Sunday, December 15, 2013

The mobile phone: central station for tele-care, tele-health and communication

The mobile phone is always with us. No matter where we go, most of us have the mobile in the pocket. So it seems a logical next step to integrate functions of tele-care that older and sick people sometimes heavily rely on for their safety. Indeed, some of the tele-care equipment providers exhibiting in November at the TSA Conference in Birmingham do offer feature phones equipped with SOS buttons, that either allow to call the emergency services or pre-assigned contacts in the phone book. And some advocate the extension of tele-care services via smartphone apps. This later aspect however rises a number of questions. 

What is the difference between tele-care apps and health apps? 

There are no established definitions yet, but the US Food and Drug Administration (FDA) has made a first step by issuing a "final guidance for developers of mobile medical applications, or apps, which are software programs that run on mobile communication devices and perform the same functions as traditional medical devices". In this guidance, the FDA specifies that it " intends to focus its regulatory oversight on a subset of mobile medical apps that present a greater risk to patients if they do not work as intended" because "the majority of mobile apps pose minimal risk to consumers".

In practice this means that the FDA will regulate mobile apps that 
  • are intended to be used as an accessory to a regulated medical device, or
  • transform a mobile platform into a regulated medical device

The FDA will not regulate apps that 
  • help manage conditions without providing specific treatment suggestions
  • help track the user's health information
  • facilitate access to information about certain conditions and general health information
  • monitor a patient's medical condition and help communicate this information to the health care provider
  • automate simple tasks for health care providers
  • enable patients or providers to interact with Personal Health Records (PHR) or Electronic Health Record (EHR) systems

A detailed explanation on which kind of apps will not fall under FDA review can be found on the webpage Examples of Mobile Apps for which the FDA will exercise enforcement discretion.

Barely standards, no regulations 

Still, the world of smartphone apps to date is the wild west. No established authority controls the quality or reliability of health apps. No regulations or internationally accepted guidelines exist on the minimum requirements for apps that can have an impact on the user's health. Apart from the FDA as one of the first government agencies to attempt formalising a regulatory approach to apps, some sort of quality control by peer review emerges in specialised areas. Websites like iMedical Apps ( for instance offer regular reviews of apps by experts in the field, in this case healthcare professionals; while lists apps that have been "selected by 456 distinct patient groups, disability groups or empowered consumers as their favourite apps. The reviews from these groups are supplied for each app, as well as weblinks to the groups themselves."

In this context, one of the participants in the Workshop "Integrating Apps so that they apply to you and me" held during the TSA Conference, asked a very pertinent questions: "When your tele-care app does not work, who are you going to blame? The developer of the app? The mobile phone manufacturer? The operating system? The tele-care equipment manufacturer? Who?" 

The overall tenor of workshop participants who partly came from network operators, partly from tele-care equipment manufacturers and partly from national agencies, was that they are very interested in the idea of employing apps as extension of or help in tele-care but that they are worried about quality control and liability. Guidelines or quality labels would certainly help. 

Exploiting the competitiveness of human nature

In the world of fitness, smartphone apps have been taken up very rapidly. The challenge to sticking to goals, the support via the community of all the people who also use the app to improve their life, are motivating factors. Some workshop participants whose background was in rehabilitation pointed out that it might be worthwhile to think about how to transfer this competitiveness and playfulness witnessed in fitness apps also to tele-care apps in order to help people engage more actively and give them incentives to follow instructions to possibly improve their condition.


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