The patient file
Introduction
Since their recognition as healthcare professionals in 2016, clinical psychologists have been subject to specific obligations related to this new status, particularly regarding the management of the "patient file.
These requirements for managing the "patient file" are mainly defined in two legislative texts:
- The Law on the Quality of Healthcare Practice (LQS)
- and the Law on Patient Rights (LDP).
Among the key provisions of the latter, Article 9, §1 states: "Patients have an undeniable right to a carefully maintained and securely stored patient file"
Other psychologists (non-clinical) should also strive to comply with the Law on Patient Rights and the Law on the Quality of Healthcare, insofar as these laws are relevant to their practice and no other specific regulations are in place. Consequently, the following provisions apply to clinical psychologists and, to the extent they are relevant, to all other psychologists in the absence of specific regulations concerning them.
What should the patient file contain?
Article 33 of the "Quality Law" defines the content of the patient file for all healthcare professionals:
"The healthcare professional shall, where applicable and within the limits of their competence, include at least the following information in the patient's file":
1° Identification of the patient by their social security number (NISS), name, gender, date of birth, address, phone numbers, and email addresses;
2° Identification of the patient's general practitioner;
3° Personal identification of the healthcare professional and, if applicable, that of the referring professional and other healthcare professionals involved in the care provided;
4° The reason for the contact or the issue at the time of the consultation;
5° Personal and family medical history;
6° The results of exams such as clinical, radiological, biological, functional, and histopathological tests;
7° A report of the consultations with the patient, other healthcare professionals, or third partie;
8° Statements, reports, or opinions received from the patient or third parties;
9° Health objectives and expressions of will received from the patient;
10° The diagnosis made by the relevant healthcare professional;
11° Characterization of the patient as referred to in Article 12;
12° A chronological overview of the care provided, including the type and date of care;
13° The progression of the condition, if relevant;
14° Referrals to other healthcare professionals, services, or third parties;
15° Medications and health products used pre, peri-, and post-operatively, including the medication plan;
16° Complications requiring additional treatment;
17° In case of hospitalization, if the healthcare professional deems it relevant, a daily note assessing the patient's health status;
18° The mention that, in accordance with [Article 11/1] of the Law of August 22, 2002, regarding patient rights, information has been communicated, with the patient's consent, to a trusted person or to the patient in the presence of a trusted person, and the identity of this trusted person;
19° The patient's express request not to be provided with information according to Articles 7, § 3, and 8, § 3, of the aforementioned Law of August 22, 2002;
20° The justification for not disclosing information to the patient under Article 7, § 4, of the aforementioned Law of August 22, 2002;
21° The patient's request, in accordance with [Article 11/1] of the aforementioned Law of August 22, 2002, to be assisted by a designated trusted person or to exercise their right to consultation through this person, including the identity of the trusted person;
22° The justification for the total or partial rejection of a patient's representative's request to access or copy the patient file, under Article 15, § 1, of the aforementioned Law of August 22, 2002;
23° The justification for the exemption from the decision made by a representative of the patient under Article 15, § 2, of the aforementioned Law of August 22, 2002;
24° The identity and scope of the competency of the trusted person referred to in Article 11/1, § 1, of the Law of August 22, 2002, on patient rights.
Should all these elements be included?
No, as stated in the law, you only need to include the elements that apply, if relevant, and that fall within your area of competence (Article 33 (1) LQS).
Can you also include other elements?
This list is not exhaustive. Therefore, you can include other elements necessary to complete and continue your care of the patient.
Note, anything you add to the patient's file is accessible to the patient.
What about personal notes?
All notes you take about the patient must be included in their file. This specifically includes your working hypotheses, personal reflections, and subjective observations.
Personal notes have always been an integral part of the patient file. However, access to these notes has recently changed as part of the reform of the Law on Patient Rights.
Therefore, a distinction must be made between notes taken before March 4, 2024, and those taken after March 4, 2024.
- Notes taken until March 3, 2024, inclusive: The patient, their representative, or a trusted person does not have access to personal notes when they request to view their file, and only a healthcare professional designated by the patient may access them.
- Notes taken from March 4, 2024, onwards: The patient, their representative, or a trusted person can view the entire file, with the exception of data related to third parties.
How long should the file be kept?
You must keep the patient's file for a minimum of 30 years and a maximum of 50 years after the last contact with the patient (Article 35 LQS). After this period, you may (or even must) carefully destroy it.
Note, the retention period for files has implications when ceasing activity: if you permanently stop your practice, you must transfer the patient's file and any other relevant and necessary information for the continuity of care to a fellow clinical psychologist with the patient's consent.
(Note that it is assumed the file must be transferred to a fellow clinical psychologist, but the Law on the Quality of Care uses the term "healthcare practitioner." Therefore, it could also be argued that it is possible to provide the patient's file to, for example, the general practitioner (Article 20, §1, first paragraph LQS)).
Can the patient request the destruction of their file?
No, you cannot comply with this request. You must keep the file for at least 30 years (Article 35 LQS).
In our opinion, the right to be forgotten (Article 17 GDPR) does not apply, as the retention of health data will continue to be necessary for the purpose for which it was collected (in particular, ensuring continuity of care and providing quality healthcare). Furthermore, the processing (note: this refers to storage, not sharing!) of health data itself does not require explicit consent that could be withdrawn. In fact, the necessity of processing for the provision of healthcare services (Article 9, paragraph 2, point h of the GDPR) constitutes a sufficient legal basis.
Must the file be kept electronically?
Article 34 of the Quality Law does indeed include the idea that "by a decree to be determined by the King after consultation with the Council of Ministers, you will be required to maintain and store the patient's file in electronic form (Article 34 LQS)."
However, as of now, no royal decree has been issued, so this measure is not yet in effect. In the meantime, you may still keep a paper file, with the understanding that your employer—if applicable—may already require you to store the patient file electronically.
Once a royal decree is published, we will be able to provide you with detailed information on recommended software and the essential considerations for data security. For now, these issues remain open.
Can the patient access their file?
Your patients have the right to directly and autonomously consult all or part of the file you have created about them (Article 9, §2 LPD).
The following rules apply in this regard (Article 9, §2 LPD):
1. You must respond to their request for consultation within 15 days.
2. Data related to third parties are excluded from the right to consultation.
It may be advisable to be present when the patient exercises their right to consultation to provide any necessary additional comments. However, your presence is not mandatory: if your patient does not wish for your assistance, they can exercise their right to consultation on their own.
A small clarification regarding personal annotations: before March 4, 2024, and the reform of the Law on Patient Rights, the patient did not have access to personal notes when requesting to view their file. Only a healthcare professional designated by the patient could access these notes.
Now, the law stipulates that the patient, their representative, or a trusted person can consult the entire file, with the exception of data related to third parties. For patients followed before March 4, 2024, all personal notes taken before this date may be removed from the file during the consultation. However, all personal notes taken after this date must be presented to the patient.
Can the patient request a copy of their file?
In addition to the right to consultation, the Law on Patient Rights also provides a right to a copy of the entire file or part of it (Article 9, §3, LDP). This copy can be written, but it is not mandatory—it can also be a digital copy (saved on a USB drive, sent by email, etc.).
The right to a copy is subject to the following conditions (Article 9, §3, LDP):
- You must respond to the request for a copy within 15 days;
- Data concerning third parties are excluded from the right to a copy;
- If there are clear indications that the patient is under pressure to share their file with third parties (family members, insurance companies, etc.), you must refuse to provide a copy of the file. Although not specified in the Patient Rights Law, it may be useful to note this in the file.
Except for the first copy, which you must provide free of charge (Article 15, §3, GDPR), you have the right to charge your patient for a copy of their file. You should adhere to the following rules:
- you cannot charge more than 0.10 euros per A4 page copied;
- the total amount for a written copy cannot exceed 25 euros;
- you cannot charge more than 10 euros for a digital copy.
Can a parent of a patient consult their child's file?
In principle, the parent of a minor patient is responsible for exercising their rights and can therefore consult their child's file. However, for minor patients, several factors must be taken into account, such as the minor's ability to discern, and whether the minor is exercising certain rights related to healthcare. It is also important to consider parental authority and the best interests of the child.
In this context, we encourage you to contact us to analyze each situation on a case-by-case basis, taking into account both the legislation and the specific circumstances of the minor.
