AKEK Statement (Aug 2023): https://www.akek.de/wp-content/uploads/Stellungnahme-EHDS_V7.1.pdf

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.

NHS England – Federated Data Platform: https://www.gov.uk/government/news/the-nhs-federated-data-platform-the-importance-of-building-bridges-with-the-public

The National Health Service (NHS) in England is in the process of procuring a Federated Data Platform (FDP), aiming to streamline IT systems and improve healthcare delivery. However, the initiative has come under scrutiny, particularly around ethics, privacy, and commercial involvement. The National Data Guardian’s role is to offer advice and ensure that the NHS maintains public trust, especially concerning data management.

Public concerns mainly revolve around commercial interest in NHS data. Research indicates that the public is generally open to commercial involvement if conditions such as transparent communication, public benefit, and adequate safeguards against misuse are met. Previous initiatives like the General Practice Data for Planning and Research (GPDPR) serve as cautionary tales. Lack of communication led to misinformation and resulted in a significant number of people opting out of data-sharing, negatively affecting health research and planning.

To avoid repeating past mistakes, the National Data Guardian advocates for meaningful and open dialogue between NHS England and the public. They outline three key focus areas:

1. Value to Patients and the NHS: Clearly communicate the FDP’s purpose and benefits. Answer critical questions like the scope of the program, public choice in data sharing, and how it solves real-time problems in healthcare delivery.
2. Integrity of Decision-making: Given the sizable contract and existing relationships with potential suppliers, the NHS must demonstrate a transparent, fair procurement process. Information should be provided about who makes decisions, how they are made, and how safeguards are in place to ensure fair competition.
3. Relationship with the Supplier: The public needs assurance that NHS maintains control over the data and the system. This includes clarifying what data the supplier can access and the safeguards against misuse. Concerns about vendor lock-in and the ability for the NHS to terminate partnerships without compromising patient care or incurring significant costs should also be addressed.

In summary, the key to the FDP’s success lies in transparent, meaningful engagement with the public and healthcare professionals. Filling the existing knowledge gap with accurate information can quell mistrust and speculation, thereby earning public trust for a smoother implementation. Open communication, even when there are no complete answers, can prevent suspicion and ensure ongoing public support for the FDP initiative.