Droit et pratique de la téléradiologie

La télémédecine, en général, et la téléradiologie, en particulier, illustrent à l’évidence le retard du droit sur la pratique, le premier se bornant à entériner la seconde.

Force est, en effet, de constater que non seulement le législateur a récemment réglementé la télémédecine a minima mais encore que la téléradiologie, qui n’est qu’une déclinaison de la télémédecine, n’est absolument pas appréhendée par les textes juridiques.

Le premier socle légal de la télémédecine, et par voie de conséquence de la téléradiologie, a été établi par les dispositions de l’article 32 et 33 de la loi n°2004-810 du 13 août 2004 relative à l’Assurance maladie.

L’article 32 disposait à l’époque que « la télémédecine permet, entre autres, d’effectuer des actes médicaux dans le strict respect des règles de déontologie mais à distance, sous le contrôle et la responsabilité d’un médecin en contact avec le patient par des moyens de communication appropriés à la réalisation de l’acte médical. »

L’article 33, lui, prescrivait que « les schémas régionaux d’organisation sanitaire intègrent la télémédecine. Chaque schéma définit les modes opérationnels pour répondre aux exigences de la santé publique et de l’accès aux soins. »

Ces deux dispositions ont, depuis lors, été abrogées par l’article 78 de la loi n°2009-879 du 21 juillet 2009 dite HPST ou encore loi Bachelot, laquelle leur a substitué un seul et unique article de valeur législative : l’article L.6316-1 du code de la santé publique.

La télémédecine : un encadrement légal et réglementaire fixé au minimum

La définition légale de la télémédecine, actuellement en vigueur, est donc la suivante :

« La télémédecine est une forme de pratique médicale à distance utilisant les technologies de l’information et de la communication. Elle met en rapport, entre eux ou avec un patient, un ou plusieurs professionnels de santé, parmi lesquels figure nécessairement un professionnel médical et, le cas échéant, d’autres professionnels apportant leurs soins au patient.

Elle permet d’établir un diagnostic, d’assurer, pour un patient à risque, un suivi à visée préventive ou un suivi post-thérapeutique, de requérir un avis spécialisé, de préparer une décision thérapeutique, de prescrire des produits, de prescrire ou de réaliser des prestations ou des actes, ou d’effectuer une surveillance de l’état des patients.

La définition des actes de télémédecine ainsi que leurs conditions de mise en œuvre et de prise en charge financière sont fixées par décret, en tenant compte des déficiences de l’offre de soins dues à l’insularité et l’enclavement géographique. »

C’est donc la géographie défavorable à l’offre de soins sur un territoire donné qui justifie le recours à la pratique de la télémédecine.

Codifié aux articles R.6316-1 à R.6316-11 du CSP, le décret n°2010-1229 du 19 octobre 2010 a complété les dispositions légales susmentionnées.

Ce décret dresse a minima la liste des actes de télémédecine, expose les conditions techniques et financières de leur mise en œuvre et il établit l’organisation de l’activité de télémédecine.

Il est, en revanche, parfaitement muet sur des questions pratiques et cruciales telles que des éventuelles procédures visant à agréer ou qualifier les dispositifs techniques concourant aux actes de télémédecine (liaison informatique, nombreux serveurs aux fonctionnalités diverses, caméras, écrans, etc.).

La responsabilité des prestataires techniques n’est pas davantage envisagée, de sorte qu’il importe de pallier cette lacune par la voie contractuelle.

La télémédecine : une mise en œuvre limitée au plan légal

Dans sa mise en œuvre, le code de la santé publique (CSP) prévoit que la télémédecine est utilisée pour le diagnostic et le traitement des patients dans le cadre de plusieurs activités, telles que la neurochirurgie (article R.6123-101 du CSP), les activités interventionnelles par voie endovasculaire en neuroradiologie (article R.6123-108 du CSP) et le traitement des grands brûlés (article R.6123-101 du CSP).

Les conditions techniques de fonctionnement de l’activité de neurochirurgie prévoient spécifiquement le recours à la télémédecine, l’article D.6124-138 du CSP indiquant en son 3ème alinéa :

« L’établissement dispose des systèmes d’information et des moyens de communication permettant la pratique de la télémédecine. »

Le législateur n’a manifestement pas entendu réserver un traitement particulier à la téléradiologie.

Aussi y a-t-il lieu de se reporter à la documentation non réglementaire produite notamment par les Pouvoirs publics, par la profession organisée autour des syndicats et société savante (SFR, SRH, FNMR, etc.) au sein du fameux G4 professionnel et par le Conseil national de l’Ordre des médecins (CNOM).

L’implication des professionnels ou le substitut de l’absence de loi

Les syndicats de radiologues, libéraux et hospitaliers, épaulés par la Société française de radiologie et adossés aux industriels du secteur des technologies médicales, ont réfléchi au bon usage de la pratique de la téléradiologie.

De leur réflexion partagée, il en est résulté une littérature importante fixant les précautions à observer dans la pratique de la téléradiologie, ses définitions pratiques et les conditions générales d’exercice y afférentes.

Il en ressort que la téléradiologie ne se substitue pas à l’examen clinique réalisé par le médecin de proximité. Son emploi doit être justifié par l’état de santé du patient, la continuité ou la permanence des soins ou plus généralement par des circonstances particulières de temps et de lieu.

Elle ne saurait justifier l’installation ou le renouvellement d’équipements d’imagerie lorsque le site ne dispose pas de radiologues nécessaires pour faire fonctionner ces équipements.

Plus concrètement, la téléradiologie recouvre deux types de situations différentes : d’une part, le télédiagnostic qui permet à un praticien de proximité non radiologue d’obtenir un examen d’imagerie d’un téléradiologue, et, d’autre part, la téléexpertise qui suppose qu’un radiologue de proximité, au contact du patient, souhaite obtenir l’avis d’un téléradiologue distant, expert dans tel ou tel organe pour :

  • guider la conduite de l’examen le plus adapté à la situation clinique,
  • effectuer une seconde lecture des images, et affiner et/ou confirmer son diagnostic et le cas échéant, guider la conduite à tenir pour le patient.

Comme nous l’avons vu précédemment, c’est par voie de convention qu’il importe de combler les lacunes de la loi, concernant la pratique de la téléradiologie.

C’est ainsi que, suivant les recommandations du G4 et du CNOM, la convention de coopération en téléradiologie, réunissant libéraux et hospitaliers, doit avoir pour objet et pour effet de préciser les modalités d’organisation, les conditions techniques, financières et juridiques des échanges médicaux par télétransmission d’images radiologiques.

Sans prétendre à l’exhaustivité, les points suivants doivent être notamment développés dans la convention à venir :

  • les règles d’organisation techniques et médicales de l’exercice
  • les règles de fonctionnement (on pourra utilement se reporter au cahier des charges techniques annexé au Guide du G4 et du CNOM)
  • les droits, obligations, et responsabilités des cocontractants et des patients
  • les modalités de rémunération de chacun des cocontractants et le mode de financement de l’activité
  • la durée et les conditions de rupture de la convention

Il faudra également évoquer les droits et obligations des prestataires techniques afin que soient assurées la permanence et la continuité des soins, en cas de dysfonctionnement de l’appareillage.

L’Océan Indien : une région illustrant la nécessité de recourir à la téléradiologie

Face aux défis posés par l’insularité de la région de l’Océan indien, les différentes structures hospitalières publiques et privées ainsi que les cabinets de médecins libéraux ont résolu de se regrouper au sein d’un groupement d’intérêt économique (GIE) dénommé Télémédecine Océan indien (TOI), et ce dès l’année 2002.

Sous l’impulsion et avec le soutien financier de l’Agence régionale de l’hospitalisation (ex-Agence régionale de santé), le GIE TOI ambitionne de favoriser le développement du recours à la télémédecine, en général et à la téléradiologie, en particulier, afin de répondre aux besoins d’un bassin de population de près de 800.000 habitants, inégalement disséminés sur tout le territoire.

Il pilote le développement des infrastructures et des services nécessaires à l’échange d’information médicale entre acteurs de santé, à la Réunion et à Mayotte.

L’un des projets actuels et ambitieux du GIE TOI consiste à fédérer tous les acteurs de la radiologie de la région autour d’un solide partenariat autour de la téléradiologie, partenariat qui se matérialiserait par une convention-cadre ayant pour objet de régir les rapports des uns vis-à-vis des autres dans la perspective du recours à la téléradiologie que la situation et l’état de santé des patients nécessiteraient.

L’expérience montre qu’une coopération imposée a peu de chance de prospérer. Il importe donc que libéraux et hospitaliers dialoguent dans le sens d’une construction équilibrée.

La négociation constitue, à n’en pas douter, la phase la plus longue et la plus ardue.

A ce titre, de nombreuses implications financières doivent nécessairement être prises en compte, telles que l’achat et les coûts de maintenance du matériel de lecture des images compte tenu des rémunérations attendues, le coût de l’archivage, les éventuelles surprimes d’assurance en responsabilité civile professionnelle, lorsqu’elles existent, et, question très délicate, la rémunération de la permanence des soins.

La préparation, le succès et la pérennité d’une convention de téléradiologie passent obligatoirement par l’élaboration d’un modèle économique respectueux des droits de chacun des partenaires, l’évaluation d’une période d’essai,… et l’intervention ponctuelle d’un ou plusieurs conseillers juridiques.

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