DATA PROCESSING ADDENDUM

This Data Processing Addendum (the “Addendum”) is incorporated into the User Agreement and applies in respect of the provision of the Services to the User if the User is subject to Regulation (EU) 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 (the “Regulation (EU) 2016/679”), only to the extent the User is a controller of patient’s personal data (as defined below) that FDNA processes on behalf of the User. The Addendum is intended to satisfy the requirements of Article 28(3) of the GDPR. This Addendum shall be effective for the term of the User Agreement.

SECTION I

Clause 1- Purpose and scope
(a) The purpose of these Standard Contractual Clauses (the “Clauses”) is to ensure compliance with Article 28(3) and (4) of Regulation (EU) 2016/679.
(b) The controllers and processors have agreed to these Clauses in order to ensure compliance with Article 28(3) and (4) of Regulation (EU) 2016/679.
(c) These Clauses apply to the processing of personal data as specified in ANNEX II.
(d) ANNEXES I to III are an integral part of the Clauses.
(e) These Clauses are without prejudice to obligations to which the controller is subject by virtue of Regulation (EU) 2016/679.
(f) These Clauses do not by themselves ensure compliance with obligations related to international transfers in accordance with Chapter V of Regulation (EU) 2016/679.

Clause 2 – Invariability of the Clauses
(a) The Parties undertake not to modify the Clauses, except for adding information to the Annexes or updating information in them.
(b) This does not prevent the Parties from including the standard contractual clauses laid down in these Clauses in a broader contract, or from adding other clauses or additional safeguards provided that they do not directly or indirectly contradict the Clauses or detract from the fundamental rights or freedoms of data subjects.

Clause 3 – Interpretation
(a) Where these Clauses use the terms defined in Regulation (EU) 2016/679, those terms shall have the same meaning as in that Regulation.
(b) These Clauses shall be read and interpreted in the light of the provisions of Regulation (EU) 2016/679.
(c) These Clauses shall not be interpreted in a way that runs counter to the rights and obligations provided for in Regulation (EU) 2016/679 or in a way that prejudices the fundamental rights or freedoms of the data subjects.

Clause 4 – Hierarchy
In the event of a contradiction between these Clauses and the provisions of related agreements between the Parties existing at the time when these Clauses are agreed or entered into thereafter, these Clauses shall prevail.

Clause 5 – Docking clause
(a) Any entity that is not a Party to these Clauses may, with the agreement of all the Parties, accede to these Clauses at any time as a controller or a processor by completing the Annexes and signing ANNEX I.
(b) Once the Annexes in (a) are completed and signed, the acceding entity shall be treated as a Party to these Clauses and have the rights and obligations of a controller or a processor, in accordance with its designation in ANNEX I.
(c) The acceding entity shall have no rights or obligations resulting from these Clauses from the period prior to becoming a Party.

SECTION II – OBLIGATIONS OF THE PARTIES

Clause 6 – Description of processing(s)
The details of the processing operations, in particular the categories of personal data and the purposes of processing for which the personal data is processed on behalf of the controller, are specified in ANNEX II.

Clause 7 – Obligations of the Parties
7.1. Instructions
(a) The processor shall process personal data only on documented instructions from the controller, unless required to do so by Union or Member State law to which the processor is subject. In this case, the processor shall inform the controller of that legal requirement before processing, unless the law prohibits this on important grounds of public interest. Subsequent instructions may also be given by the controller throughout the duration of the processing of personal data. These instructions shall always be documented.
(b) The processor shall immediately inform the controller if, in the processor’s opinion, instructions given by the controller infringe Regulation (EU) 2016/679 or the applicable Union or Member State data protection provisions.

7.2. Purpose limitation
The processor shall process the personal data only for the specific purposes of the processing, as set out in ANNEX II, unless it receives further instructions from the controller.

7.3. Duration of the processing of personal data
Processing by the processor shall only take place for the duration specified in ANNEX II.

7.4. Security of processing
(a) The processor shall at least implement the technical and organisational measures specified in ANNEX III to ensure the security of the personal data. This includes protecting the data against a breach of security leading to accidental or unlawful destruction, loss, alteration, unauthorised disclosure or access to the data (personal data breach). In assessing the appropriate level of security, the Parties shall take due account of the state of the art, the costs of implementation, the nature, scope, context and purposes of processing and the risks involved for the data subjects.
(b) The processor shall grant access to the personal data undergoing processing to members of its personnel only to the extent strictly necessary for implementing, managing and monitoring of the contract. The processor shall ensure that persons authorised to process the personal data received have committed themselves to confidentiality or are under an appropriate statutory obligation of confidentiality.

7.5. Sensitive data
If the processing involves personal data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs, or trade union membership, genetic data or biometric data for the purpose of uniquely identifying a natural person, data concerning health or a person’s sex life or sexual orientation, or data relating to criminal convictions and offences (“Sensitive data”), the processor shall apply specific restrictions and/or additional safeguards

7.6 Documentation and compliance
(a) The Parties shall be able to demonstrate compliance with these Clauses.
(b) The processor shall deal promptly and adequately with inquiries from the controller about the processing of data in accordance with these Clauses.
(c) The processor shall make available to the controller all information necessary to demonstrate compliance with the obligations that are set out in these Clauses and stem directly from Regulation (EU) 2016/679. At the controller’s request, the processor shall also permit and contribute to audits of the processing activities covered by these Clauses, at reasonable intervals or if there are indications of non-compliance. In deciding on a review or an audit, the controller may take into account relevant certifications held by the processor.
(d) The controller may choose to conduct the audit by itself or mandate an independent auditor. Audits may also include inspections at the premises or physical facilities of the processor and shall, where appropriate, be carried out with reasonable notice.
(e) The Parties shall make the information referred to in this Clause, including the results of any audits, available to the competent supervisory authority/ies on request.

7.7. Use of sub-processors
(a) The processor has the controller’s general authorisation for the engagement of sub-processors from an agreed list. The processor shall specifically inform in writing the controller of any intended changes of that list through the addition or replacement of sub-processors at least 30 days in advance, thereby giving the controller sufficient time to be able to object to such changes prior to the engagement of the concerned sub-processor(s). The processor shall provide the controller with the information necessary to enable the controller to exercise the right to object.
(b) Where the processor engages a sub-processor for carrying out specific processing activities (on behalf of the controller), it shall do so by way of a contract which imposes on the sub-processor, in substance, the same data protection obligations as the ones imposed on the data processor in accordance with these Clauses. The processor shall ensure that the sub-processor complies with the obligations to which the processor is subject pursuant to these Clauses and to Regulation (EU) 2016/679.
(c) At the controller’s request, the processor shall provide a copy of such a sub-processor agreement and any subsequent amendments to the controller. To the extent necessary to protect business secret or other confidential information, including personal data, the processor may redact the text of the agreement prior to sharing the copy.
(d) The processor shall remain fully responsible to the controller for the performance of the sub-processor’s obligations in accordance with its contract with the processor. The processor shall notify the controller of any failure by the sub-processor to fulfil its contractual obligations.
(e) The processor shall agree a third party beneficiary clause with the sub-processor whereby – in the event the processor has factually disappeared, ceased to exist in law or has become insolvent – the controller shall have the right to terminate the sub-processor contract and to instruct the sub-processor to erase or return the personal data.

7.8. International transfers
(a) Any transfer of data to a third country or an international organisation by the processor shall be done only on the basis of documented instructions from the controller or in order to fulfil a specific requirement under Union or Member State law to which the processor is subject and shall take place in compliance with Chapter V of Regulation (EU) 2016/679.
(b) The controller agrees that where the processor engages a sub-processor in accordance with Clause 7.7. for carrying out specific processing activities (on behalf of the controller) and those processing activities involve a transfer of personal data within the meaning of Chapter V of Regulation (EU) 2016/679, the processor and the sub-processor can ensure compliance with Chapter V of Regulation (EU) 2016/679 by using standard contractual clauses adopted by the Commission in accordance with of Article 46(2) of Regulation (EU) 2016/679, provided the conditions for the use of those standard contractual clauses are met.

Clause 8 – Assistance to the controller
(a) The processor shall promptly notify the controller of any request it has received from the data subject. It shall not respond to the request itself, unless authorised to do so by the controller.
(b) The processor shall assist the controller in fulfilling its obligations to respond to data subjects’ requests to exercise their rights, taking into account the nature of the processing. In fulfilling its obligations in accordance with (a) and (b), the processor shall comply with the controller’s instructions.
(c) In addition to the processor’s obligation to assist the controller pursuant to Clause 8(b), the processor shall furthermore assist the controller in ensuring compliance with the following obligations, taking into account the nature of the data processing and the information available to the processor:
(1) the 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’) where a type of processing is likely to result in a high risk to the rights and freedoms of natural persons;
(2) the obligation to consult the competent supervisory authority/ies 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 controller to mitigate the risk;
(3) the obligation to ensure that personal data is accurate and up to date, by informing the controller without delay if the processor becomes aware that the personal data it is processing is inaccurate or has become outdated;
(4) the obligations in Article 32 Regulation (EU) 2016/679.
(d) The Parties shall set out in ANNEX III the appropriate technical and organisational measures by which the processor is required to assist the controller in the application of this Clause as well as the scope and the extent of the assistance required.

Clause 9 – Notification of personal data breach
In the event of a personal data breach, the processor shall cooperate with and assist the controller for the controller to comply with its obligations under Articles 33 and 34 Regulation (EU) 2016/679, where applicable, taking into account the nature of processing and the information available to the processor.

9.1 Data breach concerning data processed by the controller
In the event of a personal data breach concerning data processed by the controller, the processor shall assist the controller:
(a) in notifying the personal data breach to the competent supervisory authority/ies, without undue delay after the controller has become aware of it, where relevant (unless the personal data breach is unlikely to result in a risk to the rights and freedoms of natural persons);
(b) in obtaining the following information which, pursuant to Article 33(3) Regulation (EU) 2016/679, shall be stated in the controller’s notification, and must at least include:
(1) 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;
(2) the likely consequences of the personal data breach;
(3) 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.
Where, and insofar as, it is not possible to provide all this information at the same time, the initial notification shall contain the information then available and further information shall, as it becomes available, subsequently be provided without undue delay.
(c) in complying, pursuant to Article 34 Regulation (EU) 2016/679 with the obligation to communicate without undue delay 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.

9.2 Data breach concerning data processed by the processor
In the event of a personal data breach concerning data processed by the processor, the processor shall notify the controller without undue delay after the processor having become aware of the breach. Such notification shall contain, at least:
(a) a description of the nature of the breach (including, where possible, the categories and approximate number of data subjects and data records concerned);
(b) the details of a contact point where more information concerning the personal data breach can be obtained;
(c) its likely consequences and the measures taken or proposed to be taken to address the breach, including to mitigate its possible adverse effects.
Where, and insofar as, it is not possible to provide all this information at the same time, the initial notification shall contain the information then available and further information shall, as it becomes available, subsequently be provided without undue delay.
The Parties shall set out in ANNEX III all other elements to be provided by the processor when assisting the controller in the compliance with the controller’s obligations under Articles 33 and 34 of Regulation (EU) 2016/679.

SECTION III – FINAL PROVISIONS

Clause 10 – Non-compliance with the Clauses and termination
(a) Without prejudice to any provisions of Regulation (EU) 2016/679, in the event that the processor is in breach of its obligations under these Clauses, the controller may instruct the processor to suspend the processing of personal data until the latter complies with these Clauses or the contract is terminated. The processor shall promptly inform the controller in case it is unable to comply with these Clauses, for whatever reason.
(b) The controller shall be entitled to terminate the contract insofar as it concerns processing of personal data in accordance with these Clauses if:
(1) the processing of personal data by the processor has been suspended by the controller pursuant to point (a) and if compliance with these Clauses is not restored within a reasonable time and in any event within one month following suspension;
(2) the processor is in substantial or persistent breach of these Clauses or its obligations under Regulation (EU) 2016/679;
(3) the processor fails to comply with a binding decision of a competent court or the competent supervisory authority/ies regarding its obligations pursuant to these Clauses or to Regulation (EU) 2016/679.
(c) The processor shall be entitled to terminate the contract insofar as it concerns processing of personal data under these Clauses where, after having informed the controller that its instructions infringe applicable legal requirements in accordance with Clause 7.1 (b), the controller insists on compliance with the instructions.
(d) Following termination of the contract, the processor shall, at the choice of the controller, delete all personal data processed on behalf of the controller and certify to the controller that it has done so, or, return all the personal data to the controller and delete existing copies unless Union or Member State law requires storage of the personal data. Until the data is deleted or returned, the processor shall continue to ensure compliance with these Clauses.

 

Last Updated: January 1, 2023

ANNEX I
LIST OF PARTIES

 

Controller: User, with legal domicile in the address provided when registering to the Services, as defined in the User Agreement.
Processor: FDNA, Inc., with legal domicile at 490 Sawgrass Corporate Parkway, Suite 200, Sunrise, FL 33325. U.S.A.

 

ANNEX II
DESCRIPTION OF THE PROCESSING

 

1. Categories of data subjects whose personal data is processed
Healthcare professionals, practitioners, students, patients and related individuals.
2. Categories of personal data processed
Names, dates of birth, date of visit, age at time of visit, gender, ethnicity, height, weight, email address, phone numbers, geolocalization, IP addresses and facial photos.
3. Sensitive data processed and applied restrictions or safeguards that fully take into consideration the nature of the data and the risks involved.
Ethnicity, medical record numbers, clinical and medical information and genetic and biometric data.
Adopted measures include strict purpose limitation, access restrictions (including access only for staff having followed specialized training), keeping a record of access to the data, restrictions for onward transfers.
4. Nature of the processing
Compute, storage and such other operations as necessary for processor to perform the Services for controller as described in the User Agreement.
5. Purpose(s) for which the personal data is processed on behalf of the controller
The processor is authorized to process, on behalf of the controller, the necessary personal data to provide the Services as described in the User Agreement.
6. Duration of the processing
Processor will process the personal data for the duration of the User Agreement and will delete or return the personal data in accordance with the User Agreement and this Data Processing Addendum.

 

ANNEX III
TECHNICAL AND ORGANISATIONAL MEASURES INCLUDING TECHNICAL AND ORGANISATIONAL MEASURES TO ENSURE THE SECURITY OF THE DATA

 

1. Measures of pseudonymization and encryption of personal data.
• All the customer data, including personal data transmitted to or accessed from the FDNA platform through a web browser, mobile application, APIs, data connector, and integrations is encrypted through HTTPS connection over TLS 1.2 using SHA-256 with 2048 bit RSA encryption.
• All response used GZIP encoding & all images stored into blob format into mongo.
2. Measures for ensuring ongoing confidentiality, integrity, availability and resilience of processing systems and services.
• All employees are required to undergo HIPAA information security and privacy trainings on an annual basis.
• Only authorized roles, as defined in the Role-Based Access Control (RBAC), are allowed to access systems processing customer and personal data using a unique username and an alphanumeric password that has at least 8 characters with one special, one lower case, and one upper case character.
• Only limited individuals are granted access to cloud infrastructure hosting customer and personal data based on the principle of least privilege.
• Authorized employees and contractors are required to connect VPN to access any internal systems or personal data.
• As part of the employee and contractor offboarding process, all accesses are revoked and data assets are securely wiped. Further, upon role change, the accesses are reviewed and modified aligned with job responsibilities.
• Only internal systems allowed through security groups can communicate with applications processing customer and personal data. Further, firewalls are configured at a load balancer level to restrict access and communication with external systems.
• Changes to the platform, software, applications, and infrastructure are made following the Software Development Life Cycle (SDLC) that includes code reviews and quality checks to ensure workflows designed to create, manage and retrieve personal data are implemented as per the design specifications.
• Personal data stored as part of user-submitted or recorded content, user profile media, and analytics data is uploaded on cloud storage that is automatically replicated in multiple availability zones physically separate from each other within a geographic region and backed up in another geographic region for disaster recovery.
• Personal data stored as part of the user profile, user progression, and analytics data is uploaded on cloud databases that are automatically replicated in multiple availability zones physically separate from each other within a geographic region and backed up in another geographic region for disaster recovery.
• Business continuity and disaster recovery plan is defined and follows Recovery Time Objective (RTO) of 6 hours and Recovery Point Objective (RPO) of 6 hour.
3. Measures for ensuring the ability to restore the availability and access to personal data in a timely manner in the event of a physical or technical incident.
• Backup of application data, databases, file contents, and audit logs is performed as per the backup policy that defines the backup scope, frequency, redundancy, failure monitoring, corrective action, retention, restoration, and archival.
• Personal data stored as part of user-submitted or recorded content, user profile media, and analytics data is uploaded on cloud storage that is automatically replicated in multiple availability zones physically separate from each other within a geographic region and backed up in another geographic region for disaster recovery.
• Personal data stored as part of the user profile, user progression, and analytics data is uploaded on cloud databases that are automatically replicated in multiple availability zones physically separate from each other within a geographic region and backed up in another geographic region for disaster recovery.
• Business continuity and disaster recovery plan is defined and follows Recovery Time Objective (RTO) of 6 hours and Recovery Point Objective (RPO) of 6 hour.
• Processes for regularly testing, assessing and evaluating the effectiveness of technical and organizational measures in order to ensure the security of the processing.
4. Measures for user identification and authorization.
• Accounts with access to systems processing customer and personal data are unique, mapped to individuals, and not shared between users.
• Only authorized roles, as defined in the Role-Based Access Control (RBAC), are allowed to access systems processing customer and personal data using a unique username and an alphanumeric password that has at least 8 characters with one special, one lower case, and one upper case character.
• Single Sign-On (SSO) and multi-factor authentication such as one-time password, authentication key codes, or device-based authentication are utilized wherever possible.
• Only limited individuals are granted access to cloud infrastructure hosting customer and personal data based on the principle of least privilege using IAM access permissions. Applications are granted access to customer and personal data using Identity and Access Management (IAM) policies.
• Only internal systems allowed through security groups can communicate with applications processing customer and personal data. Further, firewalls are configured at a load balancer level to restrict access and communication with external systems.
• Access to modify or delete log files is restricted and segregated such that users who perform privileged activities are unable to manipulate log files.
5. Measures for the protection of data during transmission.
• All the customer data, including personal data transmitted to or accessed from the FDNA platform through a web browser, mobile application, APIs, data connector, and integrations is encrypted through HTTPS connection over TLS 1.2 using SHA-256 with 2048 bit RSA encryption.
• Authorized employees and contractors are required to connect secure VPN to access any internal systems or personal data.
6. Measures for the protection of data during storage.
• All the customer data, including personal data stored in primary and backup storage of our cloud infrastructure is encrypted at rest with AES 256 encryption.
7. Measures for ensuring physical security of locations at which personal data are processed.
• Datacenter visitors are required to wear an identification badge, make an entry in the access register, and be escorted by authorized staff.
• Physical access to data centers is logged, monitored, and reviewed periodically to ensure access appropriateness.
• Physical access points to server rooms are recorded by a Closed Circuit Television Camera (CCTV) and guarded by security staff. Data centers are fully power redundant with backup power supply and use mechanisms to monitor and control temperature, humidity, and water leaks. Further, data centers are equipped with smoke detection sensors and fire suppression equipment.
• Physical entry points to office premises are recorded by a Closed Circuit Television Camera (CCTV) and have an access card verification system at every door, allowing only authorized employees to enter the office premises.
• Office visitors record an entry in the visitor management system and are escorted by authorized employees.
8. Measures for ensuring events logging.
• Events and audit trails related to platform and system access are logged, monitored, and reviewed periodically.
• Audit logs maintain detailed information such as timestamps, IP address, application name, specific action taken, request metadata, etc.
9. Measures for ensuring system configuration, including default configuration.
• Baseline systems are selected with hardened security configuration such as restricted remote access only with SSH, disabled remote root login, reduced number of non-critical packages, kernel live patching, and automatic installation of important security updates during initial boot.
• Baseline systems with hardened security configuration and vulnerability fixes are used in the production environment.
• FDNA maintains segregation between development, testing, staging, and production environment. Further, data of one customer is logically segregated from other customers using a unique ID associated with each customer. This unique ID persists throughout the data lifecycle and is enforced at each layer of the platform.
10. Measures for internal IT and IT security governance and management.
• The FDNA organization has defined structures, reporting lines with assigned authority, and responsibilities to appropriately meet business objectives ensuring proper segregation of duties, including an information security function for ensuring security, availability, confidentiality, and privacy
• FDNA has defined information security and privacy policies considering customer contractual commitments and applicable data protection laws and regulations for handling and protecting data. These policies are reviewed on an annual basis and are available on the company portal for employee reference.
11. Measures for certification/assurance of processes and products.
• FDNA complies with the applicable Data Processor requirements outlined in General Data Protection Regulation (GDPR) and HIPAA to help customers meet their obligations as Data Controllers.
12. Measures for ensuring data minimization.
• Information stored in activity logs and databases is pseudonymized wherever possible using a unique randomized user identifier that cannot be back-traced to a specific data subject.
• FDNA never share data with the third parties.
• The minimum personal data required by the FDNA platform is the business email ID to provide a unique user account, First Name, Last Name and Confirmation if user is healthcare professional or not.
13. Measures for ensuring data quality.
• FDNA has admin dashboard which provides capability to modify or delete personal data as and when required.
• FDNA have an option to send request to delete the complete account of a user and once fdna support verify the request with user then complete information will be deleted.
14. Measures for ensuring limited data retention.
• The minimum personal data required by the FDNA platform is the business email ID to provide a unique user account, First Name, Last Name and Confirmation if user is healthcare professional or not.
• The minimum data required for analyzing a case is Patient image.
15. Measures for ensuring accountability.
• FDNA platform authenticates users through an account mapped to a unique email ID or through SSO integration with an Identity Provider using SAML 2.0.
• Accounts with access to systems processing customer and personal data are unique, mapped to individuals, and not shared between users.
• Events and audit trails related to platform and system access are logged, monitored, and reviewed periodically.
• Audit logs maintain detailed information such as timestamps, IP address, application name, specific action taken, request metadata, etc., and are retained for one year.
• Access to modify or delete log files is restricted and segregated such that users who perform privileged activities are unable to manipulate log files.
16. Measures for allowing data portability and ensuring erasure.
• FDNA has admin dashboard which provides capability to modify or delete personal data as and when required. Personal data is retained as per the contractual terms agreed with the customers and as required by the laws.
• Personal data records are removed through a secure data deletion process that irreversibly destroys the data. Healthcare Professional delete any patients information as and when required.
• Healthcare Professional can send request to delete his/her account.

 

Last Updated: January 1, 2023