be managed and reduced to a reasonable level. When designing medical devices, the tier of cybersecurity risk should be determined early in the process in order to establish a cybersecurity vulnerability and management approach (including a set of cybersecurity design controls). The medical device design approach employed should be consistent with the NIST Cybersecurity Framework for managing cybersecurity-related risks. In August 2013, the FDA released over 20 regulations aiming to improve the security of data in medical devices, in response to the growing risks of limited cybersecurity. Artificial intelligence The number of approved medical devices using artificial intelligence or machine learning (AI/ML) is increasing. As of 2020, there were several hundred AI/ML medical devices approved by the US FDA or CE-marked devices in Europe. Most AI/ML devices focus upon radiology. As of 2020, there was no specific regulatory pathway for AI/ML-based medical devices in the US or Europe. However, in January 2021, the FDA published a proposed regulatory framework for AI/ML-based software, and the EU medical device regulation which replaces the EU Medical Device Directive in May 2021, defines regulatory requirements for medical devices, including AI/ML software. Medical equipment Medical equipment (also known as armamentarium) is designed to aid in the diagnosis, monitoring or treatment of medical conditions. Types There are several basic types: Diagnostic equipment includes medical imaging machines, used to aid in diagnosis. Examples are ultrasound and MRI machines, PET and CT scanners, and x-ray machines. Treatment equipment includes infusion pumps, medical lasers and LASIK surgical machines. Life support equipment is used to maintain a patient's bodily function. This includes medical ventilators, incubators, anaesthetic machines, heart-lung machines, ECMO, and dialysis machines. Medical monitors allow medical staff to measure a patient's medical state. Monitors may measure patient vital signs and other parameters including ECG, EEG, and blood pressure. Medical laboratory equipment automates or helps analyze blood, urine, genes, and dissolved gases in the blood. Diagnostic medical equipment may also be used in the home for certain purposes, e.g. for the control of diabetes mellitus Therapeutic: physical therapy machines like continuous passive range of motion (CPM) machines The identification of medical devices has been recently improved by the introduction of Unique Device Identification (UDI) and standardised naming using the Global Medical Device Nomenclature (GMDN) which have been endorsed by the International Medical Device Regulatory Forum (IMDRF). A biomedical equipment technician (BMET) is a vital component of the healthcare delivery system.