Wissenschaftliche Beiträge

Biomedical Research and Open Data -- NICHT publizieren

Prospects in Swiss law

Frédéric Erard

Mathilde Heusghem

Clément Parisato

Proposition de citation: Frédéric Erard / Mathilde Heusghem / Clément Parisato, Biomedical Research and Open Data -- NICHT publizieren, in : Jusletter 30 janvier 2023

Policies for open access to research and research data are becoming increasingly widespread in our society. Some include health data used in the context of biomedical research. The purpose of this article is to analyse the interactions between open access policy on the one hand and legal constraints on the other, with regard to biomedical research data. It also proposes a list of elements to consider before any biomedical research data is made available.

Table des matières

1. Introduction
2. Background and definitions
- 2.1. Open Science, Open Data and Open Research Data
- 2.2. Swiss context
- 2.3. Open Data and biomedical research
3. Personal data protection constraints
- 3.1. Applicable legal framework and scope
- 3.2. Opening data through anonymisation?
- 3.3. Reuse of personal data, in particular for human research purposes
  - 3.3.1. HRA Regime
  - 3.3.2. Non-HRA Regime
- 3.4. Need to adopt a contractual framework when sharing personal data
- 3.5. Use of Privacy Enhancing Technologies (PETs)
- 3.6. Excursus: European Health Data Space project in Europe
- 3.7. Interim observations and brief considerations on the legal architecture of the reuse of data for research purposes
4. Opening up data
- 4.1. Constraints related to opening up data
  - 4.1.1. Applicable legal regimes
  - 4.1.2. Examples of constraints
- 4.2. Putting data into circulation: licence & waiver
5. Practical application and check-list
6. Conclusion