The rapid evolution of technology in today’s world stimulates innovation in many industries, including healthcare products and services. The proliferation of technology is changing the way consumers and professionals think about and approach health.
In an increasingly tech savvy world, it is no surprise that consumers are looking to have instantaneous access to information at a swipe of their fingertips. Technology enables this in healthcare, and consumers now have more visibility of personal health data than ever before. This empowers them to participate more actively in medical decisions.
Leading the pack in technology products transforming the future of health care are mobile medical software applications (“apps”), wearable devices, and augmented reality. The benefits of these technologies in healthcare are twofold: According to one study, 86% of health care professionals surveyed believed that apps will increase their knowledge of patients’ conditions. On the other hand, and in the same study, 96% of health app users surveyed said that apps improve their quality of life.
Mobile medical apps
The widespread adoption of tablets and smartphones has created an increasing demand for more user-friendly and smart technology. There are now more than 165,000 mobile health apps available through smartphone app stores (IMS Institute for Health care Informatics, 2015), and these days, it seems there is an app for everything!
In recent years, apps have evolved from being reference tools and general lifestyle/fitness apps – think calorie counters, clinical reference guides, schedule trackers, and appointment reminder apps – to applications considered by regulatory authorities as actual medical devices.
Wearable medical devices
Another technology product that has exploded in recent years is wearable devices. These versatile and portable devices appeal to Americans, with 79% of the population surveyed reporting they would be willing to use a wearable device to manage their health.
Wearable devices can track nearly anything, from ovulation for women trying to conceive to glucose levels for diabetes patients; heart rates for detection and diagnosis of irregular heart rhythms to vital signs for hospital and remote patient monitoring, and pulse rates for cardio monitoring. There are also wearable devices that can provide chronic pain relief without medication and continuous temperature monitoring.
Augmented reality is also moving its way into health care. This technology adds computer-generated images to real-world environments and is more commonly recognized from the world of entertainment. A great example is Pokemon Go, an augmented reality game in which players can “see” Pokemon characters along neighborhood streets by holding up their smartphones or tablets. In the health care industry, augmented reality offers enhanced imaging and easier and more efficient surgical procedures by allowing doctors to create real-time 3D tumor reconstructions. Augmented reality can also be used to help locate patients’ veins and improve impaired vision.
So, when does an app, wearable or other type of technology become a medical device? To start, you need to assess whether or not it meets the definition of a medical device. The definition varies from country to country, but generally, it is the intended use of a product that determines its classification. In most cases, a product intended for the diagnosis, treatment or prevention of a disease or other condition will be classified as a “health product” of some kind, triggering a requirement for regulatory oversight. The regulatory requirements will vary depending on the classification of the product/device and the jurisdiction within which it is marketed.
Rapid changes in technology challenge regulators to keep pace, balancing technological advancement with appropriate regulations. Some countries like the USA (FDA’s Digital Health Program) and the UK have published specific guidance outlining their position on mobile medical apps, but Canada has not yet released their guidelines for these products.
Technology is here to stay, and it has the potential to revolutionize the future of health care. The impact may be significant for patients living in areas with poor access to health care, as technology can put health care within better economic and geographic reach where traditional technology is not affordable or accessible. Doctors could diagnose patients in more efficient ways and improve patients’ quality of life at lower costs. In addition to potentially reducing the number of face-to-face appointments, technology may also help cut health care costs by reducing readmissions and length of hospital stays by remotely monitoring patients in their homes.
The advantages seem obvious, but what about the drawbacks, such as security and privacy of patient data? Will technology make health care practitioners’ jobs and responsibilities redundant? Will we become patients to our smartphones? A future where patients will be treated and diagnosed by a form of technology, rather than traditional means doesn’t seem too far-fetched. Will the smartphone do it all one day?
NHP Consulting can help assess whether your product is considered a medical device and guide you in understanding the regulatory requirements for your technology. Contact us to know how we can assist in your concerns.