Ethical Code

1. Prevention and early detection

UpRetina promotes opportunistic retinal screening in asymptomatic patients without ophthalmological supervision, to identify early suspicion of central retinal diseases and recommend a timely referral. This activity constitutes a medical act of prevention and health promotion, performed by indirect means through telemedicine, in accordance with Article 6.1 of the Code of Medical Deontology (CDM 2022).

2. Consent and patient information

We have an informed consent and an explanatory sheet written in clear language, informing about the objectives, limitations, and scope of the test performed, in accordance with Law 41/2002, of November 14, basic regulator of patient autonomy and rights and obligations regarding clinical information and documentation. The collaborating center must always offer this consent so that participation is an informed choice by the patient.

3. Accessibility

Our commitment is to expand access to screening, prioritizing the population that does not regularly attend ophthalmological consultations and that may be outside the usual medical control circuit (7,8).

4. Complementary nature — Scope of screening

This service does not intend to nor can it replace an in-person ophthalmological consultation, which is expressly stated in the screening reports, informed consent, and all communication to the patient. The result is limited to the identification of suspected anomalies and the recommendation of a consultation with an ophthalmologist. The final diagnosis must be established exclusively in an in-person consultation.

5. Specialized medical evaluation

All images are evaluated by registered ophthalmologists with proven experience in retinal pathology. The software tools used have an auxiliary function, not substituting the specialist’s clinical judgment (SERV Recommendation 3), and have the corresponding CE marking as a medical device under Regulation (EU) 2017/745 (MDR) and Royal Decree 192/2023, under a quality management system based on the ISO 13485:2016 standard. Clinical validation studies are endorsed by ethics committees in accordance with applicable regulations.

6. Duty of abstention due to insufficient information

The evaluating ophthalmologist must refrain from issuing a screening report when the retinographic images or clinical information provided are insufficient for a responsible evaluation. Issuing a report without a sufficient basis compromises the reliability of the screening and can mislead both the optical center professional and the person being studied. In these cases, the ophthalmologist will mark the case as non-evaluable and indicate the reason, so that the center can correct the issue. This duty of abstention is an expression of clinical independence and the individual deontological responsibility of the ophthalmologist (Articles 6.5 and 49.1 CDM 2022).

7. Professionalism and identification of the doctor

Screening reports are signed by ophthalmologists with experience in retina, titled in Spain, with active registration and current professional civil liability insurance. Each report includes the full name and registration number of the doctor responsible for the evaluation, unequivocally identifying the professional in each act, according to Article 80.1 of the CDM 2022 and SERV Recommendation 5. UpRetina has a complete list of doctors responsible for and in charge of providing the offered services, published at upretina.com/equipo-medico.

8. Individual deontological responsibility

The deontological responsibility of each ophthalmologist does not disappear or dilute by acting through a telematics platform or by being part of a team, according to Article 49.1 of the CDM 2022. Each ophthalmologist is the holder of the legal and deontological consequences resulting from their professional acts. UpRetina cannot and does not intend to replace the professional’s clinical judgment: in every medical act, the doctor’s judgment will always be the one that determines the evaluation and decides the appropriate response, according to Article 6.5 of the CDM 2022.

9. Telemedicine according to the Code of Medical Deontology

The screening activity is performed through non-face-to-face telematics means, which complies with Medical Deontology as long as the three requirements of Article 80.1 of the CDM 2022 are met:

All deontological precepts of the CDM 2022 fully apply to the UpRetina screening activity, according to Article 81.1.

• Unequivocal identification of those involved: each report signed with full name and collegiate number.
• Guaranteed confidentiality: pseudonymized patient data, access through personal and non-transferable credentials.
• Secure communication channels: platform certified as a medical device with CE marking, encryption in transit (TLS 1.2+) and at rest, servers in the EU (AWS Frankfurt, eu-central-1).

10. Documentary record

All screening activity carried out through the platform is recorded in UpRetina’s information system, which constitutes the documentary support of the healthcare process. This record includes retinographic images, associated clinical data, the issued report, the identification of the evaluating ophthalmologist, and the date and time of each action, according to Article 80.2 of the CDM 2022 and Law 41/2002.

11. Regulatory framework

UpRetina operates within a comprehensive regulatory framework:

• Medical Device: The platform is a CE-marked software compliant with Regulation (EU) 2017/745.
• Manufacturing License: AEMPS No. 9280-PS, granted by the Spanish Agency of Medicines and Medical Devices.
• Healthcare affiliation: Regional regulations require that healthcare activity provided through telemedicine be backed by a healthcare center with administrative authorization. In compliance with this requirement, UpRetina is affiliated with Institut d’Oftalmologia Clínica Girona (CCN 0917001372). This affiliation is exclusively formal and administrative: it does not imply clinical, economic, or hierarchical dependence on the affiliated center, and the affiliation contract expressly accredits that there is no economic interest that could affect the independent evaluation of the ophthalmologists or any conditioning in the patient’s free choice. This configuration complies with SERV Recommendation 6, which prohibits the platform from being linked to a medical center under terms that generate referral bias.
• Quality Management System: ISO 13485:2016, with risk analysis (ISO 14971), usability (IEC 62366), and post-market surveillance according to the MDR.
• Deontological framework: CDM 2022, SERV Recommendations, Declaration of Helsinki, ICH Good Clinical Practice Guidelines.

12. Referral independence and absence of conflicts of interest

We guarantee full independence in referral: screening reports do not include references or recommendations to specific ophthalmological centers, clinics, consultations, or professionals. If a suspicion of anomaly is detected, the patient is advised to visit "their reference ophthalmologist," without any direct or indirect interest in that decision (SERV Recommendation 6). The healthcare affiliation described in point 11 does not contradict this principle: it is an administrative requirement demanded by the autonomous communities, formalized through a contract proving the absence of any clinical or economic conditioning.

13. Ethical remuneration model

The remuneration of collaborating ophthalmologists is a fixed rate per report, without commissions, volume variables, productivity bonuses, and without any link to the outcome of the report (referral or no referral) or to any specific optical center. This remuneration structure complies with the provisions of Article 92.2 of the CDM 2022, which considers charging commissions and referring patients for profit between professionals or institutions contrary to Medical Deontology. The medical act of screening is not exclusively for economic benefit (Article 92.1 of the CDM 2022), but for the prevention and promotion of visual health.

14. Pseudonymization and impartiality

Patient and collaborating center data are pseudonymized before being accessible to the evaluating ophthalmologist: they only access retinographic images and non-identifying clinical data (age, gender, anamnesis, health background). Cases are distributed randomly among collaborating ophthalmologists, avoiding any direct link between a specific ophthalmologist and a specific optical center and ensuring impartiality in evaluation.

15. Plural coverage

The evaluating medical team is composed of ophthalmologists located in different parts of the Spanish territory, favoring diversity and objectivity in image reading (SERV Recommendation 7).

16. Referral transparency

Any alteration found in the retinography is communicated to the patient through the screening report, regardless of its potential clinical relevance, recommending its definitive assessment in a face-to-face ophthalmological consultation.

17. Responsible communication and advertising

All UpRetina communication about the screening service, both directed at collaborating centers and the general public, must be objective, prudent, and truthful, according to Articles 87.3 and 88.2 of the CDM 2022. In particular:

• Informative messages will be clearly differentiated from advertising ones (Article 87.3 CDM 2022).
• False expectations will not be generated, nor will it be suggested that screening equates to a diagnosis (Article 89.1 CDM 2022).
• Clinical terminology that may cause confusion about the scope of the service will not be used.
• Collaborating centers will receive clear training and instructions on how to communicate the service to patients, consistent with this Ethical Code.

18. Data protection

We rigorously comply with the General Data Protection Regulation (EU) 2016/679 (GDPR) and Organic Law 3/2018 (LOPDGDD), as well as all applicable confidentiality regulations. UpRetina acts as a data processor on behalf of the collaborating centers or establishments, which are the data controllers. Collaborating ophthalmologists act as sub-processors according to Article 28.4 of the GDPR. The technical and organizational security measures are detailed in the corresponding processing and sub-processing assignment contracts.

19. Collegiate recognition

UpRetina has proactively communicated its activity to the Medical Associations of multiple autonomous communities. The responses obtained to date — including those from the Col·legi de Metges de Barcelona, the Medical Association of Bizkaia, the Medical Association of A Coruña, and the Medical Association of Sevilla — have recognized the ethical and deontological conformity of the activity performed by ophthalmologists and by UpRetina.

Scope of application and acceptance

This Ethical Code is of mandatory knowledge and compliance for:

Its full text is publicly available on upretina.com. Any updates will be communicated to recipients at least thirty (30) days in advance.

Failure to comply with the principles outlined in this Ethical Code may lead to the termination of the contract with the professional or center involved, without prejudice to any applicable liabilities.

• All staff of OPT RETINA, S.L.
• Collaborating ophthalmologists, who receive and accept it alongside the professional services contract.
• Collaborating centers, who receive it alongside the service terms and conditions.

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