SRI Security Research Institute, Edith Cowan University, Perth, Western Australia
The rapid adoption and evolution of mobile applications in health is posing significant challenges in terms of standards development, standards adoption, patient safety, and patient privacy. This is a complex continuum to navigate. There are many competing demands from the standards development process, to the use by clinicians and patients. In between there are compliance and conformance measures to be defined to ensure patient safety, effective use with integration into clinical workflow, and the protection of data and patient privacy involved in data collection and exchange. The result is a composite and intricate mixture of stakeholders, legislation, and policy together with national and individual perspectives. The challenges for standards development are numerous and include the cross over from traditional medical devices and mobile devices with apps, as well as harmonisation for consistent semantic terminology, and the diverse range of standards required in mobile health solutions. These issues affect the ability of conformance and compliance to be undertaken. Additionally, the need for interoperability in development of safe and secure mHealth software whilst being mindful of the implications for patient safety is vital. Conformance and compliance to established international standards is the first and, at present, the only step in meeting the mobile health challenges.