MHRA consultation on the Future Regulation of Medical Devices in the UK - Which? response

Summary

Which? welcomes the opportunity to respond to the Medicines & Healthcare products Regulatory Agency (MHRA)’s 'Consultation on the future regulation of medical devices in the United Kingdom'. Since 2020, Which? has been developing its policy and advocacy work in the area of health data, and for much longer than that Which? has tested consumer health devices as part of its Product Testing capability.

We began our policy work on Digital Health Data early 2020 in response to an explosion in popularity of consumer health and lifestyle wearables, apps and services. Now, against the backdrop of Covid-19, UK consumers are more aware than ever of the role individuals’ data can play in personal and public health. Arguably, UK consumers have also become more used to using commercially available technology to monitor and manage their health and wellbeing, since the onset of the pandemic when face-to-face access to healthcare has been harder to come by for routine issues. Post pandemic, more consumers may also seek to proactively manage their health and lifestyle in order to stay well, as opposed to seeking assistance when they’re unwell. We see this as a consumer driven shift from reactionary sick care to proactive health care.

The rise in the availability and affordability of digital devices has meant that there are now fitness trackers and other digital devices widely available to suit all budgets. More and more consumers are using these devices, not just as a fun way to count their daily steps, but to monitor their macros (the granular details of their food intake) or to monitor their heart health. Devices that offer such tracking of things that only a few years ago seemed like ’sci-fi’ capabilities - at least on the consumer market, have also acted as a gateway to consumers who may now be buying more serious health devices for use at home. 

Consumers who are used to tracking their heart rate via their watch may be more predisposed to try other devices such as blood pressure or blood glucose monitors. Indeed this may be recommended to them by health care professionals. Of course, data from such devices, apps and services needs to be analysed by medical professionals if it is to be useful in helping to identify, prevent or cure disease. At the moment, consumers only have access to one part of the puzzle, and data from consumer devices is not generally regarded as medical grade by the medical profession. Indeed there are questions relating to accuracy of the data. This will be a critical concern should the aim for consumers to upload data from a commercial device into their patient medical record be achieved as is proposed in the Data Saves Lives Strategy.

Additionally, consumers are also using software to track their health and in many cases to diagnose conditions. Apps and services, some that leverage tracking from devices such as mobile phones, wearables and other connected products that gather other inputs such as mood and behaviours (to determine mental health), are effectively being downloaded and used, and in some cases informally prescribed, as medical devices. 

Data is of course a key issue in this space. Data from tracking devices, apps and other services is being used to determine medical health. In some cases it is being used in an official 'medical health’ capacity, in other areas it is consumer health, or lifestyle, or well being. A lack of clarity and standards around how devices and how data is classified could lead to significant consumer harm. Our concerns therefore centre around the following key issues:

1. What is and what isn’t a medical device is unclear to consumers.
2. Medical devices (along with related apps and services) used for health purpose scan potentially give inaccurate information to users.
3. How pseudo medical products are sold to consumers, and health related apps are distributed on App Stores, needs more attention.
4. There is potential consumer harm from using unsafe pseudo medical devices.
5. With smart or connected pseudo medical devices, there are not always effective protections for consumers’ privacy and security.
6. The data protection measures must be stronger for health-relevant data. 

Our work in this space is early and is still being developed, particularly in relation to our exploration and testing of products, but our focus is on this intersection of patient medical health, consumer products and digital and data capability. Our response to the consultation is to offer our evidence from our product testing work to shine a light on some of these issues, with some commentary about our initial concerns about the space.