Last week, Theranos clinical lab has received more bad news. Though the final resolution is still pending, all available informations raise concerns about the acuracy of such lab.Could this happen in Europe? My feeling is that the outdated and obsolete regulation could replicate the story.
In Europe, in vitro diagnostics regulation was decided 18 years ago!. The last proposal debated two years ago in the Parliament got no final agreement. I have explained the inefficiency of european parliament formerly. Health care safety and quality deserves better regulation and specially in lab tests.
Beyond safety issues, the value of lab tests require deeper assessment. Current proposals are not taking into account properly this issue. Now is the moment to introduce it in the final proposal, otherwise it will forgotten for the next two decades.
PS. Have a look at this article: A Systematic Review of Health Economic Evaluations of Diagnostic Biomarkers
Manhattan i Queens (Fragment), oli sobre tela, 60 × 150cm
