(05/2021) Arne Thiermann, partner at Hogan Lovells, Life Sciences Commercial & Regulatory, Hamburg
The chronically ill are particularly affected by the corona pandemic - they need close medical care, but every visit to the doctor carries a risk. Telemedicine and modern medical technology now enable home therapy for many chronic diseases. Manufacturers of home therapy devices often provide doctors with software for remote monitoring or data management - free of charge. But doctors should be careful when purchasing and using the appropriate software, because there are legal pitfalls to be observed, especially when using the software for medical purposes
Services are provided and billed.
Modern home therapy devices automatically transmit patient data to the doctor using software. The software manages and analyzes patient data and enables the doctor to adjust device settings with a click of the mouse. Examples of such home therapy devices and associated software exist in many treatment fields, e.g. B. glucose measuring systems and insulin pumps, home dialysis machines, ventilation and monitoring home systems, etc. Doctors regularly receive the associated software free of charge from the device manufacturer.
Acceptance of an advantage
Very few doctors are likely to be aware that free software can be viewed as the acceptance of an unfair, unlawful advantage by the manufacturer. This is all the more critical if the associated home therapy devices were previously prescribed by the doctors themselves. The software provided is then closely related to the prescription decision. If the doctor specifically prescribes the home therapy device from a certain manufacturer, the assumption is not far removed that the free purchase of the associated manufacturer software was decisive for the prescription of the corresponding home therapy device. From a business point of view, it makes sense for the doctor to choose a home therapy device for which the manufacturer supplies the appropriate software free of charge. From a legal point of view, however, this is a constellation that not only harbors a violation of professional law, but also a high risk of criminal liability - not only for the manufacturer, but also for the manufacturer-specific doctor.
Court ruling
For example, a few years ago (judgment of November 7, 2016, AZ: 40 O65 / 16 KfH), the Stuttgart Regional Court forbade manufacturers and distributors of glucose measurement systems and insulin pumps from giving their proprietary data management software to doctors free of charge. The district court ruled, "[t] he software for reading / data transfer of blood glucose meters and exclusively of their insulin pumps made available to doctors / health professions free of charge for downloading is to be regarded as an inadmissible granting of advantages to the health professions, which at least when prescribing insulin pumps save the defendant costs that they would otherwise have to bear when reading devices from other manufacturers. Contributions are all pecuniary benefits for the purpose of sales promotion. [...] In the opinion of the Chamber, the software is therefore to be assigned to the practice equipment and not just to the device accessories for the patient with regard to use in the doctor's practice. [...] The health professions may not have such equipment available free of charge if there is a paid market for it if - as stated - the prescription behavior of the doctor could be influenced. "
Hardly noticed
Surprisingly, the judgment of the regional court went unnoticed by the medical profession and by many manufacturers. The free distribution of proprietary software is still to be found in many fields of treatment, although the regional court has also made the implementation of criminal liability for corruption or bribery in the healthcare system possible through the free distribution of the software.
Expensive alternative software
There is no doubt that the software, which is provided free of charge, has an economic impact
