Data Processing Agreement

 Standard Contractual Clauses

 

This Agreement covers data processing for the purposes of Article 28(3) of Regulation 2016/679 (the GDPR), specifically associated with the use of Adent’s Remote Dental Care solution which allows for dental professionals to conduct digital remote consultations with their patients. By accepting the terms you indicate that you have read and agree to the terms presented in the Agreement.

 

You enter into a agreement with:

 

Adent ApS
Knabrostraede 20, 3rd floor
1432 Copenhagen K
DK-Denmark
CVR no. 40512977
(”the data processor”)


You will be denoted as “the data controller” in the Agreement.

 

Each a ‘party’; together ‘the parties’ have agreed on the following Contractual Clauses (the Clauses) in order to meet the requirements of the GDPR and to ensure the protection of the rights of the data subject.

ANY USE MADE IN ANY WAY OF THE ADENT SERVICES IMPLIES COMPULSORY ACCEPTANCE OF THESE CLAUSES.

 

Table of Contents 

1. Table of Contents
2. Preamble
3. The rights and obligations of the data controller
4. The data processor acts according to instructions
5. Confidentiality
6. Security of processing
7. Use of sub-processors
8. Transfer of data to third countries or international organisations
9. Assistance to the data controller
10. Notification of personal data breach
11. Erasure and return of data
12. Audit and inspection
13. The parties’ agreement on other terms
14. Commencement and termination
15. Data controller and data processor contacts/contact points
Appendix A: Information about the processing
Appendix B: Authorised sub-processors
Appendix C: Instruction pertaining to the use of personal data
Appendix D: The parties’ terms of agreement on other subjects

Preamble

 

These Contractual Clauses (the Clauses) set out the rights and obligations of the data controller and the data processor, when processing personal data on behalf of the data controller.

The Clauses have been designed to ensure the parties’ compliance with Article 28(3) of Regulation 2016/679 of the European Parliament and of the Council of 27 April 2016 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 (General Data Protection Regulation).

In the context of the provision of Remote Dental Care via the Adent Widget and Adent Health software application, the data processor will process personal data on behalf of the data controller in accordance with the Clauses.

The Clauses shall take priority over any similar provisions contained in other agreements between the parties.

 

Four appendices are attached to the Clauses and form an integral part of the Clauses.

 

Appendix A contains details about the processing of personal data, including the purpose and nature of the processing, type of personal data, categories of data subject and duration of the processing.

Appendix B contains the data controller’s conditions for the data processor’s use of sub-processors and a list of sub-processors authorised by the data controller.

Appendix C contains the data controller’s instructions with regards to the processing of personal data, the minimum security measures to be implemented by the data processor and how audits of the data processor and any sub-processors are to be performed.

Appendix D contains provisions for other activities which are not covered by the Clauses. 

The Clauses along with appendices shall be retained in writing, including electronically, by both parties.

 

The Clauses shall not exempt the data processor from obligations to which the data processor is subject pursuant to the General Data Protection Regulation (the GDPR) or other legislation.

 

The rights and obligations of the data controller

The data controller is responsible for ensuring that the processing of personal data takes place in compliance with the GDPR (see Article 24 GDPR), the applicable EU or Member State data protection provisions and the Clauses.

 

The data controller has the right and obligation to make decisions about the purposes and means of the processing of personal data.

 

The data controller shall be responsible, among other, for ensuring that the processing of personal data, which the data processor is instructed to perform, has a legal basis. 

 

The data processor acts according to instructions

The data processor shall process personal data only on documented instructions from the data controller, unless required to do so by Union or Member State law to which the processor is subject. Such instructions shall be specified in appendices A and C. Subsequent instructions can also be given by the data controller throughout the duration of the processing of personal data, but such instructions shall always be documented and kept in writing, including electronically, in connection with the Clauses. 

The data processor shall immediately inform the data controller if instructions given by the data controller, in the opinion of the data processor, contravene the GDPR or the applicable EU or Member State data protection provisions.

 

Confidentiality

 

The data processor shall only grant access to the personal data being processed on behalf of the data controller to persons under the data processor’s authority who have committed themselves to confidentiality or are under an appropriate statutory obligation of confidentiality and only on a need to know basis. The list of persons to whom access has been granted shall be kept under periodic review. On the basis of this review, such access to personal data can be withdrawn, if access is no longer necessary, and personal data shall consequently not be accessible anymore to those persons.

 

The data processor shall at the request of the data controller demonstrate that the concerned persons under the data processor’s authority are subject to the abovementioned confidentiality.
 

Security of processing 

 

Article 32 GDPR stipulates that, taking into account the state of the art, the costs of implementation and the nature, scope, context and purposes of processing as well as the risk of varying likelihood and severity for the rights and freedoms of natural persons, the data controller and data processor shall implement appropriate technical and organisational measures to ensure a level of security appropriate to the risk.

 

The data controller shall evaluate the risks to the rights and freedoms of natural persons inherent in the processing and implement measures to mitigate those risks. Depending on their relevance, the measures may include the following:

  • Pseudonymisation and encryption of personal data;

  • the ability to ensure ongoing confidentiality, integrity, availability and resilience of processing systems and services;

  • the ability to restore the availability and access to personal data in a timely manner in the event of a physical or technical incident;

  • a process for regularly testing, assessing and evaluating the effectiveness of technical and organisational measures for ensuring the security of the processing.

 

According to Article 32 GDPR, the data processor shall also – independently from the data controller – evaluate the risks to the rights and freedoms of natural persons inherent in the processing and implement measures to mitigate those risks. To this effect, the data controller shall provide the data processor with all information necessary to identify and evaluate such risks.

Furthermore, the data processor shall assist the data controller in ensuring compliance with the data controller’s obligations pursuant to Articles 32 GDPR, by inter alia providing the data controller with information concerning the technical and organisational measures already implemented by the data processor pursuant to Article 32 GDPR along with all other information necessary for the data controller to comply with the data controller’s obligation under Article 32 GDPR.

If subsequently – in the assessment of the data controller – mitigation of the identified risks require further measures to be implemented by the data processor, than those already implemented by the data processor pursuant to Article 32 GDPR, the data controller shall specify these additional measures to be implemented in Appendix C.

Use of sub-processors

The data processor shall meet the requirements specified in Article 28(2) and (4) GDPR in order to engage another processor (a sub-processor).

The data processor shall therefore not engage another processor (sub-processor) for the fulfilment of the Clauses without the prior general written authorisation of the data controller.

 

The data processor has the data controller’s general authorisation for the engagement of sub-processors. The data processor shall inform in writing the data controller of any intended changes concerning the addition or replacement of sub-processors at least 14 (fourteen) days in advance, thereby giving the data controller the opportunity to object to such changes prior to the engagement of the concerned sub-processor(s). Longer time periods of prior notice for specific sub-processing services can be provided in Appendix B. The list of sub-processors already authorised by the data controller can be found in Appendix B.

 

Where the data processor engages a sub-processor for carrying out specific processing activities on behalf of the data controller, the same data protection obligations as set out in the Clauses shall be imposed on that sub-processor by way of a contract or other legal act under EU or Member State law, in particular providing sufficient guarantees to implement appropriate technical and organisational measures in such a manner that the processing will meet the requirements of the Clauses and the GDPR.

 

The data processor shall therefore be responsible for requiring that the sub-processor at least complies with the obligations to which the data processor is subject pursuant to the Clauses and the GDPR.

 

A copy of such a sub-processor agreement and subsequent amendments shall – at the data controller’s request – be submitted to the data controller, thereby giving the data controller the opportunity to ensure that the same data protection obligations as set out in the Clauses are imposed on the sub-processor. Clauses on business related issues that do not affect the legal data protection content of the sub-processor agreement, shall not require submission to the data controller.  

 

The data processor shall agree a third-party beneficiary clause with the sub-processor where – in the event of bankruptcy of the data processor – the data controller shall be a third-party beneficiary to the sub-processor agreement and shall have the right to enforce the agreement against the sub-processor engaged by the data processor, e.g. enabling the data controller to instruct the sub-processor to delete or return the personal data.

 

If the sub-processor does not fulfil his data protection obligations, the data processor shall remain fully liable to the data controller as regards the fulfilment of the obligations of the sub-processor. This does not affect the rights of the data subjects under the GDPR – in particular those foreseen in Articles 79 and 82 GDPR – against the data controller and the data processor, including the sub-processor.

 

Transfer of data to third countries or international organisations

 

Any transfer of personal data to third countries or international organisations by the data processor shall only occur on the basis of documented instructions from the data controller and shall always take place in compliance with Chapter V GDPR. 

 

In case transfers to third countries or international organisations, which the data processor has not been instructed to perform by the data controller, is required under EU or Member State law to which the data processor is subject, the data processor shall inform the data controller of that legal requirement prior to processing unless that law prohibits such information on important grounds of public interest.

 

Without documented instructions from the data controller, the data processor therefore cannot within the framework of the Clauses:

 

  • transfer personal data to a data controller or a data processor in a third country or in an international organization

  • transfer the processing of personal data to a sub-processor in a third country have the personal data processed in by the data processor in a third country

The data controller’s instructions regarding the transfer of personal data to a third country including, if applicable, the transfer tool under Chapter V GDPR on which they are based, shall be set out in Appendix C.6.

The Clauses shall not be confused with standard data protection clauses within the meaning of Article 46(2)(c) and (d) GDPR, and the Clauses cannot be relied upon by the parties as a transfer tool under Chapter V GDPR.

 

Assistance to the data controller

 

Taking into account the nature of the processing, the data processor shall assist the data controller by appropriate technical and organisational measures, insofar as this is possible, in the fulfilment of the data controller’s obligations to respond to requests for exercising the data subject’s rights laid down in Chapter III GDPR.

This entails that the data processor shall, insofar as this is possible, assist the data controller in the data controller’s compliance with:

 

  • the right to be informed when collecting personal data from the data subject

  • the right to be informed when personal data have not been obtained from the data subject

  • the right of access by the data subject

  • the right to rectification

  • the right to erasure (‘the right to be forgotten’)

  • the right to restriction of processing

  • notification obligation regarding rectification or erasure of personal data or restriction of processing

  • the right to data portability

  • the right to object 

  • the right not to be subject to a decision based solely on automated processing, including profiling

 

In addition to the data processor’s obligation to assist the data controller pursuant to Clause 6.3., the data processor shall furthermore, taking into account the nature of the processing and the information available to the data processor, assist the data controller in ensuring compliance with:

 

The data controller’s obligation to without undue delay and, where feasible, not later than 72 hours after having become aware of it, notify the personal data breach to the competent supervisory authority, The Danish Data Protection Agency (DPA/Datatilsynet, the data protection regulator in Denmark), unless:

 

  • the personal data breach is unlikely to result in a risk to the rights and freedoms of natural persons;

  • the data controller’s obligation to without undue delay communicate the personal data breach to the data subject, when the personal data breach is likely to result in a high risk to the rights and freedoms of natural persons;

  • the data controller’s obligation to carry out an assessment of the impact of the envisaged processing operations on the protection of personal data (a data protection impact assessment);

  • the data controller’s obligation to consult the competent supervisory authority, The Danish Data Protection Agency (DPA/Datatilsynet, the data protection regulator in Denmark), prior to processing where a data protection impact assessment indicates that the processing would result in a high risk in the absence of measures taken by the data controller to mitigate the risk.

The parties shall define in Appendix C the appropriate technical and organisational measures by which the data processor is required to assist the data controller as well as the scope and the extent of the assistance required. This applies to the obligations foreseen in Clause 9.1. and 9.2.

Notification of personal data breach

 

In case of any personal data breach, the data processor shall, without undue delay after having become aware of it, notify the data controller of the personal data breach.

 

The data processor’s notification to the data controller shall, if possible, take place not later than 72 hours after the data processor has become aware of the personal data breach to enable the data controller to comply with the data controller’s obligation to notify the personal data breach to the competent supervisory authority, cf. Article 33 GDPR.

 

In accordance with Clause 9(2)(a), the data processor shall assist the data controller in notifying the personal data breach to the competent supervisory authority, meaning that the data processor is required to assist in obtaining the information listed below which, pursuant to Article 33(3)GDPR, shall be stated in the data controller’s notification to the competent supervisory authority:  

 

The nature of the personal data including where possible:

 

  • the categories and approximate number of data subjects concerned and the categories and approximate number of personal data records concerned; 

  • the likely consequences of the personal data breach;

  • the measures taken or proposed to be taken by the controller to address the personal data breach, including, where appropriate, measures to mitigate its possible adverse effects. 

The parties shall define in Appendix C all the elements to be provided by the data processor when assisting the data controller in the notification of a personal data breach to the competent supervisory authority.
 

Erasure and return of data

On termination of the provision of personal data processing services, the data processor shall be under obligation to delete all personal data processed on behalf of the data controller and certify to the data controller that it has done so unless Union or Member State law requires storage of the personal data.

 

Audit and inspection

 

The data processor shall make available to the data controller all information necessary to demonstrate compliance with the obligations laid down in Article 28 and the Clauses and allow for and contribute to audits, including inspections, conducted by the data controller or another auditor mandated by the data controller.

 

Procedures applicable to the data controller’s audits, including inspections, of the data processor and sub-processors are specified in appendices C.7. and C.8.    

 

The data processor shall be required to provide the supervisory authorities, which pursuant to applicable legislation have access to the data controller’s and data processor’s facilities, or representatives acting on behalf of such supervisory authorities, with access to the data processor’s physical facilities on presentation of appropriate identification. 

 

The parties’ agreement on other terms 

 

The parties may agree other clauses concerning the provision of the personal data processing service specifying e.g. liability, as long as they do not contradict directly or indirectly the Clauses or prejudice the fundamental rights or freedoms of the data subject and the protection afforded by the GDPR.

 

Commencement and termination

 

The Clauses shall become effective on the date of both parties’ signature.

 

Both parties shall be entitled to require the Clauses renegotiated if changes to the law or inexpediency of the Clauses should give rise to such renegotiation. 

The Clauses shall apply for the duration of the provision of personal data processing services. For the duration of the provision of personal data processing services, the Clauses cannot be terminated unless other Clauses governing the provision of personal data processing services have been agreed between the parties.

 

If the provision of personal data processing services is terminated, and the personal data is deleted or returned to the data controller pursuant to Clause 11.1. and Appendix C.4., the Clauses may be terminated by written notice by either party.

 

Data controller and data processor contacts/contact points

 

The parties may contact each other using the following contacts/contact points:

 

The parties shall be under obligation continuously to inform each other of changes to contacts/contact points.

 

The Data Protection Officer or equivalent responsible shall be accessed via the website of the data controller, or informed by email, or as by other means agreed.

 

On behalf of the data processor:

 

Name: Thøger Bundsgaard    
Role: Data Protection Officer
Telephone: +45 61415111
E-mail: tb@adent.dk

 

 

Appendix A: Information about the processing 

 

The Remote Dental Care platform is a custom-designed software for digital consultations between dental professionals and their patients. The data processor will supply the data controller with a clinic account on the Remote Dental Care platform. 

 

This includes:

 

  • Representatives (dental professionals) of the data controller (dental clinic) ask their end-users (patients) to upload intraoral images and answer a dental health questionnaire for examination and review by the data controller’s representatives (dental professionals). The Remote Dental Care services are accessed remotely using the internet, data networks and devices which can access the internet ("Infrastructure") via the Adent Widget and the Adent Health application in its end-user sided interface. The data processor makes the service available for access using Infrastructure, but is not responsible for Infrastructure. 

  • Representatives (dental professionals) of the data controller review the submitted data via the Adent Professional application in a clinic-sided interface. This is also provided using Infrastructure.

  • When finished reviewing the submitted data, the representatives (dental professionals) of the data controller mark the digital consultation as complete and ready for display to the patient. The patient is granted access to the review via a dedicated link via Adent Professional or via the Adent Health application in its end-user sided interface (or both). A copy of the digital consultation review report is sent to the representative (dental professionals) of the data controller as a compiled file. The file is transferred with encryption and only accessible via login by the representative (dental professional) or a secret password chosen by the data controller. The report can be sent sent by email, and will in this case be encrypted in accordance with the regulatory requirements regarding transmission of personal health data via email.

  • As a follow up on the image-based digital consultation the representatives (dental professionals) of the data controller may share a link to a third party online video provider. The data processor provides this link and has provided the necessary documentation that this third party provider fulfills the necessary regulatory requirements to serve a follow up conversation between a representative (dental professional) of the data controller and the end-user (patient).


A.1. The purpose of the data processor’s processing of personal data on behalf of the data controller is:

The purpose of the processing is to be able to provide end-users with the service Remote Dental Care. Remote Dental Care is for end-users (patients) of the data controller (dental clinic) who want a professional assessment of their dental health, easily and simply through their smartphone. They can be consulted digitally by a dental professional, without visiting their dental clinic. The consultation can, if assessed relevant or necessary, be followed up by a visit to the dental clinic.

 

The Adent Widget and Adent Health application provides the necessary infrastructure to achieve this within secure Infrastructure and any instructed preprocessing and postprocessing of the data.
 

 

A.2. The data processor’s processing of personal data on behalf of the data controller shall mainly pertain to (the nature of the processing):

 

The nature of the processing is transmission of data between the data controller and the data controllers end-users, including preprocessing and/or post-processing needed to support that the data collector can provide quality digital consultations to their end-users (patients).

 

In essence, the transaction is between a dental professional and an end-user (patient). It is noted, that the end-user (patient) is the ultimate owner of the data transmitted in this transaction, and the end-user (patient) can – upholding their right to portable data – choose to import/transfer any data transmitted to the dental professional into their account on Adent Health, or into another place of choosing. In this case the Terms of Use for the Adent Health app apply.

A.3. The processing includes the following types of personal data about data subjects:

The processing included the following personal data of the end-user (“Patient”):

  • First Name, Last Name, Age

  • Email address, Phone number

  • Type of device used by the Patient

  • Device Id

  • Device statistics such as crashes

  • Pictures of the Patient’s mouth 

  • Patient responses to anamnestic questions provided via the service

 

A.4. Processing includes the following categories of data subject:

The category of the data subjects: Patients, including both existing Patients and potential Patients.

 

A.5. The data processor’s processing of personal data on behalf of the data controller may be performed when the Clauses commence. Processing has the following duration:

 

Duration of the personal data falls:

The processing facilitating the actual digital consultancy and facilitating the communication between representatives (dental professionals) of data collector and the data collector’s end-users (patients) is expected to have a duration of 1-7 days on average.

The processing, the result of the processing, and any later processing is retained for a longer period to support the sustainable relationship between a dental professional and end-user (patient). The processed data is stored as backup on behalf of the data controller in a period of 10 years.


Appendix B: Authorised sub-processors 

B.1. Approved sub-processors

On commencement of the Clauses, the data controller authorises the engagement of the following sub-processors:

Amazon Web Services EMEA SARL

38 Avenue John F. Kennedy, L-1855, Luxembourg

  • Provider of the hosted and managed Cloud infrastructure necessary to provide the service

 

Google

Gordon House, Barrow St Dublin 4, Dublin, Ireland

  • Provider of usage analytics used in the legitimate interest to develop and improve the service for the benefit of the data collector and the end-users of the data collector

 

Daily.co

1925 48th Ave, San Francisco CA USA 94116

  • Provider of video transmission between dental professional and end-user (patient) if both parties choose to use this feature, and is necessary to provide the service

 

The data controller shall on the commencement of the Clauses authorise the use of the above mentioned sub-processors for the processing described for that party. The data processor shall not be entitled – without the data controller’s explicit written authorisation – to engage a sub-processor for a ‘different’ processing than the one which has been agreed upon or have another sub-processor perform the described processing.

Appendix C: Instruction pertaining to the use of personal data 

 

C.1. The subject of/instruction for the processing

 

The data processor’s processing of personal data on behalf of the data controller shall be carried out by the data processor performing the following:

 

The processing includes the raw transmission of data between the data controller and the data controllers end-users, including the option for end-users to upload intraoral images and answer questionnaires.

 

In addition, the processing includes providing the necessary user interfaces to provide an image based digital consultation, including the option for a dental professional to comment on the images provided by the end-user.

 

In addition, the processing includes preprocessing and/or postprocessing of the data provided to the end-user, including the use of statistical algorithms to assist the digital consultation process. This includes e.g. calculation of the coverage of the mouth in the provided images (i.e.: the share of the tooth surface visible in images), calculation of the quality of the images (i.e.: blurriness, acutance, etc.) to support both dental professional and end-users to achieve the best possible result of the digital consultation.

 

C.2. Security of processing

 

The level of security shall take into account:

That the processing involves personal data which are subject to Article 9 GDPR on ‘special categories of personal data’ – specifically data concerning dental health – which is why a ‘high’ level of security should be established.

 

The data processor shall hereafter be entitled and under obligation to make decisions about the technical and organisational security measures that are to be applied to create the necessary (and agreed) level of data security.    

 

The data processor shall however – in any event and at a minimum – implement the following measures that have been agreed with the data controller:  

 

  • Ensure that data processing uses appropriate pseudonymisation and encryption of personal data.

  • Ensure that data is stored with an appropriate level of confidentiality, integrity, availability and resilience of processing systems, and accessible in a timely manner.

  • Ensure that systems are appropriately tested, assessed and evaluated for the effectiveness of technical and organisational measures to ensure appropriate security of the processing.

  • Ensure that data is available online with the appropriate security measures, such as encryption on transit of the data.

  • Ensure that physical security measures meet the appropriate level of security.

  • Ensure that an appropriate level of logging is maintained to ensure that system failures can be traced, and also ensure that the logging meets the appropriate requirements for security as the rest of the system, including not logging personal data in plain text logs, etc.

 

C.3. Assistance to the data controller

 

The data processor shall insofar as this is possible – within the scope and the extent of the assistance specified below – assist the data controller in accordance with Clause 9.1. and 9.2. by implementing the following technical and organisational measures:

 

Provide a system that to the extent which it is possible ensures both security by design and privacy by design, wherein it is intuitive and easy to meet the regulatory requirements, including providing the necessary encryption of data in transit and at rest by default.

Provide appropriate documentation of the architecture and software system upon which the service is built. Provide appropriate assistance and training to understand critical components of the 

C.4. Storage period/erasure procedures 

 

Personal data is stored for 10 years after which the personal data is erased by the data processor, unless the end-user (patient), who is the ultimate owner of the data, has requested otherwise. Upon termination of the provision of personal data processing services, the data processor shall either delete or return the personal data in accordance with Clause 11.1., unless the data controller – after the signature of the contract – has modified the data controller’s original choice. Such modification shall be documented and kept in writing, including electronically, in connection with the Clauses.

C.5. Processing location

 

Processing of the personal data under the Clauses cannot be performed at other locations than those described in the Terms of Use and Privacy Policy for the Adent Health app without the data controller’s prior written authorisation.

 

C.6. Instruction on the transfer of personal data to third countries 

 

The transfer of personal data to third countries of the personal data is detailed in Terms of Use and Privacy Policy of the Adent Health app. Any such transfer cannot be performed in other ways than those described in these without the data controller’s prior written instruction and authorisation.

If the data controller does not in the Clauses or subsequently provide documented instructions pertaining to the transfer of personal data to a third country, the data processor shall not be entitled within the framework of the Clauses to perform such transfer.  

C.7. Procedures for the data controller’s audits, including inspections, of the processing of personal data being performed by the data processor

 

The data processor shall regularly assess that processing meets the standards for applicable EU or Member State data protection provisions and the Clauses.

 

The assessment shall result in a report. The report or any specific result of the report shall without undue delay be submitted to the data controller for information, if there are any concerns that could affect the data controller. The data controller may contest the scope and/or methodology of the report and may in such cases request a new assessment under a revised scope and/or different methodology.

 

Based on the results of such an assessment, the data controller may request further measures to be taken to ensure compliance with the GDPR, the applicable EU or Member State data protection provisions and the Clauses.

 

The data processors’s costs, if applicable, relating to physical inspection shall be defrayed by the data controller. The data processor shall, however, be under obligation to set aside the resources (mainly time) required for the data controller to be able to perform the inspection.  
 
Appendix D: The parties’ terms of agreement on other subjects

The parties have in addition to this Data Processing Agreement signed a Terms of Use Agreement for the usage of the Services.