Since 2010, the well-known brand Fitbit known for selling wearable gadgets, namely fitness trackers, has sold over 127 million devices worldwide and counted around 111 million registered users in 2021.[1] The growth in the wider industry has not stopped there; by 2022, the number of connected wearable devices
worldwide increased substantially from 929 million in 2021 to 1.1 billion in 2022.[2]
The extreme growth of wearable devices opens huge opportunities for the healthcare sector with the data these devices collect but there are many challenges to overcome with using the data these devices produce. There are implications to consider around ensuring that digital care and digital acceleration do not lead to wider health inequalities in relation to those who cannot afford adoption and use being left behind, particularly the elderly.
In addition to the regulatory and compliance challenges to ensure the data is secure, protected, and not used inappropriately, to ensure there is trust, individual privacy is protected through data governance and cyber security.
What can fitness trackers do for medical field and new technologies?
What sets wearable devices such as fitness trackers apart from mobile phones? Fitness trackers have much greater performance and are more sophisticated in providing sensory and scanning features such as the tracking of physiological function than hand-held devices, such as mobile phones. Wearable devices have far-reaching impacts in the fields of health and fitness, education, aging disabilities and entertainment.[3]
What exactly can your Fitbit device do for the medical field, other than track your steps and exercise? Wearable devices such as your apple watch and Fitbit have the ability to save people’s lives by detecting any irregularities in their heartbeat.[4] Fitbit recently received approval from the US Food and Drugs Authority (FDA) for a new algorithm that detects and analyses heartbeat irregularities.[5] This new feature would give users an early warning sign for potentially fatal diseases, such as strokes, heart failure and other heart-related complications.
A study undertaken by TechCrunch, in 2020, followed 450,000 people for five months, found that the Fitbit technology was 98% as effective as an ECG patch when it came to detecting incidents of atrial fibrillation (an irregular and rapid heartbeat which can lead to formation of blood clots in the heart).[6] Subsequently, the device will be able to take readings where it can monitor heartbeat irregularities passively, without requiring the user to do anything. The feature will not be able to diagnose a heart condition but might detect any potential issues with the user and notify the user, which they can then share with their doctor, this notification can save time.
Apple has recently introduced the advanced new Apple Watch Series 9, featuring breakthrough capabilities for the world’s most popular watch and Apple’s first carbon neutral products[7]. The new double tap gesture is enabled by the faster Neural Engine in Apple Watch series 9, which processes data from the accelerometer, gyroscope, and optical heart sensor with a new machine learning algorithm. The algorithm detects the unique signature of tiny wrist movements and changes in blood flow when the index finger and thumb perform a double tap. [8]
Only time will tell how accurate this new feature will be but given the success of the inclusion of heart rate monitoring, blood oxygen detection, ECG readings, sleep tracking, fall detection, loud noise monitoring and built-in temperature sensing, I can only imagine it will be more than capable.
Privacy
Since wearable technologies gather and process considerable amounts of sensitive personal data, they raise a broad range of privacy issues such as identity theft, stalking or discrimination. The International Privacy Conference 2014 stated in a declaration that big data, a term that describes the large volume of data, derived from technologies such as wearable technology should be treated as personal data.[9] While the personal data that wearables collect have great potential to tackle contemporary health problems such as obesity, data protection experts and organisations, including the Article 29 Working Party, have raised concerns about the level of data that wearables can collect, the ability to profile users, the ease of data sharing amongst users and the security of the device and its data.[10]
If a wearable device obtains personal data, how do companies use that data? Generally, in order to be able to use a wearable device, a user needs to consent to the manufacturer’s terms and conditions, including its privacy policy. A user has little option but to consent to the collection and processing his personal data in order to use the wearable device.[11]
A more serious problem is someone else’s privacy, because they would not even be aware that their personal information is collected and processed without their express or implied consent. Since wearable devices collect information about the environment in which the wearer is present, the devices can be used to invade someone’s privacy. Since such devices are attached to the body of a person or her clothing and are therefore constantly in motion, the device will generate new data wherever the wearer goes. For instance, Google Glass was able to record real-time facial images of someone walking down the street as well as search and post data about that person on the spot. Google has stopped selling and supporting its Glass Enterprise smart glasses citing concerns over potential privacy-violating capabilities.[12] The scope of data collected and processed by such devices should be taken into serious consideration to protect third parties’ sensitive and personal data.
Product Liability
In March 2014, the US Consumer Product Safety Commission (CPSC) ordered a recall of the Fitbit Force, one of the most popular wireless activity-tracking wristbands, due to the risk of skin irritation.[13] The devices were recalled because users were likely to develop allergic reactions to the stainless-steel casing, materials used in the strap, or adhesives used to assemble the product, which had resulted in redness, rashes and blistering where the skin has been in contract with the tracker.[14]
The increasing use of wearable devices has raised concerns regarding potential product liability for manufactures due to the likelihood of malfunctions and/or the possibility of protected data getting be lost. Wearable devices fall under interconnected products which are dependant on software, networks and data and do not fall within the traditional product liability regime.[15] It is currently unclear whether software falls within the definition of ‘product’ under the Consumer Protection Act 1987 (‘CPA’) which implements the product liability directive and imposes strict liability on the producer of the defective product for damages caused by the defect.[16]
Endnotes
[1] Federica Laricchia, ‘Fitbit – statistics & facts’ (Statista, 11 April 2023) accessed 3 September 2023. [2]Ibid. [3] Young Ah Kim, ‘New Legal Problems Created by Wearable Devices’ (Illinois Business Law Journal, 29 February 2016). accessed 3 September 2023. [4] HI TECH, ‘Fitbit to now do its bit to SAVE your life; Know what this new feature is’ (22 August 2022) accessed 3 September 2023. [5] Ibid. [6] Ibid. [7] Apple ‘Apple introduces the advanced new Apple Watch Series 9’ (Apple, dated 12 September 2023) accessed 3 September 2023. [8] Ibid. [9] Laura Cropper, ‘Wearable Technology and the GDPR’ (Tech Law for everyone) accessed 6 September 2023. [10] Ibid. [11] Ibid. [12]Victor Luckerson, ‘Google Will Stop Selling Glass Next Week’ (Time, 15 January 2015) accessed 26 September 2023 [13] Consumer Product Safety Commission, ‘Fitbit Recalls Force Activity Tracking Wristband’ (20 February 2014) accessed 27 September 2023. [14] Ibid. e[15] Katie Chandler ‘BodyTech – a new wave of medical devices product liability litigation’ (TaylorWessing, 1 March 2019) accessed 6 November 2023. [16] Ibid.