Busi­ness Brunch Mobi­le health

Focus on mHe­alth: medi­cal apps, the Medi­cal Device Direc­ti­ve and data protection

Busi­ness Brunch with Miri­am Schuh and Dr. Car­lo Piltz on 3 Novem­ber 2017 in Augsburg

Manu­fac­tu­r­ers of medi­cal soft­ware and health apps are asking them­sel­ves whe­ther or not their pro­duct qua­li­fies as a medi­cal device. The bor­der bet­ween a ‘mere’ life­style app and a medi­cal app – and thus also a medi­cal device – is often unclear. If it is a medi­cal device, it has been neces­sa­ry to pay heed to the new Medi­cal Device Regu­la­ti­on (MDR) sin­ce May 2017. If the pro­duct is manu­fac­tu­red, clas­si­fied or label­led in a way that does not con­form to the MDR, the manu­fac­tu­rer may be expo­sed to major lia­bi­li­ty risks. 

At our busi­ness brunch on 3 Novem­ber 2017 in Augs­burg we would like to dis­cuss this topic with you and look into ques­ti­ons such as

• What kinds of soft­ware qua­li­fy as medi­cal devices?
• How do life­style apps dif­fer from medi­cal apps? 
• What impacts does the new MDR have on medi­cal software?
• What risks do medi­cal soft­ware and medi­cal apps ent­ail in terms of data pro­tec­tion law?
• What lia­bi­li­ty risks does the new DSGVO entail?

We look for­ward to dis­cus­sing the­se topics with you at our Busi­ness Brunch.