The rapid development of IoMTs has led to significant improvements in healthcare both in terms of efficiency and the quality of care delivered to patients. Deloitte reported recently that the IoMTs market is estimated to be worth USD158.1 billion by 2022. Wearable technology, lifestyle devices and mobile health apps are becoming increasingly popular among consumers. There is now a vast range of connected and smart health devices available including smart watches, smart earplugs, smart glasses, activity trackers and other devices which enable us to monitor our fitness levels. We are monitoring our steps, heart rate, pulse rate, blood pressure and receiving reminders about when to take medication.
As with any product, the risk of failure or defect resulting in personal injury or property damage is very real. When it comes to connected devices in particular, the legal landscape is complicated by the many different players involved in the design, development, functioning, maintaining and updating of these products. Healthcare IT providers, network providers, manufacturers, hospitals and end users will all play a part in ensuring that safety is not compromised in the pursuit of innovation.
The medical devices and healthcare sectors have been subject to product liability litigation for many years. Medical devices cover an enormous range of products from plasters you can buy from a pharmacy or supermarket to cardiac pacemakers and MRI scanners. Software can also qualify as a medical device in its own right or as an 'accessory' to a medical device. Obviously, the risk profile of the medical device will depend on what it does, how it does it, and the potential for serious harm or death of a user.
The typical claim in the UK involves an injured party pursuing a medical device manufacturer, usually under the Consumer Protection Act 1987 (CPA) which implements the Product Liability Directive and imposes 'strict liability' on the producer of defective products for damage caused by the defect. It is generally easier for a claimant to establish a claim under the strict liability regime of the CPA given that unlike in negligence, there is no need for the claimant to prove "fault" or that a manufacturer has failed to exercise reasonable care and skill in the design and manufacture of a product.
Common and recurring issues in medical devices product liability litigation include failure to comply with the authorised manufacturing procedures, events or incidents that become apparent after the product is launched on the market, and failure to provide adequate instructions for use/warnings.
Interconnected products which are dependent on hardware, software, networks and data, do not fall squarely within the traditional product liability regime, for example tangible products. A number of questions are raised in respect of the application of product liability law to connected devices:
Another area where these types of devices will affect litigation is in the data they hold. BodyTech holds vast amounts of data, which is likely to become utilised in litigation as evidence either supporting or dismissing a personal injury claim. For example, fitness tracking devices hold key data relating to a user's health (heart rate, sleep patterns etc.) which could become as important as medical records in personal injury claims to determine the severity of an alleged injury. If a claimant alleges that they have become incapacitated as a result of an injury, is the data on their fitness tracking device showing their activity levels discloseable in litigation? Can the fitness tracker be used as evidence to show a decline in physical activity following an injury caused by a defective product? There has been one known case in Canada where the plaintiff relied on data from a fitness tracker as a measure of activity in a personal injury claim. This, it seems to us, is just the start.
As with all manufacturers of products, wearable devices companies and IoMTs should undertake business planning and risk assessments to mitigate the risks of product liability litigation. In addition to physical injuries, a manufacturer may be liable for property damage or financial losses caused by a malfunctioning device. The reputational damage which can be caused when a business is forced to recall a product or face product liability claims can be significant.
Advice should be taken in respect of specific devices but as a general rule, the following matters should always be considered:
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