Mobile Health Apps: Regulatory Trends

Since the start of the Covid-19 pandemic governments in different countries have recognised the importance and benefits of mHealth apps and encouraged development of new mobile health technologies. In March 2020, US Congress lifted Medicare requirements for telemedicine in order to provide an easier access to telehealth services for patients and health workers. This action provided a promising solution to fix healthcare discrepancies in rural communities.

Listed below are the key regulatory trends impacting the mHealth app industry, as identified by GlobalData.

FDA regulation of mHealth

In 2015, the FDA set out guidelines that categorised mHealth apps as high-risk or low-risk, and stated its intent to only regulate high-risk apps whose functionality could pose a risk to patient safety.

To reach their full, transformational potential, mHealth apps must be accurate and effective enough to warrant use by healthcare practitioners or consumers, and the current FDA guidelines may not be doing enough to ensure this is the case. Broad reviews have revealed that many mHealth apps make clinical claims that lack scientific support, with some even contravening evidence-based guidelines.

Following COVID-19 pandemic FDA stated it recognises that mHealth apps can provide valuable insight and be useful tools for the general public and health officials.

General Data Protection Regulation

GDPR is particularly important in mHealth, where companies often collect and process large amounts of private health information from their users. For instance, the GDPR will be enforced for apps that collect patient data for record keeping purposes, and apps that process patient data for the purposes of providing a diagnosis, just to name a few. As a result, many companies are spending more on data privacy systems to ensure compliance with the GDPR.

International regulation

In 2011, a number of countries came together for a worldwide mHealth regulation initiative under the banner of the International Medical Device Regulators Forum (IMDRF). Their goal is a harmonised regulatory framework for mHealth apps that best suits clinicians’ and patients’ needs while also supporting the rapid mobile app innovation cycle globally. The thirteenth meeting of the IMDRF took place in March 2018 in Shanghai, when the forum adopted the new work item of conducting research into clinical evaluations of medical devices on a global scale.