ΙΑΤΡΙΚΗ, ΔΙΚΑΙΟ ΚΑΙ ΔΙΑΔΙΚΤΥΟ

Jochen Taupitz 5 conducted a study to receive an overview over the offers and to determine what ac- tion is to be taken with respect to legal provisions. They found out that most of these apps have no therapeutic or diagnostic entitlement or objective. Their target merely is to measure and to record the physical activity and nutrition of their user. They also found out that it is difficult to tell which apps are subject to the European and Ger- man Medical Devices Law. If the app is a medical device in that sense, it has to fulfill certain quality standards. In April 2017, the European Union adopted the new Medi- cal Devices Regulation. According to Article 2 “medical device means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: – diagnosis, prevention, monitor- ing, prediction, prognosis, treatment or alleviation of disease , – diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability , …”. That means, similar to the previous European Medical Devices Directive, a specific medical purpose according to the intention of the manufacturer is decisive whether or not the device has to meet the requirements of the regulation. Therefore, the definition of “medi- cal device” has a subjective character and the statements of the manufacturer are of main importance: He can decide for what purpose the app should be used. Conse- quently, releasing such apps is very easy, the special quality requirements of medical devices can easily be circumvented and nobody checks their quality. This may become very dangerous when people trust the existing capabilities and functions of the apps too much and stop consulting medical professionals. Therefore, the German Federal Ministry of Health decided to enact a law for the quality control of health apps soon. But nothing has been done so far. D. Internet pharmacies (mail-order pharmacies) As I speak about medical possibilities on the internet I cannot skip the offer and the order of pharmaceutical products through the internet. Nowadays it is not required to go to a pharmacy because you can order your medicines online. Even prescription- only drugs can be ordered online after the prescription has been sent to an internet pharmacy. There is even an offer for telephone consultation to receive all information available and needed for the medicine. Since 2004 in Germany the distribution of medicinal products via internet is allowed after it was forbidden in the beginning. The law was changed because of a decision of the European Court of Justice in 2003. The former ban in § 43 of the German Pharmaceutical Drug Act breached the free movement of goods in Europe. Today the dispatch is regulated. The legal provisions shall guarantee the safety of the pharmaceutical drugs and protect the consumers. § 11a of the German Law for Pharmacies determines a quality assurance system. It demands a proper packaging and a proper transport, the delivery to the right person, the information for the patient to consult a doctor if there are problems, and a consultancy by pharmaceutical staff in German language. The drug must be delivered within two days if it is available; otherwise the requester must be informed in an appropriate way. Of course, the despatcher must have a license as a pharmacist.