On November 29, 2023, the Irish Council for Civil Liberties (ICCL) issued its recommendations on addressing issues related to the secondary use of health data included in the European Parliament's European Health Data Space text (EHDS). These recommendations aimed to specify the legal basis and narrow down the categories of permitted health data for secondary use. The Parliament's text aligned with the ICCL's proposals by relying on Articles 6(1)(c), 9(2)(g), 9(2)(h), 9(2)(i), and 9(2)(j) of the General Data Protection Regulation (GDPR), restricting processing purposes to public interest, scientific, or statistical research.

What are the EHDS revisions?

The EHDS revisions exclude 'electronic data related to insurance status, professional status, education, lifestyle, wellness, and behavior relevant to health' from the allowed categories for secondary use, aligning with the ICCL's suggestion to reduce risks to fundamental rights. Moreover, the use of health data to train AI systems is limited to scientific research. Additionally, the ICCL noted that natural persons have the right to opt out of their health data being used for secondary purposes, a significant addition absent in the initial proposal.

ICCL concerns about secondary data use

However, the ICCL raised concerns regarding the inclusion of data from wellness applications in secondary uses. This data, often low in quality, can unveil intimate aspects of individuals' lives, amplifying privacy risks when utilized in conjunction with other datasets. Furthermore, the ICCL raises additional concerns regarding the EHDS extending beyond the secondary use of electronic health data.

Next steps

The upcoming steps involve the Parliament's full vote in December 2023 on the draft EHDS text, while the Council of the European Union is set to vote on its stance on the week of December 4, 2023. Following the Parliament and the Council's decision on their positions, the expectation is for intensive negotiations to finalize the text of this law.

You can read the press release here.