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The FDA and the Regulation of Health Apps

4th January 2016 Print

The issue of the regulation of health apps – software which can be used via a mobile device to collect and sometimes interpret physiological information – has been a grey area, left more or less in the hands of the tech companies responsible for development. 

This has now changed, however, with an announcement from the Food and Drug Administration (FDA) setting out the approach which they intend to take toward such technology. Although the positive aspects of such apps are beyond doubt, the existing lack of regulation had caused some concern, with experts fearing that patients might be misled or given raw data without sufficient interpretation. 

The final guidance issued, however, attempts to separate useful and potentially harmful apps into two distinct groups, and indicates that the FDA will adopt a ‘hands off’ approach to the regulation of apps which it feels fall into the ‘useful’ category. The companies and technicians responsible for the development of apps have welcomed the news with a huge sense of relief. 

Most apps, also known as medical device data systems (MDDS), and the software involved in sharing information with pieces of equipment such as glucose meters, will fall into the category which the FDA feels is safe to leave unregulated, as they set out in their statement:

“This guidance confirms our intention to not enforce regulations for technologies that receive, transmit, store, or display data from medical devices. We hope that finalization of this policy will create an impetus for the development of new technologies to better use and display this data.”

The exception to this rule will be those apps which the FDA feels might pose a risk to patients in the event of a malfunction. The apps in question, in the words of the FDA statement, will be those which 

“….transform a mobile platform into a regulated medical device by using attachments, display screens, sensors, or other such methods”

In recent years, some experts have expressed concern over the fact that patients might potentially be misled by health apps which attempt to go further than simply gathering information, and which provide diagnostic advice and even suggestions for treatment. The feeling has been that such matters should be left in the hands of trained clinicians, and the FDA regulations back this up, giving developers a free hand to develop and refine those apps which gather vital information or help to monitor existing conditions. 

Experts working in the health app field gave a warm welcome to the new regulations, feeling that the light touch approach will help to foster creativity, innovation and the development of new health apps able to play a greater role in patient well-being and general prevention.   

Before now, issues around the clinical effectiveness of apps have thrown up the possibility that some patients might opt to take legal action. A medical negligence solicitors team shared the legal situation of mobile health apps: 

"Health app developers are unlikely to face medical negligence suits for a misdiagnosis, since there's no doctor-patient relationship between the app developer, the provider and the patient. That's one of the reasons patients should always communicate the doctor if they are using a health app, and check the accuracy of the information it provides." 

Aside from the legal opinion, a hugely positive view of health apps in general was provided, with the feeling being that they “make the patient much better informed and to ask the doctor much better questions, so together they can do a much better job avoiding medical errors".

The key to success will lie in getting the balance right, something which the FDA clearly feels its approach will be able to achieve. That balance lies between empowering patients to live more healthily, avoid illness and prolong their lives through the ability to monitor themselves, and ensuring that apps which provide misleading information or cross the line into the realm of offering treatment – a realm which needs to be the preserve of qualified practitioners – are regulated, if need be, out of existence. 

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