Data Processing Agreement
Capitalized terms not defined herein shall have the meaning ascribed to them in the Agreement.
The execution of the Agreement involves the transfer of personal data – within the meaning of article 4 of the regulation (EU) 679/2016 of the European Parliament and of the Council of 27 April 2016 (hereinafter referred to as: “GDPR”) – from the Controller to the Processor, including personal data of third-parties such as the Controller’s patients (such personal data: the “Data”) ; and
The Controller agrees to transfer, and the Processor agrees to receive from the Controller, the Data subject to the terms and conditions set forth in this DPA; and
The Controller acknowledges and agrees that in the context of its relationship with the Processor with respect to the transfer of Data, the Controller is designated as a controller and the Processor is designated as a processor – both within the meaning of these terms in the GDPR;
The Parties have agreed as follows:
1. Processing of Data
1.1. The Controller has determined, in the Agreement or in the form attached hereto as Exhibit A:
What types of Data will be transferred to the Processor;
The categories of data subjects;
The purposes for which such Data is transferred to the Processor;
The processing activities to be performed by the Processor in connection with the Data.
1.2. The parties acknowledge that the forgoing types of Data, purposes and processing activities may be determined solely by the Controller and at its sole discretion and may be amended at any time.
1.3. The Controller acknowledges and undertakes to transfer Data to the Processor only to the extent required for the execution of the Agreement, or for the fulfillment of the purposes set out in Exhibit A attached hereto.
1.4. The Controller represents and warrants that any data that is transferred to the Processor was lawfully collected and a proper consent, if applicable, was obtained from any relevant data subject;
1.5. The Controller acknowledges and undertakes that any instruction it may give to the Processor in connection with the Data, including within Exhibit A, will comply with any and all applicable laws including, without limitation, the GDPR.
1.6. The Processor will process the Data in accordance with this DPA and only as necessary for the execution of the Agreement, the fulfillment of the purposes stipulated in Exhibit A or in accordance with other written instructions of the Controller.
2. Location of Processing
2.1. The Data is collected by a user through the MobileODT app and synced and stored by the Processor on servers located in the United States alone.
2.2. Subject to the Standard Contractual Clauses attached hereto as Exhibit B, The Controller authorizes Processor to process the Data outside the European Union and in the United States.
2.3. For the avoidance of doubt, if the Data is collected by a user and synced to the portal within the United States, then such collected Data is stored by the Processor on servers located in the United States alone.
Processor undertakes to ensure that all of those who process the Data on its behalf will be subject to confidentiality by contract or by other lawful means, except for third parties who receive Data from the Processor in accordance with specific instruction from the Controller, or if there is a statutory obligation to provide the Data to a third party.
The Controller authorizes the Processor to engage with third parties for the purpose of processing the Data pursuant to this DPA, provided however:
4.1. That such third party will commit itself to the same level of data protection as the Processor’s data protection obligations according to this DPA; and
4.2. That the Processor shall remain liable toward the Controller with regard to the processing activities performed by the third-party in connection with the Data.
4.3. The Processor will detail in a designated web page (may be found at https://www.mobileodt.com/legal-center/subprocessors) a list of third parties which perform processing activities on behalf of the Processor in connection with the Data. In the event that the Processor decides to amend the list, a notice of such a change will be posted in the Processor website at: https://www.mobileodt.com/legal-center/subprocessors. The Controller agrees that it is the Controller responsibility to review this list for changes and to inform the Processor within 14 days of any objection to the changes. In the event that the Controller objects, for reasonable cause, to the processing of Data by a certain third-party, the parties will mutually seek to resolve the differences. Should the parties fail to resolve the differences, the Processor will be entitled to terminate the Agreement without bearing any liability.
5.1. Processor will take adequate technical and organizational measures to meet the industry standard level of data protection to prevent any loss, damage, impairment wrongdoing or unauthorized access to the Data.
5.2. The Controller acknowledges that it may not expect and the Processor cannot promise or guarantee that the Data will be immune from any wrongdoings, malfunctions, unlawful interceptions or access, or other kinds of abuse and misuse.
6. Duty of Report
6.1. The Processor will notify the Controller of any security incident or breach or any other event that may compromise the Data, immediately when it comes to its attention, unless any lawful orders preclude the Processor from doing so.
6.2. Any notification of a security incident shall include the following:
- The nature of the incident;
- What Data has been compromised and if possible- of how many data subject;
- The measures that have been taken to contain the incident and to mitigate the exposure of the Data.
6.3. The Controller is solely responsible for fulfilling any legal duties to report to the relevant authorities or data subjects. The Processor will cooperate with the authorities and provide all relevant information.
7. Data Subjects Requests
7.1. Processor will assist the Controller, by reasonable means and in a timely manner, to respond to any request from data subjects seeking to exercise their rights with respect to the Data (e.g. rectification, restriction, deletion or portability of Data).
7.2. Should such request be made directly to the Processor, the Processor will promptly deliver it to the Controller and the Controller will instruct the Processor how to proceed.
7.3. The Controller is solely responsible for responding to any data subjects’ requests and undertakes to reimburse Processor for the costs arising from Processor’s assistance to the Controller.
8. Control and Audit
8.1. In the event that the Controller has a concrete reason to believe that Data has been compromised, it may provide the Processor with a reasonable written request to make available to Controller such information in Processor’s possession or control related to Processor’s compliance with its obligations as Processor under this DPA in relation to its processing of Data. Such a request must state in detail the reasons for which the Controller wishes to conduct such inspection and shall specify what the Controller wishes to inspect.
8.2. In the event that the Processor fails to demonstrate its compliance with its obligations under this DPA,Controller may, upon written request and at least 30 days’ notice to Processor, during regular business hours and without interrupting Processor’s business operations, conduct an inspection of Processor’s business operations by a qualified third party auditor subject to Processor’s approval, which shall not be unreasonably withheld.
8.3. Processor will cooperate with the audit, and pursuant to the Controller’s written request shall provide the Controller with all necessary information, to the extent that such information is within the Processor’s possession and the Processor is not precluded from disclosing it by applicable law, a duty of confidentiality, or any other obligation owed to a third party.
8.4. The findings from the audit performed will be assessed by the parties in mutual consultation and consequently implemented or not by one of the parties or by both parties jointly.
8.5. The Controller shall bear all costs and expenses incurred in connection with any such audit.
9. Term and Termination
9.1. This DPA shall enter into force at the commencement of the Agreement and shall remain in force and may not be terminated as long as the engagement between the parties lasts, unless replaced by another written DPA. Termination of the Agreement will also terminate this DPA.
9.2. Should the Agreement be amended in a manner which affects the processing of the Data, this DPA may be respectively amended or updated to reflect such an amendment.
9.3. In the event that the Agreement will be terminated, for any reason whatsoever, Processor will keep the Data available for the Controller for up to fourteen (14) days after the termination so that the Controller may instruct the Processor whether to delete the Data or to deliver it back to the Controller. Should the Controller fail to instruct the Processor with respect to the treatment of the Data, the Processor may delete the Data, or otherwise prevent access to the Data, and shall bear no liability for any loss in connection therewith.
9.4. Any cost arising in connection with the return or deletion of the Data after the termination or expiration of the Agreement shall be borne solely by the Controller.
9.5. Notwithstanding the above, in the event of termination, or if the Controller requests the deletion of the Data, Processor may retain any Data that is required in order to comply with any applicable law or regulatory order, provided that the Processor informs the Controller of the retention of such Data.
10.1. The Controller guarantees that the Data was collected lawfully, and that all obligations arising from the GDPR which apply to the Controller in connection with the processing of the Data, have been fulfilled.
10.2. The Controller undertakes to hold the Processor harmless against any and all claims related to the Controller’s failure to comply or properly comply with the GDPR, and further undertakes to reimburse the Processor for any costs or payments that the Processor may suffer due to such a failure.
10.3. This DPA shall be governed by the laws and jurisdictions as agreed in the Agreement.
10.4. Should any applicable privacy laws or regulations be amended, the parties will cooperate in order to adjust this DPA accordingly.
10.5. Logs and measurements recorded by Processor shall be considered compelling evidence, unless the contrary is proven by the Controller.
1. Types of Data to be transferred to the Processor:
User information the Controller provides us about its controllers (including but not limited to)
- Scheduling information.
- Clinicians/organization information and data (email, phone number, etc.).
- Clinicians/organization internal records.
Patient Data collected by the Controller (including but not limited to):
- Patient’s details including without limitation name, ID, region, address, phone number, and other demographic details requested by the clinicians.
- Patient’s medical records including without limitation medical history, medical sessions, cervix, vaginal and external genitalia examination images and videos, lab reports, special tests, biopsy results, diagnosis, consultations and case notes.
- Exam documentation, image annotation, and collection of specimen documentation.
2. The categories of data subjects
- Controller’s patients
3. The purposes for which such Data is transferred to the Processor:
- Render the Services, including interaction with third-party platforms.
- Store and provide access to the Data.
- Allow the flow of Data between the clinicians and the organizations or third-parties.
4. The processing activities to be performed by the Processor in connection with the Data:
- Any activity that is required for the fulfillment of the above-mentioned purposes or the Services.
- The Processor may use all types of Data in an anonymized form for any commercial or research purposes, statistical analysis, improvement of the Services and to comply with regulatory requirements, including without limitation, HIPAA requirements and HITECH guidelines. The Processor may retain such information for the longest period allowed by applicable law.
For the avoidance of doubt, the Processor will not access Patient Data and associated images collected by Controllers who are defined in a Sexual Assault Nurse Examination (SANE) scenario or their equivalent, unless technical support is requested. The Processor will only access data on a case by case basis only when explicit, written permission is given.
Exhibit B- Standard Contractual Clauses
For the purposes of Article 26(2) of Directive 95/46/EC for the transfer of personal data to processors established in third countries which do not ensure an adequate level of data protection
The Controller, as defined in the DPA
(The data exporter)
(as defined in the Agreement)
(The data importer)
Each a ‘party’; together ‘the parties’,
HAVE AGREED on the following Contractual Clauses (the Clauses) in order to adduce adequate safeguards with respect to the protection of privacy and fundamental rights and freedoms of individuals for the transfer by the data exporter to the data importer of the personal data specified in Appendix 1.
For the purposes of the Clauses:
(a) ‘personal data’, ‘special categories of data’, ‘process/processing’, ‘controller’, ‘processor’, ‘data subject’ and ‘supervisory authority’ shall have the same meaning as in Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data;
(b)‘the data exporter’ means the controller who transfers the personal data;
(c)‘the data importer’ means the processor who agrees to receive from the data exporter personal data intended for processing on his behalf after the transfer in accordance with his instructions and the terms of the Clauses and who is not subject to a third country’s system ensuring adequate protection within the meaning of Article 25(1) of Directive 95/46/EC;
(d)‘the sub-processor’ means any processor engaged by the data importer or by any other sub-processor of the data importer who agrees to receive from the data importer or from any other sub-processor of the data importer personal data exclusively intended for processing activities to be carried out on behalf of the data exporter after the transfer in accordance with his instructions, the terms of the Clauses and the terms of the written subcontract;
(e)‘the applicable data protection law’ means the legislation protecting the fundamental rights and freedoms of individuals and, in particular, their right to privacy with respect to the processing of personal data applicable to a data controller in the Member State in which the data exporter is established;
(f)‘technical and organizational security measures’ means those measures aimed at protecting personal data against accidental or unlawful destruction or accidental loss, alteration, unauthorized disclosure or access, in particular where the processing involves the transmission of data over a network, and against all other unlawful forms of processing.
Details of the transfer
The details of the transfer and in particular the special categories of personal data where applicable are specified in Appendix 1 which forms an integral part of the Clauses.
Third-party beneficiary clause
1. The data subject can enforce against the data exporter this Clause, Clause 4(b) to (i), Clause 5(a) to (e), and (g) to (j), Clause 6(1) and (2), Clause 7, Clause 8(2), and Clauses 9 to 12 as third-party beneficiary.
2.The data subject can enforce against the data importer this Clause, Clause 5(a) to (e) and (g), Clause 6, Clause 7, Clause 8(2), and Clauses 9 to 12, in cases where the data exporter has factually disappeared or has ceased to exist in law unless any successor entity has assumed the entire legal obligations of the data exporter by contract or by operation of law, as a result of which it takes on the rights and obligations of the data exporter, in which case the data subject can enforce them against such entity.
3.The data subject can enforce against the sub-processor this Clause, Clause 5(a) to (e) and (g), Clause 6, Clause 7, Clause 8(2), and Clauses 9 to 12, in cases where both the data exporter and the data importer have factually disappeared or ceased to exist in law or have become insolvent, unless any successor entity has assumed the entire legal obligations of the data exporter by contract or by operation of law as a result of which it takes on the rights and obligations of the data exporter, in which case the data subject can enforce them against such entity. Such third-party liability of the sub-processor shall be limited to its own processing operations under the Clauses.
4.The parties do not object to a data subject being represented by an association or other body if the data subject so expressly wishes and if permitted by national law.
Obligations of the data exporter
The data exporter agrees and warrants:
(a)that the processing, including the transfer itself, of the personal data has been and will continue to be carried out in accordance with the relevant provisions of the applicable data protection law (and, where applicable, has been notified to the relevant authorities of the Member State where the data exporter is established) and does not violate the relevant provisions of that State;
(b) that it has instructed and throughout the duration of the personal data-processing services will instruct the data importer to process the personal data transferred only on the data exporter’s behalf and in accordance with the applicable data protection law and the Clauses;
(c) that the data importer will provide sufficient guarantees in respect of the technical and organizational security measures specified in Appendix 2 to this contract;
(d) that after assessment of the requirements of the applicable data protection law, the security measures are appropriate to protect personal data against accidental or unlawful destruction or accidental loss, alteration, unauthorized disclosure or access, in particular where the processing involves the transmission of data over a network, and against all other unlawful forms of processing, and that these measures ensure a level of security appropriate to the risks presented by the processing and the nature of the data to be protected having regard to the state of the art and the cost of their implementation;
(e) that it will ensure compliance with the security measures;
(f) that, if the transfer involves special categories of data, the data subject has been informed or will be informed before, or as soon as possible after, the transfer that its data could be transmitted to a third country not providing adequate protection within the meaning of Directive 95/46/EC;
(g) to forward any notification received from the data importer or any sub-processor pursuant to Clause 5(b) and Clause 8(3) to the data protection supervisory authority if the data exporter decides to continue the transfer or to lift the suspension;
(h) to make available to the data subjects upon request a copy of the Clauses, with the exception of Appendix 2, and a summary description of the security measures, as well as a copy of any contract for sub-processing services which has to be made in accordance with the Clauses, unless the Clauses or the contract contain commercial information, in which case it may remove such commercial information;
(i) that, in the event of sub-processing, the processing activity is carried out in accordance with Clause 11 by a sub-processor providing at least the same level of protection for the personal data and the rights of data subject as the data importer under the Clauses; and
(j) that it will ensure compliance with Clause 4(a) to (i).
Obligations of the data importer
The data importer agrees and warrants:
(a) to process the personal data only on behalf of the data exporter and in compliance with its instructions and the Clauses; if it cannot provide such compliance for whatever reasons, it agrees to inform promptly the data exporter of its inability to comply, in which case the data exporter is entitled to suspend the transfer of data and/or terminate the contract;
(b) that it has no reason to believe that the legislation applicable to it prevents it from fulfilling the instructions received from the data exporter and its obligations under the contract and that in the event of a change in this legislation which is likely to have a substantial adverse effect on the warranties and obligations provided by the Clauses, it will promptly notify the change to the data exporter as soon as it is aware, in which case the data exporter is entitled to suspend the transfer of data and/or terminate the contract;
(c) that it has implemented the technical and organizational security measures specified in Appendix 2 before processing the personal data transferred;
(d) that it will promptly notify the data exporter about:
(i) any legally binding request for disclosure of the personal data by a law enforcement authority unless otherwise prohibited, such as a prohibition under criminal law to preserve the confidentiality of a law enforcement investigation;
(ii) any accidental or unauthorized access; and
(iii)any request received directly from the data subjects without responding to that request, unless it has been otherwise authorized to do so;
(e)to deal promptly and properly with all inquiries from the data exporter relating to its processing of the personal data subject to the transfer and to abide by the advice of the supervisory authority with regard to the processing of the data transferred;
(f)at the request of the data exporter to submit its data-processing facilities for audit of the processing activities covered by the Clauses which shall be carried out by the data exporter or an inspection body composed of independent members and in possession of the required professional qualifications bound by a duty of confidentiality, selected by the data exporter, where applicable, in agreement with the supervisory authority;
(g)to make available to the data subject upon request a copy of the Clauses, or any existing contract for sub-processing, unless the Clauses or contract contain commercial information, in which case it may remove such commercial information, with the exception of Appendix 2 which shall be replaced by a summary description of the security measures in those cases where the data subject is unable to obtain a copy from the data exporter;
(h)that, in the event of sub-processing, it has previously informed the data exporter and obtained its prior written consent;
(i) that the processing services by the sub-processor will be carried out in accordance with Clause 11;
(j)to send promptly a copy of any sub-processor agreement it concludes under the Clauses to the data exporter.
1.The parties agree that any data subject, who has suffered damage as a result of any breach of the obligations referred to in Clause 3 or in Clause 11 by any party or sub-processor is entitled to receive compensation from the data exporter for the damage suffered.
2.If a data subject is not able to bring a claim for compensation in accordance with paragraph 1 against the data exporter, arising out of a breach by the data importer or his sub-processor of any of their obligations referred to in Clause 3 or in Clause 11, because the data exporter has factually disappeared or ceased to exist in law or has become insolvent, the data importer agrees that the data subject may issue a claim against the data importer as if it were the data exporter, unless any successor entity has assumed the entire legal obligations of the data exporter by contract of by operation of law, in which case the data subject can enforce its rights against such entity. The data importer may not rely on a breach by a sub-processor of its obligations in order to avoid its own liabilities.
3. If a data subject is not able to bring a claim against the data exporter or the data importer referred to in paragraphs 1 and 2, arising out of a breach by the sub-processor of any of their obligations referred to in Clause 3 or in Clause 11 because both the data exporter and the data importer have factually disappeared or ceased to exist in law or have become insolvent, the sub-processor agrees that the data subject may issue a claim against the data sub-processor with regard to its own processing operations under the Clauses as if it were the data exporter or the data importer, unless any successor entity has assumed the entire legal obligations of the data exporter or data importer by contract or by operation of law, in which case the data subject can enforce its rights against such entity. The liability of the sub-processor shall be limited to its own processing operations under the Clauses.
Mediation and jurisdiction
1.The data importer agrees that if the data subject invokes against it third-party beneficiary rights and/or claims compensation for damages under the Clauses, the data importer will accept the decision of the data subject:
(a)to refer the dispute to mediation, by an independent person or, where applicable, by the supervisory authority;
(b)to refer the dispute to the courts in the Member State in which the data exporter is established.
2. The parties agree that the choice made by the data subject will not prejudice its substantive or procedural rights to seek remedies in accordance with other provisions of national or international law.
Cooperation with supervisory authorities
1.The data exporter agrees to deposit a copy of this contract with the supervisory authority if it so requests or if such deposit is required under the applicable data protection law.
2.The parties agree that the supervisory authority has the right to conduct an audit of the data importer, and of any sub-processor, which has the same scope and is subject to the same conditions as would apply to an audit of the data exporter under the applicable data protection law.
3.The data importer shall promptly inform the data exporter about the existence of legislation applicable to it or any sub-processor preventing the conduct of an audit of the data importer, or any sub-processor, pursuant to paragraph 2. In such a case the data exporter shall be entitled to take the measures foreseen in Clause 5(b).
The Clauses shall be governed by the law of the Member State in which the data exporter is established.
Variation of the contract
The parties undertake not to vary or modify the Clauses. This does not preclude the parties from adding clauses on business related issues where required as long as they do not contradict the Clause.
1.The data importer shall not subcontract any of its processing operations performed on behalf of the data exporter under the Clauses without the prior written consent of the data exporter. Where the data importer subcontracts its obligations under the Clauses, with the consent of the data exporter, it shall do so only by way of a written agreement with the sub-processor which imposes the same obligations on the sub-processor as are imposed on the data importer under the Clauses (3). Where the sub-processor fails to fulfil its data protection obligations under such written agreement the data importer shall remain fully liable to the data exporter for the performance of the sub-processor’s obligations under such agreement.
2.The prior written contract between the data importer and the sub-processor shall also provide for a third-party beneficiary clause as laid down in Clause 3 for cases where the data subject is not able to bring the claim for compensation referred to in paragraph 1 of Clause 6 against the data exporter or the data importer because they have factually disappeared or have ceased to exist in law or have become insolvent and no successor entity has assumed the entire legal obligations of the data exporter or data importer by contract or by operation of law. Such third-party liability of the sub-processor shall be limited to its own processing operations under the Clauses.
3.The provisions relating to data protection aspects for sub-processing of the contract referred to in paragraph 1 shall be governed by the law of the Member State in which the data exporter is established, namely …
4.The data exporter shall keep a list of sub-processing agreements concluded under the Clauses and notified by the data importer pursuant to Clause 5(j), which shall be updated at least once a year. The list shall be available to the data exporter’s data protection supervisory authority.
Obligation after the termination of personal data-processing services
1.The parties agree that on the termination of the provision of data-processing services, the data importer and the sub-processor shall, at the choice of the data exporter, return all the personal data transferred and the copies thereof to the data exporter or shall destroy all the personal data and certify to the data exporter that it has done so, unless legislation imposed upon the data importer prevents it from returning or destroying all or part of the personal data transferred. In that case, the data importer warrants that it will guarantee the confidentiality of the personal data transferred and will not actively process the personal data transferred anymore.
2.The data importer and the sub-processor warrant that upon request of the data exporter and/or of the supervisory authority, it will submit its data-processing facilities for an audit of the measures referred to in paragraph 1.
To the Standard Contractual Clauses
The data exporter is:
As determined in the Agreement
The data importer is:
As determined in the Agreement
The personal data transferred concern the following categories of data subjects:
As provided in Exhibit A to the DPA
Categories of data
The personal data transferred concern the following categories of data:
As provided in Exhibit A to the DPA
Special categories of data (if appropriate)
The personal data transferred concern the following special categories of data:
As provided in Exhibit A to the DPA
The personal data transferred will be subject to the following basic processing activities:
As provided in Exhibit A to the DPA
to the Standard Contractual Clauses
This Appendix forms part of the Clauses and must be completed and signed by the parties.
Description of the technical and organizational security measures implemented by the data importer in accordance with Clauses 4(d) and 5(c):
- Implement appropriate technical and organizational measures to protect against accidental or unlawful destruction, loss, alteration, unauthorized disclosure of, or access to Data.