Beyond the Fitbit: Wearables and Healthcare
Written by Dr Andrea Cowley
The popularity of consumer health and fitness wearable technologies (“wearables”) such as the Fitbit and Apple Watch is growing. As individuals are becoming better informed and thus, more empowered to play an active role in managing their health, it is unsurprising that the wearable market is expected to flourish. Health wearables, by definition, are autonomous, non-invasive technologies worn by individuals that are capable of measuring, tracking and storing data on physiological responses.1
The impact of wearables on healthcare
While there is still uncertainty as to whether wearables directly contribute to positive behaviour change with regards to lifestyle habits and treatment adherence, they still have the potential to impact healthcare (Figure 2).2 2 By providing a platform that facilitates telemedicine and allows remote and ambulatory monitoring, wearables can significantly improve the provision of healthcare.1,2 1,2
As healthcare systems are becoming more focused on preventative actions, wearables will play an increasing role in patient care. Healthcare professionals (HCPs) and patients are able to access real-time longitudinal health data instantly, therefore, allowing wearables to assist in the management of chronic conditions such as diabetes.1-3 1-3
Lifestyle or medical device: Rules and regulations
Wearables can be broadly classified as consumer general wellness device (e.g., health and fitness trackers like the Fitbit and Apple Watch) or regulated medical grade devices.4 4
The U.S. FDA has released a guideline to provide medical and wellness device manufacturers with clarity on the differences between general wellness and regulated medical devices.
In this guideline, general wellness products are categorised as products that are low risk and have an intended use that either:4 4
- maintains or encourages a general state of health or a healthy activity but do not make any reference to diseases or conditions
- promotes, tracks and encourages choices which, as part of a healthy lifestyle, may help to reduce the risk or help living well with certain chronic diseases or conditions and where healthy lifestyle choices are accepted to play an important role in health outcomes for the disease or condition.
Wearables that fall into the above categories will not be required to comply with pre-market review and post-market regulatory requirements. Health wearables that are medical grade and pose a higher risk would be regulated by the U.S. FDA.
In Australia, medical devices are regulated by the Therapeutic Goods Administration (TGA) as per the Australian regulatory guidelines for medical devices (ARGMD) — which are currently under review — or the In Vitro Diagnostics (IVD) guidance.5,6 5,6 Health wearables, whether as a stand-alone product and for the software contained within, would fall under the definition of a medical device and would be classified according to the risk they pose (Table 1).
Given the technological advancements and innovation, an independent review of medicines and medical device regulation in Australia was conducted and published in March 2015.7 7 With regards to medical device regulation, the panel recommended that:7 7
- Class I (non-measuring/non-sterile) devices may be included in the ARTG based on self-assessment by the manufacturer
- other classes may be included in the ARTG following a Conformity Assessment within Australia, utilising marketing approval in an overseas market if conformity assessed and approved by comparable National Regulatory Authority (NRA) or under expedited processes in some circumstances.
The future of healthcare in an era of wearables
At CRC, we understand what it takes to bring innovative new technologies to market. Health wearables will undoubtedly play a key role in healthcare, allowing patient and HCPs to work together to improve the diagnosis and management of conditions and diseases. Our expert team are ready to work with you to bring your innovations to those who need them the most.
1. Glaros, C. & Fotiadis, D.I. Wearable devices in healthcare. Intelligent paradigms for healthcare enterprises. Systems thinking. (eds B.G. Silverman, A. Jain, A. Ichalkaranje, & Jain, L.C.) 237-264 (Springer, New York, 2005).
2. Piwek, L., Ellis, D.A., Andrews, S. Joinson, A. The rise of consumer health wearables: Promises and barriers. PLOS Medicine 13, e1001953, doi:10.1371/journal.pmed.1001953 (2016).
3. Georga, E.I., Protopappas, V.C., Bellos, C.V. & Fotiadis, D.I. Wearable systems and mobile applications for diabetes disease management. Health and Technology 4, 101-112 (2014).
4. United States Food and Drug Administration. General wellness: Policy for low-risk devices. Guidance for industry and food and drug administration staff. (Silver Spring, 2016).
5. Therapeutic Goods Administration. Overview of the new regulatory framework for in vitro diagnostic medical devices (IVDs). (Canberra, 2011).
6. Therapeutic Goods Administration. Australian regulatory guidelines for medical devices. (Canberra, 2011).