In a recent article led by CRE Investigator, Associate Farah Magrabi published in BMJ Health and Care Informatics, Magrabi discusses the difficulty of governing mobile apps in healthcare and how these issues can be addressed.

Mobile apps have become a convenient way to provide health information and communication services directly in the hands of clinicians and consumers. Apps can be used to support consumers in a variety of health tasks to manage chronic diseases, support lifestyle changes and in self- diagnosis. For clinicians, they can improve access to patient information and clinical decision support tools at the point- of- care. While the use of apps in healthcare can bring many benefits, poor quality information and gaps in software functionality can pose new risks to patient safety.

At their core, apps are software that run on a mobile device. When it comes to developing software, and assuring its quality, safety and security, rigorous engineering is fundamental. By applying engineering processes, developers should ensure that software is designed to requirements with safety and security integrated into the design, including regulatory requirements; hazards can be systematically identified and mitigated, not only prior to and during deployment but through the life of the system by monitoring use and preventative maintenance. However, these processes break down with mobile apps because they are a unique form of software that is easy to develop and deploy. For a small subset of health apps that are developed as a medical device or tethered to a device, engineering processes are preserved, in part, by regulatory requirements. However, the vast majority of health apps fall outside the remit of effective regulations in most nations.

Some of the challenges of ensuring clinical governance to ensure patient safety are:

  • Apps are highly versatile
  • Anyone can build an app
  • Development occurs in diverse settings
  • No gate at implementation, little formal evaluation and no monitoring of use
  • Apps directly reach users

Health apps are perhaps the most extreme example of challenges for clinical governance in the digital health ecosystem. While current efforts are usefully directed at curating the growing numbers of apps, they are not sustainable. As with any other digital technology, we need to consider apps from a problem- driven perspective by the health information or communication service they support.

The area of health apps is immature; this is unsurprising as apps are a radical and new development, which relies on sophisticated technology that has a record of frequent innovation. Patients, clinicians, developers and regulators are inevitably beholden to this current immaturity. Unlike established healthcare fields (eg, pharmaceuticals, radiotherapy, anaesthetics, etc) there is—as yet—no professional foundation, such as requiring certified and registered developers. Once there is a professional foundation, we envisage professional developers moving to regulation, just as registered pharmacists move into pharma regulation—this is a slow process, but without it, regulation is likely to remain behind the curve. The role of citizen developers in this ecosystem needs to be carefully considered. Given IT’s record of continual radical innovation, regulatory lag is likely to be permanent, and therefore, an effective clinical governance response must be, or partly be, of a different sort than conventional regulation. Ultimately, apps should not be considered just by their form but by their function and as part of the digital health ecosystem.

Read the full article.

Jan 23, 2020