Medical Software Only Permitted After Certification Process

Since July 1, 2008, statutory health insurance physicians, in accordance with the AVWG, must use 'tamper-proof' software for electronic prescription of medicines, which is intended to prevent, for example, the physician's medication from being unintentionally substituted through suggestions.

Statutory health insurance practices may only use computer programs that comply with a 'requirements catalog' for medical software issued by the statutory health insurance funds and the National Association of Statutory Health Insurance Physicians.

This is intended to ensure that statutory health insurance physicians are no longer influenced in their selection of 'appropriate' medications by software that favors the products of specific pharmaceutical companies.

Therefore, since July 1, 2008, statutory health insurance physicians can only use software that has undergone a certification process. Several software manufacturers challenged this certification process by filing urgent applications with the Berlin Social Court. They sought to ensure that statutory health insurance physicians could continue to use their software without approval. They stated that the new regulation was expected to result in revenue losses of more than 40 million Euros in the next three years alone.

The court dismissed the applications as inadmissible. It held that only statutory health insurance physicians are affected by the regulation. Software manufacturers could continue to sell uncertified programs but have no legally protected right to the same market opportunities as in previous years. Consequently, there is no right for statutory health insurance physicians to continue using uncertified software for selecting medications. Furthermore, a representative of the software companies explicitly stated in an interview that the products 'are certified without problems because we already do what the law requires anyway'. If this is the case, the court stated, then it is not understandable why the applicants would not simply initiate the certification process, as judicial protection against the certification process would then not be necessary at all.

The software manufacturers have since filed an appeal against the decision with the Berlin-Brandenburg State Social Court.

File number of the Social Court: S 79 KA 148/08 ER

Source: Press Release from the Berlin Social Court of august 6, 2008

Attorney Michael Ullrich, LL.M. (Information Law)

Email: mailto:m.ullrich@goldberg.de