Celestina Bianco

Quality Assurance and Regulatory Affairs Director
Systelab Technologies


1:50 PM GDPR and Healthcare Data for Medical Device Software

This presentation will guide the audience through an introduction of GDPR and a roadmap example for SW Developers and Manufacturers.
- Gain an understanding of how to define “Health Data”
- Create an overview of the main changes in the regulation and concepts such as Privacy Impact Analysis, One-stop-Shop, Data Protection Officer, Transparency and Consent
- Understand the application of GDPR on Art 9 and Health Data Collection
- Examine the extent of the “scientific research” exemption for GDPR obligations – how does this interact with secondary utilisation of data for development purpose?