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 vary slightly between the two regions, but generally, the higher 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 of cybersecurity, according to the FDA. FDA categorizes medical devices 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 devices into four classes depending upon their risk level and 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 electronic form. However, HIPAA does not cover medical devices and Read more…