Medical Device Daily

PISA, Italy – In two years Europe has moved rapidly from a patchwork of implementations for electronic health records to an sustained movement that will peak this year with implementations of two key programs.

European Patient Smart Open Services (epSOS) is a pilot program beginning in June that by the end of the year will connect 3,400 care centers in 10 countries for the exchange of a primitive patient summary.

Meanwhile an 8,000 patient clinical trial for tele-monitoring in nine countries called Renewing Health will be fully enrolled for a study of the cost-effectiveness and medical benefit of virtual beds in chronic diseases.

Driving the change is the intervention of the European Commission.

Ironically, the EC has no legal power to act in the field of healthcare as Member States left this politically sensitive domain out of the charter creating the European Union.

Applying a technique used in other industries called a large-scale pilot, the EC gathered members states willing to build an infrastructure for e-health and provided a legal framework for these countries to cooperate on a shared work program.

Both programs presented progress reports at the European Connectathon organized by IHE-Europe, the Brussels based non-profit for Chicago-based Integrating the Healthcare Entrerprise (IHE).

13 countries exchange patient data

Preparing for a large-scale pilot program of cross-border exchanges of patient data, 13 Member States of the European Union participated in a Projectathon organized by epSOSas a parallel testing event for information systems during the IHE-Europe Connectathon.

Five software vendors who have developed key components used to interconnect the national systems also validated the interoperability of their systems during the event.

It was the second Projectathon organized by epSOS ahead of the launch of its real-world testing of systems in June that represents the world's most ambitious effort to date for the cross-border exchange of patient information. (Medical Device Daily, Dec. 15, 2010)

Where the first Projectathon among eight countries in November, 2010 in Bratislava, Slovakia presented no pre-testing requirements, national systems needed to pass a series of qualifications for Pisa.

According to the epSOS Coordinator Fredrik Linden, “the participation by more countries despite more demanding requirements demonstrates that national programs across Europe are reaching a level of expertise that is very promising as we prepare for live testing.“

He said both Switzerland and Turkey, which are new participants in the epSOS program, were able to meet the required testing specifications.

In June a first group of four expert countries will go live with real patient data exchanges and a second wave of six countries will join the large-scale pilot test in September, said Linden.

When fully operational the large-scale epSOS pilot will engage more than 30,000 healthcare professional in data exchanges.

“That number may seem massive, but when you consider the sheer size of the real world for healthcare in Europe you realize it is only a small part of the total number of people and medical centers who will be touched by electronic information exchanges,“ he said.

To speak “European“ among the diverse and disparate healthcare communities of Europe required creating a master set of over 10,000 terms just to enable the exchange of the limited information contained in the epSOS pilot patient summary.

“That number will easily double when we send a clinically useful patient summary,“ said Linden.

Europe's A-Team tests tele-monitoring

“If tele-monitoring is so important, why has no one been able to move from projects with 50 patients to a full tele-monitoring program with 500 patients?“ asks Claudio Saccavini.

He said the answer is that there is not a shared organizational model to support remote monitoring of patients among the different actors, which include hospitals, primary care physicians, and in-home care providers.

The technical manager for the Veneto Research Center for eHealth Innovation, Saccavini is the lead spokesman for a three-year European project called Renewing Health that is conducting the large-scale clinical trial to evaluate and validate the effectiveness of tele-medicine services for 8,000 patients with chronic diseases.

Nine of Europe's most advanced regions for remote patient monitoring services will use personal health devices and a shared methodology for collecting data in the structured study of patients with cardiovascular disease (CVD), chronic obstructive pulmonary disease (COPD) and diabetes.

Endpoints for the clinical trial include measures for patient mortality, the reduction of visits to the hospital or emergency department and quality of life metrics.

The economic benefits of tele-medicine will also be calculated according to costs to patients and healthcare systems.

“The objective is to give a clear idea to healthcare administrators of the investment needed to start a tele-monitoring program, and then to say when they can expect their program to break even,“ said Saccavini.

During the IHE European Connectathon, Katja Rääpysjärvi from the South Karelia District of Social and Health Services in Lappeenranta, Finland presented her component of the Renewing Health program as an example.

Beginning in February 2011, Rääpysjärvi said 550 patients agreed to participate in the trial with 75 patients assigned to a control group and the remainder divided into groups for heart disease and diabetes. Each patient was assigned to a health coach who visits once each month to verify the ongoing collection of data by the patient and advise them on appropriate actions to take.

Each patient is provided with monitors for glucose and blood pressure, as well as a weight scale and a pedometer to measure activity.

Patients are also provided with a smart phone programmed to collect the data from the personal care devices that can be sent in a short message text format to a dedicated server.

Presentations from regional study groups for Renewing health in Norway, Spain and Italy similarly described their implementations.

The enthusiasm for tele-medicine is most often inspired by the technology behind the new generation of personal care devices.

Yet this technology often poses more problems than solutions, according to the project managers for Renewing Health presenting at the IHE European Connectathon.

In some regions patients lack the internet connections required by many devices, and the cost of personal devices can be prohibitive in large scale projects.

Manufacturers of personal devices also continue to use proprietary interfaces that makes integration of the data into the patient's electronic health record difficult.

In the Veneto region 300 patients with implantable heart defibrillators and pacemakers are being followed with a robust set of data that can be transmitted by the devices, including clinical-quality parameters for blood pressure, pulse rate, breathing rate and level of physical activity.

But manufacturers of the devices “are at the very beginning of interoperability, still believing that a lack of interoperability creates a commercial opportunity,“ said Saccavini.

“Tele-medicine is not a technology, it is a service,“ said Saccavini.