German Radiological Society The German …€¦ · 2 Department of radiology and nuclear medicine,...

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References 1. Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee on the Regions on telemedicine for the benefit of patients, healthcare systems and society. in: Commission of the European Communities, Brussels: COM (2008) 689 final 2. Rosenberg C, Kroos K, Rosenberg B, Hosten N, Flessa S. Teleradiology from the provider’s perspective-cost analysis for a mid-size university hospital. Eur Radiol (2013) 23: 2197–205 3. Verordnung über den Schutz vor Schäden durch Röntgenstrahlen (Röntgenverordnung-RöV) i.F.v. 30.4.2003 (BGBl. I S.604), geändert durch VO v. 4.10.2011, (BGBl. I S. 2000) http://www.gesetze-im-internet.de/ bundesrecht/r_v_1987/gesamt.pdf 4. Fendrich K, van den Berg N, Siewert U, Hoffmann W. Demographic change: demands on the health care system and solutions using the example of Mecklenburg-Western Pomerania. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz (2010) 53(5): 479-85 5. Rosenberg C, Langner S, Rosenberg B, Hosten N. Medical and legal aspects of teleradiology in Germany. Fortschr Röntgenstr (2011)183: 804-11 6. Oikarinen H, Merilinen S, Pääkkö E et al. Unjustified CT examinations in young patients. Eur Radiol (2009) 19: 1161-5 7. Hendee W, Mettler M Jr, Walsh M et al. Justification of diagnostic medical exposures, some practical issues: report of an International Atomic Energy Agency Consultation. Br J Radiol (2012) 85: 523-38 8. Rosenberg B, Rosenberg C, von Zanthier H, Dziurzynska A, Hosten N. Radiologie und Teleradiologie - Gemeinsamkeiten und Potential grenzüberschreitender Konzepte zwischen Deutschland und Polen. in: Jahrbuch HealthCapital Berlin-Brandenburg 2011/12, Kunze/Mutze. Oldenbourg (2012) 93-105 9. European Society of Radiology. ESR white paper on teleradiology: an update from the teleradiology subgroup. Insights Imaging (2014) 5: 1-8 Purpose Teleradiology is defined by the EU as a telemedicine service, which involves the electronic transmission of radiographic images from one geographical location to another for the purposes of interpretation and consultation (1). Legal analysis and reflection on its international applicability is performed on a regional teleradiology network based at the Greifswald radiology department, representing a model case of providing teleradiology services to five hospitals at night, weekends and holidays only (2). Materials and methods The national POMERANIA teleradiology service is reviewed in compliance with the German ionising radiation regulation, as specified for x-ray use (RöV) (3) and EU legal requirements. For data analysis, medical and legal databases (medline, eur-lex, juris, beck-online), as well as recent statistic reports on the regional development of population, economy and healthcare supply (4), were searched. Be part of the European Society of Radiology’s radiation protection initiative, become a Friend of EuroSafe Imaging. www.eurosafeimaging.org The German teleradiology concept - a measure of radiation protection (The EU-sponsored POMERANIA project) Our Contribution to the EuroSafe Imaging Call of Action German Radiological Society B Rosenberg 1 , C Rosenberg 2 , M Kirsch3, N Hosten 3 ; 1 Telemedizin Euroregion POMERANIA Project, University Medicine Greifswald, Germany 2 Department of radiology and nuclear medicine, Waldkrankenhaus Protestant Hospital, Berlin, Germany, 3 Institute of Diagnostic Radiology and Neuroradiology, University Medicine Greifswald, Germany; Contact: [email protected] Results Teleradiology in Germany is subclassified into teleconsultation (second opinion) and teleradiology according to RöV (justifying indication and original reporting on an examination utilising ionising radiation) (5). The latter is a medical measure representing bodily harm to the individual being examined. The remote medical act is performed under the supervision of a teleradiologist, who is not on-site. Teleradiological examinations according to RöV are only permitted at night, weekends and holidays and require official approval, limited to three years, as an addition to on-site radiology (3). It may be permitted as a 24/7 service in exceptional cases if an urgent geographical need in patient care is clearly present. Examinations of children and pregnant women are prohibited. Essential requirements for teleradiology services are: 1. justifying indication, 2. proximity of services, 3. certified radiation protection qualifications for the teleradiologist and on-site physician (3). Justifying indication All radiation-based medical imaging has to be justified by a legitimate indication (3,5), which is defined as weighing the radiation risk against the medical advantages of examining an individual patient and is a major criterion for protecting the patient from excessive radiation risk (3,6,7). The teleradiologist is responsible for justifying the exam, after having collected relevant written and oral information in cooperation with the technician and on-site physician (3,5). Proximity of services Teleradiology services can only be provided to hospitals, which the teleradiologist can reach in a time that would allow him/her to react to emergencies in a reasonable amount of time (< 45 min.) (2,3,5). The principle of proximity (3) guarantees adherence to the principle of personal service delivery and the prohibition of remote treatment in compliance with the German healthcare law. Conclusion In Germany teleradiology is a radiological-medical measure performed on the patient. As the patient`s radiation protection is an exceptionally important issue, medical imaging in this context is highly regulated (3). Medical-technical and personnel requirements, as well as radiation protection aspects, must comply with high standards of patient safety and patient care derived from on-site radiology. When it comes to performing cross-border teleradiology, individual patient rights and the protection of physical integrity must not be discriminated as compared with performing national teleradiology (8, 9). An evolving and growing European cross-border healthcare market implies harmonised rules and guidelines (9). The implementation of internationally accepted radiation protection standards is essential and urgently needed. Those derived from the German criteria for radiation protection primary teleradiology services are suitable for regions close to the border only. By preserving high standards in patient safety and patient care cross-border teleradiology may be beneficial to connecting and developing remote areas at both sides of a border – better yet it could complement existing structures of regional healthcare. Fig. 1 Fig. 2

Transcript of German Radiological Society The German …€¦ · 2 Department of radiology and nuclear medicine,...

References1. Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee on the Regions on telemedicine for the benefit of patients,

healthcare systems and society. in: Commission of the European Communities, Brussels: COM (2008) 689 final2. Rosenberg C, Kroos K, Rosenberg B, Hosten N, Flessa S. Teleradiology from the provider’s perspective-cost analysis for a mid-size university hospital. Eur Radiol (2013) 23: 2197–2053. Verordnung über den Schutz vor Schäden durch Röntgenstrahlen (Röntgenverordnung-RöV) i.F.v. 30.4.2003 (BGBl. I S.604), geändert durch VO v. 4.10.2011, (BGBl. I S. 2000) http://www.gesetze-im-internet.de/

bundesrecht/r_v_1987/gesamt.pdf4. Fendrich K, van den Berg N, Siewert U, Hoffmann W. Demographic change: demands on the health care system and solutions using the example of Mecklenburg-Western Pomerania. Bundesgesundheitsblatt

Gesundheitsforschung Gesundheitsschutz (2010) 53(5): 479-855. Rosenberg C, Langner S, Rosenberg B, Hosten N. Medical and legal aspects of teleradiology in Germany. Fortschr Röntgenstr (2011)183: 804-116. Oikarinen H, Merilinen S, Pääkkö E et al. Unjustified CT examinations in young patients. Eur Radiol (2009) 19: 1161-57. Hendee W, Mettler M Jr, Walsh M et al. Justification of diagnostic medical exposures, some practical issues: report of an International Atomic Energy Agency Consultation. Br J Radiol (2012) 85: 523-388. Rosenberg B, Rosenberg C, von Zanthier H, Dziurzynska A, Hosten N. Radiologie und Teleradiologie - Gemeinsamkeiten und Potential grenzüberschreitender Konzepte zwischen Deutschland und Polen. in: Jahrbuch HealthCapital Berlin-Brandenburg 2011/12, Kunze/Mutze. Oldenbourg (2012) 93-1059. European Society of Radiology. ESR white paper on teleradiology: an update from the teleradiology subgroup. Insights Imaging (2014) 5: 1-8

PurposeTeleradiology is defined by the EU as a telemedicine service, which involves the electronic transmission of radiographic images from one geographical location to another for the purposes of interpretation and consultation (1). Legal analysis and reflection on its international applicability is performed on a regional teleradiology network based at the Greifswald radiology department, representing a model case of providing teleradiology services to five hospitals at night, weekends and holidays only (2).

Materials and methodsThe national POMERANIA teleradiology service is reviewed in compliance with the German ionising radiation regulation, as specified for x-ray use (RöV) (3) and EU legal requirements. For data analysis, medical and legal databases (medline, eur-lex, juris, beck-online), as well as recent statistic reports on the regional development of population, economy and healthcare supply (4), were searched.

Be part of the European Society of Radiology’s radiation protection initiative, become a Friend of EuroSafe Imaging. www.eurosafeimaging.org

The German teleradiology concept - a measure of radiation protection (The EU-sponsored POMERANIA project)

Our Contribution to the EuroSafe Imaging Call of Action German Radiological Society

B Rosenberg1, C Rosenberg2, M Kirsch3, N Hosten3 ; 1 Telemedizin Euroregion POMERANIA Project, University Medicine Greifswald, Germany2 Department of radiology and nuclear medicine, Waldkrankenhaus Protestant Hospital, Berlin, Germany, 3 Institute of Diagnostic Radiology and Neuroradiology, University Medicine Greifswald, Germany; Contact: [email protected]

ResultsTeleradiology in Germany is subclassified into teleconsultation (second opinion) and teleradiology according to RöV (justifying indication and original reporting on an examination utilising ionising radiation) (5). The latter is a medical measure representing bodily harm to the individual being examined. The remote medical act is performed under the supervision of a teleradiologist, who is not on-site. Teleradiological examinations according to RöV are only permitted at night, weekends and holidays and require official approval, limited to three years, as an addition to on-site radiology (3). It may be permitted as a 24/7 service in exceptional cases if an urgent geographical need in patient care is clearly present. Examinations of children and pregnant women are prohibited. Essential requirements for teleradiology services are: 1. justifying indication, 2. proximity of services, 3. certified radiation protection qualifications for the teleradiologist and on-site physician (3).

Justifying indicationAll radiation-based medical imaging has to be justified by a legitimate indication (3,5), which is defined as weighing the radiation risk against the medical advantages of examining an individual patient and is a major criterion for protecting the patient from excessive radiation risk (3,6,7). The teleradiologist is responsible for justifying the exam, after having collected relevant written and oral information in cooperation with the technician and on-site physician (3,5).

Proximity of servicesTeleradiology services can only be provided to hospitals, which the teleradiologist can reach in a time that would allow him/her to react to emergencies in a reasonable amount of time (< 45 min.) (2,3,5). The principle of proximity (3) guarantees adherence to the principle of personal service delivery and the prohibition of remote treatment in compliance with the German healthcare law.

ConclusionIn Germany teleradiology is a radiological-medical measure performed on the patient. As the patient`s radiation protection is an exceptionally important issue, medical imaging in this context is highly regulated (3). Medical-technical and personnel requirements, as well as radiation protection aspects, must comply with high standards of patient safety and patient care derived from on-site radiology. When it comes to performing cross-border teleradiology, individual patient rights and the protection of physical integrity must not be discriminated as compared with performing national teleradiology (8, 9). An evolving and growing European cross-border healthcare market implies harmonised rules and guidelines (9). The implementation of internationally accepted radiation protection standards is essential and urgently needed. Those derived from the German criteria for radiation protection primary teleradiology services are suitable for regions close to the border only. By preserving high standards in patient safety and patient care cross-border teleradiology may be beneficial to connecting and developing remote areas at both sides of a border – better yet it could complement existing structures of regional healthcare.

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