Cross-border activities in health care in Europe are increasing, and most of these are related to eHealth. The eHealth HUB Legal and Regulatory services offer support and guidance to SMEs or startups working on digital health solutions throughout Europe.
The eHealth HUB Network of Regulatory and Reimbursement Experts can help with complying with regulatory requirements for CE certification and quality management as well as the question how a digital health solution can be reimbursed in countries of the European Union.
eHealth HUB experts can also assist with answering questions such as whether a digital health solution is a medical device or concerning the correct classification of a medical device. Furthermore, advise can be given regarding the implementation of the ISO 13485:2016 quality management system, the steps that have to be taken to get the CE marking and on the payment for an eHealth solution by Public Health Authorities.
Register for the regulatory service
The eHealth Hub also offers a legal service helping to navigate throughlegal services in Europe. The eHealth Hub Network of Legal Experts is a network of specialized lawyers in jurisdictions across EU Member States that are familiar with legal issues eHealth SMEs may face.
The eHealth Hub Legal Network offers access to a network of specialized eHealth lawyers. SMEs first have to submit their legal enquiries. Then, they will be contacted by a professional in order to assess their legal needs and suggest partners within the network who may be able to help with paid-for legal assistance
Register for legal support
eHealth HUB - European eHealth business support is an EU-funded initiative, focused on cross-border and the digital health. eHealth HUB’s goal is to provide high-quality business-oriented services tailored to the needs of European eHealth startups, SMEs and stakeholders. It has received funding from the European Union’s Horizon 2020 Research and Innovation Programme under Grant Agreement No727683.