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

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

Allgemeine Information

• Semesterwochenstunden: 2
• ECTS: 3
• Benotet: Ja
• Einschreibefrist: 01.04.-26.04.2019
• Lehrform: Vorlesung
• Belegungsart: Pflichtmodul
• Lehrsprache: Englisch
• Maximale Teilnehmerzahl: 30

Studiengänge, Modulgruppen & Module

Beschreibung

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

• Block 1:

• Data Protection and Data Security, ePrivacy, eIDAS, KYC-Processes, European Program for Critical Infrastructure Protection (Philipp Kircher)

• Block 2:

• Medical Device Regulation: Classification, Clinical Trials, Contractual concepts for Clinicians, CROs and Notified Bodies. (Sebastian Retter)

• Block 3:

• 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 4:

• Machine Learning (AI): interaction with the current state of law and future development.
  Eight use cases and their legal implications (Christian Dierks)

• Block 5:

• Reimbursement and Pricing: Pathways of implementing services and products into a healthcare system. Patient relevant endpoints as criteria for designing studies and basis for negotiations and claims (Christian Dierks)

• Block 6:

• Digital Healthcare in Practice: a US Example on Pharmaceutical Benefit Management, ACA, HIPPA (Juliana Dierks)

Leistungserfassung

 Proof of participation shall be provided as (individual) assignment

Termine

Blockseminar Friday/Saturday, Seminar room G1.E 15/16
April 26/27
June 14/15

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

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