The healthcare establishment or organisation must comply with the rules of good practice defined by order of the Minister for Health, issued on a proposal from the Director General of the Agence de la biomédecine after receiving the opinion of the Agence nationale de sécurité du médicament et des produits de santé. These rules take into account the recommendations of the French National Authority for Health in accordance with the provisions of 2° of article L. 161-37 of the French Social Security Code.