Legal & Regulatory

Cross-border activities in health care in the European single market are increasing, and an increasing number of these are related to e-Health. There is therefore a need for appropriate legal and regulatory frameworks to be able to ensure its promotion in the European Union. As well as appropriate legal and regulatory efforts, suitable reimbursement strategies also have to be considered across European countries.

Coordinated legal and regulatory frameworks and reimbursement strategies are important from the viewpoint of a number of stakeholders including patients, SMEs, innovators, governments, regulators, insurers, medical providers and investors.

Some directives and regulations constitute a step in this direction. Both the General Data Protection Regulation and the E-Commerce Directive are some of the most important European legal achievements related to e-Health. To unify regulatory requirements across Europe the new Medical Device Regulation and In Vitro Diagnostic Regulation were introduced at the beginning of 2017. They will be implemented after a 3 to 5 year transition period. Although these directives and regulations are not adopted especially for e-health applications, they are very important for e-Health. Unfortunately, for reimbursement such harmonisation efforts are not applicable in Europe, reimbursement systems still vary strongly between European countries.

eHealth Hub provides two services: Legal Suport & Regulatory Guidance.