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On 29 April 2015, Public Health England organised a workshop for the European Commission in Luxembourg on the joint procurement of medical countermeasures, which featured a host of speakers from different Commission Directorate Generals, EMA, ECDC, WHO, and industry. One of the key messages was that the new Joint Procurement Agreement (JPA) tool is potentially available for many different countermeasures as long as they fall into the legal framework of serious cross-border health threats. (...)
The transposition period for the Cross-border Healthcare Directive came to an end on 25 October, however it has been reported that many Member States are not prepared and have not set up vital information and control resources.
An article published on Euractiv on 24 October revealed that some EU countries are falling so far behind that it could take years for them to fully comply with the new EU legislation and create the required control centres and information websites. Such Member (...)
On 9 October, the European Parliament overwhelmingly voted in favour of adopting a modernised Professional Qualifications Directive (DIR36), which introduces new rules including more stringent requirements to be met by mobile health professionals in order to safeguard patient safety, and a simplified administrative procedure for swifter mutual recognition of professional qualifications between Member States.
The modernisation of DIR36 was one of twelve key actions identified by (...)
One of the European Commission’s key Digital Agenda for Europe goals, namely to provide access to fast broadband across Europe by 2013, is threatened by a decision by European heads of state to slash the budget. This could further impede working towards equity in the area of eHealth.
Under its Digital Agenda for Europe strategy, which has also recently been relaunched with new targets, the Commission’s objective is for Europeans to have access to fast broadband by 2013 while (...)
Data for health research must remain available for the benefit of society as a whole, whilst respecting the rights of the individual.
27 February, Brussels - The European Commission proposal for a regulation concerning data protection, released in January 2013, contains a number of exemptions and provisions crucial to facilitating vital health research within a framework of individual rights and protections.
The public health community welcomed the proposal and its recognition of the (...)
In December, the 2012 EHTEL symposium explored, amongst other things, user perspectives in the domain of digital health. It was an opportunity to learn about new developments in eHealth and how they can help address health inequalities and improve access, particularly regarding less literate and disadvantaged population groups for whom the digital divide is still a reality.
Following an introduction of the conference theme - ’’The Future of eHealth is already here’’ (...)
Last December 7 the Employment, Social Policy Health and Consumer Affairs Council (EPSCO) , the Council of the European Union debated and adopted a number of conclusions related to the organ donation and transplantation.
The Council adopted a couple of conclusions taking in account three main challenges agreed on “Action Plan on Organ Donation and Transplantation (2009-2015): Strengthened Cooperation between Member States”. The action plan was intended to help increase the (...)
To redress concerns voiced by citizens and business representatives, the Single Market Act II represents a new chapter in the ongoing process towards a deeper and better integrated Single Market, with the current focus firmly lying on job creation, growth and social cohesion. While these factors can impact on health, economic concerns dominate the debate while health and social concerns remain marginal.
Single Market Act II
As announced in June in its new proposal, the Commission puts (...)
In light of the recent PIP breast implant scandal, more monitoring of certification bodies is requested under the new proposed Medical Devices Directive to improve patient safety.
Until now, independent certification bodies, approved by Member States, provided authorisation to medical devices coming into the market.
Some MEPs are calling for a centralised EU authorisation of medical devices, however the Commission will not propose this for the Medical Devices Directive (MDD). Eucomed, (...)
In advance of the European Commission’s legislative proposal on the recast of the Medical Devices Directive to be released in September, EPHA releases a Briefing on Medical Devices that summarises some of the issues that will be under discussion in the upcoming reform process.
As the recent PIP breast implant scandal brought to light, there has been a dramatic increase in faulty medical devices over the last decade that were able to enter the market due to serious loopholes in the (...)