Before they can be prescribed by doctors and reimbursed by health insurance providers, digital health applications must be added to a list kept by the German Federal Institute for Drugs and Medical Devices (BfArM). To be added to the list, applications must meet a range of requirements. Christoph Kiesselbach, a partner at Schrack & Partner, spoke about the regulatory conditions that software needs to fulfil as a medical product or medical app and how it can be distinguished from wellness or sports apps, for example.

Dr. Ulrike Brucklacher, a certified specialist attorney in medical law and a partner at VOELKER & Partner mbB, talked about the current legislative situation and the progress being made in implementation. Among other things, she highlighted the need to keep health insurances as well as doctors and psychotherapists in mind when developing an app and make the relevant benefits clear to all parties. She also explained the option of “digital care applications”, which help people who need nursing care keep their independence and can be funded by nursing insurance providers rather than by health insurers.

Dr. Gerrit Hötzel, certified expert attorney for information technology law and for copyright and media law and a partner at VOELKER & Partner mbB, shed light on the technical side of the registration process. He outlined the great importance of data protection, setting out relevant requirements regarding cooperation with service providers and technical pitfalls in terms of security and data protection.

Finally, Jana Fesseler, project manager at BioRegio STERN Management GmbH, presented the support that BioRegio STERN offers through the Blockstart project. A training programme created as part of this project aims to help SMEs incorporate digital solutions, notably blockchain technology, into their companies. Kiesselbach offers assistance in regulatory matters on this subject. Blockchain technology can be particularly useful in improving data security. If you are interested in this free support, please contact Jana Fesseler directly (fesseler@bioregio-stern.de).

Dr. Klaus Eichenberg, Managing Director of BioRegio STERN Management GmbH, gave a positive review of the event which, with 44 participants and six speakers, proved popular. He was delighted that “Germany can also deliver world firsts”, adding that the Digital Healthcare Act offers opportunities for both patients and companies and is therefore a positive signal for the industry.