Digital health beyond My Health Record

Smart medical devices will transform healthcare.

At the Agency we talk a lot about My Health Record, and the casual reader could be forgiven for thinking that My Health Record is the be all and end all of digital health. But that’s far from the case. Genomics, precision medicine, AI-based decision support, and epidemiological applications of “big data” are just some of the other aspects of digital health. But for this article we will focus on a less grandiose topic, namely, “smart” medical devices that incorporate digital health technologies to enable new and better ways of monitoring health and delivering care. Examples include:

• Asthma monitors that detect imminent attacks before the user notices any symptoms.
• An Australian-developed smart stethoscope with a “beat finder” that helps to determine optimal location, and collects data that can be shared remotely for specialists to interpret.
• Blood glucose monitors that actively predict a patient’s insulin needs, instead of passively responding to spikes in blood sugar.
• Smartphone-based tools that diagnose blood pressure, body temperature, respiratory problems and blood disorders.

A common theme in such developments is not just improved performance, but greatly improved ease of use. Patients are already expected to monitor their own health in various ways, and the existence of such devices raises the prospect of much greater patient autonomy than has previously been possible. One formal study has found that untrained users may be able to measure their vital signs with an accuracy comparable to that of trained nurses.¹

Developers planning to enter this market are faced with an interesting dilemma. The near ubiquity of smart phones makes them appealing foundations for smart devices, providing ample processing power, slick user interfaces, and a variety of inputs for free (camera, microphone and accelerometer). The downside of this approach is that such devices may face greater regulatory burdens than all-in-one devices. ²

It should also be borne in mind that regulatory requirements will vary from market to market, which brings a multiplier effect to the above considerations for those developers seeking an international presence. The TGA (Therapeutic Goods Administration)³ administers these regulations in Australia, whereas the U.S. counterpart is the FDA (Food and Drug Administration).⁴

Despite such hurdles, the market for smart medical devices has been forecast to be worth over USD 24 billion by 2025. ⁵ The devices and apps we are reading about today are just the tip of the proverbial iceberg. As the market swells, it seems inevitable that a more proactive, participatory approach to health and care is underway. And that is something worth looking forward to.

1. See article: A smart all-in-one device to measure vital signs in admitted patients https://doi.org/10.1371/journal.pone.0190138 ↩

2. https://www.mdtmag.com/article/2017/03/how-smart-do-smart-medical-devices-need-be  ↩

3. For “Software as a Medical Device” solutions, see also https://www.tga.gov.au/tga-presentation-digital-health-show-30-march-2017  ↩

4. See also https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/default.htm  ↩

5. https://www.researchandmarkets.com/research/s9rpkd/smart_medical ↩