Health software: a new CEI Guide for software management in medical environment.

INTRODUCTION The increasing spread of software components in the healthcare context renders explanatory guides relevant and mandatory to interpret laws and standards, and to support safe management of software products in healthcare. METHODOLOGY In 2012 a working group has been settled for the above purposes at Italian Electrotechnical Committee (CEI), made of experts from Italian National Institute of Health (ISS), representatives of industry, and representatives of the healthcare organizations. RESULTS As a first outcome of the group activity, Guide CEI 62-237 was published in February 2015. The Guide incorporates an innovative approach based on the proper contextualization of software products, either medical devices or not, to the specific healthcare scenario, and addresses the risk management of IT systems. CONCLUSIONS The Guide provides operators and manufacturers with an interpretative support with many detailed examples to facilitate the proper contextualization and management of health software, in compliance with related European and international regulations and standards.