Clinerion Ltd Contact Details:
Main address: Margarethenstrasse 47 4053 Basel, Switzerland ,
Tel:+41 61 865 60 60 , E-mail: info(at)clinerion.com Website:

Clinerion technology solution

Clinerion technology solution

Optimized study design, precise site selection and faster patient search and identification for clinical research - in real time.



Patient Privacy

Independently Assessed.

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 Europe (EU 2016/679 (GDPR)).

* 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, updated with evaluation of GDPR, in 2017.

Clinerion’s Principles of Patient Privacy.

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) (EU 2016/679). 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).


Privacy Standards

PRS was developed following “Privacy by Design” methodologies. Patient privacy is maintained through procedures and policies ensuring consistency with:

  • Good Clinical Practice (GCP).
  • Good Pharmacoepidemiology Practice (GPP).
  • The Health Insurance Portability and Accountability Act (HIPAA).
  • The European General Data Protection Regulation (GDPR) (EU 2016/679).
  • The laws of Switzerland (Bundesgesetz über den Datenschutz (DSG)).
  • The laws of Turkey (6698 Kişisel Verilerin Korunması Kanunu).
  • The security framework requirements of the ISO 27001 standard.
  • The Electronic Health Record (EHR) Association's Developer Code of Conduct.


Operational Principles

  • Anonymization: The Clinerion server is located within the secure hospital infrastructure. Patient data is stripped of all identifiers within the hospital’s own system.
  • Aggregation / anonymization: The Clinerion technology solution queries only anonymized patient data. Results are in fully anonymized and aggregated form – e.g. the count of candidates for a feasibility study.
  • Data protection is enabled by anonymization, two-way encrypted data transfer, encrypted storage, and access control mechanisms.
  • Clinerion ensures that users understand and treat their access with appropriate regard for information security.
  • All critical activities are covered by Standard Operating Procedures and best practice policies.
  • All Clinerion personnel are under secrecy obligation and trained in this security framework structure.

 

Methods for De-identification of Protected Health Information

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.

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