The i~HD governance team has examined multiple sources of good practice in governing the research use of health data, from projects such as EHR4CR, EMIF, TRANSFoRm, ETRIKS. An important governance starting point is the recently published Innovative Medicines Initiative Code of practice on the secondary use of medical data in European scientific research projects. The team has developed an overarching set of high-level principles and standard operating rules that bring together these project results, combining them with other relevant instruments developed within the informatics and bioinformatics communities. These are now being finalised and will be initially adopted by the post-EHR4CR Champion Programme running the InSite Platform.
At the i~HD conference in September we heard from distinguished speakers, but what was the most remarkable was a common theme around how the General Data Protection Regulation (GDPR) should not be seen as representing barriers and challenges to health data research, but an opportunity.
We do indeed have an opportunity to focus on what is important when it comes to protecting data - and the people about whom it has been recorded: firstly, a new focus on the “Natural Person” where their rights and concerns need to be addressed; secondly, transparency in governance and protection and finally a commitment to make the protection of data a core matter for working with sensitive data.
This is why the efforts the have been ongoing within i~HD have been such a privilege to contribute to: firstly, the completion of the first Quality Seal for Research Platforms to a software provider for clinical trials recruitment - this process harnesses the wisdom of pan European codes of practice, information security best practice, as well as the need for transparency over data use and protection, so that a meaningful assurance can be provided and the complexity of governance and security can be represented in a more meaningful, independently assessed package. Read more about the Quality Seal for Research Platforms here.
Secondly, efforts to develop independently reviewed codes of practice and operating rules when handling health data for research are continuing to grow, in order to harmonise practice throughout the innovation community so that site specific governance guidelines and policies can interoperate as data is captured in one context and the protection expectations can be honored as it is shared and used in others.
Finally, none of these efforts could be any better than window dressing without the community engagement and interchange that i~HD tries to enable through its conferences and workshops, between data service providers, data sources throughout hospital networks, patient community forums and legislators - for the betterment of health and society.