GENERAL CONDITIONS OF USE FOR AMICOMED SERVICES

PROVIDER IDENTIFICATION

The services covered by these Terms and Conditions are provided by Newel Health Srl, based in Salerno, Largo Abate Conforti, registered with the Salerno Chamber of Commerce under REA number 493165, tax code and VAT no. IT06046410657, hereinafter referred to as “Provider”

DEFINITIONS

The term “Application,” “App,” or AMICOMED means the AMICOMED application;
The term”User” means the natural person, who, after downloading the App uses the Services;
The term “Services” means the remote services offered through the use of innovative technologies by the Application and described in these General Conditions of Use in Article 3.

Terms and Conditions of Use.

These General Terms and Conditions set forth, in clear and easy-to-understand language, the terms and conditions to be applied to the use of the digital services provided through the AMICOMED Application by all Users who access and register therein.
At present, the Services made available by the Application are limited to testing the usability, security and effectiveness of the Application itself. The User, deemed eligible, will be able to use the Services free of charge by participating in the feasibility study.
When registering for the Application, the User declares that he/she has read and expressly accepted these General Terms and Conditions. In any case, the use of the Application by the User implies tacit acceptance of these General Terms of Use for AMICOMED services.
Before registering, we therefore invite you to read and accept the General Terms of Use and the information on the Service available in the App Store, in the App itself or on the Site, and to read the privacy policy and provide consent in relation to the processing of personal data, (privacy policy also published on the Site, www.amicomed.com – hereafter the “Site”), without the acceptance of which the provision of the Services may not be possible.
Services’ activation can generally be performed: (1) by filling in on a smartphone within the AMICOMED App. Upon completion of the subscription, instructions on the use of the Service, also available online, will also be sent to the User by e-mail.

Who can use “AMICOMED” services – Users

Only persons of legal age may use the services, who act as consumers (i.e. natural persons acting for purposes not related to their commercial, entrepreneurial or professional activity carried out). If, nevertheless, a minor accesses the Services claiming to be of legal age, the assessments on pressure measurements cannot be considered reliable and the Provider cannot be held responsible in any way.
The Services are not indicated for pregnant women as explicitly highlighted during the registration process. If, nevertheless, a pregnant woman registers and uses the Services, the assessments on the pressure measurements cannot be considered reliable or relevant, and the Provider cannot be held responsible in any way.
The optional “Personalized Blood Pressure Reduction Program” service (hereafter “Program”) is also not indicated for women while breastfeeding, type 1 diabetics, and persons with severe renal failure (stage IV). The Provider assumes no responsibility if a person with these conditions subscribes to the Program and omits or falsely states his or her condition.

Information and presentation of the Service.

The “AMICOMED” App provides a service for the collection of blood pressure data, upon entry into the Application of blood pressure and heart rate values measured by the User. This service enables periodic monitoring by the User himself/herself of blood pressure and heart rate thanks to the functions offered by AMICOMED using the software that illustrates the pressure trend. The result, provided to the User within a maximum of 30 minutes after receiving the blood pressure and heart rate values, will consist of a presentation of the sent measurements, both in their point value and in relation to their trend over time. Access to the blood pressure service “AMICOMED” allows the User, as long as the service is activated, to also access additional components of the Service:
special electronic and personal blood pressure diary (hereinafter “Diary”) of all blood pressure and heart rate values and their evaluations, which can be consulted by the User with his/her credentials at any time via access to the Site or via App;
Interface with the Apple Health App: the Service offers the User (i) the possibility of copying the data entered in AMICOMED also to the Health App on their device and (ii) the possibility of retrieving the blood pressure values stored in their Health App and transferring them to the AMICOMED Service Diary. In both cases, it is first of all necessary that the User provides explicit consent to such a transfer (at the first use of the AMICOMED App or later via the settings menu of the Health App) and in the case of transfer of information from the Health App, only complete systolic, diastolic and heart rate measurements that are realistic according to the international standards applied by AMICOMED and explicitly recognized by the User as valid will be considered. The User acknowledges that measurements collected prior to registration to the Application will not be evaluated ex-post by AMICOMED. If, for technical simplicity, they are taken into account and evaluated by the Application, in each case with regard to the evaluation of the pressure trend only limited to the period after interfacing, the Provider assumes no responsibility for any situations for which a physician’s evaluation would have been appropriate that occurred prior to joining the services and are reported as such ex-post. Such measures, however, will be considered in pressor trend assessments from the time of transfer to AMICOMED onward. This option is available free of charge to AMICOMED App users on compatible Apple devices.
Option for the User to request the assessment of his/her own pressor well-being status (“Clinical Lifestyle Score”), upon completion of a dedicated questionnaire, and/or to request the development of a personalized program for pressure reduction based on lifestyle actions and without the addition of medication (the Program). The Provider assumes no responsibility for the quality and impact of the Program if the information provided by the User is not complete, true, and correct.

All information on the essential features of the Services is in any case also provided within the Site www.amicomed.com. The Service is provided after the registration to the Application in the manner and under the terms set forth below.

Registration to the Application.

Registration to the Application enables Users to create their own personal Account and access the Services offered by the Application.
Registration is an essential condition: Users who do not register cannot create their own account and access the Services offered.
The User, when registering, is required to enter his/her personal data (name and surname, username and password), true and correct, and also provide some data related to his/her health: whether he/she has suffered, or suffers, from some specific conditions with a major cardiovascular impact (heart attack, atrial fibrillation, renal failure, heart failure) and whether he/she regularly takes medications. In addition, the personal data entered during registration must match those of the person who will make use of the services offered by the Application.
The e-mail address and password chosen are the User’s login credentials, which allow him/her to access the Application.
At the time of registration, the User is asked to accept these General Terms and Conditions as well as to confirm that he/she has read the Privacy Policy and consent to the processing of personal data for the provision of the services offered.
Once the login has been completed, the User undertakes to keep the access password and not to communicate it to third parties: the access credentials are in fact personal, relative to the User and not transferable, not even free of charge. It is the specific responsibility of the User to employ all appropriate measures to ensure the confidentiality of their login credentials.
Each User is directly responsible for any activity carried out using his or her Account or access credentials and undertakes to notify Provider of any unauthorized or otherwise abusive use of his or her Account and/or access credentials. The Provider shall not be held liable in any way for any damages of any nature suffered by the User as a result of the unauthorized or otherwise abusive use of the Account (and/or the User’s access credentials) made by third parties.
In case of problems related to the Account or password, the User may contact Provider by sending an e-mail to support@amicomed.com.

Methods of delivery of the Services.

Basic Pressure Data Collection Service. To facilitate maximum usability of the Services under any circumstances, Provider may allow access to the Services through multiple channels: web via the Site or by downloading the App from the App Store or Google Play Store the “AMICOMED” App. The User will be free to choose from time to time which channel to use among those available based on his/her needs at that time.
The basic service (entering measurements and receiving functionality from AMICOMED, including any measurement report that requires timely evaluation by a physician [2]) can be used on all access channels made available.
Whichever channel is chosen by the User, the data of his/her own pressure and heart rate measurements (hereinafter referred to as “Measurement”), in order to be accepted, must be complete, meaning a measurement that contains the data of systolic pressure, diastolic pressure, heart rate, date, hour and minute of the measurement. The absence of even one of these data makes it impossible to send the measurement itself and the User will be notified of the need to complete the data.
Entry via App requires preliminarily downloading and installing on the User’s smartphone or tablet the “AMICOMED” App, following the instructions provided by the provider of their phone or tablet. Once the App is downloaded, the User must enter his/her credentials and then access the measurement entry area. In all cases described above, the costs of the connection are borne entirely by the User.
Each time a measurement is entered, the Provider undertakes to provide the User with an evaluation on the measurement itself within 30 minutes of the communication of the measurement, except for causes of force majeure, impossibility or suspension and interruption of the Service or the Site due to causes not attributable to it (including but not limited to the lack of internet connection or telephone line on the transmission channel used by the User), without prejudice in any case to the other causes described within these Terms of Use that could result in a non-response or delayed response.
The Provider agrees to respond to the User directly on the same channel used to enter the measurement, it being understood that all measurements and related assessments will still be available to the User in APP.
Optional Service. In the event that the User requests the drafting of the Program, he/she will have to provide a series of additional information on his/her metabolic and nutritional profile and physical activity by filling out a questionnaire within the app. Based on the information received, AMICOMED will draft a three-month personalized nutritional and physical activity program aimed at a possible reduction of the User’s blood pressure. The Provider assumes no responsibility in case the User communicates false, incorrect or incomplete information and/or represents a reality different from the facts as well as where the User does not follow the Program correctly and accurately.
Extreme caution is recommended on the use of one’s credentials: the Userwill in general have the option by his/her choice (via browser/app settings) to store username and/or password. The Provider assumes no liability in case of loss of data provided by the User, or access to the User’s sensitive data in any case of loss, theft, destruction or failure to keep the User’s phone, smartphone, tablet or computer or loss, theft or failure to keep the User’s own access credentials due to the User’s own fact or fault or that of third parties to whom the User has voluntarily or involuntarily granted access to the above.
The Provider agrees to provide indications of blood pressure trends as indicated above, as well as, in the event that the completion of the Optional Program has been requested, to provide all appropriate indications inherent in the improvement of blood pressure through lifestyle modification, but in all cases, assumes no responsibility for the actual trend of the User’s blood pressure (blood pressure being among other things dependent on a plurality of factors), or for other and different consequences affecting the User’s health. AMICOMED likewise assumes no liability, except where established by mandatory provisions of law, and cannot guarantee the proper provision of the Service in the event that the User does not follow the instructions provided by the manufacturer of his or her blood pressure monitor on how to measure physiological data and ensure the proper functioning of the meter (by way of example only: incorrect position of the measuring cuff used, measurement under stressful conditions, or immediately after exercise, malfunction of the device), or does not enter the correct or complete data. Similarly, AMICOMED assumes no responsibility, except where established by mandatory provisions of law, and cannot guarantee the proper delivery of the Service in the event an incorrect measurement is received as a result of its acquisition through Apple’s Healthkit or similar third-party software, in compliance with the instructions received from the User. The User assumes, in any case, full responsibility for the correctness and completeness of the measure communicated for the provision of the Service, either by entering them directly, or by connecting a compatible and directly connectable blood pressure meter to the AMICOMED App, or by instructing AMICOMED to acquire them from the Apple Healthkit App or similar third-party software.

Compatible Pressure Meters for Service Delivery.

In order to use the Service, it is necessary to be in possession of or otherwise use a blood pressure monitor that is compatible with the Service, meaning those that are cumulatively: (i) certified for sale and use in Europe, thus CE marked, and (ii) included in the list of meters validated according to the European Society of Hypertension (ESH), provided by the independent European organization dabl Educational Trust – the list of meters is accessible at the link https://www.dableducational.org/sphygmomanometers.html. The updating of this list is taken care of directly by dabl educational and the Provider assumes no responsibility in this regard. By accepting these Terms of Use and registering for the Application, the User confirms that he/she is using only compatible meters as defined above.
The Provider assumes no liability, except where established by mandatory legal provisions, and cannot guarantee the proper provision of the Service in the event that the User does not use compatible measuring instruments as described above or uses them contrary to the recommendations for use provided by the respective manufacturer.

Right to terminate registration to the Application.

The User may communicate his/her wish to cease using the Application at any time by giving notice to the Provider by e-mail communication to support@amicomed.com containing his/her data necessary for proper identification (personal data and username used to access the AMICOMED service) with a request to cease registration to the Application. The Provider will verify the correct execution of the above terms and conditions and in case the verifications are positively concluded, it will send to the User, via e-mail, the relevant confirmation of the cancellation of the registration.
Following the cancellation of registration, the Provider will deactivate the User’s personal account and delete all personal data registered with the exception of the data it is obliged to keep in compliance with legal obligations.

Termination of the usability test

Upon completion of the usability evaluation phase of the Application, the User will receive instructions from the Provider regarding how to continue using the Services.

Force Majeure Causes.

The Provider shall not be liable for and shall be relieved of any contractual obligation to do or provide the Service and shall not be liable to pay any indemnity in the event of causes beyond the control of the Provider or force majeure events that prevent the performance of obligations placed upon the Provider, such as, but not limited to, riots, insurrections, wars, natural disasters, nuclear explosions, acts of terrorism, social unrest, telephone or computer failures or serious injury to the security and operability of the Internet, strikes and impossibility or serious difficulty in supplying (even temporarily) the Service or materials.

Liability

The Provider reserves the right to modify, limit or discontinue the scope and functionality of the Site, Apps and the Service at any time. The Provider shall endeavour to offer and deliver the Service without technical failure; however, any use of the Site, Apps or the Service may be suspended or discontinued at any time due to maintenance work or other issues, malfunctions of the Service or Internet or telephone connectivity of the operator chosen by the User or the providers that guarantee or perform the management of the network, Apps or the Site. This could possibly cause the Site, App or Service to malfunction, to be suspended or interrupted, or to lose data. Therefore, the Provider assumes no responsibility, subject to mandatory legal regulations, for the availability and continuity of the Service, App and Site, the absence of technical failures or the loss of data.
The Service does not provide diagnosis [3] for any pathology but provides timely and historical evaluation of measured parameters. However, should the system provide responses that indicate significant alterations in blood pressure and/or heart rate values (such as, for example, significantly high blood pressure above the normal thresholds [4] indicated by the European Society of Hypertension and/or the World Health Organization), the Provider urges the User to seek prompt evaluation by a physician.

Complaints and Dispute Resolution.

AMICOMED may edit these General Terms and Conditions at any time, such as but not limited to, for the purpose of adaptation to legal regulations or adaptation to changed functions. The valid Terms of Use are in any case available on the Site. If the User does not accept the modified terms of use, he/she may no longer use the Service.
Any complaints may be sent to the Provider at Newel Health Srl, Largo Abate Conforti – 84121 Salerno, Italy, or by e-mail to support@amicomed.com by including “complaint” in the subject line of the communication.
For customers domiciled in Italy, the provisions of Legislative Decree No. 206 of September 6, 2005, as well as Legislative Decree No. 70 of April 9, 2003, on electronic commerce apply to these general conditions of use. In case of disputes between the Provider and the User, arising from the use of the Application, the Provider declares to adhere to the online conciliation method “Resolvi Online” provided by the Chamber of Arbitration of the Milan Chamber of Commerce. You may access www.risolvionline.com for information or to submit a request for conciliation. The User is in any case free to choose a different method of dispute resolution and a different conciliation service or to refer the matter to the competent judge at his residence or domicile.

Intellectual Property Rights of AMICOMED

The Provider (together with its subsidiaries and affiliates as defined above) holds all rights to its proprietary trademarks and distinctive signs, all copyrights, and all other rights to the Service and the content, information, images, videos, and databases contained therein. Modification, reproduction, publication and transfer to third parties or other use of Provider’s intellectual property is expressly prohibited.

Use of the Site and Apps and Security

It is prohibited to violate or attempt to violate security measures on the Site and/or Mobile Applications, including, without limitation:

Using a false password or one belonging to another user or accessing data not intended for the user or accessing a server or account for which the User is not authorized;
Disclosing a password or allowing others to use a password or failing to disclose when a password is fraudulent;
Attempt to and/or seize, examine or test system or network vulnerability or breach security or authentication measures without proper authorization;
Attempt to and/or interfere with direct service to any user, host, or network, including, without limitation, by means of “overloading,” “flooding,” “mail bombing,” or “crashing”;
Sending unsolicited e-mail, including promotions and/or advertising of products or services;
Cloning/counterfeiting any TCP/IP header, or any part of the header information, in any e-mail or newsgroup; or
Hijack all or any part of the content of the Site or the Apps, delete or modify any content of the Site or the Apps, distribute pop-up messages or advertising, run or display this Site or the Apps or any content of the Site or the Apps in frame or by similar means on another site, or make a link to the Site or the Apps or to any page within the Site or the Apps, without our specific written permission.

You agree to use the Site and the Apps only for lawful purposes, and only for your own personal use. You are prohibited from using the Site and the Apps to transmit, post, download, distribute, copy, publicly display, store, or destroy material (a) in violation of any applicable law or regulation, (b) in a manner that infringes the copyright, patents, trademarks, trade secrets, or other intellectual property rights of others or violates the privacy or publicity or other personal rights of others, or (c) that is defamatory, obscene, offensive, threatening, racist, or hateful.
User agrees to indemnify and hold Provider harmless from and against any and all claims, damages, costs and expenses, including attorneys’ fees, arising out of or in connection with User’s own or any third party’s use of the Site and Apps.

Account Deactivation and Miscellaneous

The personal account will be deactivated, resulting in the interruption of the Service, as well as in the case of violation of the obligations referred to in Article 13 above, if prohibited and/or fraudulent behaviour is found. The Provider reserves the right to conduct random or targeted checks aimed at discovering any prohibited and/or fraudulent behaviour. The following shall be deemed prohibited conduct: use of the Service for commercial purposes, use of the Service by one or more unauthorized persons, frequent entry of measures that are patently impossible or for the sole purpose of testing and learning the features of the Service, entry of data relating to more than one person, use of automated computer systems for repeated submission of measures, attempts to sabotage the AMICOMED computer system, or abusive attempts to access the same.
The personal account will also be deactivated if at the end of the usability evaluation phase of the Application, the User does not comply with the registration and completes the purchase of the Services, in the manner that will be indicated by the Provider.
If the aforementioned verifications reveal one or more of these cases, Provider may at its sole discretion immediately deactivate the User’s Account by giving written notice to the User by email, (or registered letter if the User has not provided an email), or contact the User in advance to urge the User to desist from such behaviour or to arrange to renew registration or purchase the Service by means of messages in the customer area or App, email, phone call, letter, and thereafter, if the behaviour does not cease or the User fails to purchase the Services and renew registration, deactivate the User’s Account.
The User’s data will be stored and processed for the period necessary to pursue the purposes for which they were collected and, in any case, in accordance with the terms established by law. In case of deactivation of the Account for any cause occurred, the User may within these terms, request by PEC (administration@pec.newel.health), the sending of its data and, in particular, in addition to personal data, the list of measurements entered, without clinical feedback. The aforesaid data will be sent to the User in encrypted PDF format to the e-mail address he/she shall provide or on CD-ROM to the postal address he/she shall provide subject to a charge for the cost of producing and sending the materials.
If any of the provisions of these Terms of Use are or become invalid or ineffective by applicable law, or by arbitration rulings or judgments, the validity and effectiveness of the remaining provisions shall not be affected in any way, unless the very fitness of this Agreement to achieve its purposes is irreparably affected.

Protection of Personal Data.

For information on the processing of the User’s personal data, please read carefully the privacy policy provided at the time of registration and available on the Site. Please note that the activation and provision of the Service presupposes that the User provides personal data and special categories of personal data concerning health as explained in the information provided at the time of registration and also available on the Site and that the provision of the Service will not be possible if the data indicated therein are not provided or consent to their processing is not given.

Customer Service

For any information related to the use of the Services through the Site or through the App, the User may contract AMICOMED Customer Service:
via e-mail at support@amicomed.com