Understanding the risks of healthtech – Kennedys’ guide looks to ensure new technology works for patients and healthcare providers

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.

Our newly published second edition of Healthtech in the future – The legal ramifications demonstrates 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 (the human genome being complete genetic information about an individual). 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. This provides the opportunity to positively change the landscape of diagnostics, but also gives rise to an increased liability risk.

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. New case law is likely to develop as a result.

Further, the role of genetic testing as an issue in causation will develop in the coming years, the report notes – what would be the situation if a genetic test they are not given the consent to undertake would have alerted the healthcare provider that the patient had a genetic mutation predisposing them to the development of a particular condition?

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 (who may not wish to know but will do so through the litigation process).

We recommend 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.

For doctors prescribing treatment based on genomic profiling, they will need training to ensure they have full knowledge of how profiles are created and how they work to ensure patients are properly informed and advised, “particularly if the doctor’s judgement is to prescribe a different pathway than that recommended by the genetic profile”.

Training should also encourage clinicians to intervene and seek guidance in treatment decisions where their clinical judgement tells them that the profiling may be wrong.

Other issues highlighted by the report include the move towards more virtual and remote care models, which experience suggest will lead to an increased risk of claims exposure as a result of seeing fewer patients on a face-to-face basis.  While new technologies like AI are currently at a nascent stage, they will undoubtedly develop. With the right checks and balances in place, we will likely reach a point when AI-based decision making will exceed human judgement. How societies approach that trajectory in the meantime is important, so that the risks can be effectively managed at the same time as realising the benefits that can enhance patient wellbeing and care.

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, says: “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.”