BioPharma Beat: mHealth Apps - to Regulate or Not to Regulate

BioPharma Beat logo As healthcare apps for mobile devices continue to proliferate, soon to be in the thousands, there is a lingering question as to whether or not they will be regulated, by whom, and to what extent.

We are witnessing exuberance about all things digital, especially in the health space. There is no doubt that many of the connected devices and apps being introduced are very useful and will result in improved outcomes (health or economic) – if they have not already. At the same time, there are a lot of devices and apps that offer marginal utility at best, and are misleading or even dangerous at worst.

Government regulators, public and private payors, providers and provider groups, and patient advocacy groups are all watching closely to see whether there is a shift in the balance between risk and benefit. For now, everyone seems comfortable watching the field evolve, but for how long before they intervene?

Today, the Royal College of Physicians (UK) released a set of mHealth app “guidelines” (see link below). As stated in the document, “the medical app market is evolving rapidly, and the RCP is monitoring it closely. The RCP has no plans to endorse particular medical apps … although it is centrally involved with other organisations in establishing quality criteria for apps.”

https://www.rcplondon.ac.uk/sites/default/files/apps_guidance_factsheet.pdf

The main points in this guideline (and my brief observations) are:

1) Protecting Yourself and Your Patients

“Always look for the CE mark, it indicates that the app meets certain essential criteria.”

The guideline also suggests that the CE mark indicates the app is “safe”, a claim that should be questioned given the broad and somewhat generic requirements of CE marking.

2) What is a medical app? Which apps need a CE mark?

“Briefly, apps that diagnose, support diagnosis or clinical decisions, make calculations to determine diagnosis or treatment, or are used for any medical purpose are classed as ‘medical devices’. “

This is a very broad definition and one that many will likely disagree with.

3) What is NOT a medical app?

“Apps that have only administrative functions, eg to book
an appointment or request a prescription, are unlikely to be classed as medical apps. Apps that give general guidance or support training, such as books that you read or MRCP(UK) test questions that you answer on your smartphone, are not medical apps as such. Equally, apps that are not marketed as medical apps, such as a generic calculator on your mobile phone (which could be for general use in offices or at home), are not medical apps, even if you use them at the bedside. Apps that do not provide personalised advice are unlikely to be considered medical apps.”

This seems very general and, with all the creativity and innovation in this field, likely will be adjusted very quickly.

4) What to do now if you use apps?

“If you rely on an app for your professional work, you should check that it has an official CE mark. If there is no CE mark, you must urgently ask the app’s developers to obtain one; meanwhile, you should stop using the app. “

This and other tips in this section appear a bit naïve in that they overemphasize CE mark and automatically dismiss anything that does not have one. Also, they speak to the physicians’ own professional work and ignore the bulk of the apps, which are entirely in the hands of the public or the patient.

5) Reporting issues or problems with apps

“If you know of any problems with apps used for medical purposes (such as calculation errors), please report these to the MHRA online at www.mhra.gov.uk/safetyinformation/ reportingsafetyproblems/devices”

Not sure what they can do since there are no clear or robust standards against which to evaluate whether or not an app is questionable – other than the CE mark. And then, there does not seem to be any regulatory authority to do anything about adverse findings.

6) Finally, what to do if you are developing apps?

“If you develop an app that is intended for use in any
medical context in Europe, it will need a CE mark, whether it is free to download or not.”

Seems like a relatively low standard to meet

Even if these guidelines are very general, impractical and weak, the Royal College of Physicians (UK) should be commended for coming up with something that will get the dialogue going and create a point of reference.