Eva von Mühlenen and Alejandro Bes of Novartis consider how the proposed European Health Data Space may speed up research for medicinal products by increasing access to health data, with the help of data scientists within the EU. This development is likely to generate five sticking points that the life sciences industry will need to address, they add.
The proposed European Health Data Space (EHDS), like other modern data platforms, is intended to actively contribute to an agile and interactive data ecosystem. The impetus for the regulation which proposed the creation of the EHDS earlier this year was the realization that the EU was behind other regions when it came to the management of the health data that was available in the market, which impacted the ability of researchers and industry players to access those data.
For comparison, traditionally, China has held a more collectivist approach than Europe’s General Data Protection Regulation (GDPR) to the processing and management of personal data. China has systems that facilitate access to digital resources for players in the life sciences industry. However, its relatively recent Personal Information Protection Law and the new (7 July 2022) Measures for Security Assessment for Cross-Border Data Transfers bring an additional set of challenges when managing Chinese personal data, particularly for international companies. Though exporting data out of China is not within the current scope of this blog post, a great deal of granular data is generated throughout China, including through the principle that hospitals should have the ability to digitally track and take a 360-degree view of a patient from their point of entry in the hospital to post-discharge, and throughout the duration of their treatment.
In the U.S., the effect of the Health Insurance Portability and Accountability Act (HIPAA) has been to create a less stringent regulatory environment than the GDPR. This means that, in the U.S., data pools are generally stronger and more cohesive, in part because of large networks that involve a significant number of hospitals, all of which use similar records and systems. The effect is to facilitate data-based research.
In Europe, the situation has until now been that, when European data scientists conducted research, data collection has involved attempting to source data from different hospitals and research institutions and from different, not always interconnected, systems. One of the biggest challenges when conducting research on data of European origin has therefore been cleaning the data and reducing their noise in order to generate data that is actionable and capable of generating insights.
The EHDS proposal regulation is definitely a step towards rectifying this situation for Europe and, if properly implemented, may help facilitate research under the EU framework above that of other markets. However, its creation is likely to generate the following key challenges:
- Secondary use of data: Processes, timeframes and data access applications will need to be properly assessed if research is to be facilitated.
- Skills and knowledge: Notified bodies and other relevant agents will need to increase their knowledge base.
- Real World Evidence (RWE): Regulatory acceptance of RWE gathered through the secondary use of data will need to be embedded in the legislation and guidance.
- IP rights: Data access will need to adequately balance the need to protect the rights of commercial data holders.
- Coordination: Regulators would be well advised to learn lessons from the GDPR, whose interpretations were at points somewhat fragmented.
It makes sense for industry players to go through the proposed regulation and identify those points that might be problematic for their organizations, and to do so while they still have a chance to influence the shape of the EHDS. Demanding clear guidelines on the EHDS will also greatly facilitate the path ahead.
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.