Wearable technology issues relating to the potential qualification of such products as a medical devices have become popular on the press following the presentation of the first smartphone with a heart rate sensor, quickly followed by the smartwatch and the smartbracelet with the same functionality. During the same days UK authorities took an unexpected position on mobile apps aimed at controlling or monitor users’ health.
We previously covered the issue relating to the increase in the number of wearable technologies (and in general of any technology) able to collect information about users’ health conditions and their potential qualification as medical devices with the relevant negative consequences in terms of regulatory approvals to be obtained before their launch on the market.
In the case at issue, the South Korea’s Ministry of Food and Drug Safety held that the smartphone was not subject to medical devices regulations adding that they plan to revise the current laws on the matter in order to distinguish between heart rate sensors used for leisure and those used for medical purposes. Indeed, the unusual position taken by the Korean Ministry was that the product is “technically” a medical device, but will be excluded from the category.
This very forward looking approach comes at the same time when the UK Medicines and Healthcare products Regulations Agency issued a guidance on medical device stand-alone software including apps holding in particular that
apps acting as accessories to medical devices such as in the measurement of temperature, heart rate, blood pressure and blood sugars could be a medical device
Also adding that software providing “general information but does not provide personalised advice [---] is unlikely to be considered a medical device” so setting the field on which disputes as to the qualifications of software will take place.
The consequence of the qualification of software or products as medical devices is that technology companies – which in relation to this type of technology already have to deal with considerable data protection issues – will have to face an additional obstacle given by compliance obligations applicable to medical devices. Also, product liability issues might arise in terms a damages claims that might be brought against apps companies, and insurance policies that they will be obliged to put in place. Yet such obstacles might also slow down the introduction of future updates/upgrades should they go through the approval process required for medical devices so delaying the technological development.
Hopefully, the position adopted by the Korean authorities will be followed by other countries, but, in the current situation of uncertainty on the qualification of products collecting health related data, a prior analysis by the competent authorities or at least an expert in the field will be absolutely necessary.