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Aplicaciones Móviles (Apps) de Salud: Normativas, Evidencia e Iniciativas Propuestas

Máster de La Salle. Universitat Ramon Llull
by

Miguel Angel Mayer

on 19 March 2016

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Transcript of Aplicaciones Móviles (Apps) de Salud: Normativas, Evidencia e Iniciativas Propuestas

¿Evidencia...?
Miguel Angel Mayer
Research Programme on Biomedical Informatics (GRIB)
Hospital del Mar Medical Research Institute (IMIM)
Universitat Pompeu Fabra (UPF)
@mmayerp
Aplicaciones Móviles (Apps) en salud:
Normativa, Uso y Evidencia

Features of Mobile Diabetes Applications: Review
of the Literature and Analysis of Current Applications
Compared Against Evidence-Based Guidelines
J Med Internet Res 2011
Dr. Google
Dra. Apps
Dr. Facebook
Dr. Twitter
Vida Saludable
Gestión de citas, búsqueda consultas y médicos
Seguimiento
y control de enfermedades crónicas
Diagnóstico y DgD
Screening
Prevención
BD biomédicas
Farmacología,...
Evaluación de Apps de Salud

Barcelona, 19 de marzo 2016
iPhone Apps for Smoking Cessation: a content analysis
Am J Prev Med 2011
Las organizaciones sanitarias y los profesionales
deben asegurarse de que les apps que utilizan:
- están basadas en la
evidencia científica
,
- son
fiables, seguras y actualizadas
,
- pueden
integrarse
en el sistema asistencial,
- tengan el
conocimiento
adecuado para su uso.
Propuestas actuales
"Reliance on these applications, which are not subject to regulatory oversight, in lieu of medical consultation can delay the diagnosis of melanoma and harm users."
Diagnostic Inaccuracy of Smartphone Applications for Melanoma Detection
JAMA Dermatol 2013
"Apps identified for smoking cessation were found to have low levels of adherence to key guidelines"
Mobile Phone Applications for the Care and Prevention of HIV and Other Sexually Transmitted Diseases: A Review
J Med Internet Res 2013
"Most available HIV/STD apps have failed to attract user attention and positive reviews
"
Apps de salud
Usuarios
Seguridad
Evaluación
Investigación
Las Apps de Salud constituyen una gran oportunidad
aportando mejoras en la salud y el bienestar de las personas
Todavía disponemos de poco conocimiento sobre la eficacia, idoneidad y riesgos asociados a su utilización
Clasificación de las Apps según:
- a quién va dirigida (pacientes, profesionales, público general)
- objetivo o función (información, promoción salud, diagnóstico)
- entorno de uso (clínico-asistencial, general)
Es importante valorar a quién, cómo y dónde pueden ser utilizadas las Apps de Salud
Su desarrollo debe basarse en Estándares de diseño, en Evidencia científica, Seguridad y requerimientos legales, así como en la
Participación Coordinada de todos los actores necesarios
Es recomendable establecer procesos y propuestas que faciliten la selección de Apps de Salud de calidad y la
Creación de Sitios Web específicos para su selección y acceso
Es fundamental:
- Promover la investigación,
- Garantizar la integración e interoperabilidad en los sistemas de salud y
- Protocolizar su uso en las instituciones sanitarias
Apps de Salud
43.689 (23.682) apps de salud en US AppleStore (octubre 2013)
50% de apps tienen menos de 500 descargas y son irrelevantes

50% son gratuitas

La gran mayoría son healthy living apps

15% del total de descargas corresponden a 5 aplicaciones (2015: shows that just 36 apps account for nearly half of all downloads, while 40% of apps have fewer than 5,000 downloads)
Fuente: IMS Institute for Health Care Informatics. Informe en:
Normativas
por Miguel Angel Mayer y Angela Leis
¿Qué aspectos deberíamos tener en cuenta al diseñar y distribuir una app en el mercado?
¿Cómo puedo confiar en una app?
¿Cuál es el uso que puedo realizar profesionalmente? y ¿en mi organización? ¿Requerimientos legales y deontológicos?
No están definidos del todo los medios para conocer si una app es segura y adecuada o no

Los verdaderos criterios para elaborar muchas apps no parecen cubrir necesidades o utilidades reales
Diferentes instituciones y personas disponen de la capacidad para desarrollar apps y cada institución puede cubrir simplemente sus necesidades
En realidad dónde nos encontramos...
Pero...

¿Cuándo las Apps son
dispositivos médicos?
Producto sanitario:

Cualquier instrumento, dispositivo, equipo, programa informático, material u otro artículo, utilizado solo o en combinación, incluido los programas informáticos destinados por su fabricante con finalidades específicas de diagnósticos y/o terapias y que intervengan en su buen funcionamiento, destinados por los fabricantes con finalidad de...
Dispositivos médicos

1) diagnóstico, prevención, control, tratamiento o alivio de una enfermedad
2) diagnóstico, control, tratamiento, alivio o compensación de una lesión o de una deficiencia
3) investigación, situación o modificación de la anatomía o de un proceso fisiológico
4) regulación de la concepción y que no ejerza la acción principal que se
desee obtener en el interior o en la superficie del cuerpo humano por medios farmacológicos, inmunológicos ni metabólicos pero a cuya función puedan contribuir estos medios
(Real Decreto 1591/2009 y
European Medical Device Directive 2012/0266 del 26/09/2012)
Apps
Riesgos jurídicos de las Apps de Salud
Fuente: Eloi Font y Ramon Cifuentes (abogados)
a) Propiedad intelectual
Derechos de propiedad intelectual, Registro de propiedad intelectual, contrato de licencia de uso
b) Comercio electrónico
Términos y servicios de la plataforma de venta, condiciones generales de contratación (LSSICE)
c) Protección de datos personales
Datos de salud sensibles, transferencia datos internacionales
d) Branding
Marca cormercial: oficina Patentes y Marcas, Oficina Armonización del Mercado Intenerior (CE), Oficina Mundial de Propiedad Intelectual
e) Normativa sectorial y producto sanitario
No regulación específica de apps de salud, producto sanitario, marca CE
Key points and existing guidance

Stand-alone software
Software which has a medical purpose which at the time of it being placed onto the market is not incorporated into a medical device.

Intended purpose
Regulation of medical devices is limited by the intended purpose as defined by the manufacturer. This will include claims given in promotional materials for the device, eg brochures and webpages.

Medical purpose
Software that has a medical purpose could be a medical device. A medical device is defined in the medical device Directive (MDD) as:
“software… intended by the manufacturer to be used for human beings for the purpose of:
diagnosis, prevention, monitoring, treatment or alleviation of disease,
diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
investigation, replacement or modification of the anatomy or of a physiological process,
control of conception….”
The other directive where this guidance is applicable is the active implantable medical device directive.

Systems
There is no definition of a system in the directive but there are specific requirements for products placed on the market that combine CE marked devices and non-CE marked products, eg a combination of laptop (not a medical device), software (a medical device) and heart monitoring hardware (an accessory) is considered to be a ‘system’ if these are placed on the market together.
Guidance on medical device
stand-alone software
(including apps)
Guidance on medical device
stand-alone software
(including apps)
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

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.
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
Types of apps:
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.
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 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.
VIEWPOINT
In search of a Few Good Apps
JAMA May 14, 2014;311(18)
Usabilidad
Algunos Criterios para evaluar Apps
MD
No MD
A Lot of Action, But Not in the Right Direction: Systematic Review and Content Analysis of Smartphone Applications for the Prevention, Detection, and Management of Cancer

J Med Internet Res 2013
"There is a lack of evidence on their utility, effectiveness, and safety. Future efforts should focus on improving and consolidating the evidence base into a whitelist for public consumption"
"While a wide selection of mobile applications seems to be available for people with diabetes, this study shows there are obvious gaps between the evidence-based recommendations and the functionality used in study interventions or found in online markets"
https://novoed.com/mhealth/reports/52109
Evidence Based mHealth (EBmH)
by Seleen Ong, MA Mayer, Florencia Rolandi et al.

Fuente: MA Mayer y Angela Leis, 2014
Fuente: MHRA. Regulating Medicines and Medical Devices
...
Mayer MA, Sánchez-Laguna FJ, Leis A, Rodriguez-Blanco O.
más información: http://www.linkedin.com/in/mmayerp
Regulación
Seguridad (Safety)
Privacidad y confidencialidad
Calidad
Aspectos esenciales relativos a la regulación y uso de las Apps de Salud
Apps de Salut
Apps promoting illicit drugs - a need
for tighter regulation?
J Consum Health Internet 2014
The content of the identified apps contained organised information, teaching techniques and simulations with explicit advocacy for illicit drug use. The number of pro-illicit drug use apps identified in this study (410)
Mobile Application Rating Scale (MARS)
Soluciones propuestas
Regulación, Uso y Evidencia
https://developer.imshealth.com/Content/pdf/IIHI_Patient_Apps_Report.pdf
Respondents also
suggested
that:

EU and national actions should ensure
interoperability
of mHealth solutions with
Electronic Health Records
(EHRs) for continuity of care and for research purposes.
Greater emphasis should be put on actions to promote
open standards
and the use of the common open architecture or open Application Programming Interfaces.
Health professionals, care-givers and users should be actively involved in
co-designing mHealth solutions.

https://ec.europa.eu/digital-single-market/en/news/new-eu-working-group-aims-draft-guidelines-improve-mhealth-apps-data-quality
http://myhealthapps.net/
http://www.calidadappsalud.com/
http://www.nlm.nih.gov/mobile/
http://mobihealthnews.com/28165/happtique-suspends-mobile-health-app-certification-program/
Suspendido el programa
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf
http://apps.nhs.uk/
http://www.d4.org.uk/research/
Imagen de http://blog.kulikulifoods.com/2014/12/16/top-3-health-apps-new-year-new/
mHealth in Europe: consultation results published, January 2015
AppScript™ is the leading discovery and distribution platform for mobile health technologies. Improve patient satisfaction by prescribing mobile health apps, connected devices and content.
IMS INSTITUTE
for Healthcare Informatics
September 2015
Patient Adoption of mHealth
165.000 apps (iTunes and Google Play)
Prescribing Apps
The relevant EU legal framework is the
Data Protection Directive (95/46/EC)
. It applies in any case where the use of apps on smart devices involves processing personal data of
individuals.

Additionally to the Data Protection Directive, the
ePrivacy directive (2002/58/EC, as revised by 2009/136/EC)
, sets a specific standard for all parties worldwide that wish to store or accessinformation stored in the devices of users in the European Economic Area.

ARTICLE 29 DATA PROTECTION
Working Party
Many types of data stored on or generated by a smart device are personal data. According to Recital 24 of the ePrivacy directive:

"Terminal equipment of users of electronic communications networks and any information stored on such equipment are part of the private sphere of the users requiring protection under the European Convention for the Protection of Human Rights and Fundamental Freedoms."
Examples of such personal data that can have a significant impact on the private lives of the users and other individuals are:
- Location
- Contacts
- Unique device and customer identifiers (such as IMEI, IMSI, UDID and mobile phone number)
- Identity of the data subject
- Identity of the phone (i.e. name of the phone)
- Credit card and payment data
- Phone call logs, SMS or instant messaging
- Browsing history
- Email
- Information society service authentication credentials (especially services with social features)
- Pictures and videos
- Biometrics (eg facial recognition, fingerprint templates)
http://ec.europa.eu/justice/data-protection/article-29/documentation/opinion-recommendation/files/2013/wp202_en.pdf
EU
Smartphone technology
particularly impacts on health policy via two new challenges:

(1) smartphone app stores can act as mass global media channels to augment or undermine public health efforts and

(2) smartphone apps are portals to a multitude of health
interventions with unprecedented proximity to health consumers.


Nasser F BinDhim, Trevena L. Health-related smartphone apps: regulations, safety, privacy and quality. BMJ Innov 2015;0:1-3.
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