Hasso-Plattner-Institut20 Jahre HPI
Hasso-Plattner-Institut20 Jahre HPI

Legal and compliance framework for digital health from a national and international (EU, US) viewpoint (Sommersemester 2019)

Lecturer: Prof. Dr. Dr. Christian Dierks (Gastdozenten oder Dozenten der Uni-Potsdam)

General Information

  • Weekly Hours: 2
  • Credits: 3
  • Graded: yes
  • Enrolment Deadline: 01.04.-26.04.2019
  • Teaching Form: Lecture
  • Enrolment Type: Compulsory Module
  • Course Language: English
  • Maximum number of participants: 30

Programs & Modules

Digital Health MA
  • Ethics, Law and Compliance for Digital Health
IT-Systems Engineering MA


The students will learn how to distinguish the different legal frameworks for data protection, medical devices, telemedicine and reimbursement. An exploration of the overarching structure of the relevant EU regulations will provide the understanding for different legislatures throughout the EU. This is the regaltory system which is applied to data, devices, diagnostics and drugs. The unity of these 4 areas is described as 4 D medicine. Many products and procedures in digital health are at the intersections of these different frameworks and therefore provide multiple challenges. The students will learn how to categorize and identify these challenges and seek solutions within the existing system of legal boundaries by exploring from a use case viewpoint.

Learning Objectives:

  • Understand the scope and concepts in the legal framework of digital health
  • Identify the applicability of EU Regulations, Member State law and regional deviations
  • Ability to critically assess impact of data protection regulations in engineering and implementing digital solutions
  • Integrate regulatory preconditions into the development of digital products
  • Ability to assess scope and applicability of regulations for digital health services, identify red flags and find solutions
  • Develop concepts for reimbursement of digital products


Blockseminar Friday/Saturday
April 26/27
June 14/15