Is there a classical role for the clinical laboratory in digital health?

The classical role of the clinical laboratory, seen as the central place where the samples converge and from where the results are distributed, will be challenged by the development of digital health, the application of information technology (big data) and genomics to health care. When the development of disruptive new technologies will allow the production of accurate results outside the laboratory, its role will dramatically change. However, several factors are slowing down these evolutions. The quality of the existing data is relatively poor: lack of standardization of results, different units, different reference intervals, etc. The lab-on-a-chip technology is still relatively far from broad range application and the costs are higher than the traditional methods. There is the need for regulations of direct to consumer approaches that are posing big ethical problems. In the future, the clinical laboratory will maintain part of the “classical” role in the areas of research education and services. The large production will continue, favored by consolidation and reduction of the number of laboratories. The specialists of laboratory medicine have the task of collaborating with the national scientific societies and with the industry for improving harmonization of all the production phases, thus allowing the production of meaningful big data. Clinical laboratories have the role of implementing translational medicine. The new point-of-care (POC) technologies still need validation, the clinical laboratory is the place to do it. The advisory role toward clinicians and patients has to be improved, and a role in validating laboratory data interpretation apps and in controlling and supervising the functionality and the quality of the POC devices has to be developed.