Legal and compliance framework for digital health from a national and international (EU, US) viewpoint (Sommersemester 2020)

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

General Information

• Weekly Hours: 2
• Credits: 3
• Graded: yes
• Enrolment Deadline: 06.04.2020-22.04.2020
• Teaching Form: Seminar
• Enrolment Type: Compulsory Module
• Course Language: English
• Maximum number of participants: 30

Programs, Module Groups & Modules

Description

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 regulatory system which is applied to data, devices, diagnostics and drugs. The unity of these 4 areas is described as 4D 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

Content
• Block 1: Intro & Use Case, Ethical, Legal and Compliance Overview (Christian Dierks)
• Block 2: Patient Journey, Stakeholder Map, Digital Health Applications (Christian Dierks)
• Block 3: Data Protection and Data Security, ePrivacy, eIDAS, KYC-Processes, European Program for Critical Infrastructure Protection (Peter Schüller)
• Block 4: Compliance, Responsibility, Accountability and Litigation for Digital Services in an international setting with regard to the various EU Directives, legal frameworks for telemedicine (Peter Schüller)
• Block 5: Medical Device Regulation: Classification, Clinical Trials, Contractual concepts for Clinicians, CROs and Notified Bodies. (Sebastian Retter)
• Block 6: Machine Learning (AI): interaction with the current state of law and future development. Eight use cases and their legal implications (Christian Dierks)

Examination

 Proof of participation shall be provided as (individual) assignment

Dates

Blockseminar Friday/Saturday, (Seminar room G1.E 15/16)
May 15/16
June 19/20

Fridays    9 am - 5 pm
Saturdays  9 am -1 pm

Udate 05/07/2020: Due to the Pandemic, we will have the seminar as a zoom meeting,
materials will be available in openHPI course room (links will be provided a few days before 05/15/2020 via email to all registered participants)

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