mHealth: big challenge, big problems - the Apps qualification

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On Semptember, 9 Apple has launched HealthKit.

The new creative idea of Cupertino company is bringing together practitioners, patients and people everywhere to make health efficient, effective and accessible all over the world.

Tools to this purpose are Website and Apps. Forbes has described HealthKit as “a revolution hidden”

There is no question that mHealth will be a big challenge with big problems.

To work in the right way, the European Commission has recently launched a public consultation alongside the Green Paper on mobile health (mHealth) to help in identifying the right way forward to unlock the potential of mobile health in the EU (April 2014).

The principal problems which we should afford will be:

1. State of play in the applicable EU framework and medical device qualification;

2. Data protection, including security of health data;

3. Big datas;

4. Patient safety and trasparency of information;

5. Mhealth role in healthcare system;

6. Interoperability;

7. Liability;

8. Reserch and innovation.

Besides those big issues, there is, in my opinion, another relevant aspect that deserve a special focus: apps legal qualification.

The issue is: do apps working in the health field belong to medical device category?

Answering is not simple because the legal framework is not clear and well-defined yet.

Currently, the most important documents regarding this aspect are the following:

1) The European Community MEDDEV 2.1/6[1] Guidelines on the qualification and classification of standalone software used in healthcare within the regulatory framework of medical devices - issued by Ue Commission on 2012 January - establishs the “Stand alone software must have a medical purpose to be qualified as medical device” and regarding “Qualification criteria as medical device” sets forth

Software can be used for a large variety of medical purposes15. In that respect the arguments do not differ from those used for other medical devices.?Stand alone software can directly control an apparatus (e.g. radiotherapy treatment), can provide immediate decision triggering information (e.g. blood glucose meters), or can provide support for healthcare professionals (e.g. ECG interpretation).
Not all stand alone software used within healthcare can be qualified as a medical device. Stand alone software may run on different operating systems or in virtual environments. These operating systems or virtual environments do not impact the qualification criteria.

The recent ‘Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices’ contains standards for qualification of APP and Software as a DM (see my previous article).

2) the Guidance on medical device stand-alone software (including apps) issued by MHRA (UK) on 2014 March

In this document MHRA determines that:

If software applications meet the definition of a medical device, it will be regulated by MHRA as a medical device and will have to undergo a conformity assessment.

The words and phrases listed below are all likely to contribute to a determination by the MHRA that the app they were associated with is a medical device: amplify, analysis, interpret, alarms, calculates, controls, converts, detects, diagnose, measures, monitors

There are a number of different types of apps and these could be categorised by function such as:

Decision support or decision making software that applies some form of automated reasoning, such as a simple calculation, a decision support algorithm or a more complex series of calculations, eg dose calculations, symptom tracking, clinicians guides. These are the types of software most likely to fall within the scope of the medical devices directives
Apps acting as accessories to medical devices such as in the measurement of temperature, heart rate, blood pressure and blood sugars could be a medical device as are programmers for prosthetics.
Software that monitors a patient and collects information entered by the user, measured automatically by the app or collected by a point of care device may qualify as a medical device if the output affects the treatment of an individual.
Software that provides general information but does not provide personalised advice, although it may be targeted to a particular user group, is unlikely to be considered a medical device.
Software that is used to book an appointment, request a prescription or have a virtual consultation is also unlikely to be considered a medical device if it only has an administrative function.

Some decision support software may not be considered to be a medical device if it exists only to provide information to enable a healthcare professional to make a clinical decision as they ultimately rely on their knowledge. However, if the software or app performs a calculation or interprets or interpolates data and the healthcare professional does not review the raw data, then this software may be considered a medical device. Increasingly apps are being used by clinicians who will rely on the outputs from this software and may not review the source/raw data.

3) The FDA Guideline called Mobil medical Application - Guidance for Industry and Food and Drug Administration Staff, September 25, 2013

This very interesting document defines a small subset of mobile medical apps that impact or may impact on the performance or functionality of currently regulated medical devices.

This subset includes mobile medical apps that:

a. are used as an accessory to medical device already regulated by the FDA

(For example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archive and communication system (PACS) on a smartphone or a mobile tablet); or

b. transform a mobile communication device into a regulated medical device by using attachments, sensors or other devices

(For example, an application that turns a smartphone into an ECG machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack).

The legal qualification is not the only problem.

First, without any doubt, another issue will be the application of the Reg UE 2012/207 on electronic instruction for use of medical device, requiring paper label for mHealth apps that are medical devices not intended for professional users (unreasonable and illogic).

Finally, also unannounced audits in this specific medical device sector, according to 2013/473/Reg, could represent a great problem.

I suggest to read an interesting article of Erik Vollebregt here, as an indepth analysis on this matter.