5

Health Care Technologies in the Home

Hospital patients today are being discharged sooner than in the past, sometimes with complex continuing care plans that require the use of medical technologies in the home for an extended period following discharge, if not permanently. Some of these technologies are simple, and others are quite sophisticated and require that care recipients and/or their caregivers be trained in their use; retraining is also often needed. Evidence from the Agency for Healthcare Research and Quality suggests that, for some individuals, electronic tools may become important adjuncts to treatment, improving medication adherence or enabling delivery of mental health interventions, such as cognitive behavioral therapy on demand (Gibbons et al., 2009).

Care recipients and health care consumers are generally becoming more engaged in managing their own health and health care. Self-help and wellness books regularly make the bestseller lists, online health information seeking has increased dramatically over the last decade, and people are purchasing various devices and software to monitor and maintain their own health (e.g., to measure their blood sugar, check their blood pressure, log exercise). Some types of medical devices have become de facto consumer products, and more and more individuals expect to be able to choose products that suit their lifestyles and are convenient and easy to use.

In effect, health care requires the use of technology, both by formal and informal caregivers and by care recipients. Much of the medical equipment now used in homes was designed by device manufacturers to be used only in clinical settings and by trained health care professionals (U.S. Food and Drug Administration, 2010). Its migration to the home poses many



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5 Health Care Technologies in the Home Hospital patients today are being discharged sooner than in the past, sometimes with complex continuing care plans that require the use of medi- cal technologies in the home for an extended period following discharge, if not permanently. Some of these technologies are simple, and others are quite sophisticated and require that care recipients and/or their caregiv- ers be trained in their use; retraining is also often needed. Evidence from the Agency for Healthcare Research and Quality suggests that, for some individuals, electronic tools may become important adjuncts to treatment, improving medication adherence or enabling delivery of mental health interventions, such as cognitive behavioral therapy on demand (Gibbons et al., 2009). Care recipients and health care consumers are generally becoming more engaged in managing their own health and health care. Self-help and well- ness books regularly make the bestseller lists, online health information seeking has increased dramatically over the last decade, and people are purchasing various devices and software to monitor and maintain their own health (e.g., to measure their blood sugar, check their blood pressure, log exercise). Some types of medical devices have become de facto consumer products, and more and more individuals expect to be able to choose prod- ucts that suit their lifestyles and are convenient and easy to use. In effect, health care requires the use of technology, both by formal and informal caregivers and by care recipients. Much of the medical equip- ment now used in homes was designed by device manufacturers to be used only in clinical settings and by trained health care professionals (U.S. Food and Drug Administration, 2010). Its migration to the home poses many 103

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104 HEALTH CARE COMES HOME challenges to both caregivers and care recipients. This is because the equip- ment generally was not designed with their capabilities and limitations in mind, and because the home environment differs in significant ways from the controlled environment of the hospital or clinic. These developments also pose a challenge to the medical device industry, which must take into account these factors when designing medical technology which may be used in the home. Technology relevant to health care can be separated into two major categories: medical devices and health information technologies (HIT). The dividing line between these two categories is becoming less clear as technol- ogy evolves (similar to the case of voice and data in telecommunications; see Federal Telemedicine News, 2010, April 25). This chapter describes issues, challenges, and relevant research related to these technologies. MEDICAL DEVICES Medical devices in the United States are regulated by the U.S. Food and Drug Administration (FDA). The Center for Devices and Radiological Health (CDRH) of the FDA defines a medical device as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar article that is . . . intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease” (21 U.S.C. 321, Federal Food, Drug, and Cosmetic Act, 2005, Section 201(h)). The FDA’s Home Health Care Committee, recognizing the need for a definition of home medical device, drafted a definition that takes into account device use in a nonclinical environment under the direction of nonprofessional users. As of this writing, however, this definition is still under review, and the FDA solicited industry input on its wording at a May 2010 public meeting. The FDA divides medical devices into three classes based on a number of factors, including the degree of risk a device presents to the patient. Only devices that pose a significant degree of risk require that developers/ manufacturers complete a 510(k) premarket notification submission that documents, in great detail, an assessment of the risks associated with the device and describes the actions taken by the developer to address each risk identified. Although the determination of the class to which a particular device is assigned is not always simple, in general, the device classes are as follows: 1. Class I—devices with a minimum potential for harm to the user and generally simpler than Class II and Class III devices. They are

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105 HEALTH CARE TECHNOLOGIES IN THE HOME usually exempt from good manufacturing practice requirements,1 and almost all Class I devices are exempt from the FDA’s 510(k) premarket notification requirements. Such devices are subject only to general controls by the FDA, such as manufacturer registra- tion, branding and labeling requirements, and general reporting procedures. Devices in this category include elastic bandages, canes, weight scales, flow meters, and other simple devices used in the home or in clinical environments. 2. Class II—devices that involve some risk to the user. Most Class II devices require a 510(k) premarket notification submission. These devices require more than general controls by the FDA to ensure safety and effectiveness, such as meeting special labeling require- ments and mandatory performance standards and being subject to postmarket surveillance. Most devices in this category are non- invasive and include blood pressure cuffs, catheters, heating pads, powered wheelchairs, and many other electrically powered home care and clinical use devices. 3. Class III—devices in this class present the highest potential risk to the user and require a 510(k) premarket notification submission and additional scientific review to ensure device safety and effectiveness. Many of the devices in this category are invasive, such as pacemak- ers, heart valves, other implantable devices, or high-risk medical devices, such as defibrillators. Medical Device Use in the Home Over the past decade and a half, the range of types and level of com- plexity of medical devices used in the home have increased dramatically. Prior to this time, it was common to see fairly simple equipment for first aid (thermometers, bandages, heating pads) and medication admin- istration (e.g., dosing cups, pill splitters) in the home, along with various assistive technologies (e.g., hearing aids, reaching tools), durable medical equipment, such as wheelchairs, walkers, and crutches, and prosthetic or orthotic devices (e.g., artificial limbs, shoe inserts). Oxygen concentrators, nebulizers, and CPAPs were also in use. Now medical equipment that previously was used only in the hospital or clinic is finding its way into the home (see Table 5-1). Home dialysis is 1 The FDA has many good manufacturing practices (GMPs), which are well known to device developers and pharmaceutical companies and relate to every aspect of the design, develop- ment, and manufacturing practices. These are generally regulatory documents. For example, 21 CFR Part 210/211 are the Pharmaceutical Industry GMPs, and 21 CFR Part 820 is the Good Manufacturing Practice for Medical Devices—Quality System Regulation.

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106 HEALTH CARE COMES HOME TABLE 5-1 Types of Health Care Devices and Technologies Used in the Home Category Device or Technology Medication administration equipment Dosing equipment (cups, eyedroppers, blunt syringes) Nasal sprays, inhalers Medication patches Syringes/sharps Test kits Pregnancy test Male/female stress hormone test Cholesterol test Allergy test Bladder infection test HIV test Hepatitis C test Drug, alcohol, nicotine test First aid equipment Bandages Ace bandage, compression stocking Snakebite kit Heating pad Traction Ostomy care Tracheotomy care Defibrillator Assistive technologya Eyeglasses Hearing aid Dentures (full or partial) Prosthetic device Orthotic device, including braces Cane or crutches Walker Wheelchair Scooter Durable medical equipment Hospital bed Specialized mattress Chair (e.g., geri-chair or lift chair) Lift equipment Commode, urinal, bed pan Meters/monitors Thermometer Stethoscope Blood glucose meter Blood coagulation (PT/INR) meter Pulse oximeter Weight scale Blood pressure monitor Apnea monitor Electrocardiogram (ECG) monitor Fetal monitor

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107 HEALTH CARE TECHNOLOGIES IN THE HOME TABLE 5-1 Continued Category Device or Technology Treatment equipment IV equipment Infusion pumps Dialysis machines Transcutaneous electrical nerve stimulation (TENS) systems Respiratory equipment Ventilator, continuous positive airway pressure (CPAP), bi-level positive airway pressure (BiPAP), and demand positive airway pressure (DPAP) equipment Oxygen cylinder Oxygen concentrator Nebulizer Masks and canulas Respiratory supplies Cough assist machine Suction machine Manual resuscitation bags Feeding equipment Feeding tubes (nasogastric, gastrostomy, jejunostomy) Enteral pump Voiding equipment Catheter Colostomy bags Infant care Incubator Radiant warmer Bilirubin lights Phototherapy Apnea monitor Telehealth equipment Cameras Sensors Data collection and communication equipment (e.g., computer, smart phone) Telephone or Internet connections aAssistive technology or adaptive technology is an umbrella term. Given various definitions of the term, an assistive technology is essentially anything (e.g., item, piece of equipment, device, or system) that can help an individual do anything that he/she would be unable to do otherwise, or have difficulty doing otherwise. SOURCE: Story (2010).

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108 HEALTH CARE COMES HOME becoming more common, for example, and such devices as apnea monitors, infusion pumps, ventilators, and left ventricular assist devices (the latter used to provide circulatory support before cardiac transplantation) are being used—to a great extent independently—by care recipients at home. Similarly, more complex diagnostic and testing devices are being made available for use at home or “on the go,” so that people can monitor their own cholesterol, blood glucose levels, and even blood coagulation (if they take blood-thinning medications) wherever they are. For example, see the vignette in Box 5-1 for use of both conceptually simple devices (e.g., weight scale) and more conceptually complex ones (e.g., pulse oximeter) in the management of congestive heart failure. Access to medical equipment has also changed significantly in recent years. It was once limited to the modest array of devices available over the counter or equipment obtainable from health care professionals or durable medical equipment providers, often only by prescription, but this is no longer the case. Care recipients can now purchase many medical devices, medications, assistive technologies, and health information technologies from a variety of sources via the Internet, including sources like Craigslist and eBay. In some cases, devices purchased through these sources may not be up to date, may not come with instructions, and indeed may not be appropriate or even work correctly. There is little or no customer support for devices purchased through many third-party sources. Currently, few regulations address medical device use in the home. In April 2010, the FDA announced a Home Use Device Initiative that would more closely scrutinize medical devices being approved for home use. As part of this initiative, the FDA is developing a guidance document that would assist device manufacturers in understanding the complexities of developing devices for home use instead of, or in addition to, clinical use. The guidance is to focus on existing standards, the unique characteristics of the physical environment, and the unique characteristics of the untrained user when designing and testing a device for home use. In addition, the FDA cautioned manufacturers that knew their devices were being used in the home but not labeled as such and were causing injury or death: their subsequent premarket applications would either have to include the proper user testing and design needed for home use or would have to declare that the device would be specifically labeled “not for home use” (U.S. Food and Drug Administration, 2010). General Problems with Device Use in the Home Problems with medical device use in the home can be expected to mimic, to some extent, those found in hospitals and clinics, but they may be more likely to have negative consequences. This is because the capabilities

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109 HEALTH CARE TECHNOLOGIES IN THE HOME BOX 5-1 The Stames Family Martin Stames, 70 years old, has had congestive heart failure for 7 years. He lives with his wife, Nanako, who is retired, in rural Michigan about 35 miles from the hospital where he has been admitted several times for acute episodes of congestive heart failure. Martin and Nanako have an adult son, Dennis, and a daughter, Lynn, who are supportive but do not live close by. Martin was discharged to nursing care at home after his most recent hospitalization. Based on an initial screening and home visit by the nurse case manager, Martin was enrolled in telehealth services, which allow him to monitor his vital signs using a blood pressure cuff, weight scale, and fingertip pulse oximeter that are provided and send the data daily via a small portable computer telehealth unit to his visiting nurse. Using the same telehealth unit, he can participate in an educational program designed to help him better manage his condition. The nurse installed the telehealth unit with help from a support person back at the office. Martin mastered the home-unit user interface easily, despite having never used a computer before. Some of the medical devices, however, posed difficulties. Martin has some difficulty weighing himself with the scale provided when he is fatigued. Stepping up onto the scale and maintaining his balance are challenging for him, unless his wife is close by to assist. Martin learned to take his blood pressure with the standard blood pressure cuff provided, but he does not fully understand what the readings mean. The educational software is not always appropriate to Martin’s needs. For example, the software has provided little help in terms of interpreting his blood pressure. It asked if his blood pressure was within its normal range but did not provide feedback as to whether his answer was cor- rect. Often it was not, which triggered a phone call from the nurse to provide additional training about blood pressure. Nanako commented to the nurse that on some days Martin has difficulty remembering this sort of information. Martin completed 55 sessions over 59 days, missing days when a winter storm caused him to be without telephone service for 2 days and for 3 days when he did not transmit his weight because his wife was out of town and he could not weigh himself without her assistance. Missed sessions triggered contacts from the nurse. SOURCE: Clinical profile of participants in telehealth study evaluated by committee member Daryle Gardner-Bonneau.

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110 HEALTH CARE COMES HOME and limitations of untrained users in the home are quite different, as are the environments in which the devices are used. Problems with device use often manifest themselves through human errors. As mentioned in Chapter 2, there are many types of human error, and the causes and consequences of errors vary. Some errors and their consequences are preventable via good design and selection of the device, whereas others must be handled through procedural or administrative solu- tions or through user education and training. Senders (1994) describes an error taxonomy with five categories that is useful in describing human error in medical device use: 1. Input error based on misperception. The user misperceives data dis- played on a medical device and performs an incorrect action based on that misperception (e.g., misperceiving the infusion rate on an infusion pump display and acting based on the incorrectly perceived data). 2. Mistake. The user correctly perceives the data but forms and car- ries out an incorrect intention (e.g., a user of a blood pressure cuff correctly perceives his blood pressure reading as 210/96 but does not realize that he should call his health care provider immediately, instead of taking an extra dose of blood pressure medication). 3. Execution error or slip. The user correctly perceives the data and forms the correct intention but performs an incorrect action (e.g., a device user presses the “increase volume” button on a device instead of the “decrease volume” button, which the user intended). 4. Endogenous error. These are errors that arise from processes internal to the user of which he or she may not even be aware (e.g., biases and assumptions that may not be appropriate in a given circumstance, errors caused by becoming distracted or interrupted during use of a medical device). An actual case serving as an example (described in U.S. Food and Drug Administration, 2010) involved a care recipient who received a new infusion pump and was not trained in its use. He assumed it was programmed in the same way as the old pump and acted accordingly. As a result, his medication was delivered too quickly. 5. Exogenous error. These are errors that arise from situations, condi- tions, or processes external to the user and include the following four subcategories: • rrors of omission—leaving out one in a sequence of steps E required to operate a device because, for example, the step has been omitted or deemphasized in instructional materials or the device allows the step to be omitted with no immediate conse- quences. Also reported in U.S. Food and Drug Administration

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111 HEALTH CARE TECHNOLOGIES IN THE HOME (2010) was the case of a care recipient who failed to remove the cap from the infusion line of an infusion pump after inserting a new infusion cassette, blocking the medication flow. She was hospitalized as a result. • Errors of insertion—adding an inappropriate step to a process. • rrors of repetition—repeating a step inappropriately (may occur E because the device user has lost his or her place in a complex sequence of steps, for example). • rrors of substitution—using an inappropriate object, action, E place, or time instead of the appropriate one (e.g., using a glu- cometer test strip other than the one specified for the device, using a diagnostic device within 1 hour after eating instead of the necessary 2 hours). Potential use errors during medication administration include giving the wrong drug, at the wrong time, through the wrong route, or through improper execution of the procedure. In operating a device to provide treatment, users might make errors due to missing a step in a procedure, inserting or substituting a step, or repeating a step they already executed because they were distracted. It is easy to see why the number of errors as well as the severity of their consequences might be greater for untrained caregivers and care recipients operating medical devices. These individuals usually do not have the edu- cation and training of health care professionals, so they are more apt to misperceive visual information or audible signals and more likely to make incorrect judgments and take inappropriate actions based on those data. Even if untrained users can correctly perform the activities involved in oper- ating a device, they may not understand the implications of the information they receive, given their level of knowledge about health care in general and the specific circumstances. Some errors and their consequences may be minimized through design of the device, and this is the preferred method when it can be achieved, whereas other errors must be reduced through procedural or administra- tive solutions. In comparison, user education and training, though often used, are far less effective and should not be relied on as the sole means of mitigating errors and their consequences. The positive effects of education and training tend to dissipate over time and to erode quickly when cogni- tive capacity fluctuates for a number of reasons (e.g., task overload, fatigue, pain, drugs, and/or disease progression). Some types of errors will be more common in the home because the procedural and administrative safeguards that exist in formal clinical environments are not likely to be present in homes. For example, hospitals and clinics have procedural, regulatory, and administrative safeguards in place to ensure that the environment meets the

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112 HEALTH CARE COMES HOME operational requirements of devices in terms of cleanliness, temperature, humidity, electrical power requirements, etc. If electrical power is lost in the hospital, emergency power is available, but this is often not true in the home. Hospitals have rules that limit access to equipment by children and pets, but these are present in many homes, and their actions and unintended effects (e.g., pet hair clogging a device’s air filtration system) are not always predictable or easily controlled. It is not currently possible to estimate the magnitude of errors in medical device use in the home—or even the most common types of errors. Much of the data collected about adverse events in the home comes from home health agencies and other organizations. Although the FDA received over 19,000 reports of adverse events in the home related to device use between 1997 and 2009, it is difficult, if not impossible, to ascertain the cause of the events from the data contained in many of these reports (U.S. Food and Drug Adminisration, 2010). It is also likely that the reports reflect only the most egregious events with immediate consequences of severe injury or death that were viewed as reportable by the agencies involved. Until the FDA’s recent introduction of new mechanisms for adverse event reporting (e.g., the HomeNet subnetwork of MedSun), care recipients and caregivers had limited avenues by which to report problems. Even with new reporting systems in place, however, many may not be aware of the exis- tence or purpose of these systems or may be reluctant to report problems (National Research Council, 2010). In an analysis of adverse events in the home reported to the FDA’s MedSun database between 2002 and 2007, problems with infusion pumps topped the list; there were also notable adverse events for venous access devices, hospital beds, oxygen concentrators, ventilators, and powered wheelchairs (Marion, 2007).2 These types of devices are among the most complex used in the home and carry the highest risks for injury, supporting the hypothesis that more serious events involving sophisticated technologies tend to be reported. This also mirrors the adverse event analyses described for hospitals in the Institute of Medicine’s 2000 report, To Err Is Human: Building a Safer Health System, in that problems that are clearly report- able and egregious become part of the statistics, whereas other problems, which may be more common but have latent or more subtle consequences, are rarely reported. Infusion pumps, the most problematic device according to the Marion (2007) analysis, have been a major source of problems in hospitals, as well as in home use. The concern was so great that, several years ago, an indus- try consortium led by AdvaMed took steps to try to prevent infusion pump 2 Notethat dialysis machines were not commonly used in the home during the period covered by the analysis.

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113 HEALTH CARE TECHNOLOGIES IN THE HOME use errors or at least reduce the consequences of those errors. The group considered design solutions to correct problems with IV tubing, administra- tion of the wrong drug, administration of an incorrect drug dosage, and administration of the drug at an incorrect infusion rate. As a result, design of these devices is improving to the benefit of both formal and informal caregivers as well as care recipients caring for themselves. Problems remain, however, and this work continues (see, for example, Medical Device Con- sultants Inc., 2010). Sometimes care recipients do not have the opportunity to acquire the medical device that is the best fit for them. Devices may not be appropri- ately or adequately prescribed by physicians when they have little knowl- edge of the differences among devices in a given category, of the specific capabilities and limitations of the care recipients, or of the conditions of the home environment. For some, the insurance provider determines which of several devices in a category the care recipient is eligible to receive, and the device received may not be the one that would best suit his or her needs (Vance, 2009; National Research Council, 2010). The Role of Human Factors In 1996, the NRC published a workshop report on the usability of home medical devices, Safe, Comfortable, Attractive, and Easy to Use (National Research Council, 1996). The workshop participants noted prob- lems with device design, communications, support, training, and standards, among others. At that time the medical devices being used in the home were typically less complex and less sophisticated than they often are today, but the same problems highlighted in that workshop are still evident today. The workshop participants recognized the varied and often conflicting stake- holder interests and forces bearing on device design, but even then they noted that there were many problems that could be addressed by applying human factors knowledge and research methods. Better understanding of the characteristics, capabilities, and limita- tions of care recipients and caregivers, the environment in which they must operate devices, and the tasks they must perform will enable better design of medical devices and equipment to prevent errors, or at least reduce the negative consequences of errors, and to better meet care recipient needs. As described in Chapter 2, the users of medical devices in the home can be virtually anyone. Some device users in the home are formally trained caregivers, who have knowledge of and experience with such medical devices. But many users are untrained persons—older spouses caring for their mates, neighbors caring for neighbors, parents caring for a child, or children (sometimes fairly young children) caring for parents or grandpar-

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130 HEALTH CARE COMES HOME TABLE 5-3 Key Standards for Medical Device Design ANSI/AAMI HE74:2001 The document describes “a recommended human factors engineering process for use in fulfilling user interface design Human Factors Design requirements in the development of medical devices and Process for Medical systems, including hardware, software, and documentation.” Devices The standard includes an overview and a discussion of the benefits of human factors engineering, a review of the human factors engineering process and its analysis and design techniques, and a discussion of implementation issues. The information about humans comes from a variety of sources, such as review of existing literature, databases, and information from laboratory and observational studies, surveys, and questionnaires. ANSI/AAMI HE75:2009 This document’s 25 sections provide requirements and recommendations for nearly all human factors aspects of Human Factors medical device design, including visual display, controls, Engineering—Design of alarms, connectors and connections, device software, Medical Devices documentation and labeling, packaging, and testing and evaluation. Special topics with particular relevance for health care in the home are covered in sections on home health care, medical device accessibility, mobile devices, and cross-cultural and cross-national design. IEC 62366:2007 This standard: “Specifies a process for a manufacturer to analyse [sic], specify, design, verify and validate usability, as it Medical Devices— relates to safety of a medical device. This usability engineering Application of Usability process assesses and mitigates risks caused by usability Engineering to Medical problems associated with correct use and use errors, i.e. Devices normal use. It can be used to identify but does not assess or mitigate risks associated with abnormal use.” IEC 60601-1-11:2010 This standard addresses some of the issues related to electrical medical devices used in the home. Although it Requirements for Medical offers significant guidance with respect to electrical power Electrical Equipment and considerations for home use devices, as well as some guidance Medical Electrical Systems on instructions for use, remotely audible alarms (since Used in the Home untrained caregivers may not always be in close proximity to Healthcare Environment the equipment or the care recipient in the home), and other issues, it is by no means complete. Its guidance is limited, for example, to electrically powered devices and does not address other devices. Furthermore, its guidance on the design of instructions for use is quite limited, and it has little to say with regard to user training and instructional materials that are critical for home users.

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131 HEALTH CARE TECHNOLOGIES IN THE HOME TABLE 5-4 Standards and Guidelines for User Interfaces Microsoft Common Health User By far the most developed and rich set of standards Interface for health information technology applications are those developed by Microsoft under the Microsoft Common Health User Interface (MCHUI) initiative. Together with the United Kingdom’s National Health Service, Microsoft has developed an impressive evidence-based set of standards, guidelines, and design patterns to help developers quickly and easily generate user interfaces related to health. MSHUI, in over 1,000 pages, provides detailed guidance to developers on content-specific areas, along with required and recommended elements and any research studies they did to substantiate the findings. Usability.Gov The research-based web design and usability guidelines at usability.gov are among the best set of guidelines available for web-based user interfaces. It was developed under the aegis of the National Cancer Institute and U.S. Department of Health and Human Services. Usability.gov guidelines cover a broad range of usability and user experience issues with extensive references and “strength of evidence” ratings. While these guidelines are not specific to health care, designers and developers will find them very usable. User Interface Requirements This document provides guidelines for the design for the Presentation of Health of effective user interfaces for health information Data—Australia HB 306-2007 technology systems. It focuses on improving how the system meets the needs of users in their workflows, learning, information architecture in design of the user interface, error/warning messaging, and user acceptance. It identifies the specific requirements for designing user interfaces for health care information systems in order to ensure care recipient safety and consistent use of graphical elements and interface components in health information systems. Web Content Accessibility Primarily intended for people who develop web Guidelines-W3C content, the intent of these guidelines is to make web content accessible to people with disabilities. By adhering to these standards, designers and developers do make web content more available and usable to anyone who uses a compliant site.

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132 HEALTH CARE COMES HOME or mobile robots, and environmental sensors. Devices and systems will be capable of sensing the environment, detecting resident movements or lack of movement, inferring what people are doing, and determining when they might need or want assistance. Medical devices or other devices in the environment, such as mobile telephones, televisions, or other information appliances, may generate alerts or other “just-in-time” information (i.e., presented at the moment at which it may be needed). It will be possible for devices or systems to provide instructions for use, to alert and inform users to modify or correct their behaviors, and, in some cases, to provide physi- cal, cognitive, or emotional support. Instructions for use may appear on paper, but in addition or instead they may reside in the device or appear in a dedicated information product or within an existing home technology (such as a television); electronic instructions may be updatable over time, and their formats may be customizable to the needs and preferences of the individual user. Robotic systems may augment their users’ functional abili- ties, such as their strength, balance, and sensory and cognitive capabilities, while conducting daily activities. Some components of these systems may interact with one another and may transmit information to health care providers in another location. In applications such as these, the challenges of interoperability among devices, systems, and information sources will be especially important. If there is no way to ensure that the components, whatever their origins or providers, are designed from the beginning to work together, it may be very difficult to implement effective systems. Information technologies will play an increasing role in supporting health and wellness in the home. Some current remote telemonitoring devices in home care, such as the Health Buddy (Bosch Healthcare), are being leapfrogged by technical advances and, in fact, the definition of a medical device is growing fuzzier. For example, smart phone applications are available that can perform functions that were once relegated to single- purpose medical devices, such as glucose monitoring. Emerging technolo- gies will not necessarily originate from traditional health care companies; many high-tech firms recognize the opportunities that exist in health care and are responding with creative solutions. In these technologies, both the medium and the message are important. As enabling technologies prolifer- ate, they are becoming wireless, more specialized, and highly embedded, and the user interface of tomorrow will not necessarily involve a display. The user interface could be a surface that recognizes human gestures, a biometric device that detects sleep patterns, or even advanced robotic pros- thetics (Bogue, 2009). Future technological advances will bring new devices, such as improved pacemakers, cochlear implants, and medicine delivery systems. Miniaturiza- tion of various components, including microprocessors and nanotechnology, will make possible advances in many types of medical devices used inside

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133 HEALTH CARE TECHNOLOGIES IN THE HOME and outside formal health care settings. Some of the devices envisioned will be embedded in common household objects, such as a biosensing chip in a toothbrush that will check blood sugar and bacteria levels; “smart” bandages made of fiber that will detect bacteria or a virus in a wound and then recommend appropriate treatment; “smart” t-shirts that will monitor the wearer’s vital signs in real time; or “heads-up” displays for glasses that use pattern recognition software to help people remember human faces, inanimate objects, or other data. Novel handheld devices may provide new capabilities for home health care, such as skin surface mapping, an imag- ing technology that will track changes in moles to detect malignancies; biosensors that will perform as portable laboratories; or alternative input devices, such as eye blinks (electromyography) or brain activity (electroen- cephalography), that will facilitate hands-free device control, which will be especially useful for people with limited use of their upper extremities (e.g., people with paralysis or arthritis) (Lewis, 2001). A few technologies that have a lot of promise are available now. For example, there is evidence that text messaging can be effective in disease monitoring and care recipient self-management, improving adherence to medication, and preparing for certain procedures (Miloh et al., 2009). The smart phone (e.g., iPhone, BlackBerry) is a multifunctional tool that enables users to download applications that assist them in tracking important mea- sures, such as sleep, exercise, nutrition, blood sugar, and overall wellness. Several applications currently available allow care recipients to update and view their personal health record, understand and track medication usage, communicate with their physicians, and even participate in clinical trials. Internet-based information resources have great potential to assist people to make well-informed health care choices and navigate health care systems. One of the most innovative areas of new digital technologies is the use of game systems to support rehabilitation regimens. Recent advances in accelerometers have propelled the development of small digital devices that monitor movement (personal motion technologies) and are highly adaptable. Game systems like the Nintendo Wii that use unique input and feedback measures can be used to support aerobic activity, flexibility, and even physical therapy (Halton, 2008). These systems are increasingly being used in nursing homes and rehabilitation centers, but the affordability and creativity of the software make the technology appropriate for use in the home. Technologies like exercise game systems support health and wellness goals by providing real-time feedback on progress, such as toward a daily goal of calories burned. The theory behind these devices is that knowledge will motivate the user, although many of these applications go beyond the individual and provide opportunities to create a social network. Some studies suggest that participation in a group provides greater motivation

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134 HEALTH CARE COMES HOME to reach a goal than does individual participation. But the application of personal motion technologies extends far beyond measuring and report- ing calories; these devices can also be important in care recipient safety by monitoring for falls or ensuring that care recipients get sufficient exercise (National Research Council, 2010). Most of the technologies come with an online component that may make them more useful for monitoring daily behaviors and detecting patterns that occur over time. New “smart home” technologies, which include automatic sensors, collect data that gets stored or transmitted to off-site caregivers (Demiris, 2010). Increasing numbers of wireless-enabled devices, like pulse oxim- eters, blood pressure cuffs, and scales, automatically log and transmit their values to personal health records and care providers. Some initiatives, such as Dossia (personal health platforms) and Continua Health Alliance (hardware), provide tightly coupled health “eco-systems” of applications and devices to manage disease, track wellness, and provide for healthier living. Even in the area of medication management, medication-dispensing machines for the home can be remotely managed over an Internet con- nection. Recent advances in digital TV will soon enable care recipients to have access to rich Internet applications on their television sets. These can include using video content sites to deliver training or instructional material and perhaps full two-way communications between individuals and their caregivers in different locations. Technologies that provide remote access to monitor care recipient status have become important aids to caregivers and clinicians. Although episodic monitoring is currently used in some telehealth systems that enable a care recipient–caregiver dyad to check in remotely with a health care pro- fessional, more continuous monitoring of caregiver performance and pro- viding real-time instruction or guidance have not been implemented (Schulz and Tompkins, 2010). Many of these technologies raise privacy concerns that may make them difficult to implement, but recent research in this area suggests that with increasing levels of disability, individuals become more willing to relinquish privacy for increased functioning and independence (Beach et al., 2009). However, little is known about caregivers’ willingness to be monitored and remotely guided by health care professionals. Issues of cost, usability, and privacy will prevent some of these advanced technologies from realizing widespread adoption, creating a penetration gap that has been called the “digital divide.” Many of these technologies are not particularly expensive relative to health care costs in general, yet they pose a cost burden that must be recognized. For example, although adop- tion of technologies such as the Internet is generally high among adults in the United States, rates of computer technology use and broadband access are lower among minority populations and people of lower socioeconomic status, people who have a physical disability, and older adults. This is

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135 HEALTH CARE TECHNOLOGIES IN THE HOME problematic, given the increased use of the Internet as a vehicle for the delivery of health information and services. Health care solutions that can be delivered on ubiquitous technologies, such as smart phones, may help bridge this divide. At the same time, cost may not be as imposing an issue as usabil- ity. Although these products may be promising, many of them, from a usability point of view, still display the rough edges of nascent technology. Applications that rely on care recipient behavior to generate accurate data will always be prone to human error (e.g., a blood pressure cuff wrapped around the wrong location). For optimal health outcomes, it is important that these technologies be developed by applying a user-centered design approach that takes into consideration the needs, characteristics, abilities, and preferences of all potential user populations. For example, it is impor- tant to consider the full range of users’ functional abilities, health literacy, self-efficacy, readiness to change, and motivations for and barriers to chang- ing health behaviors. It is also important to honor the users’ cultural norms and their preferences for how and with whom to share data, action recom- mendations, or options and key decisions. For example, an older adult may be willing to share home monitoring or health data with one adult child but not another, requiring simple but effective system authentication and access control protocols. Technology developments have the potential to increase the amounts of health care information transmitted to and from the home. There is general agreement regarding the protection of individuals’ privacy and the need to reach an appropriate balance between keeping health information confiden- tial and sharing essential information among caregivers to assure proper treatment as well as among researchers to advance knowledge about health care (Institute of Medicine, 2001, 2009). In a recent workshop on the role of human factors in home health care, participants noted that “the Health Insurance Portability and Accountability Act (HIPAA) plays a major role in telehealth applications and web-based applications in which individuals transmit personal health information over the Internet. However, HIPAA cannot address some of the new and emerging trends in health informa- tion technology” (National Research Council, 2010, p. 42). Adding to the complexity of privacy concerns, emerging tools aren’t necessarily regulated by HIPAA because developers of the PHR and other applications are not considered “covered entities” as defined by HIPAA. There have been calls to address this gap in current HIPAA regulations (Kahn et al., 2009; Demiris et al., 2010; Geiger, 2010).

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