The Journal of mHealth Vol 1 Issue 3 (June 2014) - Page 48

The Changing Face of Healthcare: Quality in Medical Applications Continued from page 45 the FDA proposed that certain types of mobile apps targeted for medical use be considered medical devices and placed under its scrutiny before they can be released for public use. However, the FDA clearance processes for medical apps do not require comprehensive clinical testing to ensure safety and quality as the processes for drugs and medications. With the increasing complexity of software systems, the possibility of failure through software defects increases exponentially, reinforcing the need for stringent quality assurance measures. Even though FDA's guidelines on medical apps has been finalised, it only addresses a subset of the entire medical app space. According to a study, “Medical apps for smartphones: lack of evidence undermines quality and safety”, although no harm caused by medical apps has been reported, without app quality assurance and safety standards, it's only a matter of time before some medical errors happen and unintended harm to patient occurs. To ensure quality of medical apps, authors of the study suggest: 1. Official certification marks that guarantee quality 2. Peer review system implemented by physicians’ associations or patient organisations 3. Making high quality apps more findable by adding them to hospital or library collections Presently, the feedback and ranking mechanism in place at app stores, while good for games and less critical apps, is highly inadequate for medical apps. The medical community, app store operators, regulatory bodies, auditors, patients, and other stakeholders need to get more involved in evaluating medical apps, at least on the following aspects: 1. Validation and certification of software quality that endorses apps' fitness for purpose and use 2. Peer reviews by diverse stakeholders – physicians, medical associations, patients, regulatory agencies, subject matter experts, etc. 3. Continuous monitoring of user feedbacks, complaints through establishment of vigilance systems The responsibility of addressing 46 June 2014 the aforementioned requirements falls on the medical app development companies; they are required to validate the apps they develop – a responsibility requiring a spectrum of expertise and experience. Many medical app development companies have neither the bandwidth nor the resources to handle comprehensive quality assurance and validation. Though several journals now include app reviews by doctors and healthcare practitioners, evaluating the apps from a 360-degree perspective requires cross-functional skills and knowledge. For example, medical app design is an area of paramount importance when developing mobile medical apps. Medical apps are intricate tools placed in the hands of doctors and patients, which can significantly influence healthcare outcomes. Hence, these apps must be designed and developed with usability in mind and addresses human factors, including user errors that result from unintuitive design. In an article titled, “Developing a Mobile Medical App? Don’t Forget Human Factors!”, medical app developers should consider at least the following human factors: 1. Preliminary analyses (such as hazard analyses, contextual inquiries, task analyses, heuristic analyses, and human factors expert reviews) 2. Exploratory human factors research 3. Formative human factors usability testing 4. Human factors validation testing The FDA guidance also recommends app manufacturers to follow the human factors guidelines, even when their apps are not subject to regulation. This strategy is perceived to be the best way to both, mitigate risks and encourage adoption, while simultaneously avoiding high costs associated with unnecessary redesigns and product recalls. From a software engineering perspective, even small changes in software could dramatically change the way a mobile medical app works. Q