculations, or the use, misuse, or inability to use mySmartBlood or other documentation provided, regardless of the cause of action or the theory of liability, whether in tort, contract, or otherwise, even if we have been notified of the likelihood of such damages. In particular, we are not liable for any loss, delay, inconvenience or damage you suffer as a result of:
incorrect data provided by you within mySmartBlood;
inaccessibility of mySmartBlood;
failure to use the most recent version of mySmartBlood;
any use you choose to make of the findings mySmartBlood report (including any healthcare comment which may accompany the report). The 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. mySmartBlood report, and any healthcare comment (if provided), is intended for informational purposes only and does not constitute medical advice and is not a substitute for a medical diagnosis conducted.
The exclusions and limitations of liability under this clause shall operate to the benefit of our affiliates and subcontractors under this Terms of Use to the same extent such provisions operate to our benefit.
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 paid by a user for the use of mySmartBlood.
We will not be liable or responsible for any failure to perform or delay in performance of any of our obligations under an order that is 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 disaster, 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. You may cancel an order/purchase affected by an event outside our control which has continued for more than 30 days. To cancel, please contact us.
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; or (ii) your activities in connection with the use of mySmartBlood.
SBAS collects, processes and/or stores only personal data necessary for the use of mySmartBlood, in accordance with applicable data protection legislation and our Privacy Policy. Privacy Policy is hereby incorporated in these Terms and Conditions and represents a part thereof.
Other than for providing you with mySmartBlood, i.e. automatic generation of the mySmartBlood report, SBAS does not willingly collect, process and/or store any User Content (as defined in clause 11.5).
SBAS grants to validly registered users, subject to the timely payment of the fees (if applicable), a non-exclusive, personal, restricted, non-sublicensable and non-transferable license to use mySmartBlood in accordance with these Terms of Use ("License"). You are not allowed to use mySmartBlood for any commercial purposes or to use mySmartBlood, or a component of the foregoing in a manner not authorized by us. You shall use mySmartBlood solely in full compliance with (i) the present Terms and Conditions; (ii) any additional instructions or policies issued by us, including, but not limited to, those posted within mySmartBlood or on our website; (iii) any applicable legislation, rules or regulations and (iv) additional documentation provided.
The information (including the mySmartBlood report), content graphics, text, sounds, images, buttons, trademarks, service marks, trade names and logos (the “Materials”) contained within mySmartBlood are protected by copyright and other intellectual property laws. mySmartBlood report may be used for individual non-commercial purposes (in line with the License and these Terms and Conditions), 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 interference with mySmartBlood, its contents and its underlying software, including the reproduction, modification, distribution, transmission, republication, or performance of the content on mySmartBlood are strictly prohibited.
Within the limits of the applicable law, you are not permitted to (i) make mySmartBlood, Materials and/or additional provided documentation available or to sell or rent mySmartBlood and/or additional provided documentation to any third parties, without explicit written consent of us; (ii) adapt, alter, translate or modify in any manner mySmartBlood, Materials or additional provided documentation; (iii) sublicense, lease, rent, loan, distribute, or otherwise transfer mySmartBlood, Materials or additional provided documentation to any third party; (iv) decompile, reverse engineer, disassemble, or otherwise derive or determine or attempt to derive or determine the source code (or the underlying ideas, concepts, algorithms, structure or organization) of mySmartBlood, Materials or additional provided documentation, except and only to the extent that such activity is expressly permitted by applicable law notwithstanding this limitation; (v) use or copy mySmartBlood, Materials or additional provided documentation except as expressly allowed under this clause; (vi) gain unauthorized access to Accounts of other users or the IT equipment or structure of us to provide mySmartBlood, Materials or additional provided documentation or use mySmartBlood, Materials or additional provided documentation to conduct or promote any illegal activities; (vii) use mySmartBlood, Materials or additional provided documentation to generate unsolicited email advertisements or spam; (viii) impersonate any person or entity, or otherwise misrepresent your affiliation with a person or entity; (iv) use any high volume automatic, electronic or manual process to access, search or harvest information from mySmartBlood, Materials or additional provided documentation (including without limitation robots, spiders or scripts); (x) alter, remove, or obscure any copyright notice, digital watermarks, proprietary legends or other notice included in mySmartBlood, Materials or additional provided documentation; (xi) intentionally distribute any worms, Trojan horses, corrupted files, or other items of a destructive or deceptive nature or use mySmartBlood, Materials or additional provided documentation for any unlawful, invasive, infringing, defamatory or fraudulent purpose; or (xii) remove or in any manner circumvent any technical or other protective measures in mySmartBlood, Materials or additional provided documentation.
Except as expressly set forth herein, no express or implied license or right of any kind is granted to you regarding mySmartBlood, Materials or additional provided documentation or any part thereof, including but not limited to any right to obtain possession of any source code, data or other technical material relating to mySmartBlood.
By uploading, creating or otherwise providing information, data or images on or through mySmartBlood (the "User Content"), and without prejudice to the provisions of our Privacy Policy, you grant us a non-exclusive, royalty-free, worldwide, sublicensable, transferable, license to use, copy, store, modify, transmit and display User Content to the extent necessary to provide and maintain mySmartBlood for you. We reserve the right, but are not obliged, to review and remove any User Content which is deemed to be in violation with the provisions of the Terms and Conditions or otherwise inappropriate, any rights of third parties or any applicable legislation or regulation.
mySmartBlood may include links to other sites and resources on the internet provided by third parties. 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 use of or reliance on any such content, goods, or services available on or through any such hyperlinked site or resource.
It is expressly acknowledged and agreed that you shall, regardless of whether or not formally requested to do, provide to mySmartBlood reasonable suggestions, comments and feedback regarding the mySmartBlood Services, including but not limited to usability and test results (the “Feedback”). If you provide such Feedback to mySmartBlood, you shall grant mySmartBlood the following worldwide, non-exclusive, perpetual, irrevocable, royalty free, fully paid up rights:
to make, use, copy, modify, sell, distribute, sub-license, and create derivative works of, the Feedback as part of any mySmartBlood product, technology, services, specification or other documentation;
to publicly perform or display, import, broadcast, transmit, distribute, license, offer to sell, and sell, rent, lease or lend copies of the Feedback (and derivative works thereof) as part of any mySmartBlood product;
share Feedback with competent regulatory bodies.
Further, you warrant that its Feedback is not subject to any license terms that would purport to require mySmartBlood to comply with any additional obligations with respect to any mySmartBlood products that incorporate any Feedback.
SBAS may revise these Terms and Conditions at any time. Such changes, revisions or modifications shall be effective after 5 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 mySmartBlood. Any use of them by you after such notice shall be deemed to constitute acceptance of the changes.
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.
You acknowledge and agree that the form and nature of the services or products which SBAS provides, including mySmartBlood, may change from time to time without prior notice 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 mySmartBlood) 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 unactive for a relatively long period, if their amount balance is zero.
You may decide at any point of time to disable your account and thus terminate your relationship with SBAS. You do not need to specifically inform SBAS why you want to stop using mySmartBlood. You may disable your account by sending an email to support@mysmartblood.com. Following such action any data and any mySmartBlood reports will be permanently deleted without the possibility of a recovery. A confirmation email of such deletion will be sent to you.
If we become aware or suspect, in our sole discretion, any violation by you of these Terms and Conditions or any other instructions, guidelines or policies (including but not limited to the Privacy Policy issued by us), then we may suspend or limit your access to mySmartBlood or terminate the agreement. The duration of any suspension by SBAS will be until you have cured the breach which caused such suspension or limitation or even indefinitely, if so decided by SBAS.
When these Terms and Conditions come to an end, either by termination or you not using mySmartBlood 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 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.
Please note that under consumer protection legislation you may be entitled to a right of withdrawal within 14 days from a purchase, in case of remotely concluded agreements. Nevertheless, mySmartBlood consist solely of the supply of digital content that is not supplied on a tangible medium. Consequently, you can no longer claim any right of withdrawal with respect to the purchased products or services.
Without prejudice to any mandatory legislation, 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 City of Zurich, Switzerland.
Regardless of the above, if you are a consumer with residence in an EU Member State or Switzerland, please note that you will continue to benefit from the mandatory consumer protection provisions applicable in the Member State of your residence.
SBAS does not recognize any provider of out-of-court settlement of consumer disputes as competent for resolving consumer disputes that could be initiated by a private user in accordance with the legislation on out-of-court settlement of consumer disputes.
SBAS publishes an electronic link to the online consumer dispute resolution platform (SRPS). The platform is available online at https://ec.europa.eu/odr.