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Apps and Smartphone Attachment as Medical Device
Apps and Smartphone Attachment as Medical Device
Apps and Smartphone Attachment as Medical Device
Apps and Smartphone Attachment as Medical Device
Apps and Smartphone Attachment as Medical Device
Apps and Smartphone Attachment as Medical Device
Apps and Smartphone Attachment as Medical Device
Apps and Smartphone Attachment as Medical Device
Apps and Smartphone Attachment as Medical Device
Apps and Smartphone Attachment as Medical Device
Apps and Smartphone Attachment as Medical Device
Apps and Smartphone Attachment as Medical Device
Apps and Smartphone Attachment as Medical Device
Apps and Smartphone Attachment as Medical Device
Apps and Smartphone Attachment as Medical Device
Apps and Smartphone Attachment as Medical Device
Apps and Smartphone Attachment as Medical Device
Apps and Smartphone Attachment as Medical Device
Apps and Smartphone Attachment as Medical Device
Apps and Smartphone Attachment as Medical Device
Apps and Smartphone Attachment as Medical Device
Apps and Smartphone Attachment as Medical Device
Apps and Smartphone Attachment as Medical Device
Apps and Smartphone Attachment as Medical Device
Apps and Smartphone Attachment as Medical Device
Apps and Smartphone Attachment as Medical Device
Apps and Smartphone Attachment as Medical Device
Apps and Smartphone Attachment as Medical Device
Apps and Smartphone Attachment as Medical Device
Apps and Smartphone Attachment as Medical Device
Apps and Smartphone Attachment as Medical Device
Apps and Smartphone Attachment as Medical Device
Apps and Smartphone Attachment as Medical Device
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Apps and Smartphone Attachment as Medical Device

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Presentation for the Italian Association of Clinical Engineer Meeting - 2013

Presentation for the Italian Association of Clinical Engineer Meeting - 2013

Published in: Healthcare, Health & Medicine
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  • 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/

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