Data management, security and informatics

Secure storage and sharing of data

A key aspect to GMS is respecting the personal integrity of patients in Sweden and we are committed to integrating gene sequencing into clinical practice in a responsible and ethical way.
An important work is clarifying how to, in accordance with the national and European Union legislation such as the General Data Protection Regulation (GDPR), reach a common interpretation on how data storage and data sharing should be handled within clinical diagnostics and research. This work is carried out in cooperation with the umbrella organisation. The Swedish Association of Local Authorities and Regions (SKR). We will also identify potential obstacles in the current legislation that could delay a full-scale implementation of precision medicine within Swedish healthcare.

The informatics infrastructure is being developed in close dialogue with the IT organisations within healthcare and universities. In an initial phase the National Genomics Platform (NGP) can be used to share personal data, such as genomic data from healthcare, within research projects. However, the current legislation impedes sharing many individuals’ personal data for the purpose of another patient’s health, care and treatment. An ongoing governmental investigation on secondary usage of health data will hopefully lead to an update of this legislation.

Who has access to data?

Patient information is never provided to external parties without consent. We develop and design information material and consent forms for patients, families and healthcare employees. We also produce guidelines on disclosure of results to research projects, future usage of data (for instance to research), to provide feedback on results to patients and to reanalyse data.

Genomics data for healthcare and research

The informatics infrastructure, NGP, is set up to be available for both diagnostics within healthcare and for research. GMS aims to establish a national database covering genetic variants that are important for the development of different diseases. The database will be available for healthcare providers and research provided that the necessary ethical approvals are in place. The opportunity to combine this information with Sweden’s extensive national disease registers will be an invaluable resource for research, potentially leading to new discoveries and breakthroughs in precision medicine.

The development of informatics within the genomic medicine area is very fast. We therefore adopt flexible information technology solutions to be able to integrate new technical solutions. For instance, different artificial intelligence-based tools for diagnostics are likely to be on the market within the next coming years.