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Fragmented legal frameworks hindering 'm-health' innovations in EU, says expert

Major companies are holding back on developing new technology to help with the provision of health care and services as a result of legal barriers in the EU, an expert has said.15 May 2013

Technology law specialist Matthew Godfrey-Faussett of Pinsent Masons, the law firm behind, said that inconsistent regulation across different EU countries may be hindering innovations in electronic health (e-health), and in particular, mobile health (m-health).

M-health is a broad term that refers to the practice of using mobile technology to deliver services in the health sector. The applications vary widely, from engaging in patient records management through tablet devices, to recording patients' heart rate, glucose or blood oxygen levels remotely through applications available on smartphones, to providing medical interventions and diagnostics.

EU Ministers have agreed on a number of measures that will need to be actioned in order to establish a new e-health "ecosystem" within the trading bloc, according to the Irish Presidency of the Council of Ministers. Ministers agreed that laws, such as those governing the regulation of medical devices and cyber security, would need to be reformed before the objectives of an e-health ecosystem could be achieved.

The ecosystem should promote cooperative innovation between the private and public sector, "ensure a vibrant economy for the deployment of e-health applications" and complement national and regional health and social care strategies, the Ministers agreed.

Before those objectives can be achieved, there needs to be a "strengthening coordination of all policies related to e‐Health (from support for research and deployment, to developing a legal framework in specific areas like medical devices, patient safety, cyber security and interoperability), in particular through the high level e-health Network under the Directive on patients' rights in cross‐border healthcare", the Ministers agreed, according to a Declaration issued by the Irish Presidency at the e-health Ministerial Conference 2013 (5-page / 141KB PDF).

"Ministers underlined the importance of addressing the remaining barriers to fully deploying e-health solutions in their countries and endeavoured to surmount them in order to ensure benefits for citizens, the sustainability of health and care systems, economic growth and jobs," the Irish Presidency said. "A strong commitment to developing e-health ecosystems in support of reforming health systems and innovation was demonstrated by all participants."

Godfrey-Faussett said that a lack of consistent regulation within the EU on some areas of the law affecting e-health projects had caused innovation to be stifled.

"In recognising the need to establish ecosystems that will stimulate national and cross border e-health projects, the Declaration correctly identifies the need to address a number of legal constraints that currently hold back some of the most innovative e-health initiatives, particularly those based on mobile health technologies – services delivered through mobile phones, tablets or personal digital assistants," Godfrey-Faussett said.

"However, it stops short of explaining how Member States are to address the key issues concerning: compliance with medical device regulations; data security and data protection compliance; and liability for medical negligence," he said. "With separate Member States taking different approaches in some of these key areas, a number of private sector players have yet to commit fully to major initiatives. The Declaration is therefore helpful in recognising the issues, but it offers little by way of answers as to how the above constraints will be addressed."