German industry group publishes telemedicine standards

Leading German electronic association the VDE has published a new set of standards for telemedicine to spur the development of telecare and telemonitoring.

A series of recommendations are set out in the new telecare standards, addressing both the technical and organisational issues of telemonitoring, and may lead to the development of quality labels for telecare products and services.

The VDE’s recommendations should help to bridge a significant gap in the growing market of telemonitoring solutions for patients with chronic illnesses.

Companies interested in the telemonitoring business to optimise their services can use the new recommendations. However, the paper also aims to provide a guideline for certification authorities that might one day develop quality labels – similar to the CE mark – not only for individual products, but for complete telemonitoring solutions.

“What we see today is a rather uncontrolled growth of telemonitoring services,” said Johannes Dehm of the VDE Initiative MikroMedizin, a project group within the VDE that has been working on standardisation and quality issues related to telemonitoring for several years.

“There are people today that take a computer and a hard drive and say ‘fine, let us do telemonitoring’ because it is attractive and because it is reimbursed reasonably well.”

Dehm told E-Health Europe such a piecemeal approach is no good for promoting telemonitoring efforts in medicine in the long run. To improve the situation, in its ‘Recommendations for Telemonitoring Applications’ the VDE addresses three main areas where it believes quality standards are essential.

The first key recommendation is for care facilities that want to offer telemonitoring services: “In their premises they have to fulfil the same standards like other medical facilities,” said Dehm. Among other things, this has to do with hygiene issues.

The second key recommendation concerns technical components that have direct contact with patients. For example the electrodes of an ECG for the telemonitoring of patients with cardiac disease. According to the VDE, these components should fulfil the DIN EN 60601-1 standard, which is similar to the international IEC standard 601-1 for medical devices.

Furthermore, staff in telemedicine call centres needs appropriate training with the devices that are on offer, and this training should be recorded in detail, according to the VDE. In case of dealing with personalised patient data, the data protection guidelines of the service host country should be served.

Telemonitoring has been gaining acceptance in the German healthcare system after a number of clinical and health economic studies showing both medical and financial benefits, especially of the telemonitoring of patients with heart failure. More than twenty health insurance companies are now offering a variety of telemonitoring options to patients with chronic heart failure. Among them are big players like the Barmer Ersatzkasse with 7m members and the Techniker Krankenkasse with 4m members.

At this time precise data on the adoption of Telecare is not easily obtainable, but it is estimated that more than 25,000 patients within the German public healthcare system are currently receiving telemonitoring.

There are two big telemedicine providers. By far the biggest is PHTS, a subsidiary of the Israelian SHL Telemedicine. PHTS alone claims to have more than 15,000 customers. Vitaphone is slightly smaller, with services for cardiac patients, diabetics, and patients with chronic pulmonary disease. Both companies have been actively involved in establishing the new VDE recommendations.

A third big provider, also cooperating with the VDE, is currently being established at Charité university hospital Berlin. Their ‘Partnership for the Heart’ project is being developed in co-operation with firms including Bosch and with ICW.

Most other players, though, are of minor size. There is a widespread feeling that nobody really knows what they do and to what extent.

The German government does not seem to feel too comfortable with what is happening in the telemonitoring arena at the moment. This was probably the reason why the Federal Department of Trade and Industry decided to fund the ‘Partnership for the Heart’ project with five million Euros in its ‘Next Generation Media’ programme.

‘Partnership for the Heart’ is essentially a clinical study for telemonitoring in patients with chronic heart failure. Because of its heavy public funding, the project has provoked considerable animosities, which became obvious recently at the conference of the German Society of Telemedicine, where two major players started to quarrel with each other in public. The VDE as a neutral authority might help to quiet the minds with its recommendations in this situation.

Links

VDE-initiative „MikroMedizin“ (German language only)

Next Generation Media-project (German language only)