Patient consent: legal obligations of healthcare professionals

Patient consent: legal obligations of healthcare professionals

The patient's free and informed consent constitutes a fundamental pillar of French medical law. Enshrined by the Kouchner law of March 4, 2002 relating to the rights of patients and the quality of the health system, it imposes strict obligations on health professionals in terms of information and collection of consent. Any establishment or practitioner failing to comply with these obligations is subject to civil, criminal and ordinal sanctions.

The legal framework of consent in healthThe legal framework of consent in healthArticle L.1111-4 of the Public Health Code provides that

“no medical procedure or treatment may be performed without the free and informed consent of the person” ⬥⬥⬥. This principle is reinforced by article 16-3 of the Civil Code which requires prior consent for any attack on the integrity of the human body, except therapeutic necessity or vital emergency.

• “no medical procedure or treatment may be performed without the free and informed consent of the person” ⬥⬥⬥. This principle is reinforced by article 16-3 of the Civil Code which requires prior consent for any attack on the integrity of the human body, except therapeutic necessity or vital emergency.Consent must meet three cumulative criteria:
• Free ⬥⬥⬥: free from any constraint or pressureInformed ⬥⬥⬥: preceded by clear, fair and appropriate information (art. L.1111-2 CSP)
• Informed ⬥⬥⬥: preceded by clear, fair and appropriate information (art. L.1111-2 CSP)Revocable ⬥⬥⬥: the patient can withdraw it at any time

The General Data Protection Regulation (GDPR) and the Data Protection Act complete this system for the processing of health data, considered sensitive data within the meaning of article 9 of the RGPD.

The General Data Protection Regulation (GDPR) and the Data Protection Act complete this system for the processing of health data, considered sensitive data within the meaning of article 9 of the RGPD.

The obligation to provide prior information

• Before any consent is obtained, the professional must provide information on:
• The patient's state of health and its foreseeable evolution
• The patient's state of health and its foreseeable evolution
• The investigations, treatments or preventive actions proposed
• Their usefulness, possible emergency and consequences
• Their usefulness, possible emergency and consequences

Frequent or serious risks normally predictable

Possible therapeutic alternatives

The foreseeable consequences in the event of refusal

• The foreseeable consequences in the event of refusalThe burden of proof of this information has fallen on the professional since the Hédreul judgment of the Court of Cassation (February 25, 1997). Traceability therefore becomes essential: signed forms, detailed reports in the medical file, mentions of the provision of information documents. ⬥⬥cat adapted according to the regime (guardianship, curatorship, safeguard)
• Biomedical research ⬥⬥⬥: specific written consent (Jardé law of March 5, 2012)Biomedical research ⬥⬥⬥: specific written consent (Jardé law of March 5, 2012)
• Organ donation, PMA, IVG ⬥⬥⬥: specific formalisms imposed by the Public Health CodeVital emergency ⬥⬥⬥: exemption possible if the patient is unable to express his wishes and no trusted person has been designated
• Sanctions in the event of breachSanctions in the event of breach
• Lack of consent or information exposes the practitioner to triple liability:civil

civil

(compensation for the loss of unpreparedness recognized by the judgment of June 3, 2010),criminal(attack on physical integrity, art. 222-19 Penal Code) and(attack on physical integrity, art. 222-19 Penal Code) anddisciplinarybefore the Order of Physicians. Healthcare establishments may also see their HAS certification called into question.before the Order of Physicians. Healthcare establishments may also see their HAS certification called into question.

Conclusion

Informed consent is not a simple administrative formality but a legal and ethical obligation structuring the caregiver-patient relationship. Its rigorous implementation, supported by documented procedures and impeccable traceability, protects both the patient in their fundamental rights and the professional in the exercise of his practice.