Medical Device Daily European Correspondent

At the first-ever workshop for electronic health records (EHR) collaboration between Europe and America, a senior executive for an international information technology (IT) company grumbled, "There is just not a business case for cooperation."

From an industry point of view, that may seem true, though until recently the IT industry itself has been the source of the problem by assuring an incompatibility between systems to keep a unique hook with each customer.

All that is changing as both President George Bush and European Union President Angela Merkel have recently demanded interoperability between systems as the key requirement for any future national plan on the U.S. side, or an e-health roadmap for 27 countries on the European side.

In early May in Brussels, after two years of promising to get together, the top e-health directors for the U.S. and the European Commission finally met face-to-face for a day-long workshop.

Hosted by the commission, the conference brought together for the first time on the same podium the U.S. national coordinator for Health Information Technology at the Department of Health and Human Services (HIT-HHS) with the director of the European Commission's Directorate for the Information Society and Media (EU DG-InfoSoc).

Participants were divided between some 50 directors of European e-health programs and 50 representatives from the companies that are building e-health infrastructure.

The immediate pressure for cooperation is based less on a business case than a public health need.

Bluntly put by the conference organiser, Michael Maibach, president of the European-American Business Council (EABC), "People travel today, and so do diseases. Healthcare has no frontier."

The first point of agreement was the need to establish a trans-Atlantic cooperation for sharing data crucial to the containment of infectious disease. More generally, both sides agreed on the principle for creating open, standards-based, interoperable trans-Atlantic systems for electronic storage and transmission of patient records and prescriptions.

The conference concluded with agreement on two other areas for future cooperation: deployment of home-based healthcare technologies, and harmonising the testing and quality labelling of EHR systems, including functionality, interoperability and security. Agreement was also found on the need for IT infrastructure to support greater deployment of home-based health care technologies.

Robert Kolodner, National Coordinator for HIT-HHS, called the meeting "an ice-breaker." He said America has a solid political commitment to move forward but a low adoption of HIT by physicians compared to Europe.

"Generally there is a higher adoption of electronic health records in Europe, and we are here to find out why that is working economically, politically and technically," he said.

Frans de Bruine, director for HIT for EU DG-InfoSoc told the group that EU-US cooperation for e-health in the short term, "saves lives. In the long term, it is about economic development that will create jobs."

He said Europe estimates 121 billion ($29 billion) spent annually on HIT, of which 80% goes to infrastructure and system maintenance. Growth is projected to be 8.6% annually, "though the larger companies are expecting double-digit growth over the next few years."

The emerging market opportunity, he said, and the area that is expected to generate the greatest job growth, is for personal health systems, with telemonitoring of patients, homecare support and especially chronic disease management.

De Bruine told the group that by the end of 2007 Europe will see the launch of what is called a large-scale pilot project where six countries will agree to standards for exchanging patient summaries and medication records across borders.

Kolodner said the U.S. is focused on building the Nationwide Health Information Network as a "network of networks" for trial implementations of state and regional health information exchange. Four protoype architectures are now being considered.

Another significant encounter between the EU and U.S. came when the respective heads for certification of medical devices and HIT systems took the podium. Here the industry faces a formal effort by governments on both sides of the Atlantic to assure interoperability.

Marc Leavitt, head of the Certification Commission for Healthcare IT (CCHIT, Chicago) said that by April of this year some 81 products had met EHR certification standards. The group, which must become self-supporting when funding from HHS runs out next year, is rapidly moving to certification of IT networks where stand-alone record-keeping systems are connected to larger systems and required to exchange information.

In Europe the certification effort is less agile, said Georges de Moor, president of the EuroRec Institut (Ghent, Belgium), that is spearheading the effort to harmonize requirements issued by 27 different countries in almost as many languages.

"Yes, e-health is becoming global," he said, "but we still need to do Europe first."

De Moor said the problem of interoperability between legacy systems concerns clinicians more than governments. For most specialists, he said, changing from one institution to another to continue research or medical practice often means losing all previous data from their work due to incompatibility.

During the workshop luncheon, a rumor circulated that EuroRec is approaching an end to its work and will soon launch a European-wide certification process for HIT systems and medical devices similar to the CCHIT effort.

De Moor was not available for comment, but de Bruin of EU DG-InfoSoc told Medical Device Daily that certification "is indeed being considered."

The new European directive for medical devices read to th Europen Parliament earlier this year states that software used by a medical device is to be considered as a medical device itself and subject to the same certification requirements.

During a panel discussion session one senior EU official cautioned the industry that in Europe, "certifying a medical device has changed to where today we are certifying the process of developing the device rather than the device itself."

The result will be added costs, said one executive, as well as subjecting software developers to an unaccustomed oversight requiring documentation of their work.

The panel discussion turned lively when an several industry representatives complained about the lack of coordinated regulation in Europe where a single device is reviewed 27 times. "At least in the United States there is only one government to deal with," said one representative.

Marc Leavitt fielded the response, saying that while it seems foolish to re-certify products "it is also foolish to ignore the specific requirements set for specific markets."

A participant from Germany said he found it "curious" that industry is seeking on one hand an end to regulation and at the same time is calling for greater regulation to establish interoperability standards.

"When an industry calls for regulation it can only mean that industry has failed to solve the problems," he said. Each company wants to hold on to its specific technological advantages to the detriment of others, so there can be no agreement, he said.