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7/30/2019 mHIMSS Roadmap 5
http://slidepdf.com/reader/full/mhimss-roadmap-5 1/15
5-01mHIMSS Roadmap
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StandardS andInteroperabIlIty
5Standardsand Interoperability
ContentS
Role o Standards ���������������������������������������������������������������������������������������������������������������������5-02
Telecommunications Standards and Organizations ������������ ������������ ������������ ������������ ������������ ��������5-02
Wireless Health and mHealth Organizations ������������������������������������������������������������������������������5-08
Table o Engagement Opportuniti es or mHealth Standards ����������� ������������ ������������ ������������ ��������5-10
“At-a-Glance” Standards Overview �������������������������������������������������������������������������������������������5-11
Strategies and Recommendations ��������������������������������������������������������������������������������������������5-14
Authors ������������ ������������ ������������ ������������ ����������� ������������ ������������ ������������ ������������ ������������ ������������ ��5-14
Reerences �������������������������������������������������������������������������������������������������������������������������������5-14
7/30/2019 mHIMSS Roadmap 5
http://slidepdf.com/reader/full/mhimss-roadmap-5 2/15
5-02mHIMSS Roadmap
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seCurItylegal aNd PolICy
T e m p l e
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Role of Standards
Never in history has standards in health-
care been more important. “Health data
is doubling (volume) every 18 months”,
stated Tina Brown-Stevens at the 2012
StrataRX conerence in 20121. This exponential rate
o data growth is just one o the reasons standard are
needed to capture this deluge o data in healthcare.
Standards take on dierent roles in dierent area
o healthcare IT, however, interoperability standards
provide the cornerstone or building usable inter-
aces between disparate systems. Mobile systems and
devices are becoming more prevalent in Healthcare.
Nevertheless they are just starting to be recognized
by traditional standards committees (e.g., HL7) and
agencies (e.g., FDA, FCC, FTC). Non-proft organi-
zation, such as Continua Health Alliance, produces
development guidelines based on existing standards
that ocus on mobile health product certifcation.
Happtique, a startup or-proft company has been
working on mobile health App guidelines, their own
standards and accompanying App certifcation pro-gram. John Wilbanks reerence to caution o mo-
nopolies in standards; “We’re aced with this choice
right now, and the decisions we make will defne the
next twenty years o technology in health.”2
This section o the mHIMSS Roadmap illustrates
the current state o interoperability standards in
mobile health (aka, mHealth). Telehealth systems
and wireless devices (e.g., smartphone, tablets and
sensors) are used or remote monitoring and disease
management as an extension to traditional health-
care deliver. Remote-monitoring and patient-report-
ed data collection sensors and wireless devices that
are accessed within healthcare acilities and beyond
require standards and interoperability certiica-
tions. Hospital administrators need to consider the
standards options needed to support their current
systems and the uture growth.
Mobile Health IT (mHealth IT) an Overview
The Pew Internet Project reported that 40 percent o
American adults accesses the Internet via their mobile
phones, and in some cases, mobile phones are their
primary source o Internet access� Twenty-ve percent
o smart-phone owners go online primarily using their
phone; o these, roughly one-third have no high-speed
home broadband connection� Thereore, it is not
surprised that healthcare providers and hospitals would
want to move into this area and leverage the increase
usage o mobile devices to improve the delivery and cost
eectiveness o care�
As hospital admin istrators consider mobil ity or their
hospital environment they must rethink the workfow
and interaction with the patient beyond the hospital’s
walls� The Cloud inrastructure, which enables mobile
and extends the providers ability to utilize multiple
devices that capture patient data and store within
the EHR encounter all require standards� This section
provides a brie overview o many o the standards
available today and their role or dening communication
leading to interoperability�
mHh – a ri emgig G Mk3
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5-03mHIMSS Roadmap
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seCurItylegal aNd PolICy
T e m p l e
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T e
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See other examples o mHealth examples in
Issues in Technology Innovation rom mHIMSS�
The ollowing is a list o interchange between:
■ Mobile to mobile devices or visual output systems
(M2M - aka machine to machine),
■ Mobile to internal hospital system electronic medical
record (M2EMR),
■ Mobile to patient (M2Patient),
■ Mobile to Device (M2D)
■ Mobile to electronic health record (M2EHR),
■ Mobile to external health inormation
exchange (M2HIE)�
Challenges in Mobile Health4
■ Mobile Devices vs� Controlled/ Secure Network Environments
■ Limited Local Storage vs� Cloud Storage
■ All-in-one device vs� Bluetooth and
secondary computing
■ Tablet/Phone - GPS, Image, Audio,
Video and Text Capture
■ Scale, BP Cu,
■ No Dominant Platorm Form
Tool
■
Tablets■ Phones
■ Smartphones
■ Phablets
■ Other Devices
Operating System
■ IOS
■ Windows Mobile
■ Android
■ Blackberry
mHh ts i pcic
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5-04mHIMSS Roadmap
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ATIS
In 2011 ATIS Wireless Technologies and Systems
Committee (WTSC) ocused eorts in mobile healthcare�
The ATIS mHealth initiative ocuses primarily on protocols
and enhancements to wireless networks and the IP
Multimedia Subsystem (IMS) to securely transport
medical data, rather than dening the actual content o
the data that will be sent to health providers� As such,
ATIS plans to work closely with other groups, such as
Continua, Liecomm, GSMA and mHealth Alliance to
dene an end-to-end system or mHealth�
About the ATIS Wireless Technologies
and Systems Committee
The ATIS Wireless Technologies and Systems Committee(WTSC) develops and recommends standards related to
wireless and/or mobile services and systems, including
service descriptions and wireless technologies� WTSC
develops and recommends positions on related subjects
under consideration in other North American, regional
and international standards bodies� For more inormation,
please visit the WTSC website�
About ATIS
ATIS is the leading technical planning and standards
development organization committed to the rapid
development o global, market-driven standards or the
TelecommunicationsStandards and OrganizationsCurrently, telecommunication carriers are developing
new architectures and networks to improve wireless
broadband throughput� Presently, the carriers are using:
■ 3G (3rd Generation telecommunication) that meets
the International Mobile Telecommunications (IMT)
2000 technical standards/specications rom the
International Telecommunication Union, including
standards or reliability and speed (data transer rates)
– this includes wide-area wireless telephone, mobile
Internet access, video calls, and mobile television -
can provide peak data rates up to 56 Mbit/s in thedownlink in theory (28 Mbit/s in existing services) and
22 Mbit/s in the uplink�
■ 4G (4th Generation telecommunication) to allow
ultra-broadband Internet Services or devices with
USB wireless modems, IP telephone, high-denition
TV, video conerencing – use either the Long term
evolution (LTE) standard (Scandinavia 2009), IMT 2000
technical standards, IEEE 802�16m, or WirelessMAN-
Advanced�
■ Other next-gen wireless
The speeds and capability o wireless will continueto grow� International Mobile Telecommunications -
Advanced (IMT-Advanced) may be the next 5G with
speeds up to 10 times aster than 4G5
■ Telecommunications and managing costs:
http://www�temia�org/resources/view-webinars/205-
healthcare-and-telecom-expense-management-
nding-the-right-prescription-or-curing-chronic-costs
■ WBAN -Wireless Body Area Network
■ IEEE 802�11x (Wi-Fi) Connectivity Protocols
Programming Language
■ Objective C
■ C#
■ Java
■ HTML, CSS, JavaScript
■ Emerging Standards
HTML-5
*Source: Keith W� Boone, Standards Opportunities in
Mobile Health, Healthcare Interoperability: ‘ocus on SOA
and Modeling’, June 20, 2012
Telecommunications Connectivity Standards
and Health Information Exchange Standards:
■ FCC Broadband Plan –
■
Recommends substantial changes to the FCC’sRural Health Care Program, better utilizing
authorized unding o $400 M per year to help meet
these challenges�
■ Recommendations will help health care providers
purchase broadband services and expand the
program to more institutions�
■ Improve Indian Health Services broadband
inrastructure
■ Create the economic incentives or broader health IT
adoption and innovation
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5-05mHIMSS Roadmap
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seCurItylegal aNd PolICy
T e m p l e
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n s a r k
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inormation, entertainment and communications industry�
More than 200 companies actively ormulate standards
in ATIS’ Committees, covering issues including: IPTV,
Cloud Services, Energy Eciency, IP-Based and
Wireless Technologies, Quality o Service, Billing and
Operational Support, Emergency Services, Architectural
Platorms and Emerging Networks� In addition, numerous
Incubators, Focus and Exploratory Groups address
evolving industry priorities including Smart Grid, Machine-
to-Machine, Networked Car, IP Downloadable Security,
Policy Management and Network Optimization�
ATIS is the North American Organizational
Partner or the 3rd Generation Partnership Project
(3GPP), a member and major U�S� contributor to the
International Telecommunication Union (ITU) Radio and Telecommunications’ Sectors, and a member o the
Inter-American Telecommunication Commission (CITEL)�
ATIS is accredited by the American National Standards
Institute (ANSI)� For more inormation, please visit
www�atis�org�
Standards or mHealth components –
Telecommunications Area
Small components and electronics technology that
t into these small telecommunication devices must
meet certain standards so these tools don’t overheatand have enough power to run complicated healthcare
applications� Many standardization organizations,
including the In ternational Telecommunications Union
(ITU), work on various areas o eHealth� The eHealth
Standardization Coordination Group (eHSCG), supported
by ITU-T Study Group 16, maintains a list o standards in
both technical and non-technical areas o eHealth on the
World Health Organization web site�
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StandardS andInteroperabIlIty
than a common one but i the industry bodies can
negotiate a way or M2M devices to be device carrier
and network agnostic, there’s the lucrative prospect
o a massive acceleration in the development o things
untethered to a specic carrier, platorm or server� The
alternative is many internets, each with its own separate
sets o things and associated complexities or users� Not
an ideal standard�”6
Continua Health Alliance
Continua Health Alliance is a non-prot, open industry
coalition o healthcare and technology companies joining
together to improve the quality o personal healthcare�
With more than two hundred member companies around
the world, Continua is dedicated to establishing a systemo interoperable personal health solutions with the
knowledge that extending those solutions into the home,
osters independence, while empowers individuals and
provides the opportunity or truly personalized health and
wellness management�
The Continua Health Alliance’s Design Guidelines
contains reerences to the standards and specications
that Continua selected or ensuring interoperability
o devices� It also contains additional interoperability
design guidelines that urther clariy these standards
and specications by reducing options in the underlyingstandard or specication or by adding a eature missing
in the underlying standard or specication� Continuea’s
End-to-End (E2E) Reerence Architecture provides these
communications (July 2012)� There are now multiple
organization rom around the world working together on
this initiative�
M2M communications, known as the emerging
“Internet o things,” allows seamless communication
across any device anywhere in the world� With 50 billion
devices predicted to be connectable by 2020, M2M
is an economic engine driving growth and innovation
throughout a range o global industries, including health
care, security, transportation and utilities�
AS Telecommunications companies around the world
optimize their networks to meet industry needs or M2M
communications, there is A growing need or the ICT
industry to develop global standards that ensure devices
all over the world can eectively communicate with oneanother�
These leading ICT organizations are joining together
with other organizations and those representing specic
aspects o M2M applications to conront the critical
need or a common M2M Service Layer� Embedded
within various hardware and sotware, and relied upon
to connect the myriad o devices in the eld with M2M
application servers worldwide�
An example o the unctionality; “This common “service
layer” can be embedded in every M2M device, making it
compatible with M2M application servers hosted by anyglobal operator� This requires a business arrangement
with each carrier and also a common protocol� An
alliance, such as this one, can have multiple benets� It
could, or instance, solve Amazons’ predicament with
the Kindle� At present, the Kindle only has one home
network, AT&T, which means that i a user is in a country
not served by the company, download ees would apply�
However, i AT&T were to join the alliance (it’s also a
Jasper Wireless customer), download charges could be
waived� Ad-hoc standards currently seem more easible
Wireless and mHealth Standards &
Interoperability Organizations:
■ Continua Health Alliance■ Bluetooth SIG
■ ZigBee Alliance
■ Wi-Fi Alliance
■ DASH7 Alliance
■ IHE
■ Clinical Groupware Collaborative (CGC)
■ Healthcare Inormation and
Management Systems Society (HIMSS)
■ AAMI
■ IEEE
■
ISO■ NIST
■ HL7
■ W3C
■ NIH-(Bridge Model)
■ DICOM
■ CDISC
Specifc mHealth Activities o Standards
& Interoperability Organizations
Alliance for Telecommunications
Industry Solutions (ATIS)
ATIS is a collaboration o companies, accredited by
the American National Standards Institute (ANSI), who
set standards and solutions in the eld o Inormation
and Communication Technology (ICT)� A standard that
is relevant to the mHealth area is their virtual desktop
standard� ATIS along with the Telecommunication
Industry Association (TIA), and the European
Telecommunications Standards Institute (ETSI) launched
a global organization ocused on the advancement
and standardization o machine-to-machine (M2M)
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StandardS andInteroperabIlIty
are to publish Bluetooth specications, administer the
qualication program, protect the Bluetooth trademarks
and evangelize Bluetooth wireless technology�
ZigBee Alliance
The ZigBee Alliance is an association o companies
working together to enable reliable, cost-eective, low-
power, wirelessly networked, monitoring and control
products based on an open global standard� The goal
o the ZigBee Alliance is to provide the consumer with
ultimate fexibility, mobility, and ease o use by building
wireless intelligence and capabilities into everyday devices�
ZigBee technology will be embedded in a wide range o
products and applications across consumer, commercial,
industrial and government markets worldwide� For therst time, companies will have a standards-based wireless
platorm optimized or the unique needs o remote
monitoring and control applications, including simplicity,
reliability, low-cost and low-power�
Wi-Fi Alliance
The Wi-Fi Alliance is a global non-prot industry
association o hundreds o leading companies devoted to
the prolieration o Wi-Fi technology across devices and
market segments� With technology development, market
building, and regulatory programs, the Wi-Fi Alliance
has enabled widespread adoption o Wi-Fi worldwide�
The Wi-Fi CERTIFIED program was launched in March
2000� It provides a widely-recognized designation o
interoperability and quality, and it helps to ensure that Wi-
Fi enabled products deliver the best user experience� The
Wi-Fi Alliance has completed more than 8,000 product
certications to date, encouraging the expanded use
o Wi-Fi products and services in new and established
markets�
DASH7 Alliance
The DASH7 Alliance was ormed to advance the use
o DASH7 wireless data technology by developing
extensions the ISO 18000-7 standard, ensuring
interoperability among devices, and educating the
market about DASH7 technology� Formed in 2009, the
Alliance now has more than 20 members� Manuacturers,
systems integrators, developers, regulators, academia,
and end-users all work together to promote the use
o DASH7 technology in a wide array o industries and
applications� The DASH7 Alliance provides a ramework
or extensive application development, seamless
interoperability, and security or DASH7-enabled
transactions� Goals:
■ Develop improvements and extensions to the ISO
18000-7 standard
■ Work to ensure that products claiming DASH7
capabilities comply with DASH7 specications
■ Encourage the development o products using DASH7
technology
■ Educate consumers and enterprises globally about
DASH7 technology
guidelines ocusing on the ol lowing interaces:
■ PAN-IF - Interace to Personal Area Network
health devices
■ Both wired and wireless links (such as USB and
Bluetooth based technologies
■ ISO/IEE 11073-20601 Optimized Exhange Protocols
(data model)– utilizing guidance rom the ISO/IEEE
11073 Medical Device Communication working
group\
■ LAN-IF – Local Area Network Interace
■ xHRN-IF - Interace between Disease
Management Services (DMS)
■ WAN (Wide Area Network) devices (xHR Senders) and
■ Electronic Health Record (EHR) devices
(xHR Receivers)�“These guidelines were specically written or device
manuacturers that intend to go through the Continua
Certication process with their devices, companies that
integrate Continua devices in systems and subsystems,
and test labs that certiy compliance to Continua
specications”, states Continua 7� Members o Continua
may download the Version 2011 Design Guidelines,
Version 2010 Design Guidelines and Version One Design
Guidelines or ree�
Bluetooth SIG
The Bluetooth Special Interest Group (SIG) is a
privately held, not-or-prot trade association ounded
in September 1998� The Bluetooth SIG itsel does
not make, manuacture, or sell Bluetooth enabled
products� The SIG member companies are leaders in
the telecommunications, computing, automotive, music,
apparel, industrial automation, and network industries�
SIG members drive development o Bluetooth wireless
technology, and implement and market the technology
in their products� The main tasks or the Bluetooth SIG
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IHE Mobile Access to
Health Document (MHD) Paper in Review
Health Enterprise (IHE) International submitted a DratSupplement o the IHE IT In rastructure Prole entitled,
Mobile access to Health Documents (MHD) or public
comment on June 5, 2012� Comments were collected
through July 2012, to specically address the MHD
Prole� Some o the issues addressed in this prole are
the resource and platorm constraints, which lead to
employing less complicated network technologies�
“The Mobile access to Health Documents (MHD) prole
strives to dene one standardized interace to health
documents or use by mobile devices so that deployment
o mobile applications is more consistent and reusable� Inthis context, mobile devices include tablets and smart-
phones, and also include embedded devices like home-
health devices� This prole is also applicable in l arger
systems where the needs are simple, such as to pull the
latest summary or display on a secondary monitor,” the
drat says�8
Wireless Healthand mHealth Organizations Wireless-Life Sciences Alliance (WLSA)
The Wireless-Lie Sciences Alliance is an unparalleled
international think tank that puts CEOs rom the world’s
most innovative wireless health companies together with
global leaders in healthcare and technology, to accelerate
business opportunities�
European MHealth Alliance (EuMHA)
The European MHealth Alliance (EuMHA) is an initiative
to support and promote the wider adoption o healthcare
and wellbeing (including sports and tness) products,
services, applications and innovation across Europe�
EuMHA is a non-prot organization that will concentrate
on the economic development o the MHealth sector�
mHealth Alliance
The mHealth Alliance seeks to leverage the global
reach o wireless networks and mobile devices to
improve health outcomes in underserved communities
through co-development and deployment o innovative,
interoperable mobile health (mHealth) solutions�
mHealth Working Group
The mHealth Working Group is a collaborative orum
or sharing knowledge on mobile technology or health�
Founded in 2009 with global health organizations,
the group seeks to rame mobile technology within a
larger global health strategy� By applying public health
standards and practices to mHealth, the group promotes
approaches that are appropriate, evidence based,
interoperable and scalable in resource-poor settings�
Meetings are hosted by member organizations, recently
including USAID, the World Bank, MSH, PSI and FHI�
More than 150 organizations in over 20 countries
participate in mHealth Working Group�
mHealth Regulatory Coalition (MRC)
The mHealth Regulatory Coalition is a single issue,temporary organization ormed with the single objective
o bringing clarity to the mHealth industry as to what
aspects o the ecosystem, that the FDA intends to
regulate�
WestHealth
The Institute’s mission is to lower health care costs by
accelerating the availability o wireless mHealth solutions�
Founded in March 2009 by the Gary and Mary West
Foundation, the independent nonprot is dedicated to
innovating, validating, advocating or, investing in and
commercializing the use o wireless technologies to
transorm medicine�
UCLA Wireless Health Institute
The UCLA Wireless Health programs are dedicated
to improving the timeliness and reach o healthcare
by development and application o wireless network-
enabled technology solutions combining personal
communication devices, wireless wearable sensors, and
other technologies integrated with medical enterprise
computing� This program leverages clinical, academic,
and industry partnerships to rapidly translate innovative
wireless applications into validated health solutions�
Partnerships with industry have been created in eortsto bridge the well-recognized gap between available
wireless inormation technologies and their translation
into successul, widely adopted products and services�
Wireless Health applications range rom those in
health and wellness to rehabilitative care� In addition
to the primary benets o Wireless Health or new
health management and healthcare delivery methods,
this UCLA program also seeks to exploit technology
advantages to extend healthcare services to those who
otherwise have limited access today�
Center for Connected Health
The Center or Connected Health, a division o Partners
HealthCare in Boston, develops innovative and eective
solutions or delivering quality patient care outside o
the traditional medical setting� The Center engages
in pioneering research in a wide range o connected
health-related areas and works to advance the eld
through its convening and publishing activities� Their
programs use a combination o remote-monitoring,
online communications and intelligence, and technology
applications to improve patient adherence, engagement
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and clinical outcomes� Participants in our programs are
patients and providers at Partners-aliated practices and
hospitals throughout New England� Their programs are
also being oered by large sel-insured employers who
wish to help employees better manage their health, to
contain healthcare spending and to improve productivity
and satisaction�
Center for Wireless and Population
Health Systems at UCSD
(University of California, San Diego)
Their research ocuses on how the health o individuals,
amilies, communities, social networks, and populations
can be improved through the creative use o wireless
and networked technologies and ubiquitous computing� Their studies include how to promote health and prevent
disease and disability through systems-level interventions
in clinical and community settings�
Focused on Health issues addressed in recent research
have included pediatric and adult obesity and their co-
morbidities, depression, improving outcomes in cancer
survivors, successul aging, the use o games to promote
improved health behaviors, and the dynamics o health-
related states within social networks� Center research is
supported through public and private sources, including
the National Institutes o Health, the U�S� Centers or
Disease Control and Prevention, the National Science
Foundation, the Robert Wood Johnson Foundation, the
American Cancer Society, and Nokia Research�
European Connected
Health Campus (ECHCampus)
The European Connected Health Campus is a ‘not-or-
prot’ organization registered in Northern Ireland, as
a Community Interest Company (CIC NI 070344) and
supervised by the UK CIC Regulator� ECHCampus was
ounded by a team o independent business leaders,
who identied the need to enable innovation in this
extraordinary eld� It is thereore a timely response to
both societal and economic needs� Its primary mission is
to ‘deliver leadership or the development o Connected
Health markets and practice across Europe’�
The ECHCampus is ocused on:
■ The need to transorm Healthcare Delivery, thus
enhancing the quality and eectiveness o care�
■ The need to develop the ‘Connected Health
Economy’, thus enabling innovation and sustainable
investment in the expansion o healthcare�
WavefrontWaveront is a not-or-prot commercialization centre
accelerating the growth o Canada’s wireless and new
media companies� Waveront improves speed-to-
market and delivery o mobile applications and devices
by providing emerging companies with a suite o
WaveGuide™ training, mobile industry advisory services,
incubation oce space and testing resources� Waveront
also helps to acilitate commercial engagement
between the mobile ecosystem (mobile operators,
platorm providers, device manuacturers), enterprise
companies and the innovative developers in Canadaand Pacic Northwest� Mobile network operators value
Waveront as a neutral, independent entry point to
identiy and assess high potential mobile applications
or their particular market and business requirements�
Waveront is in terested in working with international
application providers that are looking to develop business
relationships in the North American market�
ITU
The International Telecommunications Union (ITU) is
a long-standing worldwide standards organization�
Their ocus is on interoperability and coordination via
standards� They support many o the standards mention
in this Roadmap such as HL7 and DICOM to name a
ew� ITU published their report on E-health Standards
and Interoperability in April,2012 There global initiative are
as ollows:
■ (x)DSL – Digital Subscriber Line
■ Digital Video Compression Standards
■ Digital Image Compression Standards
■ Inormation Security Standards
■ Quality o Service Standards
■ Voice over the Internet (VOIP)
epSOS: European Patients
Smart Open Services
epSOS is a emerging standard Initiative, composed o 47
members, 23 EU states� They ocus on building cross-
border Interoperability o EHRs and rameworks
GS1 Healthcare
GS1 global non-prot standards whose ocus to assist
companies in eciency o care delivery, saety and
supply chain�
Prerequisites:
1. Emphasizing Greater Interoperability
2. Increasing Coordination over e-heal Standardization
3. Ensuring Privacy, Security and Saety
4. Reducing the Standardization Gap in the Developing
World
5. Leveraging existing ICTs like Mobile Device and
Social Media
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Table of EngagementOpportunities formHealth StandardsUnderstand the Secret Sauce - http://projecthdata�org
HL7
■ New Mobile Health Working Group in HL7
■ Announced March 19, 2012
■ Charter In Development
■ Interim Leadership Elected May 22, 2012
■ http://www�hl7�org/Special/committees/mobile/
■ Fast Health Inormation Resources (FHIR)
■ HL7 FHIR 6/15/2012■ Granular concepts that can be composed to quickly
create and exchange inormation�
■ HL7 RIM-based
■ Simple, well-documented, standard
■ Covers 80% o use cases, with built-in extensibility
■ Exchanges constrained by proling
■ JSon and XML
■ JSon name/key are o CDA headers
■ Good t or mHealth
Documents for Mobile Health
■ IHE Prole Proposed last September
■ Two Use Cases:
■ Download Metadata & Documents
■ Upload o a Single Document
■ RESTul Protocol
■ Aligned with OMG/HL7 hData Eorts
■
JavaScript Object Notation (JSON)■ OAuth authentication
t eggm oiis mHh Ss9
ONC S&I Framework
■ RHEX Project Announced 6/7
■ Promoted as “Web 2�0 or Health”
■ See http://wiki�siramework�org/RHEx
■ Auto-Blue Button
■ Push and Pull documents
■ Pull is based on Direct Project
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“At-a-Glance”Standards OverviewEmerging Standards
Happtique is an emerging standard created to
benchmark apps developed with a robust interaction
with the healthcare environment� Happtique provides
both patient centric and developer ocused standards
to create a benchmark o authenticity and quality� This
helps patients and provider to manage healthcare app
away rom the noise o other non-healthcare Apps,
in June 2012 there were 650,000 Apps on the Apple
app store and 500,000 on Google Play� They currently
support three phone manuactures Operating Systems;
Blackberry, Android and iPhone� Because o Apple’s
regulations all Apps must be purchased via Apple’s
iTunes site�
Happtique plans to create a set o criteria by which
to judge health applications and build a standards
program around those criteria� These standards are
being developed to help consumers and doctors know
what apps to trust and help them lter the myriad o
available options� Once those standards are released,
developers may have to pay to get their apps certied
by Happtique� This is not a replacement or the
manuactures certication process, which will also have
to be completed by the developer� Happtique is a model
that is similar to the Wi-Fi Alliance certication process�
Source: http://gigaom�com/2012/01/11/happtique-aims-
to-build-a-standard-or-mobile-health-apps/
Standard Use Benefts Other Inormation
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IEC 80001-Risk Management
for Medical Devices
Risk management application or IT-networks
incorporating medical devices� The drat documentis available on the AAMI marketplace� “The goal o
IEC 80001 is to apply appropriate risk management
consistent with ISO 14971 to address the key properties
o saety, eectiveness, data and system security, and
interoperability�” -Sherman Eagles�
Getting Started with IEC 80001: Essential Information
for Healthcare Providers Managing Medical IT-Networks
- “The handbook is intended to take the ear out o
implementing this standard inside the hospital regardless
o the hospital size,” says Yadin David, director o
Biomedical Engineering Consultants in Houston, TX, oneo three co-authors o the handbook�
The handbook includes an overview o the standard,
how to start a pilot project, and how to identiy who in
an organization is responsible or complying with the
standard� – Source: http://www�aami�org/publications/
Books/80001-GS�html
HL7 Fast Healthcare Interoperability Resources
(FHIR - pronounced “FIRE”)
Designed to be web based, using XLM documents
or mHealth preerred, JSon, with an http-based
RESTul protocol with predictable URLs� This new
specication is aimed at making implementation o the
HL7 interoperability standards easier to implement and
compatible with mobile standards�
The next section, briefy describes a variety o eHealth
standardization initiatives including: DICOM, CEN/TC
251, HL7, ISO/TC 215, and ISO/IEEE 11073�
DICOM
Digital Imaging and Communications in Medicine
(DICOM) is a standard or exchanging medical images�
S&I Framework, ONC
The ONC’s S&I Framework initiative is an open
crowdsourcing collaborative to promote interoperability
or Meaningul Use� Example o current project are ound
on their wiki:
■ Automatic Blue Button (ABBI)
■ Certicate Interoperability (CI)
■ Data Segmentation or privacy
■ Health eDecision (HeD)
■ Transitions o Care (ToC)
■ Lab Results Interace (LRI)
■ Query Health
Existing Interoperability Standards
in mHealth & Wireless
ISO/IEEE 11073
ISO/IEEE 11073 Medical/Health Device Communication
Standards are a set o joint ISO, IEEE, and CEN
standards or medical device interoperability� In this
context, medical devices include primarily personnel, or
end user, health devices such as blood glucose monitors,
blood pressure monitors, thermometers, pulse oximeters,
etc�, that patients use in their own homes or other end
points to monitor existing medical conditions� The ISO/
IEEE 11073 (ormerly called IEEE 1073) standards denemessaging structures but not the transport layer upon
which messages are transmitted�
ISO 18000-7 standard
ISO 18000-7 standard, ensuring interoperability among
mobile devices�
More specically, it is a le ormat and transmission
standard or exchanging medical images and associated
inormation between medical imaging equipment made
by dierent manuacturers� The DICOM standardsare widely adopted in equipment and inormation
systems used in hospitals, imaging centers, and in
providers’ oces to produce, display, store, or exchange
medical images� The standard provides a number o
specications including:
■ Network protocols
■ Syntax and semantics o commands and associated
inormation
■ Media storage services, le ormats, medical
directory structure
There are twenty DICOM working groups, made upo technical and medical proessionals, which maintain
the various DICOM standards� The National Electrical
Manuacturers Association (NEMA) oversees and holds a
copyright to the DICOM standards, originally developed
by a joint committee ormed by NEMA and the American
College o Radiology�
CEN/TC 251
The Comité Européen de Normalisation or European
Committee or Standardization (CEN) is a standards
development organization made up o 31 nationalmembers developing pan-European standards� CEN has
a Health Inormatics Technical Committee (TC 251) which
coordinates the development o standards or Health�
According to its business plan and recent activities, the
ocus o CEN/TC 251 is primarily on technologies at the
content level rather than dealing with communication
technologies� CEN/TC 251 is urther broken down
into working groups such as Working Group IV, which
ocuses on the interoperability o data among devices
and inormation systems�
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HL7
Health Level Seven (HL7) is a standards development
organization, which issues international application-
layer healthcare standards or the electronic exchange
and management o health inormation such as clinical
data and administrative inormation� HL7 reers to the
standards organization itsel but is also commonly used
to reer to specic standards the institution develops�
HL7 dates back to the mid-1980s, when it was ormed
to develop a standard or hospital inormation systems�
Like other standards organizations, HL7 is organized
into Work Groups chaired by two or more co-chairs and
responsible or dening some area o HL7 standards� HL7
has dozens o Work Groups, including groups addressing
electronic health records, inrastructure and messaging,and imaging integration� To provide one example o an
HL7 specication, the HL7 Clinical Document Architecture
(CDA) serves as an XML-based markup standard dening
the structure, encoding parameters, and semantics o
electronic clinical documents�
HL7 partners with other institutions, such as the
International Organization or Standardization (ISO) in
issuing international eHealth standards, (ISO/HL7 217
31:2006 Health Inormatics-HL7 version 3-Reerence
Inormation Model)�
ISO/TC 215
ISO’s Technical Committee 215 addresses health
inormatics� ISO/TC 215 ocuses primarily on electronic
health records� Various Working Groups (WGs) within TC
215 address topics such as data structure, messaging
and communication, security, pharmacy and medication,
devices, and business requirements or electronic health
records� For example, ISO/TS 25237:2008 address
pseudonymization principles and requirements or privacy
protection o electronic health records�
Many o ISO’s standards are collaborations or
endorsements o standards developed by other standards
organizations such as HL7 or IEEE� For example, ISO/
HL7 27931:2009, Data Exchange Standards - HealthLevel Seven (HL7) Version 2�5 establishes an application
protocol or electronic data exchange in healthcare
environments� ISO Technical Committee 215, WG 8
(Business Requirements or Electronic Health Records)
provides guidance or identiying business requirements to
dene an eHealth enterprise�
FTC – How do others use
inormation rom mobile technology?
The Federal Trade Commission (FTC) recommends
the ollowing “Do Not Track” guidelines or mobiletechnology: 1) “privacy by design,” simpler and
streamlined privacy choices, and transparency as to
what demographic data or detailed inormation about
preerences can be captured o mobile devices that
leads to targeted marketing to dierent groups o
consumers, by previous choices made on the mobile
device or by location tracking GPS� In particular, the
FTC is concerned mostly about the high used o mobile
devices o young people and minors and is reviewing the
Children’s Online Privacy Protection (COPPA) Rule to see
i applies to some o the new mobile technologies�
Health and Human Services (HHS)
Health IT plays a key role in advancing policy priorities
that improve health and health care delivery� Priorities set
orth by HHS include the ollowing:1
■ Improving care quality, saety, eciency
and reducing disparities
1 Medicare and Medicaid Programs; Electronic Health Record Incentive
Program; Proposed Rule, 75 Fed� Reg� 1851 (Jan� 13, 2010)�
■ Engaging patients and amilies in managing
their health
■ Enhancing care coordination
■ Improving population and public health■ Ensuring adequate privacy and security o
health inormation
Federal Communications Commission (FCC)
The FCC controls the requency o radio transmitters
and receivers as in Cell phones, and RFID devices� They
do not play a di rect role in the classication o medical
device as that is the FDA responsibility; however they
do infuence the market and policies� They recently
published a public drat, “mHealth Task Force, Finding
and Recommendations, Improving care delivery throughenhanced communications”10
The report recommendations are organized within the
ollowing ve goals:
■ Goal 1: FCC should continue to play a leadership
role in advancing mobile health adoption�
■ Goal 2: Federal agencies should increase
collaboration to promote innovation, protect patient
saety, and avoid regulatory duplication�
■ Goal 3: The FCC should build on existing programs
and link programs when possible in order to expand
broadband access or healthcare�■ Goal 4: The FCC should continue eorts to increase
capacity, reliability, interoperability, and RF saety o
mHealth technologies�
■ Goal 5: Industry should support continued
investment, innovation, and job creation in the
growing mobile health sector�
7/30/2019 mHIMSS Roadmap 5
http://slidepdf.com/reader/full/mhimss-roadmap-5 14/15
5-14mHIMSS Roadmap
New Care Models roI PayMeNtteChNologyPrIvaCy aNd
seCurItylegal aNd PolICy
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StandardS andInteroperabIlIty
referenCeS
1 Tina Brown-Stevens� Keynote speaker, StrataRX conerence, San
Francisco, CA� October 2012�
2 John Wilbanks� (2012, October)� Choose Your Monopolies Wisely,
Keynote at StrataRX� San Francisco, CA�
3 Keith W� Boone, Standards Opportunities in Mobile Health, OMG
Healthcare Interoperability: Focus on SOA and Modeling, June 20,
2012
4 Source: Keith W� Boone, Standards Opportunities in Mobile Health,
OMG Healthcare Interoperability: ‘ocus on SOA and Modeling’, June
20, 2012
5 http://www�digitaltrends�com/mobile/is-5g-mobile-broadband-just-
around-the-corner-imt-advanced-explained/
6 How far are we from a unifying standard for the Internet of Things?
Adriana Hamacher, ICT Knowledge Transer Network, July 18, 2012,�
7 Continua Alliance� Guidelines 2011� Available http://www�
continuaalliance�org/products/design-guidelines�html
8 IHE IT Inrastructure� Technical Framework Supplement 10, Mobile
access to Health Documents (MHD)� Available: http://www�ihe�net/
Technical_Framework/upload/IHE_ITI_Suppl_MHD_Rev1-0_PC_2012-06-05�pd
9 *Source: Keith W� Boone, Standards Opportunities in Mobile Health,
OMG Healthcare Interoperability: ‘ocus on SOA and Modeling’, June
20, 2012
10 mHealth Task Force, Finding and Recommendations� FCC� 9/24/2012�
Avail @ https://s3�amazonaws�com/www2�iti�org/2012-mhealth-
taskorce-recommendations�pd �
autHorS & ContrIbutorS
■ Je Brandt Principle
ComSi
■ Charles Jae, MD, PhDCEO
HL7
■ Chuck Parker Executive Director
Continua Health Alliance
Staff lIaISonS
■ James St. Clair Director
HIMSS
■ Mary Ellen Johnson Manager
HIMSS
■ Thomas Martin, MBA Manager
mHIMSS
Strategies andRecommendations
The uture o Interoperability and standards is wide
open and will be changing quickly� As more health
data becomes digitize, technology will play an even
more signicant role in healthcare� Interoperability
becomes more important as the source o data points
increase� Patient-reported data will play a signicant
role in the production o “Big Data”� Sensors, Apps,
home monitoring devices, cars and many soon to be
discovered technologies will produce an onslaught
o patient-reported data� These devices must be
interoperable with EHRs, PHRs and HIEs�
Mobile shall play a signicant role in patient-centric
healthcare and standards organizations are changing to
accommodate the transition� HL7 recently announced a
lightweight protocol, FHIR that is more compatible with
the needs o mobile� A keynote speaker at StrataRX in
San Francisco, 2012 mentioned that we should consider
using open standards such as “iCalendar” which
currently interaces with most calendar programs on the
Web instead o HL7 ADT messages� The S&I ABBI (Auto
Blue Button) utilizes SMTP the Internet email sending
protocol to deliver patient record via the Direct Project�
The point, standards and priorities are changing and we
must keep abreast o these movements�
7/30/2019 mHIMSS Roadmap 5
http://slidepdf.com/reader/full/mhimss-roadmap-5 15/15
5-15mHIMSS Roadmap
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seCurItylegal aNd PolICy
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P a r k
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W a
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StandardS andInteroperabIlIty
referenCeS
http://www�atis�org/about/
http://www�hospitalmanagement�net/eatures/eaturemobile-medicine-top-
remote-healthcare-innovations/?WT�mc_id=WN_Feat
http://www�crn�com/news/applications-os/231500365/
cover-story-the-mobile-technology-revolution�htm?pgno=1
https://www�wirelesshealthstrategies�com/organizations�html
http://www�tc�gov/opa/2011/05/mobiletestimony�shtm
http://www�pewinternet�org/
http://www�k4health�org/toolkits/mhealth/mhealth-working-group-0
The mHealth Toolkit, http://www�k4health�org/toolkits/mhealth
ITU E-health Standards and Interoperability: http://www�itu�int/dms_pub/
itu-t/oth/23/01/T23010000170001PDFE�pd (April 2012)
http://www�omg�org/news/meetings/tc/ma-12/special-events/Healthcare_
Inormation_Day�htm
mHealtH reSourCeS
on tHe teCHWeb dIGItal lIbrary
Gvm: Cloud/SaaS, Mobile & Wireless
Hw: Handhelds/PDAs, Grid/Cluster Computing Hhc: Mobile & Wireless
Isc: Remote Access, VPNs,
I: B2B, B2C, Browsers, E-Business/E-Commerce, E-retail,
Google, Web Development, Internet Security, Search, Social Networks,
Trac Reporting/Monitoring, Web 2�0, Internet Policy
Mii : WLAN, Wireless Security, Wi-Fi/WiMax, Wi-Fi VOIP,
Smartphones, 3G Wireless/Broadband, Muni Wireless, Mobile
Messaging, Mobile Business, Fixed Mobile Convergence,
802�11x, RFID
ps tch: Blackberry, Bluetooth, Bluray, Digital Cameras,
Digital Music, Digital Rights Management, Virtual worlds, iPhone,
iPod, Peripherals, Smartphones, TVs/Home Theater, Global
Positioning Systems
Sci : Encryption, Perimeter Security, Vulnerabilities and Threats,
Intrusion Prevention
Svics: Telecom/Voice ServicesSw: Web Services
Sg: Data protection, Removable/Portable Storage, Security,
tcm: VOIP, Unied Communications, Voice services, PBXs,
Internet policy, Presence, Collaboration Systems, Business,
Regulation, Call Centers
oh i pivc & Sci : BYOD Security -Virtualization
like a Citrix Receiver: http://www�citrix�com/English/ps2/products/
subeature�asp?contentID=2300390 – TEMIA
170.314(b)(7) Test Tool Supplement: Data portability ONC�
http://www�healthit�gov/sites/deault/les/standards-certication/2014-
edition-drat-test-procedures/170-314-b-7-data-portability-test-tool-
supplement-v-2�pd
Copyright © 2012
Healthcare Inormation and Management Systems Society (HIMSS)
The inclusion o an organization name, product or service in this document
should not be construed as a HIMSS endorsement o such organization,
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product or service to be construed as disapproval�
For more inormation: www.mhimss.org