Royal Decree 957/2020 simplifies the process for conducting observational studies through a common single evaluation procedure for all studies of this type and by reducing the prior requirements. It also introduces changes in relation to the informed consent of patients participating in the study and the associated financial elements, as well as to the transparency and reporting obligations, among other matters.
Below we summarize some of the specific measures adopted in relation to medical devices by the main European and Spanish authorities. These measures are part of the set of new pieces of legislation affecting the pharmaceutical and healthcare industry as a result of the crisis caused by the impact of the COVID-19 virus, which are being analyzed by the firm.
Some of the measures adopted in recent weeks to tackle the economic and social impact of COVID-19 have special implications for the healthcare and pharmaceutical industry. In this article we analyze the key information that companies in this field need to take into account.
Foundation29 (Fundación 29 de febrero) is a non-profit organization specialised in artificial intelligence applied to health. It creates technological tools based on aggregation, treatment and protection of medical data and its use in intelligent systems that help patients, professionals and industry take decisions.