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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

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At the end of each course you can test your knowledge and earn a certificate for an 10 euro administrative fee. If interested, click the button below:

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Topic outline

Lesson 1: Introduction

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  Introduction Page
Lesson 2: European Commission: eHealth: Digital Health and care
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  1. Introduction Page
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  2. The European Health Data Space (EHDS) Page
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  3. Overview of the proposed Regulation: Page
Lesson 3: Real world data (RWD) and real-world evidence (RWE) - Big data
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  1. Introduction Page
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  2. Data Analysis and Real World Interrogation Network (DARWIN EU) Page
Lesson 4: Regulatory
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  1. Introduction Page
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  2. Applicability of Medical Device Regulations Page
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  3. Additional Role of EMA Page
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  4. Digital Health Services Page
Lesson 5: Data protection and data privacy
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  1. Introduction Page
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  2. The GDPR Page
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  3. GDPR and Data Privacy Page
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  4. The Data Protection Law Enforcement Directive Page
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  5. Data Protection in the EU Institutions and Bodies Page
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  6. The e-Privacy Regulation proposal Page
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  7. Other aspects Page
Lesson 6: Health Technology Assessment (HTA)
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  1. Health Technology Assessment (HTA) Page
Assessment
- Receive a grade Receive a passing grade
  
  Assessment Quiz