PMcardio Terms and Conditions

Introduction
1. These Terms and Conditions (“T&C”) covers the use, functionality, and access to the Services (as defined below). The T&C are a binding agreement between POWERFUL MEDICAL s. r. o., a limited liability company organized and existing under the laws of the Slovak Republic, with its registered seat at Bratislavská 81/37, 931 01 Šamorín, Slovak Republic, Company ID No. 50 948 431, registered with the Commercial Register maintained by District Court Trnava, section Sro, file No. 46781/T (“Powerful Medical”) and the Customer (as defined below). The Customer accepts the T&C prior to using the Services and agrees to comply at all times with the terms set out in the T&C. The T&C, together with the attached Data Processing Addendum, constitute the full contract between the Customer and Powerful Medical.
2. Terms of the T&C, in particular, without limitation, obligations accepted by the “Customer” within these T&C, except Sections 3 and 4, shall also apply to each User who uses the Application as a member of an Institutional Plan. Such User acknowledges and accepts the terms of these T&C and the obligations imposed on the Customer herein, except Sections 3 and 4.
Definitions
In these T&C, the capitalised terms have the following meanings given to them below:
“Application” means the mobile application named PMcardio which is a Class IIb medical device with declared conformity to Annex VIII of the Medical Device Regulation (MDR), providing ECG signal digitization, processing, analysis and detection of various diagnostic categories consisting of rhythms, heart blocks, infarctions and others, as well as patient management recommendations.“Billing Period” means one month starting on the Effective Date and at the start of each following month of the term of the Institutional Plan, unless defined otherwise by separate agreement between the Customer and Powerful Medical; this is only applicable for the Institutional Plan.“Customer” means either a legal entity that has ordered the Services or a User that has ordered the Services. “Data Processing Addendum” means addendum to the T&C governing the relationship between Powerful Medical and the Customer in relation to processing of personal data.“ECG” means electrocardiogram – the result of a cardiovascular test that measures electrical activity of the heart.
“Effective Date” means the date the Customer has accepted these T&C in accordance with Section 3.3.
“Individual Plan” means a monthly or an annual subscription plan consisting of single-user access to the Services.
“Institution Admin” means the individual whom the Customer with an Institutional Plan appoints to administer its subscription.
“Institutional Plan” means a subscription plan consisting of multiple accesses to the Services for individual users which are managed by the Customer via the PMcardio Web Platform.
“License” has the meaning given in Section 8 of the T&C.
“MDR” means REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC, and includes, insofar as the T&C relates to the United Kingdom, consideration with The Medical Devices Regulations 2002 No. 618 (as amended from time to time).
“PMcardio Web Platform” means the website where the Customer can manage personal accounts for Users of Application or Institution Admins. PMcardio Web Platform itself is not a medical device.“Powerful Medical” means Powerful Medical (as defined above) and includes any and all entities affiliated to Powerful Medical by common control, management or ownership on behalf of which Powerful Medical is acting.
“Privacy Notice” means the notice provided to the Customer and the relevant data subjects informing them about the processing of personal data in relation to the Application and their respective rights and available at www.powerfulmedical.com/legal/pmcardio-privacy.
“Report” means the result of ECG digitization and interpretation consisting of diagnosis and patient management recommendations, which is created through the Application.
“Services” mean the PMcardio Web Platform and the Application provided by Powerful Medical to the Customer.
“Subscription Plan” means either an Individual Plan or an Institutional Plan.“Trial Period” has the meaning given in Section 6.5 of the T&C.
“User” means a healthcare professional who uses the Application.
Scope of the T&C
1. Powerful Medical undertakes to provide the Services as defined in these T&C and in the relevant Subscription Plan and the Customer undertakes to use the Services in compliance with the T&C and pay the agreed price for Services.
2. Each of the following constitute an offer from Powerful Medical:
  1. Individual Plan accessible via Apple App Store or Google Play;
  2. Institutional Plan accessible via website of Powerful Medical;
  3. specific offer from Powerful Medical.
3. The T&C are concluded upon Customer´s acceptance of the offer, by:
  1. placing an order for the Individual Plan via Apple App Store or Google Play; or
  2. placing an order for the Institutional Plan via the website of Powerful Medical;
  3. accepting a specific written offer from Powerful Medical.
Fees, Payments and Subscription Plan
1. The Customer agrees to pay the fee specified for the relevant Subscription Plan.
  1. For Individual Plan, the fees are payable on the date of placing order for a subscription via Apple App Store or Google Play, and then on the first day of automatically-renewed subscription period. The Individual Plan will automatically renew at the end of the subscription period, unless the Customer cancels the Individual Plan before the end of the then-current subscription period.
  2. For Institutional Plan, the fees are payable as specified in the invoice issued by Powerful Medical, in any case no later than 30 days from the date of issue of the invoice.
2. Powerful Medical reserves the right to unilaterally change the fees. Powerful Medical will inform the Customer about such change at least 2 months before the change takes effect. If such changed fees are not acceptable to the Customer, the Customer may choose not to renew the Subscription Plan after the end of the Billing Period.
3. The Customer may cancel or change its Subscription Plan at any time. Such change will take effect the next Billing Period. The Customer’s obligation to pay for Reports already created before cancellation is not affected.
Functionality and Access
1. Using the Application
  1. To use the Application, each User must create an account. The User must provide the following details to successfully create an account: country of practice, phone number, first name, last name, email address, occupation.
  2. The User must be a healthcare professional (health professional), providing healthcare, as defined by Articles 3(a) and 3(f) of the Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare, or the equivalent legislation of the United Kingdom, with basic knowledge of ECG interpretation. In particular, the User must be a healthcare professional authorized to provide healthcare in the country where the User uses the Application and the User must follow all regulatory requirements imposed on healthcare professionals by that country (including continuing medical education). Persons who are not healthcare professionals are not authorized to use the Application.
  3. Users must keep their log-in credentials confidential, not disclose them to third parties and ensure their adequate protection to avoid any access to the Application by an unauthorized party.
  4. The registration is complete after the User logs in to the Application for the first time.
  5. The User is not allowed to log in using registration details of other Users, nor is the User allowed to obtain or collect registration details of other Users.
  6. The User must not use the Application in life supporting or sustaining systems, nor in ECG-monitoring and/or alarm devices.
  7. User can be a member of one or more Institutional Plans.
  8. The User must use the Application in compliance with the applicable Instructions for Use, available online at www.powerfulmedical.com/user-manuals.
2. Managing Access
  1. In Institutional Plans, the Customer can manage access to the Application by Users, access to PMcardio Web Platform by Institution Admins, institution account and payment details of the institution via the PMcardio Web Platform.
  2. Each Customer with an Institutional Plan must have at least one Institution Admin.
  3. For each Institutional Plan, Customer must create an institution account. The following details are required to create an institution account: institution name, address, registration number, payment and billing details.
  4. The individual who created the first account for an institution automatically becomes its first Institution Admin.
  5. An Institution Admin can use the PMcardio Web Platform to manage the institution’s subscription, payment details, Users who are members of the institution, reports created under the institution and add or remove other Institution Admins.
  6. Sections 5.1.3 to 5.1.5 shall apply also to Institution Admins.
3. Reports
  1. Each Report can be edited during 90 days from its creation. After 90 days from its creation, each Report is frozen and cannot be further edited. Users can only download PDF copies of frozen Reports.
Rights and Obligations of Customer
1. The Customer acknowledges and agrees that:
  1. The Customer shall use the Services exclusively in accordance with the T&C, the laws of the Slovak Republic, European Union and the United Kingdom, and, if a Customer´s use of Services is subject to any other laws, in accordance with any such applicable laws and regulations; this Section 6.1.1 is without prejudice to Section 17.1 of the T&C;
  2. the Customer will not disrupt or damage the operation of Services (or attempt to do so), violate rights of third parties, or conduct any activities that may be considered unethical, illegal or contrary to good faith;
  3. the Customer will not make any fully automated decisions on the basis of information provided by Powerful Medical during the use of the Services and must always ensure appropriate human intervention by a User, review and verification before using such information for any purpose;
  4. the Customer is fully and exclusively responsible for using the Services and for any consequences of that use;
  5. the Customer must not (i) make and distribute copies of the Application unless authorized to do so under Institutional Plan; (ii) attempt to copy, reproduce, alter, modify, reverse engineer, disassemble, decompile, transfer, exchange or translate the Application; or (iii) create derivative works of the Application of any kind whatsoever; nor allow any third parties to do anything under (i), (ii) or (iii) above on Customer’s behalf;
2. The Customer acknowledges that Powerful Medical is based in the European Economic Area and the Customer is responsible for the compliance with obligations relating to the transfer of data from the Customer’s country outside of the European Economic Area to the European Economic Area.
3. The Customer agrees to compensate to Powerful Medical any damages arising as a consequence of the violation of the T&C by the Customer.
4. The Customer must ensure that each Institution Admin and each User who is a member of the Customer’s Institutional Plan acts in full compliance with these T&C, in particular with the obligations applicable to the Customer. The Customer must ensure and is responsible that all Users registered under Customer’s Institutional Plan bill all Reports, that are created within the Customer’s institution, to the respective Customer’s Institutional Plan.
5. For the purposes of the initial testing of the Services, Powerful Medical may grant to each Customer the following rights for a limited duration (the “Trial Period”):
  1. For Individual Plan:
    1. The Trial Period starts on the Effective Date;
    2. The Services during the Trial Period are provided to the Customer free of charge; and
    3. The Customer is entitled to a maximum of 5 Reports during the Trial Period.
  2. For Institutional Plan:
    1. The Trial Period starts on the Effective Date and lasts 14 days;
    2. The Services are provided to the Customer on a paid basis during the Trial Period, unless the Customer terminates the T&C within the Trial Period. If the Customer terminates the T&C within the Trial Period, Powerful Medical waives any fees incurred during the Trial Period. If the Customer does not terminate the T&C during the Trial Period, Powerful Medical is entitled to bill to the Customer all Reports created during the Trial Period.
6. Powerful Medical may extend the Trial Period at the Customer’s request.
7. The Customer acknowledges and agrees that once a quota of 200 Reports per User per month has been reached, Powerful Medical may limit the functionality of the Application, and upon such limitation, the Customer may not be able to create additional Reports.
Rights and Obligations of Powerful Medical
1. Powerful Medical is entitled to change the scope of Services. In such case, the Customer is not entitled to demand any compensation for damage or other compensation, unless stated otherwise by Section 14.4 of the T&C. The Customer is entitled to terminate the T&C in line with Section 16.3 of the T&C.
2. The Customer is solely responsible for the use of Services, including where applicable for the use of Services by Institution Admins and Users who are members of the Customer, and Powerful Medical is under no circumstances responsible for such use of Services or its consequences, other than for liability set out in applicable mandatory law relating to defective devices.
3. Powerful Medical does not offer any guarantee relating to Services other than that provided in these T&C nor any confirmation of characteristics required for a medical device under the MDR. Specifically, without the following list being exhaustive, Powerful Medical does not guarantee that (i) the Services are free from any programming or other errors, (ii) the Services meet all expectations of all Customers, (iii) the Services will not be subject to any malfunctions, (iv) the Services will provide accurate or reliable results or (v) the use of Services will be without interruptions.
4. The Customer and the User specifically acknowledge and agree that the functionality of the Application, as a software medical device, may be subject to errors. The User as a healthcare professional is solely responsible for their patient’s treatment. When providing treatment to a patient, the User must not solely rely on the Application, but must act with due care and evaluate the overall clinical condition of their patient, including taking into account factors which may not be incorporated within the Application (such as the patient’s condition on visual examination or the results of other examinations).
5. If Powerful Medical determines that the use of the Services by the Customer or, in the case of an Institutional Plan, by any Users or Institution Admins covered by such Institutional Plan, is in violation of the T&C or applicable legal regulations, Powerful Medical may, at its discretion, cancel the registration of the particular Customer, User or Institution Admin, temporarily or permanently block the access of such Customer, User, Institution Admin access to the Services, or terminate the T&C.
6. The Customer acknowledges that Powerful Medical may review each User´s registration to determine such User´s compliance with conditions set out in Section 5.1.2.
Intellectual Property and License
1. The Application and PMcardio Web Platform are subject to intellectual property rights of Powerful Medical, in particular copyright and trademarks.
2. By concluding the T&C, Powerful Medical grants the Customer and in case of an Institutional Plan each Customer, Institution Admin and Users who are members of the relevant institution a non-exclusive, non-transferable, non-sublicensable, revocable license to use the Application and PMcardio Web Platform in accordance with and for the purposes set forth in these T&C (the “License”). The License is granted for the term of the T&C. The Customer must not modify the Application or PMcardio Platform or their source code in any way nor update the Application or PMcardio Web Platform or their source code in any manner.
Content Provided by the Customer
1. In connection with the use of the Services, the Customer may provide feedback, recommendations, contribute to improvements of the Services or participate in various surveys, by which the Customer provides to Powerful Medical information or materials (including documents in writing, photographs, video or audio recording, software, statistical data, databases) that may be protected by intellectual property rights (the “Customer Content”).
2. The Customer agrees that Powerful Medical is entitled to unhindered use, including commercial use, of Customer Content to the fullest extent possible. To achieve such unhindered use, the Customer hereby agrees to the following:
  1. If the Customer provided the Customer Content upon request by Powerful Medical, such Customer Content shall be deemed as “work for hire” (in Slovak: dielo na objednávku) in accordance with Section 91 of Act no. 185/2015 Coll., the Copyright Act and Powerful Medical shall be the holder of the economic rights relating to such Customer Content.
  2. If the Customer provided the Customer Content otherwise or if, for any reason, the rights granted to Powerful Medical do not allow the full and unhindered use of Customer Content, the Customer grants to Powerful Medical, upon disclosure of Customer Content an exclusive, sublicensable, perpetual, irrevocable, royalty-free, worldwide license for the full unhindered use of Customer Content as outlined in Section 9.2 above. For the avoidance of any doubts, such use shall include, but not be limited to, reproduction, adaptation, translation, modification, transformation, and development of derivative works of, public display, public performance, sublicensing, making available and distribution of Customer Content and any derivative works.
Availability
1. The Application is available for use by compatible mobile phones or handheld mobile devices running operating systems specified in the Application. The Customer acknowledges that the Application is provided via the internet and mobile networks, and thus the quality and availability of the Application may be affected by factors outside of reasonable control of Powerful Medical.
2. The Customer acknowledges that the Application can only be used in countries where the Application meets regulatory requirements for being placed on the market as a medical device. Powerful Medical undertakes to use reasonable efforts to inform the Customer that the Application is used outside of such country.
3. Powerful Medical may discontinue the performance of Services in certain countries due to regulatory limitations without Customer’s consent.
4. Powerful Medical may pause access to the Services for a limited period of time to make necessary updates, maintenance and changes to the Services without Customer’s consent. Powerful Medical undertakes to make the Application available to the extent required by the MDR to ensure that its performance, safety and reliability is in line with its intended use.
5. Powerful Medical does not accept any responsibility for unavailability of Services, nor for any other communications system failure that may result in the Services being unavailable.
System Requirements
1. To use the Application, the Customer must have a compatible mobile phone or handheld mobile device defined in the applicable Instructions for Use.
2. The version of the Application software may be upgraded from time to time to add support for new functionality and services, to improve user experience, or to remove bugs or certain features.
3. To use the PMcardio Web Platform, the Customer must have a device with internet access and a compatible web browser.
Data Protection
1. The parties acknowledge and agree that the Services provided by Powerful Medical may involve the processing of personal data of individuals on behalf of the Customer and that, with respect to such personal data, Powerful Medical will be acting as a processor and the Customer will be acting as controller of such personal data. Such processing is subject to the Data Processing Addendum, which forms part of these T&C. The Privacy Notice provides a full description of the processing by Powerful Medical within the Services.
2. Customer´s Obligations as a Controller of Personal Data
  1. The Customer commits to fully comply with applicable data protection laws and regulations, in particular by providing appropriate notice and by having an appropriate legal basis for the full processing of personal data as outlined in these T&C and performing any assessments as may be required by applicable data protection laws.
  2. The Customer acknowledges that it is solely accountable and responsible for its own processing, systems, IT infrastructure, mobile of other devices used (for example, the mobile device to which the Customer installs the Application). The Customer must ensure compliance with applicable laws and maintain appropriate technical and organizational measures.
  3. The Customer must ensure that (i) only such individuals use the Services and have access to personal data within the Services who have a need to know, (ii) individuals using the Services are subject to a binding confidentiality obligation, and that (iii) any individual using the Services uses the application only in accordance with the instruction of the Customer as the controller and only in compliance with the T&C. The Customer shall ensure that appropriate access controls and appropriate technical and organizational measures are in place to ensure the foregoing requirements.
3. The parties acknowledge and agree that the Services provided by Powerful Medical may involve (i) the processing of personal data of the Customer or its representatives or (ii) in de-identified or pseudonymized form of the individuals whose data the Customer collects, or (iii) processing for purposes linked to regulatory requirements (e.g., vigilance) or legal claims. Powerful Medical will be acting as a controller in relation to such processing.
4. Further information relating to data protection and the cases in which Powerful Medical acts as a controller can be found in the Privacy Notice.
Confidentiality
1. The following information is considered as confidential (the “Confidential Information”):
  1. all trade secrets, know-how, procedures, ideas, proposals, proprietary technologies and techniques and all related information made available or disclosed, whether orally, in writing, in the form of an electronic document, visual or audio recording or by any other means;
  2. information of a technical, economic and commercial character, information about prices and their calculation, information about products and/or related documentation and manuals, including their content, any information about research and development, including research and development plans, business and development plans, business and product marketing plans, past and present economic results, forecasts and estimates of economic results, budgets and other economic data, details of the internal structure of Powerful Medical and its employees, as well as any future strategies of Powerful Medical made available or disclosed, whether orally, in writing, in the form of an electronic document, visual or audio recording or by any other means;
  3. the existence and content of any discussions relating to the subject matter of the T&C, unless agreed otherwise;
  4. any information designated by Powerful Medical as confidential; and
  5. any notes, records or copies relating to information referred to in 13.1.1 to 13.1.4 above made by one of the parties or one of their personnel.
2. Powerful Medical may provide the Customer the access to the Confidential Information. The Confidential Information made available shall be used only in accordance with the purpose for which it was provided, but not for any other purpose.
3. Confidential Information that are being disclosed must be kept confidential by the Customer and must not be disclosed to any third parties and persons, unless agreed otherwise by Powerful Medical and the Customer or as provided in these T&C.
4. The Customer undertakes to ensure the confidentiality and protection of Confidential Information against access by unauthorized persons, and to notify Powerful Medical without undue delay of a suspicion of breach of this Section 13. The Customer further undertakes to return all Confidential Information provided, at any time upon Powerful Medical’s request. If the Confidential Information are on material documents, the Customer obliged to return them physically. In the event that the Confidential Information is stored in electronic form, the Customer is obliged to securely delete all Confidential Information stored in electronic form and destroy any media to the extent it contains such Confidential Information. The Customer is obliged to provide Powerful Medical with a written certification of deletion and destruction.
5. All Confidential Information belonging to each party will remain the sole property of and available to that party and the recipient does not acquire any rights related to the Confidential Information upon their provision, unless otherwise provided in the T&C.
Term of the T&C and Termination
1. The T&C are concluded on the Effective Date for an indefinite period of time, unless otherwise terminated. The T&C are valid and the Customer remains to be bound by the T&C as long as the Customer uses and/or has access to the Services.
2. For Institutional Plan – the Customer may terminate the T&C by written notice addressed to support@powerfulmedical.com at any time with effect from the next Billing Period. If the Customer terminates the T&C during the Trial Period in line with Section 6.5.2(ii) of the T&C, the T&C are terminated with immediate effect.
3. For Individual Plan – the Customer may terminate the T&C and thus cancel the Individual Plan at any time. The termination will take effect:
  1. at the end of the then-current monthly subscription plan;
  2. one month after the date of termination of the T&C in relation to the annual subscription plan. Customer is not entitled for a refund of any unused part of the subscription period.
4. The Customer acknowledges that the Customer loses access to the Services upon effectiveness of the termination of the T&C.
5. Powerful Medical is entitled to terminate the T&C at any time without giving any reason by a written notice with effect from the next Billing Period.
6. If Powerful Medical terminates the T&C or stops providing Services to the Customer for whatever reason, the Customer is entitled to a refund for purchased Services.
Limitation of Liability
1. Maximum aggregate liability of Powerful Medical under the T&C whether in contract, tort (including negligence) or otherwise, shall in no circumstances exceed the amount of actual fees paid by the Customer to Powerful Medical for the Services during the course of one year prior to the event causing the damage, in any case not more than EUR 500,000. The parties agree that the limited liability for damages arising out of any breach of the T&C is appropriate to the circumstances of the subject matter of the T&C and business relations. The limitation of the extent of compensation for damage represents a foreseeable and reasonable rate of compensation for damage, which, on the date of concluding the T&C the parties anticipated as the possible consequence of the breach of obligations arising out of the T&C, and which could be anticipated in connection with the given facts and objectives of the T&C. Nothing in the T&C shall limit or exclude liability of Powerful Medical caused by gross negligence or any liability which cannot be excluded by law including death or personal injury arising from the negligence of Powerful Medical.
2. Powerful Medical is not liable to the Customer for any damage or alteration to their equipment, including but not limited to handheld devices or mobile telephones as a result of the installation or use of the Application or by any use of the Services of the Customer in violation of these T&C.
Modification of the T&C
1. Powerful Medical reserves the right to amend and supplement any part of the T&C at any time. This provision is without prejudice to the rights and obligations that have already arisen during the effective period of the previous version of the T&C.
2. In the event of any modification or update of the T&C, Powerful Medical will notify the Customer by email reasonably in advance before any such modification becomes effective to the email address indicated in the Customer’s account.
3. In the event of any modification of these T&C, except for any modification merely reflecting changes in applicable legislation, the Customer has the right to reject the planned changes to the T&C and to terminate the T&C without giving any reason in accordance with Section 14 of these T&C. The termination pursuant to the preceding sentence shall take effect at the end of the current Billing Period.
Applicable Law and Jurisdiction
1. The T&C and any dispute or claim arising thereof or in connection therewith shall be governed by and construed in accordance with Slovak laws and the parties jointly agree that Slovak Act no. 513/1991 Coll., the Commercial Code, shall govern the T&C.
2. Should any dispute arise in connection with the T&C, Data Processing Addendum or with the provision of Services described herein, the parties will attempt to settle any such dispute amicably without pursuing legal action.
3. All disputes or claims arising out of or in connection with the T&C, including disputes relating to its validity, breach, termination or nullity, shall be finally settled under the Rules of Arbitration (Vienna Rules) of the Vienna International Arbitral Centre (VIAC) of the Austrian Federal Economic Chamber by one or three arbitrators appointed in accordance with the said Rules. The place of arbitration shall be Vienna, Austria and language of the proceedings shall be English. This clause shall be governed by and construed exclusively in accordance with the laws of the Slovak Republic.
4. Notwithstanding the above, Powerful Medical is also entitled to bring before the courts of Slovak Republic any monetary claims against the Customer arising from payment obligations under the T&C, provided that a single monetary claim does not exceed EUR 30,000 (excluding interests, default fees, costs incurred in pursuing the claim).
Notifications and Communication
1. The Customer consents to any communication sent by Powerful Medical or any notifications anticipated under the T&C being sent to the Customer via email to the email address provided in the Customer’s account.
2. Any notifications, comments, feedback or any questions must be sent to Powerful Medical in accordance with the T&C using the following email address: support@powerfulmedical.com.
Final Provisions
1. The Customer declares that they consider the rights and obligations set out in the T&C to be fair, comprehensible and fully agrees with them.
2. The T&C and, if applicable, the specific offer from Powerful Medical, constitute the entire agreement between the parties and supersedes all previous agreements, promises, assurances, warranties, representations and understandings between them, whether written or oral, relating to the subject matter.
3. The Customer is not entitled to assign or transfer any rights or claims under the T&C or arising in connection with the T&C to any third party, in whole or in part, without prior consent of Powerful Medical, other than explicitly permitted by these T&C.
4. Data Processing Addendum are an inseparable and integral part of the T&C concluded between the Customer and Powerful Medical.
5. If any provision of the T&C or Data Processing Addendum, or any part of such provision, is or becomes invalid, illegal or unenforceable, it shall be deemed amended to the least extent necessary to make it valid, legal and enforceable. If such amendment is not possible, the relevant provision or part shall be deemed deleted without affecting the remainder of the T&C.

DATA PROCESSING ADDENDUM

(the “Addendum”)

Introduction
1. This Addendum describes privacy practices of Powerful Medical regarding the Processing of Personal Data on behalf of the Customer, to the extent applicable, as part of the provision of Services to the Customer. Where Powerful Medical provides Services to the Customer, Powerful Medical acts as a Processor and the Customer acts as a Controller. This Addendum applies globally to any and all Services provided by Powerful Medical to the Customer, unless otherwise agreed by the parties.
2. For the avoidance of doubt, this Addendum does not apply to such Processing where Powerful Medical acts as a Controller. Powerful Medical refers to its separate Privacy Notice for more information about what specific activities are conducted by Powerful Medical as Controllers.
3. Powerful Medical reserves the right to update this Addendum in accordance with Section 16 of the T&C.
Definitions
Any capitalized terms not defined herein shall have the meaning given to them in the T&C. Solely for the purposes of this Addendum, the capitalized terms below have the following meanings:
“Act” means the Act no. 18/2018 Coll. on Personal Data Protection.
“Controller” means the natural or legal person, public authority, agency or other body which, alone or jointly with others, determines the purposes and means of the Processing of Personal Data.
“Data Protection Legislation” means the Act and the Regulation.
“Personal Data” mean any information about an identified or identifiable natural person or which may directly or indirectly identify a natural person processed by Powerful Medical as Processor in accordance with Section 3.1 of this Addendum.
“Processing” means any operation or set of operations which is performed upon Personal Data or on sets of Personal Data, whether or not by automated means, such as collection, recording, organization, structuring, storage, adaption or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, restriction, erasure or destruction.
“Processor” means the party, which Processes Personal Data on behalf of the Controller.
“Regulation” means Regulation (EU) 2016/679 of the European Parliament and of the Council on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC.
Processing of Personal Data
1. Powerful Medical will process (i) data provided by the Customer, in particular ECG image, sex, age, patient’s national identification number (optional), and further data required to determine patient management recommendations about those individuals that the Customer determines (e.g. volunteers, patients), and (ii) identification, contact details, workplace, occupation, profile picture about the Customer or its representatives who use the Application in relation to the operation and administration of the Application (ECG digitization, ECG interpretation, patient management recommendation). The data processed may include information about the ECG device used, such as the paper speed settings, voltage gain settings, and similar.
2. Powerful Medical will not provide Personal Data to any third party other than (i) as necessary to perform activities and Services outlined in the T&C; (ii) in accordance with the documented instructions of the Customer; (iii) within entities affiliated to Powerful Medical by common control, management or ownership; (iv) as part of a merger, acquisition or other investment by a third party into Powerful Medical, or (v) as required to comply with Data Protection Legislation or other laws to which Powerful Medical is subject, in which case Powerful Medical shall (to the extent permitted by law) inform the Customer of that legal requirement before Processing the Personal Data.
3. In addition, Powerful Medical is allowed to use (i) aggregated data, to the extent they can no longer be considered personal data, or (ii) de-identified data (i.e., data which does not allow an identification of the patient) for scientific research purposes, for internal operations, including troubleshooting, data analysis, testing, research, for statistical purposes and for improving the quality of Services, or (iii) personal data in accordance with the Privacy Notice and Section 12 of the T&C.
4. In the event this Addendum, or any actions to be taken or contemplated to be taken in performance of this Addendum, do not or would not satisfy either party’s obligations under future Data Protection Legislation, rules, regulations, orders or guidance adopted, enacted, implemented, promulgated, issued, entered or deemed applicable by or under the authority of any governmental body having jurisdiction over matters covered by this Addendum, Powerful Medical and Customer must cooperate with each other in good faith and must execute an appropriate amendment to this Addendum or the T&C or, if applicable, conclude another type of agreement, including a data processing agreement or a join-controllership agreement, to give effect to either party’s obligations under such future Data Protection Legislation, rules, regulations, orders or guidance.
Obligations of Powerful Medical
1. Powerful Medical undertakes to:
  1. process the Personal Data only on documented instructions from the Customer, including with regard to transfers of personal data to a third country or an international organization, unless required to do so by European Union or Member State law to which Powerful Medical is subject; in such a case, Powerful Medical will inform the Customer of that legal requirement before processing, unless that law prohibits such information on important grounds of public interest. The documented instructions are contained in this Addendum and the T&C;
  2. take all commercially reasonable technical and organizational measures to protect the Personal Data in conformity with the provisions of Article 32 of the Regulation;
  3. assist the Customer, as the Controller, to perform their obligations resulting from Article 32-36 of the Regulation taking into account the nature of processing and the information available to the processor;
  4. taking into account the nature of the Processing, assists the Controller by appropriate technical and organizational measures, insofar as this is possible, for the fulfilment of the Controller’s obligation to respond to requests exercising the data subject’s rights laid down in Chapter III of the Regulation, subject to Section 5 of this Addendum;
  5. ensure that the persons authorized to process the Personal Data have committed themselves to confidentiality or are under an appropriate statutory obligation of confidentiality;
  6. inform the Customer about a Personal Data breach without undue delay after Powerful Medical becomes aware of it, specifying (1) the nature of the Personal Data breach, (2) the likely consequences and (3) the measures taken to address the Personal Data breach; such information may be provided gradually if not readily available. Powerful Medical shall provide full cooperation to the Customer and act as instructed by the Customer to assist in the investigation and remediation of such Personal Data breach;
  7. at the choice of the Customer, delete or return all Personal Data without undue delay after the termination of the T&C, delete existing copies of Personal Data, unless otherwise provided by law or agreed by the parties in the T&C and this Addendum;
  8. make available to the Customer upon reasonable request all information necessary to demonstrate compliance with the obligations laid down in Article 28 of the Regulation and allow for, and upon reasonable prior notice not shorter than 2 weeks contribute to, audits, including inspections if provision of documents is insufficient to demonstrate compliance, conducted during regular business hours, not more often than once per year by an independent third party expert auditor mandated by the Customer at the expense of the Customer.
Data Subject Requests
1. The Customer, acting as a controller, is solely responsible for handling all data subject requests addressed to the Customer. Powerful Medical will support Customer in handling data subject requests as described below.
2. Deletion Requests
  1. If the Customer receives a deletion request (Art. 17 of the GDPR) from a data subject or if the data subject otherwise requests deletion (including deletion in accordance with Section 4.1(vii) of this Addendum), the Customer must inform Powerful Medical about the request without undue delay and Powerful Medical will revoke any access to the Personal Data and Powerful Medical will only process such data for storage purposes for 180 days after receiving the deletion request by the Customer. Upon lapse of the 180 days, Powerful Medical will definitely and irreversibly delete the requested Personal Data, unless necessary to comply with a legal request from public authorities (including healthcare authorities), compliance with legal obligations, or for the establishment, exercise or defence of legal claims.
3. Access Requests
  1. If the Customer receives an access request (Article 15 of the Regulation) from a data subject, the Customer must verify the identity of the data subject and, subsequently, the Customer must instruct us to provide a copy of Personal Data and Powerful Medical will undertake the following:
    1. either provide the relevant Personal Data directly to the data subject using the contact details which the Customer provides to Powerful Medical, or
    2. provide the relevant Personal Data to the requesting User, who will comply with their obligation as an independent controller and respond to the data subject.
Subprocessors and Recipients
1. Powerful Medical may appoint certain third parties to provide parts of the Services or assist with providing technical or professional support. By accepting the T&C, the User authorizes Powerful Medical to subcontract the Processing of Personal Data to subprocessors, in particular to procure services, such as regulatory compliance, authentication, customer support. Subprocessors are, in each case subject, to binding obligations between Powerful Medical and the subprocessor, which contain substantially similar provisions as those set out in this Addendum. Powerful Medical will inform the Customer of the details of such subprocessor(s) upon a written request from the Customer.
2. Powerful Medical may share Personal Data with third parties, in particular (i) as necessary to perform activities outlined in the T&C; (ii) as required to comply with applicable regulatory requirements, in particular regarding medical devices, healthcare and Regulation, (iii) within entities affiliated to Powerful Medical by common control, management or ownership; (iv) as part of a merger, acquisition or other investment by a third party into Powerful Medical; or (v) as required to comply with the Regulation or other laws to which Powerful Medical is subject, in which case Powerful Medical will (to the extent permitted by law) inform the Customer of that legal requirement before Processing the Personal Data.
International Data Transfers
1. Powerful Medical stores and processes Personal Data within the European Economic Area (the “EEA”) or within countries recognized by the European Commission as providing adequate level of protection of personal data. Powerful Medical may, however, transfer Personal Data to countries outside the EEA in the following circumstances:
  1. if the User resides, is based in or operates the Services from a country outside of the EEA, the Personal Data from such use will be transferred to the EEA and back to the User; the respective Customer and Powerful Medical hereby specifically agree to be bound by the Standard Contractual Clauses annexed to these T&C as Annex 1 (the “SCCs”);
  2. with Affiliates of Powerful Medical located outside of the EEA, if relevant for the provision of Services;
  3. in the limited circumstances where Powerful Medical uses subprocessors located outside the EEA; and
  4. if Powerful Medical shares Personal Data with other recipients strictly as necessary and in accordance with these T&C or the Privacy Notice.
2. Any transfer of Personal Data outside of the EEA is undertaken in compliance with the Regulation, in particular Chapter V of the Regulation and subject to the conclusion of SCCs.
Liability
1. The Customer commits to Process all Personal Data, in particular to provide the Personal Data to Powerful Medical, in accordance with Data Protection Legislation, including, without limitation:
  1. ensuring that all notifications to and approvals from regulators, which are required by Data Protection Legislation, are made and maintained by the User; and
  2. ensuring that all Personal Data is processed fairly and lawfully (in particular, the User has a valid legal basis for any Processing necessary in accordance with the T&C and this Addendum), in a transparent manner (in particular, the User has provided appropriate privacy notices to data subjects), is accurate and up to date.
2. The Customer shall indemnify and hold Powerful Medical harmless from and against any losses, fines, damage, fees or any additional expenses (including reasonable attorney fees and other reasonable costs of litigation), due from or incurred in relation to a breach of this Addendum or non-compliance with Data Protection Legislation by the User. In accordance with Article 82(2) of the Regulation, Powerful Medical, as a Processor, shall be liable for the damage caused by Processing only where it has not complied with obligations of the Regulation specifically directed to processors or where Powerful Medical has acted outside or contrary to lawful instructions of the Controller.
Final Provisions
1. Powerful Medical may charge reasonable fees for any activities or assistance undertaken upon request by the User which go beyond the scope of Services.
2. This Addendum has been concluded for the term of the T&C (as defined in the T&C) and shall be governed and subject to the same laws and jurisdiction as the T&C.

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