Real World Evidence studies, requiring access to PMSI data and on behalf of persons producing or marketing health products, may be carried out in France in accordance with the Benchmark Methodology MR-006.
In this context, such data processing must be in the public interest and must not have as purposes the promotion of health products or the exclusion of insurance contract guarantees or the modification of insurance premiums.
The Data Controller shall organize an independent external audit every 3 years following the signature date of the Compliance Commitment, in order to ensure compliance with the principles laid down by the law, in particular compliance with the prohibited purposes.
The audit covers the purposes pursued and the use made by the Data Controller of the results of the studies carried out.
Corresponding report must be sent to the Chairman of the SNDS Audit Committee.
Starting from this requirement, we have developed an audit methodology, based on applicable regulatory framework, related challenges and our experience of more than 25 years in health research.
Since 2021, Sunnikan has performed about ten MR-006 audits.