Building Functional Safety and Security into Medical IoT Devices: IEC 62304 Conformance

Due to increased connectivity between devices and local access networks and the increased value of data being exchanged, corporate espionage, data theft, and cyber terrorism are very real concerns and drive a major focus on security issues. Since the software is where much of the functionality of a device occurs, it stands to reason that this is where serious consideration for safety and security must take place. Luckily, standards have emerged to direct development to mitigate both safety and security risk and much can be leveraged from what has been mandated in the medical industry to other vertical markets.