RWE 201 – Germany – AKEK – Secondary Use of Patient Data for Research Purposes


AKEK Statement (Aug 2023):

The Working Group of Medical Ethics Commissions in Germany (AKEK) has emphasized the importance of secondary patient data use for research in public health. Its relevance was magnified during the COVID-19 pandemic, showing the need for efficient data collection and evaluation. Germany requires a robust regulatory framework promoting both data privacy and research.

During the pandemic, the lack of standardization in country-specific regulations made data handling challenging. The upcoming European Health Data Space Regulation (EHDS-R) and the proposed German Health Data Use Act (Gesundheitsdatennutzungsgesetz – GDNG) aim to harmonize regulations, facilitating responsible health data access at multiple governance levels.

The pandemic also spurred interest in alternative consent models, like “broad consent” and “dynamic consent”, aiming to balance personal data rights, research freedom, and public health. As obtaining individual consent becomes complex, the German law needs clear rules to reconcile these rights.

Germany’s legislators need to evaluate consent models, considering pandemic-driven challenges. They should provide compensatory measures, such as defining standards for data pseudonymisation and anonymisation. Ensuring transparency in research results and balancing intellectual property rights are also vital.

For effective secondary patient data use in research, a strong governance structure, inclusive of ethics committees, is essential. These committees are pivotal in ensuring data protection and balancing the risks and benefits of research.

AKEK highlights key demands for promoting secondary patient data use:

  1. Nationwide standardisation of legal regulations to reduce bureaucratic hurdles.
  2. A balance between individual data rights, research freedom, and societal welfare.
  3. Risk-adapted methods to reconcile scientific evidence with data privacy.
  4. The involvement of ethics committees in governance for a balanced approach.

In conclusion, secondary patient data use is crucial for medical advancements. Germany needs a comprehensive strategy that balances individual rights with research benefits. The urgency brought by the COVID-19 pandemic necessitates swift legislative action by Germany.

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