Optimized study design, precise site selection and faster patient search and identification for clinical research - in real time.
Clinerion's technology solution has been evaluated by an independent, third party expert* and is confirmed to be fully compliant with data privacy regulations in the USA (HIPAA) and the EU (Directive 95/46/EC).* NB. The expert’s evaluation is based on the design of the Clinerion tool suite and the practices according to their design, as of July 25, 2016.
Clinerion is committed to the trustworthy re-use of health data for research. Anonymized patient records remain inside the secure IT infrastructure of a hospital. Clinerion’s technology solution is permitted by the hospital to send queries to this anonymized database, resulting in aggregated counts of matching patients. No additional ethics committee permissions for the data use are required.
For the responsible use and disclosure of health data without the need for patient consent, Clinerion follows the standards established by Health Insurance Portability and Accountability Act (HIPAA) (Safe Harbor and Expert Determination) and the European General Data Protection Regulation (GDPR) (effective May 25th 2018). However, Clinerion’s technology solution only receives and processes anonymized patient data, and anonymized patient data in itself does not fall under GDPR, nor HIPAA.
The Clinerion technology solution is regularly audited by an independent, third party expert and is confirmed to be fully compliant with data privacy regulations in the USA (HIPAA), and the EU (GDPR).
PRS was developed following “Privacy by Design” methodologies. Patient privacy is maintained through procedures and policies ensuring consistency with:
For the responsible use and disclosure of health data without the need for patient consent, the Clinerion technology solution follows the standard methods for Safe Harbor and Expert Determination established by HIPAA.