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Standards and Interoperability


ContentS
Role of Standards 5-02 Telecommunications Standards and Organizations5-02 Wireless Health and mHealth Organizations 5-08 Table of Engagement Opportunities for mHealth Standards 5-10 At-a-Glance Standards Overview 5-11 Strategies and Recommendations 5-14 Authors5-14 References 5-14

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Role of Standards
ever in history has standards in health-

mHealth a rapidly emerging Global Market 3


Medical app revenues to grow 25% annually global mobile health market worth $8B by 2018 the global wireless health market is forecasted to reach $38.51 billion by 2016 global revenue for mhealth apps in 2012 at $1.3B 44M health app downloads in 2012 13K iPhone consumer health apps in 2012 MobihealthNews June 14, 2012 MobihealthNews april 16, 2012 Fast Market research april 13, 2012

care been more important. Health data is doubling (volume) every 18 months, stated Tina Brown-Stevens at the 2012
1

StrataRX conference in 2012 . This exponential rate

of data growth is just one of the reasons standard are needed to capture this deluge of data in healthcare. Standards take on different roles in different area of healthcare IT, however, interoperability standards provide the cornerstone for building usable interfaces 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-profit organization, such as Continua Health Alliance, produces development guidelines based on existing standards that focus on mobile health product certification. Happtique, a startup for-profit company has been working on mobile health App guidelines, their own standards and accompanying App certification program. John Wilbanks reference to caution of monopolies in standards; Were faced with this choice right now, and the decisions we make will define the next twenty years of technology in health. 2 This section of the mHIMSS Roadmap illustrates the current state of interoperability standards in mobile health (aka, mHealth). Telehealth systems and wireless devices (e.g., smartphone, tablets and

research2guidance January 25, 2012 MobihealthNews November 30, 2011 MobihealthNews september 22, 2011

sensors) are used for remote monitoring and disease management as an extension to traditional healthcare deliver. Remote-monitoring and patient-reported data collection sensors and wireless devices that are accessed within healthcare facilities and beyond require standards and interoperability certifications. Hospital administrators need to consider the standards options needed to support their current systems and the future growth.
Mobile Health IT (mHealth IT) an Overview The Pew Internet Project reported that 40 percent of American adults accesses the Internet via their mobile phones, and in some cases, mobile phones are their primary source of Internet access Twenty-five percent of smart-phone owners go online primarily using their phone; of these, roughly one-third have no high-speed

home broadband connection Therefore, it is not surprised that healthcare providers and hospitals would want to move into this area and leverage the increase usage of mobile devices to improve the delivery and cost effectiveness of care As hospital administrators consider mobility for their hospital environment they must rethink the workflow and interaction with the patient beyond the hospitals walls The Cloud infrastructure, 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 brief overview of many of the standards available today and their role for defining communication leading to interoperability

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See other examples of mHealth examples in Issues in Technology Innovation from mHIMSS The following is a list of 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 information exchange (M2HIE)

mHealth tools in practice


mHealth Example Pocket-sized mobile phone ultrasound scanners telemedicine possibilities via satellite Motion sensor tele-rehabilitation Business Continuation North america Benchmark Fda approved october 2011

europe

utilized by european space agency remote monitoring of patient recovery in spain In connection with mental and behavioral health Consultations being conducted in the united Kingdom Photographs of the digestive track being used in Japan data being updated on-site during in-home visits in england In 2011 images display at the patient beside urban physicians provide advice to rural clinics in India

europe

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 Cuff, No Dominant Platform Form

smart phone apps to track emotional well-being for those with depression Conference call stroke diagnosis and Ct scan Cameras embedded into pill caplets

North america

europe

asia

Tool

Tablets Phones Smartphones Phablets Other Devices

tablets for community care nurses and therapists Mobile X-rays

europe

North america

Operating System

video connection

asia

IOS Windows Mobile Android Blackberry

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Programming Language Objective C C# Java HTML, CSS, JavaScript Emerging Standards HTML-5 *Source: Keith W Boone, Standards Opportunities in Mobile Health, Healthcare Interoperability: focus on SOA and Modeling, June 20, 2012

Telecommunications Standards and Organizations


Currently, 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/specifications from the International Telecommunication Union, including standards for reliability and speed (data transfer 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 the downlink 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 for devices with USB wireless modems, IP telephone, high-definition TV, video conferencing use either the Long term evolution (LTE) standard (Scandinavia 2009), IMT 2000 technical standards, IEEE 80216m, or WirelessMANAdvanced Other next-gen wireless The speeds and capability of wireless will continue to grow International Mobile Telecommunications Advanced (IMT-Advanced) may be the next 5G with speeds up to 10 times faster than 4G5 Telecommunications and managing costs: http://wwwtemiaorg/resources/view-webinars/205healthcare-and-telecom-expense-managementfinding-the-right-prescription-for-curing-chronic-costs WBAN -Wireless Body Area Network IEEE 80211x (Wi-Fi) Connectivity Protocols

ATIS In 2011 ATIS Wireless Technologies and Systems Committee (WTSC) focused efforts in mobile healthcare The ATIS mHealth initiative focuses primarily on protocols and enhancements to wireless networks and the IP Multimedia Subsystem (IMS) to securely transport medical data, rather than defining the actual content of the data that will be sent to health providers As such, ATIS plans to work closely with other groups, such as Continua, Lifecomm, GSMA and mHealth Alliance to define an end-to-end system for 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 information, please visit the WTSC website About ATIS ATIS is the leading technical planning and standards development organization committed to the rapid development of global, market-driven standards for the

Telecommunications Connectivity Standards and Health Information Exchange Standards:

FCC Broadband Plan Recommends substantial changes to the FCCs Rural Health Care Program, better utilizing authorized funding of $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 infrastructure Create the economic incentives for broader health IT adoption and innovation

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information, entertainment and communications industry More than 200 companies actively formulate standards in ATIS Committees, covering issues including: IPTV, Cloud Services, Energy Efficiency, IP-Based and Wireless Technologies, Quality of Service, Billing and Operational Support, Emergency Services, Architectural Platforms and Emerging Networks In addition, numerous Incubators, Focus and Exploratory Groups address evolving industry priorities including Smart Grid, Machineto-Machine, Networked Car, IP Downloadable Security, Policy Management and Network Optimization ATIS is the North American Organizational Partner for the 3rd Generation Partnership Project (3GPP), a member and major US contributor to the International Telecommunication Union (ITU) Radio and Telecommunications Sectors, and a member of the Inter-American Telecommunication Commission (CITEL) ATIS is accredited by the American National Standards Institute (ANSI) For more information, please visit wwwatisorg

Wireless Standards and technology


Name Bluetooth Use short-range wireless standard, connection rate 3sec, xfer 1mbit/s wireless device connectivity + security Frequency spread-spectrum 2.4 ghz 2.4 ghz Regulatory/Standards Bluetooth special Interest group (sIg) wI-FI aliance based on Ieee 802.11 standards ZigBee alliance based on 802.15

wI-FI, wlaN

ZigBee

wireless device connectivity + security, automation, low data rate, less power consumption, quick connection 30Mbps, xfer 250Mbps In-patient, body sensor network, body-worn or implanted sensors, which transmit patient information to a nearby control device, which in turn transmits a signal to the remote monitoring and evaluation site device Communication, low power 1avg as low as 7.5ua .5hz Mr=2.99 years, Compact, secure 128 bit aes encryption wireless sensors

2.4 ghz

MBaNMedical Body area Network

2360 to 2400 Mh

FCC

Standards for mHealth components Telecommunications Area


Small components and electronics technology that fit into these small telecommunication devices must meet certain standards so these tools dont overheat and have enough power to run complicated healthcare applications Many standardization organizations, including the International Telecommunications Union (ITU), work on various areas of eHealth The eHealth Standardization Coordination Group (eHSCG), supported by ITU-T Study Group 16, maintains a list of standards in both technical and non-technical areas of eHealth on the World Health Organization web site

aNt+

2.4 ghz

short range

dash7 alliance

sub 1 ghz radio

low-power long rage

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Wireless and mHealth Standards & Interoperability Organizations:


Continua Health Alliance Bluetooth SIG ZigBee Alliance Wi-Fi Alliance DASH7 Alliance IHE Clinical Groupware Collaborative (CGC) Healthcare Information and Management Systems Society (HIMSS) AAMI IEEE ISO NIST HL7 W3C NIH-(Bridge Model) DICOM CDISC

Specific mHealth Activities of Standards & Interoperability Organizations


Alliance for Telecommunications Industry Solutions (ATIS) ATIS is a collaboration of companies, accredited by the American National Standards Institute (ANSI), who set standards and solutions in the field of Information 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 focused on the advancement and standardization of machine-to-machine (M2M)
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communications (July 2012) There are now multiple organization from around the world working together on this initiative M2M communications, known as the emerging Internet of 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 of global industries, including health care, security, transportation and utilities AS Telecommunications companies around the world optimize their networks to meet industry needs for M2M communications, there is A growing need for the ICT industry to develop global standards that ensure devices all over the world can effectively communicate with one another These leading ICT organizations are joining together with other organizations and those representing specific aspects of M2M applications to confront the critical need for a common M2M Service Layer Embedded within various hardware and software, and relied upon to connect the myriad of devices in the field with M2M application servers worldwide An example of the functionality; This common service layer can be embedded in every M2M device, making it compatible with M2M application servers hosted by any global operator This requires a business arrangement with each carrier and also a common protocol An alliance, such as this one, can have multiple benefits It could, for instance, solve Amazons predicament with the Kindle At present, the Kindle only has one home network, AT&T, which means that if a user is in a country not served by the company, download fees would apply However, if AT&T were to join the alliance (its also a Jasper Wireless customer), download charges could be waived Ad-hoc standards currently seem more feasible

than a common one but if the industry bodies can negotiate a way for M2M devices to be device carrier and network agnostic, theres the lucrative prospect of a massive acceleration in the development of things untethered to a specific carrier, platform or server The alternative is many internets, each with its own separate sets of things and associated complexities for users Not an ideal standard6 Continua Health Alliance Continua Health Alliance is a non-profit, open industry coalition of healthcare and technology companies joining together to improve the quality of personal healthcare With more than two hundred member companies around the world, Continua is dedicated to establishing a system of interoperable personal health solutions with the knowledge that extending those solutions into the home, fosters independence, while empowers individuals and provides the opportunity for truly personalized health and wellness management The Continua Health Alliances Design Guidelines contains references to the standards and specifications that Continua selected for ensuring interoperability of devices It also contains additional interoperability design guidelines that further clarify these standards and specifications by reducing options in the underlying standard or specification or by adding a feature missing in the underlying standard or specification Continueas End-to-End (E2E) Reference Architecture provides these

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guidelines focusing on the following interfaces: PAN-IF - Interface 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 from the ISO/IEEE 11073 Medical Device Communication working group\ LAN-IF Local Area Network Interface xHRN-IF - Interface between Disease Management Services (DMS) WAN (Wide Area Network) devices (xHR Senders) and Electronic Health Record (EHR) devices (xHR Receivers) These guidelines were specifically written for device manufacturers that intend to go through the Continua Certification process with their devices, companies that integrate Continua devices in systems and subsystems, and test labs that certify compliance to Continua specifications, states Continua 7 Members of Continua may download the Version 2011 Design Guidelines, Version 2010 Design Guidelines and Version One Design Guidelines for free

are to publish Bluetooth specifications, administer the qualification program, protect the Bluetooth trademarks and evangelize Bluetooth wireless technology ZigBee Alliance The ZigBee Alliance is an association of companies working together to enable reliable, cost-effective, lowpower, wirelessly networked, monitoring and control products based on an open global standard The goal of the ZigBee Alliance is to provide the consumer with ultimate flexibility, mobility, and ease of use by building wireless intelligence and capabilities into everyday devices ZigBee technology will be embedded in a wide range of products and applications across consumer, commercial, industrial and government markets worldwide For the first time, companies will have a standards-based wireless platform optimized for the unique needs of remote monitoring and control applications, including simplicity, reliability, low-cost and low-power Wi-Fi Alliance The Wi-Fi Alliance is a global non-profit industry association of hundreds of leading companies devoted to the proliferation of Wi-Fi technology across devices and market segments With technology development, market building, and regulatory programs, the Wi-Fi Alliance has enabled widespread adoption of Wi-Fi worldwide The Wi-Fi CERTIFIED program was launched in March 2000 It provides a widely-recognized designation of interoperability and quality, and it helps to ensure that WiFi enabled products deliver the best user experience The Wi-Fi Alliance has completed more than 8,000 product certifications to date, encouraging the expanded use of Wi-Fi products and services in new and established markets

DASH7 Alliance The DASH7 Alliance was formed to advance the use of 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 Manufacturers, systems integrators, developers, regulators, academia, and end-users all work together to promote the use of DASH7 technology in a wide array of industries and applications The DASH7 Alliance provides a framework for extensive application development, seamless interoperability, and security for 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 specifications Encourage the development of products using DASH7 technology Educate consumers and enterprises globally about DASH7 technology

Bluetooth SIG The Bluetooth Special Interest Group (SIG) is a privately held, not-for-profit trade association founded in September 1998 The Bluetooth SIG itself does not make, manufacture, 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 of Bluetooth wireless technology, and implement and market the technology in their products The main tasks for the Bluetooth SIG

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IHE Mobile Access to Health Document (MHD) Paper in Review


Health Enterprise (IHE) International submitted a Draft Supplement of the IHE IT Infrastructure Profile entitled, Mobile access to Health Documents (MHD) for public comment on June 5, 2012 Comments were collected through July 2012, to specifically address the MHD Profile Some of the issues addressed in this profile are the resource and platform constraints, which lead to employing less complicated network technologies The Mobile access to Health Documents (MHD) profile strives to define one standardized interface to health documents for use by mobile devices so that deployment of mobile applications is more consistent and reusable In this context, mobile devices include tablets and smartphones, and also include embedded devices like homehealth devices This profile is also applicable in larger systems where the needs are simple, such as to pull the latest summary for display on a secondary monitor, the draft says8

services, applications and innovation across Europe EuMHA is a non-profit organization that will concentrate on the economic development of the MHealth sector mHealth Alliance The mHealth Alliance seeks to leverage the global reach of wireless networks and mobile devices to improve health outcomes in underserved communities through co-development and deployment of innovative, interoperable mobile health (mHealth) solutions mHealth Working Group The mHealth Working Group is a collaborative forum for sharing knowledge on mobile technology for health Founded in 2009 with global health organizations, the group seeks to frame 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 formed with the single objective of bringing clarity to the mHealth industry as to what aspects of the ecosystem, that the FDA intends to regulate WestHealth The Institutes mission is to lower health care costs by accelerating the availability of wireless mHealth solutions Founded in March 2009 by the Gary and Mary West Foundation, the independent nonprofit is dedicated to

innovating, validating, advocating for, investing in and commercializing the use of wireless technologies to transform medicine UCLA Wireless Health Institute The UCLA Wireless Health programs are dedicated to improving the timeliness and reach of healthcare by development and application of wireless networkenabled 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 efforts to bridge the well-recognized gap between available wireless information technologies and their translation into successful, widely adopted products and services Wireless Health applications range from those in health and wellness to rehabilitative care In addition to the primary benefits of Wireless Health for 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 for Connected Health, a division of Partners HealthCare in Boston, develops innovative and effective solutions for delivering quality patient care outside of the traditional medical setting The Center engages in pioneering research in a wide range of connected health-related areas and works to advance the field through its convening and publishing activities Their programs use a combination of remote-monitoring, online communications and intelligence, and technology applications to improve patient adherence, engagement

Wireless Health and mHealth Organizations


Wireless-Life Sciences Alliance (WLSA) The Wireless-Life Sciences Alliance is an unparalleled international think tank that puts CEOs from the worlds 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 of healthcare and wellbeing (including sports and fitness) products,
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and clinical outcomes Participants in our programs are patients and providers at Partners-affiliated practices and hospitals throughout New England Their programs are also being offered by large self-insured employers who wish to help employees better manage their health, to contain healthcare spending and to improve productivity and satisfaction Center for Wireless and Population Health Systems at UCSD (University of California, San Diego) Their research focuses on how the health of individuals, families, communities, social networks, and populations can be improved through the creative use of 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 comorbidities, depression, improving outcomes in cancer survivors, successful aging, the use of games to promote improved health behaviors, and the dynamics of healthrelated states within social networks Center research is supported through public and private sources, including the National Institutes of Health, the US Centers for 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-forprofit organization registered in Northern Ireland, as a Community Interest Company (CIC NI 070344) and

supervised by the UK CIC Regulator ECHCampus was founded by a team of independent business leaders, who identified the need to enable innovation in this extraordinary field It is therefore a timely response to both societal and economic needs Its primary mission is to deliver leadership for the development of Connected Health markets and practice across Europe The ECHCampus is focused on: The need to transform Healthcare Delivery, thus enhancing the quality and effectiveness of care The need to develop the Connected Health Economy, thus enabling innovation and sustainable investment in the expansion of healthcare Wavefront Wavefront is a not-for-profit commercialization centre accelerating the growth of Canadas wireless and new media companies Wavefront improves speed-tomarket and delivery of mobile applications and devices by providing emerging companies with a suite of WaveGuide training, mobile industry advisory services, incubation office space and testing resources Wavefront also helps to facilitate commercial engagement between the mobile ecosystem (mobile operators, platform providers, device manufacturers), enterprise companies and the innovative developers in Canada and Pacific Northwest Mobile network operators value Wavefront as a neutral, independent entry point to identify and assess high potential mobile applications for their particular market and business requirements Wavefront is interested 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 focus is on interoperability and coordination via standards They support many of the standards mention in this Roadmap such as HL7 and DICOM to name a few ITU published their report on E-health Standards and Interoperability in April,2012 There global initiative are as follows: (x)DSL Digital Subscriber Line Digital Video Compression Standards Digital Image Compression Standards Information Security Standards Quality of Service Standards Voice over the Internet (VOIP) epSOS: European Patients Smart Open Services epSOS is a emerging standard Initiative, composed of 47 members, 23 EU states They focus on building crossborder Interoperability of EHRs and frameworks GS1 Healthcare GS1 global non-profit standards whose focus to assist companies in efficiency of care delivery, safety and supply chain Prerequisites: 1. Emphasizing Greater Interoperability 2. Increasing Coordination over e-heal Standardization 3. Ensuring Privacy, Security and Safety 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 Engagement Opportunities for mHealth Standards


Understand the Secret Sauce - http://projecthdataorg HL7

table of engagement opportunities for mHealth Standards9


Opportunity Ihe mhealth Profile Dates of Importance Comments accepted through July 5, 2012 Website references http://bit.ly/Ihemhealth http://healthcaresecprivacy.blogspot.com/ 2012/06/ihe-iti-mhealth-profile-publiccomment.html http://www.hl7.org/special/committees/mobile

New Mobile Health Working Group in HL7 Announced March 19, 2012 Charter In Development Interim Leadership Elected May 22, 2012 http://wwwhl7org/Special/committees/mobile/ Fast Health Information Resources (FHIR) HL7 FHIR 6/15/2012 Granular concepts that can be composed to quickly create and exchange information HL7 RIM-based Simple, well-documented, standard Covers 80% of use cases, with built-in extensibility Exchanges constrained by profiling JSon and XML JSon name/key are of CDA headers Good fit for mHealth

hl7 Mobile health workgroup review hl7 efforts on FhIr oNC hreX Project

Meets weekly on Fridays 3-4 et

released June 2012 Kickoff meeting June 21, 2012

http://www.hl7.org/fhir http://wiki.siframework.org/rhex

Documents for Mobile Health

ONC S&I Framework

IHE Profile Proposed last September Two Use Cases: Download Metadata & Documents Upload of a Single Document RESTful Protocol Aligned with OMG/HL7 hData Efforts JavaScript Object Notation (JSON) OAuth authentication

RHEX Project Announced 6/7 Promoted as Web 20 for Health See http://wikisiframeworkorg/RHEx Auto-Blue Button Push and Pull documents Pull is based on Direct Project

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At-a-Glance Standards Overview


Emerging 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 focused standards to create a benchmark of authenticity and quality This helps patients and provider to manage healthcare app away from the noise of 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 manufactures Operating Systems; Blackberry, Android and iPhone Because of Apples regulations all Apps must be purchased via Apples iTunes site Happtique plans to create a set of 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 filter the myriad of available options Once those standards are released, developers may have to pay to get their apps certified by Happtique This is not a replacement for the manufactures certification process, which will also have to be completed by the developer Happtique is a model that is similar to the Wi-Fi Alliance certification process Source: http://gigaomcom/2012/01/11/happtique-aimsto-build-a-standard-for-mobile-health-apps/

at-a-Glance Standards overview


Standard hl7 Cda rel. 2 Use Interoperability hIe, ehr, exchange protocol for patient health records exchange protocol for patient health records Interoperability hIe, ehr, Patient management system Mobile, web, exchange protocol for patient health records Benefits New excepted standard, XMl based Other Information

hl7 v2.x

highly used edI standard

Not recommended for mobile, heavy, complex recommended for mobile. use Cda headers (rIM) for Name/Key Based on direct Project using sMtP

FhIr

light weight, compact, ease of use, Json compatible, rest Interface, oauth

auto Blue Button (aBBI) s&I Framework digital Imaging and Communications in Medicine (dICoM)

Mobile, web apps, small healthcare orgs, connection to hIe

ease of use, Many companies agree to support highly excepted standard

standards for exchanging medical images

Need specific training in protocol and PaCs

Body area Network

Body sensors, implants, diagnostics


FCC allocated band to reduced Interference Ca standards

Ieee 802.15.6 tM2012 Minimize costs to obtain, maintain, and use digital certificates

Certificate Interoperability s&I Framework

Nationwide trust fabric

Certification authorities (Ca) to issue interoperable digital certificates Medical device interoperability Primarily use, personnel, or end user, health devices, patient-reported data

Iso/Ieee 11073

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S&I Framework, ONC The ONCs S&I Framework initiative is an open crowdsourcing collaborative to promote interoperability for Meaningful Use Example of current project are found on their wiki: Automatic Blue Button (ABBI) Certificate Interoperability (CI) Data Segmentation for privacy Health eDecision (HeD) Transitions of Care (ToC) Lab Results Interface (LRI) Query Health

IEC 80001-Risk Management for Medical Devices Risk management application for IT-networks incorporating medical devices The draft document is available on the AAMI marketplace The goal of IEC 80001 is to apply appropriate risk management consistent with ISO 14971 to address the key properties of safety, effectiveness, 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 fear out of implementing this standard inside the hospital regardless of the hospital size, says Yadin David, director of Biomedical Engineering Consultants in Houston, TX, one of three co-authors of the handbook The handbook includes an overview of the standard, how to start a pilot project, and how to identify who in an organization is responsible for complying with the standard Source: http://wwwaamiorg/publications/ Books/80001-GShtml HL7 Fast Healthcare Interoperability Resources (FHIR - pronounced FIRE) Designed to be web based, using XLM documents or mHealth preferred, JSon, with an http-based RESTful protocol with predictable URLs This new specification is aimed at making implementation of the HL7 interoperability standards easier to implement and compatible with mobile standards The next section, briefly describes a variety of 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 for exchanging medical images

Existing Interoperability Standards in mHealth & Wireless


ISO/IEEE 11073 ISO/IEEE 11073 Medical/Health Device Communication Standards are a set of joint ISO, IEEE, and CEN standards for 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 (formerly called IEEE 1073) standards define messaging 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 specifically, it is a file format and transmission standard for exchanging medical images and associated information between medical imaging equipment made by different manufacturers The DICOM standards are widely adopted in equipment and information systems used in hospitals, imaging centers, and in providers offices to produce, display, store, or exchange medical images The standard provides a number of specifications including: Network protocols Syntax and semantics of commands and associated information Media storage services, file formats, medical directory structure There are twenty DICOM working groups, made up of technical and medical professionals, which maintain the various DICOM standards The National Electrical Manufacturers Association (NEMA) oversees and holds a copyright to the DICOM standards, originally developed by a joint committee formed by NEMA and the American College of Radiology CEN/TC 251 The Comit Europen de Normalisation or European Committee for Standardization (CEN) is a standards development organization made up of 31 national members developing pan-European standards CEN has a Health Informatics Technical Committee (TC 251) which coordinates the development of standards for Health According to its business plan and recent activities, the focus of CEN/TC 251 is primarily on technologies at the content level rather than dealing with communication technologies CEN/TC 251 is further broken down into working groups such as Working Group IV, which focuses on the interoperability of data among devices and information systems

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HL7 Health Level Seven (HL7) is a standards development organization, which issues international applicationlayer healthcare standards for the electronic exchange and management of health information such as clinical data and administrative information HL7 refers to the standards organization itself but is also commonly used to refer to specific standards the institution develops HL7 dates back to the mid-1980s, when it was formed to develop a standard for hospital information systems Like other standards organizations, HL7 is organized into Work Groups chaired by two or more co-chairs and responsible for defining some area of HL7 standards HL7 has dozens of Work Groups, including groups addressing electronic health records, infrastructure and messaging, and imaging integration To provide one example of an HL7 specification, the HL7 Clinical Document Architecture (CDA) serves as an XML-based markup standard defining the structure, encoding parameters, and semantics of electronic clinical documents HL7 partners with other institutions, such as the International Organization for Standardization (ISO) in issuing international eHealth standards, (ISO/HL7 217 31:2006 Health Informatics-HL7 version 3-Reference Information Model) ISO/TC 215 ISOs Technical Committee 215 addresses health informatics ISO/TC 215 focuses 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 for electronic health records For example, ISO/TS 25237:2008 address pseudonymization principles and requirements for privacy protection of electronic health records

Many of ISOs standards are collaborations or endorsements of standards developed by other standards organizations such as HL7 or IEEE For example, ISO/ HL7 27931:2009, Data Exchange Standards - Health Level Seven (HL7) Version 25 establishes an application protocol for electronic data exchange in healthcare environments ISO Technical Committee 215, WG 8 (Business Requirements for Electronic Health Records) provides guidance for identifying business requirements to define an eHealth enterprise

Engaging patients and families in managing their health Enhancing care coordination Improving population and public health Ensuring adequate privacy and security of health information

Federal Communications Commission (FCC)


The FCC controls the frequency of radio transmitters and receivers as in Cell phones, and RFID devices They do not play a direct role in the classification of medical device as that is the FDA responsibility; however they do influence the market and policies They recently published a public draft, mHealth Task Force, Finding and Recommendations, Improving care delivery through enhanced communications10 The report recommendations are organized within the following five 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 safety, and avoid regulatory duplication Goal 3: The FCC should build on existing programs and link programs when possible in order to expand broadband access for healthcare Goal 4: The FCC should continue efforts to increase capacity, reliability, interoperability, and RF safety of mHealth technologies Goal 5: Industry should support continued investment, innovation, and job creation in the growing mobile health sector

FTC How do others use information from mobile technology?


The Federal Trade Commission (FTC) recommends the following Do Not Track guidelines for mobile technology: 1) privacy by design, simpler and streamlined privacy choices, and transparency as to what demographic data or detailed information about preferences can be captured off mobile devices that leads to targeted marketing to different groups of 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 of mobile devices of young people and minors and is reviewing the Childrens Online Privacy Protection (COPPA) Rule to see if applies to some of 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 forth by HHS include the following:1 Improving care quality, safety, efficiency and reducing disparities
1 Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule, 75 Fed Reg 1851 (Jan 13, 2010)

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Strategies and Recommendations


The future of Interoperability and standards is wide open and will be changing quickly As more health data becomes digitize, technology will play an even more significant role in healthcare Interoperability becomes more important as the source of data points increase Patient-reported data will play a significant role in the production of Big Data Sensors, Apps, home monitoring devices, cars and many soon to be discovered technologies will produce an onslaught of patient-reported data These devices must be interoperable with EHRs, PHRs and HIEs Mobile shall play a significant 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 of mobile A keynote speaker at StrataRX in San Francisco, 2012 mentioned that we should consider using open standards such as iCalendar which currently interfaces with most calendar programs on the Web instead of 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 of these movements

referenCeS
1

autHorS & ContrIbutorS

Jeff Brandt
Principle ComSi

Charles Jaffe, MD, PhD


CEO 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

Tina Brown-Stevens Keynote speaker, StrataRX conference, 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: focus on SOA and Modeling, June 20, 2012 5 http://wwwdigitaltrendscom/mobile/is-5g-mobile-broadband-justaround-the-corner-imt-advanced-explained/ 6 How far are we from a unifying standard for the Internet of Things? Adriana Hamacher, ICT Knowledge Transfer Network, July 18, 2012, 7 Continua Alliance Guidelines 2011 Available http://www continuaallianceorg/products/design-guidelineshtml 8 IHE IT Infrastructure Technical Framework Supplement 10, Mobile access to Health Documents (MHD) Available: http://wwwihenet/ Technical_Framework/upload/IHE_ITI_Suppl_MHD_Rev1-0_PC_201206-05pdf 9 *Source: Keith W Boone, Standards Opportunities in Mobile Health, OMG Healthcare Interoperability: focus on SOA and Modeling, June 20, 2012 10 mHealth Task Force, Finding and Recommendations FCC 9/24/2012 Avail @ https://s3amazonawscom/www2itiforg/2012-mhealthtaskforce-recommendationspdf

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StandardS and InteroperabIlIty

PrIvaCy aNd seCurIty

referenCeS
http://wwwatisorg/about/ http://wwwhospitalmanagementnet/features/featuremobile-medicine-topremote-healthcare-innovations/?WTmc_id=WN_Feat http://wwwcrncom/news/applications-os/231500365/ cover-story-the-mobile-technology-revolutionhtm?pgno=1 https://wwwwirelesshealthstrategiescom/organizationshtml http://wwwftcgov/opa/2011/05/mobiletestimonyshtm http://wwwpewinternetorg/ http://wwwk4healthorg/toolkits/mhealth/mhealth-working-group-0 The mHealth Toolkit, http://wwwk4healthorg/toolkits/mhealth ITU E-health Standards and Interoperability: http://wwwituint/dms_pub/ itu-t/oth/23/01/T23010000170001PDFEpdf (April 2012) http://wwwomgorg/news/meetings/tc/ma-12/special-events/Healthcare_ Information_Dayhtm

mHealtH reSourCeS on tHe teCHWeb dIGItal lIbrary


Government: Cloud/SaaS, Mobile & Wireless Hardware: Handhelds/PDAs, Grid/Cluster Computing Healthcare: Mobile & Wireless Infrastructure: Remote Access, VPNs, Internet: B2B, B2C, Browsers, E-Business/E-Commerce, E-retail, Google, Web Development, Internet Security, Search, Social Networks, Traffic Reporting/Monitoring, Web 20, Internet Policy Mobility: WLAN, Wireless Security, Wi-Fi/WiMax, Wi-Fi VOIP, Smartphones, 3G Wireless/Broadband, Muni Wireless, Mobile Messaging, Mobile Business, Fixed Mobile Convergence, 80211x, RFID personal tech: Blackberry, Bluetooth, Bluray, Digital Cameras, Digital Music, Digital Rights Management, Virtual worlds, iPhone, iPod, Peripherals, Smartphones, TVs/Home Theater, Global Positioning Systems Security: Encryption, Perimeter Security, Vulnerabilities and Threats, Intrusion Prevention Services: Telecom/Voice Services Software: Web Services Storage: Data protection, Removable/Portable Storage, Security, telecom: VOIP, Unified Communications, Voice services, PBXs, Internet policy, Presence, Collaboration Systems, Business, Regulation, Call Centers other info for privacy & Security: BYOD Security -Virtualization like a Citrix Receiver: http://wwwcitrixcom/English/ps2/products/ subfeatureasp?contentID=2300390 TEMIA 170.314(b)(7) Test Tool Supplement: Data portability ONC http://wwwhealthitgov/sites/default/files/standards-certification/2014edition-draft-test-procedures/170-314-b-7-data-portability-test-toolsupplement-v-2pdf

Copyright 2012 Healthcare Information and Management Systems Society (HIMSS)


The inclusion of an organization name, product or service in this document should not be construed as a HIMSS endorsement of such organization, product or service, nor is the failure to include an organization name, product or service to be construed as disapproval For more information: www.mhimss.org

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