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Data-protection considerations make life difficult for researchers:

Why the experts want to share our health data

Unclear data-protection issues make it difficult to utilize technological progress in the health sector.

Bobbie and Vibeke pointing

Digital health and precision medicine have a central place in DNV GL's strategy. Bobbie Nicole Ray-Sannerud, Director of DNV GL's Precision Medicine Programme Director, says they have dedicated more and more time and resources to the health sector in the past few years.

"As a company, DNV GL wants to help make the quality of health services as good as possible and ensure that patient security is constantly safeguarded. For more than 150 years, we've functioned as an objective third party in security-critical areas, and the health sector is definitely such an area," she says.

BigMed

One of the health initiatives that DNV GL has helped to start is BigMed. The project manager of this is the head of research in the company's precision-medicine group, Vibeke Binz Vallevik.

"Precision medicine is about mapping an individual patient's characteristics – such as biology and genetics - so that the treatment can be tailored to the individual in so far as possible. To do this, access to data is essential.

"Precision medicine is a natural consequence of us knowing more about how several processes in the body function at micro-level, and of us having greater accessibility to analysis technology and data for analyses. Precision medicine provides many opportunities for more effective treatment and for minimizing the use of the wrong medication. But before we get there, we must overcome a number of challenges," she says.

Vallevik says that, in both Norway and the rest of the world, a number of organizational, technical and legal bottlenecks are delaying the implementation of precision medicine. One of the challenges that the BigMed project has focused heavily on is the legislation governing the safe and secure sharing of genetic data.

 

Influenced the statutory interpretation

BigMed is a project that, with funding from the Research Council of Norway, is trying to identify the most important obstacles facing precision medicine. In 2019,  DNV GL developed a solution allowing laboratories to share their knowledge of genetic variants. Before the solution could be implemented, a key issue had to be clarified:

Did the current legislation allow the sharing of information on genetic variants?

Genetic data is basically sensitive and protected by the Personal Data Act. But is the interpretation of an individual genetic variant really personal data or is it medical knowledge? That was a key issue that had to be resolved, and BigMed took on the job.

"We worked closely with all the interested parties through our legal network, and created a meeting place for academia, companies and bureaucrats at which we discussed difficult legal and ethical issues.  We arrived at agreement on a new interpretation of the statutory wording. This has meant that we can share knowledge of genetic variants to a far greater extent than before, which will help to ensure the quality of the work and provide better medical help," says Vallevik. DNV GL's solution, Variant Exchange, is now being tested as a tool for sharing knowledge between various laboratories in the Nordic region.

 

New way of working

Ray-Sannerud is pleased that BigMed's work is bearing fruit. She says the project is a good example of how the health sector now has to work in a different way.

"In DNV GL, we've noticed that the health sector has changed a lot in recent years. Health has traditionally been organized in different silos, while today there is a need for cooperation across professional environments and between the public health service and companies. This means that lawyers, doctors, researchers and public health experts must all work together to ensure progress. We believe DNV GL has a natural role to play in that mix as an independent third party," she concludes.

Vibeke Binz Vallevik
Vibeke Binz Vallevik
Bobbie Ray-Sannerud
Bobbie Ray-Sannerud
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