"We need to raise awareness of existing legislation"

Legal uncertainties are often highlighted as one of the reasons for the relatively slow adoption of cross-border eHealth services in Europe. Luba Hromkova, Legal Officer of the European Commission’s “ICT for health” Unit, advises keeping the existing legal framework in mind.

Published: 05/09

PORTOROZ, SLOVENIA - (HealthTech Wire) - What are the main legal barriers to cross-border eHealth services in Europe at the moment?

There is no easy answer. During discussions in the i2010 subgroup for eHealth, the issue of “legal uncertainty” often comes up. Legal uncertainty around e-Health was also identified as one of the most compelling barriers to the eHealth market’s potential in the recently adopted Communication of the European Commission on a Lead Market Initiative. Legal certainty is a prerequisite for businesses to invest in innovation and for users and buyers to take up new products and services. But dialogue with the Member States often reveals that the main barrier to legal clarity and certainty is not the lack of legal norms, but the lack of knowledge or lack of awareness about existing legislation.

So what is out there?

The reality is that at EU level a number of directives or regulations have been adopted in recent years, impacting on eHealth services. Perhaps they do not address all relevant issues, but we are definitely not starting from zero. If we regard cross-border eHealth services as information society services, we have, for example, the e-Commerce Directive, which certainly addresses some of the issues relevant for eHealth services. We have a Transparency Directive, a Personal Data Protection Directive, the e-Privacy Directive, the Directive on Recognition of Professional Qualifications and others. All of them have been adopted at EU level, and all Member States have had to transpose and implement these directives in their respective national legal orders. This means that there is a robust legal platform in place. However, it should be better explored and adapted to the peculiarities of eHealth.

Can you illustrate this with an example?

Take liability in a cross-border eHealth service. The e-Commerce Directive provides for the liability of service providers. Then there is the regulation on the law applicable to non-contractual obligations, Rome II or the Rome Convention on the law applicable to contractual obligations. Here, too, it should be analysed as to what extent they might be applicable to cross-border liability in eHealth matters.

Why are so few stakeholders aware of this legislative framework?

One of the reasons is probably that the ministries involved in the implementation of these directives have generally not been the ministries of health. It may be that some people in the healthcare arena are not aware of what is going on in the field of information society services and vice-versa. According to Article 152 of the Treaty establishing the European Community, the organisation and delivery of healthcare are the responsibility of the Member States. eHealth services and products, however, have a broader concept with implications for the free movement of persons and products. Here, we are touching on the Internal Market acquis communautaire, and in this respect more could be achieved through a cooperative approach of the Member States.

What is your advice to the ministries of health of the EU Member States?

The European Commission launched the eHealth Action plan in 2004, under which all Member States committed themselves to adopting national roadmaps for eHealth. The Commission is monitoring the actions proposed by the Member States and tries to recommend the best practices learnt from this process, with full respect to the principle of subsidiarity. We listen to the Member States and other stakeholders when we are planning all our initiatives on eHealth. With regard to the legal framework on eHealth, the European Commission tries to provide a list of recommendations, also based on the “Legally eHealth” study, to show them which European legal acts they should be looking at while implementing their national roadmaps.

Ms. Hromkova, thank you for your answers. (PP)

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