The project officer and legal consultant for the European Commission's ICT for Health Unit, Ms. Catalina Dima presented at the European Radiology Congress (4-8 March 2010) the main ideas of its draft Staff Working Paper on the applicability of EU legislation to telemedicine services. 

During the joint session of the European Commission and the European Society of Radiology: 'Legal aspects in cross-border teleradiology in Europe', Ms. Dima stated that the aim of the draft working paper is to "bring medical practitioners closer to the European Commission in the field of eHealth, especially in radiology where eHealth is part of the workflow." The paper which is currently under preparation mainly consists of identifying relevant EU legislation and cross-referencing it to five key areas of telemedicine:

• licensing, accreditation and registration of professionals;
• liability;
• reimbursement;
• conflict of jurisdiction;
• personal data protection.

"Telemedicine is a healthcare service provided at a distance. Only the service moves, not the patient or the provider," said Ms. Dima. "We have case law which confirms that medical services should circulate freely within the European Union. Also, there is case law stating that services provided at a distance should enjoy the same freedom." As a logical consequence, telemedicine services, defined as healthcare services provided remotely, should also be subject to the principle of freedom to provide services. It should be noted at this point that if telemedicine is classified as a service of the information society, then additional EU legislation applies.

Furthermore, quoting from the Commission Communication on Telemedicine for the benefit of patients, healthcare systems and society [COM(2008)689 final] Ms. Dima stated that "Teleradiology is considered a telemedicine service involving the electronic transmission of images for the purpose of interpretation. It is the most advanced telemedicine case at the moment."

Various questions were raised as to what is the legal framework that covers for instance a healthcare provider in an EU country that outsources the reading of X-ray images to a teleradiologist based in another EU country. The patient and the healthcare provider are in a contractual relationship under the same national law. Likewise, the healthcare provider and the teleradiologist are in a cross-border contractual relationship. However, there is, in principle, no contract between the teleradiologist and the patient.

Finally, data protection legislation should be taken into consideration when processing personal data, since there is a certain prohibition. One of the exceptions to this prohibition is for treatment purposes and only if subject to professional secrecy or any other equivalent obligation. Privacy issues should be considered in the contract between the healthcare provider (who can be seen as the data controller) and the teleradiologist (who can be seen as the data processor, on behalf of the data controller); the patients must be informed of who has access to their personal health data.

Talking about the homogenous accreditation criteria for providers across the EU and a careful monitoring of service providers, Professor Luís Donoso stated: "The position of the European Society of Radiology is that regulation of telemedicine should be the national responsibility of the Member State where the patient undergoes the imaging procedure or referral."

The European Commission will issue its Staff Working Paper on the applicability of the EU legislation to telemedicine services later in 2010.

Further information:

• Original News Article - HealthTech Wire  
• Related ePractice Library Item: Communication on telemedicine for the benefit of patients, healthcare and society