MOBILE MEDICAL APPS GUIDANCE

Medica17 November 2011 Erik Vollebregt

www.axonadvocaten.nl

There’s an app for that• More and more decision support goes to the handheld

• E.g. for interpretation of diagnostic results• eHealth / Telemedicine- new paradigms, new problems

• EU harmonisation initiatives for law and standards• Increasing convergence between consumer electronics and medical

devices• Kinect in the operation theatre, Wii balance board for

biofeedback

US draft guidance mobile medical apps• The FDA proposes that the guidance is applicable to mobile medical

applications or “mobile medical apps”, defined as

• “a software application that can be executed (run) on a mobile platform, or a web-based software application that is tailored to a mobile platform but is executed on a server”; and

• has an intended use within the scope of the concept of medical ‘device’ as regulated by the FDA; and

• are used as an accessory to a regulated medical device; or• transform a mobile platform into a regulated medical device.

FDA proposes no medical apps are:• “electronic “copies” of medical textbooks, teaching aids or reference

materials, or are solely used to provide clinicians with training or reinforce training previously received.

• apps that are solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness, provided that they are not intended for curing, treating, seeking treatment for mitigating, or diagnosing a specific disease, disorder, patient state, or any specific, identifiable health condition.

• possible borderline problems in EU as no ‘general health and wellness’ exempted category exists under MDD

• apps that are generic aids that assist users but are not commercially marketed for a specific medical indication, such as recording audio, note-taking, replaying audio with amplification, and other similar functionalities.

• apps that perform the functionality of an electronic health record system or personal health record system.

Who is manufacturer?

• In the US the party that:

• Creates, designs, develops, labels, re-labels, remanufactures, modifies, or creates a software system from multiple components;

• Provides mobile medical app functionality through a “web service” or “web support” for use on a mobile platform;

• Initiates specifications or requirements for mobile medical apps or procures product development/manufacturing services from other individuals or entities (second party) for subsequent commercial distribution;

• Creates a mobile medical app intended to be used on a mobile platform, or that manufactures a mobile app to be supported by hardware attachments to the mobile platform with a device intended use.

Comments on FDA draft guidelines

• Intended use approach leads to too broad scope and is not clear enough; FDA should specify positively the intended uses that trigger regulation

• Define “health and wellness”• Impact of consumer use versus professional use in regulation

• Low risk products should be exempted• Normal accessory rule problematic in mobile and electronic health

scenarios, because risk profile of these accessories is not necessarily the same as parent device

• More guidance needed for roles and responsibilities of other parties involved in the manufacturing (vendors), network services (ISPs) and distribution (app stores)

• Provide for modularisation of software and software specific classification rules

Further steps FDA

• ~ 90 submissions received on draft guidelines, some very substantial (100+ pages)

• FDA is expected to come out with definite guidance somewhere in Q1 2012

• Subsequent project for FDA guidance: Clinical Decision Support Systems (CDS)

EU developments

• Standalone software MEDDEV more or less finished – to be published in December 2011

• Next edition of Manual on Borderline and Classification expected to contain some software borderline guidance

• Recast developments

• Expectation that Recast will include more direct supply chain actor responsibilities, like in new Toy Directive and Cosmetics Directive

• Borderline solution via (likely) EMA

MEDDEV decision treegeneral

• Software decision tree as per EU draft MEDDEV on standalone software under MDD

• Caution: final version may differ

Thank you for your attention

Erik VollebregtAxon AdvocatenPiet Heinkade 1831019 HC AmsterdamT +31 88 650 6500F +31 88 650 6555M +31 6 47 180 683E erik.vollebregt@axonadvocaten.nlT @meddevlegalB http://medicaldeviceslegal.com