08-16-2017, 10:42 PM
Patient Management Software (PMS) is known as software that is regulated as a medical device. It is software that is used to acquire medical information from a medical device to be used in the treatment or diagnosis of a patient. It may also be software that is a complement to a medical device and contributes directly to the patient's treatment by performing analysis or providing diagnostic treatment or functionality that replaces the decision and judgment of a physician. Medical devices are classified and these classifications became Somewhat less restrictive in December 2010. The regulations establish rules for classifying medical devices into four increasing risk levels: Class I, Class II, Class II and Class IV. Patient management software is classified as Class I or Class II. Software intended to be used to view images, or other real-time data, as an adjunct to the monitoring device itself, in order to aid in the treatment or diagnosis of a patient, would be Class I medical devices. Medical Device Software Which is a complement to another medical device and is involved in data manipulation, data analysis, data editing, image generation, determination of measurements, identification of a region of interest in an image or identification (by an alarm or alert ) Of the results of a monitor that are outside a set range, it is a Class II medical device if:
(1) provides the only means and the opportunity to capture or acquire data from a medical device to assist directly in the diagnosis or treatment of a patient; or
(2) replaces a diagnostic or treatment decision made by a physician.
Examples of patient management software are PACS, remote patient monitoring. Others include any medical device that is used to transmit data from a medical device or analyse data from a medical device, such as blood pressure monitors and glucose monitors.
