Digi­tal Health

Making sure that digi­ta­liza­ti­on in the health­ca­re sec­tor is both legal and efficient.

Digi­ta­liza­ti­on is pro­found­ly chan­ging the health­ca­re sec­tor. Medi­cal devices are beco­ming incre­asing­ly software-based or net­work­ed. New tools such as digi­tal health apps, smart gad­gets and weara­bles, arti­fi­ci­al intel­li­gence, and inter­ope­ra­ble plat­form solu­ti­ons are accom­pany­ing dia­gno­sis, the­ra­py, and care. Data-driven sys­tems and the secon­da­ry use of health data are also sha­ping new orga­niza­tio­nal and busi­ness models. At the same time regu­la­to­ry com­ple­xi­ty is on the rise. The deve­lo­p­ment, intro­duc­tion and ope­ra­ti­on of digi­tal health solu­ti­ons is deter­mi­ned by seve­ral intert­wi­ned requi­re­ments, inclu­ding tho­se rela­ting to medi­cal device law, data pro­tec­tion and data use, IT and cyber secu­ri­ty, and arti­fi­ci­al intel­li­gence regulation.

Digi­tal health, the­r­e­fo­re, signi­fies the clo­se con­nec­tion bet­ween inno­va­ti­on, tech­no­lo­gy and regu­la­ti­on. Digi­tal health solu­ti­ons regu­lar­ly pro­cess high­ly sen­si­ti­ve data, are part of security-critical infra­struc­tures, and incre­asing­ly use auto­ma­ted or AI-supported func­tions. It is impe­ra­ti­ve to ack­now­ledge that issues of legal­ly com­pli­ant data use, data gover­nan­ce, IT and cyber secu­ri­ty, and the use of AI sys­tems are inte­gral com­pon­ents of every digi­tal health pro­ject. New Euro­pean regu­la­ti­ons have signi­fi­cant­ly increased the com­pli­ance requirements.

Our Digi­tal Health team advi­ses cli­ents from across the enti­re health­ca­re eco­sys­tem. We pro­vi­de com­pre­hen­si­ve sup­port for digi­ta­liza­ti­on pro­jects and digi­tal health solu­ti­ons – from the con­cep­ti­on pha­se and stra­te­gic ori­en­ta­ti­on to the imple­men­ta­ti­on and exe­cu­ti­on, ongo­ing moni­to­ring and the fur­ther deve­lo­p­ment of exis­ting solu­ti­ons. Throug­hout this pro­cess, we moni­tor legal, tech­ni­cal and orga­niza­tio­nal interactions.

We inte­gra­te regu­la­to­ry pro­fi­ci­en­cy with a pro­found com­pre­hen­si­on of digi­tal tech­no­lo­gies, data-driven metho­do­lo­gies, and the distinct requi­re­ments of the health­ca­re sec­tor. Our con­sul­ting ser­vices are inter­di­sci­pli­na­ry, prac­ti­cal, and focu­sed on the enti­re life cycle of digi­tal solu­ti­ons. Our objec­ti­ve is to assist our cli­ents in imple­men­ting digi­tal inno­va­tions in the health­ca­re sec­tor in a legal­ly com­pli­ant man­ner, addres­sing regu­la­to­ry risks at an ear­ly stage, and estab­li­shing digi­tal pro­ducts, pro­ces­ses, and busi­ness models in the mar­ket in a sta­ble and sus­tainable way.

Our ser­vices

• Com­pre­hen­si­ve sup­port for digi­ta­liza­ti­on pro­jects in the health and med­tech environment
• Iden­ti­fi­ca­ti­on of Euro­pean and natio­nal regu­la­to­ry requirements
• Imple­men­ta­ti­on of legal requi­re­ments in exis­ting com­pli­ance manage­ment sys­tems or new implementations
• Data pro­tec­tion, data use, and data gover­nan­ce, inclu­ding the Euro­pean Health Data Space (EHDS)
• IT and cyber­se­cu­ri­ty law
• Arti­fi­ci­al intelligence
• Sup­port for digi­tal busi­ness and dis­tri­bu­ti­on models, inclu­ding mail-order pharmacies
• Legal sup­port for elec­tro­nic pati­ent files (ePA)
• Con­tract review, con­tract draf­ting, and due diligence
• Trai­ning and workshops
• Legal moni­to­ring

Cont­act us

Plea­se feel free to cont­act us at any time if we can sup­port you or if you have any ques­ti­ons. We would be hap­py to explain our approach to you in a per­so­nal con­ver­sa­ti­on, ans­wer your ques­ti­ons and crea­te a sui­ta­ble offer for your company.

Chris­ti­na Ziegler-Kiefer

Seni­or Associate

• T + 49 681 / 859 160 0 
• E christina.ziegler-kiefer@reuschlaw.de

Down­loads

NIS 2 Com­pli­ance by manu­fac­tu­r­ers of medi­cal devices

NIS 2 Com­pli­ance by manu­fac­tu­r­ers of in vitro dia­gno­stic medi­cal devices