http://www.ebglaw.com/files/47347_Thompson-SRA_October_Mobile%20medical.pdf

1. Regulatory Analysis
Mobile medical apps guidance: what’s good for the US is
good for the EU
Bradley Merrill Thompson and Erik Vollebregt argue that draft guidance from the
US Food and Drug Administration on mobile medical applications could apply in the EU too.
On 21 July, the US Food and Drug (run) on a mobile platform, or a web-based solely used to provide clinicians with
Administration released draft guidance on software application that is tailored to a training or reinforce training previously
mobile medical applications1,2, a document we mobile platform but is executed on a received. These types of apps do not
think has great significance for the regulation server; and contain any patient-specific information, but
of the EU eHealth and medical device • has an intended use within the scope of the could show examples for a specific medical
markets, even while in draft form. If the FDA concept of medical “device” as regulated by specialty. In EU regulation terms, these
revises the guidance based on the substantial the FDA; and devices quite clearly do not achieve a
comments it is receiving from industry, the – are used as an accessory to a regulated therapeutic or diagnostic effect “in or on
importance of the guidance will only increase. medical device; or the human body” as required by the
In our opinion, because of the underlying – transforms a mobile platform into a definition of “medical device” under the
similarities in the basic legal framework in the regulated medical device. MDD;
two jurisdictions, this FDA guidance could be Although the word “app” is misleading here – • are solely used to log, record, track, evaluate,
used more or less without changes in the EU because that seems to refer to software that or make decisions or suggestions related to
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under the Medical Devices Directive3. is stored and run locally – it is quite clear that developing or maintaining general health
There are several reasons this document is web applications are also covered by the and wellness, provided that they are not
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so significant for regulation of eHealth and definition. The above points work exactly the intended for curing, treating, seeking
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medical devices markets in the EU. same in the EU: the intended purpose of the treatment for mitigating, or diagnosing a
Firstly, as we have indicated, the similarities app determines whether it is regulated under specific disease, disorder, patient state, or
in the basic legal framework in the US and the MDD. Accessories are regulated in the EU any specific, identifiable health condition.
the EU with regard to the scope of software
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as well, even though the definition of This outcome would be largely similar
or
and hardware regulation are substantially accessory may differ somewhat. under EU law as there is no intended
similar, so any guidance in one of those Examples of regulated applications include: therapeutic or diagnostic use except that
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jurisdictions is likely to be useful in the other. • mobile apps that are an extension of one or the EU definition also covers “investigation
Secondly, although the MDD and associated more medical device(s) by connecting to [...] of the anatomy or of a physiological
guidance address software in very general terms, such device(s) for purposes of controlling process” which makes these apps
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EU regulation is behind the US in terms of the the device(s) or displaying, storing, analysing borderline cases under EU law;
sophistication and level of detail provided. The or transmitting patient-specific medical • only automate general office operations
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different EU stakeholders and regulators cannot device data; or with functionalities that include billing,
seem to agree on guidance, either as to • mobile apps that transform the mobile inventory, appointments or insurance
substance or form, after the publication of the platform into a medical device by using transactions. These are also excluded under
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so-called “Swedish report” – proposals for attachments, display screens, or sensors or the MDD as general purpose software8 or
guidelines on the classification of software based by including functionalities similar to those as not having an intended use within the
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information systems used in health care from of currently regulated medical devices; or scope of the MDD;
Sweden’s Medical Products Agency – in June • mobile apps that allow the user to input • are generic aids that assist users but are not
20094,5. In the meantime, the industry, and in patient-specific information and – using commercially marketed for a specific
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particular the clinical institutions in the EU, are formulae or processing algorithms – output medical indication, such as recording audio,
having difficulties understanding how apps, a patient-specific result, diagnosis or note-taking, replaying audio with
websites and software with diagnostic and/or treatment recommendation to be used in amplification, and other similar
therapeutic functionality are regulated6. clinical practice or to assist in making clinical functionalities. These are currently also
Thirdly, because the reasoning of the FDA decisions (emphasis added). excluded under the MDD; and
guidance fits so well into the EU regulatory The FDA plans to address in a separate • perform the functionality of an electronic
system, medical technology and software issuance mobile medical apps intended to health record system or personal health
companies can rely on the same software and analyse, process or interpret medical data record system. These are also excluded
devices being regulated as medical devices. Of (electronically collected or manually entered). under the MDD.
course, the underlying authorisation process The FDA held a hearing on that topic in early
differs significantly between the EU and the September7, and seems to be moving along Manufacturer
US, but guidance as to the scope of regulation quite quickly towards a draft guidance. This A mobile medical device manufacturer may
that seems to work under both systems is a category of devices would fall as well under include anyone who initiates specifications,
big step forwards for the market. the EU definition of medical devices with designs, labels, or creates a software system or
diagnostic functionality and be regulated application in whole or from multiple software
Scope of software regulated accordingly. components. Examples of mobile medical
The FDA proposes that the guidance be Excluded from regulation are mobile apps device manufacturers include any person or
applicable to mobile medical applications or that: entity that:
“mobile medical apps”, defined as: • are electronic “copies” of medical textbooks, 1. Creates, designs, develops, labels, re-labels,
• a software application that can be executed teaching aids or reference materials, or are remanufactures, modifies or creates a
10 October 2011 www.scripregulatoryaffairs.com © Informa UK Ltd 2011

2. Regulatory Analysis
software system from multiple components. regulatory framework for EU directives relating to References
CE-marked products lead us to expect that this 1. Draft Guidance for Industry and Food and Drug
2. Provides mobile medical app functionality
Administration Staff - Mobile Medical Applications,
through a “web service” or “web support” will be included in the planned recast of the
21 July 2011, http://1.usa.gov/mXpVfZ
for use on a mobile platform. MDD10.
2. US FDA consults on proposals to regulate mobile
3. Initiates specifications or requirements This is a very important point because, in
medical apps, Scrip Regulatory Affairs, 20 July 2011
for mobile medical apps or procures product our experience, manufacturers distributing apps
3. Directive 93/42/EEC of 14 June 1993 concerning
development/manufacturing services from via larger stores will have no control
medical devices, OJ, 12 July 1993, L169, 1-43, as
other individuals or entities (second party) whatsoever over these stores, like the iTunes
amended
for subsequent commercial distribution. Store or the Android Market. They will have
4. The [Swedish] Medical Products Agency’s Working
4. Creates a mobile medical app intended very limited options to implement field safety
Group on Medical Information Systems, Project
to be used on a mobile platform, or that corrective action (in US wording: recall) in case
summary, Proposal for guidelines regarding
manufactures a mobile app to be supported of serious issues. If the FDA and the EU classification of software based information
by hardware attachments to the mobile authorities are serious on safety in this respect, systems used in health care, 2 June 2009 revised
platform with a device intended use. All of they should require design functionality that 18 January 2010, http://bit.ly/oiPQ90
this fits perfectly in the definition of gives the manufacturer sufficient reach through 5. Sweden drafts proposals for classification of
manufacturer under the MDD, defined to the user (eg by means of push messages to software-based IT systems, Scrip Regulatory Affairs,
as “the natural or legal person with discontinue use or to upgrade the app to a 8 July 2009
responsibility for the design, manufacture, new version), but also make it clear to the 6. Blog on Eucomed website by Erik Vollebregt (Axon
packaging and labelling of a device before it middle men that they have a duty to Lawyers and co-author of this article), 7 June 2011,
is placed on the market under his own co-operate as they may be facilitating illegal/
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http://bit.ly/kr4XQz
name, regardless of whether these unsafe medical devices. In the EU, that would 7. US FDA schedules workshop on mobile medical apps,
operations are carried out by that person mean that the store would, for example, lose Scrip Regulatory Affairs, 12 August 2011
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himself or on his behalf by a third party”. An its “mere intermediary” immunity under the 8. Recital 6 of EU Directive 2007/47 (the so-called
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important point is that the FDA urges e-Commerce directive11. “amending directive”) of 5 September 2007, OJ,
manufacturers of applications that do not 21 September 2007, L 247, 21-55
meet the definition of “device” still to apply a Conclusion 9. EN 62304, harmonised under the MDD, see
quality system to the design and
y
A lot more can be said about this subject, Commission communication in the framework of the
or
development processes. like how to implement in practice all the implementation of the Council Directive 93/42/EEC
A standard that in our view would work for consequences of a mobile app being regulated of 14 June 1993 concerning medical devices, OJ,
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the EU is EN 623049 on life cycle requirements as a medical device in practice, but we will 19 August 2011, C242, 8
for medical devices software harmonised under leave it at this for the moment. In the US, as 10. See Regulation (EC) No 765/2008 of 9 July 2008
the MDD. we write this article, industry is drafting setting out the requirements for accreditation and
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substantial comments on the FDA proposal to market surveillance relating to the marketing of
Distributors identify additional areas where clarity is needed. products and repealing Regulation (EEC) No 339/93,
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A very important final point in the draft guidance Even so, this draft guidance should be OJ, 13 August 2008, L218, 30-47 and Decision No
is that the FDA expects distributors of mobile welcomed on both sides of the Atlantic. 768/2008/EC of 9 July 2008 on a common
medical apps who may or may not be a platform While we believe the final guidance in the US framework for the marketing of products, and
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or service provider to co-operate with may change substantially to address the additional repealing Council Decision 93/465/EEC,OJ,
manufacturers in conducting corrections and questions raised by industry, we believe that the 13 August 200, L218, 82-128
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removal actions.The agency requires medical app EU authorities should use the US process to their 11. Directive 2000/31/EC of 8 June 2000 on certain
manufacturers to make timely reports of advantage as a basis for the much-needed and legal aspects of information society services, in
corrections and removals made to reduce a health due step in the clarification of EU regulation of particular electronic commerce, in the Internal
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risk or remedy a violation of the Food, Drug & mobile medical apps under the MDD. We hope Market (“Directive on electronic commerce”), OJ,
Cosmetics Act that presents a health risk, and to the EU regulatory authorities will study not only 17 July 2000, L178, 1-16
keep records regarding other corrections and the FDA draft but the comments industry is
Bradley Merrill Thompson is a member of law firm
removals. In EU wording: the manufacturer must submitting. Further, companies faced with the
Epstein Becker & Green’s Health Care and
exercise control over its supply chain and be able question of whether or not their app is regulated Life Sciences Practice based in Washington, DC.
to implement corrective action through its supply under EU medical device law can use the Erik Vollebregt is a partner at Axon Lawyers, a new
chain, as is currently the case under the MDD, guidance, and especially the final guidance, as a Dutch law firm specialising in legal and regulatory
while the supply chain is expected to co-operate. rule of thumb to determine whether it is likely aspects of the life sciences sector.
This latter requirement is not laid down in the that their app would be regulated under Emails: BThompson@ebglaw.com and
MDD yet, although developments in the new the MDD. erik.vollebregt@axonlawyers.com.
© Informa UK Ltd 2011 www.scripregulatoryaffairs.com October 2011 11