Other regulations and laws impacting use of health data
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In addition to general data legislation, there may be other laws, policies or regulations that impact governance of health data. For example:
National laws protecting sensitive data about patients such as the or EU’s European Medicine Agency (EMA) .
In Europe, some countries are bolstering data protection requirements with a ‘secondary use of health data’ law that specifically governs the conditions for sharing of health data beyond their primary uses. The Towards a European Health Data Space body is also advocating that .
Data strategies defining data governance principles at the national, regional and local levels, such as the .
Broader laws on how data should be collected, used and shared, such as digital economy, confidentiality and competition laws.
Key questions to ask:
Are there any other applicable laws, policies or regulations that may impact the access, use or sharing of health data between third parties?
To what extent is there a data policy or strategy for your jurisdiction, including data access, use and sharing?
Is the country a member of any international organisation, policies or frameworks that promote a specific type of data collection, use and sharing? For example, .
Useful resources:
The Canadian Institute for Health Information’s .
The ODI’s Data landscape playbook has a play on .
The includes data governance best practices.