Patient Management Software

Patient management software (PMS) is referred to 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 can also be software that is an adjunct to a medical device and directly contributes to the treatment of the patient by performing analysis, or providing treatment or diagnosis functionality that replaces the decision and judgment of a physician.

Medical devices are classified and these classifications became somewhat less restrictive in December, 2010. Regulations provide rules for classifying medical devices into four increasing risk levels – Class I, Class II, Class III, and Class IV. Patient management software is classified as either Class I or Class II. Software that is intended to be used to view images, or other real time data, as an adjunct to the monitoring device itself, for the purpose of aiding in treatment or diagnosis of a patient, would be Class I medical devices. Medical device software that is an adjunct 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 results from a monitor that are outside of an established range, is a Class II medical device if it: (1) provides the only means and opportunity to capture or acquire data from a medical device for aiding directly in 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 analyze data from a medical device such as blood pressure monitors and glucose monitors.

Many in the health care industry have raised concerns over the quality and software development process of PMS. The development of PMS is often criticized as too focused on simply the software development process and not the product. Much of these concerns are rooted in safety issues

Computerized physician order entry, an example of PMS, highlights some of these safety concerns.

Other criticisms are aimed at the regulations in place. Some critics argue that regulations stifle innovation and that vendors will no longer have any incentive to create new products. Also, existing and future products will have to adhere to strict licensing procedures and this may affect the sustainability of these products.

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Wikipedia