ISO/TR 17522:2015

Health informatics — Provisions for health applications on mobile/smart devices

ISO/TR 17522:2015 is applicable to the developments of smart health applications available anywhere, anytime and supporting new health businesses based on the smart devices. This Technical Report is to investigate the areas of ongoing developments and analyses of emerging interoperability standards for smart mobile devices.

Informatique de santé — Provisions pour les applications de santé sur les dispositifs smart/mobiles

General Information

• Status: Published
• Publication Date: 03-Aug-2015
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: ISO/TC 215 - Health informatics
• Drafting Committee: ISO/TC 215/WG 2 - Systems and Device Interoperability
• Current Stage: 6060 - International Standard published
• Completion Date: 04-Aug-2015

Standards Content (Sample)

TECHNICAL ISO/TR
REPORT 17522
First edition
2015-08-01
Health informatics — Provisions for
health applications on mobile/smart
devices
Informatique de santé — Provisions pour les applications de santé sur
les dispositifs smart/mobiles
Reference number
ISO/TR 17522:2015(E)
©
ISO 2015

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ISO/TR 17522:2015(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2015, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
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ISO/TR 17522:2015(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Symbols and abbreviated terms . 3
5 Mobile health applications based on Registry and Repository (Reg/Rep) .5
5.1 Transportation of emergency patient . 6
5.2 Manage medication . 7
5.3 Telehealth . 7
5.4 Referenced Standards . 7
6 Mobile health applications in a health provider . 8
6.1 Mobile electronic medical record system . 8
6.2 Scheduling medical examination . 8
6.3 Manage chronic diseases patient . 9
6.4 Nursing home . 9
6.5 Mobile PACS architecture . 9
6.6 Veterans personal electronic health record .10
7 Mobile medical application .10
7.1 Mobile application for the purpose of processing patient medical device data .11
7.2 Mobile application to function as a medical device .11
8 Analysis of required architectures for mHealth .12
8.1 IHE MHD .12
8.2 Mobile EMR .12
8.3 Mobile Medical Application .13
Bibliography .16
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ISO/TR 17522:2015(E)

Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 215, Health informatics.
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Introduction
Development and implementation of smart devices are rapidly progressing around world. An appropriate
deployment of smart health applications and services on smart device platforms will enhance various
aspects of healthcare delivery. Smart devices will also enable health organizations to provide essential
care and health information anytime, anywhere through information and telecommunications
technologies. This includes a broad spectrum of capabilities including health sensors, devices, manager,
server, health information systems, and call centre services of patient information.
Recent development of smart devices such as smart phone, TV, and electronic book where the patients’
services are stored and distributed securely whenever necessary (sharing EHR information at point of
care) requires a robust architecture to be able to manage the mobile data effectively.
This Technical Report describes the status and requirements of health applications and services on
smart devices platforms and suggests the reference architecture for these. The report is not intended
to be prescriptive either from a methodological or technological perspective.
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TECHNICAL REPORT ISO/TR 17522:2015(E)
Health informatics — Provisions for health applications on
mobile/smart devices
1 Scope
This Technical Report is applicable to the developments of smart health applications available
anywhere, anytime and supporting new health businesses based on the smart devices. This Technical
Report is to investigate the areas of ongoing developments and analyses of emerging interoperability
standards for smart mobile devices.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
There are no normative references.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
accelerometer
device that measures proper acceleration
3.2
access
provision of an opportunity to approach, inspect, review, make use of data, or information
3.3
android
open source operating system for mobile devices developed by a group of organizations led by Google
3.4
application
software program or set of related programs that provide some useful healthcare capability or
functionality
3.5
Apple iOS
previously iPhone OS
mobile operating system developed by Apple Inc. and distributed exclusively for Apple hardware
Note 1 to entry: It is the operating system (3.12) that powers iPhone, iPad, iPod Touch, and Apple TV.
3.6
BlackBerry
line of wireless handheld devices and services (3.20) designed and marketed by BlackBerry Limited,
formerly known as Research In Motion Limited
3.7
bluetooth
standard for sending information wirelessly over short distances
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3.8
healthcare professional
person entrusted with the direct or indirect provision of defined healthcare services to a subject of
care or population of subjects of care
3.9
electronic health record
health record with data structured and represented in a manner suited to computer calculation
and presentation
3.10
medical device
instrument, apparatus, implant, in vitro reagent, or similar or related article that is used to diagnose,
prevent, or treat disease or other conditions and does not achieve its purposes through chemical action
within or on the body
3.11
metadata
“data about data”
Note 1 to entry: The term is ambiguous, as it is used for two fundamentally different concepts.
3.12
operating system
set of programs that provide basic operating functions for hardware devices
EXAMPLE Starting up the device and running other software applications.
3.13
out-of-the-box functions
used to describe the functions of a device that run when you first buy it and start it up without the need
to purchase or install any additional software or hardware
3.14
patient
individual person that is a subject of care
3.15
personal health record
may have contributions from providers of healthcare and the person or their carer/s
Note 1 to entry: The legal rules for a health record still apply to this record.
3.16
picture archiving and communication system
PACS
application system that uses an image server to exchange X-rays, CT scans, and other medical images
over a network
3.17
registry
collection of all the official records relating to something or the place where they are kept
3.18
repository
place where something is kept safely
3.19
security
combination of confidentiality, integrity, and availability
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3.20
service
specific behaviour that a communication party in a specific role is responsible for exhibiting
3.21
smartphone
additional features usually include media player and the ability to run mobile apps
Note 1 to entry: There is no single fixed definition of a smartphone.
3.22
standard
technical specification which addresses a business requirement, has been implemented in
viable commercial products, and, to the extent practical, complies with recognized standards
organizations such as ISO
3.23
tablet computer
mobile computer based around a flat touchscreen operated by finger or stylus
3.24
Windows phone
Windows mobile
proprietary smartphone operating system developed by Microsoft
3.25
data carrier
all-encompassing term covering the different encoding modalities for machine readable data applied to
the product packaging or directly to the product
Note 1 to entry: The possibilities include barcodes both 1 and 2 dimensions and radio frequency identification
tags. It is critical to standards based mobile applications that the data is represented in symbol using ISO based
standards such as GS1 and industry adopted guidelines.
3.26
vital sign
clinical information relating to one or more patients (3.14) that is measured by or derived from
apparatus connected to the patient, or otherwise gathered from the patient
3.27
healthcare provider
healthcare organization or healthcare professional (3.8) responsible for the provision of healthcare to a
subject of care or to a population
4 Symbols and abbreviated terms
AAC Augmentative and Alternative Communication: Communication methods such
as use of signs, symbols, or software tools to help people who have problems
with the use of speech or written language to express themselves and
communicate
API Application Programming Interface: An interface that allows one piece of
software to interact with another allowing developers to add new functions on
top of existing software
BECS Blood Establishment Computer Software
CDA Clinical Document Architecture
DOC Document query
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ebXML Electronic Business Extensible Markup Language
ECG Electrocardiogram
ECG/EKG Electrocardiography is the recording of the electrical activity of the heart
EHR Electronic Health Record
FDA Food and Drug Administration
FHIR Fast Healthcare Interoperability Resources
GS1 General Specifications and Standards
HL7 Health Level 7
HIE Health Information Exchange
HTTP Hypertext Transfer Protocol
IHE Integrating the Healthcare Enterprise
ISO International Organization for Standardization
JSON JavaScript Object Notation
[38]
MHD Mobile Access to Health Documents
OASIS Organization for the Advancement of Structured Information Standards
OS Operating System
PACS Picture Archiving and Communication System
PCD Patient Care Device
PDQ Patient Demographics Query
PHR Personal Health Record
[37]
PIX Patient Identifier Cross Referencing
PMA Premarket Approval
QPB Query by Parameter/Segment Pattern Response
QRY Query, original mode
RHEx RESTful Health Exchange
RIM Reference Information Model
RS Registry Service
RSP Segment Pattern Response
RTB Tabular Response
SDK Software Development Kit: A set of software tools that enable a developer to
create applications for a specific operating system or other software environment
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WAI Web Accessibility Initiative: A project of workstream of the W3C (see below)
that develops guidelines and techniques to make the web more accessible.
Website: www.w3.org/WAI
W3C World Wide Web Consortium: An open, collaborative international community
of technology organizations, academic bodies, and others which creates and
maintains the web’s core technical standards. Website: www.w3.org
XDS Cross Enterprise Document Sharing
[36]
XDW Cross-Enterprise Document Workflow
XML Extensible Markup Language
5 Mobile health applications based on Registry and Repository (Reg/Rep)
The mobile access to health documents (MHD) profile
a) defines a simple HTTP interface to an XDS like environment, and
b) defines transactions to
1) submit a new document and metadata from the mobile device to a document receiver,
2) get the metadata for an identified document,
3) find document entries containing metadata based on query parameters, and
4) retrieve a copy of a specific document.
The above four transactions leverage the document content and format agnostic metadata concepts
from XDS, but simplify them for access by constrained environments such as mobile devices. The MHD
profile does not replace XDS. It can be used to allow mobile devices constrained access to an XDS health
information exchange.
Figure 1 shows one possible way to implement the MHD with a document sharing environment (that
may, but is not necessarily, XDS based).
NOTE From Reference [38], Figure 1.
Figure 1 — Mobile access to a document sharing environment
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The MHD profile supports a broad set of the XDS use cases and functionality while keeping the
technology as simple as possible.
— Medical devices such as those targeted by the Patient Care Devices (PCD) domain or Continua
organization submitting data and documents.
— Kiosk used by patient in hospital registration departments where it is anticipated that a hospital staff
member will review, edit, and approve the document before it is allowed into the hospital system.
— PHR publishing into a staging area for subsequent import into an EHR or HIE.
— Patient or provider application that is configured to securely connect to a PHR in order to submit. a
medical history document.
— Electronic measurement device participating in an XDW workflow and pulling medical history
documents from an HIE.
— A general practitioner physician’s office with minimal IT capabilities using a mobile application to
connect to an HIE or EHR.
— MHD has defined simple HTTP RESTful transactions using the Document Entry metadata as the
object acted upon. Metadata is described in JSON format.
Figure 2 shows the actors directly involved in the MHD Profile and the relevant transactions
between them.
Document Source
Document Consumer
Get Document Dossier [ITI-66]
Put Document Dossier [ITI-65]
Find Document Dossiers [ITI-67]
Get Document [ITI-68]
Document Recipient Document Responder
NOTE From Reference [38], Figure 33.1-1.
Figure 2 — MHD actor diagram
5.1 Transportation of emergency patient
— Paramedic looks for hospitals in the emergency hospital list displayed on the device where the
patient can be accepted.
— The paramedic sends the patient information using the device to the selected hospital.
— During transportation, the paramedic takes pictures and/or videos of patient and sends them to the
hospital, as well as the patient’s vital signs.
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— The clinician at the hospital observes the data from the ambulance and gives directions and advice
to the paramedic.
5.2 Manage medication
— Patient reads/scans the data carrier of the medicine and stores the identity of the drug and other
associated data into the medication list in the device. Open standards such as GS1 enable globally
interoperable solutions.
— When the patient goes to a new clinic, the clinician checks the medication list to avoid contraindication.
5.3 Telehealth
— When the healthcare provider communicates with the informal healthcare provider through a voice
or computer link, there is no face-to-face contact.
— Informal healthcare provider can provide medical images or bio-signals.
— In tele-dermatology, an image of the skin is the main information exchanged.
— When an informal healthcare provider provides information at a distance, the accredited healthcare
provider is available to provide a medical opinion or advice concerning medical images or bio-signals.
5.4 Referenced Standards
Table 1 — Referenced standards of mobile health applications based on Reg/Rep
Contents Standards
RESTful interface —   IHE MHD(mobile access to healthcare document)
definition profile
—   IHE XDS.b (cross enterprise document sharing)
Document sharing
profile
—   IHE ITI Technical Framework Supplement -
Identity Patient Identifier Cross-Reference(PIX)/Patient
Demographic Query (PDQ) HL7 v3
—   JSON
—   HL7(Health Level 7) V2 Messaging
—   ISO/HL 727932:2009
Data Exchange Standards — HL7 Clinical Document
Architecture, Release 2
Communication —   ISO/TR 16056-1
Health informatics — Interoperability of telehealth
systems and networks — Part 1: Introduction and
definitions
—   ISO/TR 16056-2
Health informatics — Interoperability of telehealth
systems and networks — Part 2: Real-time systems
—   SNOMED-CT
Code —   ICD-10
—   GS1
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Table 1 (continued)
Contents Standards
—   ISO/IEC 27001
Information technology — Security techniques —
Information security management systems —
Requirements
—   ISO/TR 27809
Security
Health informatics — Measures for ensuring patient
safety of health software
—   ISO 27789:2013
Health informatics — Audit trails for electronic health
records
6 Mobile health applications in a health provider
This Clause describes mobile health applications which are utilized for healthcare providers. The use of
mobile health applications in healthcare facilities is increasing, so this subclause will explain about it.
6.1 Mobile electronic medical record system
— Figure 3 is the representative model of mobile health applications in a health provider. It is for
mobile electronic medical record.
— We can manage patient information, vital signs, medication information, laboratory result, and
nursing records using smart device.
— If we request required information, mobile server convert to HL7 request message (QRY, QPB) and
then it request to healthcare system.
— The healthcare provider converts from request information to HL7 response message (RSP, RTB,
DOC) and return to mobile server. Mobile server converts to JSON format that is easy and light to use
in smart device.
— RESTful health exchange (RHEx) technology can be used to make health information exchange
simple, secure, and standards-based.
HL7 Interface
HTTP
GET/PUY
HL7
HL7 Data msg
HL7 msg
Mobile
HIS/
Smart
Conversion
Processor
EMR/
Server/
to JSON
Devices
EHR
HL7 msg
Gateway
JSON
CDA
CDA Parser HL7 msg
Generator
+ CDA
Figure 3 — Mobile electronic medical record system
6.2 Scheduling medical examination
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— Patient makes a reservation medical examination using the smart device (medical appointment).
— The clinician checks the schedule using the smart device.
— The patient checks, changes, and cancels reservation.
6.3 Manage chronic diseases patient
— Patient with chronic diseases measures the vital values such as weight, blood pressure, blood
sugar level, etc.
— The patient inputs and mails them to the clinician through the device.
— The clinician checks the measurements and mail back clinical comment and/or advice to the patient.
6.4 Nursing home
— Nurses share the schedule of visiting patient’s home.
— Nurses share the nursing reports of the patients.
— Nurse adds the new nursing report when visiting the patient.
— Nurse asks the doctor an advice by transmitting the images and/or movies of the patient.
— Nurses write and send the nursing summary monthly to the doctors.
6.5 Mobile PACS architecture
Figure 4 — Mobile PACS architecture
— Figure 4 shows the Mobile PACS Architecture. It is the system that supports and allows doctors
to better treat patients. The PACS system converts from medical image to digital type and send
to physician.
— Mobile PACS certification process is performed in a couple of countries such as United States of
America and Republic of Korea.
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— US FDA has responsibility for 510(k) premarket notification and its medical device certification
process. Medical devices are classified into three levels (Class I, II, and III) and different
regulatory level.
— Class I and class II medical device have to obey the 510(k) (premarket notification). Class II medical
device has to obey PMA (premarket approval).
— Mobile PACS is class II medical device and it is certified 510(k) by the FDA.
— Regulation number “892.2050” means PACS.
— Mobile PACS can be used for disaster. It should include the use case that the mobile PACS might be
applied in the case of disaster, big earthquake, typhoon, or tornado.
— The big earthquake: Many medical facilities were destroyed.
— They lost medical records of their patients.
— They do not have the way to take pictures of patients and to get a diagnosis either.
— We have mobile modalities, but there are few radiologists who can read MRI/CT images.
— If images stored at a safe area were accessed remotely, doctors could read images on their
mobile devices wherever they are.
6.6 Veterans personal electronic health record
— My HealtheVet allows veterans to self-enter their personal health indicators (blood pressure,
weight, heart rate), emergency contact information, test results, family health history, military
health history, and other health related information.
— My HealtheVet users who receive VA health care services can also refill their prescriptions and view
their appointments, allergies, and laboratory results online.
— The Blue Button feature allows veterans to access and download their information into a very simple
text file or PDF that can be read, printed, or saved on any computer.
— The download can include all their data or be broken out by data class or by date range.
— Blue Button gives veterans complete control of this information without any special software and
enables veterans to share this data with their health care providers, caregivers, or people they trust.
7 Mobile medical application
— “Mobile Medical Application” is a mobile application that meets the definition of “device” in section
201(h) of the federal food, drug, and cosmetic act (FD&C Act) and either of the following:
— used as an accessory to a regulated medical device;
— transforms a mobile platform into a regulated medical device.
— The intended use of a mobile application determines whether it meets the definition of a “device”.
— When the intended use of a mobile application is for the diagnosis of disease or other conditions (or
the cure) mitigation, treatment, or prevention of disease.
— When a mobile application is intended to affect the structure or any function of the body of man (the
mobile app is a device).
— In South Korea, a guideline for the safety and management of mobile medical application is developed
based on the guidance of US FDA.
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Personal Health Devices
Smart Devices
Figure 5 — Mobile medical app
7.1 Mobile application for the purpose of processing patient medical device data
— Mobile medical applications that are extensions of regulated medical device for the purpose of
displaying, storing, analyzing, or transmitting patient-specific medical device data.
— Applications that connect to a home use diagnostic medical device such as a blood pressure
meter, body composition analyzer, or blood glucose meter to collect historical data or to receive,
transmit, store, analyze, and display measurements from connected devices.
— Applications that analyze, assess, or interpret electrocardiogram or electroencephalogram data.
— Applications that connect the mobile platform to vital signs monitors, bedside monitors,
cardiacmonitors, or other similar devices.
— Applications that are used as patient screening tools for blood transfusion (extension of blood
establishment computer software (BECS) or other biologics.
7.2 Mobile application to function as a medical device
— If a mobile application is intended for use in performing a medical device function, it is a medical
device regardless of the platform on which it is run.
— Mobile applications intended to run on smart phones to analyze glucose meter readings would
be considered similar to software running on a desktop computer which is regulated under 21
CFR 862.1345 (“g
...