It Seems To Me The TGA Has A Lot Of Catching Up To Do As A Medical Device Regulator.

This appeared a few days ago:TGA to reform regulation for software as medical devices as apps, AI and 3D printing in healthcare boomLynne Minion | 11 Oct 2018 Health apps, diagnostic AI systems and the 3D printing of body parts are among the tech innovations that could soon be subject to strengthened oversight, with the Therapeutic Goods Administration planning to put forward regulatory amendments for the emerging technologies.Within its new business plan for 2018-19, the TGA said software as a medical device – such as the recently announced Apple Watch 4, which includes an atrial fibrillation-detecting algorithm and an ECG – will soon need to jump through custom-fit hoops.In response to the “complicated and dynamic” healthcare landscape, the TGA is chasing the health tech pioneers to put in plac e rules that manage risk and weed out the cowboys.“Scientific advancements such as new cancer treatments and new technologies such as 3D bio-printing continue to bring opportunities for... This is the initial part of the post - read more by clicking on the title of the article. David.
Source: Australian Health Information Technology - Category: Information Technology Authors: Source Type: blogs