Busi­ness Brunch – cyber secu­ri­ty for medi­cal devices

What do the manu­fac­tu­r­ers of medi­cal devices need to know about cyber security?

Busi­ness Brunch with Miri­am Schuh & Dr. Car­lo Piltz in Munich on 16 March 2018 

e‑health, m‑health and con­nec­ted health cea­sed to be futu­ristic sce­na­ri­os a long time ago. Accor­din­gly, manu­fac­tu­r­ers of medi­cal devices, medi­cal soft­ware and health apps must design their pro­ducts in accordance with the requi­re­ments of the new Euro­pean Medi­cal Devices Regu­la­ti­on (MDR). This also means pay­ing heed to the aspect of cyber-security throug­hout the enti­re life cycle of the pro­ducts. If the pro­duct is not manu­fac­tu­red in a way that ensu­res that it is safe and con­forms to the MDR, the manu­fac­tu­rer is expo­sed to major lia­bi­li­ty risks. 

For medi­cal apps and health apps, fur­ther­mo­re, regu­la­ti­ons rela­ting to data pro­tec­tion beco­me rele­vant as soon as data rela­ting to the sta­te of health of the users are gathe­red and ana­ly­sed. As from 25 May 2018 the new EU Gene­ral Data Pro­tec­tion Regu­la­ti­on (DSGVO) will app­ly throug­hout Euro­pe. Like the MDR, the DSGVO also ent­ails a lar­ge num­ber of new obli­ga­ti­ons for com­pa­nies in the health and phar­maceu­ti­cal indus­try, and manu­fac­tu­r­ers of medi­cal apps and health apps abso­lut­e­ly must pay heed to the­se in order to mini­mi­se their lia­bi­li­ty risks. The obli­ga­ti­ons rela­te, among other things, to the prin­ci­ples of pri­va­cy by design and by default, and to a level of data secu­ri­ty which is ori­en­ted toward the cur­rent sta­te of technology. 

We would like to dis­cuss the­se topics with you at our Busi­ness Brunch in Munich on 16 March 2018.

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If you have any pro­blems with on-line regis­tra­ti­on, just drop us a line by e‑mail let­ting us know of your wish to take part. Thank you.