Access to patient record data
The Guidance Function often receives inquiries regarding access to patient record data. We have therefore created an overview of how patient record data can be accessed.
There are generally four ways of obtaining permission to gain access to patient record data:
1. Patient consent
You can acquire permission to access patient records by obtaining written consent from the patient. However, you should be aware that consent lapses no later than 1 year after it has been given, and must be obtained once again.
2. Approval from a scientific ethics committee
If the research project requires the approval of a scientific ethics committee, e.g. if the project contains human biological material or sensitive bioinformatic data, etc., then you can also be approved to obtain patient record information through this. Read more about what must be reported to the Scientific Ethics Committee on the following website (in Danish): Hvad skal jeg anmelde? | Nationalt Center for Etik
It must be emphasized that permission is only given for the disclosure of patient record information, i.e. the researcher must personally contact the department in question, which must hand over the patient record information and make a further agreement about the record extract.
3. Approval from the Regional Council
If the research project does not require scientific ethics approval, the regional council in the region where the researcher works can grant approval for disclousre of patient record information.
Again, it must be emphasized that permission is only given for the disclosure of patient record information, i.e. the researcher must personally contact the relevant department that must hand over the patient record information and make a detailed agreement on how the data is handed over.
4. Quality assurance or quality development projects
The management at the treatment facility, cf. section 42 d, subsection of the Health Act 2, can only approve the acquisition of patient record information for use in quality assurance or quality development projects.
In some cases, it can be difficult to define whether one’s project is a research or quality project. In case of doubt, it is recommended to contact the local hospital management for clarification.
On the Guidance Function’s website, you can find guides to data access and approvals, where you can read more about how to access patient record data, as well as links to the Regional Councils.
Remember that the Guidance Function is a free advisory service for both public and private researchers, both Danish and international. You can always reach out to us at email@example.com or call us at +45 2494 7969.
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