ECR 2010: European Commission discusses legal framework for teleradiology

Published: 03/11/2010

VIENNA, AUSTRIA - (HelthTech Wire / News) - Room I at Vienna International Center is packed with listeners who have come to follow the joint session of the European Commission and the European Society of Radiology: legal aspects in cross-border teleradiology in Europe is on the agenda. Catalina Dima is on stage, her aim: “to bring medical practitioners closer to the European Commission in the field of eHealth, especially in radiology where eHealth is part of the workflow.”

Catalina Dima is the project officer and legal consultant for the European Commission’s ICT for Health Unit. At the European Radiology Congress she presents the main ideas of the draft Staff Working Paper on the applicability of EU legislation to telemedicine services, currenty under preparation. It consists, mainly, of identifying relevant EU legislation and cross-referencing it to five key areas of telemedicine:

• icensing, accreditation and registration of professionals
• liability
• reimbursement
• conflict of jurisdiction
• personal data protection

Some of these ideas were also presented at a recent workshop held in Brussels.

“Most advanced telemedicine case”

“Telemedicine is a healthcare service provided at a distance. Only the service moves, not the patient or the provider,” Catalina says. “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 at a distance, should also be subject to the principle of freedom to provide services.

If telemedicine is also classified as a service of the information society, then additional EU legislation applies.

“Information society services are defined as any service normally provided for remuneration, at a distance, by electronic means, at the individual request of a recipient of the service” Catalina says. Most telemedicine services, in her view, are such services.

What does this mean for teleradiology?

“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,” Catalina says, quoting from the Commission Communication on Telemedicine (COM(2008)689 final).

Cross-border cooperation

An example: a healthcare provider in an EU country outsources the reading of x-ray images to a teleradiologist based in another EU country. What is the legal situation for the three parties involved: the patient, the healthcare provider and the teleradiologist?

The patient and the healthcare provider are in contractual relations under the same national law. The healthcare provider and the teleradiologist are in a cross-border contractual relationship. There is, in principle, no contract between the teleradiologist and the patient.

If teleradiology is an information society service, the country of origin principle applies. This implies that the teleradiologist does not have to be registered in the country of the patient. This prohibits Member States from imposing a specific prior authorisation for providers of information society services and the normal medical license is sufficient. If teleradiology is not a service of the information society, the principle of free movement of the service shall apply.

Reimbursement in this case is not of relevance, because the healthcare provider, and not the patient, pays for the services of the teleradiologist.

“There is no case law with regards to reimbursement of telemedicine services and at this stage the court’s decision would be unclear,” says Catalina, highlighting also that in some Member States telemedicine is not recognized as a proper medical act, which constitutes a barrier for reimbursement.

Liability between the healthcare provider and the teleradiologist, usually, is covered by national law and the contract between the healthcare provider and the teleradiologist should specify which national law applies; if not, in principle, the national law of the country of the teleradiologist applies. Liability between the patient and the healthcare provider in the same country should be covered by the their common national law.

Finally, data protection legislation should be observed when processing personal data. There is a prohibition to process health data. One of the exceptions to this prohibition is for treatment purposes and only if subject to an obligation of professional secrecy or any other equivalent obligation. Privacy issues should be considered in the contract between the healthcare provider (who can be seen as athe data controller) and the teleradiologist (who can be seen as a the data processor, on behalf of the data controller); the patient must be informed of who has access to his or her personal health personal data.

ESR: Request for homogenous accreditation

Speaking after Catalina Dima, Professor Luís Donoso from Barcelona called for teleradiology to be granted the status of a medical act in its own right.

“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,” he said.

He demanded homogenous accreditation criteria for providers across the EU and a careful monitoring of service providers.

“The legal framework can pave the way for the development of teleradiology as a medical practice,” he said. “We need to reengineer and embrace ICT to really impact healthcare provision.”

The European Commission will issue a Staff Working Paper on the of the applicability of EU legislation to telemedicine services later this year. The topic is also on the agenda at eHealth Week 2010 in Barcelona, March 15-18. www.ehealthweek2010.org

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Source: HealthTech Wire on behalf of the European Commission ICT for Health