mHealth Apps in Life Sciences Progressing Slowly
mHealth apps have been shown to increase patient participation in clinical trials, yet many life science organizations have been reluctant to adopt them. This reluctance persists, despite a survey showing that a small percentage of patients are likely to enroll in clinical trials largely due to unreasonable travel burdens for most patients. According to a recent report, 70% of patients would have to travel over 2 hours for participation at the nearest study center, making involvement unsustainable.
Virtual trials are one viable solution, using a mix of virtual video consults, e-consent, mHealth apps and biosensors to ease the barriers to joining and participating in these important studies. Additionally, the use of Internet of Things (IoT) sensors and virtual health technologies allows both passive and active data to be collected, painting a more comprehensive and accurate image of patients’ health. For example, researchers have reported that a suite of smartphone apps used in clinical trials of a treatment for Parkinson disease were often more accurate than traditional in-office manual assessments. Additionally, when automation solutions are integrated into clinical trials, costs can be lowered, as overhead costs are mitigated.
Nonetheless, barriers to adoption of mHealth apps have limited clinical trial sponsors’ willingness to incorporate these technologies into their trials. Fragmented infrastructure, differences in patient data privacy rules across state lines and cultural barriers all present obstacles to implementation.
mHealth App Recalled
Despite the many benefits that mHealth apps bring to patients and providers, they also involve a certain amount of risk. Recently, this risk was realized as the US FDA issued a Class 2 device recall for the Accu-Chek Connect diabetes management app by Roche. More than 67,000 people are reported to be using the device.
The primary problem with the app concerns a feature that advises users on how much insulin to administer based on data from the Accu-Chek blood glucose meter. This is not the first time this has been an issue for Roche. In 2015, the FDA initially cleared the mobile platform to provide an insulin-dosing recommendation: just one month later, it issued a brief recall when the app provided incorrect information to users in South Africa, Germany and Italy.
While the value of this type of app is significant, the dangers of a miscalculated insulin dose could be catastrophic. As a result, regulators are under significant pressure to ensure that mHealth apps and other virtual health devices are capturing accurate data and translating those data in an appropriate way to provide clinical decision support.
While mHealth apps can be used to improve the health of many patients, it is essential that they are used properly and held to rigorous standards. As health systems continue to integrate virtual health technologies into their offerings, they must stay up-to-date to ensure they are maximizing their potential while minimizing their risk. For more on developing your virtual health business unit to minimize your risk, refer to the Sg2 Virtual Health Resource Kit.