Electronic medical records: what they must contain under Spanish Law 41/2002

The electronic medical record is the same one as always, in software instead of on paper. Spanish Law 41/2002 requires each centre to file medical records, whatever the format, in a way that guarantees their security, their proper preservation and the retrieval of the information. And it sets a minimum content, the same on paper as on screen.

What the law means by a medical record

The reference law is Spanish Law 41/2002, the basic law regulating patient autonomy. Its scope expressly includes healthcare centres and services, public and private, in matters of information and clinical documentation. If you are unsure whether your centre falls within that scope, check with your adviser.

The law defines the medical record as “the set of documents containing the data, assessments and information of any kind on the situation and clinical progress of a patient throughout the care process”. And its article 14 adds that it comprises the documents of each patient's care processes, with the identification of the doctors and other professionals who took part in them.

Two practical ideas follow. First: it is not a single document, but a set that grows with every visit. Second: what was recorded is not enough; it must show who took part.

Paper or software: what the law says about the format

Article 14 does not commit to any format: each centre will file its patients' medical records, “whatever the paper, audiovisual, computer-based or other format in which they are held”, in a way that guarantees their security, their proper preservation and the retrieval of the information.

The technical detail it leaves to others. According to the same article, the health authorities will establish mechanisms that guarantee the authenticity of the content of the medical record and of the changes made to it, as well as the possibility of its future reproduction. And the autonomous communities (Spain's regions) will approve the provisions necessary for centres to adopt the appropriate technical and organisational measures to file and protect records and to prevent their destruction or accidental loss. That is why, before accepting a way of filing as good, your adviser should also check what your autonomous community says.

In practice, the questions are the same on paper as in software: is it secure? Is it properly preserved? Can it be retrieved when needed? Does it show who wrote each entry?

What it must contain: the minimum content

Article 15 sets the purpose: the medical record will include the information considered essential for a truthful and up-to-date knowledge of the patient's state of health. Its main purpose is to facilitate healthcare, recording the data that, in medical judgement, allow that knowledge. It then lists the minimum content, and clarifies that part of it is required only in hospital admission processes or when so provided:

Section of the minimum content	Condition set by the law
a) Clinical-statistical sheet	None
b) Admission authorisation	Hospital admission or if so provided
c) Emergency report	Hospital admission or if so provided
d) Medical history and physical examination	None
e) Progress notes	None
f) Medical orders	None
g) Consultation referral sheet	None
h) Reports of complementary tests	None
i) Informed consent	Hospital admission or if so provided
j) Anaesthesia report	Hospital admission or if so provided
k) Operating theatre report or birth record	Hospital admission or if so provided
l) Pathology report	Hospital admission or if so provided
m) Nursing progress and care planning	None
n) Nursing therapeutic application	None
ñ) Vital signs chart	Hospital admission or if so provided
o) Clinical discharge report	Hospital admission or if so provided

Be careful not to read too much into the table. The fact that informed consent appears in the group tied to hospital admission does not alter what article 8 of the same law says: consent will be given in writing for surgery, for invasive diagnostic and therapeutic procedures and, in general, for procedures involving risks or drawbacks with a notable and foreseeable negative impact on the patient's health. How to sign it without paper is explained in signing consent forms on a tablet.

Article 15 adds two more rules: the record will be kept according to criteria of unity and integration, in each care institution at least, and when care is the result of violence against minors, the medical record will specify this circumstance. Which sections are used in your clinic and in how much detail is up to each practitioner and, in legal terms, to your adviser; software only provides the place and the order.

How this works in a clinic without inpatients

In an aesthetic medicine, physiotherapy, nutrition or psychology clinic, the day-to-day record can be organised into four pieces:

• Medical history and examination: what the patient says and what the practitioner observes.
• Progress notes: what was done in each session, with its date and the practitioner who saw the patient.
• Reports and tests: the clinic's own reports, those of other professionals and the results the patient brings.
• Signed documents: consent forms and authorisations, inside the patient's record and not in a separate folder.

A mistake when going digital is to move only the diary and the invoicing into the software, and leave the record in a word processor or in shared folders. With the record spread over several places, it is harder to keep it with the unity and integration mentioned in article 15, and also to know who has consulted it. Who should be able to open it is explained in who can see the medical record.

Digitising paper medical records

If you are coming from paper, the practical question is what to do with the old records. The law already provides that clinical documentation may be kept under conditions that guarantee its proper maintenance and security, “although not necessarily in the original format”. For how long, see how long to keep the medical record.

Before scanning anything, decide three things with your adviser:

1. What gets digitised: all the records or only those of patients who still come.
2. What happens to the paper: whether it is kept, where and who holds the key, or whether it is destroyed, when and with what prior checks.
3. How it is found afterwards: each scanned document, locatable from its patient's record and not in a loose folder.

If what you have is other software, the route is a migration and not scanning. Today Mi Clínica imports patients and appointments, but not the medical record, documents or invoices from another program; how to plan that change without losing anything is explained in changing your clinic management software.

How Mi Clínica stores the record and what it does not do

Mi Clínica is management software: it gives the clinic the place and the order to keep the record, but it does not decide what is recorded nor certify that a clinic complies with any rule. This is what it does today:

• General record in the patient's file, with allergies, medication, history and habits.
• One record per specialty, prepared for aesthetic medicine, advanced aesthetics, physiotherapy, nutrition and psychology; each specialty has history, consultations, progress notes, body chart and files.
• Each progress note with its author: it is stored with its date, its specialty and the practitioner who wrote it. Only a registered practitioner can write in the medical record.
• Body chart by versions: each visit is stored as a version. The map of a consultation is not changed afterwards; to correct it you start from it and create a new version.
• Documents that are not altered: once a document leaves draft it is frozen and can no longer be deleted or changed.
• Photos and files in the patient record, up to 25 MB per file.
• Access log: who consults the medical record is logged, with user, date and time.

And what it does not do, said just as clearly. The specific record for dentistry, podiatry or general medicine is not prepared. It does not import records from other software. And the prescription and the treatment are PDF documents in the name of the practitioner who makes them, not an official electronic prescription. You can see the other features in what Mi Clínica does (in Spanish).

Sources consulted

Checked on 12 October 2026. We link to the original source so that you can consult the current text.

• Ley 41/2002, básica reguladora de la autonomía del paciente y de derechos y obligaciones en materia de información y documentación clínica (texto consolidado). BOE.