EU tackles legal issues of e-health, teleradiology

VIENNA - The European Commission (EC) is working to provide clarity on the murky legal issues relating to telemedicine in Europe, focusing initially on teleradiology and home health monitoring, according to a presentation Saturday at the European Congress of Radiology (ECR).

"Teleradiology is considered to be one of the most important [telemedicine applications] and is already on the market and used as a mainstream service," said Catalina Dima, a project officer with the European Commission's Information and Communication Technologies (ICT) for Health initiative.

Dima shared developments from an EC workshop earlier this week in Brussels, Belgium, regarding a draft staff working paper aimed at clearly identifying the scope, depth, and borders of the applicability of the existing EC legal framework to telemedicine, she said. The working paper is a follow-up action to the EC's 2008 communication on telemedicine, which had mentioned the need for improved legal clarity.

The working paper takes the approach of analyzing existing EC law that can be related to telemedicine from a general perspective, and cross-referencing it to specific telemedicine applications. However, it also acknowledges that telemedicine apps are various and heterogeneous in terms of scope, maturity, and procedures, Dima said.

"No single approach can be used to grasp the distinct peculiarities [of the various telemedicine applications]," she said. "So we are not saying that this is the perfect solution."

The paper addresses:

  • Licensing, accreditation, and registration of professionals
  • Liability
  • Reimbursement
  • Conflict of jurisdictions
  • Personal data protection

The EC defines telemedicine as a healthcare service provided at a distance; the service moves but not the patient or the health professional. It involves the secure transmission of medical data and information through text, sound, images, or other forms needed for the prevention, diagnosis, treatment, and follow-up of patients.

Placed in the context of the European Union's legal framework, telemedicine services should enjoy the EC's overarching principle of freedom of movement in the EU market, Dima said.

"We have case laws stating that medical services should enjoy this freedom to provide services, and also that services provided at a distance should circulate freely within the European community," he said. "So if telemedicine is defined as a healthcare service provided at a distance, we find that the freedom to provide services should apply to telemedicine."

An information society service

ICT for Health is also evaluating whether telemedicine services would fall within the EC's definition of an information society service (ISS), which covers any service normally provided for remuneration, at a distance, by electronic means, at the individual request of a recipient of service, Dima said.

"Most telemedicine services fall within that definition," she said.

The legal consequences of categorizing telemedicine as an ISS involve a general obligation to inform (per the EC's e-Commerce directive) the beneficiary of an ISS service, as well as specific information requests for regulated professions, she said.

"So a member of a regulated profession should be informed about the professional body with whom they are registered, about his professional title, and the applicable professional rules," she said.

Also, the EC encourages that EU member states draw up of codes of conduct, addressing areas such as telemedicine ethical issues. If telemedicine is considered an ISS, any national legislation should be presented to the commission before it's adopted at a national level, she said.

As an ISS and a business-to-business transaction, telemedicine would also be covered by the EC's e-Commerce directive and country of origin principle with regard to licensing and registration of healthcare professionals, she said. As such, the professional would need to be licensed in the country where he or she is established; no registration is required in the country where the patient is located.

However, exceptions are possible for reason of public health protection, she said.

If telemedicine is not considered an ISS, though, the e-Commerce directive would not be applicable. Then, the EC's principle of freedom to provide services and corresponding European Court of Justice (ECJ) case law would apply, she said.

The proposed paper also takes the position that member states may not impose a specific license for practicing telemedicine, citing the e-Commerce directive that prohibits the imposition of a specific prior authorization that is specifically and exclusively targeted at an ISS.

"This means that no special license for providing telemedicine can be imposed, and a normal medical license should be enough," she said.

Reimbursement and liability

The reimbursement of telemedicine services provided across borders can be a thorny issue. But the group believes that telemedicine in the EU would be covered under the mechanism of health services established by the ECJ regarding the free movement of services, Dima said.

However, current case law refers to traditional healthcare and not to healthcare provided at a distance. No rulings have been made yet regarding reimbursement of telemedicine services.

On a national level in the EU, reimbursement is governed by the national legislation of member states according to their health systems. In some member states, telemedicine is not recognized as a proper medical act for reimbursement purposes, she said.

Medical and services liability are covered by national law, as there is no EU legislation on this. As a result, the applicable legislation in a cross-border situation would need to be identified, Dima said.

EC product liability legislation and e-Commerce directive provisions involving intermediaries such as internet service providers (ISPs) may also apply.

As for data protection, some general principles of EC's data protection directive state that health data are considered sensitive, and it is prohibited to process the data. However, there are exceptions, she said.

Also, the data protection directive delineates the obligation of the data controller to implement appropriate security measures for protection of personal data, she said.


Take an envisaged teleradiology scenario in which a patient goes to a healthcare provider in one country and has his or her x-ray interpreted by a teleradiologist in another country: In the ICT for Health's opinion, this arrangement encompasses a contractual relationship between the patient and the healthcare provider and another contractual relationship between the healthcare provider and the teleradiologist, Dima said.

"In principle, [there is] no contractual relationship between the patient and the teleprofessional," she said. "However, the patient, in our opinion should be informed of the possibility that the reading of his x-rays may be outsourced."

Patients would pay the healthcare provider in their own country, therefore not bringing the EU rules on reimbursement into play. The teleprofessional would then be paid by the healthcare provider outsourcing the service, she said.

National law would apply if a liability issue arises between patients and their healthcare professional in their own country. Liability issues between the healthcare professional and a teleradiologist would typically be dealt with in their contract, she said.

As for personal data protection, this scenario would involve the healthcare professional acting as the "data controller" and the teleradiologist serving as the "data processor" on behalf of the healthcare professional.

"The healthcare professional is the only one who would determine the means and the purposes of the processing of personal data," she said. "The contract between the two should specify the obligation to ensure the protection of data processed by the teleprofessional."

EC's data protection laws would apply to the data processing by the teleprofessional, she said.

"One of the exemptions [to the EC prohibition of sensitive data] is that the professional is processing the personal data for treatment and that he is subject to the obligation of professional medical secrecy," she said.

Patients will need to be informed of the identity of the data controller (the teleprofessional), as well as any recipients or categories of recipients, she said.

By Erik L. Ridley staff writer
March 6, 2010

Related Reading

Regional RIS/PACS maximizes radiology service in Spain, March 4, 2010

Radiology IT explores new frontiers, February 18, 2010

ACR: Use of teleradiology triples from 2003-2007, October 20, 2009

Radiation oncology telemedicine system may reduce errors, improve care, October 19, 2009

Teleradiology offers opportunities, challenges, August 25, 2008

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