New Recommendation on the processing of personal health-related data

The Committee of Ministers of the Council of Europe adopted a new Recommendation on the processing of personal health-related data for insurance purposes, including data resulting from genetic tests.

On 26 October 2016, the Council of Europe adopted a new CM/Rec(2016)8 Recommendation CM/Rec(2016)8 of the Committee of Ministers to the member States on the processing of personal health-related data for insurance purposes, including data resulting from genetic tests. This document is not directly related to research biobanking practices but needs to be considered as an additionnal tool to protect personal sensitive data (health genetic data) from dicriminatory uses by third party (here health insurers).

With this new Recommendation, the Council of Europe calls upon the Governments of its Member States to ensure non-discrimination, including on grounds of genetic characteristics, and the protection of private life in the framework of insurance contracts covering risks related to health, age or death.

The new Recommendation sets out essential principles aimed at protecting the rights of persons whose personal data are processed for insurance purposes. It takes into account insurance companies’ legitimate interest in assessing the level of risk presented by the insured person.

The recommended measures include strict safeguards for the collection and processing of health-related personal data, based on the insured person’s consent, as well as the prohibition of requiring genetic tests for insurance purposes. As a first international legal instrument in this field, the Recommendation notably aims at preventing any processing of health-related data which would not be justified and would not comply with the criteria of relevance and validity. The text also underlines the necessity of facilitating access to insurance, under affordable conditions, to persons presenting an increased health risk, and the importance of promoting fair and objective settlement of disputes between insured persons and insurers.

While this text is not specifically adressing biobanking as such, it is adding new rules to protect sensitive personal data (genetic data) including where they are stored by a third (like a biobank) where access to the data is required from insurers. In this regard, Principle 2 al.11 of the Recommendation is relevant. Reltated to this rule, the Explanatory Memorandum of the Recommendation states that “The processing of health-related personal data obtained in a research context involving the insured person also raises serious concerns with regard to the respect for the insured person’s private life. It is important that people are not deterred from participating in research studies for fears about their insurability. Any reluctance to participate in research studies could limit the potential for the member States to exploit the benefits of scientific developments, both to improve patient outcomes and to improve efficiency. Health-related data about any symptoms, diagnosis, screening or treatment that a person receives outside the research programme and which appear in the medical file (even if related to information they discovered through the research programme) may be processed if the information satisfies the conditions in paragraph 5” (justification of the processing by the insurer).

Related documentation:

Interview of Mark Bale, Chair of the Council of Europe Committee on Bioethics