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Foreword
Over the last decade we have seen a transformation in the delivery of healthcare with telemedicine, virtual consultations, virtual wards, use of artificial intelligence, wearables, genomic medicine. All transforming the way healthcare practitioners make a diagnosis and the delivery of healthcare.
These technological advances will no doubt continue bringing opportunities and benefits. The challenge for healthcare providers globally is to ensure that the legal and regulatory framework is fit for purpose and appropriate indemnity is in place should there be any claims as a consequence of the transformation of healthcare services.
A panel of our global healthcare lawyers in Australia and Hong Kong, Canada and Chile, and England, France, Ireland, and Spain, recently explored healthtech in these jurisdictions through the lens of medical malpractice claims.
In this series of articles, we provide an overview of key areas of discussion. We recently held our annual 2024 global healthcare conference programme, which has been recorded for you to watch.
Christopher Malla, Global Head of Healthcare
England
Modern healthcare is built on the premise that treatment is a shared decision between a doctor and a patient, with the role of technology now increasingly a part of that conversation. There is a definite shift towards greater patient autonomy and control with new virtual healthcare initiatives.
Contributory negligence is very rarely pleaded as a defence in medical negligence claims, particularly as that indicates some fault on the part of the patient where the healthcare provider has acted negligently. However, it is possible that with the shift towards greater patient autonomy we may also see a shift towards contributory negligence becoming more commonplace in litigation involving for example the supply and use of wearable devices, as their successful operation depends largely upon the patient themselves. It seems likely that patient harm could arise as a result of the patients’ failures to care for devices and use them in accordance with the manufacturer’s and/or clinician’s instructions.
Hospitals are moving towards virtual and remote care models to streamline patient care and experience, and to reduce costs and manage resources. Wearable devices and patient self-management plays an increasing role here.
Whilst we wait to see if this uptake in telemedicine affects notifications and claim volumes, experience suggests an increased risk of claims exposure for primary care clinicians as a result of seeing fewer patients on a face-to-face basis.
One of the significant changes brought about by telemedicine, remote care, and wearables is the data that the technology produces, which will become part of the patient’s medical record. In the future, if not now already, when we look at the patient’s medical records we are not only looking at the interaction between the patient and their practitioners, but also at a huge swathe of data that has been produced – detailing exactly what was done, when it was done and why.
Contact: Rob Tobin
France
Wearable devices
The legal classification under French law of connected objects, including wearable devices, has become a key legal issue, since it determines the level of regulation the device is subject to in terms of marketing, and raises the question of the applicable liability regime pursuant to the French Civil Code.
On 28 September 2022, the European Commission published a directive proposal revising the 1985 Directive on liability for defective products (transposed into French law at articles 1245 to 1245-17 of the French Civil Code). The aim being to adapt existing rules of law to recent technological developments, including new uses of artificial intelligence, to provide greater legal certainty for businesses and to protect consumers in the event of injury/harm suffered.
Telesurgery
On 13 October 2023, the Conseil d’Etat (administrative Supreme Court in France) (CE, 13 Oct. 2023, n°464464) handed down the very first decision in France relating to telesurgery.
The claimant underwent surgery at a hospital in Paris, during which one of the surgeons who operated, did so remotely whilst based in Italy. The surgery resulted in a perforation of the colon and the creation of a fistula, leading to multiple complications. The claimant brought a claim for compensation against the hospital in Paris, arguing in particular that she only discovered the surgery had been performed by the surgeon based in Italy who was not a member of the hospital and was not registered with the French Order of Physicians, on the day of the operation and without obtaining her prior consent.
The hospital in Paris was held liable by both the first instance and appeal courts for medical fault during the procedure. The hospital appealed the decision before the Conseil d’Etat, which whilst rejecting the appeal and confirming the AP-HP (Assistance Publique Hôpitaux de Paris) hospital’s liability, held there was no failure to provide information.
Whereas it was not the case here, in the event of a technology-related failure, telesurgery inevitably raises the question of potential liability of a manufacturer and/or an other third party (for example the internet provider). If this were to be the case, joint liability is a possibility.
Contact: Lucrezia Violet-Vianello
Ireland
Telemedicine
The HSE has identified telemedicine as a significant growth area and this is represented by the roll out of the HSE Telemedicine Roadmap 2024 – 2027 as part of the Digital Health - Strategic Implementation Plan.
There is currently no specific legislation addressing the provision of telemedicine services in Ireland. However, the Medical Council Guide to Professional Conduct and Ethics states that telemedicine services can be provided by doctors as long as a number of specific safeguards are in place, such as strong security measures and clear information policies.
We are receiving queries from clinicians regarding passporting and providing international medical services across a number of jurisdictions. We are also seeing jurisdictional issues for litigation and national laws around licensing and prescribing.
Robotic-assisted surgery
Robotic-assisted surgery (RAS) is becoming increasingly prevalent in Ireland and we are seeing an increase in litigation relating to RAS. To date these cases have involved compression injuries as a result of the significant length of RAS, where it is alleged the failure to position and reposition the patient appropriately caused significant and permanent neurological injury.
Artificial Intelligence (AI)
Machine learning continues to play an increasingly important role in digital health, particularly regarding diagnostics and patient monitoring.
AI is currently not specifically regulated in Ireland, however, this will change following the enactment of the EU Artificial Intelligence Act.
Cases involving AI are in their infancy in Ireland. The applicability of general negligence principles to AI presents a particularly interesting question.
Contact: Olan Kelleher
Spain
In relation to the use of new technologies in healthcare, the limitations provided for under legislation in Spain primarily relate to data protection and the protection of patient rights, with a principal requirement being for patient consent to be obtained.
The technology being developed will enable doctors to have access to data obtained from a significant number of patients, assisting them with diagnosis. Informed patient consent is central to that.
Under Spanish legislation, medical practitioners must respect the will of the patient, the right of the patient to be informed about the intended use of their information, the right to revoke their consent to the use of their information and for the information they have provided to the healthcare provider to be kept confidential. Patients also the right to access to their medical records.
Healthcare insurers in Spain are liable for the compensation arising from the negligence of doctors and hospitals, and harm resulting from new technologies used by them. Insurance policies in Spain sometimes cover new technology liabilities, mainly for product liability and personal injury.
Contact: Alfonso De Ramos
Healthcare
United Kingdom
France
Ireland
Spain