Rapid advances in genomic medicine – with the NHS now able to perform whole genomic sequencing – present many welcome opportunities but are also raising significant legal issues that need to be addressed, warns law firm Kennedy’s.

The latest edition of Healthtech in the future – the legal ramifications, details how technology is becoming increasingly embedded in the delivery of healthcare. The NHS reported in October 2022 that it now has the analytical capabilities to perform whole genomic sequencing. It is the first clinical service in the world to systemically offer this as part of routine care for patients.

This, coupled with reports of significant reductions in the cost of sequencing due to new technologies and competition, means that its use is expected to become more widespread in the coming years. While this provides the opportunity to positively change the landscape of diagnostics, it also gives rise to an increased liability risk.

Kennedy’s says that, for example, healthcare providers could see claims from patients who have had poor outcomes following treatment based on doctors’ interpretation of their genetic profiles and the treatment pathways they suggest. The liability of the genetic profilers themselves could be an issue too if they make errors, and new case law is likely to develop as a result.

It is anticipated the courts will continue to take a cautious approach to allowing the use of genetic evidence, given the risk of the tests revealing unexpected and incidental findings for the claimant and, crucially their families.

Kennedy’s recommends that, in order to limit liability risk and minimise future claims in this area, healthcare providers should consider reviewing employment contracts where clinicians are actively using genetic profiling to treat patients, to ensure that they are insured to do so.
Other issues highlighted by the report include the move towards more virtual and remote care models, which could initially lead to an increased risk of claims exposure as a result of seeing fewer patients on a face-to-face basis.

The report also suggests ways to mitigate the risks of wearable technology and patient self-management, as well as robotic-assisted surgery.

Rob Tobin, head of medical law at Kennedys, said: “There is no doubting that technology is bringing about radical and in some cases life-saving changes in the way healthcare operates. But as we dive into this future, new legal risks emerge too and these cannot be ignored.
“Our aim is not to discourage these developments but to examine how those risks can be best managed to ensure that healthtech delivers the benefits it promises to both patients and healthcare providers.”

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