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

After completing the 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.

8 hours

EUR 8.00

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Topic outline

Lesson 1: Introduction

Page

Introduction Page

Lesson 2: European Commission: eHealth: Digital Health and care

Page

1. Introduction Page

Page

2. The European Health Data Space (EHDS) Page

Page

3. Overview of the proposed Regulation: Page

Lesson 3: Real world data (RWD) and real-world evidence (RWE) - Big data

Page

1. Introduction Page

Page

2. Data Analysis and Real World Interrogation Network (DARWIN EU) Page

Lesson 4: Regulatory

Page

1. Introduction Page

Page

2. Applicability of Medical Device Regulations Page

Page

3. Additional Role of EMA Page

Page

4. Digital Health Services Page

Lesson 5: Data protection and data privacy

Page

1. Introduction Page

Page

2. The GDPR Page

Page

3. GDPR and Data Privacy Page

Page

4. The Data Protection Law Enforcement Directive Page

Page

5. Data Protection in the EU Institutions and Bodies Page

Page

6. The e-Privacy Regulation proposal Page

Page

7. Other aspects Page

Lesson 6: Health Technology Assessment (HTA)

Page

1. Health Technology Assessment (HTA) Page

Assessment

Quiz

Assessment Quiz

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