This article was originally published in Insurance Day, January 2024.
Liability insurers face many new risks as healthcare provision changes. Emerging areas of healthtech, including the application of artificial intelligence (AI), continue to evolve and offer new and significant opportunities that are transforming the delivery of healthcare.
For healthcare providers and their insurers, however, these technological advancements introduce further potential risk of claims.
Kennedys’ recently published report, Healthtech in the future: the legal ramifications, examines the landscape today and recommends steps to take to ensure risks are effectively managed at the same time as realising the benefits that can and are already enhancing patient wellbeing and care.
The UK’s National Health Service now has the analytical capabilities to perform whole genomic sequencing and is the first clinical service in the world to systematically offer this as part of routine care. Its use is expected to become more widespread in the coming years, giving rise to a potential for increased liability risks. Healthcare providers could see claims arising from patients who have had poor outcomes following treatment based on doctors’ interpretation of their genetic profiles and the treatment pathways they suggest.
The use of genetic testing to resolve matters of causation in clinical negligence claims may also develop – for example, where a claimant suffers neurological injury as a result of a delay in diagnosis and there is evidence of a pre-existing condition or predisposition to neurological impairment.
Genetic profiling
Policies will need to be reviewed closely and certain requirements may be imposed, such as the need for clinicians using genetic profiling not only to be adequately insured, but also for training to be given, including in how to intervene where their clinical judgment tells them the profiling may be wrong.
The role of remote and virtual care is growing, with online consultations becoming a central part of primary care. Hospitals are also increasingly using AI and other technology to deliver secondary care, with almost 500,000 patients supported at home with digital home care and remote monitoring in the past three years.
Health data is valuable and threat groups are increasingly extorting organisations following cyber attacks. Records are used to commit fraud, exposing organisations to financial loss or third-party claims.
While we wait to see if this will affect claims volumes, experience suggests an increased risk of claims exposure as a result of seeing fewer patients face-to-face. Targeted training for healthcare staff may become a key requirement of indemnity providers. Healthcare providers may also want to explore limitation of liability through the negotiation of contracts and licence agreements with the developers/producers of AI-enabled apps, ensuring they contain effective indemnities for any harm caused to patients as a result of AI or other technical malfunctions or misuse.
Wearable devices
Wearables are digital devices used to monitor patients’ health and fitness and reduce the need for routine appointments. Claims could arise in respect of clinicians’ failures to properly interpret data or to intervene quickly enough when data shows an imminent risk to a patient’s health. Proper training, including in data analytics, is vital, as is the proper maintenance of devices. Patients themselves may be required to undergo some form of training or at least sign user agreements given the successful operation of a wearable will to a certain extent depend on the person wearing it. Contributory negligence may become more commonplace.
Contracts with manufacturers should also clearly stipulate that they will indemnify the healthcare provider where harm is caused as a result of a defective device.
Robotic-assisted surgery is available in more than 100 UK hospitals at present. Patients must be adequately advised of the risks of robotic versus conventional surgery to make an informed choice. Healthcare providers should also ensure they have the facility to capture and store data relating to the robot’s functioning for at least three years post-surgery if needed for evidence and disclosure purposes.
Health data is valuable and threat groups are increasingly extorting organisations following cyber attacks. Records are used to commit fraud, exposing organisations to financial loss or third-party claims. The rise in technology and smart devices is also increasing the number of records created during a patient’s lifetime.
Cyber insurance is often unavailable for policyholders who have not done enough to ensure data is secure and protected. Healthcare providers should incorporate cyber security into any new devices and systems and have well-designed breach response plans so exploited vulnerabilities can be addressed quickly.
There is no doubt technology is bringing about radical and in some cases life-saving changes in healthcare, but it also presents new legal risks. Such developments should not be discouraged, but equally the risks cannot be ignored and must be managed effectively to ensure healthtech delivers the benefits it promises.