The global remote patient monitoring devices market is driven by several factors. These include: Rising prevalence of chronic conditions, increasing geriatric population, which accentuates the uptake of patient monitoring devices for home use, and the accelerating burden on hospitals due to hospital readmissions that propel the adoption of these devices. According to a market research firm, Transparency Market Research, the global remote patient monitoring devices market will expand at a CAGR of 14.2% during the forecast period of 2014 to 2020. In 2013, the global remote patient monitoring devices market was estimated at US$0.38 billion and by 2020, the market is projected to be worth US$0.98 billion.
Although the global remote patient monitoring devices market is expected to demonstrate good growth in the coming few years, the rising trend of hacking medical devices is expected to restrain the market greatly.
Rising Risk of Hacking in the Global Remote Patient Monitoring Devices Market
Medical devices such as continuous glucose monitors, insulin pumps, and pacemakers have become increasingly compact in size and thus wearable in the past few years. They can be connected with a handheld remote over short distances via Bluetooth. Furthermore, the remote or the device itself is connected to the Internet using wireless connection to enable data sharing between patients and physicians. However, several security experts have demonstrated how easily the hardware, user manual, or a PIN number of a device can be taken control of.
Plausible Scenarios: Hacking Medical Devices
Here are some of the plausible scenarios that talk about how a medical device can be hacked.
- Drug infusion pumps can be remotely accessed, allowing unauthorized people to alter the doses
- Bluetooth-based defibrillators can be hacked in order to deliver unnecessary shocks or avoid necessary shocks
- Another major threat to the global remote patient monitoring devices market is the altering of electronic health records (EHRs), which can lead to misdiagnosis or unnecessary treatment
- Furthermore, several patient monitoring devices that have a web interface lack password protection or have weak or universal passwords can be easily hacked
FDA’s Role so Far to Curb Hacking of Remote Patient Monitoring Devices
The rising risk of hacking in the global remote patient monitoring devices market has encouraged medical equipment and device makers to beef up their security features. According to the U.S. FDA, they have yet to discover a case where a patient/user of a medical device was directly harmed due to cyber threats; however, experts are of the opinion that it is just a matter of time.
Nevertheless, the FDA has recently issued a safety notice against devices such as infusion pumps that are vulnerable to cyber attacks. Infusion pumps are used in hospitals all over the U.S. and many other countries. Prior to this, in October 2014, the FDA had issued their final guidance document, titled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices: Guidance for Industry and Food and Drug Administration Staff”. This requires manufacturers to develop a set of cybersecurity controls to ensure medical device safety and functionality during the design and development stages.