Model information on the processing of personal data of the FSE

This privacy notice is updated based on the model approved on December 21, 2023, by the Data Protection Authority and contains information on all the treatments provided for by the decree of the Ministry of Health of September 7, 2023 "Electronic Health Record 2.0".

The services not active as of today, as they are in the implementation or realization phase within the interventions of the National Recovery and Resilience Plan (PNRR), are indicated with an asterisk. 

1. Introduction

The Electronic Health Record (hereinafter also referred to as “EHR”) is a collection of digital health and social health data and documents generated by clinical events that concern you, related to services provided by the National Health Service (NHS) and private healthcare facilities.

The EHR is a fundamental tool for improving the quality of care, as it provides a detailed clinical picture when you consult a healthcare professional (your family doctor, a specialist, in case of access to the emergency room, etc.). 

2. L’alimentazione del FSE

Consents to the consultation of the FSE

3.1. Legal basis

Based on current regulations, the FSE is fed with data and documents related to the services provided to you and is accessible by you and the doctor who produced them.

In order for the FSE to be accessible by healthcare personnel for the purposes of care, prevention, and international prophylaxis, it is necessary for you to express specific consents. 


3.2. Expression of consents to the consultation of the FSE

Your consents, free, specific, informed, and unequivocal, are required to allow the consultation of the data and documents present in the FSE separately for each of the following purposes:

  • diagnosis, treatment, and rehabilitation; 

  • international prophylaxis (set of medical procedures adopted internationally to prevent the onset and spread of diseases); 

  • prevention.

Regarding the purpose of prevention, consent is required separately for:

  • subjects of the SSN and regional social health services of the region of assistance and healthcare professionals who take care of you or provide you with healthcare assistance; 

  • regions through the competent offices in the field of health prevention, as well as the Ministry of Health through the competent General Directorate in the field of health prevention.

The lack of consent to the consultation of the FSE does not have consequences on the provision of healthcare services. However, making this information available allows healthcare professionals to have a broader and more accurate clinical information framework for safer and more appropriate care, targeted prevention activities, or international prophylaxis. In fact, in the absence of consent, the data and documents contained in the FSE are visible only to you and the doctor who produced them and will not be accessed for the purposes of diagnosis, treatment, rehabilitation, international prophylaxis, and prevention.

You can express and revoke your consents to the consultation online, by directly accessing your FSE, or through the dedicated offices of each Local Health Authority in the Lazio Region.

The revocation of each consent prevents the consultation of the data and documents of the FSE, for the purposes and towards the subjects of the aforementioned consent, without prejudice to the right to receive healthcare services and keeping the data and documents visible to you and the doctor who produced them.

You can subsequently express new consents to the consultation of the data and documents of the FSE, making all your data and documents of the FSE available for consultation again, for the specific purposes for which such consents were expressed.

At the time of expressing consents or revocations by you, the Consents and Revocations Registry*2 is electronically updated and the information is used to verify at each request for consultation that you have previously expressed consent for consultation. 


3.2.1 Expression of consents to the consultation of the FSE of minors and subjects under guardianship 

In the case of a minor, consents are expressed by the person exercising parental responsibility, after identifying themselves.

Upon reaching the age of majority, consents must be confirmed by an express manifestation of will from the newly of age individual, after having reviewed the Information, even electronically.

For subjects under the forms of protection provided by the Civil Code in cases of total or partial incapacity to manage their own interests, consents are expressed by the guardian, curator, or support administrator, where this falls within the powers conferred to them based on the provisions issued by the Judicial Authority.

In the event that you are expressing consents as the person exercising parental responsibility, or as a guardian, curator, or support administrator, you can do so in the same manner as described in the previous paragraph 3.1, once access to the FSE of your minor child or the subject under your guardianship has been requested and obtained in the manner described in the subsequent paragraph 9 of this information.


3.3 Data controllers for the collection and registration of consents

The region of assistance and the Ministry of Health, limited to SASN3 beneficiaries, are the data controllers for the collection and registration of consents.


2 Currently, the Consents and Revocations Registry is not updated with information regarding consents granted for the purposes of prevention and international prophylaxis. 

4. Trattamenti per finalità di cura

5. Trattamenti per finalità di prevenzione*

6.Trattamenti per finalità di profilassi internazionale*

Trattamenti per finalità di programmazione sanitaria, verifica delle qualità delle cure e valutazione dell'assistenza sanitaria (“di governo”)*

Trattamenti per finalità di studio e ricerca scientifica, in campo medico, biomedico ed epidemiologico (“di ricerca”)*

9. Accesso e consultazione da parte del cittadino

10. Delega

11. Oscuramento di dati e documenti

12. Altri diritti dell’interessato

13. Modalità di esercizio dei diritti

14. Registrazione delle operazioni sul FSE

15. Periodo di conservazione dei dati

16. Modello architetturale del FSE

17. Il Responsabile della Protezione dei Dati personali (RPD)

18. Soggetti autorizzati al trattamento e ambito di comunicazione dei dati

19. Trasferimento dei dati personali verso paesi non appartenenti all’Unione Europea

20. Principali riferimenti normativi di settore

21. Glossario