healthcare technology in a wireless...
TRANSCRIPT
Priority Issues from the 2012 Wireless Workshop Convened by AAMI, ACCE, ASHE, and ECRI Institute
Healthcare TechnologyIn a Wireless World
Wireless Workshop Conveners
AAMIThe Association for the Advancement of Medical Instrumentation (AAMI), a nonprofit organization founded in 1967, is a diverse alliance of nearly 7,000 members from around the world united by one critical mission—supporting the healthcare community in the development, management, and use of safe and effective medical technology.
AAMI serves as a convener of diverse groups of committed professionals with one common goal—improving patient outcomes. AAMI also produces expert and objective information on medical technology and related processes and issues. AAMI is not an advocacy organization and prides itself on the objectivity of its work.
American College of Clinical EngineeringACCE is committed to enhancing the profession of clinical engineering. With members in the United States and abroad, the ACCE is the only internationally recognized professional society for clinical engineers. Visit www.accenet.org.
American Society for Healthcare EngineeringWith more than 11,000 members, ASHE is the largest association devoted to optimizing the healthcare physical environment. As a trusted industry resource, ASHE is committed to its members, the facilities they build and maintain, and the patients they serve. Visit www.ashe.org/.
ECRI InstituteECRI Institute is an independent nonprofit organization that researches the best approaches to improving the safety, quality, and cost-effectiveness of patient care. Visit www.ecri.org.
Published by
Association for the Advancement of Medical Instrumentation 4301 N. Fairfax Dr., Suite 301Arlington, VA 22203-1633www.aami.org
© 2013 AAMI
Permission is granted to distribute or reproduce this report in its entirety for noncommercial and educational purposes. For other uses, or to order reprints of this report, contact Joe Bremner at [email protected].
Contents
A Call to Action 2Executive Summary 3Top 10 Mistakes in Implementing Wireless Solutions in Healthcare 5How We Got Here 6Unifying Theme 1 9Unifying Theme 2 12Unifying Theme 3 16Unifying Theme 4 20Unifying Theme 5 24Conclusion and Next Steps 30Glossary 32Acknowledgments 34
Healthcare Technology In a Wireless WorldPRIoRIty ISSuES fRoM tHE 2012 WoRkSHoP ConvEnEd by AAMI, ACCE, ASHE, And ECRI InStItutE
2 2012 AAMI Wireless Workshop © AAMI
dear Colleagues,
While we didn’t start 2012 knowing we would be bringing together 75 experts to address wireless challenges in healthcare, we’re glad we took the bait when three amazing AAMI members asked us to convene this invitation-only event. We all owe this dedicated, enthusiastic group a big thank you for their commitment to tackle the persistent and growing problem to improve the current state of healthcare technology in a wireless world.
their gift to the entire healthcare community was to spend october 4–5 developing a list of the highest priority issues that need to be addressed to solve wireless problems, and to come up with solutions that a wider group of experts in the healthcare community can and hopefully will begin to address. In the process, they came up with a useful list of the top 10 most common wireless mistakes.
our gift to the healthcare community was to capture their work in this post-workshop publication. We have also committed to convening a task force to refine and address some of the priority solutions.
What do we hope you will do with this publication? 1. Learn from it and apply its lessons to improve patient safety.2. Share it with colleagues.3. nudge the “responsible organizations” that you know to pick up the tasks they can tackle.4. tell us your success stories and lessons learned.
Many thanks to the American College of Clinical Engineering (ACCE), American Society for Healthcare Engineering (ASHE), and ERCI Institute for co-convening this unique workshop with us. Many thanks as well to don Witters at the fdA and Elliot Sloane of the Center for Healthcare Information Research and Policy for starting these conversations several years ago and for inspiring this expert community to keep at it. I would be remiss if I also didn’t thank Rick Hampton (Partners HealthCare), Phil Raymond (Philips Healthcare), and Steve baker (Welch Allyn) for the nudge.
As noted in a recent Institute of Medicine (IoM) report, learning is a continuous process. this workshop was a big step forward in capturing what and why we need to learn about wireless. the projects that we hope it inspires will result in even deeper and broader continuous learning. In five years, it will be fun to see the progress in our growth together.
Sincerely,
A Call to Action
Mary LoganAAMI President
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Seventy-five experts converged in Herndon, VA, in October 2012 for an invitation-only AAMI Wireless Workshop
to lay out the risks, challenges, and opportuni-ties of wireless technology in healthcare.
These experts are an elite, tight-knit group. Despite the rapid influx of wireless medical technology into hospitals, distributed care facilities, and home healthcare, expertise in this domain is still very much a niche specialty. The wireless experts of healthcare are limited in number. So they rely on one another to patch together solutions to the myriad challenges they are encountering as wireless connectivity goes mainstream.
At the workshop, however, the experts made clear that they have reached a tipping point when it comes to managing wireless technology on their own. The scope of the challenges goes beyond their organizations and authority. It spans the realms of patient safety, institutional leadership, regulations, standards, risk management, the security of technology and data, the reliability of the wireless infrastructure, and the capacity of the wireless spectrum.
Addressing the challenges requires engaging a broader group of stakeholders, including C-Suite executives and clinicians in healthcare delivery organizations; systems safety experts; manufacturers; standards-setting organizations; regulatory bodies; and professional groups. And the solutions must include home healthcare experts, since home
use is a fast-growing segment of the wireless medical device market.
Workshop participants know the specific challenges they are facing. They spent two days prioritizing the challenges, which AAMI synthesized into five unifying themes:1. Clarify roles and responsibilities.2. Manage the spectrum to improve safety
and security.3. Design the wireless infrastructure for high
reliability.4. Learn from other industries.5. Manage risk and prevent failure: Patient
safety comes first.
Executive Summary
“Given the explosion of wireless devices, regulated and unregulated, no doubt we have a tsunami ahead of us. How do we manage the wireless infrastructure?” — Elliot Sloane, president, Center for Healthcare
Information Research and Policy
Wireless technology has the potential to improve every aspect of healthcare delivery.
4 2012 AAMI Wireless Workshop © AAMI
Participants in this workshop are among the biggest champions of the opportunities that wireless technology offers to healthcare. Clinicians and patients can benefit from wireless medical equipment that is used to monitor, diagnose, treat, and record patient conditions. Wireless technology can support every aspect of healthcare delivery and administration by providing easy, ubiquitous access, transmission, and use of information.
But the full potential of wireless technology will be realized only if it is managed safely and effectively. If not, workshop participants warn, it could cause patient harm—a grow-ing possibility, given the increasing number of wireless devices, networks, systems, and critical applications that use wireless technol-ogy in healthcare.
There is a silver lining in this warning: The wireless experts at the workshop offered many specific, ready-to-go solutions to the chal-lenges. By working together on the priority actions they identified, all stakeholders can help to ensure the safety, security, and effec-tiveness of wireless technology in healthcare.
About This Report
This publication reports on the unifying themes and priority actions developed by consensus at the workshop. It also highlights solutions identified for making progress, and recommends organizations that could take the lead on specific solutions. The report summarizes workshop presentations and provides additional perspectives from experts. The views expressed by these individuals do not necessarily represent the views of their organizations. They also have not been endorsed by AAMI or the workshop conveners.
More Workshop Information on AAMI Website
The workshop agenda, PowerPoint® presentations of speakers, reference materials, and updates are posted on the AAMI website.
www.aami.org/wireless
AAMI/FDA Interoperability Summit
In the two days preceding the workshop, AAMI and the FDA convened a summit on interoperability of medical devices. Some of the issues raised at the summit pertain to wireless challenges as well. The summit report, Medical Device Interoperability: A Safer Path Forward, and related information are posted on the AAMI website.
www.aami.org/interoperability
52012 AAMI Wireless Workshop© AAMI
Top 10 Mistakes in Implementing Wireless Technology in Healthcare
1 Underestimation of the potential risk to patient safety
2 Lack of planning •Inadequatetesting •Toolittletimeforverification
•Unrealisticand/orincompletebudgetingand schedule
•Lackofforesightaboutthepaceofchange and the need to plan for it
•Failuretohiresufficientlytrainedprofessionals to support and maintain wireless technology
3 Decision making with false assumptions •“Shinyobjectsyndrome”—assumingthe
desire for a new product trumps the need to design a system to support it
•“Believingthehype”—assumingvendorshave the healthcare organization’s best interests in mind
•Failuretoconsiderelectronicmedicalrecords (EMRs), personal health devices, and consumer mobile devices, such as smartphones and tablets, as “medical devices”
•Failuretoreadmanuals
4 Purchasing end-point wireless devices before realizing the limitations of the current infrastructure
5 Failuretodesignwithasafetymargin
6 Failuretoproperlymanagechangesmade to the wireless network, such as failure to analyze and verify the impact ofafirmwarechangetoanaccesspointon the medical devices on that network, or failure to properly analyze and test the impact of adding new applications to the network
7 Failuretoembracevendorsitetestingofthe network
8 Failuretotakeintoaccountdifferentenvironments of care, intended uses, and intended use environments
9 Failuretoperformroutinemaintenance
10 Failuretoconsiderthatconstructionprojects,orphysicalchangestoafacility,could impact wireless performance
Workshop participants identified these 10 common mistakes that healthcare delivery organizations make when they move to wireless technology:
6 2012 AAMI Wireless Workshop © AAMI
The Explosion of Wireless Technology in HealthcareWith all due respect to Heinrich Hertz, who in the 19th century proved the existence of the electromagnetic waves that now carry the signals that animate wireless devices, the healthcare community has put his discovery to amazing practical uses.
As in many industry sectors, wireless technology is pervasive and ubiquitous in healthcare, according to workshop presenter Elliot Sloane, president of the Center for Healthcare Information Research and Policy. Given the popularity of smartphones, tablets, e-readers, and other mobile devices among consumers, that shouldn’t come as a surprise. “Look at it from a human perspective,” Sloane said. “We’re addicted to data and information. It has become like the oxygen we breathe.”
To fully appreciate the unifying themes, priority actions, and solutions articulated at the wireless workshop, it’s worth noting the many environments, applications, and types of wireless technology in healthcare. Work-shop participants generated these lists:
Wireless Technology Environments• Hospitals• Physician practices• Freestanding clinics, surgical centers, and
emergency rooms• Skilled nursing facilities• Rehabilitation hospitals• Long-term care facilities• Assisted living facilities • Homes and home-care services• Emergency and first-responder services
Wireless Technology Applications• Patient telemetry monitoring• Infusion pumps• Inter- and intra-enterprise clinical, security,
and public safety communications, such as two-way paging systems, nurse call paging, and wireless waveforms
• Critical pharmaceutical and medical/surgical supply management
• Electronic patient records—electronic medical records (EMRs), electronic health records (EHRs), and personal health records (PHRs)
• Radio-frequency identification (RFID) for asset (patient, product, or device) location, tracking, data capture, or data transforma-tion, inventory management, and more
• Voice over Internet Protocol (VoIP)• Access to medical reference materials and to
health, medical, and analytic applications• 3G and 4G connectivity for staff, patient,
and visitor mobile devices
How We Got Here
“I do not think that the wireless waves I have discovered will have any practical application.” — Heinrich Hertz, German physicist
72012 AAMI Wireless Workshop© AAMI
• E-mailing and texting between care providers
• Social networking and Internet-based research about healthcare
• Patient/family entertainment and hospital-ity services
• Outpatient care and followup• Home healthcare• Self-managed personal medical care,
fitness, and wellness activities in the home, at work, and “on the go”
• And many more
The penetration of wireless technology into healthcare is fairly astonishing, given that it has been widely available for only a decade or so. More wireless technology is arriving daily, Sloane said, with applications such as:• Machine to Machine (M2M) communica-
tion, which includes wireless device-to-device, device-to-system, and system-to-system communications. M2M began as proprietary, single-vendor solutions and is now rapidly staged for open-source, multi-vendor solutions.
• Robotic food, pharmacy, and supply delivery• iPhone, iPad, and Android medical
applications for physicians, nurses, and patients—with some now approved by the U.S. Food and Drug Administration (FDA) as medical devices
In a connected world, the number of wireless devices is “rabbitly increasing,” puns workshop presenter Shawn Jackman, princi-pal, manager, wireless product management and engineering at Kaiser Permanente. Among those in widespread use now:
Wireless Technology Devices• Phones• Vocera badge• Other wireless voice devices• Pagers• Tablets• Laptops• Barcode scanners• Carts/workstations (mobile and stationary)• Biomedical devices—too many to list• RFID tags• Digital signage• Patient entertainment systems• Home health devices
What’s Driving the Rapid Adoption of Wireless Technology in Healthcare?A number of factors are contributing to the keen interest in wireless technology, Sloane said. The lines between medical devices, information technology (IT), and information systems (IS) are blurring.
Federal investments in EHRs are accelerat-ing the adoption of wireless medical systems as well. The Medicare and Medicaid EHR Incentive Programs provide a financial incentive to eligible providers and hospitals, as well as critical access hospitals for achiev-ing “meaningful use” of certified EHR technology. Meaningful use requires physi-cians, other clinical providers, physician practices, and hospitals to use computerized physician order entry (CPOE) and ePrescrib-ing, regardless of their location.
Wireless devices can help healthcare providers meet federal requirements—and deliver high-quality, cost-effective patient care. Accountable care organizations (ACOs)—groups of doctors, hospitals, and other healthcare providers who coordinate care for Medicare patients—are “transform-ing to new paradigms of care, almost exclusively based on mobile devices,” Sloane said. ACOs can score high with the Centers for Medicare and Medicaid Services (CMS) by using inexpensive mobile devices. “More than 33 percent of ACO metrics can be supported with available and emerging medical and personal health devices,” Sloane added.
Expert Perspective
At the AAMI/FDA Interoperability Summit that preceded the wireless workshop, presenter Rick Hampton, wireless communications manager for Partners HealthCare, focused on the impact of wireless technology on a leading healthcare system:
“We have several tens of thousands of devices on our wireless network concurrently, at a minimum, at 3 a.m. on a Saturday. On Wednesday at noon, that number quadruples. We’re getting slammed on the wireless side.”
8 2012 AAMI Wireless Workshop © AAMI
For example, portable wireless devices can help clinicians and patients monitor falls and such conditions as diabetes, coronary artery disease, congestive heart failure, and chronic obstructive pulmonary disease. Soon, wearable or implantable micro-scale devices (or MEMS, for micro-electrical-mechanical systems), voice-activated devices, and nano-sensors with radio frequency (RF) capabilities will be broadly used to detect or track diseases, injuries, and treatments.
Moreover, “the home care market is huge,” Sloane explained. Acute-care medical devices began moving into home care more than a decade ago. In home environments, a wireless cell phone may be a patient’s only link to caregivers.
The technical capabilities of wireless devices are only part of the story, however. “The social part of this is huge,” Sloane said. “Digital nurses and physicians are using these devices to make decisions 24 hours a day. We have to figure out how to manage all of this fusion of data on patient conditions, patient records, and clinical decision making to create a ‘cockpit of care.’”
Increasingly, a Bring Your Own Device (BYOD) model applies, whether explicitly sanctioned by healthcare organizations or not. Caregivers are using their own personal devices to support healthcare services, includ-ing medical device-like applications. Already, healthcare organizations are struggling with
how to manage and control clinicians’ personal devices used for medical applications.
In the foreseeable future, healthcare organizations will have to contend with a “Bring Your Own Medical Device” environ-ment, said workshop presenter Ken Fuchs, senior principal architect, Mindray of North America. The time will soon come when patients will bring a wide assortment of wireless medical devices or apps into healthcare settings.
Healthcare organizations should be thinking and planning ahead for this. Indeed, in a 2012 survey commissioned by AAMI, 42 percent of healthcare technology manage-ment professionals already believe that “medical devices brought in by patients” is a top challenge.
“Healthcare technology professionals must effectively design, assess risk, and deploy wireless solutions, meeting intended use cases with the entire infrastructure in mind, to face the increasing wireless demands,” said Brian Long, director of field systems operations, at Masimo.
The rapid and unrelenting growth of wireless technology in healthcare instills a sense of urgency in addressing the unifying themes and priority actions that follow.
Data Points
• Forty-five percent of clinicians say they are using mobile technology to collect data at the patient bedside in 2012, up from 30 percent in 2011.
• Half of clinicians say they will be using more mobile medical apps in the next year.
• Three-quarters of organizations say they will be using more mobile devices, especially tablets, in the future.
— 2nd Annual HIMSS Mobile Technology Survey, 2012
• Sixty-nine percent of nurses interviewed say that nursing staff use their personal smartphones on the job, particularly to fill “critical communication gaps” with hospital IT.
• Twenty-five percent of nurses say they are dissatisfied with the quality and reliability of the wireless network in their facilities.
— Point of Care Computing for Nursing 2012, Spyglass Consulting Group
92012 AAMI Wireless Workshop© AAMI
Unifying Theme 1: Clarify roles and responsibilities.
“I’m sorry, Dave. I’m afraid I can’t do that.” — HAL, 2001: A Space Odyssey
Challenge Priority Actions Accountability
A void in leadership and direction for implementing wireless technology in hospital settings
Engage and educate the C-Suite (e.g., chief executive officers, chief information officers, chief medical officers, chief nursing officers) on their role in leading and directing the management of the wireless technology infrastructure.
onC, CMS, the Joint Commission and other accrediting organizations, AAMI, CHIME, ECRI, ACHE, ASHE, other professional societies
Showcase wireless technology solutions and best practices in hospitals, in a similar format as the HIMSS Health Information Exchange or HIMSS Interoperability Showcase™ at the HIMSS Annual Conference and Exhibition. use webinars and videos as additional channels of communication and education.
CHIME, AAMI, ACCE, ECRI, HIMSS other organizations: bluetooth SIG, dECt forum, fCC, fdA, Wi-fi Alliance, Zigbee® Alliance, West Health, and others
Promote cross-functional and cross-industry collaboration. offer a workshop to address common wireless guidelines and architecture, grounded in best practices, for healthcare delivery organizations, medical device manufacturers, wireless infrastructure vendors, and EHR vendors.
AAMI, ACCE, ECRI, ASHE, CHIME, HIMSS other organizations: fCC, fdA
A lack of accountability for managing wireless technology in hospital settings
Clarify who is responsible for managing wireless technology in hospital settings.
Healthcare delivery organizations (Hdos)
uncertainty about who is responsible for managing wireless medical technology in distributed care environments
Clarify who is responsible for managing wireless technology in distributed care settings, including patient transport and homes.
All stakeholders
10 2012 AAMI Wireless Workshop © AAMI
The Role of LeadershipBecause wireless consumer devices are so pervasive and easy to use, the perception persists that wireless medical technology is equally easy to implement in healthcare.
But wireless medical technology can be mission-critical—and even life-critical. Consider the potential organizational impact of a few very realistic scenarios:• If a personal smartphone or tablet loses
wireless connectivity for a moment or two, it’s at most inconvenient or irritating. If a wireless telemetry monitoring or infusion system loses service, patient care could be compromised, and lives could be lost. These are quality of care, patient safety, risk, and liability issues.
• If a wireless service interruption in a hospital results in incomplete or inaccurate data transfers to EHRs, hospitals could lose money on Medicare, Medicaid, or other insurance reimbursements. Or if a wireless infrastructure or network is not well-planned and configured to meet current and future clinical and administrative needs, it’s an expensive proposition to reconfigure it. These are financial, facili-ties, standards, and technical issues.
• If wireless devices, networks, and systems are not protected, sensitive organizational data or confidential patient or clinical data could be compromised. These are regula-tory, privacy, and security issues.
These are the types of issues that keep wireless technology managers awake at night. Clearly, the takeaway point is that wireless technology management goes beyond technical expertise. “Organizations deploying wireless medical solutions must have the appropriate, qualified personnel in place to manage this complex environment,” explained Brian Long of Masimo.
Right now, many senior leaders in hospi-tals are largely hands-off in their dealings with wireless technology management, workshop participants believe. And there is no clear line of accountability. Ultimately, however, hospitals and their leaders could be on the hook for any failures—whether they know it or not.
Wireless experts are worried about dangers that might not even be on the leadership radar screen. “Hospitals and companies are using wireless technology in ways you can’t imagine,” warns Rick Hampton of Partners HealthCare. “Where is there an understand-ing of how hospitals are using technology? There is a disconnect between what the hospital thinks it’s using and what it’s actually using.”
Workshop participants made it a priority to engage and educate the C-Suite about both the risks and opportunities of wireless technology in healthcare. They recom-mended outreach at specific forums and identified specific organizations that could take the lead or support this effort.
Expert Perspective: “Wireless for Wireless’ Sake” Is Not a Good Strategy
KenFuchs Senior principal architect, Mindray of north America
“Sometimes wireless is just not reliable enough to assure adequate patient safety, and a wired approach should be used. In general, wired should be used whenever it will meet the clinical needs. It does not make sense to have a wireless patient monitor if it will always be sitting at the same bedside. If it needs to be used for transport from time to time, then it should be wired while at rest and wireless on transport (when someone will probably be with the patient). Wireless for wireless’ sake is not a good strategy for critical medical applications. This is an education issue for the healthcare delivery organizations.”
112012 AAMI Wireless Workshop© AAMI
WhereDoestheBuckStop?Within hospitals, C-Suite leaders have a role to play in delineating who is responsible for wireless healthcare technology manage-ment—and getting actively involved in directing and supervising this work, work-shop participants said. Senior leaders have a clear understanding of institutional goals, environments, and cultures, which should inform the planning and implementation of wireless technology.
Wireless technology management requires more than one point person or even depart-ment. In fact, medical technology vendors and wireless service providers share some accountability for the performance of their products or services. Healthcare professionals with expertise in medical devices, networks, and systems; patient safety and risk manage-ment; clinical practices; and facilities should work collaboratively on the design, testing, hazard analysis, installation, monitoring, and maintenance of equipment.
Workshop participants also believe that The Joint Commission and other accrediting
organizations should address the safety, security, and reliability of wireless technology in their accreditation and certification programs for healthcare organizations.
Questions about accountability extend to healthcare settings outside of hospitals. As more wireless technology is deployed outside of hospitals—in hospital-affiliated facilities and physician practices, by con-tracted service providers and independent care facilities, in patients’ homes, and by patients on the go—who is responsible for ensuring robust wireless connectivity and wireless technology performance?
The answers to these questions are as yet unknown. The entire healthcare community will need to come together to address them. “We need a concerted effort to bring all parties together to understand the issues, create a road map for all parties, and arrive at a full range of solutions amicably,” Hampton said.
The unifying themes that follow examine the most important issues for cross-functional, cross-industry collaboration in more detail.
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A Supplement to Biomedical Instrumentation & Technology
MOBILE HEALTHThe Revolution Has StartedAre You Ready?
Including:Connecting Mobile Medical Devices
Reliable and Secure Information Access
12 2012 AAMI Wireless Workshop © AAMI
Unifying Theme 2: Manage the spectrum to improve safety and security.
“Spectrum is the oxygen that your devices breathe. You need to manage it.” — Mark Gibson, senior director, Comsearch
Challenge Priority Actions Accountability
balancing the finite radio spectrum with unlimited demand for wireless connectivity
Maximize spectrum allocation and efficiency for healthcare uses. Reserve some bands of the spectrum for healthcare. Minimize the potential for spectrum interference. Prioritize healthcare requirements for spectrum use from most to least critical. Manage the spectrum in collaboration with the healthcare community.
fCC ntIA fdA onC Hdos
Lack of security of wireless devices, networks, and software
More actively enforce security of wireless technology as part of accreditation of healthcare organizations.
the Joint Commission and other accrediting organizations
develop reasonable approaches for dealing with security risks. Survey the healthcare industry and other industries to discover the guidance on cybersecurity that is already available. Create a flowchart or software tool to identify and enumerate all the questions and issues relevant to covering security risks. Hold off on security regulations until there is consensus on reasonable approaches.
Hdos Industry fdA nISt Sdos
The Limits of the Spectrum for Wireless Technology in HealthcareAny efforts to manage wireless medical technology must be informed by an under-standing that the radio frequency bands on the electromagnetic spectrum—the wireless waves that Heinrich Hertz discovered—are in high demand and limited supply.
The full frequency of the radio spectrum that can be used for wireless communication ranges from 3kHz to 300 GHz, as shown in Figure 1.
Within that frequency range, the radio spectrum is allocated for many uses and technologies, as shown in Figure 2. “You can see how complicated this has become,” said workshop presenter Mark Gibson, senior director, Comsearch. “There is no place where the spectrum is not being used, except in the kilobyte range.” In other words, the spectrum is crowded with users.
The wireless traffic jam comes into sharper relief in view of the even more precious spectrum resources that are allocated to
132012 AAMI Wireless Workshop© AAMI
healthcare, as shown in Figure 3. The MedRadio (Medical Device Radiocommuni-cations Service) band is allocated to implanted medical devices and devices worn on the body, which are used for diagnostic and therapeutic purposes. The WMTS (Wireless Medical Telemetry Service) band is used for remote patient monitoring.
In 2012, the Federal Communications Commission (FCC) set aside part of the spectrum for MBANs (Medical Body Area Networks), which will be used for wireless networks made of body-worn medical sensors that collect and transmit data from patients to telemetry systems and other systems, such as EMRs. MBANs will allow patients to be monitored whether they are stationary or ambulatory, without being tethered to wires and cables.
The FCC and the National Telecommuni-cations and Information Administration (NTIA) regulate and coordinate spectrum allocation. “Regulation of the radio spectrum is becoming more and more important in the medical community,” said workshop pre-senter Ira Keltz, deputy chief, Office of Engineering and Technology, at the FCC.
Spectrum management at the national level is a mix of engineering, law, economics, diplomacy (including international agree-ments), and public policy, Keltz said. Engineering expertise, for example, helps the FCC understand how much power devices need to operate and, thus, where on the spectrum they need to be. On the diplomacy side, the FCC works with international regulators to harmonize spectrum allocation. For medical uses of the spectrum, this ensures that people with implantable or wearable medical devices can travel with the assurance that their devices will work safely.
It’s in the policy arena that hospitals, manufacturers, medical practitioners, other federal agencies (such as the FDA), and the general public can collaborate and advocate for spectrum management practices that benefit healthcare. Indeed, GE Healthcare and Philips Healthcare petitioned the FCC for the MBANs’ spectrum allocation.
Keltz shared the FCC’s spectrum manage-ment goals:• Maximize the use of a limited resource for
non-federal users by adopting rules
Figure1. the Radio Spectrum
Source: http://ptolemy.eecs.berkeley.edu/eecs20/sidebars/radio/spectrum.gif
THIS CHART WAS CREATED BY DELMON C. MORRISONJUNE 1, 2011
UNITEDSTATES
THE RADIO SPECTRUM
NON-GOVERNMENT EXCLUSIVE
GOVERNMENT/NON-GOVERNMENT SHAREDGOVERNMENT EXCLUSIVE
RADIO SERVICES COLOR LEGEND
ACTIVITY CODE
PLEASE NOTE: THE SPACING ALLOTTED THE SERVICES IN THE SPECTRUM SEGMENTS SHOWN IS NOT PROPORTIONAL TO THE ACTUAL AMOUNT OF SPECTRUM OCCUPIED.
ALLOCATION USAGE DESIGNATIONSERVICE EXAMPLE DESCRIPTION
Primary FIXED Capital LettersSecondary Mobile 1st Capital with lower case letters
U.S. DEPARTMENT OF COMMERCENational Telecommunications and Information AdministrationOffice of Spectrum Management
August 2011
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alling
)
MAR
ITIM
E M
OBIL
E(s
hips o
nly)
AERO
NAUT
ICAL
RADI
ONAV
IGAT
ION
(radio
beac
ons)
AERO
NAUT
ICAL
RADI
ONAV
IGAT
ION
MARI
TIME
MOB
ILE
(telep
hony
)
MOBILEexcept aeronautical mobile
MOBI
LEex
cept
aeron
autic
al mo
bile
MOBILE
MOBI
LE
MARI
TIME
MOB
ILE
MOBI
LE (d
istre
ss a
nd ca
lling)
MARI
TIME
MOB
ILE
MOBILEexcept aeronautical mobile
BROADCASTING
AERONAUTICALRADIONAVIGATION
(radiobeacons)
Non-Federal Travelers Information Stations (TIS), a mobile service, are authorized in the 535-1705 kHz band. Federal TIS operates at 1610 kHz.300 kHz 3 MHz
MaritimeMobile
3MHz 30 MHz
AERO
NAUT
ICAL
MOBI
LE (O
R)
FIXE
DM
OBIL
Eex
cept
aer
onau
tical
mob
ile (R
)
FIXED
MOBILEexcept aeronautical
mobile
AERO
NAUT
ICAL
MOBI
LE (R
)
AMATEUR MAR
ITIM
E M
OBIL
EFI
XED
MARITIMEMOBILE
FIXE
DM
OBIL
Eex
cept
aer
onau
tical
mob
ile (R
)
AERO
NAUT
ICAL
MOB
ILE (R
)
AERO
NAUT
ICAL
MOB
ILE (O
R)
MOB
ILE
exce
pt a
eron
autic
al m
obile
(R)
FIXE
D
STAN
DARD
FRE
QUEN
CY A
ND TI
ME S
IGNA
L (5 M
Hz)
FIXE
DM
OBIL
E
FIXE
D
FIXED
AERO
NAUT
ICAL
MOB
ILE
(R)
AERO
NAUT
ICAL
MOB
ILE (O
R) FIXE
DM
OBIL
Eex
cept
aer
onau
tical
mob
ile (R
)
MAR
ITIM
E M
OBIL
E
AERO
NAUT
ICAL
MOB
ILE
(R)
AERO
NAUT
ICAL
MOB
ILE (O
R) FIXE
D
AMAT
EUR
SATE
LLIT
EAM
ATEU
R
AMAT
EUR
BR
OA
DC
AS
TIN
G
FIXED
MOBILEexcept aeronautical
mobile (R)
MAR
ITIM
E M
OBIL
EFI
XE
D
AERO
NAUT
ICAL
MOB
ILE
(R)
AERO
NAUT
ICAL
MOB
ILE (O
R)
FIXE
D
BR
OA
DC
AS
TIN
G
FIXE
DST
ANDA
RD F
REQU
ENCY
AND
TIME
SIG
NAL (
10 M
Hz)
AERO
NAUT
ICAL
MOB
ILE (R
)AM
ATEU
R
FIXED
Mobileexcept
aeronautical mobile (R)
AERO
NAUT
ICAL
MOB
ILE (O
R)
AERO
NAUT
ICAL
MOB
ILE
(R)
FIXE
D
BROA
DCAS
TING
FIXE
D
MAR
ITIM
EM
OBIL
E
AERO
NAUT
ICAL
MOB
ILE (O
R)
AERO
NAUT
ICAL
MOB
ILE
(R)
RADI
O AS
TRON
OMY
F
IXE
DM
obile
exce
pt a
eron
autic
al m
obile
(R)
BROA
DCAS
TING
F
IXE
DM
obile
exce
pt a
eron
autic
al m
obile
(R)
AMAT
EUR
Mob
ileex
cept
aer
onau
tical
mob
ile (R
)
FIX
ED
STAN
DARD
FRE
QUEN
CY A
ND TI
ME S
IGNA
L (15
MHz
)AE
RONA
UTIC
AL M
OBIL
E (O
R)
BROA
DCAS
TING
MAR
ITIM
EM
OBIL
E
AERO
NAUT
ICAL
MOB
ILE
(R)
AERO
NAUT
ICAL
MOB
ILE (O
R)
FIX
EDAM
ATEU
R SA
TELL
ITE
AMAT
EUR
SATE
LLIT
E
FIX
ED
3.0
3.155
3.2
3 3.4
3.5
4.0
4.0
63
4.438
4.6
5 4.7
4.7
5 4.8
5 4.9
95
5.005
5.0
6 5.4
5 5.6
8 5.7
3 5.5
9 6.2
6.5
25
6.85
6.765
7.0
7.1
7.3
7.4
8.1
8.1
95
8.815
8.9
65
9.04
9.4
9.9
9.995
1.0
05
1.01
10.15
1 1
.175
11.27
5 11
.4 11
.6 12
.1 12
.23
13.2
13.26
13
.36
13.41
13
.57
13.87
14
.0 14
.25
14.35
14
.99
15.01
15
.1 15
.8 16
.36
17.41
17
.48
17.9
17.97
18
.03
18.06
8 18
.168
18.78
18
.9 19
.02
19.68
19
.8 19
.99
20.01
21
.0 21
.45
21.85
21
.924
22.0
22.85
5 23
.0 23
.2 23
.35
24.89
24
.99
25.01
25
.07
25.21
25
.33
25.55
25
.67
26.1
26.17
5 26
.48
26.95
26
.96
27.23
27
.41
27.54
28
.0 29
.7 29
.8 29
.89
29.91
30
.0
BROA
DCAS
TING
MAR
ITIM
E M
OBIL
E
BROA
DCAS
TING
F
IXE
D
F
IXE
D
MAR
ITIM
E M
OBIL
E
F
IXE
D
STAN
DARD
FRE
QUEN
CY A
ND TI
ME S
IGNA
L (20
MHz
)M
obile
Mob
ile
F
IXE
D
BROA
DCAS
TING
F
IXE
D
AERO
NAUT
ICAL
MOB
ILE
(R)
MAR
ITIM
E M
OBIL
E
AMAT
EUR
SATE
LLIT
EAM
ATEU
R
F
IXE
D
Mob
ileex
cept
aer
onau
tical
mob
ile (R
)
FIX
ED
AERO
NAUT
ICAL
MOB
ILE
(OR)
MOB
ILE
exce
pt a
eron
autic
al m
obile
F
IXE
D
AMAT
EUR
SATE
LLIT
EAM
ATEU
RST
ANDA
RD F
REQ.
AND
TIME
SIG
NAL (
25 M
Hz)
LAN
D M
OBIL
EM
ARIT
IME
MOB
ILE
LAN
D M
OBIL
E
F
IXE
DM
OBIL
E exc
ept a
erona
utical m
obile
RADI
O AS
TRON
OMY
BROA
DCAS
TING
MAR
ITIM
E M
OBIL
E
LAN
D M
OBIL
E
MOB
ILE
exce
pt a
eron
autic
al m
obile
MOB
ILE
excep
t aero
nautic
al mob
ile
FIX
ED
LAN
D M
OBIL
E
F
IXE
DM
OBIL
Eex
cept
aer
onau
tical
mob
ile
F
IXE
D
F
IXE
D
MOB
ILE
F
IXE
D
AMAT
EUR
SATE
LLIT
EAM
ATEU
R
LAN
D M
OBIL
E
FIX
ED
F
IXE
D M
OBIL
E
F
IXE
D
AMAT
EUR
MOB
ILE
exce
pt a
eron
autic
al m
obile
(R)
AMAT
EUR
F
IXE
DBROA
DCAS
TING
MAR
ITIM
E M
OBIL
E
MOBILEexcept aeronautical
mobile
300
325
335
405
415
435
495
505
510
525
535
1605
16
15
1705
18
00
1900
20
00
2065
21
07
2170
21
73.5
2190
.5 21
94
2495
25
05
2850
30
00
30 MHz 300 MHz
FIXE
DM
OBIL
E
LAND
MOB
ILE
MOB
ILE
MOB
ILE
MOB
ILE
LAND
MOB
ILE
LAND
MOB
ILE
FIXE
D
FIXE
D
FIXE
D
FIXE
D
FIXE
D
FIXE
D
LAND
MOB
ILE LA
ND M
OBIL
ERa
dio a
stron
omy
FIXE
DM
OBIL
EFI
XED
MOB
ILE
LAND
MOB
ILE
MOB
ILE
FIXE
D
FIXE
DLA
ND M
OBIL
E
LAND
MOB
ILE
FIXE
DM
OBIL
E
LAND
MOB
ILE
FIXE
DM
OBIL
E
AMATEUR BROADCASTING(TV CHANNELS 2-4)
FIXE
DM
OBIL
E
RADIO
ASTRO
NOMY M
OBIL
EFI
XED
AERO
NAUT
ICAL
RAD
IONA
VIGA
TION
MOB
ILE
MOB
ILE
FIXE
DFI
XED
BROADCASTING(TV CHANNELS 5-6)
BROADCASTING(FM RADIO)
AERONAUTICALRADIONAVIGATION
AERO
NAUT
ICAL
MOB
ILE
(R)
AERO
NAUT
ICAL
MOB
ILE
(R)
AERON
AUTIC
AL MO
BILE
AERON
AUTIC
AL MO
BILE
AERON
AUTIC
AL MO
BILE (R
)AER
ONAU
TICAL
MOBIL
E (R)
MOBIL
E-SAT
ELLIT
E(sp
ace-t
o-Eart
h)
MOBIL
E-SAT
ELLIT
E(sp
ace-t
o-Eart
h)
Mobile
-satel
lite(sp
ace-t
o-Eart
h)
Mobile
-satel
lite(sp
ace-t
o-Eart
h)
SPAC
E RES
EARC
H(sp
ace-t
o-Eart
h)SP
ACE R
ESEA
RCH
(spac
e-to-E
arth)
SPAC
E RES
EARC
H(sp
ace-t
o-Eart
h)SP
ACE R
ESEA
RCH
(spac
e-to-E
arth)
SPAC
E OPE
RATIO
N(sp
ace-t
o-Eart
h)SP
ACE O
PERA
TION
(spac
e-to-E
arth)
SPAC
E OPE
RATIO
N(sp
ace-t
o-Eart
h)SP
ACE O
PERA
TION
(spac
e-to-E
arth)
MET.
SATE
LLITE
(spac
e-to-E
arth)
MET.
SATE
LLITE
(spac
e-to-E
arth)
MET.
SATE
LLITE
(spac
e-to-E
arth)
MET.
SATE
LLITE
(spac
e-to-E
arth)
FIXE
DM
OBIL
EAM
ATEU
R- S
ATEL
LITE
AMAT
EUR
AMAT
EUR
FIXE
DM
OBIL
E
MOBIL
E-SAT
ELLIT
E(Ea
rth-to
-spac
e)
FIXE
DM
OBIL
EFI
XED
LAND
MOB
ILE
FIXE
D LA
ND M
OBILE
RA
DIO
NAV
-SAT
ELL
ITE
MAR
ITIME
MOB
ILE
MAR
ITIME
MOB
ILE M
ARITI
ME M
OBILE
MOB
ILE
exce
pt a
eron
autic
al m
obile
FIXE
D LA
ND M
OBILE
MAR
ITIME
MOB
ILE
MOB
ILE
exce
pt a
eron
autic
al m
obile
MAR
ITIME
MOB
ILE (A
IS)
MOB
ILE
exce
pt a
eron
autic
al m
obile
FIXE
D
FIXE
DLa
nd m
obile
FIXE
DM
OBIL
E FIXE
DM
OBIL
E ex
cept
ae
rona
utica
l mob
ile
Mob
ileFI
XED
MOB
ILE
exce
pt a
eron
autic
al m
obile
FIXED
MOBILE
LAND
MOB
ILE
MAR
ITIM
E M
OBIL
E (d
istre
ss, u
rgen
cy, s
afet
y and
callin
g)
MAR
ITIME
MOB
ILE (A
IS)
MOB
ILE
exc
ept a
eron
autic
al m
obile
FIXE
D
Amate
ur
AERO
NAUT
ICAL
MOB
ILE
(R)
MOBIL
E-SAT
ELLIT
E(Ea
rth-to
-spac
e)
BROADCASTING(TV CHANNELS 7 - 13)
FIXE
DAM
ATEU
R
Land m
obile
Fixe
d
30.6
30.56
32
.0 33
.0 34
.0 35
.0 36
.0 37
.0 37
.5 38
.0 38
.25
39.0
40.0
42.0
43.69
46
.6 47
.0 49
.6 50
.0 54
.0 72
.0 73
.0 74
.6 74
.8 75
.2 75
.4 76
.0 88
.0 10
8.0
1 17.9
75
121.9
375
123.0
875
123.5
875
128.8
125
132.0
125
136.0
13
7.0
137.0
25
137.1
75
137.8
25
138.0
14
4.0
146.0
14
8.0
149.9
15
0.05
150.8
15
2.855
15
4.0
156.2
475
156.7
25
156.8
375
157.0
375
157.1
875
157.4
5 16
1.575
16
1.625
16
1.775
16
1.962
5 16
1.987
5 16
2.012
5 16
3.037
5 17
3.2
173.4
17
4.0
216.0
21
7.0
219.0
22
0.0
222.0
22
5.0
300.0
FIXE
D
Fixe
dLan
d mobil
e
LAND
MOB
ILE
LAND
MOB
ILE
300.0
32
8.6
335.4
39
9.9
400.0
5 40
0.15
401.0
40
2.0
403.0
40
6.0
406.1
41
0.0
420.0
45
0.0
454.0
45
5.0
456.0
46
0.0
462.5
375
462.7
375
467.5
375
467.7
375
470.0
51
2.0
608.0
61
4.0
698.0
76
3.0
775.0
79
3.0
805.0
80
6.0
809.0
84
9.0
851.0
85
4.0
894.0
89
6.0
901.0
90
2.0
928.0
92
9.0
930.0
93
1.0
932.0
93
5.0
940.0
94
1.0
944.0
96
0.0
1 164
.0 12
15.0
1240
.0 13
00.0
1350
.0 13
90.0
1392
.0 13
95.0
1400
.0 14
27.0
1429
.5 14
30.0
1432
.0 14
35.0
1525
.0 15
59.0
1610
.0 16
10.6
1613
.8 16
26.5
1660
.0 16
60.5
1668
.4 16
70.0
1675
.0 17
00.0
1710
.0 17
55.0
1850
.0 20
00.0
2020
.0 20
25.0
2110
.0 21
80.0
2200
.0 22
90.0
2300
.0 23
05.0
2310
.0 23
20.0
2345
.0 23
60.0
2390
.0 23
95.0
2417
.0 24
50.0
2483
.5 24
95.0
2500
.0 26
55.0
2690
.0 27
00.0
2900
.0 30
00.0
300 MHz
AERO
NAUT
ICAL
RAD
IONA
VIGA
TION
FIXE
DM
OBIL
E
RAD
IONA
VIGA
TION
SATE
LLITE
MOBI
LE S
ATEL
LITE
(Eart
h-to-s
pace
)
STAN
DARD
FRE
QUEC
Y AN
D TI
ME S
IGNA
L - S
ATEL
LITE
(400
.1 MH
z)ME
T. AIDS
(Radio
sonde
)MO
BILE
SAT
(S-E)
SPAC
E RES
.(S-
E)Sp
ace Op
n. (S
-E)ME
T. SAT
.(S-
E)
MET. A
IDS(Ra
dioson
de)
SPAC
E OPN
. (S
-E)ME
T-SAT
. (E
-S)EA
RTH
EXPL
SAT. (
E-S)
Earth
Expl S
at(E-
S)
Earth
Expl S
at(E-
S)EA
RTH
EXPL
SA
T. (E-S
)ME
T-SAT
. (E
-S)ME
T. AIDS
(Radio
sonde
)
Met-S
atellite
(E-S)
Met-S
atellite
(E-S)
MET
EORO
LOGI
CAL A
IDS
(RAD
IOSO
NDE)
MOB
ILE
SATE
LLIT
E (E
arth
-to-s
pace
)RA
DIO
ASTR
ONOM
YFI
XED
MOB
ILE
FIXE
DM
OBIL
ESP
ACE
RES
EARC
H (s
pace
-to-sp
ace)
RADI
OLOC
ATIO
NAm
ateu
r
LAND
MOB
ILE
FIXE
DLA
ND M
OBIL
ELA
ND M
OBIL
EFI
XED
LAND
MOB
ILE
MeteorologicalSatellite
(space-to-Earth)
LAND
MOB
ILEFI
XED
LAND
MOB
ILE
FIXE
D LA
ND M
OBILE
LAND
MOB
ILE
LAND
MOB
ILEFI
XED
BROADCASTING(TV CHANNELS 14 - 20)
FIXEDBROADCASTING
(TV CHANNELS 21-36)
LAN
D M
OB
ILE
(med
ical
tele
met
ry a
ndm
edic
al te
leco
mm
and)
RADI
O AS
TRON
OMY
BROADCASTING(TV CHANNELS 38-51)
BRO
ADCA
STIN
G(T
V CH
ANNE
LS 5
2-61
)M
OBIL
E
FIXE
DM
OBIL
E
FIXE
DM
OBIL
E
FIXE
DM
OBIL
E
FIXE
DM
OBIL
E
LAND
MOB
ILE
FIXE
DLA
ND M
OBIL
EAE
RONA
UTIC
AL M
OBILE
LA
ND M
OBIL
E
AERO
NAUT
ICAL
MOB
ILE
FIXE
DLA
ND M
OBIL
E
FIXE
DLA
ND M
OBIL
EFI
XED
MOB
ILE
RADI
OLOC
ATIO
N
FIXE
DFI
XED
LAND
MOB
ILE
FIXE
DM
OBIL
EFI
XED
LAND
MOB
ILE
FIXE
DFI
XED
LAND
MOB
ILE
FIXE
DM
OBIL
EFI
XED
FIXE
D AERONAUTICALRADIONAVIGATION
RADI
ONAV
IGAT
ION-
SATE
LLIT
E(s
pace
-to-E
arth
)(spa
ce-to
-spa
ce)
EARTHEXPLORATION-
SATELLITE(active)
RADIO-LOCATION
RADI
ONAV
IGAT
ION-
SATE
LLIT
E(s
pace
-to-E
arth
)(s
pace
-to-s
pace
)
SPACERESEARCH
(active)
Space research(active)
Earthexploration-
satellite (active)
RADIO-LOCATION
SPACERESEARCH
(active)
AERONAUTICALRADIO -
NAVIGATION
Amateur
AERO
NAUT
ICAL
RAD
IONA
VIGA
TION
FIXE
DM
OBIL
E RA
DIOL
OCAT
ION
FIXE
DM
OBIL
E **
Fixe
d-sa
tellit
e (E
arth
-to-s
pace
)
FIXE
DM
OBIL
E **
LAND
MOB
ILE
(med
ical te
lemet
ry a
nd m
edica
l telec
omm
and)
SPAC
E RES
EARC
H(pa
ssive)
RADI
O AS
TRON
OMY
EART
H EXP
LORA
TION -
SATE
LLITE
(passi
ve)
LAND
MOB
ILE
(telem
etry
and
telec
omm
and)
LAND
MOB
ILE
(med
ical te
lemet
ry a
nd
med
ical te
lecom
man
d
Fixe
d-sa
tellit
e(s
pace
-to-E
arth
)FI
XED
(telem
etry
and
telec
omm
and)
LAND
MOB
ILE
(telem
etry
& te
lecom
man
d)
FIXE
DM
OBIL
E **
MOB
ILE
(aer
onau
tical
telem
etry
)
MOBIL
E SAT
ELLIT
E (sp
ace-t
o-Eart
h)
AERO
NAUT
ICAL
RADI
ONAV
IGAT
ION-
SATE
LLIT
E(s
pace
-to-E
arth
)(spa
ce-to
-spa
ce)
MOBIL
E SAT
ELLIT
E(E
arth-t
o-spa
ce)
RADI
ODET
ERMI
NATIO
N-SA
TELL
ITE (E
arth-t
o-spa
ce)
MOBIL
E SAT
ELLIT
E(E
arth-t
o-spa
ce)
RADI
ODET
ERMI
NATIO
N-SA
TELL
ITE (E
arth-t
o-spa
ce)
RADI
O AS
TRON
OMY
MOBIL
E SAT
ELLIT
E(E
arth-t
o-spa
ce)
RADI
ODET
ERMI
NATIO
N-SA
TELL
ITE (E
arth-t
o-spa
ce)
Mobil
e-sate
llite(sp
ace-t
o-Eart
h) MOBIL
E SAT
ELLIT
E(Ea
rth-to
-spac
e)
MOBIL
E SAT
ELLIT
E(E
arth-t
o-spa
ce)
RADI
O AS
TRON
OMY
RADI
O AS
TRON
OMY
FIXE
DM
OBIL
E **
METE
OROL
OGIC
AL AI
DS(ra
dioso
nde)
MET
EORO
LOGI
CAL
SATE
LLIT
E (s
pace
-to-E
arth
)
MET
EORO
LOGI
CAL
SATE
LLIT
E (s
pace
-to-E
arth
)
FIXE
D
FIXE
D
MOB
ILE
FIXE
DM
OBIL
E SP
ACE
OPER
ATIO
N (E
arth
-to-s
pace
)
FIXE
DM
OBIL
E
MOBIL
E SAT
ELLIT
E(E
arth-t
o-spa
ce)
FIXE
D
MOB
ILE
SPAC
E RES
EARC
H (pa
ssive)
RADI
O AS
TRON
OMY
METE
OROL
OGIC
AL AI
DS(ra
dioso
nde)
SPACERSEARCH
(Earth-to-space)(space-to-space)
EARTHEXPLORATION-
SATELLITE(Earth-to-space)(space-to-space)
FIXED
MOBILE
SPAC
E OPE
RATIO
N(E
arth-t
o-spa
ce)
(spac
e-to-s
pace
)
MOB
ILE
FIXE
D
SPACERESEARCH
(space-to-Earth)(space-to-space)
EARTHEXPLORATION-
SATELLITE(space-to-Earth)(space-to-space)
SPAC
E OPE
RATIO
N(sp
ace-t
o-Eart
h)(sp
ace-t
o-spa
ce)
MOBILE(line of sight only)
FIXED (line of sight only)
FIXE
DSP
ACE R
ESEA
RCH
(spac
e-to-E
arth)
(deep
spac
e)M
OBIL
E**
Amat
eur
FIXE
DM
OBIL
E**
Amat
eur
RADI
OLOC
ATIO
N
RADI
OLOC
ATIO
NM
OBIL
EFI
XED
Radio
-loc
ation
Mob
ileFi
xed
BROA
DCAS
TING
- SA
TELL
ITE
Fixe
dRa
dioloc
ation
Fixe
dM
obile
Radio
-loc
ation
BROA
DCAS
TING
SATE
LLIT
EFI
XED
MOB
ILE
RADI
OLOC
ATIO
N
RADI
OLOC
ATI
ON
MOB
ILE
MOB
ILE
AMAT
EUR
AMAT
EUR
Radio
locat
ionM
OBIL
EFI
XED
Fixe
d
Amat
eur
Radio
locat
ionMO
BILE S
ATEL
LITE
(spac
e-to-E
arth)
RADI
ODET
ERMI
NATIO
N-SA
TELL
ITE (s
pace
-to-E
arth)
MOBIL
E SAT
ELLIT
E(sp
ace-t
o-Eart
h)RA
DIOD
ETER
MINA
TION-
SATE
LLITE
(spa
ce-to
-Eart
h)FI
XED
MOB
ILE*
*
MOB
ILE*
*FI
XED
Earth exploration-satellite
(passive)
Space research(passive)
Radioastronomy
MOBILE**
FIXEDEARTH
EXPLORATION-SATELLITE
(passive)
RADIOASTRONOMY
SPAC
E RES
EARC
H(pa
ssive
)
AERO
NAUT
ICAL
RADI
ONAV
IGAT
ION
MET
EORO
LOGI
CAL
AIDS
Ra
dioloc
ation
Radiolocation
RADIOLOCATION
MARITIMERADIO-
NAVIGATION
MOB
ILE
FIXE
D
BROA
DCAS
TING
BROA
DCAS
TING
Radio
locati
on
Fixe
d(te
lemet
ry)
FIXE
D (te
lemet
ry a
ndte
lecom
man
d)LA
ND M
OBIL
E (t
elem
etry
& te
lecom
man
d)
AERO
NAUT
ICAL
RADI
ONAV
IGAT
ION
AERO
NAUT
ICAL
RADI
ONAV
IGAT
ION
AERO
NAUT
ICAL
RADI
ONAV
IGAT
ION
AERO
NAUT
ICAL
RADI
ONAV
IGAT
ION
AERO
NAUT
ICAL
RADI
ONAV
IGAT
ION
Space research(active)
Earthexploration-
satellite (active)
EARTHEXPLORATION-
SATELLITE(active)
Fixe
d
FIXE
D
FIXE
DM
OBIL
E
ISM – 24.125 ± 0.125 ISM – 5.8 ± .075 GHz3GHz
Radio
locat
ionAm
ateu
r
AERO
NAUT
ICAL
RADI
ONAV
IGAT
ION
(grou
nd ba
sed)
RADI
OLOC
ATIO
NRa
dioloc
ation
FIXED
-SAT
ELLIT
E (s
pace
-to-E
arth)
Radio
locati
on
FIXED
AERO
NAUT
ICAL
RAD
IONA
VIGA
TION M
OBIL
E
FIXE
DM
OBIL
E
RADI
O AS
TRON
OMY
Spac
e Res
earch
(Pas
sive)
RADI
OLOC
ATIO
N
RADI
OLOC
ATIO
N
RADI
OLOC
ATIO
NMETE
OROL
OGIC
AL
AIDS
Amat
eur
FIXED SP
ACE
RESE
ARCH
(dee
p spa
ce)(E
arth-
to-sp
ace)
Fixed
FIXED
-SAT
ELLIT
E (sp
ace-t
o-Eart
h)
AERO
NAUT
ICAL
RAD
IONA
VIGA
TION
RADI
OLOC
ATIO
NRa
dioloc
ation
MAR
ITIM
E RA
DION
AVIG
ATIO
N
RADI
ONAV
IGAT
ION
Amat
eur
FIXE
D
RADI
O AS
TRON
OMY
BROA
DCAS
TING
-SAT
ELLI
TE
Fixed
Mobil
e Fixed
Mobil
eFI
XED
MOBI
LE
SPAC
E RE
SEAR
CH(pa
ssive
)RA
DIO
ASTR
ONOM
YEA
RTH
EXPL
ORAT
ION
-SA
TELL
ITE (p
assiv
e)
FIXE
D
FIXE
DMO
BILE
FIXED
-SAT
ELLIT
E (s
pace
-to-E
arth)
FIXED
MOBILE MOBI
LE
AERO
NAUT
ICAL
RAD
IONA
VIGA
TION
Standard frequencyand time signal
satellite(Earth-to-space)
FIXED
FIXE
DM
OBIL
E** FIXE
DM
OBIL
E**
FIXE
D SA
TELL
ITE
(Ear
th-to-
spac
e)
Amat
eur
MOBI
LE
BROA
DCAS
TING
-SAT
ELLIT
E
FIXE
D-SA
TELL
ITE
(spac
e-to-
Earth
)
MOBI
LE
FIXE
DMO
BILE
INTE
R-SA
TELL
ITE
AMAT
EUR
AMAT
EUR-
SATE
LLIT
E
Radio
-loc
ation
Amat
eur
RADI
O-LO
CATI
ON
FIXE
DIN
TER-
SATE
LLITE
RADI
ONAV
IGAT
ION
RADIO
LOCA
TION-S
ATEL
LITE (
Earth
-to-sp
ace)
FIXE
D-SA
TELL
ITE
(Ear
th-to-
spac
e)
MOBI
LE-S
ATEL
LITE
(Ear
th-to-
spac
e)MOBILE
INTE
R-SA
TELL
ITE
30 GHz
Earthexploration-
satellite(active)
Space resea
rch(activ
e)RA
DIOL
OCAT
ION
RADI
OLOC
ATIO
NAE
RONA
UTIC
ALRA
DION
AVIG
ATIO
N(gr
ound
base
d)
FIXED-SATELLITE(space-to-Earth)
FIXE
D
RADI
ONAV
IGAT
ION-
SATE
LLITE
(Eart
h-to-s
pace
)AE
RONA
UTIC
AL R
ADIO
NAVI
GATI
ON
AERO
NAUT
ICAL
RAD
IONA
VIGA
TION
RADI
ONAV
IGAT
ION-
SATE
LLITE
(sp
ace-t
o-Eart
h)(sp
ace-t
o-spa
ce)
AERO
NAUT
ICAL
RADI
ONAV
IGAT
ION
FIXE
D-SA
TELL
ITE
(Ear
th-to-
spac
e)
Earthexploration-
satellite (active)
Space research
Radiolocation
EARTHEXPLORATION-
SATELLITE(active)
SPACE RESEARCH(active)
RADI
OLOC
ATIO
N
Earthexploration-
satellite (active)
Radiolocation
Space research(active)
EARTHEXPLORATION-
SATELLITE(active)
SPACE RESEARCH(active)
RADI
OLOC
ATIO
N
Radiolocation
Space research(active)
EARTHEXPLORATION-
SATELLITE(active)
SPACE RESEARCH(active)
RADIOLOCATION
AERONAUTICAL
RADIONAVIGATION
Earthexploration-
satellite (active)
RadiolocationSpace research
(active)
EARTHEXPLORATION-
SATELLITE(active)
SPACE RESEARCH(active)
RADIOLOCATION
RADIONAVIGATION
Earthexploration-
satellite (active)
Space research(active)
EARTHEXPLORATION-
SATELLITE(active)
SPACE RESEARCH(active)
MARI
TIME
RADI
ONAV
IGAT
ION
RADI
OLOC
ATIO
N
MARI
TIME
RAD
IONA
VIGA
TION
RADI
OLOC
ATIO
NMA
RITI
ME
RA
DION
AVIG
ATIO
N
Amat
eur
RADI
OLOC
ATIO
N
MOBI
LEFI
XED-
SATE
LLIT
E (E
arth-
to-sp
ace)
FIXED
FIXE
D-SA
TELL
ITE
(Ear
th-to-
spac
e)FIX
EDFI
XED-
SATE
LLIT
E (E
arth-
to-sp
ace)
(spac
e-to-
Earth
)
FIXED
FIXE
D-SA
TELL
ITE
(Ear
th-to-
spac
e)(sp
ace-
to-Ea
rth)
MOBI
LE
FIXE
D-SA
TELL
ITE
(Ear
th-to-
spac
e)MO
BILE
FIXED
MOBI
LEFIX
EDFIX
EDFIX
EDSP
ACE
RESE
ARCH
(Ear
th-to-
spac
e)
FIXED
MOBI
LE-S
ATEL
LITE
(spac
e-to-E
arth) FI
XED
Mobil
e-sate
llite (
spac
e-to-E
arth)
FIXED
-SAT
ELLIT
E (sp
ace-t
o-Eart
h)
FIXE
DMo
bile-s
atellit
e (sp
ace-t
o-Eart
h)ME
TEOR
OLOG
ICAL
SAT
ELLIT
E (sp
ace-t
o-Eart
h)FIX
ED-S
ATEL
LITE (
spac
e-to-E
arth)
FIXE
DMo
bile-s
atellit
e (sp
ace-t
o-Eart
h)FIX
ED-S
ATEL
LITE (
spac
e-to-E
arth)
FIXED
-SAT
ELLIT
E (Ea
rth-to
-spac
e)MO
BILE
-SAT
ELLIT
E (E
arth-t
o-spa
ce)
Fixed
FIXE
DMo
bile-s
atellit
e(E
arth-t
o-spa
ce)
(no ai
rborne
)
FIXED
SATE
LLITE
(Eart
h-to-s
pace
)EA
RTH
EXPL
ORAT
ION-
SATE
LLITE
(spa
ce-to
-Eart
h)Mo
bile-s
atellit
e(E
arth-t
o-spa
ce)
(no ai
rborne
)FI
XED
EART
H EX
PLOR
ATIO
N-
SATE
LLITE
(spac
e-to-E
arth)
FIXED
-SAT
ELLIT
E (E
arth-t
o-spa
ce)
METE
OROL
OGIC
AL-
SAT
ELLIT
E (s
pace
-to-E
arth)
FIXE
DMo
bile-s
atellit
e(E
arth-t
o-spa
ce)
(no ai
rborne
)
FIXED
-SAT
ELLIT
E (E
arth-t
o-spa
ce)
EART
H EX
PLOR
ATIO
N-SA
TELL
ITE (s
pace
-to-E
arth)
Spac
e res
earch
(dee
p spa
ce)(s
pace
-to-E
arth)
SPAC
E RE
SEAR
CH (d
eep s
pace
)(spa
ce-to
-Ear
th)FI
XED
SPAC
E RE
SEAR
CH (s
pace
-to-E
arth)
FIXE
D Earthexploration -
satellite (active)
Radio-location
Space research (active)
EARTHEXPLORATION-
SATELLITE (active)
RADIO-
LOCATION
SPACERESEARCH
(active)
Radio
locat
ionRA
DIOL
OCAT
ION
Radio
locat
ionRa
dioloc
ation
Radio
locat
ionMe
teoro
logica
l Aids
Earthexploration -
satellite (active)
Radio-location
Space research (active)
EARTHEXPLORATION
SATELLITE (active)
RADIO-
LOCATION
SPACERESEARCH
(active)
Radio
locat
ionRa
dioloc
ation
Amat
eur-s
atell
iteAm
ateu
rRa
dioloc
ation
RADI
OLOC
ATIO
N
RADI
OLOC
ATIO
N
FIXE
DEA
RTH
EXPL
ORAT
ION-
SATE
LLITE
(pas
sive)
SPAC
E RE
SEAR
CH (p
assiv
e)
EART
H EX
PLOR
ATIO
N-SA
TELL
ITE (p
assiv
e)SP
ACE
RESE
ARCH
(pas
sive) FIX
ED-S
ATEL
LITE (
spac
e-to-E
arth)
FIXE
D FIXED
-SAT
ELLIT
E (sp
ace-t
o-Eart
h)
FIXE
D FIXE
DFI
XED-
SATE
LLIT
E (E
arth-
to-sp
ace)
Space research (active)
EARTHEXPLORATION -
SATELLITE (active)
SPACERESEARCH
(active)
Aerona
tuical
Radiona
vigation
Earthexploration -
satellite (active)
RADIO -LOCATION
SPACE
RESEARCH
Radio-location
Space research
RADIO - LOCATION
Space research
FIXED-SATELLITE
(Earth-to-space)
Space research
Radio - location
FIXE
D-SA
TELL
ITE
(Ear
th-to-
spac
e)Mo
bile-s
atellit
e (Ea
rth-to
-spac
e)Sp
ace
rese
arch
Mobil
e-sate
llite (
spac
e-to-E
arth)
FIXE
D-SA
TELL
ITE
(Ear
th-to-
spac
e)
Mobil
e-sate
llite
(Eart
h-to-s
pace
) Spac
e res
earch
MOBI
LESP
ACE
RESE
ARCH
Fixed
FIXE
DSP
ACE
RESE
ARCH
Mobil
e
FIXE
D-SA
TELL
ITE
(Ear
th-to-
spac
e)AE
RONA
UTIC
AL
RADI
ONAV
IGAT
ION
AERO
NAUT
ICAL
RAD
IONA
VIGA
TION
RADI
OLOC
ATIO
NSp
ace r
esea
rch (d
eep s
pace
)(Ear
th-to-
spac
e)RA
DIOL
OCAT
ION
RADI
OLOC
ATIO
N
EARTHEXPLORATION-
SATELLITE (active)
RADIO-LOCATION
SPACERESEARCH
(active)
Earthexploration-
satellite (active)
Radio-location
Space research (active)
Radio
locat
ion
FIXE
D-SA
TELL
ITE
(Ear
th-to-
spac
e)
FIXE
DFI
XED-
SATE
LLIT
E (sp
ace-
to-Ea
rth)
SPAC
E RE
SEAR
CH(pa
ssive
)EA
RTH
EXPL
ORAT
ION
-SA
TELL
ITE (p
assiv
e)FI
XED-
SATE
LLIT
E (sp
ace-
to-Ea
rth)
FIXE
D-SA
TELL
ITE
(spac
e-to-
Earth
)MO
BILE
-SAT
ELLIT
E (sp
ace-t
o-Eart
h)
Standardfrequency
andtime signal
satellite(space-to-
Earth)
FIXE
D-SA
TELL
ITE
(spac
e-to-
Earth
)
MOBI
LE-S
ATEL
LITE
(spac
e-to-E
arth)
FIXED
EART
H EX
PLOR
ATIO
N -
SATE
LLITE
(pas
sive)
SPAC
E RE
SEAR
CH(pa
ssive
)
FIXE
DMO
BILE
**
EARTHEXPLORATION-
SATELLITE (passive)
MOBILE**
FIXED
SPAC
ERE
SEAR
CH(pa
ssive
)RA
DIO
ASTR
ONOM
Y
MOBI
LEFI
XED
FIXE
DMO
BILE
FIXE
DMO
BILE
EART
H EX
PLOR
ATIO
N -
SATE
LLITE
- (pa
ssive
)SP
ACE
RESE
ARCH
(pass
ive)
RADI
OAS
TRON
OMY
Earthexploration -
satellite (active)
RADI
ONAV
IGAT
ION
FIXE
D-SA
TELL
ITE
(Ear
th-to-
spac
e)FI
XED
Standard frequency and time signal satellite
(Earth-to-space)
FIXE
D
FIXED
EARTHEXPLORATION -
SATELLITE(space-to-Earth)
SPACERESEARCH
(space-to-Earth)
MOBILE
INTER-SATELLITE
Inter-
satel
liteFI
XED
INTE
R-SA
TELL
ITE
FIXE
D-SA
TELL
ITE
(Ear
th-to-
spac
e)
FIXE
D-SA
TELL
ITE
(Ear
th-to-
spac
e)
RADI
OLOC
ATIO
NMA
RITI
MERA
DION
AVIG
ATIO
N
AERO
NAUT
ICAL
RAD
IONA
VIGA
TION
INTE
R-SA
TELL
ITE
Inter-satellite
Earthexploration -
satellite (active)
FIXE
DFIXE
D-SA
TELL
ITE
(Ear
th-to-
spac
e)
FIXED
Spac
e res
earch
Radio
locat
ionRa
dioloc
ation
Radio
locat
ion
RADI
OLOC
ATIO
N
RADI
OLOC
ATIO
N
Earthexploration-
satellite (active)
3.0
3.1
3.3
3.5
3.6
3.65
3.7
4.2
4.4
4.5
4.8
4.94
4.99
5.0
5.01
5.03
5.15
5.25
5.255
5.3
5 5.4
6 5.4
7 5.5
7 5.6
5.6
5 5.8
3 5.8
5 5.9
25
6.425
6.5
25
6.7
6.875
7.0
25
7.075
7.1
25
7.145
7.1
9 7.2
35
7.25
7.3
7.45
7.55
7.75
7.85
7.9
8.025
8.1
75
8.215
8.4
8.4
5 8.5
8.5
5 8.6
5 9.0
9.2
9.3
9.5
9.8
10
.0 10
.45
10.5
10.55
10
.6 10
.68
10.7
11.7
12.2
12.7
13.25
13
.4 13
.75
14.0
14.2
14.4
14.5
14.71
45
14.8
15.13
65
15.35
15
.4 15
.43
15.63
15
.7 16
.6 17
.1 17
.2 17
.3 17
.7 17
.8 18
.3 18
.6 18
.8 19
.3 19
.7 20
.2 21
.2 21
.4 22
.0 22
.21
22.5
22.55
23
.55
23.6
24.0
24.05
24
.25
24.45
24
.65
24.75
25
.05
25.25
25
.5 27
.0 27
.5 29
.5 30
.0
MOBI
LE
FIXE
D-SA
TELL
ITE
(spac
e-to-
Earth
)
FIXE
D-SA
TELL
ITE
(spac
e-to-
Earth
)
FIXE
D-SA
TELL
ITE
(Ear
th-to-
spac
e)
Earthexploration -
satellite (active)
Amat
eur-s
atell
ite(s
pace
-to-E
arth
)
FIXE
D-SA
TELL
ITE
(Ear
th-to-
spac
e)
FIXE
D -
SATE
LLIT
E(E
arth-
to-sp
ace)
MOBI
LE -
SATE
LLIT
E(E
arth-
to-sp
ace)
Standard Frequency and
Time SignalSatellite
(space-to-Earth)
FIXE
DMO
BILE
RADI
OAS
TRON
OMY
SPAC
ERE
SEAR
CH
(pas
sive)
EART
HEX
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Amateur
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RADIOASTRONOMY
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ISM - 6.78 ± .015 MHz ISM - 13.560 ± .007 MHz ISM - 27.12 ± .163 MHz
ISM - 40.68 ± .02 MHz
3 GHzISM - 915.0± .13 MHz ISM - 2450.0± .50 MHz
3 GHz
ISM - 122.5± 0.500 GHz
This chart is a graphic single-point-in-time portrayal of the Table of Frequency Allocations used by the FCC and NTIA. As such, it does not completely reflect all aspects, i.e. footnotes and recent changes made to the Table of Frequency Allocations. Therefore, for complete information, users should consult the Table to determine the current status of U.S. allocations.
For sale by the Superintendent of Documents, U.S. Government Printing OfficeInternet: bookstore.gpo.gov Phone toll free (866) 512-1800; Washington, DC area (202) 512-1800
Facsimile: (202) 512-2250 Mail: Stop SSOP, Washington, DC 20402-0001
ISM - 61.25± 0.25 GHz ISM - 245.0± 1 GHz
AERONAUTICALMOBILE
AERONAUTICALMOBILE SATELLITE
AERONAUTICALRADIONAVIGATION
AMATEUR
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EARTH EXPLORATIONSATELLITE
FIXED
FIXED SATELLITE
INTER-SATELLITE
LAND MOBILE
LAND MOBILESATELLITE
MARITIME MOBILESATELLITE
MARITIMERADIONAVIGATION
METEOROLOGICAL
METEOROLOGICALSATELLITE
MARITIME MOBILE
MOBILE
MOBILE SATELLITE
RADIO ASTRONOMY
RADIODETERMINATIONSATELLITE
RADIOLOCATION
RADIOLOCATION SATELLITE
RADIONAVIGATION
RADIONAVIGATION SATELLITE
SPACE OPERATION
SPACE RESEARCH
STANDARD FREQUENCY AND TIME SIGNAL
STANDARD FREQUENCY AND TIME SIGNAL SATELLITE
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Foramoredetailedviewoftheimage,clickhere.
Figure2. How the Spectrum Is Allocated
Source: u.S. department of Commerce, national telecommunications and Information Administration, office of Spectrum Management, August 2011. http://www.ntia.doc.gov/files/ntia/publications/spectrum_wall_chart_aug2011.pdf
Figure3. Spectrum Allocations for Healthcare
Source: u.S. department of Commerce, national telecommunications and Information Administration, office of Spectrum Management, August 2011, and Comsearch. Source: Mark Gibson: Radio-frequency terminology and Challenges: understanding the Concepts and Applicable Challenges to Wireless Connectivity,” presentation at the AAMI Wireless Workshop, oct. 4–5, 2012. http://www.ntia.doc.gov/files/ntia/publications/spectrum_wall_chart_aug2011.pdf
14 2012 AAMI Wireless Workshop © AAMI
designed to allow radio users to operate with minimal interference from other users.
• Meet a mandate to manage spectrum in the “public interest, convenience, and necessity”—by finding the “highest” and “best” uses of radio spectrum for society, in terms of economic value, societal value (such as public safety), and research and development, among other considerations.
• Maximize spectrum to: – Maximize spectrum efficiency – Minimize potential for interference
An important implication for the health-care community with spectrum management at the national level is that all not spectrum allocations are created equal. Spectrum allocation is licensed—but wireless devices using the spectrum for healthcare purposes typically are not:• Licensedspectrum allows for exclusive,
and sometimes non-exclusive, use of particular channels in particular locations and conveys interference rights—the right to commandeer use of the limited spec-trum in case of emergency. Licensed spectrum for public safety conveys exclu-sive use for law enforcement agencies or first responders. Licensed spectrum is also allocated to commercial users, such as the cellular, broadcasting, satellite, aviation, and maritime industries.
• Unlicenseddevices can use the spec-trum—with no rights to exclusive use and no interference rights. Devices must not cause harmful interference to the spec-trum, and must accept interference from authorized services. In healthcare, many medical devices operate under these rules, such as assistive listening devices; implant-able pacemakers, cardioverter defibrillators, and cardiac resynchroniza-tion therapy devices that use inductive coupling; enteromedics, or implantable devices to treat gastrointestinal disorders;
and retinal prosthesis systems. • Licensebyrule is similar to unlicensed use
of the spectrum, but it conveys some interference rights. In healthcare, MedRa-dio and WMTS are licensed by rule; MBANs will operate under this license as well. For WMTS and MBANs, there are some obligations that healthcare organiza-tions register their use of the spectrum with a frequency coordination agency.
Notably, the FCC is considering offering experimental licenses to promote research and development of new radio technologies, devices, and applications. One type of proposed experimental license would provide “test beds” for medical institutions and manufacturers to test new devices over a wide variety of frequencies and other operat-ing parameters under real-world conditions.
On this front, Elliot Sloane of the Center for Healthcare Information Research and Policy said, “We need testing and develop-ment ‘sandboxes’ so that everyone can learn together quickly.”
Access to the Spectrum Does Not Convey Safety or SecurityThe crux of the spectrum limitations for healthcare is this: The FCC is not a medical safety agency. The agency regulates spectrum allocation through technical rules on transmit-ters. It tries to resolve interference issues—but “tracing interference can be very difficult,” Keltz said. And its enforcement jurisdiction extends to illegal RF jamming devices, which intentionally cause interference.
The FCC does not regulate wireless medical technology or medical apps used on wireless devices. “The federal Communica-tions Act gives us the authority to regulate transmitters, not receivers,” Keltz said. “We don’t set receiver standards. We rely on industry groups to come up with receiver standards and requirements for power, emissions, and bandwidth. This is becoming a bigger issue.”
This issue surfaced with the MBANs spectrum allocation petition. “Experts … worry that because the FCC didn’t specify rules requiring interoperability in the bands set aside for MBANs, companies will not make their products compatible with one another—
“Ninety-three percent of the spectrum is shared among federal and non-federal uses.” — Ira keltz, deputy chief, office of
Engineering and technology, fCC
152012 AAMI Wireless Workshop© AAMI
a problem already apparent in the WMTS” (Hartford, 2012).* Wireless expert Rick Hampton of Partners HealthCare already sees that happening with incompatible wireless medical systems from different manufactur-ers that, when placed too close together in a hospital, interfere with one another.
“The challenge is that with more wireless devices, and a lot of congestion, how do we make everything compatible?” Keltz said. “You have to think about these things as you implement systems within facilities. You need people to understand the equipment they’re buying, especially on the receiver side. Ask manufacturers, ‘How well do the receivers filter out and discriminate for interference?’”
Managing the Wireless SpectrumFor these reasons, for healthcare delivery organizations and manufacturers, the spectrum is a critical asset that must be managed accordingly, Gibson noted.
“I’ve noticed over the years that hospitals have really embraced the concept of the FCC and spectrum management a lot more,” Gibson said. “The key point about all of this is that, in most cases, the spectrum must be shared with other users. You should know who those other users are. You may have exclusive rights, but you’ll be sharing the spectrum with someone. There is no spec-trum that is allocated to a single source that you don’t have to worry about.”
The worry is interference—disrup-tion of the operation of wireless device when it is in the vicinity of an electromagnetic field in the spectrum that is caused by another wireless device. “Interference will be a limiting factor in the success of wireless technologies,” Gibson said.
Interference can compromise a wireless device, network, and software security and reliability. Healthcare organizations will have to deal with this interference through effective wireless
planning, including taking stock of all of the wireless medical devices in their inventories and in personal use. An emerging technology, device databases, can help healthcare organiza-tions manage all of these devices by dynamically locating vacant spectrum and switching them to available segments of the spectrum.
In the future, the FCC may unlock underu-tilized slivers of the broadcast TV spectrum, known as “white space,” which could change the wireless mobile landscape with more secure technology. For example, one promis-ing technology to watch is TD-LTE (Time Division-Long Term Evolution), according to Gibson. LTE is the fast, efficient technology that powers 4G networks; TD makes LTE even more efficient. Telecommunications companies around the world are experiment-ing with this technology.
Other ways of securing and managing wireless technology are addressed in the unifying themes that follow.
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Association for the Advancement of Medical Instrumentation
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*HartfordJ. MBANs Could Advance Patient Care, But Interoperability Is a Concern. Medical Device and Diagnostic Industry News. Sept. 11, 2012.
16 2012 AAMI Wireless Workshop © AAMI
Unifying Theme 3: Design the wireless infrastructure for high reliability.
“Design for performance more than anything. The faster and the healthier a device can get on and off the network, the better.” — Shawn Jackman, principal and manager, wireless product
management and engineering, kaiser Permanente
Challenge Priority Action Accountability
Lack of a robust wireless infrastructure compromises the reliability of wireless technology
understand, define, and document the purpose, business requirements, and intended uses of wireless technology. design, build, and test the infrastructure against these requirements and uses. Involve all critical stakeholders, including, at a minimum, senior leaders, clinicians, biomedical and It professionals, and vendors.
Hdos Industry
uneven use of best practices in designing, building, and testing wireless infrastructures
Identify best practices on wireless deployments and the effective co-existence of hardware and software.
Wi-fi Alliance Industry All stakeholders
develop consensus around a reference wireless architecture, with consistent and explicit use of standards, for healthcare organizations and industry.
Industry Sdos
build test cases of the wireless infrastructure around intended uses focused on clinical workflows.
Hdos Industry Sdos
different challenges to building a robust wireless infrastructure in different care settings
Consider the wireless infrastructure requirements and intended uses of wireless technology in distributed care settings, including patient transport and home healthcare. Include these environments in the exploration of best practices and development of test cases.
Hdos Industry Sdos
Overcoming“ShinyObjectSyndrome”Healthcare organizations can be blindsided when the allure of shiny (wireless) objects meets the reality of inadequately designed, built, and tested wireless infrastructures.
Workshop participants offered a veritable litany of common, infrastructure-related shortcomings in “Top 10 Mistakes in Imple-
menting Wireless Technology in Healthcare” (page 5). The mistakes include lack of planning, poor decision making, premature purchases, inadequate testing, and failure to consider the patient safety risks, business requirements, infrastructure capacity, and intended uses by real people. Compromised reliability can result.
172012 AAMI Wireless Workshop© AAMI
Workshop presenter Peter Thornycroft, engineer, office of the CTO at Aruba Net-works, a Wi-Fi service provider, describes reliability as “delivering bits as fast as we can and as uninterrupted as we can” to enable mission-critical medical mobility.
The advice of personal finance guru Suze Orman—“People first, then money, then things”—is an apt analogy for designing a wireless infrastructure for high reliability. Aruba Networks frames its infrastructure focus in its registered trademark: “People move. Networks must follow.”
The wired and wireless infrastructure is the foundation on which security, devices, applications, and users operate, as shown in Figure 4. The infrastructure enables people, processes, and technology to work more effectively. “All of them are constantly changing,” Thornycroft said. “We have to give them the best possible performance within the parameters we’re given. You want to get all the devices, users, and services to play well together at a predictable level—particularly at the high-priority level.”
Figure4. delivering Mission Critical Mobility
© 2012 Aruba networks. Source: Peter thornycroft. “Enabling Mission Critical Medical Mobility,” presented at the AAMI Wireless Workshop, oct. 4–5, 2012.
Getting Started with IEC 80001: Essential Information for Healthcare Providers Managing Medical IT-Networks
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Essential Information for Healthcare Providers Managing Medical IT-Networks
This handbook seeks to put readers on the right path for applying 80001.
It includes: • an overview of the standard• how to start a pilot project• how to identify who in an organization is responsible for
complying with the standard
Don’t miss this practical guidance on CE-IT collaboration, assessing and managing risk, and reviewing overall risk.
Order Code: 80001-GS or 80001-GS-PDFList / AAMI member: $140 / $85
18 2012 AAMI Wireless Workshop © AAMI
To achieve this result, healthcare organiza-tions must first define their current and anticipated expectations for wireless technol-ogy, with patient safety, effectiveness, and reliability as top-of-mind concerns. They need to develop a plan that supports all of the people, processes, and technology that will rely on the infrastructure. This is more than a technical exercise; it requires multidiscipli-nary expertise and leadership involvement.
To support organizational planning, work-shop participants generated a list of the key characteristics of a high-reliability infrastruc-ture—and the top obstacles to building such an infrastructure, detailed in the sidebar.
Given the enormous amount of mission-critical wireless technology, healthcare has unique infrastructure requirements, Thorny-croft said. “We’re talking about access points in every third room, every 15 meters—we’re already getting into something fairly unique in hospitals.” In addition, workshop participants believe this uniqueness extends to the wireless infrastructure for distributed care environ-ments, which at this point are even less well planned than hospital infrastructures.
A robust wireless infrastructure builds in checks and balances for reliability. For example, Thornycroft said, it monitors who is on the network and which devices they are using, with different authentication and encryption levels to access data and applica-tions for different authorized uses. The infrastructure also monitors traffic on the network, analyzes how the spectrum alloca-tion is being used, and prioritizes mission-critical access.
Characteristics of a High-Reliability Infrastructure in a Healthcare Organization
• Strong leadership and accountability – Coordination among users and stakeholders – Use of 80001 to guide change management
• Clearly established business requirements
• Sufficient for intended use—tailored to each facility
• Managed and supervised by skilled personnel with knowledge of all wireless services
• Resourced adequately
• Built-in safety, using risk mitigation and risk avoidance strategies
• Secure, with protections from unauthorized access and for data
• Self-aware, self-monitoring, and self-protecting against intrusion
• Fully tested and verified
• Designed for quality of service—speed, availability, adequate coverage, and minimal latency (delays in processing data)
• Built-in redundancy to compensate for assumed failure and overload
• Support for legacy technology
• Easy to repair
TopObstaclestoBuildinga High-Reliability Infrastructure
• Failure to catalogue all the requirements and intended uses of wireless devices that currently use, or will use, the infrastructure
• Failure to assess the existing infrastructure and its capabilities
• Failure to plan for BYOD (Bring Your Own Device) and BYOI (Bring Your Own Infrastructure) realities
• Lack of agility in anticipating and planning for change
• Failure to account for the true cost of implementation
• Lack of agreement on standards for safety
192012 AAMI Wireless Workshop© AAMI
Lead User ProfileKaiserPermanenteThe Goldilocks Challenge
kaiser Permanente offers Wi-Fi connec-tivity for guest access at nearly 150 sites, with plans to provide this
connectivity to 800 sites. Guest access is important to Kaiser in providing patients and families with positive healthcare experiences. Right now, some 25,000 users are on the network at any one time, at an aggregate bandwidth usage of 150 Mbps.
Future plans include offering a “digital health strategy,” with member-facing services that allow auto sign-on for Kaiser Perma-nente members; mapping and “wayfinding” on member smartphones with a Kaiser Permanente app; and notifying personnel
about prescriptions, lab results, and more. These plans may be augmented and lever-aged as a Bring Your Own Device/Network Access Control (BYOD/NAC) remediation VLAN (virtual local area network). This solution has the potential to serve as an onboarding mechanism for new devices, such as employee devices, using a down-loaded, automated configuration package.
Managing this infrastructure requires choosing just the right infrastructure tech-nology, vendor, and design methodology to support current and future plans. It’s what Kaiser’s Shawn Jackman calls “the Goldilocks challenge.” To get the mix just right, Kaiser attends to these Wi-Fi design considerations:
Wi-FiDesignConsiderations• Plan for voice and video• Use a real-time locating system (RTLS) to
identify and track the location, status, and movement of devices and people for general positioning, with an infrastructure of location sensors (overlay) needed
• High availability• Consider 3D RF propagation• Don’t rely on automated RF configuration
features• Plan for heavy guest access use• Client power/capability imbalance• Outdoor uses• Remote, offsite events
Jackman characterized the Goldilocks challenge as follows:• Physical layer (PHY) rates—the speeds at
which devices communicate via an access point or AP—are directly proportional to signal quality.
• The number of transmitters on the same channel is inversely proportional to performance.
According to Jackman, two aspects of the infrastructure are underemphasized in healthcare today: the importance of managing
client devices (wireless devices and accessories that use the wireless infrastructure) and radio firmware that controls network connectivity. To address these issues, he recommended these considerations:
Client Device Considerations• Precisely manage client radio firmware
versions that control network connectivity.• Understand client settings are equally as
important as infrastructure.• Consider radio characteristics: frequency(s)
of operation, antenna(e), Tx/Rx power.• Assess device density; plan for a high
amount of device growth.• As devices are not created equal, baseline
them against each other to guide design standards and support efforts.
It is also important to provide fast, secure roaming (FSR) as an optimized way of quickly moving devices between APs to maximize performance.
“Hospitals are now Internet service providers. Get used to the idea.” — Shawn Jackman, principal, manager, wireless product management
and engineering at kaiser Permanente
20 2012 AAMI Wireless Workshop © AAMI
Unifying Theme 4: Learn from other industries.
“Even the best safety standards are useless unless they are actually implemented.” — yukiya Amano, director general of the International
Atomic Energy Agency, urging a worldwide safety review after Japan’s fukishima nuclear disaster
Challenge Priority Action Accountability
Lack of agreement on standards and other guidance for wireless safety, security, testing, and reliability
Empanel a team to survey existing standards, policies, guidance documents, and best practices in healthcare and other industries (e.g., guidance on cybersecurity for manufacturing). find and address gaps and vague language. develop consensus on which standards and guidance should be used consistently by medical device developers. Share findings in a white paper and bibliography. Commission case studies of both successes and failures.
AAMI, IEEE, nISt, fdA, other Sdos
Establish minimum, baseline security standards for specific environments that healthcare delivery organizations can use in requests for proposals.
All stakeholders
Consider “medical grade” wireless standards. Sdos Industry
The Role of Standards, Guidance, andBestPracticesWorkshop participants are charting new territory in their efforts to develop and implement wireless technology in healthcare. Standards, guidance, and sharing of best practices are not keeping up with the demand for roadmaps for this work.
Standards do exist—but gaps and vague language inhibit their usefulness and, hence, their actual use, workshop participants said. Likewise, guidance and best practices are
lagging behind wireless implementations. “Add to this the lack of qualified wireless personnel in healthcare organizations and it creates a situation where wireless applica-tions do not meet their intended use cases,” said Brian Long of Masimo.
But many other high-risk industries are tackling similar challenges with standards, policies, guidance, and best practices. Workshop participants are eager to learn from these industries, and from best practi-tioners in healthcare. Participants also called
212012 AAMI Wireless Workshop© AAMI
• ANSI/AAMI/IEC TIR 80001-2-1:2012, Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks; Practical applications and examples
• ANSI/AAMI/IEC TIR 80001-2-2:2012, Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls
• ANSI/AAMI ISO 14971:2007, Medical devices - Application of risk management to medical devices
• ANSI/AAMI/IEC 80001-1:2010: Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities
• ANSI/AAMI/IEC TIR 80001-2-3:2012, Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks
• AAMI TIR18:2010 -- Guidance on electromagnetic compatibility of medical devices in healthcare facilities
• ANSI C63.18, Recommended Practice for an On-Site, Ad Hoc Test Method for Estimating Radiated Electromagnetic Immunity of Medical Devices to Specific Radio-Frequency Transmitters
• FDA Draft Guidance: Radio-Frequency Wireless Technology in Medical Devices
• IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
• IEEE 802®: Overview & Architecture
• IEEE 802.1™: Bridging & Management
• IEEE 802.2™: Logical Link Control
• IEEE 802.3™: Ethernet (Carrier Sense Multiple Access with Collision Detection (CSMA/CD) Access Method and Physical Layer Specifications
• IEEE 802.11™: Wireless LANs
• IEEE 802.15™: Wireless Personal Area Networks (PANs)
• IEEE 802.16™: Broadband Wireless Metropolitan Area Networks (MANs—”Wi-Max”)
• IEEE 802.17™: Resilient Packet Rings
• IEEE 802.20™: Mobile Broadband Wireless Access
• IEEE 802.21™: Media Independent Handover Services
• IEEE 802.22™: Wireless Regional Area Networks
• IEEE 473-1985, IEEE Recommended Practice for an Electromagnetic Site Survey (10 kHz to 10 GHz)
• IEEE 11073-00101:2008, Healthcare informatics – PoC medical device communication: Part 00101: Guide – Guidelines for the use of RF wireless technology
• ISO/IEC 15408-2:2008, Information technology – Security techniques –- Evaluation criteria for IT security – Part 2: Security functional components
• ISO/IEC 27001:2005, Information technology – Security techniques – Information security management systems – Requirements
• ISO/IEC 27002:2005, Information technology – Security techniques – Code of practice for information security management
ExIStInG StAndARdS And GuIdAnCE foR WIRELESS tECHnoLoGy
22 2012 AAMI Wireless Workshop © AAMI
for a concerted effort to examine the state of the art in wireless technology and to dissemi-nate findings broadly. Where there are gaps in standards, or where standards are lacking, they support efforts to develop additional standards.
In healthcare, as in other industries, it’s important to express security requirements in a common way—and to design security to allow for the adoption of new technology and adaptation for security threats that are constantly changing. Developing standard approaches to testing, and usability stand-ards, are important security steps as well.
“Medical Grade” Wireless StandardsAn emerging concern of workshop partici-pants is the increasing use of consumer devices and medical applications that run on them—without medical equipment standards.
Smartphones and tablets are communicat-ing with medical devices using applications, thus putting these consumer devices “in charge” of the communication, according to workshop presenter Bill Saltzstein, president,
connectBlue, Inc. Effectively, there are a whole new set of
medical devices, developers, and
designers, raising a number of issues and challenges, including:• Inexperience with medical device
development – Insufficient understanding by app developers on why regulatory agencies need to be involved.
– Lack of distinction between a fitness vs. a medical device
– Different mindset of quality – No understanding of hazard/risk analysis – Disbelief that apps can kill
• Off-the-shelf hardware and software – A challenge that predates wireless technology, and one for which the FDA has issued guidance, but the challenge now is consumers installing apps on platforms that cannot be configured or managed by healthcare technology managers. So, if a vendor verifies with a certain operating system (OS) release, it is likely that by the time the user installs the app, it will be on a newer version of that OS
• Multiple wireless interfaces• Interference/coexistence• Security
This will require educating the new medical device development community on the hows and whys of device development processes and hazard analysis, Saltzstein said.
Elliot Sloane of the Center for Healthcare Information Research and Policy suggested that there could be value in “medical grade”
wireless standards, akin to existing Medical Grade Oxygen and
Hospital Grade Electrical Outlets standards.
Wireless devices and applications have a direct role in patient care.
232012 AAMI Wireless Workshop© AAMI
“Discussion, collaboration, standardiza-tion, and coordination of safe and orderly coexistence among many wireless healthcare devices and applications would help immensely, and probably cannot be ignored for much longer,” Sloane said. Issues that need to be addressed include:• Frequency allocations• Quality of service• Priority management• Bandwidth management• Security and access management
At this point, cautioned workshop presenter Steve Baker, senior principal engineer, Welch Allyn, “No one may declare that a network meets the requirements of a medical device except the manufacturer of that device. Simply being marketed as ‘medical grade’ does not mean that it is approved by the device manufacturer or the FDA. A cellular provider cannot say its products are medical grade. The definition of medical grade depends on the intended use.”
Regulatory Perspective: Key Considerations for Wireless Medical DevicesWorkshop presenter Don Witters, regulatory review scientist, Center for Devices and Radiological Health, FDA, said that safe, effective, reliable, and secure medical devices should be designed and deployed with the following considerations, which will ensure their performance now in the future.
• Selectionandperformanceofwirelesstechnology. “My approach is to be fre-quency agnostic,” Witters said. “Whatever you choose, test and manage it.”
• Wirelessqualityofservice(QoS). “I am heartened by the conversation I’ve heard [at this workshop], with the discussion of quality of service and medical devices together,” he said.
• Wirelesscoexistence.“It’s important to associate wireless with components that are going to use it,” he said. “What does the quality of service need to be for it to work properly? If you need certain reliability, this is where you start to describe that.” Witters added that the American National Stand-ards Institute (ANSI) has started a group
working to develop a coexistence test method and standard.
• Impactonotherdevices.As a part of wireless infrastructure preparation for a medical grade environment, it’s important to check to ensure that one device doesn’t make it impossible for a second device to operate. Some wireless experts contend that this is easy to do, but medical device experts who have done installations and see the vast differences between hospitals know something very different. It’s extremely difficult to codify this type of check-in requirements.
• Wirelesssecurity. Assessing the appropri-ate wireless security requirements must be accounted for with all medical applications.
• Electromagneticcompatibility(EMC).The collateral standards that accompany IEC 60601-1 cover requirements for EMC including emissions, electrostatic dis-charge (ESD), and susceptibility. A medical grade wireless infrastructure should be tested to these standards and provide some way of assuring that the wire-less infrastructure: a) does not cause performance issues with the medical devices it supports, and b) provides a reliable data connection.
• Informationforset-upandoperation.Wireless infrastructure manufacturers need to provide best practices for the design and implementation of the variety of devices that may exist in healthcare environments.
• Maintenance. As new software, features and capabilities become available, health-care organizations must assess the impact on already-deployed applications before deploying new solutions—and have a backup plan if things go south.
24 2012 AAMI Wireless Workshop © AAMI
Unifying Theme 5: Manage risk and prevent failure—Patient safety comes first.
“Hold on! There’s safety involved here.” — bill Saltzstein, president, connectblue, Inc.
Challenge Priority Actions Accountability
Inadequate recognition that wireless technology could jeopardize patient safety
Make patient safety the top priority of wireless medical technology in hospitals, distributed care settings, and for patient transport and mobility. design wireless devices, networks, and system components for failure, using engineering principles and strategies.
Hdos Wireless infrastructure and component providers Industry
Inadequate attention to risk management
use AnSI/AAMI/IEC 80001-1:2010: Application of risk management for IT Networks incorporating medical devices to manage risk, and the AAMI technical Information Report (tIR) on risk management.
Hdos tJC and other accrediting organizations
Prioritize wireless technology by risk level to patient safety and clinical applications. Conduct hazard analyses.
Industry Hdos
develop a standard approach to performance testing. Plan for the cost of testing and maintenance during design. view testing as a system that requires ongoing monitoring. define testing responsibilities and staff testing appropriately. Allow adequate time for testing and verification.
Industry Hdos
Inattention to clinical needs, patient care settings, and workflow
define clinical users and characterize use environments. design wireless devices, networks, and systems to meet user needs in environments of care.
Industry Hdos
develop usability standards (e.g., a wireless icon, understanding of who the user is, a link between applications and wireless issues). Simplify the user interface.
Sdos Industry
Improve the efficiency of the clinical workflow. Hdos
252012 AAMI Wireless Workshop© AAMI
Manage RiskAs with all medical technology, patient safety is too often an afterthought in wireless technology design, development, and imple-mentation—a challenge that pertains to both industry and healthcare delivery organiza-tions. Workshop participants advocated for making patient safety the top priority, the driver of wireless technology design, usabil-ity, testing, and risk management.
For healthcare delivery organizations, the focus must be on risk management.
The place to start is with the ANSI/AAMI/IEC standard 80001-1:2010: Application of Risk Management for IT-Networks Incorporat-ing Medical Devices—Part 1: Roles, Responsibilities, and Activities. Just what is 80001? It’s a standard that “introduces a new framework for managing safety and security when medical devices are included on a convergent, heterogeneous IT-network,” according to AAMI.
The standard identifies the activities necessary to maintain key properties of the network—safety, effectiveness, and security. This standard, and guidance and tools associated with it, helps healthcare delivery organizations prioritize high-risk technology to focus on; discover emergent, or unexpected, properties in IT networks; and assign roles and responsibilities to risk management.
Workshop presenter Todd Cooper, co-chair of the ISO/IEC 80001 Joint Working Group 7, outlined current approaches to manage risk arising from the increasing deployment of devices in multi-vendor/multi-modality networking environments.
In one example, he highlighted a situation in which a hospital aimed to virtualize its infusion pump server. However, the hospital allowed oversubscription to increase average utilization. For 18 months, hospital and technology providers chased intermittent system malfunctions.
By implementing the network risk man-agement standard IEC 80001, first published in 2010, Cooper revealed, the hospital was able to define critical operational require-ments, identify hazards and risks (severity and probability), and deploy risk controls (e.g., bandwidth alerts).
In another example, a hospital acquired a new radiology system, which it was in the
process of integrating and testing. However, management wanted to meet annual goals and pushed to have the system “go live” even though the deployment processes had not been completed.
Using 80001, the hospital was able to define organizational roles and responsibili-ties and a risk management policy and process, identify violation of the policy and process, leading to an executive “signoff” and assumption of responsibility.
According to the IOM’s 2011 report, Health IT and Patient Safety: Building Safer Systems for Better Care, health IT may lead to safer care and/or introduce new risks. Because system-level failures almost always occur from unforeseen combinations of component failures, the report recommends that health-care accrediting organizations adopt criteria relating to EHR safety; that all health IT vendors be required to publicly register and list their products, as well as adopt quality and risk management processes; and that reporting of health IT-related adverse events should be mandatory for vendors and voluntary and confidential for users.
These recommendations align, Cooper said, with the main elements of 80001. According to the standard, a hospital medical-IT network’s “key properties” include:• Safety—freedom from unacceptable risk of
physical injury or damage to the health of people or damage to property or the environment.
• Effectiveness—the ability to produce the intended result for the patient and the responsible organization.
• Dataandsystemsecurity—an operational state in which information (data and systems) is reasonably protected from degradation of confidentiality, integrity, and availability. Accountability is key.
As Cooper noted, 80001-1 is only the first of a series of standards in this growing area. Several other related technical reports (TIRs)
“AtPartnersHealthCare,weareuniquelyparanoid and proud of it.” — Rick Hampton, wireless manager,
Partners HealthCare
26 2012 AAMI Wireless Workshop © AAMI
in process include 80001-2-1 on step-by-step risk management; 80001-2-2 on communica-tion of medical device security needs, risks and controls; and 80001-2-3 on wireless networking.
BottomLineUpFront(BLUF)Partners HealthCare’s Rick Hampton delivered a presentation prepared by Andrew McGraw, medical device Information Assurance project manager, U.S. Air Force, with risk perspectives from the military. McGraw’s BLUF (Bottom Line Up Front) message about risk: • Operational risk is a reality.• Zero risk is impossible.• Some risk is needed.• Ignoring risk is foolish.• Allowing or avoiding too much risk results
in mission failure.
Like the healthcare industry, defense has a difficult time meeting every requirement on devices themselves, according to McGraw. But risk is a reality. So risk management at the wireless operating system, network, and system levels must be business as usual as well. Strategies for risk management at these
levels include encrypting information, authenticating users and uses, installing a wireless intrusion prevention system (WIPS) on the network, embedding fire-walls, filtering wireless traffic with access control lists
(ACLs), and isolating sensitive data.
PreventFailuresIn industry, patient safety considerations should begin in the design phase, with “design for failure” as the guiding principle. “No single-fault failure should result in a high-risk event,” said Steve Baker, senior principal engineer, Welch Allyn. In other words, if some part of a wireless system, network, device, or component fails, other parts of the system should continue to operate, even at reduced level, without putting patients at risk. “Seek and destroy single-fault failures,” he said.
“Consider cascading failure events,” he added. In other words, how likely is it for that
initial failure to precipitate additional failures or disruptions in service? “It is amazing the many ways that things can be broken.”
Reliability must be designed into the system. Just bolting reliable equipment together can result in an unreliable system. Instead, Baker offered this sequence of activities for systems design, which is relevant both to industry providers designing wireless products and connectivity services and to healthcare delivery organizations integrating wireless technology into their enterprises:• Define the requirements
– Conduct a failure modes and effects analysis (FEMA)
– Conduct a hazards analysis• Implement • Test each component and subsystem• Test the system• Go live• Test the live system
Baker and other workshop participants emphasized that adequate budget, time, and professional skills are required for testing and verification.
(The AAMI/FDA Interoperability Summit that preceded the Wireless Workshop explored systems design in detail. To learn more about systems design, see that report at www.aami.org/interoperability/Interoperability _Summit_publication.pdf).
Baker offered some specific solutions to guard against and mitigate Wi-Fi failure:• Make use of fail-over redundancy sup-
ported by servers and infrastructure• Ensure redundant RF coverage with
interleaved backhaul (every other AP’s Ethernet backhaul is to a different Power over Ethernet, or PoE, switch)
• Ensure uninterruptible power supply (UPS) backup
• Establish robust connections, drivers, and middleware
• Support 6Mbps data rate for maximum coverage and to minimize loss
• Follow wireless infrastructure design guide best practices to maximize coverage and minimize loss
• Consider disabling 802.11b support• Use best-in-class security
– WPA2 Enterprise and PSK – FIPS 140-2
“No single-fault failure should result in a high-risk event.” — Steven baker, senior
principal engineer, Welch Allyn
272012 AAMI Wireless Workshop© AAMI
Even with rigorous safety measures, “all medical device manufacturers still have ‘problem’ sites that exhibit worse RF perfor-mance than the rest,” Baker said. In some cases, the physical facility impedes wireless performance. Failure to take facility con-straints into account, and plan for them during design, can compromise wireless service and performance.
Another worrisome reality is that health-care delivery organizations make changes to wireless devices, networks, or systems without notifying others within their organi-zations, let alone the manufacturer, Baker said. For safety’s sake, it’s important to collaborate with internal and external stakeholders when changes are made—and it’s important to document changes as well.
Workshop participants recommended using additional tools and strategies to ensure the safety and security of wireless technology, including fault tolerance and software assurance. Fault tolerance is the ability of a system to respond gracefully to unexpected hardware or software failures, or power outages, with duplication built in so if one system fails, another can take over. Software assurance is a rigorous regimen of tools and processes to test and validate software to ensure safe and secure operations and reduce vulnerabilities to breaches and other threats.
The needs of clinical users tend to take a back seat in wireless technology design, development, and implementation as well, workshop participants said. Wireless technol-ogy is not always easy to use—and clinicians do not always have the skill set to trouble-shoot problems. Designing wireless devices, networks, and systems to meet clinical needs in patient care settings, including hospitals, distributed care environments, and for patient transport and mobility, is paramount.
Participants also called for the develop-ment of usability standards to express users’ needs, and attention to the clinical workflow to enable clinicians to make better use of wireless technology. Streamlined clinical processes would facilitate industry design of wireless products and services that are easier to integrate into healthcare.
Workshop participants also recommended the use of onboard diagnostics and remote
diagnostic capability, which would help healthcare technology managers identify and correct any issues or failures with wireless technology, take the burden of handling wireless issues away from clinicians, and avert patient harm. In addition, they recom-mended proactive battery management to keep wireless technology powered without unanticipated interruption.
ANSI/AAMI ES60601-1:2005Medical electrical equipment—Part 1: General requirements for basic safety and essential performance(Includes Amendment 1:2012)
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Association for the Advancement of Medical Instrumentationwww.aami.org
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MI ES 60601-1:2005/(R
)2012
AAMI Standards and Recommended Practices
ANSI/AAMI ES60601-1:2005/(R)2012and C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text)
Medical electrical equipment— Part 1: General requirements for basic safety and essential performance(IEC 60601-1:2005, MOD).
Testing, Testing: What Medical Device Manufacturers and Hospitals Can Do
What an MDM Can Do• Define system-level performance specification
(e.g., latency, traffic types)
• Characterize device and radio performance specification (e.g., QoS, security)
• Establish RF environment requirements (e.g., received signal strength indication or RSSI; signal-to-noise ratio, or SNR)
• Provide device-specific intended use(s)
• Test to some specific wireless local area net-work (WLAN) vendor configurations
• Test to ensure there is minimal to no negative impact on clinicians from the network
What an MDM Cannot Do• Test to a specific hospital RF environment
• Test every network topology
• Create a replica environment of hospital devices (coexistence)
• Test every variation of WLAN vendor configuration (standard and proprietary)
What Hospitals Should Do• Apply a risk management umbrella within the
design, deployment, and management of a medical IT network
• Understand clinical use, networking perfor-mance, and characteristics of end devices
• Know your WLAN vendor (read the manual)
• Test according to hospital RF environment, network topologies, configurations, device coexistence
When to Test• Changes to the network & devices
– WLAN configuration – New device(s) introduction – WLAN physical layout – New construction (RF environment
changes) • Consider risk management as a tool to identify the “when”
– If the risk level is high and testing decreases the probability or severity of unintended consequences, then test
• Compare the difficulty in testing vs. the diffi-culty in recovering from network failure
• Example:
– Test failover recovery on a redundant controller
What to Test• Depends on what has changed (risk review)
• Include regression testing
– Existing devices included for interoperability
• Both medical and non-medical devices
– New VoIP devices added to hospital WLAN
– WLAN vendor software upgrade – WLAN configuration changes (vendor
recommended, QoS implementation, security upgrade to RADIUS)
– APs added or AP location changed
• Interoperability between WLAN and device configurations
Just who is responsible for testing wireless medical technology? Workshop presenters Phil Raymond, wireless architect, Philips Healthcare, and Welch Allyn’s Steve Baker offered the following advice to medical device manufacturers (MDMs) and hospitals, as well as specific advice on when, where, and how to test:
• Basic connectivity of all devices
– Example: IT security certificates SNAFU – From device to server, not just “on” the
network – Test procedures are not just a set of
check boxes!
• Long-term operation
– 24 to 96 hours
• Roaming or device handover
– AP to AP, ward-to-ward
• WLAN Load
– Particularly with new devices, test on single AP if not actual network
Where to Test• Small clinic or IT network in a non-patient area
of the hospital
• Pros:
– Isolated physically and logically: Elimi-nate direct risk of connected patients
– Uses IT network configurations – Includes both medical and non-medical
traffic
• Cons:
– Requires changes (additions, modifica-tions) to IT network configuration (consider a permanent test subnet/VLAN to mitigate this)
– May need to coordinate scheduling with IT and hospital administration
– Test traffic pathways require definition: routing, etc.
• A stand-alone lab
• Pros:
– Test when needed with full control over network configurations
– Physically isolated from hospital IT network
• Cons:
– Smaller network footprint (fewer network devices, less complex)
– Device numbers not representative of IT network loading
• Use a phased approach from isolated testing IT to network testing live-patient, high-confidence testing
How to Test• Not on patients! Most devices have demo modes.
• Collaborative effort
– In hospital—clinical engineering CE and IT
– External to hospital—MDM and network manufacturer
• Understand device-level networking requirements
• Understand and duplicate current production configuration
– Device configuration – WLAN configuration—duplicate
hospital network configuration
• Proper tools
– Site survey tool (RSSI, SNR, Interference) – Wireless and wired packet capture – WLAN and device manufacturer built-in
performance monitoring tools
• Test device, WLAN, configurations prior to going live
30 2012 AAMI Wireless Workshop © AAMI
Conclusion and Next Steps
the AAMI Wireless Workshop had a “roll up our sleeves, get to work, and get something done” flavor to it. In two
days, 75 wireless experts in healthcare, developed specific priority actions, offered smart solutions, and recommended organiza-tions that could take the lead on solving the most urgent challenges.
After struggling for some time to address these issues on their own, these experts are eager to engage a broader group of stakehold-ers to improve patient safety in an increasingly wireless world.
AAMI is not a “wireless” organization, nor does it inherently possess wireless expertise. AAMI does, however, know how to convene experts, and that is exactly what it has done and will continue to do to “do our part.”
The follow-up work has already begun. After the workshop, AAMI formed a wireless task force, a small group of experts who have graciously agreed to keep this moving forward. The group will meet in March 2013 to clarify and refine the work and determine what is best suited for standards-setting organiza-tions, healthcare delivery organizations, the medical technology industry, wireless infra-structure providers, and so on. Some challenges will require collaboration among different stakeholders, which is exactly the spirit in which all of this work should proceed.
Bob Stiefel ([email protected]) will coordinate and manage the task force for AAMI. When the task force has completed its work, it will disband or morph into some-
thing else, yet to be determined. In the meantime, here’s a heads-up: AAMI or the wireless task force might be nudging other organizations to take on projects that are clearly needed.
If you have made it through this publication and are pondering what your organization can do to help, thank you. Real progress will take many organizations and committed individu-als doing their part. Together, we can create a wireless world in which patient safety comes first, wireless medical technology is more secure and reliable, and the healthcare community harnesses the wireless waves for maximum effectiveness.
AAMI Guidance For Healthcare Providers Managing Medical IT-Networks
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ANSI/AAMI/IEC 80001-1:2010, Application of risk management for IT Networks incorporating medical devices— Part 1: Roles, responsibilities and activities
Order Code: 8000101 or 8000101-PDFList $100 / AAMI member $50
ANSI/AAMI/IEC 80001-1: 2010Application of risk management for IT Networks incorporating medical devices—Part 1: Roles, responsibilities and activities
American National Standard
ANSI/AAMI/IEC TIR80001-2-1:2012, Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks; Practical applications and examples
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ANSI/AAMI/IEC TIR80001-2-2:2012, Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the communication of medical device security needs, risks and controls
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ANSI/AAMI/IEC TIR80001-2-3:2012, Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks
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© AAMI2012 AAMI Wireless Workshop32
Editor’s Note: This glossary of wireless networking terms and definitions is based on one from the wireless guidance technical report, ANSI/AAMI/IEC TIR80001-2-3:2012; Application of risk management for IT-networks incorporating medical devices—Part 2-3: Guidance for wireless networks. Reprinted from AAMI Horizons “Managing Medical Devices on the IT Network.”
802.11: a series of IEEE standards that relate to wireless local area networks typically in the 2.4GHz ISM and 5GHz ISM and unlicensed national information infrastructure (UNII) bands
802.11A: an IEEE standard that relates to wireless local area networks in the 5GHz ISM and UNII bands
802.11B/G: an IEEE standard that relates to wireless local area networks in the 2.4GHz ISM band
Access Point (AP): a bridge from a wireless medium to a wired medium
Advanced Encryption Standard (AES): a symmetric-key encryption standard. One of its uses is for the WPA2 wireless encryption standard.
Body Area Network (BAN): a network of wireless sensors placed on the human body that communicate with each other
Basic Service Set Identifier (BSSID): an 802.11 term for the MAC address of an AP
Bootstrap Protocol (BOOTP): a network protocol used by a network client to obtain an IP address from a configuration server
Encoder/Decoder (CODEC): a module that can encode data and decode data
Chief Information Officer (CIO): person in the organization who is responsible for IT strategy and deployment
Data Integrity: assurance that transmitted files are not deleted, modified, duplicated, or forged without detection
Digital Enhanced Cordless Telecommunications (DECT): a digital communication standard, which is primarily used for creating cordless phone systems
Distributed Antenna System (DAS): an antenna system that collects wireless signals and routes them to centralized locations
Dynamic Frequency Selection (DFS): a mechanism for dynamically selecting frequencies to avoid interference sources – usually used in conjunction with the mechanism 802.11A-based systems use to avoid frequencies used by radar systems
Dynamic Host Configuration Protocol (DHCP): a method to allocate IP addresses to client devices upon request by the client
Extensible Authentication Protocol (EAP): an authentication framework frequently used in wireless networks and Point-to-Point connections. It is defined in Request for Comments (RFC) 3748 and was updated by RFC 5247
Extensible Authentication Protocol – Transport Layer Security (EAP-TLS): a specific authentication method using the EAP authentication framework (RFC 5216)
Electromagnetic Interference (EMI): degradation of the performance of a piece of equipment, transmission channel, or system (such as medical devices) caused by an electromagnetic disturbance
Electronic Medical Record (EMR): a computerized medical record created in an HDOElectronic Protected Health Information (EPHI): any protected health information (PHI) which is stored, accessed, transmitted or received electronically
Extended Service Set Identifier (ESSID): a term that describes a logical grouping of multiple BSSIDs NOTE: This term is sometimes used in place of SSID.
Frequency Hopping Spread Spectrum (FHSS): A method of transmitting radio signals by rapidly switching a carrier among many frequency channels, using a pseudorandom sequence known to both transmitter and receiver
Hazardous Situation: circumstance in which people, property, or the environment are exposed to one or more hazard(s)[ISO 14971:2007, definition 2.4]
Healthcare Delivery Organization (HDO): a facility or enterprise such as a clinic or hospital that provides healthcare services
Health Insurance Portability And Accountability Act (HIPAA): legislation enacted in the United States that among its provisions requires the protection of Protected Health Information (PHI)
Go-Live: the point at which a system transitions from the installation phase to the active use phase
Immunity: the ability of an electrical or electronic product to operate as intended without performance degradation in the presence of an electromagnetic disturbance.
Intensive Care Unit (ICU): a defined area or department in the hospital allocated for critically ill patients, sometimes also referred to as an Intensive Therapy Unit (ITU)
Internet Group Multicast Protocol (IGMP): a communications protocol used by hosts and adjacent routers on IP networks to establish multicast group memberships
Intrusion Detection System (IDS): a system that monitors the wireless environment and detects unauthorized uses such as “rogue” access points, viruses, worms, etc.
Internet Group Multicast Group (IGMP): a communications protocol used to manage the membership of Internet Protocol multicast groups
Intrusion Protection System (IPS): a system that includes an IDS and actively attempts to block system intrusions
Information Technology (IT): synonymous with Information Systems, as used in many HDOs
Industrial, Scientific, and Medical (ISM) Band: certain radio bands that were originally reserved internationally for the use of radio frequency (RF) energy for industrial, scientific and medical purposes
Latency: the time it takes for a unit of information to cross a wireless link or network connection, from sender to receiver, also known as transfer delay
Local Area Network (LAN): a computer network covering a small physical areaNOTE: In 802.3 parlance, a LAN is a set of devices that share a broadcast domain.Media Access Control (MAC): part of the Link Layer in the Open System Interconnection Reference Model
GLoSSARy
332012 AAMI Wireless Workshop© AAMI
Medical Device Manufacturer (MDM): a manufacturer of medical devices
Multiple-In Multiple-Out (MIMO): the use of multiple antennas at both the transmitter and receiver to improve communication performance
Multicast Addressing: a technology for delivering a message to a group of destinations on a network simultaneously
Personal Area Network (PAN): a computer network used for communication among computer devices, including telephones and personal digital assistants, in proximity to an individual's body
Personal Communication Services (PCS): term used for the 1900 MHz band that is used for digital mobile phone services in North America
Physical Interface (PHY): the layer of a communication controller that interfaces to the physical world
Portable Digital Assistant (PDA): a small computing device used for applications such as maintaining a personal diary or schedule
Pre-Shared Key (PSK): a shared secret that was previously shared between the two parties to be used for the encryption of data to be communicated between them
Quality of Service (QoS): A level of performance in a data communications system or other service, typically encompassing multiple performance parameters, such as reliability of data transmission, transfer rate, error rate, and mechanisms and priority levels for time-critical signals
Radio Frequency (RF): a rate of oscillation in the range of about 30 kHz to 300 GHz, which corresponds to the frequency of radio waves, and the alternating currents which carry radio signals
Radio Frequency Identification (RFID): identification of objects or persons using special tags that contain information (such as demographics, serial number, etc.) that can be read using RF based readers
Received Signal Strength Indicator (RSSI): a measure, typically in dBm, of the RF power detected by a receiver
Security: a collection of services, policies, and mechanisms that provides some level of assurance that unauthorized parties are meaningfully restricted from accessing, manipulating, or leveraging particular system resources NOTE: Some security services might include data encryption, data integrity-checking, user and device authentication, and non-repudiation.
Service Level Agreement (SLA): the necessary level of performance in a data communications system or other service, typically encompassing multiple performance parameters, such as reliability of data transmission, transfer rate, error rate, and mechanisms and priority levels for time-critical signals NOTE: A typical network services SLA covers metrics such as availability, latency and throughput. It can also include specifications for mean time to respond, mean time to repair and problem notification/escalation guarantees. In wireless systems, examples include data rate, signal strength, jitter, and latency.
Simple Network Management Protocol (SNMP): an Internet-standard protocol for managing devices on IP networks
Signal to Noise Ratio (SNR): a comparison of signal power to noise power
Susceptibility: the potential for equipment (including medical devices) to respond to an electromagnetic disturbance. The inability of a device, equipment or system to perform without degradation in the presence of an electromagnetic disturbance. Note: Susceptibility is a lack of immunity.
TCP: one of the core protocols within the Internet protocol suiteNOTE: Differs from UDP in that TCP is acknowledged and connection oriented
Temporal Key Integrity Protocol (TKIP): this was an interim security solution that legacy hardware could support when WEP was found vulnerableNOTE: Also known under the 802.11 branding as WPA
User Datagram Protocol (UDP): one of the core protocols within the Internet protocol suiteNOTE: Differs from TCP in that UDP is not acknowledged and connectionless oriented.
Validation: a process or test to determine if the device, under actual or simulated use conditions, conforms to defined user needs and intended uses
Verification: a process or test to determine if the device performs according to design and development input specifications
Virtual Lan (VLAN): a group of hosts that communicate as if they were attached to the same broadcast domain, regardless of their physical location or physical attachment to the same network switch
Voice over Internet Protocol (VoIP): a technology that allows telephone calls to be made over computer networksNOTE: A typical CODEC, the G.711 consumes a network bandwidth of 64 kbps comprised in 50 packets per second.
Vulnerability: See latency, security and susceptibility.
Wide Area Network (WAN): A network that covers a very broad area (i.e., any network whose communications links cross metropolitan, regional, or national boundaries)
Wired Equivalent Privacy (WEP): the original security mechanism of 802.11 has been superseded by TKIP (aka WPA) for legacy devices and AES (aka WPA2) for all 802.11 certified devices since 2006
Wireless Coexistence: the ability of one wireless system to perform a task in a given shared environment where other systems (in that environment) have an ability to perform their tasks and might or might not be using the same set of rules
Wireless Fidelity (WI-FI™): a trademark of the Wi-Fi Alliance
Wireless Local Area Network (WLAN): a Local Area Network (LAN) in which devices communicate using wireless means (such as 802.11 based technology)
Wireless Medical Telemetry Service (WMTS): a wireless service (set of RF bands) specifically defined in the United States by the Federal Communications Commission (FCC) for transmission of data related to a patient's health (biotelemetry)
Wi-Fi Multi-Media (WMM): a subset of the 802.11e standard that provides a higher Quality of Service for delivery of messages for some traffic classes
Wi-Fi Protected Access (WPA): an interim security solution that fixed many of the weaknesses in WEP and could be implemented on legacy hardware designed to implement WEP
Wi-Fi Protected Access 2 (WPA2): The long-term security solution put in place to replace WEP and WPANOTE: WPA2 uses the Advanced Encryption Standard and adds security features such as a message integrity check.
34 2012 AAMI Wireless Workshop © AAMI
ACknoWLEdGMEntS
Workshop Presenters
Steve Baker Welch Allyn
Todd Cooper 80001 Experts
Ken Fuchs Mindray
Mark Gibson Comsearch
Rick Hampton Partners HealthCare
Shawn Jackman Kaiser Permanente
Ira Keltz Federal Communications Commission (FCC)
Phil Raymond Philips
Bill Saltzstein connectBlue, Inc.
Elliot Sloane Center for Healthcare Information Research and Policy
Peter Thornycroft Aruba Networks
Donald Witters U.S Food and Drug Administration
Writing
Martha Vockley Vockley•Lang
Erika Hatva AAMI
Kristin Blair, Design AAMI
West Health www.westhealth.org
Aaron Goldmuntz [email protected] 202-729-8568
A special thank you to West Health for supporting both the workshop and the publication.
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Health Information Technology Collection: A Biomed’s Guide
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It examines:
• Device connectivity
• IT Security, bots, malware, and spyware
• Integrating patient data
• Network management and applying 80001
• Picture archiving and communications systems (PACS)
• Radio frequency identification technology (RFID)
• Networked medical devices
• Bluetooth wireless technology
The CD features a detailed glossary of terms, and a convenient search function.
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This comprehensive CD includes more than 200 articles from AAMI publications, specifically on major IT issues in the medical profession.
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