Digital medical records will be mandatory from 1 December

-Automatic translation

A news item published by the Directorate on 17 December 2025 provides an overview of the main changes that took effect when the Act entered into force.

The amendments aim to improve healthcare efficiency, support digital development, and enhance patient safety.

One of the main changes is that, from 1 December next, maintaining digital medical records will be mandatory. The Directorate of Health urges all healthcare providers to comply with the above and ensure the secure digital recording of medical record data in a medical records system that meets the requirements for data security and access control.

Neither the Directorate of Health nor Digital Health approves or certifies individual medical records systems, nor do they maintain a register of approved systems or system providers. It is the responsibility of the supervisor of medical records to select a system and system provider and to assess whether they meet the applicable requirements. The Directorate of Health must be notified of the system used, and the healthcare provider is obliged to guarantee that it meets the requirements set for such systems.

The websites of the Directorate of Health and Digital Health contain guidance on digital medical records systems, together with a checklist for controllers comprising 39 questions for application service providers, as well as four templates for security systems for smaller practices.

The purpose of the checklist is to enable controllers of medical records to obtain and assess information about the medical records systems themselves. This obligation can be met by referring to information provided by the system provider, which also incentivises providers to keep security information readily available.

More information
Þórgunnur Hjaltadóttir, Head of Division, Administration and Safety