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What do ISO standards mean for mobile App services?

There are a number of different kinds of app technology currently on the market. Some feature internal sensors that measure what is going on inside our bodies, others measure external sensory information such as temperature. Some sensors, like those used in the medical field, can sense changes to our health even before we do. Then, of course, there are all the algorithms and the calculations they can do in a way that we can’t – well, not easily, at least. This covers the whole parade of features including calorie counting, distances covered, body mass index, progress we make in terms of weights and reps, and so on.

Assessing the risks

As with any trend, when an industry grows, so too do the potential risks. It’s about real risk and perceived risk, notes Cooper. “Wanting to use an app to find the lowest-priced gasoline within five miles is one thing. If it isn’t accessible or gives me bogus guidance, oh well, better luck next time,” he says. “However, when health is involved, the risks become much more personal, ranging from a slight inconvenience to having to call the emergency services, to even death. If an app for medication dosage gets it wrong by putting the decimal point in the wrong place, for example, the effect can be disastrous.”

Gora Datta, an international expert on e-health and mobile ICT to ISO/TC 215, ISOʼs technical committee for health informatics, says risks also lie in the fact that health apps can have access to highly detailed, personally identifiable and clinical information about the user. “This clearly raises questions about privacy, security, permission control and confidentiality, as well as the integrity of the infrastructure,” he suggests.

“There is also a need to clarify how to ensure practicalities of data storage and management, availability and maintenance of the network, not to mention compatibility and interoperability.” Some standards and regulations already exist to help. For example, the US Food and Drug Administration (FDA) recognizes many of the benefits of health information technology but requires that risk assessments are carried out and risks appropriately managed. In its report titled FDASIA Health IT Report – Proposed Strategy and Recommendations for a Risk-Based Framework, the FDA states: “A nationwide health IT infrastructure can offer tremendous benefits to the American public, including the prevention of medical errors, improved efficiency and healthcare quality, reduced costs, and increased consumer engagement. However, if health IT is not designed, developed, implemented, maintained, or used properly, it can pose risks to patients.” So, while there is a strong public health case for the use of mobile health apps, the identification, development and adoption of standards and best practices are a key aspect of a health IT framework that promotes innovation and protects patient safety.

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