01 July 2019 - Authored by:Laurie-Anne Ancenys
On 29 May 2019, the French National Ethical Consultative Committee for Life Sciences and Health (CCNE) delivered its Opinion (n°130) on ethical issues in connection with big data in the health sector (the Opinion). The Opinion aims at identifying the ethical challenges raised by the exploitation of large set of data in healthcare and provide twelve recommendations supporting the development of digital innovation in healthcare.
The CCNE first of all underlines the complex and unstable environment due to the diversity of stakeholders using vast amount of data for various purposes, the significant growth of digital technologies, the cultural changes driven by the multiplication of connected tools and the disclosure by individuals of their personal information.
In the light of this technical revolution, the Opinion points out the need for an ethical debate to find a balance between the development of digital innovation and the protection of fundamental rights and individual freedoms in the health sector.
Information and consent
The Opinion insists on the need to strengthen the protection of individuals with regard to the use of their personal data in healthcare. In particular, consideration is given to data subject’s information and consent in the context of big data.
According to the CCNE, collecting free, specific and informed consent can be challenging, if not impossible, given the propensity of big data to find unexpected correlations between datasets and therefore to find new uses for that data. The Opinion also notes that the combination of data sets generates another level of complexity in relation to anonymisation tools which may turn to be ineffective considering the risks of re-identification.
Therefore, the CCNE recommends providing the data subjects with comprehensible, transparent and fair information on the use of their personal data, whether or not consent is required. Information must be adapted to the different contexts of use (care, research etc.) and easily accessible in particular for data subject in vulnerable situation.
Control of stakeholders and medical relationship
Regarding the relationship between health providers and the patient, the Opinion highlights the importance to ensure a secure and trustworthy environment in particular through the preservation of a “human guarantee” in the decision-making process. This guarantee aims at limiting the risk of incorrect or discriminatory decisions resulting from the processing of large dataset that may contain hidden bias. The CCNE also calls for continued awareness, in particular to limit the risks of profiling and stigmatization.
Beyond the central role played by the French Data Protection Authority (CNIL), the CCNE considers that a periodic control of the mechanisms implemented by stakeholders to ensure the protection of personal data provided under the General Data Protection Regulation is necessary, as well as further consideration on the notion of consent and its possible evolution.
In light of the technical challenges raised by the storage, sharing and processing of vast amount of data in healthcare, the CCNE recommends the development of a shared and interconnected national platform. This recommendation supports the recent French initiative to launch the Health Data Hub, a unique platform opening access to health data.
This article was co-authored by Juliette Olliveaud.