Health Technology Assessment for in silico medicine: social, ethical and legal aspects

The application of in silico medicine is constantly growing in prevention, diagnosis and treatment of diseases. These technologies allow to support medical decisions, self-management and reduce, refine and partially replace real studies of medical technologies. In silico medicine may challenge some key principles: transparency and fairness of data usage; data privacy and protection across platforms and systems; data availability and quality; data integration and interoperability; intellectual prop-erty; data sharing; equal accessibility for persons and populations. Several social, ethical and legal issues may consequently arise from its adoption. In this work, we provide an overview of these issues along with some practical suggestions for their assessment from a Health Technology As-sessment perspective. We performed a narrative review with a search on MEDLINE/Pubmed, ISI Web of Knowledge, Scopus, and Google Scholar. The following key aspects emerge as general reflections with an impact on operational level: cultural resistance, level of expertise of users, degree of patient involvement, infrastructural requirements, risks for health, respect of several patient's rights, potential discriminations for access and use of the technology, intellectual property of innovations. Our analysis shows that several challenges still need to be debated to allow in silico medicine to express all its potentiality in healthcare processes.