Opportunities and limitations for secondary use of genomic data between caregivers for care and treatment
A legal investigation
In Sweden, there is a high level of expertise in the field of genetic testing and the application of its results within the healthcare. However, there is no legal basis for sharing such data concerning patients for the benefit of other patients for care and treatment purposes (secondary use of data), which is a prerequisite for fully enabling precision medicine. Genomic Medicine Sweden (GMS) aims to implement precision medicine across Sweden and is building a joint, national IT infrastructure within healthcare for the purpose of sharing genetic data. The purpose of the investigation, from a legal perspective, has been to clarify the possibilities and limitations of secondary use of personal data between caregivers for the purpose of care and treatment as follows.
- There are currently no legal opportunities for either public health authorities and private caregivers to search for or access personal data at another caregiver for secondary use of data purposes, even though the value of access to such information could save lives or prevent unnecessary suffering.
- At the individual level, there are also no realistic options within the current legislation to achieve secondary use of genetic or other health-related data for care and treatment purposes. Constitutional amendments are required. The restrictions on personal integrity which may be necessary in order to realise secondary use are deemed justified when weighted against the benefits to individual patients affected by rare diseases and cancer diseases.
- Federated multi-party computation can, to some extent, meet the need for caregivers to share genetic data between each other for care and treatment purposes, without disclosing personal data. However, in order for the shared patient data to be useful, most situations require them to not be completely anonymous. Therefore, federated multi-party computations are not a realistic option for the positive effects of secondary use to be properly realised.
- The Committee for Technological Innovation and Ethics (Komet) has, on the initiative of parties such as GMS, proposed to the Government that an investigation on the collection and sharing of health data to be launched. However, the Government has not yet launched an investigation based on Komet’s proposal. It is therefore recommended that GMS send a written communication to the Ministry of Enterprise and Innovation and the Ministry of Health and Social Affairs in order to realise Komet’s proposal for an inquiry.
- The government has tasked the Swedish eHealth Agency to present a preliminary study on 1 December 2022 on the development of a state-run national “data space” for health data for medical imaging within the field of mammography. GMS should monitor this initiative. However, it is not a foregone conclusion that when the government declares that the data in this service is to be sharable, it is referring to secondary use of data for individual patient care and treatment.
- The investigation on coherent information within the health and care proposal (SOU 2021:4) does not meet GMS’s needs regarding secondary use.