Legal and Ethical Inventory on In Silico Trials, the one-stop repository for resources on In Silico Trials.
This task will map legal and ethical requirements that should be implemented when developing new technology from its early stage design. In particular, this task will kick-off by conducting a legal analysis of the EU legislative framework dealing with privacy and data protection (i.e., ECHR, GDPR, case law of the CJEU and ECtHR). Further it will provide an analysis of the legislation applicable to medical devices (in particular, class III MD).
In that regard, relevant articles of the new EU medical devices regulation (applicable as of May 2020; EU-MDR) will be examined into detail and the main requirements relevant for the success of the ISW technology will be highlighted.
Since both data protection and medical devices fields are rapidly advancing and changing, new normative guidelines and recommendations from policy and lawmakers will be closely monitored. A third field of law that has to be analysed in the context of ISW technology concerns medicinal products (in particular, Directive 2001/83/EC). Lastly, ethical principles considered relevant (such as trust, beneficence, non-maleficence, autonomy, etc.) for the technology development will be carefully looked at.