Course: Legal, Regulatory, and Health Technology Assessment (HTA) Concepts of Digital Health

Topic outline

Select section General

General

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After completing this course, you will be able to:

Identify the prerequisites for the European Health Data Space to operate.

Understand basic concepts in information governance, e.g. EU digital health policy, regulatory and compliance, real-world data/evidence (Big data), data protection & data privacy.

Discuss the impact of digital health solutions in the HTA process.

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- Select activity Announcements
  
  Announcements Forum
Select section Lesson 1: Introduction

Lesson 1: Introduction
- Select activity Introduction
  
  Introduction Page
  
  Learners must
  
  View
Select section Lesson 2: European Commission: eHealth: Digital Health and care

Lesson 2: European Commission: eHealth: Digital Health and care
- Select activity 1. Introduction
  
  1. Introduction Page
  
  Learners must
  
  View
- Select activity 2. The European Health Data Space (EHDS)
  
  2. The European Health Data Space (EHDS) Page
  
  Learners must
  
  View
- Select activity 3. Overview of the proposed Regulation:
  
  3. Overview of the proposed Regulation: Page
  
  Learners must
  
  View
Select section Lesson 3: Real world data (RWD) and real-world evidence (RWE) - Big data

Lesson 3: Real world data (RWD) and real-world evidence (RWE) - Big data
- Select activity 1. Introduction
  
  1. Introduction Page
  
  Learners must
  
  View
- Select activity 2. Data Analysis and Real World Interrogation Network (DARWIN EU)
  
  2. Data Analysis and Real World Interrogation Network (DARWIN EU) Page
  
  Learners must
  
  View
Select section Lesson 4: Regulatory

Lesson 4: Regulatory
- Select activity 1. Introduction
  
  1. Introduction Page
  
  Learners must
  
  View
- Select activity 2. Applicability of Medical Device Regulations
  
  2. Applicability of Medical Device Regulations Page
  
  Learners must
  
  View
- Select activity 3. Additional Role of EMA
  
  3. Additional Role of EMA Page
  
  Learners must
  
  View
- Select activity 4. Digital Health Services
  
  4. Digital Health Services Page
  
  Learners must
  
  View
Select section Lesson 5: Data protection and data privacy

Lesson 5: Data protection and data privacy
- Select activity 1. Introduction
  
  1. Introduction Page
  
  Learners must
  
  View
- Select activity 2. The GDPR
  
  2. The GDPR Page
  
  Learners must
  
  View
- Select activity 3. GDPR and Data Privacy
  
  3. GDPR and Data Privacy Page
  
  Learners must
  
  View
- Select activity 4. The Data Protection Law Enforcement Directive
  
  4. The Data Protection Law Enforcement Directive Page
  
  Learners must
  
  View
- Select activity 5. Data Protection in the EU Institutions and Bodies
  
  5. Data Protection in the EU Institutions and Bodies Page
  
  Learners must
  
  View
- Select activity 6. The e-Privacy Regulation proposal
  
  6. The e-Privacy Regulation proposal Page
  
  Learners must
  
  View
- Select activity 7. Other aspects
  
  7. Other aspects Page
  
  Learners must
  
  View
Select section Lesson 6: Health Technology Assessment (HTA)

Lesson 6: Health Technology Assessment (HTA)
- Select activity 1. Health Technology Assessment (HTA)
  
  1. Health Technology Assessment (HTA) Page
  
  Learners must
  
  View
Select section Assessment

Assessment
- Select activity Assessment
  
  Assessment Quiz
  
  Learners must
  
  Receive a grade
  
  Receive a passing grade

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Topic outline