Skip to main content
QMSQMS
QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
  • Records
    • GP-001 Documents and records control
    • GP-002 Quality planning
    • GP-003 Audits
    • GP-004 Vigilance system
    • GP-005 HR and training
    • GP-007 Post-market surveillance
    • GP-009 Sales
    • GP-010 Suppliers
    • GP-012 Design, Redesign and Development
    • GP-018 Infrastructure and facilities
    • GP-019 Software validation
    • GP-023 Change control management
    • GP-050 Data Protection
      • Deprecated
      • R-050-001 Record of Processing Activities (ROPA)
      • R-050-001 Compliance statement 2024
      • R-050-003 Data access key
      • R-050-004 Controllers, processors and subprocessors
    • GP-051 Security violations
    • GP-052 Data Privacy Impact Assessment (DPIA)
    • GP-200 Remote Data Acquisition in Clinical Investigations
  • TF_Legit.Health_Plus
  • Licenses and accreditations
  • External documentation
  • Records
  • GP-050 Data Protection
  • R-050-001 Record of Processing Activities (ROPA)

R-050-001 Record of Processing Activities (ROPA)

  • Comes from: template T-050-001 Record of Processing Activities (ROPA)

Purpose​

In accordance with article 30.2 of Regulation (EU) 2016/679, of April 27, 2016 (GDPR), we must create and keep updated a registry of the treatment activities carried out under our responsibility. To that effect, we conduct a formal, documented, comprehensive and accurate record of processing activities based on a data mapping exercise that is reviewed regularly.

Procesing activities​

In the following table, you can find a full list of our processing activities:

CodeNameDescriptionWe areSystemCategory
PA-001 CO RecruitmentRecruitmentHiring processes for new employeesControllerDigitalBasic
PA-002 CO EmployeesEmployeesAdministrative management of our hired employeesControllerMixedBasic
PA-003 CO InternshipsInternshipsAdministrative management of our internsControllerMixedBasic
PA-004 CO WorkhoursWorkhoursHourly recording of working hours of our personnelControllerDigitalBasic
PA-005 PR APIAPIManagement of medical data provided via API integration by the customers that use our service.ProcessorMixedSpecial
PA-006 PR Web appWeb appManagement of patient and medical data provided by the users through our web applicationProcessorMixedSpecial
PA-007 CO Scientific publicationsScientific publicationsManagement of data for scientific publications, including clinical validationsControllerMixedSpecial
PA-008 CO SalesSalesManagement of contact details of parties who contract our service.ControllerMixedBasic
PA-009 CO Outbound marketingOutbound marketingData management for outbound commercial activities such as email marketing.ControllerDigitalBasic
PA-010 CO Inbound marketingInbound marketingManagement of data provided by customers with the purposes of knowing more about our serviceControllerDigitalBasic
PA-011 CO Fine tuningFine tuningManagement of the data used to train the medical features of our solution.ControllerDigitalSpecial

Identification of involved parties​

We are​

PropertyValue
Company nameAI Labs Group, S.L.
TrademarkLegit.Health ®
ID Number(ES)B95988127
ActivityProvision of clinical intelligence and communication software for HCP.
AddressGran Via, BAT Tower, 48001, Bilbao, Spain
Telephone+34 653 08 83 37
Emailhello@legit.health
Websitehttps://legit.health
Legal representativeMs. Aguilar Robles

Our DPO is​

Identifying information
Company nameAudens Legal, S.L.P.
AddressCalle del Marqués de Cubas 12, 5ºC, 28014 Madrid
ID Number(ES)B85808954
AddressGran Via, BAT Tower, 48001, Bilbao, Spain
Telephone+34 910 099 875
Emailrgpd@audens.es
Website https://audens.es

PA-001 CO Recruitment​

CodePA-001 CO Recruitment
NameRecruitment
We act asData Controller
DescriptionHiring processes for new employees
Source of the dataJob applicants directly or via recruitment agencies.
PurposesEmployee recruitment and selection.
Interested partiesJob applicants.
Identifying dataNames, contact details, curriculum vitae, employment history, educational background.
Special or criminal data categoriesNone, unless voluntarily provided by the applicant (e.g., health information relevant to the job).
Other type of dataEmployment history, educational background.
Transfer to 3rd partiesRecruitment agencies, background check services (only if applicable and with consent).
International transfersNone, unless data needs to be shared with an international branch of our company for specific job roles.
Deadlines planned for data suppressionData of unsuccessful applicants is kept for a maximum period of 1 year unless consent is given for longer to consider them for future positions.
General description of technical and organizational security measuresAccess to recruitment data is restricted to the HR department and senior management only, with password-protected systems and data encryption. Regular security audits are conducted.
Risk of processingNo probability of a high risk to the rights and freedoms of the data subjects
Lawfulness (legitimization of processing)Unequivocal consent through a clear action by the data subject (Article 6.1.a GDPR)

PA-002 CO Employees​

CodePA-002 CO Employees
NameEmployees
We act asData Controller
DescriptionAdministrative management of our hired employees
Source of the dataDirectly from employees, and occasionally from third-party services for background checks or benefit administration.
PurposesEmployee management, including payroll, benefits, compliance with employment law, and other HR responsibilities. This excludes interns.
Interested partiesEmployees, legal entities (e.g., tax authorities, social security institutions, insurance companies).
Identifying dataNames, addresses, contact details, government-issued IDs (such as social security numbers), employment records.
Special or criminal data categoriesHealth data (only where relevant for benefits management or compliance with employment obligations), union membership (if applicable).
Other type of dataFinancial information (e.g., bank account details for payroll), employment history, performance reviews.
Transfer to 3rd partiesPayroll processing companies, benefit providers, legal advisors (if necessary), government agencies (for reporting purposes).
International transfersNone, unless the company operates in multiple countries and needs to manage employee information across borders.
Deadlines planned for data suppressionEmployee data is retained as long as required by law for tax and employment recordkeeping purposes, typically X years after the end of employment.
General description of technical and organizational security measuresAccess to employee data is restricted to authorized HR personnel and management. Data is stored in secure, encrypted databases with regular audits.
Risk of processingNo probability of a high risk to the rights and freedoms of the data subjects
Lawfulness (legitimization of processing)Performance of a contract or pre-contract with the data subject (Article 6.1.b GDPR)

PA-003 CO Internships​

CodePA-003 CO Internships
NameInternships
We act asData Controller
DescriptionAdministrative management of our interns
Source of the dataDirectly from interns and educational institutions.
PurposesManagement of intern recruitment, training, and evaluation processes.
Interested partiesInterns, educational institutions, mentors within the company.
Identifying dataNames, contact details, educational background, evaluation reports.
Special or criminal data categoriesNone, unless voluntarily disclosed for specific legal or health accommodations.
Other type of dataPerformance evaluations, project assignments, feedback from supervisors.
Transfer to 3rd partiesEducational institutions for the purpose of reporting performance (with consent), third-party platforms for intern management (if applicable).
International transfersNone, unless data needs to be shared with educational institutions or project partners located abroad, under relevant international data transfer rules.
Deadlines planned for data suppressionIntern data is typically retained for the duration of the internship plus X years for performance evaluation and legal compliance purposes.
General description of technical and organizational security measuresAccess to intern data is restricted to relevant HR personnel and intern supervisors. Data is stored in secure systems with access controls and encryption.
Risk of processingNo probability of a high risk to the rights and freedoms of the data subjects
Lawfulness (legitimization of processing)Performance of a contract or pre-contract with the data subject (Article 6.1.b GDPR)

PA-004 CO Workhours​

This processing activity is required by Real Decreto-ley 8/2019, de 8 de marzo, de medidas urgentes de protección social y de lucha contra la precariedad laboral en la jornada de trabajo.

CodePA-004 CO Workhours
NameWorkhours
We act asData Controller
DescriptionHourly recording of working hours of our personnel to comply with Real Decreto-ley 8/2019, which addresses the fight against job insecurity in workdays.
Source of the dataDirect input from employees via digital time tracking systems or manual timesheets.
PurposesTo ensure compliance with Spanish labor laws regarding work hours and to prevent labor abuses.
Interested partiesEmployees, HR department, labor inspectors, and legal entities such as social security and tax authorities.
Identifying dataNames, employee IDs, and the exact times of starting and ending work each day.
Special or criminal data categoriesNone.
Other type of dataWork hours logged, overtime hours, absences, and leave records.
Transfer to 3rd partiesNone, except as required by law (e.g., to labor inspectors or tax authorities).
International transfersNone.
Deadlines planned for data suppressionWork hours data is retained for a minimum of 4 years, as required by Real Decreto-ley 8/2019, to allow for audits and inspections by labor authorities.
General description of technical and organizational security measuresSecure logging systems with access controls limit data access to authorized HR personnel. Data encryption and regular audits ensure data integrity.
Risk of processingNo probability of a high risk to the rights and freedoms of the data subjects
Lawfulness (legitimization of processing)Fulfillment of a legal obligation of the data controller (Article 6.1.c GDPR)

PA-005 PR API​

CodePA-005 PR API
NameAPI
We act asData Processor
DescriptionManagement of medical data provided via API integration by the customers that use our service.
Source of the dataThe interested party or their legal representative to the data controller, who then provides the data to us.
PurposesProvision of computer services
Interested partiesPatients. Other interested groups: doctors.
Identifying dataImages of lesions, which may include birthmarks or tattoos, and in some cases the sex and the age.
Special or criminal data categoriesHealth
Other type of dataPersonal data, limited to sex and age.
Transfer to 3rd partiesNone
International transfersNone
Deadlines planned for data suppressionPreserved following the instructions of the data controller.
General description of technical and organizational security measuresThe implanted security measures correspond to those provided for in Annex II (Security Measures) of Royal Decree 311/2022, of May 3, which regulates the National Security Scheme (ENS) in the field of administration Electronics, which are described in the documents that make up the data protection policy and information security of our entity.
Risk of processingThere is probability of a high risk to the rights and freedoms of the data subjects. DPIA could be required.
Lawfulness (legitimization of processing)Processing is governed by a binding contract or other legal act (Article 28.3 GDPR)
Information to data subjects

Article 24 of the GDPR states that the controller shall implement appropriate technical and organisational measures to ensure and to be able to demonstrate that processing is performed in accordance with the Regulation. In the case of the processing activity PA-005 PR API where we act as processors,** due to the technical nature of the API implementation** it is impossible for us to carry out privacy-by-design measures to inform data subjects of our processing. As such, the controller shall inform the data subject of the processing carried out by us is they are required to do so under the GDPR.

PA-006 PR Web app​

CodePA-005 PR Web app
NameWeb app
We act asData Processor
DescriptionManagement of medical data provided via API integration by the customers that use our service.
Source of the dataThe interested party or their legal representative to the data controller, who then provides the data to us.
PurposesProvision of computer services
Interested partiesPatients. Other interested groups: doctors.
Identifying dataImages of lesions, which may include birthmarks or tattoos, and in some cases the sex and the age.
Special or criminal data categoriesHealth
Other type of dataPersonal data, limited to login credentials, sex and age. I can also include HIS number and other health record identifyer.
Transfer to 3rd partiesNone
International transfersNone
Deadlines planned for data suppressionPreserved following the instructions of the data controller.
General description of technical and organizational security measuresThe implanted security measures correspond to those provided for in Annex II (Security Measures) of Royal Decree 311/2022, of May 3, which regulates the National Security Scheme (ENS) in the field of administration Electronics, which are described in the documents that make up the data protection policy and information security of our entity.
Risk of processingThere is probability of a high risk to the rights and freedoms of the data subjects. DPIA could be required.
Lawfulness (legitimization of processing)Processing is governed by a binding contract or other legal act (Article 28.3 GDPR)

PA-007 CO Scientific publications​

CodePA-007 CO Scientific Publications
NameScientific Publications
We act asData Controller
DescriptionManagement of data for scientific publications to advance the state of the art in medicine, including clinical validations.
Source of the dataData collected from clinical trials, patient records provided by healthcare facilities, or directly from patients under specific research protocols. Also, in some cases, publicy available datasets that are gathered for the purposes of research.
PurposesTo publish scientific findings that contribute to the medical community and enhance understanding of medical conditions and their treatments.
Interested partiesResearchers, healthcare professionals, patients (as study subjects), academic institutions, scientific journals.
Identifying dataDependent on the study but can include patient identifiers, medical histories, and results from clinical assessments.
Special or criminal data categoriesHealth data, potentially including sensitive health information relevant to the research study.
Other type of dataDemographic information, clinical data related to the study, outcome measurements.
Transfer to 3rd partiesData may be shared with academic institutions, research partners, and publication platforms as required for research collaboration and publication.
International transfersData may be transferred internationally as necessary for research collaboration or publication in international journals.
Deadlines planned for data suppressionData is retained as long as necessary to support the research findings, usually as dictated by research protocols and applicable regulatory requirements.
General description of technical and organizational security measuresStrict access controls to ensure that only authorized research personnel can access the data. Data anonymization and encryption where possible.
Risk of processingNo probability of a high risk to the rights and freedoms of the data subjects
Lawfulness (legitimization of processing)Unequivocal consent through a clear action by the data subject (Article 6.1.a GDPR)

PA-008 CO Sales​

CodePA-008 CO Sales
NameSales
We act asData Controller
DescriptionManagement of contact details of parties who contract our service.
Source of the dataData obtained directly from clients during the sales process, through forms, meetings, or other communication channels.
PurposesTo manage client relationships, process orders, and provide services as agreed upon in contracts.
Interested partiesClients, potential clients, business partners.
Identifying dataContact names, company details, job titles, contact information (phone numbers, email addresses).
Special or criminal data categoriesNone.
Other type of dataTransactional details, contractual agreements, communication records.
Transfer to 3rd partiesNone.
International transfersNone.
Deadlines planned for data suppressionClient data is retained for as long as necessary to fulfill the contract and then as required by applicable law for record keeping and tax purposes.
General description of technical and organizational security measuresClient data is stored in secure CRM systems with access controlled by authentication mechanisms and data encryption. Regular security audits are conducted.
Risk of processingNo probability of a high risk to the rights and freedoms of the data subjects
Lawfulness (legitimization of processing)Performance of a contract or pre-contract with the data subject (Article 6.1.b GDPR)

PA-009 CO Outbound marketing​

CodePA-009 CO Outbound Marketing
NameOutbound Marketing
We act asData Controller
DescriptionData management for outbound commercial activities such as email marketing.
Source of the dataData collected from subscriptions on our website, trade shows, or other marketing activities where individuals provide their contact information.
PurposesTo promote products or services to potential customers, including sending updates, newsletters, or special offers.
Interested partiesSubscribers, potential clients, current clients.
Identifying dataNames, email addresses, phone numbers, job titles, company names.
Special or criminal data categoriesNone.
Other type of dataMarketing preferences, interaction records with previous campaigns (e.g., open rates, click-through rates).
Transfer to 3rd partiesNone
International transfersNone
Deadlines planned for data suppressionData is retained as long as the individual is considered an active subscriber or until they opt out or request deletion. Retention periods may also be governed by specific legal requirements.
General description of technical and organizational security measuresUse of secure, compliant marketing platforms that ensure data protection. Access controls and encryption protect the data. Regular audits verify adherence to security policies.
Risk of processingNo probability of a high risk to the rights and freedoms of the data subjects
Lawfulness (legitimization of processing)Unequivocal consent through a clear action by the data subject (Article 6.1.a GDPR)

PA-010 CO Inbound marketing​

CodePA-010 CO Inbound Marketing
NameInbound Marketing
We act asData Controller
DescriptionManagement of data provided by customers with the purposes of knowing more about our service.
Source of the dataData collected from website forms, live chats, emails, and during phone calls where customers express interest in our services.
PurposesTo respond to customer inquiries, provide detailed information about our products and services, and nurture potential sales leads.
Interested partiesPotential customers, existing customers, marketing and sales teams.
Identifying dataNames, email addresses, phone numbers, organizational affiliation.
Special or criminal data categoriesNone.
Other type of dataCommunication records, interaction histories with marketing content (e.g., downloads of whitepapers, webinar attendance).
Transfer to 3rd partiesNone.
International transfersNone.
Deadlines planned for data suppressionData is retained for as long as it is deemed necessary for customer relationship management and until consent is withdrawn or the customer requests deletion, adhering to legal retention requirements.
General description of technical and organizational security measuresSecured databases with strict access controls. Data encryption in transit and at rest. Regular security assessments to ensure compliance with privacy standards.
Risk of processingNo probability of a high risk to the rights and freedoms of the data subjects
Lawfulness (legitimization of processing)Unequivocal consent through a clear action by the data subject (Article 6.1.a GDPR)

PA-011 CO Fine tuning​

CodePA-011 CO Fine Tuning
NameFine Tuning
We act asData Controller
DescriptionManagement of the data used to train and refine the medical features of our solution, in compliance with medical device regulations.
Source of the dataData collected from clinical trials, partnerships with healthcare facilities, and directly from patients under specific agreements.
PurposesTo enhance the accuracy, efficiency, and safety of our medical device solutions through ongoing refinement and compliance with industry standards.
Interested partiesPatients (data subjects), clinical researchers, regulatory bodies.
Identifying dataDependent on the medical device being refined but may include health metrics and images.
Special or criminal data categoriesHealth data, potentially including sensitive health information necessary for device calibration and performance improvements.
Other type of dataDevice performance data, software interaction logs, feedback from healthcare professionals.
Transfer to 3rd partiesData may be shared with regulatory authorities, clinical research organizations, and third-party auditors involved in compliance and certification.
International transfersData may be transferred internationally as necessary, in accordance with global compliance requirements for medical devices.
Deadlines planned for data suppressionData is retained as long as necessary for compliance with medical device regulations and to support validation and certification processes, then securely disposed of as per legal and regulatory guidelines.
General description of technical and organizational security measuresData is processed in compliance with ISO 13485, ensuring robust security measures such as encryption, access control, and regular security audits to protect data integrity and confidentiality.
Risk of processingNo probability of a high risk to the rights and freedoms of the data subjects
Lawfulness (legitimization of processing)Unequivocal consent through a clear action by the data subject (Article 6.1.a GDPR)
Previous
R-050-001 Compliance statement 2023
Next
R-050-001 Compliance statement 2024
  • Purpose
  • Procesing activities
  • Identification of involved parties
    • We are
    • Our DPO is
  • PA-001 CO Recruitment
  • PA-002 CO Employees
  • PA-003 CO Internships
  • PA-004 CO Workhours
  • PA-005 PR API
  • PA-006 PR Web app
  • PA-007 CO Scientific publications
  • PA-008 CO Sales
  • PA-009 CO Outbound marketing
  • PA-010 CO Inbound marketing
  • PA-011 CO Fine tuning
All the information contained in this QMS is confidential. The recipient agrees not to transmit or reproduce the information, neither by himself nor by third parties, through whichever means, without obtaining the prior written permission of Legit.Health (AI LABS GROUP S.L.)