RWE: The Missing Link

This article is from our latest ' Trends in Real-World Evidence ' magazine.  Download for free.Data linkage challenges Linking data is not an easy process; not only does it require the right technological tools and knowhow, it raises a range of concerns, from patient anonymity and data ownership, to how to transcend geographical barriers.Anonymizing data is a fundamental challenge, says Nigel Hughes, Scientific Director at Janssen Clinical Innovation – Patient Data for Research. “Data linkage requires, via an underlying consent model, linking different data together – with the patient being the common linker.”He says this is a challenge from a “socio-technical perspective”, especially in term of complying with the EU’s GDPR [General Data Protection Regulation] or HIPAA [Health Insurance Portability and Accountability Act of 1996] in the US.“For instance, HIPAA comprises 18 identifying variables which, when removed, can ensure compliance with anonymized data, but it degrades our ability to link the data,” says Hughes.Creating a “safe haven” where data can be linked before it is anonymized is one potential solution, says Hassan Chaudhury, Director and co-founder at Health iQ. A safe haven permits access to only a few data operators who replace all identifying information with unique coded identifiers, attached to the da ta permanently. This is already being employed by NHS Digital [in the UK], which plans to link datasets by default.“This is only the b...
Source: EyeForPharma - Category: Pharmaceuticals Authors: Source Type: news