Play seven: Assessing the legal, regulatory and policy context for sharing health data

The method set out in this play has been validated as useful for the health sector. The steps have been inspired by a method the Open Data Institute used to review the legal, regulatory and policy context when putting together health data challenge prizes.

Purpose of this play

As a project leader, you need to identify and understand the local, regional and national context to your data governance framework in the jurisdiction(s) you are planning to collect, access, use or share data in. This play will help you to identify:

• any legal or regulatory barriers affecting the use of health data

• if and when you would need to engage with regulators

• any cultural considerations related to health data use.

Who should read this play

• Senior data leaders, policy leaders and non-technical leaders who need to identify and understand the legal, regulatory and policy context that might impact governance and use of health data.

• Third parties subcontracted to undertake a review of the legal, regulatory and policy context impacting health data governance.

When to use this play

• As part of a wider landscape review to understand the key data and data-related resources, and regulatory context that might impact the data governance framework in a specific sector or domain.

• When designing a new project that may collect, use or share health data.

• When needing to access or share health data across geographical boundaries.

Please note that this guidance is not legal advice and if you are uncertain, you should seek support from a legal professional.