ResearchKit & French law
Despite the innovation that could bring ResearchKit to clinical research, its use in France is currently limited. Indeed, legislation about clinical studies puts several limitations at a national level, such as :
- The informed consent of subjects taking part in a clinical trial must necessarily be paper based and administered by a healthcare professional
- Data that arise from the study – even anomymized – can’t be used for purposes other than those intended.
However, this situation could quickly evolve favorably. Indeed, the EU Data Protection Reform is currently being debated – the discussions started in 2012 – and should be adopted by the end of 2015. This reform – that doesn’t need a transposition in national law – would overrule the national legislative hurdles.