Legislative framework on the European level (key legislation and legislation needed for successful eHealth implementation)

author: Catalina Dima, DG Information Society and Media, European Commission
published: Feb. 19, 2010,   recorded: January 2010,   views: 3263


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Defining eHealth: Ehealth tools or solutions include products, systems and services that go beyond simply Internet‐based applications, as mentioned in the eHealth Action Plan (2004). The eHealth market includes the following categories of applications: Clinical information systems; Telemedicine systems and services; Regional/national health information networks and distributed electronic health record systems and associated services; Secondary usage / non‐clinical systems (health education, specialized systems for research).

The EU Member States have the prime responsibility for protecting and improving the health of their citizens. As part of that responsibility, it is for them to decide on the organisation and delivery of health services and medical care. However, when exercising these competences, Member States nonetheless have to comply with Community law.

There are a number of examples in the health area on which Member States cannot act alone effectively and where cooperative action at the EU level is indispensable, especially regarding issues with a cross‐border dimension or relating to the free movement of persons within the internal EU market.

eHealth has been proposed as an alternative to more conventional forms of healthcare. It is assumed that it contributes to fairer health services across geographical and social boundaries, as well as helping to reduce (or at least limit) the growing costs of the healthcare.

However, despite the potential benefits identified and the potential for growth of the market, the use of eHealth, and in particular of telemedicine applications in everyday medicine is still relatively low. One of the reasons identified is the lack of legal clarity. In view of enhancing legal clarity regarding telemedicine services, the Commission will publish a Staff Working Paper (SWP) on Community legal framework applicable to telemedicine in 2010.

The main objective of this initiative is to enhance legal clarity for providers of telemedicine services by clearly identifying the scope, depth and borders of applicability of existing Community legal framework to telemedicine services. The SWP will address the following areas which have been identified as being particularly problematic: licensing, accreditation and registration of health professionals providing telemedicine services; reimbursement of costs for telemedicine services; liability; personal data protection.

It is important to mention some guiding documents adopted by the Commission in the field of eHealth, although not they are only "soft law" documents. Also, the recently adopted Council Conclusions on Safe and efficient healthcare through eHealth, 1 December 2009 and the Draft Directive on the application of patients’ rights in cross‐border healthcare, COM(2008) 414 final are relevant.

Conclusion: eHealth is a dynamic legal environment; eHealth derives its competences from competences of other policies; eHealth is a tool, a solution, a system, a product, a service; eHealth does not constitute any specific branch of health law; eHealth is already covered by EU law.

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