eHealth, including telemedicine and teleradiology, is one of the big future challenges within the European Union. Therefore, a lot of different initiatives are being undertaken to build homogenous legislation, and to enhance standardization.
One of the first milestones was the European Commission (EC) Communication entitled "Telemedicine for the benefit of patients, healthcare systems and society" (COM 2008/689), published in November 2008, which laid down a number of specific actions in the area of telemedicine and telemonitoring. This document set out to build confidence and acceptance of telemedicine services, to bring legal clarity, to solve technical issues, and facilitate market development. One of the actions foreseen in this document was the drafting of a "staff working paper on EU legislation applicable to telemedicine services." This working paper should mark the beginning of a legislative process to regulate this sensitive area, and to create a homogeneous legislative framework.
Although several discussions and workshops have already taken place to gather first impressions of what should be included in this paper (e.g., the eHealth session at the European Congress of Radiology 2010, where the responsible EC policy officer outlined the key issues), this working paper is still on hold until another European law is adopted -- the directive on the application of patients' rights in cross-border healthcare. The reason is this piece of legislation will include provisions for cross-border eHealth that should also be reflected in the paper.
Cross-border eHealth
After a long-winded process, the European Parliament finally approved this new law in January 2011. The directive sets out patients' rights to seek medical care in another EU country. The directive is primarily focused on ensuring that patients from one country within the EU may obtain healthcare within another EU country without hindrance. The main emphasis of the directive is to make it easier for patients to obtain approval, and for an organized financial framework to be put in place to pay for the healthcare.
This approach is overdue as there have been several cases settled by the European Court of Justice since 1998 and this proposal would bring about the needed legal clarity. In addition, it emphasizes the importance of quality and safety of care for patients traveling across borders for healthcare. However, from the beginning the European Society of Radiology (ESR) has been concerned there is little in the initial draft to ensure quality and safety for patients whose treatment involves cross-border eHealth. This is the reason why the ESR has tried to raise the awareness of several decision-makers in the European Commission, the European Parliament, as well as at member state level, to this important lack since the moment the proposal for the directive was tabled.
However, the text approved by MEPs in January is the result of an agreement reached with the Council, which must also give its formal approval. To achieve this compromise, the regulations in the area of eHealth were downscaled. The directive does not include regulations that apply the same safety and quality standards to eHealth as to nonelectronic health services. A European eHealth Network will be established to foster cooperation between member states, and to draw up guidelines on cross-border patient data -- this cooperation is weakened by being entirely voluntary. At least some provisions regarding the registration of health professionals were included in the directive, an issue that was also highly emphasized by the ESR.
Teleradiology is a medical act
The ESR will now continue its efforts in order not to leave the important area of teleradiology unregulated. One of the main claims is that teleradiology must be defined as a medical act.
According to the EC, most telemedicine services, including teleradiology, fall under the definition of information society services (ISS) (Art. 1(2) of Directive 98/34, as amended by Directive 98/48): "any service normally provided for remuneration, at a distance, by electronic means, at the individual request of a recipient of service."
The fact that the EC considers teleradiology an ISS means the e-Commerce directive is applicable where the country-of-origin principle applies. This affects the licensing/registration of health professionals: The professional has to be licensed in the country where he/she is established, while no registration is required in the country of the patient. Member states are not allowed to impose a specific prior authorization, which is specifically and exclusively targeted at ISS.
The EC now considers teleradiology to be a medical act. However, in the EC's opinion, a medical act can also be an information society service, which is a position the ESR clearly disagrees with. The problem is this opinion covers the whole range of telemedicine, of which teleradiology is only a small element. Next to this problem, other questions arise in the realm of eHealth (e.g., patient information, and liability).
Therefore, the ESR claims:- The regulation of telemedicine and teleradiology should be the responsibility of the member state where the patient undergoes the imaging or telemedical referral.
- Patients must give informed consent when the clinical details and images are electronically transferred from one EU country to another.
- Responsibility/liability for cross-border teleradiology services lie within the member state of the patient.
- Member states should ensure the safety of the patient; that doctors undertaking cross-border telemedicine and teleradiology should have the equivalent regulatory requirement to those of the country where the patient accesses healthcare.
Interested in further information on this topic?
Please visit the EU Affairs section at myESR.org or contact [email protected].
Originally published in ECR Today March 6, 2011.
Copyright © 2011 European Society of Radiology
