In recent years, most leading pharmaceutical companies have been moving to reinvent their business models to face the challenges of providing low-price medicines, of the patent cliff, and of demographic changes. This has led to the entry of large information technology (IT) based companies, and of mobile-based healthcare firms who have been recently very active in the healthcare mobile sector. Information technology, telecommunications and internet-based digital and social innovations are leading to an increase in accessibility in the healthcare sector and the healthcare market enabled by a mobile health (mHealth) applications revolution. The areas into which mHealth has made the most inroads are: improved efficiency of primary care delivery, portability, convenience and improved patient monitoring. Current mHealth apps help to control and monitor common conditions like high blood pressure and diseases like diabetes and, indirectly, to encourage users to change their lifestyle due to the continuous monitoring of the mHealth apps. mHealth applications' functionality is already well developed by the mobile application companies, who continue to play a vital role in providing affordable healthcare solutions to patients and serious revenue stream to investors, as illustrated in PwC diagram.
Since mHealth applications involve personal data related to healthcare, the US Food and Drug Administration (FDA) is starting to regulate the mobile app sector. "The FDA has already cleared a few mobile medical apps used by health care professionals, such as a smartphone-based ultrasound and mHealth application that allows doctors to view medical images and X-rays. The FDA issued its Draft Guidance on Mobile Medical Applications in July 2011 stating that it would apply its regulatory requirements to a subset of mobile health apps that both: (1) meet the definition of a "device" under Section 201(h) of the Federal Food, Drug and Cosmetic Act; and (2) were "used as an accessory to a regulated medical device" or "transform a mobile platform into a regulated medical device". On August 1, 2014, the FDA released draft guidance that exempted from premarket 510(k) review many low-risk medical devices including certain mobile applications that can convert a cell phone into a medical device, such as a thermometer or a stethoscope. The FDA also announced its intention not to enforce compliance with premarket review requirements for these devices and noted that it did not expect manufacturers to submit 510(k)s for these devices prior to adoption of a final rule or order. The FDA’s recognition that these devices are sufficiently well understood and do not present risks that require premarket review to ensure their safety and effectiveness and its corollary decision to exercise enforcement discretion as to these devices, eases the regulatory burden on medical application developers and expands opportunities for continued development and dissemination of important mobile tools for improving patient care and physician practice."
(According to Mobile Medical Applications: Guidance for Food and Drug Administration Staff issued on September 25, 2013)
The patent scenario
There has been a "mobile revolution", with consumers using smartphones with different software platforms to access global information at any time from any location and with individuals able to share information at the click of a button, whatever their locations may be. As illustrated in the patent filing graph to the right , this has resulted in a wide range of patents being filed, covering various aspects of such applications.
For mHealth applications, apps and devices provide accurate diagnosis and targeted therapy. Examples of patents for mHealth apps include: management of blood pressure by utilizing wearable intelligent sensors and personal healthcare information systems; and a smart phone that can perform an electrocardiogram (ECG) monitoring the electrical activity of a person’s heart.
To summarize, the above data shows that mHealth is an emerging field. mHealth can combine a variety of platforms and protocols such as staff scheduling; tracking and travel management; and visit record and care plan administration. Other mHealth applications which may be patentable include, for field service personnel such as visiting staff in the home healthcare field, providing improved monitoring, reporting, data communication, and tracking of information.
Therefore, there are excellent opportunities for both start-ups and Big-Pharma companies to direct, combine and leverage current technology to the mHealth future.