Updated on 17 September 2013
More recently, Happtique has filed mHealth app for patent protection before USPTO. The patent specification has been titled "provision of a mobile health product" and published as US20130066650 on March 14, 2013. The mHealth application provides a mechanism to healthcare providers to recommend and, prescribe mobile health product apps to patients' smartphones and tablets, or refer them to Apple store to help the patients manage or alleviate their conditions.
Ethical and legal issues
As these healthcare applications involve personal data related to healthcare, Food and Drug Administration (FDA) is trying to regulate the mobile app sector. There are numerous confidentiality and privacy issues in social media which needs to be legalized to draw a line between what data is ethical to share over a communication network. Moreover, some medical applications could cause serious risks to consumers if they do not work as they ought to work. However, FDA has already cleared few mobile medical apps used by health care professionals, such as a smartphone-based ultrasound and mHealth application for iPhones and iPads that allows doctors to view medical images and X-rays.
FDA had issued its Draft Guidance on Mobile Medical Applications in July 2011. In the guidance, the FDA stated that it would apply its regulatory requirements to a subset of mobile health apps and FDA uses the term "mobile medical applications" 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." However, a final guidance document from the FDA in expected to come soon for the regulation of mobile applications.
In May 2013, the FDA made its first inquiry into a urinalysis medical app. Biosense Technologies uChek system's mobile app lets users check levels of protein and other substances in their urine. The smartphone app relies on users, to dip test strips in urine and use the smartphone's camera to allow the system to processes and generate automated results.
mHealth applications are interactive, easy to use, and functionality aspect is well taken care off by the mobile application developers and will continue to play a vital role in providing affordable healthcare solutions. In addition, mobile-based healthcare applications provide improved efficiency, portability, convenience and will help patients to improve and get better healthcare monitoring. Moreover, using mHealth apps in daily routine can help to control common old ages diseases like blood pressure, diabetes and indirectly promote users to change their lifestyle under continuous monitoring of the mHealth apps. mHealth apps, therefore, provide affordable healthcare for both urban and rural populations.
However, the need of the hour is balancing act between patients' medical data being shared over internet with physicians in a secured environment on one hand and the privacy data and security issues associated with medical data to be handled effectively is a challenge in the current scenario where tonnes of data are being generated on a daily basis. Therefore, policymakers worldwide while formulating the laws and regulations should keep in mind these points and take precise well planned steps to achieve the balancing act.