To learn more about the technology and how it will benefit the industry and patients, Outsourcing-Pharma.com caught up with Ulf Claesson, CEO of Clinerion.
How does the technology work?
The new technique uses exclusively anonymized records, wherein all private, personal identifiers are already stripped from a patient record. Clinerion performs all its normal query processes on these anonymized records inside the hospital, and then receives its usual aggregate counts signaling the number and locations of clusters of patients who fit the query criteria.
This is sufficient for certain feasibility analysis, but to specifically enable patient recruitment, some information is subsequently sent back from the Clinerion server (NB: located inside the hospital infrastructure) to the hospital’s EMR-side, where the original patient data resides. Authorized trial staff at each hospital can then re-identify the patients using the new ANID technology.
In essence, the technology works by indirectly comparing certain characteristics and calculated attributes of an anonymous record with records at the source. Such setup allows us to move all identity-related tasks to the hospital part of the system. Identity information is consequently no longer touched or managed by Clinerion in any form.
All of this happens automatically but obviously, adds calculation cycles to the process. A small price to pay for a significant increase in patient privacy. We have in any case been able to optimize this to the point where it’s not noticeable to clinical staff.
What are the benefits to sponsors, CROs?
Permission to use electronic patient data differs from country to country, and can also depend on the interpretation thereof by hospital authorities. This limits the pool of hospitals which can be called upon for online patient recruitment for clinical trials.
With Clinerion’s ANID technology, all these concerns are automatically allayed, because the technology only uses anonymized data – which is considered acceptable for reuse by every standard of consideration.
How is it different from similar solutions?
To our knowledge, there are no other patient recruitment solutions which work using fully anonymized data. Any current, existing solutions at best uses pseudonymized patient data.
What is the need for such a product in the industry?
Patient privacy is a major topic of concern in the storage and use of electronic patient data, today. The concerns are of private, personal health details being accessed without the permission of the patient. This is reflected, e.g. in the EU General Data Protection Regulation (GDPR) coming into effect in 2018.
The current state of technology is to use pseudonymized data, wherein all personal identifiers in a patient record are replaced by pseudo ID information, according to some kind of applicable key. However, even this can be open to dangers of privacy breach because a key exists.
Use of fully anonymized patient data avoids possible privacy problems and is generally considered to be acceptable. Clinerion’s new ANID technology allows re-identification of patients by authorized trial personnel at hospitals even using fully anonymized data.
As technically groundbreaking as this is, it is in essence for us in the interest of the patient. We expect this to change the dynamics in contacts between us and sponsors and CROs, but as importantly, in any discussions with patient organizations, ethic committees, clinical staff, hospital management, or other representatives in the industry.