Medical Device Daily Contributing Writer

Germany's ambitious electronic healthcare program moved out of testing labs in December and into real-world trials with the distribution of new "smart" health cards in two test regions.

Five pharmacies, 20 general practitioners and 10,000 patients are participating in each test, one in Flensburg on the Danish border, the other in a rural area surrounding Zittau in Saxony, bordering Poland and the Czech Republic.

Five more regions will launch similar tests this year as part of a structured roll-out strategy for what is described as the largest healthcare information technology (IT) program in Europe. The second phase of the test in each region will expand the program to 100,000 patients and add physicians and pharmacies.

When fully implemented, the program will provide 82 million Germans with an electronic health card, or Gesundheitkarte (eGK), which is "the key element in modernizing the healthcare system," said Federal Minister of Health Ulla Schmidt. "It ensures that health data are available when and where they are needed to improve treatment for patients."

The plastic health card is the most visible sign of a sweeping reform for Germany's expensive, generous and troubled healthcare system, an effort that has been dogged by controversy and delays. Unlike France, where government is centrally managed from the capital, the German federation is made up of 16 independent states with legal powers that rival America's tradition of states' rights.

The reform of processes, payments and especially the specification of a national infrastructure marks a first in Germany for a federally managed healthcare initiative.

Schmidt said the program will cost 11.4 billion, in addition to the estimated 1585 million for production and distribution of the cards. The savings for the program are estimated by the ministry at 114 billion over a nine-year period.

However, an investigative report by the newspaper Frankfurter Allgemeine Sonntagszeitung in September reported the program will actually cost between 14 billion and 17 billion. Not surprisingly, the articles were hotly contested by the Ministry of Health.

But even critics of the program do not challenge the aims and benefits of the new infrastructure, finally approved and precisely specified with the Statutory Health Insurance Modernization Act that took the force of law in January 2004.

"The project's technical feasibility is undisputed," said Dirk Schuhmann of InterComponentWare (Walldorf, Germany), a healthcare IT company that independently set up a program with 500 patients, four pharmacies and four physician groups to test the capabilities of the card when linked with supporting IT architecture.

The political gridlock among the individual states as well as interest groups representing pharmacies, clinical groups and patients blocked advancement for years. "Now with the test regions, slowly but surely the program is advancing," Schuhmann said.

The plastic cards being distributed to patients in the test regions hold a microprocessor capable of running applications, encryption protocols and enabling digital signatures. Patients can view and manage personal health information through publicly available kiosks, in physician offices and, at some future date, on the Internet. The memory capacity of the card can hold essential identification data, health insurance entitlements, electronic prescriptions, and detailed treatment history, including electronic memos and notices to physicians.

German law establishing the healthcare reform program specifies that information can be accessed only with patient permission, except for an emergency healthcare profile compiled by the patient in consultation with a physician covering, for example, blood group, chronic organ dysfunction, allergies, heart disease, dialysis, asthma and so on.

The card also carries patient identification for the European Health Insurance Card program that enables cross-border treatment for employees and tourists as well as patients seeking treatment in a specialized clinic located across a river in a neighboring country rather than in a more distant German city.

Using a distributed server architecture to store information in diverse locations, rather than a central data repository, the system will connect 130,000 general practice physicians, 55,000 dentists, 2,200 hospitals, 22,000 pharmacies, and 300 health insurance companies, according to Gematik, a non-profit agency established to certify supporting technical systems, implement the program and administeer operations.

In addition to smart cards for patients, health professionals also will be issued cards to identify themselves and securely access and edit patient data. A third card will be issued for secure access to information by allied providers such as pharmacies, expected to handle about 15.4 million prescriptions a week when the system goes live.

An e-prescription is the moment when the three key actors come together and provides a glimpse into the complexity and ambition of the system.

Dr. Stefan Skonetzki, of the Department of Medical Informatics at the University of Heidelberg, said, "In transactions essential for an electronic prescription, it is necessary to create 15.4 million online signatures and to handle up to 15.4 million recalls from dispensing pharmacies. This means that only for this service the telematics platform must bear up to 8,500 transactions per minute not to mention the transaction necessary for verifying contract data or accessing personal health records."

Physician acceptance is another challenge confronting the program. A general practitioner must purchase new card readers, have broadband Internet access and install the connectors and software for the virtual private networks running the access to medical files and communications. The German ministry estimates the cost at 11,500 per office. The German association of physicians predicts a minimum of 13,000 per office. Roughly 50% of physicians' offices in Germany do not have high-speed Internet access.

The strategy for implementation is to build clusters within individual regions that progressively solve problems with legacy IT infrastructure, win patient confidence in the confidentiality of the cards and gain physician acceptance for the interface with their practice as well as the costs for equipment and system upgrade.

As each region become operational, the national system will be built by connecting the various clusters.

In late November 2006, Sagem Orga won the first certification from Gematik to distribute eGK cards to patients. Certification includes approval for card readers and the secured operating system. Another smart card manufacturer, Gieske & Devrient, followed several weeks later. Other manufacturers are expected to win approval for their systems this year. When the program is fully implemented, insurance companies will manage bidding among manufacturers for the cards to be issued to subscribers.

The first steps have been taken, but a long journey has been planned by Gematik to reach the end goal.

Entering a physician's office this week in Flensburg or Zittau would disappoint anyone hoping to plug a card into a magical medical system. The card readers continue to be an early model, able only to read basic patient identification information on the current memory cards. And Gematik has not yet approved any secure connectors to link the system online to any other computers, for example at participating pharmacies or between physician offices.

Follow-up series of pilot tests will extend to other administrative functions such as verifying the holder's insurance status to prevent fraud and eventually to e-prescriptions.

"These functions are important, of course, but they do not have a medical value," said Schuhmann. "It is the management of personal medical information on the card that is important. This is where the benefit of the system will come."

The next building block of the new architecture awaiting certification is the secure connector that links the systems of service providers with the network infrastructure.

"As the secure endpoint of communications, the connector combines all the functions needed for safe handling of the medical data," said J rg Kunsmann of the Fraunhofer Institute for Industrial Engineering. "Encryption, signature and authentication functions ensure that data can be saved securely and that confidentiality is maintained, even though the data are stored at distributed locations."

Jumping ahead of a Gematik certification for connectors, Schuhmann said ICW set up a pilot of its proprietary connectors in Waldorf to link physicians and pharmacies for treatment of the mandatory applications specified for the eGK. The ICW system also enables a fuller set of applications outlined for the card, such as web-based personal health records that go beyond mandatory functions.

"Citizens can store copies of their relevant health data in their online personal health record in an organized manner and make them available to physicians and pharmacists," Schuhmann said. The online file also is being used in a second physician network, the Bavarian Patient-Partner Association, which connects 340 physicians to a shared patient database, he said. n

(Tomorrow: Europe struggles to build compatible e-health standards.)