Risiken und Nebenwirkungen der Integration medizinischer Software in klinische IT-Strukturen – Erlanger Memorandum [Software as a medical device – side effects when applying the new European regulation on medical devices for IT products]

[english] European medical device regulations have been altered to cover pure software applications as well. They now may be classified as a medical device if used for medical diagnostics and/or medical treatment. Slowly, these regulations are being implemented into national law of the EEC member states, for example into the German MPG (Medical Product Law).For some software applications such as Picture Archiving and Communication systems (PACS) a classification as medical device is – at least for parts of it – routine today, ruling e.g. the quality of medical monitor screens for assessment of x-ray pictures. For software applications such as patient data management systems (PDMS), electronic health records (EHR), laboratory information systems and similar systems this was not the case so far. This paper deals with the consequences which may arise if a PDMS used on intensive care units or even an EHR is now classified as a medical device, e.g. because it is able to deliver intelligent composite views on laboratory data, medical data, and treatment information to support diagnostic assessment or treatment advice.Modern clinical information systems, PDMS and EHR support the user with medical information and clinical decision support (CDSS). So there is doubt that they are used for diagnostics and/or treatment. Medical device regulations distinguish between medical product classes I (low risk), II and III (high risk) of medical devices according to potential risks for the patient. IF CDSS functions e.g. as modules of a PDMS use vital sign values in the decision algorithms, the PDMS may even be classified as class II medical product, similar to e.g. intravenous pumps. If decision rules of a decision support-system are defined by IT-administrators working for a hospital itself it could even become manufacturer of the medical device.The authors discuss implications and demonstrate difficulties which arise for manufacturers as well as for hospitals or the users of medical software if the new regulation is strictly enforced. [german] Durch die nderung der Medizinger terichtlinie auf europ ischer Ebene kann nun auch eigenst ndige medizinische Software zum Medizinprodukt werden, wenn sie zur medizinische Diagnostik oder Therapie eingesetzt wird. Sukzessive werden diese Vorgaben seitens der EU-Mitgliedstaaten in nationales Recht implementiert, beispielsweise in das deutsche Medizinproduktrecht. Für einige Systeme aus der angewandten medizinischen Informatik, beispielsweise für Picture Archiving and Communication Systeme (PACS) ist diese Einordnung als Medizinprodu