Patient Identification Vigilance: The Key to Health Data Security and Quality of Care

In the digital age, where health data is increasingly accessible and shared, patient identification vigilance has become a fundamental pillar for guaranteeing the security of patient information and the quality of care pathways. Ensuring that each piece of data is correctly associated with the right patient is an ethical, legal, and clinical imperative. This article explores in depth the concept of patient identification vigilance, its regulatory framework in France around the National Health Identity (INS), the key procedures to implement, the role of the various stakeholders, the essential security measures, and the expected benefits for the healthcare system.

What is patient identification vigilance? Definition and Challenges

identity vigilance is the set of procedures and measures implemented to guarantee the unique and reliable identification of a person throughout their healthcare journey. It aims to prevent identification errors, such as duplicates, identity clashes, or data assignment errors, which can have serious consequences for patient care.

In a context where digital health services are developing rapidly, the challenge of identity vigilance has become crucial. The ability to securely and permanently associate personal health data with the person to whom it relates is essential for several reasons:

• Safety of care: Incorrect identification can lead to errors in diagnosis, treatment, medication administration, or even surgical interventions on the wrong patient. Patient identification vigilance helps minimize these risks and ensure the safety of care.
• Data Quality: By guaranteeing the correct association of data, patient identification vigilance contributes to the creation of reliable and complete patient records, thus facilitating continuity and coordination of care.
• System Interoperability: The use of a unique and qualified identity facilitates the secure exchange and sharing of health data between the various stakeholders in the care pathway, thereby improving the efficiency of the system.
• Respect for Patient Rights: Patient identification vigilance guarantees patients' access to their own health data and respects their right to confidentiality and privacy.
• Risk Management: Identification errors can have significant legal and financial implications. for healthcare facilities and professionals. Patient identification vigilance contributes to managing these risks.

Faced with these challenges, France has implemented a regulatory framework and specific tools, notably the National Health Identity (INS), to strengthen patient identification vigilance within the healthcare system.

The National Health Identity (INS): Foundation of Patient Identification Vigilance in France

The National Health Identity (INS) is the reference identifier for individuals receiving healthcare and social care in France. It relies on the use of the National Identification Number (NIR), more commonly known as the social security number, or the pending registration number (NIA) for individuals whose NIR is being assigned. It is crucial to distinguish the National Health Service (INS) identification number, which is the same as the NIR or NIA used for referencing health data for healthcare or social care monitoring purposes, from the NIR used for other administrative purposes. The use of the NIR as an INS identification number is strictly regulated and limited to the health and social care sectors. The main objective of the INS is to enable reliable and unambiguous referencing of users' health data throughout the country. It consists of several elements:

• The INS registration number (NIR or NIA).
• The INS traits, which are the reference identity elements associated with the NIR/NIA in the national reference databases (surname at birth, list of given names at birth, sex, date of birth and official geographical code of the place of birth).
• The organization that assigned the INS, in the form of an OID (Object Identifier).

The use of the INS has become mandatory for professionals, establishments, services and organizations involved in the health or medico-social care of individuals. Any other identifier may only be used if access to the INS is impossible, in order to avoid hindering patient care.

The INS, combined with identity traits, has emerged as the most suitable solution for identifying users of the healthcare system, referencing their data, and facilitating its secure sharing among healthcare providers, while respecting confidentiality rules.

The National Identity Vigilance Reference Framework (RNIV): The normative framework and best practices

The National Identity Vigilance Reference Framework (RNIV), annexed to the INS reference framework, is an essential document that specifies all the rules and procedures to be implemented by the organizations responsible for referencing health data with the INS in the field of identity vigilance. It was developed in close collaboration with the association of regional identity vigilance coordinators (3RIV), healthcare professionals, and digital health companies. The RNIV aims to guarantee the quality of user identification through the implementation of rigorous procedures. It defines, in particular, the rules for determining the status of the INS, distinguishing between an unqualified INS and a qualified INS (with the status "qualified identity").

An INS is considered qualified if it meets two conditions:

• The identity of the person has been validated in accordance with the identity vigilance procedures described in the RNIV.
• The INS (INS registration number and associated identity features) has been retrieved from the national reference databases (RNIPP or certified copy) via the INSi online service or the Carte Vitale app.

The RNIV describes the procedures Identity vigilance measures to be implemented during primary (first contact) and secondary (subsequent contacts) identification with the user. It also addresses the management of homonyms, the correction of identification errors, and the measures to be taken in case of suspected identity fraud. The INS reference document, in its version 2.1 of December 2024, cancels and replaces the previous version and specifies the rules for integrating and "qualifying" the INS in professional software, particularly in the private sector. The changes made take into account feedback from healthcare professionals and aim to simplify qualification procedures in certain situations.

Key Steps and Procedures of Patient Identification Vigilance

Implementing patient identification vigilance relies on a set of key steps and procedures, ranging from the initial patient identification to managing errors and updates to their identity.

1. Primary Identification: During the initial care of a patient, it is essential to carry out a rigorous identification to create a unique digital identity in the health information system. This step generally includes:

• Collecting the user's identity details (surname, first names, date and place of birth, gender).
• Verifying this information using supporting documents (identity card, passport, etc.).
• Searching the information system to check if the user has already been identified (avoiding duplicates).
• If a qualified INS number is not available, an attempt to retrieve the INS number via the INSi online service (by reading the health insurance card or entering identity details) or the Carte Vitale app must be made as soon as possible.
• Assigning a confidence level to the registered identity, in accordance with the procedures defined in the RNIV.

2. Secondary Identification: During subsequent contact with the user, it is necessary to verify their identity before any consultation or treatment. This can be done through various methods (questioning the user, reading their health insurance card, etc.) and must ensure that it is indeed the person concerned.

3. Qualification of the National Health Identifier (INS): The INS must be qualified as soon as possible to guarantee its reliability. This qualification involves validating the user's identity through identity vigilance procedures and retrieving the INS from the reference databases via the INSi online service or the health insurance card app. An unqualified INS must not be circulated internally or externally.

4. Use of the qualified INS: As soon as a user's INS has been qualified, the INS number and identifying features from the reference databases must be used for their identification, particularly during health data exchanges. The retrieved identifying features must replace the local strict features in the corresponding fields.

5. Error and update management: Procedures must be in place to detect and correct identification errors. In the event of an INS correction, measures must be in place to ensure the dissemination of the information to the actors and systems to which the data has been transmitted. The history of a person's INS numbers must be retained.

6. Periodic Verification of the INS: After a configurable period (approximately 5 years), a verification operation of the INS via the online service must be requested to ensure its validity. This verification can be carried out during a patient care episode or an interaction with the user.

Stakeholders in Patient Identification Vigilance: Roles and Responsibilities

The effective implementation of patient identification vigilance is a shared responsibility among the various stakeholders in the healthcare system.

• Healthcare Professionals, Healthcare Facilities, and Social Care Services: They are required to use the INS for referencing the health data of the individuals they care for. They must implement the identity vigilance procedures defined in the RNIV and ensure the INS is qualified. They are responsible for complying with legal requirements and security measures related to data referencing with the INS within their organizations.
• Health data referencing managers: They are responsible for ensuring the application of rules relating to the INS and identity vigilance within their organization. In particular, they must ensure that authorized users of the INS belong to the "circle of trust," define the INS retention period, inform the individuals concerned about the use of the INS, and implement appropriate security measures.
• Service providers and software publishers: They are key players in the integration of the INS and identity vigilance functionalities into health information systems. They can act as data processors for the data controller and must comply with the requirements of the INS framework. Their software solutions must facilitate the retrieval, qualification, and use of the INS, as well as the implementation of patient identification vigilance procedures. The French Digital Health Agency (ANS) and the National Health Insurance Fund (Cnam): They are jointly responsible for the INSi online service. Cnam is responsible for the operational implementation of the online service and the Carte Vitale app, which enable the retrieval and verification of the INS. The ANS maintains the IGC-Santé certification authority, which issues electronic identification credentials for accessing the online service.
• Regional Identity Vigilance Coordinators (3RIV): They play a vital role in supporting and disseminating best practices in identity vigilance at the regional level.

Raising awareness and training of all staff involved in user identity verification are essential to ensure the effectiveness of identity vigilance. Particular attention must be paid to the distinction between the INS registration number and other potential uses of the NIR.

Security and identity vigilance: Protecting the INS and health data

Linking health data to the INS introduces an additional risk that must be controlled by implementing appropriate security measures. These measures must be integrated into the risk analysis and data protection impact assessment (DPIA) carried out by data controllers. The main risk categories to consider following the integration of the National Health Identifier (INS) are the loss of availability, the loss of integrity, and the loss of confidentiality of data (health data and INS), as well as the loss of auditability of actions performed. The minimum security measures to be implemented for the INS include: Identity Management: Definition and application of identity vigilance procedures compliant with the National Health Insurance Information System (RNIV). Prohibition of the transmission of unqualified INS. Prohibition of local modification of the INS number and reference identity features. Use of the qualified INS for data exchanges. Mandatory sending of reference identity details with the INS registration number during exchanges. Traceability of exchange partners. Procedures for disseminating INS corrections. User awareness.

The person responsible for referencing health data must justify compliance with these measures, which may be included in the information system's security accreditation.

The benefits of patient identification vigilance and future prospects

The rigorous implementation of patient identification vigilance and the widespread use of qualified National Health Identifiers (NHIs) bring numerous benefits to the healthcare system:

• Significant reduction in medical errors related to identification problems.
• Improved quality and reliability of health data, promoting more informed and personalized care.
• Facilitated coordination and continuity care thanks to a smooth and secure exchange of information between professionals.
• Strengthening the security of health data and respect for patient privacy.
• Optimizing the efficiency of the healthcare system by reducing duplication and administrative errors.
• Contributing to the creation of reliable health databases for research and practice evaluation.

The Digital Health Roadmap aims for widespread use of the National Health Identifier (INS) in digital health services, with a significant target of 90% qualified identities in the active patient list of healthcare facilities.

The arrival of the Vitale Card App considerably simplifies The management of the National Health Identity (INS) for healthcare professionals, by allowing the direct retrieval of the patient's (or their legal representatives') qualified identity when the application is opened. This development helps facilitate the qualification of the INS and achieve the set objectives.

In conclusion, patient identification vigilance, supported by the National Health Identity framework and the National Patient Identification Vigilance Reference Framework, is a major issue for the digital transformation of the healthcare system. It is the cornerstone of data security and quality of care, ensuring that each patient is correctly identified and that their health information is protected throughout their care pathway. The mobilization and commitment of all stakeholders are essential to achieving robust and widespread patient identification vigilance for the benefit of all users of the healthcare system.

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