The Health Data Hub: health data protected by a demanding access process
In France, the reuse of personal health data is governed by precise regulations: a project submitted to the Health Data Hub must have a public interest purpose and must be authorized by the CNIL (Commission Nationale de l’Informatique et des Libertés), unless there are exemptions. The CESREES (Comité Ethique et Scientifique pour les Recherches, les Etudes et les Evaluations dans le domaine de la Santé) has one month, renewable once, to give its approval to the project. Then, the request is transmitted to the CNIL, which has two renewable months to give its decision. If no opinion is given within the time limit, the response is automatically favorable.
Today, among the 1635 projects submitted to the Health Data Hub, 620 projects have been accepted by the CNIL, i.e. an acceptance rate of 38%. Of these 620 projects, 557 (90%) use several databases, 311 (50%) of which use at least the three SNDS databases, demonstrating the expected value of cross-referencing information sources. These SNDS databases, accessible before the Health Data Hub, allow a wide variety of objectives to be addressed, since they make it possible to create a link between financial data (Health Insurance), hospital data (PMSI) and cause of death data. The remaining projects are built on data from medical records or cohorts, targeted on a specific pathology and/or treatment.
Read also: Alcimed Position Paper – Health data: which models for tomorrow?
The Health Data Hub addresses three major current socio-medical challenges: reducing diagnosis times, optimizing care and improving patient living conditions
The Health Data Hub opens the door to new projects with varied perspectives: from basic research, through the development of drugs and the monitoring of their use in real life, to the care pathway (including prevention, hospital management and patient follow-up).
From our point of view, these projects enable us to respond to three major current socio-medical challenges:
- Reducing diagnosis times by improving screening systems
- Optimizing hospital and outpatient care through new ways of organizing and supporting healthcare professionals
- Improving patient follow-up/life conditions by studying the progression of diseases in order to anticipate any relapse, evaluating treatments and their performance, but also by better understanding side effects.
Take for example sarcoma, a rare tumor for which the effectiveness of isolated clinical trials has reached its limits. According to a study conducted via the Health Data Hub in 2019 by the Centre de Lutte Contre le Cancer (CLCC) in Bordeaux, the analysis of data collected from patients (cohorts) combined with data on healthcare consumption from the Assurance Maladie, has made it possible to assess the relevance of chemotherapy before or after surgery, a conclusion that was not previously provided by 40 years of clinical trials.
A strong interest for healthcare industries, in projects to analyze/optimize the care pathway and evaluate treatment effectiveness
This is an opportunity for the pharmaceutical industry in particular, which has submitted 569 applications to the Health Data Hub (35% of total projects), of which 144 have been accepted, i.e. an acceptance rate of 25%. This rather low acceptance rate should lead manufacturers to question the acceptance criteria for projects. In France, Sanofi and Janssen are at the top of the ranking with 8 projects, followed by Amgen and Novartis with 6 projects each.
Among the different data available, laboratories mainly use real-life data that highlight real-life practices and make it possible to highlight therapeutic effects or undesirable effects in real life, which cannot be identified in clinical trials, and in particular long-term effects that can have serious consequences for the most fragile patients and those with comorbidities, who are often not included in clinical trials.
With regard to the projects submitted to the Health Data Hub, the objectives of the healthcare industry are to understand, evaluate and analyze:
- Epidemiological concepts and medico-economic or medico social issues:
- The prevalence and incidence of a disease
- The common characteristics of populations affected by diseases of interest
- The burden of a disease
- Patient care pathway
- Therapeutic management:
- Effectiveness/use of a treatment
- Drug safety
- Current prescribing trends
These projects promise significant advances in the health sector and there is no doubt that the coming years will bring us their share of successes and discoveries. The Health Data Hub, now democratized, must therefore be considered as a new reference player in the French healthcare ecosystem, notably to improve care pathways. It will have a key impact on innovation in the healthcare field. This platform is definitely a tool to be integrated in the French ecosystem of industrial actors. Alcimed is there to accompany you to capture the associated opportunities!
About the author,
Mathilde, Consultant in Alcimed’s Healthcare team in France