What can be done to prevent a health app from becoming a medical device?

Many pharmaceutical and healthcare companies would like to provide their patients and customers with apps as add-ons to medications, therapies or healthcare products. The aim is often not only to provide additional information, but also to increase compliance by tracking the general state of health and, in particular, the state of health to be observed. For example, by providing a diary function so that a more accurate picture of the patient's condition can be documented over time. In the best-case scenario, this data can then support treatment by the doctor on site. Pharmaceutical and healthcare companies are driven by the desire to support patients and customers digitally and also to act as an extended healthcare partner. However, these companies are quickly treading the narrow path to medical devices.

However, the marketing experts responsible for such applications often shy away from developing a medical device. No wonder. If an app is to become a medical device, it must be ensured that the strict regulatory requirements are taken into account during development even before the initial conception. My colleague gives an overview of how extensive these are and can be in her blog post on „Requirements engineering for medical devices“. Increased effort is also to be expected during the development process, but even after approval and placing on the market, continuous monitoring of the app as a medical device is necessary and ensures a long-term commitment of the manufacturer and thus of resources.

However, in order to ensure that the purpose of the supporting app is still useful for patients, many companies need advice on what an app may contain and achieve in the medical sense in order to explicitly avoid becoming a medical device. The following is a brief overview of the relevant points.

Medical device? No thanks!

In the European Union, the Medical Device Regulation (MDR) regulates what exactly constitutes a medical device. If an app is to be developed that does not fall into the medical device category, it is worth taking a look at the requirements. The following checklist can be used to check whether the human app is actually a medical device.

If only one question can be answered with "Yes", this is the case. If all questions can be answered with "No", care must be taken to ensure that the app does not cross the line into a medical device.

The following points must be observed:

Clearly define the intended use:

• Ensure that the app does not have a medical purpose. This means that the app may not be used for the diagnosis, treatment, monitoring or alleviation of illnesses or injuries of human patients or customers, as can already be seen in the checklist.

Functionality of the app:

• Implementation of app functions that only offer general wellness or fitness functions, such as pedometers, calorie counters, general health information, motivational aids for healthy lifestyle habits, etc.
• Avoidance of functions that can be used explicitly for medical purposes, such as the monitoring of chronic diseases, the provision of therapy recommendations or the transmission of data to the attending physician.

Disclaimers and terms of use:

• Definition of clear disclaimers and terms of use stating that the app is not intended for medical purposes and does not provide medical advice.

Advertising and marketing:

• Differentiation in advertising, marketing materials or app descriptions and avoid statements that suggest the app is for medical purposes.
• Avoid medical terms such as "diagnosis", "therapy", "treatment", "medical", etc.

Not a medical product! Safe?

In addition to the content and all information required to place the app on the market and advertise it, further details may need to be clarified to ensure that it is not unintentionally a medical device. As explained above, it is worth consulting experts in medical device law before developing the app. Legal advice should also be sought to check whether all legal requirements have been taken into account, not only in the country of manufacture but also, in particular, in the countries in which the app is to be published. If the requirements of the MDR apply in the EU, the guidelines of the Food and Drug Administration (FDA) apply in the USA, for example. The assessment of whether a product is a medical device can therefore vary from country to country.

In this regard, internal processes should also be established that carry out a regular evaluation of the implemented app functions. These should ensure that the app does not unintentionally fall into the classification of a medical device in the various countries due to an update or revision of the legal requirements. A new analysis should also be carried out each time new functions or updates to the app are implemented. In doing so, it should be ensured that the app does not exceed the medical device threshold in all countries to be considered. Both monitoring measures described apply to the entire product life cycle of the app. Distributors and other persons responsible for the app should be aware that they will incur these costs even or especially if the app was not developed as a medical device. In addition to the monitoring effort of a health app, a monitoring phase of the medical device status should therefore always be planned and taken into account.

Conclusion

The provision of apps for patients and customers is a strictly regulated process, particularly in the healthcare sector. As the marketing manager of a pharmaceutical or healthcare company, it is not always easy to recognise the subtle differences that make an app stand out in the classification of a medical device. To this end, medical device law experts often support the design process of such an app. For example, adesso offers "Ask the Expert" sessions for medical devices to get a quick answer to the question of whether the general framework conditions are right.

But even during the development process, there are always decisions that make the difference between an app that can be published without regulatory hurdles and a medical device. As shown above, the monitoring phase that follows the release requires the involvement of medical device experts. Here, adesso provides support with experts and many years of expertise in the field of medical technology in order to safely develop an app, whether it is a medical device or not, and accompany it to the market.

It is important to accept and take into account the fact that testing for medical device classification is a recurring process for every app in the healthcare sector and must be factored into the cost of such an app.

You can find out more about exciting topics from the world of adesso in our previous blog posts.