Finnish Social and Health Data Permit Authority Findata has significantly reformed and accelerated the processing of data permit applications. Thanks to the reform, it can pre-screen arriving applications in approximately a week and start processing applications even during within a month.
Medaffcon warmly welcomes the reform. Findata informed about the reform in their press release. (The press release is in Finnish: https://findata.fi/uutiset/jonotusaika-lyhentynyt-tietolupahakemuksia-otetaan-kasittelyyn-jopa-kuukaudessa/)
Real-world evidence studies are of interest to domestic researchers, the international scientific community and the pharmaceutical industry. Finland provides excellent data sources and possibilities for register studies. The reformed application process of Findata enables studies and simultaneously strengthens the position of Finland.
After the reform, Findata has started to divide applications into two groups: pre-screened applications sufficient for processing and applications that need to be supplemented.
Applications sufficient for processing include information needed for processing and are directly moved to wait for the processing. When an application has been pre-screened, Findata will send an email to the applicant in ten working days after submitting the application.
Medaffcon’s Senior Scientific Advisor Kristiina Uusi-Rauva sees many positive sides in the reform. It brings certainty to the overall schedule of RWE projects, shortening them with several months. It also facilitates resourcing, that is, it is possible to plan earlier and in more detail the resources used in the projects. This ensures effective realisation of projects. It also brings flexibility to the work of both Medaffcon and its customers.
Medaffcon’s customers can more specifically assess when the valuable knowledge received with joint research can be utilised.
– Still, one should reserve the time and start preparations early on in order for the project to advance smoothly. Often the result is the better the earlier one starts. When the data permit process accelerates, the applications need to be carefully planned and prepared.
Findata started operating in early 2020. Uusi-Rauva states that during its two-year existence, Findata has actively pursued to develop their activities. It has requested development ideas from its cooperation partners as well as listened to their partners and their needs. The accelerated pre-screening of the applications is a good example of this.
– RWE studies are complicated, which means that the applications often need to be supplemented. Thanks to accelerated pre-screening, Findata screens the applications that need to be supplemented and the applicant can start supplementing them on time.
The work of the applicant should become easier due to the fact that a Findata expert sends a detailed request and instructions for applications that need to be supplemented. Alongside the accelerated pre-screening, this is a welcome development trend.
Findata received 312 applications and made 262 decisions in 2021. The processing time of the applications was 1–440 days. The median processing time was 80 days.
In 2019, the Secondary Use Act entered into force, one of the purposes of which was to improve possibilities for conducting studies based on real-world data. In accordance with the Secondary Use Act, data permit applications should be processed and decided in three months after being submitted to Findata.
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