Medical Malpractice Liability in Spain: Medical Records, Informed Consent and Medical Standard of Care (2026)

Medical Liability: General Framework

The civil liability of physicians and healthcare facilities falls primarily under the tort liability framework of Article 1902 of the CC (Código Civil, the Spanish Civil Code): or under contractual liability where a contract for medical services exists (Art. 1101 CC). In the public sector, the patrimonial liability of the Administration applies (Arts. 32–37 LRJSP (Ley de Régimen Jurídico del Sector Público), the Law on the Legal Regime of the Public Sector).

The distinguishing feature of medical liability is that a harmful outcome alone is not sufficient: medicine does not guarantee a cure. Liability arises only when the professional breaches the lex artis ad hoc (the standard of care required of a medical professional of the same specialty under the same circumstances).

The Lex Artis Ad Hoc

The Tribunal Supremo (Spain's Supreme Court) (STS 1ª of 25 November 2013; STS 1ª of 30 June 2020) has developed the concept of lex artis as the body of technical rules and standards of care that medical science imposes at any given time and within each specialty:

• It encompasses clinical guidelines and protocols issued by scientific societies
• It depends on the resources available at the facility (the same standard of care is not expected of a rural hospital as of a major university teaching hospital)
• It is assessed in light of the specific circumstances of the case (ad hoc)

Breach of the lex artis gives rise to an obligation to compensate provided that damage and a causal link are established. The STS of 30 June 2020 clarifies: a physician is liable for negligence in the diagnostic and therapeutic process, not for an adverse outcome as such.

Informed Consent (Law 41/2002)

Legal Framework

Law 41/2002, of 14 November, the basic law governing patient autonomy (LAP (Ley de Autonomía del Paciente)) regulates the patient's right to clinical information and to informed consent.

Scope of the Duty to Inform

The physician must inform the patient of:

• The diagnosis
• The typical risks of the treatment or procedure (those occurring with appreciable frequency even if not serious, and those that are serious even if infrequent, where relevant to the patient's decisión)
• The therapeutic alternatives available
• The foreseeable prognosis

The information provided must be comprehensible, truthful, and sufficient to enable the patient to make a free and informed decisión.

Form of Informed Consent

• Verbal as a general rule
• Written consent is mandatory (Art. 8 LAP) for: surgical interventions, invasive diagnostic and therapeutic procedures, and procedures that carry risks or drawbacks with a notoriously foreseeable and significant negative impact on the patient's health

A signed informed consent document serves as evidence that information was provided, but does not relieve the physician of the burden of proving that the information was comprehensible and appropriate.

Consequences of Failure to Obtain Informed Consent

The STS (Full Chamber/Pleno) of 29 October 2020 unified the applicable doctrine: failure to obtain informed consent may give rise to civil liability even where the procedure was performed in compliance with the lex artis, provided the patient demonstrates that, had they been aware of the risks, they would not have consented to the procedure. Compensation covers the non-pecuniary damage (daño moral) arising from the infringement of patient autonomy, plus physical damage where the undisclosed risk materialised.

The Medical Record as Evidence

The medical record (historia clínica), regulated under Art. 15 LAP, is the primary evidentiary instrument in medical malpractice proceedings:

• Retention obligation: 5 years from the date of discharge (Art. 17 LAP); certain CCAA (Comunidades Autónomas, Autonomous Communities) extend this to 10–15 years
• Patient access: the right of access is recognised under Art. 18 LAP, records may be requested even in the course of civil proceedings by way of Art. 328 LEC (Ley de Enjuiciamiento Civil, the Civil Procedure Act)
• Alteration or destruction: gives rise to a reversal of the burden of proof in favour of the claimant (STS of 29 July 2020)

A medical expert report (informe pericial médico) is essential in these proceedings. The choice of expert (forensic physician vs. privately appointed expert) and the quality of the report are decisive.

Liability of Healthcare Facilities

Healthcare facilities ( whether public or private ) are jointly and severally liable alongside the treating physicians:

• For the acts of their employees (Art. 1903 CC)
• For organisational failures: absence of protocols, inadequate equipment, unjustified delays
• For nosocomial infections where a failure in hygiene protocols is established (the SSTJS/TS ( judgments of the Superior Courts of Justice and the Supreme Court ) admit liability even though such infections are not always preventable)

In the public sector (the National Health Service and the regional health services), liability claims are brought through the administrative patrimonial liability procedure: claim filed with the relevant health authority → administrative silence → appeal before the administrative courts (recurso contencioso-administrativo). Jurisdiction lies with the Administrative Law Chamber (Sala de lo Contencioso-Administrativo), not the civil courts.

Quantification of Damages and the Compensation Scale

Personal injury damages: since 2015, courts have applied the Road Traffic Accident Scale (Baremo de accidentes de tráfico, established by Law 35/2015) on an indicative basis in civil malpractice proceedings (the STS of 20 October 2020 endorsed its use as a reference point). It is not binding outside the road traffic context, but judges increasingly rely on it to lend objectivity to compensation awards.

Non-pecuniary damages (daño moral): subject to free judicial assessment, with no binding scale. Factors considered include: suffering, loss of quality of life, psychological sequelae, and frustrated life expectancy.

Conclusion

A medical liability claim requires proof of: (1) breach of the lex artis, (2) actual damage, and (3) a causal link. Deficient informed consent opens an independent ground of liability. Lawyers must obtain the complete medical record and commission a rigorous medical expert report from the outset.

Lexiel enables you to search Supreme Court case law on medical malpractice and informed consent, and to draft pleadings with verified citations.