"Software as a Medical Device": Possible Framework for Risk Categorization and Corresponding Considerations

This article targets Cybersecurity within the Healthcare Industry. It introduces an approach to unify the way in which manufacturers, regulators, and other Healthcare agents interact over cybersecurity. The central focus of the article is on SaMDs - Software as a Medical Device. It addresses the socio-technical environment in which SaMDs exist and the other commercial off-the-shelf (COTS) software that exists in the Healthcare industry. It discusses the regulations that target the SaMD vulnerabilities and recommends ways in which these regulations can be worked on by suggesting common practices that could be implemented to reduce vulnerabilities in the cyberspace. This is supported by the various challenges the article presents about how patients are affected by cyber attacks. It finally addresses how manufacturers can tweak the SaMD to ensure Healthcare agents are encouraged to know about the existing and possible vulnerabilities of SaMDs.