How MDs are classified in America and Europe according to the risks they are subject to. In both America and Europe, medical devices are classified based on the level of risk they pose to patients and users. The classification criteria Read more…
Health Insurance Portability and Accountability Act The HIPAA privacy rule protects Personal Identifiable health information (PHI) and medical records. HIPAA rules are applicable to covered entities, including healthcare providers, health plans, and healthcare clearinghouses in case they transmit information in Read more…
Summary of the actual regulations valid in the European Union Medical Device Directive (MDD) has been the body which regulates the marketing and safety of medical devices in Europe since the 1990s. In contrast to FDA, the EU classifies medical Read more…
Summary of the actual regulations imposed by the USA Food and Drug Administration Averting unauthorized access, unauthorized use, unauthorized modification, or abuse of information that is obtained, stored, or communicated from a device to an external receiver is the process Read more…
Is it possible to also attack non-network connected devices? Broadly, there are two categories of IMDs – network-connected and non-network connected IMDs – and each category has very specific security risks and vulnerabilities. Adversaries, hackers, and attackers may exploit specific Read more…
Why medical devices are vulnerable to cyber attacks? Smart healthcare is an integral part of smart cities. Modern medical devices are becoming increasingly software dependent. Doctors and patients are now using their smartphones to control and monitor implantable medical devices (IMDs) such as Read more…
