Medical IT

Medical IT , also known as MIT ( medical technology and information technology ), combines the engineering principles and rules of medical technology with the acquisition, processing, storage and distribution of electronic data , information and knowledge in the healthcare sector. This can include software as well as hardware that is used for medical, therapeutic or diagnostic purposes for humans.

MIT's tasks

One of the most important tasks of MIT is the secure operation of IT as a medical product or networked medical products. This is supported by the following fields of action:

• Risk management according to EN 80001-1 in medical networks
• Integration or operation of IT as a medical product in accordance with legal regulations
• Management of IT as a medical product in in-house production (MPG §12)

background

For some years now, the manufacturers of medical devices have begun to expand their products with information technology and thus to digitize many functions. As a result, many medical devices received corresponding data interfaces in order to be able to forward the increasingly generated data to other systems. In 2007 the European Medical Device Directive MDD (2007/47 / EC) was changed. After that, software could be defined as a separate medical product for the first time. This was also adopted into German law by the 4th MPG Amendment Act and came into force on March 21, 2010.

The industry and the legislature thus created two new challenges for the operators of medical technology in the healthcare sector:

• networked medical devices
• Software as an independent medical product