Medical Device Daily Contributing Writer

BERLIN — A large-scale pilot project aimed at establishing interoperable electronic health systems across borders was announced by a core group of European Union member nations during eHealth Week here on April 19.

The declaration signed by the core group was officially adopted by health ministers from all 27 EU member states the following day at a meeting held in Aachen, Germany (see sidebar, P. 7).

With 112 million ($16.2 million) funding from the European Commission, the large-scale pilot will define a working model for interoperability between national records for patient identification, as well as for medical and medication data needed for emergency care.

Norway, Iceland and Liechtenstein, which are not members of the EU, also agreed at the Aachen meeting to adopt the declaration.

In adopting the declaration, "we seek to ensure that, in the future, electronic health services for Europe's citizens do not stop at national borders," said Klaus Theo Schr der, State Secretary at the German Federal Ministry of Health.

"We want to give patients access to their medication records and patient summaries from everywhere within the European Union," he said. "This not only serves the continuity of care, but also affords safety in an emergency."

In mid-May, the European Commission will issue a formal call for proposals to set specifications for the interoperability pilot.

A May 10 meeting between the EU and the U.S. will take place in Brussels, Belgium, where interoperability standards for health records will be discussed with the aim of aligning international data exchange, according to G rard Comyn, the head of information and communications technology for health for the European Commission.

The EC's strategy, evident in the lobbying of health ministers of different countries at the Berlin conference to sign on with the declaration, is to encourage a lead group of member states to form a consortium to respond to the EU call. This core group would receive the EU funding and then issue its own call for proposals to industry to meet the program requirements and create the supporting IT architecture.

"If a company applied for this funding, the result would be some kind of tool just like any of the dozens of health information systems already on display out there on the exhibition floor," said John Ryan, head of the Health Information Unit of the European Commission.

Ryan told Medical Device Daily, "With member states driving the process, they will already be on board for the solution, so when we roll it out they will be the ones selling the solution to other member states, not salespeople from an international company.

"The EU does not have any legislative authority for health," Ryan said. "Since we cannot impose a system on the members, we have to use influence. The EU research fund is being used as the tool to start this process."

The core group that will lead the large-scale pilot was reported to be made up of as many as eight EU member nations, though executives from two EU commission directorates declined to name the countries. Both Germany and France are certain to be participants. IT directors for the Dutch and Swedish national eHealth programs told MDD they will join the core group. The Czech Republic was reported to be joining the group, and Slovenia, which will take over the EU presidency for the next six months, is expected to participate.

The parade of presentations at the Berlin conference, part of an annual updating of progress in each country toward eHealth, offered convincing proof of Europe's claim to be leading the world with the development of electronic medical systems, including an advanced program for cross-border exchanges among Baltic Sea nations.

Yet it became equally clear that Europe may be quickly constructing the world's tallest Tower of Babel, brick after brick, with systems unable to communicate even basic patient identifiers across national borders, and in many cases an incompatibility for patient records between regions within the same country.

For example, Sweden, the most advanced European nation for eHealth systems, is currently in the process of establishing a national system to integrate data among the 21 autonomous regional authorities.

"For the moment we have a program but not the hardware," said Daniel Forslund, head of the eHealth section for the Swedish Ministry of Health and Social Affairs. He told MDD, "Our long experience of advanced functions with medical data shows that IT systems are built for storage and not the exchange of data."

Agreement on technological standards through the large-scale pilot program is a first hurdle for cross-border exchange, but far from the most difficult for sharing patient information in Europe.

Resolving legal and regulatory barriers may prove to be a greater challenge for "harmonization and balance," to use the European language for creating a single, unified market.

Patient confidentiality, data security and especially patient control of information are protected by laws at the European level, yet many countries have far more restrictive laws that by treaty must be respected, for example, by caregivers for a German tourist injured on the ski slopes of France or a British retiree living in Barcelona.

On the other hand, Europe recognizes there are powerful economic incentives to harmonizing eHealth that are driving programs forward. In the Berlin declaration, the ministers noted, "A reliable technical framework will support a growing market for European industry, and create cost-effective solutions for national eHealth implementations."

Addressing the conference, Viviane Reding, the EU commissioner responsible for the information society, said, "The commission is determined to transform the potential of e-health into a reality. We have doubled the budget for eHealth. It is an economic issue, it creates economic opportunities, it can sustain double-digit growth. Europe can deliver, and it will."

But she added, "We need joined-up strategies."

According to Nicole Denjoy, executive director of COCIR (Brussels), an industry association for health information systems, "From the industry's point of view, this large-scale pilot is a very good thing. Right now each country is working on its own solution, so having a core group of countries is a good way to force other countries to work together, to set specifications and especially a calendar for implementation, saying what they want and when they want it."

She said she shares the frustration of the European Commission that the program cannot start until 2008 for the earliest.

"My question is, who is paying for this?" asked Ursula O'Sullivan, the IT manager for Ireland's Health Service Executive, who also is a member of the EU's i2010 Working Group. "The EU's 112 million is the funding available for coordinating the development activities, but what is the real cost going to be for EU member states?"

She added, "Scalability of the technology is not going to be the issue ultimately." Rather, the cost to individual nations of the agreed-upon solution will become the problem. "To simply set up a switchpoint required by the program is going to be enormously expensive per capita for many nations," O'Sullivan said, citing the example of Cyprus, with a population of 500,000 that welcomes almost 10 million tourists in a six-month period.

"God love them," she said, "When someone is injured in Cyprus, they try to intervene before packing them off to Athens for treatment. But how will they pay for the eventual EU-wide requirements for exchanging care information?"

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