Full-service health platforms with video sessions, the supply of drugs, blistering, all-round checks, health files and networking of all service providers does not yet exist, but ever more service providers are coming to the correct conclusion that joint provision is appropriate and important. The regulatory challenges are many and extend from data protection law and social law provisions, special eCommerce, platform and remote sales issues to special statutory regulations e.g., in the drugs/drugs trading or drugs supply area. In addition, advertising law and professional law requirements which dominate telemedicine are further factors. We are aware of all the reefs and guide you safely to port.
We advise comprehensively on platform concepts of the most varied kind with or without the inclusion of ePrescriptions. You benefit from our industry know-how, our detailed knowledge of the special legislation and the relevant context as for example data protection law. We have extensive experience in innovative distribution concepts, pharmacies, drugs distribution and sales platforms including pharmacy express delivery services, video consultations, remote treatment issues, and, of course, all facets of ePrescriptions including telematic connections.
Weitere Schwerpunkte aus der Expertise "Health"
We support individual pharmacies and pharmacy chains on the commencement and further operation of business.
The compliance requirements in the health system have intensified massively in recent years. We advise on legally secure cooperations in the health sector from the observation of applications to benefits, so that cooperation is not equated with corruption.
Medical products constitute a wide spectrum and have been, for some time, subject to the intensified requirements of the MDR (Medical Devices Regulation) and/or the IVDR (Invitro Diagnostic Regulation) and a meanwhile unmanageable number of implementation regulations. Whether radiation appliances, apps, material medical products or diagnostic products: we support you to keep abreast and to market products in a legally secure manner. We advise manufacturers, importers, providers of and traders in medical products of all classes.
We clarify questions of demarcation, design and advertising of cosmetic products and uphold the interests of companies in the industry before courts and authorities.
We advise in this complex and highly regulated area whether you produce and/or distribute “classical“ nutritional products, nutritional supplements, diet food, “functional foods“ or novel food.
We act in the establishment of doctors‘ and professional training communities and provide support in conflicts with SHI accredited doctors‘ associations, statutory health insurers and chambers.
Pharmaceutical wholesalers benefit from our detailed industry know-how, our experience in product demarcation and our expertise in regulatory and logistic matters.
Health Data Protection Law
Processing health-related data is necessarily inherent in the business of companies in the pharmaceutical and health areas. The data protection legal requirements on the processing of such sensitive data are onerous. At the same time, discussions about the more intensive use of health data for the improvement of treatment and research become louder. With our experience in the industry, we advise on all health data protection law issues and the possibilities for safe use of sensitive data.
Cannabis products are widely discussed. Whether medical cannabis or lifestyle products: the growth in the cannabis and CBD areas is enormous and will be even greater based on current political developments. Many linked legal areas such as the Narcotics Act, the Drugs Trading Act and food law must be considered when giving legally secure advice. We support you therein.
Health System Procurement Law
We have been from the beginning at the forefront of the development of health system procurement law. In particular, we have achieved a number of important leading judgments for our clients on discount agreement invitations to tender, drugs procurement and the statutory health insurers’ Open-House model.