There are currently no legal opportunities for the healthcare regions to, on a large scale, access the genetic data of patients in other regions for the purpose of providing better and more equal care for patients all across Sweden. This is shown in a new report by Genomic Medicine Sweden, which is being published today.
The ability to share genetic data and other patient related data between healthcare regions and caregivers is critical in order for precision medicine to reach its full potential. And to also contribute to equal care for patients nationwide in Sweden.
For patients with rare diseases, every diagnosis is inherently unusual. It is therefore of direct benefit to the patient that data regarding genetic variants, along with for example data regarding the clinical assessment and interpretation, be sharable within healthcare in an effort to improve diagnosis and finding the best treatment, in addition to avoid over-interpretations of incidental findings.
Investigator Manólis Nymark, a lawyer with extensive experience in matters pertaining to healthcare, has on GMS’ behalf conducted a thorough review of the legislation currently governing how patient data can be shared among caregivers. Manólis Nymark has also reviewed previous and ongoing investigations from various government authorities in the field.
The investigation shows that there are currently no legal options for public health authorities and private caregivers to search for and access personal data held at other caregivers in order to use this data to treat other patients. This despite the fact that the value of accessing this type of information could save lives or avoid unnecessary suffering.
“There are no realistic options within the current legislation that would allow for secondary use, i.e. the ability to broadly share genetic and other health-related data on an individual level for the purpose of care and treatment”, says Lars Palmqvist, co-chair for GMS’ legal committee and the person who ordered the report.
The government committee Komet has previously proposed that an investigation is needed to assess “how secondary use of health-related data should be organised and applied, such as whether a government agency (or equivalent) should, when tasked with providing information, gather, merge, and disclose information which is based on secondary use of health-related data”. The Government has not yet launched an investigation based on Komet’s proposal. The investigation also shows that the government investigation on cohesive information within the healthcare sector (SOU 2021:4) does not meet the needs for secondary use within the healthcare sector in order to be able to provide equal care and a broad implementation of precision medicine.
“We have built an IT infrastructure within GMS in order to make genetic data accessible across the healthcare regions. With this thorough review of the current legislative situation, we can conclude that we cannot move forward under the current circumstances. Our next step will be to petition the Government Offices to firstly review the Swedish Patient Data Act (PDL) and propose changes that will enable secondary use within healthcare”, says Lars Palmqvist.
The report titled “Möjligheter och begränsningar för vidareanvändning av genomiska data mellan vårdgivare för vård och behandling” (Opportunities and limitations for the further use of genomic data between caregivers for care and treatment) is available in Swedish for download at genomicmedicine.se.