mHealth applications for smartphones are increasingly employed in everyday life, providing information on treatment options, tips on managing illness, and helping to monitor conditions from high blood pressure to diabetes. The market is growing to such an extent that it has been estimated that by next year some 500 million people will be using healthcare apps.
While mHealth apps present the opportunity to administer treatment more efficiently, there have been some glitches. Pfizer recently had to recall a rheumatology calculator app because it generated inaccurate values for markers of disease activity, while an app for diagnosing skin cancer was found to be unreliable.
Furthermore, in an industry that recorded a turnover of £17.6bn in 2013, there remains a lack of clarity in the regulations that govern the market, often leaving insurers struggling to understand the framework of liability.
According to the Medical Device Directive 93/42/EEC (MDD), software that has a medical purpose could be a medical device, with a medical device defined as, “software… intended by the manufacturer to be used for human beings for the purpose of: diagnosis, prevention, monitoring, treatment or alleviation of disease… alleviation of or compensation for an injury or handicap, investigation, replacement or modification of the anatomy or of a physiological process, control of conception…”
Furthermore, the Medicines and Healthcare Products Regulatory Agency (MHRA) identifies that, where an app provides decision support or decision making software which applies some form of automated reasoning, such as calculations or symptom tracking, it is very likely to be classified as a medical device and therefore regulated by the MHRA.
The Consumer Rights Act 2015 introduces a contract between a trader and consumer in relation to “digital content”, which may include software and mobile phone apps. The Act provides implied terms to such contracts that the digital content must be of satisfactory quality, fit for a particular purpose and as described, thus providing potential remedies for consumers which had previously applied to the sales of goods.
Customer rights under the Consumer Protection Act 1987 (CPA) are, however, less than clear. While it covers any goods or electricity, the definition arguably does not apply to software downloaded by a consumer where no physical property has passed. Having said this, there may be a good argument for a claim in negligence where the manufacturer arguably has a duty of care to the ultimate consumer.
Insurers tempted to provide cover for any potential liabilities in the mHealth arena should have a clear appreciation of the risks and regulatory regime in addition to the licensing and supply chain involved and have appropriately worded exclusion clauses. mHealth apps are evolving rapidly and regulators in the UK, EU and USA need to respond accordingly to the challenges of protecting consumers.
Written by Jim Sherwood, partner at BLM