Can Standards and Regulations Keep Up With Health Technology?

Abstract

Technology is changing at a rapid rate, opening up new possibilities within the health care domain. Advances such as open source hardware, personal medical devices, and mobile phone apps are creating opportunities for custom-made medical devices and personalized care. However, they also introduce new challenges in balancing the need for regulation (ensuring safety and performance) with the need to innovate flexibly and efficiently. Compared with the emergence of new technologies, health technology design standards and regulations evolve slowly, and therefore, it can be difficult to apply these standards to the latest developments. For example, current regulations may not be suitable for approaches involving open source hardware, an increasingly popular way to create medical devices in the maker community. Medical device standards may not be flexible enough when evaluating the usability of mobile medical devices that can be used in a multitude of different ways, outside of clinical settings. Similarly, while regulatory guidance has been updated to address the proliferation of health-related mobile phone apps, it can be hard to know if and when these regulations apply. In this viewpoint, we present three examples of novel medical technologies to illustrate the types of regulatory issues that arise in the current environment. We also suggest opportunities for support, such as advances in the way we review and monitor medical technologies.

User Experience of Cognitive Behavioral Therapy Apps for Depression: An Analysis of App Functionality and User Reviews

“…This work indicates the potential of appropriately designed apps and could drive future innovation in mental health apps to ultimately deliver large-scale impact on public health. However, given the openness of app stores to developers [32,33], challenges with regulating health apps [34], and the time it typically takes for evidence-based research to make its way into health care practice [35], it is unsurprising that current research is not always reflected in the apps available in app stores.…”

Bring-your-own-device in medical schools and healthcare facilities: A review of the literature (Preprint)

“…Medical schools can also use policy to promote increased use of technology in the curriculum through provisional mobile devices [27] as at Stanford University's medical school [46] and the University of Botswana Faculty of Medicine [31][32][33]. In addition, investments in opensource hardware can allow medical schools and healthcare facilities to study, customize or modify, repair, make, and distribute hardware, thereby reducing reliance on external providers [47].…”

“…That is, the BYOD policy should cater for other mobile device uses such as diagnosis [45,[57][58][59][60][61], patient monitoring, follow-up [46,[62][63][64][65][66], data collection [43,46,51,67], and medication adherence [68,69]. Integration of mobile devices into hospital systems, especially patient record management [70], including patient participation in computerized patient record management [71], is also worth policy consideration.…”

“…Integration of mobile devices into hospital systems, especially patient record management [70], including patient participation in computerized patient record management [71], is also worth policy consideration. Other areas of policy consideration include patient self-diagnosis using unregulated medical apps, technology intimidation especially for older physicians, and overdependency on technology [46].…”

User Experience of Cognitive Behavioral Therapy Apps for Depression: An Analysis of App Functionality and User Reviews (Preprint)

“…This work indicates the potential of appropriately designed apps and could drive future innovation in mental health apps to ultimately deliver large-scale impact on public health. However, given the openness of app stores to developers [32,33], challenges with regulating health apps [34], and the time it typically takes for evidence-based research to make its way into healthcare practice [35], it is unsurprising that current research is not always reflected in the apps available in app stores.…”