The Applicability of Existing Community Legal Framework to Telemedicine Services

ICT for Health - European Commission - Information society and Media DGTelemedicine can help increase accessibility to healthcare for patients living in remote geographical areas, allow patients with chronic diseases to be monitored at home and involve patients in the management of their own healthcare.

However, despite the potential benefits identified and the potential for growth of the market, the use 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.

On 4 November 2008 the Commission adopted the Communication on telemedicine for the benefit of patients, healthcare systems and society. In this Communication the Commission undertook to publish, in cooperation with Member States, an analysis of the Community legal framework applicable to telemedicine services. This was listed in the Communication as an action aimed to bring legal clarity to telemedicine.

The Communication was followed by an explanatory document [Commission Staff Working Document - SEC(2009)943 final] that includes details of the extensive consultation process which led to the Communication.

Also relevant as a background for the present EC initiative are two studies on legal aspects of eHealth available on the website of the Commission. The Legally eHealth study addresses the need to establish greater legal certainly in Europe with respect to the practice of eHealth service delivery and the use of eHealth tools focusing on the existing legal framework of relevant EU legislation. The study on the Legal framework of Interoperable eHealth in Europe focuses more on individual Member States' legislation. It identifies and analyses the range of legal and regulatory frameworks for electronic health delivery and services in each Member State and proposes recommendations to facilitate cross-border service provision via eHealth applications. It also provides ten use cases of telemedicine services (such as the NHS Direct Telephone Line or the Barcelona Telemedicine Clinic).

Objective of the initiative
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 dialogue with healthcare providers disclosed that awareness about which rules and norms currently apply to telemedicine is a primary precondition to boost wider deployment of telemedicine services both within and across Member States' borders.

Issues to be addressed
During the consultations with the stakeholders on the subject of telemedicine, several legal issues have been identified. These include: licensing, accreditation and registration of health professionals providing telemedicine services; reimbursement of costs for telemedicine services; liability; personal data protection and conflict of jurisdictions. The present EC initiative will provide guidance for telemedicine users on the Community legal framework applicable to these areas.

Envisaged structure of the SWP
The SWP will be composed of two main parts. The first part will present the Community legislation applicable to telemedicine services structured around the main problematic areas identified above. The second part will comprise a practical approach. It will present several cases of telemedicine services. These cases will be analysed by cross-reference to the relevant Community legislation presented in the first part.

For further information:
ICT for Health - European Commission - Information society and Media DG
Office: BU31 06/41 B-1049 Brussels
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
Tel: +32 (0)2 296 41 94
http://ec.europa.eu/information_society/eHealth

Most Popular Now

Open Call HORIZON-MISS-2022-CANCER-01-04…

The overall goal of the Mission on Cancer[1] and the Europe's Beating Cancer Plan[2] includes a better quality of life for patients and their families living with, and after, cancer. Project...

Insilico Medicine Raises $60 Million in …

Insilico Medicine, a clinical-stage end-to-end artificial intelligence (AI)-driven drug discovery company, announced today that it has completed a $60 million Series D financing from a syndicate of global investors with...

Philips' Future Health Index 2022 Report…

Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced the publication of its Future Health Index (FHI) 2022 report: 'Healthcare hits reset: Priorities shift as...

KTU Researchers Investigate the Links Be…

In recent years Alzheimer's disease has been on the rise throughout the world and is rarely diagnosed at an early stage when it can still be effectively controlled. Using artificial...

Speech Analysis App Predicts Worsening H…

A voice analysis app used by heart failure patients at home recognises fluid in the lungs three weeks before an unplanned hospitalisation or escalation in outpatient drug treatment. The late...

Screening for Diabetic Retinopathy Prove…

Both telemedicine and community screening for diabetic retinopathy (DR) in rural and urban settings are cost-effective in China, and telemedicine screening programs are more cost-effective, according to a study led...

App Detecting Jaundice in Babies a Succe…

A smartphone app that identifies severe jaundice in newborn babies by scanning their eyes could be a life-saver in areas that lack access to expensive screening devices, suggests a study...

Researchers Develop Smartphone-Powered M…

A University of Minnesota Twin Cities research team has developed a new microfluidic chip for diagnosing diseases that uses a minimal number of components and can be powered wirelessly by...

InterSystems Wins Data Driven Product of…

InterSystems, a provider of next-generation solutions for enterprise digital transformation to help customers solve the most critical data challenges, has announced it received the prestigious Data Driven Product of the...

Siemens Healthineers Introduces Symbia P…

Siemens Healthineers introduces Symbia Pro.specta™, a single-photon emission computed tomography/computed tomography (SPECT/CT) system with CE Mark and Food and Drug Administration (FDA) clearance that has advanced SPECT and CT imaging...

Oracle Purchase of Cerner Approved

Oracle Corporation (NYSE: ORCL) announced that all required antitrust approvals have been obtained for its proposed acquisition of Cerner, including European Commission clearance. Cerner is a leading provider of digital...