Presentation for the Italian Association of Clinical Engineer Meeting - 2013

1. Apps
and smartphone attachments
as medical devices.
Ing. Nicola Volonterio
Servizio Ingegneria Clinica
A.O. Sant'Anna Como
XIII Convegno Nazionale AIIC – Napoli – 11 e 12 Aprile 2013

2. ing. Nicola Volonterio – XIII Convegno Nazionale AIIC 2
What is mHealth?

diagnostic tools (US probes, glucose monitor, heart monitor, ...)

EHR

PACS

education, awareness and adherence programs

epidemic tracking

telemedicine

3. ing. Nicola Volonterio – XIII Convegno Nazionale AIIC 3
Why are we talking
about mHealth?

4. ing. Nicola Volonterio – XIII Convegno Nazionale AIIC 4
MD Definition (CE 07/47)
Any instrument, apparatus, appliance, software, material
or other article, whether used alone or in combination,
together with any accessories, including the software
intended by its manufacturer to be used specifically for
diagnostic and/or therapeutic purposes and necessary for
its proper application, intended by the manufacturer to
be used for human beings for the purpose of:
• diagnosis, prevention, monitoring, treatment or
alleviation of disease, [...]

5. ing. Nicola Volonterio – XIII Convegno Nazionale AIIC 5
What is mHealth?

diagnostic tools (US probes, glucose monitor, heart monitor, ...)

EHR

PACS

education, awareness and adherence programs

epidemic tracking

telemedicine

6. ing. Nicola Volonterio – XIII Convegno Nazionale AIIC 6
Some numbers
physicians owning a
smartphone in 2011
(Manhattan Research)
medical apps reviewed
each year by FDA
(0,5% of MD reviewed)
2017 estimated value
of European mHealth
market (PWC)
20
6.9bn $
about 6% in Italy
81%

7. ing. Nicola Volonterio – XIII Convegno Nazionale AIIC 7
mHealth opportunities
• continuous and remote monitoring
• personalized therapy
• telemedicine
• MPOC

8. ing. Nicola Volonterio – XIII Convegno Nazionale AIIC 8
mHealth opportunities
• continuous and remote monitoring
• personalized therapy
• telemedicine
• MPOC

9. ing. Nicola Volonterio – XIII Convegno Nazionale AIIC 9
mHealth opportunities
• continuous and remote monitoring
• personalized therapy
• telemedicine
• MPOC

10. ing. Nicola Volonterio – XIII Convegno Nazionale AIIC 10
mHealth opportunities
• continuous and remote monitoring
• personalized therapy
• telemedicine
• MPOC

11. ing. Nicola Volonterio – XIII Convegno Nazionale AIIC 11
mHealth opportunities
• continuous and remote monitoring
• personalized therapy
• telemedicine
• MPOC
costs reduction
due to reduction of admissions and hospitalization time

12. ing. Nicola Volonterio – XIII Convegno Nazionale AIIC 12
mHealth pitfalls
• lack of standards
• security concerns
• BYOD risks
“Digital Health feels like the PC industry in
the early ’80′s.”
John Sculley, former CEO of Apple, Digital Health Summit 2012

13. ing. Nicola Volonterio – XIII Convegno Nazionale AIIC 13
mHealth pitfalls
• lack of standards
• security concerns
• BYOD risks
Wireless devices by their nature can facilitate
remote access to sensitive data.
Lack of “security culture” in mobile context.

14. ing. Nicola Volonterio – XIII Convegno Nazionale AIIC 14
mHealth pitfalls
• lack of standards
• security concerns
• BYOD risks
BYOD is risky in consideration of the
previous two pitfalls.

15. ing. Nicola Volonterio – XIII Convegno Nazionale AIIC 15
Innovation is faster
than regulation.

16. ing. Nicola Volonterio – XIII Convegno Nazionale AIIC 16
EU legal framework
93/42 as amended by 07/47
• apps are medical devices only by virtue of the
intended purpose as described by the manufacturer
– who is the manifacturer of an app?
• apps might also be an accessory of a medical
device
• apps are considered to be an active medical device
– classification as in art. 9 and annex IX (see also
MedDev 2.4/1)

17. ing. Nicola Volonterio – XIII Convegno Nazionale AIIC 17
EU legal framework
MedDev 2.4/1 rev.9
• if Rule 9, 10 or 11 apply, then apps may be classified as Class
IIa or IIb; if none of these three rules apply, then by default
apps would be Class I under Rule 12

18. ing. Nicola Volonterio – XIII Convegno Nazionale AIIC 18
EU legal framework
MedDev 2.1/6
• app for general purposes when used in a healthcare setting are
not MD
• apps may run on different OS, the OS do not impact the
qualification criteria
• if the app does not perform an action on data, or performs an
action limited to storage, archival, communication, ‘simple
search’ or lossless compression it is not a MD. Altering the
representation of data for embellishment purposes does not
make the app a MD. In other cases, including where the app
alters the representation of data for a medical purpose, it could
be a medical device.

19. ing. Nicola Volonterio – XIII Convegno Nazionale AIIC 19
EU legal framework
MedDev 2.1/6

20. ing. Nicola Volonterio – XIII Convegno Nazionale AIIC 20
EU legal framework
eHealth Action Plan 2012-2020
• communication from the European Commission to the
European Parliament about barriers in eHealth
adoption
• the “Addressing Legal Issues” chapter make
reference to mHealth
– […] The rapid developments in this sector raise
questions about the applicability of the current
frameworks [...] This needs to be achieved without
over-regulating […] it is proposed that by 2014, the
Commission will adopt a Green Paper on mHealth
and health and wellbeing applications.

21. ing. Nicola Volonterio – XIII Convegno Nazionale AIIC 21
EU legal framework
Sweden stand alone medical software guidance
• Sweden Medical Products Agency released on January 2013 a
paper entitled “Medical Information Systems - Guidance for
qualification and classification of standalone software with a medical
purpose” to help understand MedDev 2.1/6
• paragraph 4.1.6 make reference to medical apps qualification
criteria:
– […] Cell phone apps shall also be CE marked if they are
considered to have a medical purpose according to the definition
of a medical device. […] If the purpose is to collect data for
diagnosis to influence the health of the individual who sends the
information, then the app has a medical purpose and shall be CE
marked. […] A cell phone or "smartphone" that the software is run
on, or through, however, is not a medical device unless it is
converted for an explicit medical purpose.

22. ing. Nicola Volonterio – XIII Convegno Nazionale AIIC 22
Apps and attachments on the
european market
• tool for calculating burn area percentages and prescribing
fluids using Parkland formula (first app to obtain CE marking, in
2012)
• neutral vendor system that collects and delivers patient's data
to mobile devices and apps to visualize them (CE marking in
2012 and FDA clearance in 2010)
• glucometers and apps from different vendors
• suite that includes blood pressure measure devices that
connects via Bluetooth to an iOS device and an app that
archive and visualize measured parameters and trend
(received CE mark in 2013 - glucometer and pulse oxymeter
presented at CES 2013)

23. ing. Nicola Volonterio – XIII Convegno Nazionale AIIC 23
USA legal framework
section 201(h) of the FD&C Act
medical device: an instrument, apparatus, implement, machine,
contrivance, implant, in vitro reagent, or other similar or related article,
including a component part, or accessory which is:
– recognized in the official National Formulary, or the United States
Pharmacopoeia, or any supplement to them,
– intended for use in the diagnosis of disease or other
conditions, or in the cure, mitigation, treatment, or
prevention of disease, in man or other animals, or
– intended to affect the structure or any function of the body of man
or other animals,
– and which does not achieve its primary intended purposes
through chemical action within or on the body of man or other
animals and which is not dependent upon being metabolized for
the achievement of any of its primary intended purposes

24. ing. Nicola Volonterio – XIII Convegno Nazionale AIIC 24
USA legal framework
21 CFR 860
Medical devices are classified into:
• class I devices, exempt from Premarket
Notification 510(k)
• class II devices, require Premarket Notification
510(k)
• class III devices, require Premarket Approval
(including clinical investigation)

25. ing. Nicola Volonterio – XIII Convegno Nazionale AIIC 25
USA legal framework
software regulation
• Draft Software Policy
– releasend in 1989
– general policy statement about computer-based and/or
software-based medical device regulation
– withdrawn after realizing it would be impractical to
address all of the issues related to software in a single
policy
• FDA has through classification has identified specific
regulatory requirements that apply to products that feature
one or more software components, parts, or accessories,
as well as devices that are composed solely of software

26. ing. Nicola Volonterio – XIII Convegno Nazionale AIIC 26
USA legal framework
Mobile Medical Application Draft Guidance
• released in 2011 to collect comments and suggestion
• a “mobile medical app” is a mobile app that meets the definition
of “device” in section 201(h) of the FD&C Act and either:
– is used as an accessory to a regulated medical device; or
– transforms a mobile platform into a regulated medical
device.
• the intended use of a mobile app determines whether it meets
the definition of a device
• entities that distribute medical apps are not manifacturers but
are expected to cooperate with them for corrections and
removals

27. ing. Nicola Volonterio – XIII Convegno Nazionale AIIC 27
USA legal framework
Mobile Medical Application Draft Guidance
MD not MD
displaying, storing, transmitting
datas in its original format
electronic version of medical
books
controlling connected medical
devices
wellness related
transforming mobile platform in a
regulated medical device
insurance related
interpretation of medical device
data (acessory of the main MD)
mobile EHRs
CASE BY CASE EVALUATION
medication lookup/logging/tracking,
patient education, organization of
personal health information

28. ing. Nicola Volonterio – XIII Convegno Nazionale AIIC 28
USA legal framework
Mobile Medical Application Draft Guidance
• in March 2013 the US House of
Representatives’ Energy and Commerce
Committee hosted a hearing focused mostly on
the FDA regulation of mobile medical apps
• FDA had prioritized final guidance for
publication by the end of this fiscal year
(October 2013)

29. ing. Nicola Volonterio – XIII Convegno Nazionale AIIC 29
USA
Happtique Health Certification Program
• Happtique (for-profit subsidiary of the Greater New York
Hospital Association) Health Certification Program intend to
help healthcare providers and consumers easily identify
medical, health and fitness apps that deliver credible content,
contain safeguards for user data and function as described.
• Happtique Certification Standards and associated Performance
Requirements (evaluated by internationally recognized third
party organizations) are designed to complement regulations
and guidelines of FDA but also raises the bar for a growing
segment of apps that are currently not subject to heightened
regulatory oversight

30. ing. Nicola Volonterio – XIII Convegno Nazionale AIIC 30
Apps and attachments on the
american market
• more than 80 apps have been cleared by FDA
• Mobile Medical Application Draft Guidance Appendix B lists
examples of regulated apps including and not limiting to:
– cardiac monitor
– endoscopic camera
– radiological images storage and visualization
– LED light source
– spyrometer
– fetal phonocardiographic monitor
– ultrasound imaging system

31. ing. Nicola Volonterio – XIII Convegno Nazionale AIIC 31
Conclusions
• an update of the legal framework is needed (EU can
“take inspiration” from the USA)
• actual risks
– not regulated apps on not regulated devices
(BYOD) used in hospital context
– security breach
• we need to accept “consumerization of MD”
– intended use/purpose is the discriminating factor

32. ing. Nicola Volonterio – XIII Convegno Nazionale AIIC 32
Thanks for
your attention

33. ing. Nicola Volonterio – XIII Convegno Nazionale AIIC 33
Resources
• http://ec.europa.eu/health/medical-devices/
• http://www.fda.gov/MedicalDevices/default.htm
• http://www.medicaldeviceslegal.com
• http://mobihealthnews.com/
• http://www.d4.org.uk
• http://www.happtique.com/
• http://www.mHIMMS.org
• http://mhealthregulatorycoalition.org/