EU Digital Reforms: How They Impact Healthcare Deep Tech

2023-10-26 17:22:49

In this article, we will explore the implications of the EU Digital Reforms Package on deep-tech companies in the healthcare and life science sectors. These reforms have far-reaching effects on data protection, privacy, AI systems, and more.

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Table
  1. EU Digital Reforms and Data Protection
  2. High-Risk AI Systems and Compliance
  3. Transparency vs. Confidentiality

EU Digital Reforms and Data Protection

The EU regulations, including the Data Act, Data Governance Act, and Health Data Space Regulation, have a significant impact on data protection and privacy laws in the healthcare and life science industries. These regulations reinforce GDPR's right to data portability, making it easier for healthcare end-users to switch providers.

The Data Governance Act also requires public sector bodies in the healthcare sector to share non-personal data, offering immense opportunities for private sector organizations and research institutions to access vast quantities of healthcare data for research and development purposes.

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New e-privacy rules further complement data protection rules, particularly for electronic communications such as direct marketing.

High-Risk AI Systems and Compliance

The EU's recent AI Act introduces regulations to prohibit dangerous technology and ensure close monitoring of AI applications. For life sciences and healthcare industries, this means establishing a robust risk management system for high-risk AI systems.

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Moreover, training data used for AI system development must meet stringent quality criteria. They should accurately represent all population groups on which the high-risk AI system is intended to be used.

Transparency vs. Confidentiality

The proposed Health Data Space Regulation aims to empower EU patients to access their health data and promote its use in research, innovation, and policymaking. This regulation primarily targets healthcare providers and medical device and digital health technology providers.

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However, there is a core tension between the transparency and accountability promoted by the EU Digital Reforms and the confidentiality and secrecy associated with intellectual property rights. Deployers and users of AI systems in the life sciences industry may need to reveal details of how models were trained, raising concerns about protecting intellectual property.

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