Digital health applications: Your compass through the regulatory jungle!

Would you like to guide your DiGA project safely and successfully through the regulatory challenges? In our exclusive two-part webinar, we highlight the key legal and regulatory aspects you need to know for your project to succeed.

Session 1: Legal & Regulatory requirements

Friday, 17 October 2025, 12:00 p.m. – 1:00 p.m.

Voelker examines the legal framework:

• Data protection: IT security: GDPR and the perspective of supervisory authorities.
• BfArM guidelines & DiGAV: New requirements and updates for 2025.
• Interoperability: Interfaces and connection to ePA/KIM.
• Compliance & remuneration: Sections 299a, 299b StGB (German Criminal Code), benefits, Section 128 SGB V (German Social Code).
• Roles; liability: manufacturers, doctors, platforms and cooperation models.

novineon guides you through the regulatory requirements and study practice:

• Regulatory requirements: Stay up to date with relevant legislation.
• Project planning and study preparation: Study setting, submission and the positive effect on care.
• Project management: Process and activities for successful study implementation and completion.
• Practical experience: What to consider when conducting a DiGA study.

Session 2: Q&A session with a DiGA manufacturer

Friday, 7 November 2025, 12:00 p.m. – 1:00 p.m.

At the second event, you will have the exclusive opportunity to pose your questions directly to an experienced DiGA manufacturer. Benefit from authentic insights from the field and learn first-hand how to overcome typical hurdles.
Further details will follow.

Secure your place now and gain a knowledge advantage!

This webinar duo is a must for all manufacturers, developers and product managers in the DiGA environment.

Join us on Friday at 11:50 a.m. via the link below using MS Teams. The event will run from 12:00 p.m. to approximately 1:00 p.m. You can request the slides for the Virtual Lunch from the organisers.

Click here to add the event to your calendar or to participate directly.

Date 1: Friday, 17 October 2025, 12:00 p.m. – 1:00 p.m.

Date 2: Friday, 7 November 2025, 12:00 p.m. – 1:00 p.m.

We look forward to welcoming you to our Virtual Lunch.