Digital Health Legal
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Volume: 5 Issue: 5
(May 2018)

eu commission seeks encourage cross border health data sharing european commission (‘ec published 25 april 2018 communication ‘on enabling

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EU Commission seeks to encourage cross border health data sharing

The European Commission (‘EC’) published on 25 April 2018 a Communication ‘on enabling the digital transformation of health and care in the Digital Single Market; empowering citizens and building a healthier society’ (‘Communication’), which sets out a plan of action to put citizens at the centre of the healthcare system by enabling secure, cross border access to electronic health records and the possibility of sharing records across borders; by facilitating the use of larger data sets through a shared European infrastructure to inter alia help determine personalised medicine; and by providing tools that enable citizens to manage their health more actively within integrated care systems. The Communication lists actions the EC will take in order to achieve its objectives, which include reviewing relevant regulations, adopting recommendations on a European electronic health record exchange format, setting up a mechanism for the voluntary coordination of authorities and stakeholders to share data, and supporting the exchange of best practice, technical assistance and capacity building between healthcare authorities.

The available patient data that can be exchanged in a cross border capacity is currently limited to patient summaries and ePrescriptions through the eHealth digital service infrastructure, and in the Communication, the EC identifies a need to gradually extend the services offered to cover the interoperability of Member States’ electronic health record systems, by supporting the development and adoption of an EU electronic health record exchange format. The EC plans to adopt a recommendation on the technical specifications of such an exchange format, whilst monitoring the implementation of relevant EU legislation, such as the GDPR, and addressing citizens’ secure access to their health data. “I salute this approach,” said Piet Weinreich, Counsel at Osborne Clarke. “The EC should take into consideration experiences from other countries (particularly the US, where the exchange of health data is still often obstructed by incompatibilities between systems), as well as the existing systems already in place in Member States. As these systems will not be easily amended, the goal for the specifications should be a format which can integrate existing formats, or at least one that makes it easy to convert the old formats to the new format.”

The Communication observes that at present many citizens in Europe have limited access to their own health data, as it is “often untraceable and scattered in different places,” and acknowledges that current efforts to exchange patient data across borders rely on the voluntary cooperation of health authorities to connect to the eHealth digital service infrastructure. Mikael Salmela, Partner at Hogan Lovells, believes that promoting cross border interoperability of electronic health records and introducing an electronic health record exchange format could be effective on a voluntary basis “provided that financial and technical incentives are offered to Member States, and that the right technologies are put in place at the EU level via blockchain-based systems, for instance,” explains Salmela.

The EC lists further measures it will take to incentivise the uptake of digital health solutions and the pooling of data at EU level, in sections entitled ‘Better data to promote research, disease prevention and personalised health and care’ and ‘Digital tools for citizen empowerment and for person-centred care,’ with the EC stating that “significant breakthroughs can be achieved by linking Europe’s fragmented resources through secure cross-border digital infrastructures.” These measures include mobilising funds from the Connecting Europe Facility and Horizon 2020 programmes to encourage further collaboration between Member States and regions on the cross border exchange of health data, setting up a mechanism for the voluntary coordination of authorities and stakeholders to share data and infrastructure, supporting exchange of best practice, capacity building and technical assistance for health and care authorities, and the launching of pilot actions to demonstrate the benefits of advancing research, disease prevention, personalised medicine, health technology assessment, and clinical and regulatory decision making. “I think these pilots could adapt and build on the methodology of some of the Innovative Medicines Initiative projects currently underway,” adds Laëtitia Benard, Partner at Allen & Overy. “The EC will need to consider carefully to ensure that disincentives to cooperation by companies are not built in by inadvertently providing routes to early public disclosure of data in a way that could potentially undermine intellectual property rights. The EC could also consider providing commercial incentives to share data.”

In the concluding section of its Communication, the EC states that “the swift deployment of innovative digital health solutions can best be achieved by working together at EU level, sharing experiences in deploying, measuring impact and transferring innovation across Member States and regions,” adding that the active engagement of all parties is essential for success in creating a “triple win” that benefits people, health systems and the market. Torsten Kraul, Associated Partner at Noerr LLP, notes however that there is a limit to what the EC can address in the Communication, commenting that “Fragmentation amongst Member States is an immense source of difficulties in cross border healthcare. This goes well beyond what the EC has addressed (and is competent to address) in the Communication. The healthcare sector is a very specific animal, with systems ranging from largely privately organised concepts to government-heavy institutions. For digital innovations to be implemented in treatment and care, it is paramount that they are acknowledged by insurers and competent authorities as reimbursable. Such transfer of digital solutions into practice is, however, a matter to ultimately be dealt with by Member States.”

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