Labs doing genomic testing have come a long way: NATA accreditation. Workflow optimisation. Getting the science right.
And just as many labs are finding their feet, and really wanting to scale up, the compliance goalposts are shifting (and for good reason). National Pathology Standards are increasingly focused on data security. Globally, we’re seeing regulatory attention tighten around how genomic data is stored, accessed, and protected.
Most genomic labs are using cloud-based software (at least for some parts of their genomic test). But this creates new compliance considerations. Running hybrid environments with some systems on-premise and some in the cloud expands the compliance scope significantly:
• The attack surface is larger
• Audit trails span multiple environments
• Security documentation requirements multiply
• Implementing standards like ISO 27001 becomes more complex
Working in this space has reinforced how much we need to be thinking about data security architecture now, not as an afterthought. If not, getting the compliance that will be needed in the future is going to be too hard and too costly. And we wouldn’t want that to be getting in the way of patients getting access to genomic tests.
The sector is going to be busy preparing for what’s coming with security requirements. We’re keen to hear how labs are thinking about this, and are always down for a chat!
The New Compliance Challenge for Genomic Labs
