United Kingdom: 3 Steps to Access Health Data for Research in the UK – New Health Research Authority Guidance – Lexology




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In brief
The UK’s Health Research Authority (HRA) has unveiled new guidance which signposts the three essential steps to access health and care data for research purposes. The guidance delves into a point that researchers often miss: the common law duty of confidentiality runs in parallel to data privacy laws, and each regime needs to be considered separately to ensure data access requests can stand up to regulatory scrutiny.
Step 1: Scoping – What are the data requirements for your project?
The GDPR principle of ‘data minimisation’ is key in scoping out data requirements i.e. you should only process the minimum data necessary to fulfil your purpose. Wherever possible, you should only access anonymous or synthetic data. Where identifiable data needs to be used, this should be pseudonymised (where direct identifiers have been removed, but it may be possible to re-identify individuals if you link that dataset with other available datasets).
The guidance differentiates between legal bases for disclosure under each of: (a) the common law duty of confidentiality; and (b) the UK GDPR.
Step 2: Clearly document how you plan to manage data
This step maps out the documentation you need to put in place, including:
Step 3: Reach out to data providers
It’s important to have a dialogue with your data provider where possible. This will help manage timelines and assess (for example) variables missing in datasets that could cause issues for your project.
New streamlined process for accessing health data?
In parallel, the HRA are trialling a streamlined process for accessing health data for research (see here).
All research studies that need advice from the Confidentiality Advisory Group (CAG), also need a Research Ethics Committee (REC) opinion. Traditionally, applying for these has always been two separate processes. However, the HRA are trialling a new approach to align both CAG and REC reviews via a single electronic submission, so researchers can save time and communications are easier to manage (great news for researchers!).
 

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