Related Experiment Video
Updated: Dec 16, 2025

Targeted Next-generation Sequencing and Bioinformatics Pipeline to Evaluate Genetic Determinants of Constitutional Disease
Published on: April 4, 2018
Legal Challenges for IT Service Providers in Pharmacogenomics
Lea Meier1, Kevin Tippenhauer1, Murat Sariyar1
1Institute for Medical Informatics I4MI, Bern University of Applied Sciences, Switzerland.
Abstract:
IT providers offering services based on genetic data face serious challenges in managing health data in compliance with the General Data Protection Regulation (GDPR). Based on a literature research and our experiences, an overview of GDPR compliant processing of sensitive data is given. The GDPR requirements for processing sensitive data were specified for a use case concerning a service provider of a pharmacogenomic decision support system. Start-ups who want to enter into the health market also have to comply with the Medical Device Regulation (MDR). The associated efforts for legal compliance constitute an impediment for many start-ups. We created a comprehensive overview, which aligned the requirements of the GDPR with the life-cycle of a medical device. This overview shall help start-ups to grasp and overcome the regulatory hurdles faster.
More Related Videos
09:30Pre-Implantation Genetic Testing for Aneuploidy on a Semiconductor Based Next-Generation Sequencing Platform
Published on: August 17, 2022
08:46Implementation of In Vitro Drug Resistance Assays: Maximizing the Potential for Uncovering Clinically Relevant Resistance Mechanisms
Published on: December 9, 2015
Related Concept Videos
Drug Products: Biologics, Biosimilars and Interchangeables
Dosage Regimen: Individualization
Issues And Trends In Healthcare Delivery System
Cost Containment
Payment for healthcare services has historically promoted adoption of costly and often unnecessary or inefficient...
Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence
Drug Control Governance: Regulatory Bodies and Their Impact
Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence