E-Health services and wireless, wearable devices are spawning new products regularly. Last year monitoring devices grossed $2.9 million and is expected to grow to $17.1 million over the next five years. There is increasing demand for expanding the old point of care paradigm from the traditional hospital/doctor’s office setting to a more mobile medical environment. With this expansion, come new challenges with compatibility, wireless performance, security and compliance with the somewhat fledgling regulations.
Ease of Use
Consumers and patients desire tools that work with commonly used devices like smart phones and tablets. Many want more knowledge and control over their health. The data must be in a compatible format in order to allow for sharing regardless of the platform. Standards are slowly emerging to facilitate data transfer across devices and applications that may be from multiple vendors.
Exciting Capabilities are not Without Risks
Current technology has monitoring, diagnostic and drug delivery capabilities. In some cases, the data can be read from miles away. Health care providers can make decisions without actually seeing the patient. Future state predictions indicate that results could be directly sent to populate an electronic patient specific file. This remote monitoring is more cost effective and may actually improve the level of care as well as patient safety.
Like most guidance documents, the FDA wants to ensure the safe and effective use of these devices. It explicitly sites the following “potentially problematic” issues:
- poorly characterized or poorly utilized wireless systems (e.g., wireless networks);
- lost, corrupted, or time-delayed transmissions, and degradations in wireless transmissions including when caused by competing wireless signals or electromagnetic interference (EMI) to the medical device or its wireless transmissions;
- lack or compromise of wireless security;
- and potential misuse of a wireless medical device because of lack of or inadequate instructions for use.
They specifically discuss the hacking risk of medical data and expect that manufacturers include cybersecurity in the design process for these devices. It may also be required that security information is included as part of the submission package. The concern with a breach goes beyond the receipt of personnel information but into an incident that would compromise patient safety. Could a drug delivery system be hacked and administer a fatal dose? Although the incidence of compromised systems is fairly low, the risk is there and should be addressed. The FDA may not clear a product without data on the device’s security. Manufacturers will need to have the expertise to support these requirements.
Thoughtful Diligence
Historically technological advances have almost always driven growth but not at the meteoric rate that occurs today. With these advancements come risks, some foreseen and others less conspicuous. It may seem empowering to have healthcare in your hands but be careful what you wish for.