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
challenges to both caregivers and care recipients. This is because the equipment 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 technology 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 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:
- Class I—devices with a minimum potential for harm to the user and generally simpler than Class II and Class III devices. They are
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 registration, 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.
- 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 requirements and mandatory performance standards and being subject to postmarket surveillance. Most devices in this category are noninvasive and include blood pressure cuffs, catheters, heating pads, powered wheelchairs, and many other electrically powered home care and clinical use devices.
- 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 pacemakers, 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 complexity 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 administration (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
1The 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, development, 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.
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
Male/female stress hormone test
Bladder infection test
Hepatitis C test
Drug, alcohol, nicotine test
|First aid equipment||
Ace bandage, compression stocking
Dentures (full or partial)
Orthotic device, including braces
Cane or crutches
|Durable medical equipment||
Chair (e.g., geri-chair or lift chair)
Commode, urinal, bed pan
Blood glucose meter
Blood coagulation (PT/INR) meter
Blood pressure monitor
Electrocardiogram (ECG) monitor
|Category||Device or Technology|
Transcutaneous electrical nerve stimulation (TENS) systems
Ventilator, continuous positive airway pressure (CPAP), bi-level positive airway pressure (BiPAP), and demand positive airway pressure (DPAP) equipment
Masks and canulas
Cough assist machine
Manual resuscitation bags
Feeding tubes (nasogastric, gastrostomy, jejunostomy)
Data collection and communication equipment (e.g., computer, smart phone)
|Telephone or Internet connections|
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
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 correct. 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.
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 solutions 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:
- Input error based on misperception. The user misperceives data displayed 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).
- Mistake. The user correctly perceives the data but forms and carries 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).
- 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).
- 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.
- Exogenous error. These are errors that arise from situations, conditions, or processes external to the user and include the following four subcategories:
- Errors of omission—leaving out one in a sequence of steps 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 consequences. Also reported in U.S. Food and Drug Administration
(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.
- Errors of repetition—repeating a step inappropriately (may occur because the device user has lost his or her place in a complex sequence of steps, for example).
- Errors of substitution—using an inappropriate object, action, place, or time instead of the appropriate one (e.g., using a glucometer 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 education 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 operating 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 administrative 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 cognitive 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
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 existence 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 reportable 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 industry consortium led by AdvaMed took steps to try to prevent infusion pump
2Note that dialysis machines were not commonly used in the home during the period covered by the analysis.
use errors or at least reduce the consequences of those errors. The group considered design solutions to correct problems with IV tubing, administration 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 Consultants 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 appropriately or adequately prescribed by physicians when they have little knowledge 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 problems 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 stakeholder 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 limitations 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-
ents. Some care recipients operate devices themselves to provide self-care, sometimes independently, sometimes with the support of others.
Regardless of their capabilities and levels of support, individuals using medical devices in the home should be able to use the devices safely, effectively, efficiently, and without making errors that could compromise the health of care recipients (Kaye and Crowley, 2000). This requirement has implications for medical device design, user training programs, and ongoing support. If the demands of the medical device exceed the capabilities of the user, the equipment burden may be too great to manage and the device may be abandoned.
As described in Chapter 6, residential environments can present a range of complexities for the introduction of medical devices. They are apt not to meet many of the environmental requirements assumed for devices used in clinical settings. For example, many homes do not meet electrical codes or maintain controlled temperature, humidity, air quality, water quality, lighting, or noise levels. Standards for cleanliness or sterile conditions may not be met. In addition, electromagnetic interference from other consumer electronic devices in the environment may interfere with device performance. Guarding against this problem may require targeted education of both device users and others who may be in the vicinity of the device. Manufacturers have started to focus on stronger shielding for these devices, but many older devices will remain in use for years.
The variety of use environments presents significant challenges for device design. It has implications for device portability (size and weight), appearance, and discreetness, as well as battery life, durability, and ruggedness. Aesthetics of a device are important to users. People generally do not want to advertise their medical condition or their need for a medical device to others; to the extent possible, devices should be unobtrusive, compatible with the lifestyles of their users.
Premarket Device Assessment
The FDA requires medical device manufacturers to demonstrate that they addressed human factors during the product’s development process. The FDA requires design controls for all medical devices sold in the United States. These are explained in Title 21 of the Code of Federal Regulations (CFR), Part 820 of which is the Quality System Regulation (QSR). Section 820.30, Design Controls, contains key human factors requirements in its subsections c, f, and g (U.S. Food and Drug Administration, 1996):
(c) Design input. Each manufacturer shall establish and maintain procedures to ensure that the design requirements relating to a device are ap-
propriate and address the intended use of the device, including the needs of the user and patient….
(f) Design verification. Each manufacturer shall establish and maintain procedures for verifying the device design. Design verification shall confirm that the design output meets the design input requirements….
(g) Design validation. Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions. Design validation shall include software validation and risk analysis, where appropriate.
In support of successful device designs, two primary human factors guidance documents have been developed by the FDA: Do It by Design: An Introduction to Human Factors in Medical Devices (U.S. Food and Drug Administration, 1996) and Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management (Kaye and Crowley, 2000). These documents include descriptions of human factors engineering methods, such as analytical and empirical approaches to identify and understand use-related hazards, methods of assessing and prioritizing hazards, strategies for mitigating and controlling hazards, and methods of verifying and validating hazard mitigation strategies. They also discuss exploratory studies and usability testing methods.
Representative care recipients and home caregivers should be included in any user testing that is conducted in order to assess the safety of the medical device and its use in the home. By studying their use of the device and its labeling to conduct essential tasks, device manufacturers can develop medical devices to minimize any potential risks and mitigate residual risks and determine whether devices are appropriate for home use. Although it is often difficult to recruit individuals for usability tests due to travel limitations and in some cases the low prevalence of certain disabilities, appropriate user testing is essential to ensure adequate design of medical devices (Petrie et al., 2006).
Postmarket Device Surveillance
Although the application of human factors engineering processes during the design process can identify most potential problems and mitigate them through design before the device goes to market, postmarket surveillance of products is still critical to uncover unforeseen problems and to identify problems that may only appear after long-term device use. If problems are discovered, manufacturers are required to notify current users and address the problems by providing information or replacement parts or recalling the product, as appropriate to the severity of the issue.
A postmarketing study of ventricular assist devices (Geidl et al., 2009)
serves to demonstrate the importance of postmarketing surveillance in further assessing the usability and safety of a home care device. Geidl found that the usability of these devices affected the success and acceptance of the treatment. Of the 16 study participants, 38 percent accidentally disconnected important components of the system at least once; 38 percent reported that parts of the system rubbed against their skin (particularly the shoulder strap against the abdomen when using a bag belt); and 56 percent reported that the noises from the pump, ventilators, and alarms were annoying; however, the alarm signals were too quiet to wake 32 percent of them. Most participants (63 percent) used a carrying case other than the one that accompanied the device, and many (44 percent) overstuffed the case with additional gear, mainly medical documents, cell phones, or eyeglasses (without which the older participants had difficulty reading the messages on the device), for which space was not provided.
Given the number of problems identified in this study and the percentage of care recipients in this small sample who experienced the same problem, it is difficult to believe that premarket human factors usability testing would not have uncovered many of these problems, especially had adequate user testing been employed. Some, however, might have been seen only in a postmarketing study, thus the importance of continuing surveillance. Data from such studies are also useful to designers as they consider the development of updated versions of the same product or new products that involve similar design aspects.
In regard to assessing use-related errors and adverse events, the FDA’s postmarket surveillance process is passive, depending on people to report problems as they occur. “Postmarket issues may be identified through a variety of sources, including analysis of adverse event reports, a recall or corrective action, reports from other governmental authorities, or the scientific literature” (U.S. Food and Drug Administration, 2010). The primary mechanism for learning about problems with medical devices in the home is the FDA’s adverse event reporting systems, including Maude and MedSun. Entry of incident data by health care providers and consumers, however, is not straightforward, and the system does not elicit data that could be useful to designers as they develop updated versions of products or new devices that are similar to existing ones. In addition, the reporting systems and importance of their use are not widely promoted, and many people are unaware of them. Furthermore, the FDA appears to have few resources dedicated to active surveillance or monitoring of problems as they occur in the field.
Device Labeling, Instructions for Use, and Training Issues
The adequacy of device labeling, instructions, and training can affect whether use errors occur even with well-designed medical equipment. Poor labeling increases the likelihood that users will make mistakes using a device or will be forced to seek help to answer their questions. If labels or instructions for use create too much confusion, potential users may abandon a device, which can compromise the quality of care. For this reason, the FDA has very explicit requirements for device labeling and ensuing instructions that designers must meet before a medical device is approved for placement on the market (see U.S. Food and Drug Administration, 2001).
An important limitation of this requirement is its dependence on premarket evaluation and device approval. Although it is likely that manufacturers recognize the need for specific labeling and instructions targeted toward untrained users and home environments, the current regulations present an unexpected barrier to labeling improvements as manufacturers become aware of problems with device use. Currently, in the case of many devices, changes in labeling automatically trigger a new 510(k) premarket review of the device, as well, by the FDA. Since this review presents a significant burden to manufacturers, they are unlikely to propose changes unless circumstances require them (U.S. Food and Drug Administration, 2010).
The vignette in Box 5-2 illustrates a technical support problem commonly faced by families who purchase devices over the Internet (in this case, nebulizers and replacement tubing), which sometimes come without instructions related to care and maintenance or come with instructions that are difficult to understand. The vignette also illustrates the substantial stresses and strains on caregivers, especially the burdens of complex treatment regimens and sophisticated medical devices when training and instruction have not been provided or are not readily available.
There is also the problem, for devices used both in hospitals and homes, that home use may not require many of the elements incorporated into the device. As new technologies are developed and existing technologies are enhanced, medical devices are becoming increasingly complex. Devices that were designed for hospital or clinical use by professionals often come with many features and enhancements, some of them based on marketing data from the professionals themselves. Although these features and enhancements may be useful to trained professionals, they generally increase the complexity of both the device and its operation and can overwhelm untrained users who do not need them. Burdened with requirements of care provision and busy with other aspects of their lives, untrained users need medical devices to be as simple as possible, while still achieving treatment goals. In some cases, this may suggest that manufacturers develop different models of devices for untrained and for professional users.
The Morgan Family
Lynn and Bob Morgan and their two daughters live in the southeast United States. After their 8-year-old, Amy, was diagnosed at age 4 with asthma, they used the Asthma Home Environment Checklist from the U.S. Environmental Protection Agency (EPA) (EPA402-F-03-030, Feb 2004) to check for and eliminate triggers in their home.
Lynn purchases nebulizers and replacement tubing for Amy online without a prescription. She reuses the tubing frequently but does not know the number of times she can reuse it or how to clean it. Amy has six prescription medications, one of which requires refrigeration. The family finds it difficult to read and understand all the labeling for the medication and the equipment. The local pharmacist is able to help them understand the essential information about the medications, but he is unfamiliar with the nebulizers Lynn has purchased online.
To keep Amy safe, Bob and Lynn must constantly monitor her symptoms and medication regimens. The family was part of a web-based Asthma Action Plan until it ended. The Morgans found the online plan easy to follow, and it helped them to document events and interventions and to keep Amy’s school informed as well. Without the plan, they find the care regimen a greater burden.
It is easy to see that the design of training materials for users of medical devices in the home is critical. But few care recipients and informal caregivers receive formal training on the proper use of a device. If they do, the timing of that training may well not coincide with a “teachable moment” since they may be feeling stressed, emotionally upset, and/or fatigued at the very time when a formal caregiver attempts to train them. The conditions are therefore often not optimal for training. Furthermore, one cannot expect care recipients or informal caregivers to master a new technology, especially a complex one, after a single training session, although this is often the most they can expect to receive. In addition, the training may not be delivered in a culturally appropriate manner. These challenges necessitate that users be provided with training and instructional materials that are appropriate, if not tailored, for them, to which they can refer at a time that is more conducive to learning.
Another key element in the design of labeling, including instructions
for use and training materials, is limiting the burden on the user’s memory. Caregivers may not use devices on a regular basis, so providing informative labeling, procedural checklists, and reminder lists can both reduce errors and increase caregiver efficiency and effectiveness. For devices that are used infrequently, it is better to have knowledge in, on, or around the device, so the user is less dependent on knowledge from memory (Norman, 1980).
For example, the failure to consider memory burden led to an unsuccessful patient education application in the vignette in Box 5-1. Martin had difficulty remembering the information that would have allowed him to interpret his blood pressure (which the system required him to do). A reminder card, an interpretative display, or an application that did the interpretation and provided feedback may have been far more effective and saved a significant amount of the formal caregiver’s time. A Western Michigan University study of telehealth applications (West-Frasier, 2008; Gardner-Bonneau, 2010) showed that about one-third of chronic obstructive pulmonary disease and congestive heart failure patients in the study had difficulty taking or interpreting their blood pressure at one time or another. These difficulties resulted in many hours of training and retraining by nurses (time they could ill afford). Had the designers of the training package understood the limitations of patients, the package could have been designed to avoid the problem and to ease the training burden significantly.
It is also important to recognize that people learn differently, and training materials should reflect this. Some people learn better through pictures, others through text, and still others through the spoken word. Some people may benefit most from a video presentation dynamically demonstrating the operation of the device. It is often the case in home care that a formal home care provider (e.g., a nurse) assumes the responsibility for training members of the household and for determining the best training technique for a particular individual on a specific device because good training materials are not available. A sizable body of knowledge employed in many aspects of user interface design for home health care applications (e.g., Tufte, 2001; Association for the Advancement of Medical Instrumentation, 2009) has yet to be put to good use in the design of instruction and training. However, excellent human factors guidance is available for the design of instructional materials and user training (see, for example, Swezey and Llaneras, 1997).
Much of the FDA’s guidance does not take into account many of the principles and design guidelines in the instructional systems design and training literature in the field of human factors. Swezey and Llaneras (1997), in a chapter on models of training and instruction, provide more than 100 guidelines for the design of training and instructional materials based on models of learning (acquisition), retention (memory), transfer of training, and instructional systems development. They also provide guidelines for selecting and using various types of media for instructions and
training. Instructional and training materials are being provided increasingly not in paper-based manuals or instructions printed on devices but via other media, including the Internet. Valuable human factors guidance for the development of instructional and training materials using these media can be found in texts on human-computer interaction (e.g., Jacko and Sears, 2008) and instructional systems design texts, which could be used by the FDA to improve its guidance to manufacturers.
Usability testing of labeling, including the instructions for use and training, is also essential, just as usability testing is required of the device itself. This testing usually involves a representative sample of users that includes individuals with the highest risk of experiencing problems. If it is demonstrated to be difficult to produce explanatory materials for a device so that untrained users can understand them and execute tasks properly, then it is likely that the device is not suitable for home use. But as important as it is for manufacturers to produce well-designed labels, instructions, and training materials, it is equally important that they not rely on these materials to solve problems in place of modifications to the design of the device itself.
Finally, it is not obvious who should be responsible for training users of devices in the home. Health care professionals may often be in a position to provide initial instruction in the use of a device, but they are often not in the best position to address maintenance and repair issues that may occur later. In addition, because formal caregivers may not always be aware when users independently purchase devices, the manufacturers ultimately may need to provide direct support for their devices.
HEALTH INFORMATION TECHNOLOGIES IN THE HOME
The range of electronic tools, applications, and devices that individuals may use in the course of managing their health and health care is indeed broad, and several new categories of devices are emerging. The fields of biomedicine and public health are expected to become closely intertwined in the next century (Zerhouni, 2005; Gibbons, 2007). Addressing the health problems of the 21st century will require a new set of biomedical and public health resources that extend beyond historic and traditional medical devices and are built on current and emerging information technologies (Hesse, 2005). These new information technology tools will enable the future health care system to become predictive, preemptive, and personalized to the needs of individual providers, care recipients, and caregivers to an extent not previously possible (Gibbons, 2007).
Progress toward this goal began with a report by the National Committee on Vital and Health Statistics (NCVHS) (1998) entitled Ensuring a Health Dimension for the National Information Infrastructure, which suggested that the nation’s information infrastructure could be a valuable
resource to promote health (Thompson and Brailer, 2004). To achieve this vision, NCVHS experts, in a 2001 follow-up report entitled Information for Health: A Strategy for Building a National Health Information Infrastructure, outlined the need for a seamless network of tools, data, and people. The report further suggested that this network should focus its developments in the areas of health care providers, personal health, and population health (National Committee on Vital and Health Statistics, 2001).
Important issues of compatibility and interoperability remain in health information technology. The recent surge of activity from both public and private sectors to use and share health-related information has proceeded without a discussion concerning what the building blocks are and how they fit together. For example, myriad meanings for terms have emerged and the relationships among the terms have been inadequately defined.
To address some of these issues and to provide support for increased adoption of health information technology, in 2008 the Office of the National Coordinator for Health Information Technology requested a report entitled Defining Key Health Information Technology Terms (National Alliance for Health Information Technology, 2008) in which the term “health information technology” is used as an umbrella term for at least six types of technologies:
- Electronic medical record (EMR): “an electronic record of health-related information on an individual that can be created, gathered, managed, and consulted by authorized clinicians and staff within one health care organization.”
- Electronic health record (EHR): “an electronic record of health-related information on an individual that conforms to nationally recognized interoperability standards and that can be created, managed, and consulted by authorized clinicians and staff across more than one health care organization.”
- Personal health record (PHR): “an electronic record of health-related information on an individual that conforms to nationally recognized interoperability standards and that can be drawn from multiple sources while being managed, shared, and controlled by the individual.”
- Health information exchange (HIE): “the electronic movement of health-related information among organizations according to nationally recognized standards.”
- Health information organization: “an organization that oversees and governs the exchange of health-related information among organizations according to nationally recognized standards.”
- Regional health information organization: “a health information organization that brings together health care stakeholders within a
defined geographic area and governs health information exchange among them for the purpose of improving health and care in that community.”
Equally important for home health care, a growing number of experts are collectively describing tools that are designed primarily for consumers as consumer health informatics (CHI) tools, applications, and devices.
Generally speaking, with the exception of the personal health record, the health information technology tools defined above are designed for and used by medical providers (e.g., physician, nurse, allied health professional) working in a hospital, clinic, or office-based setting. Currently, health information technology tools are not in widespread public use or even generally accepted as tools for providing health care, although this may change in the future, especially with the emergence of secure web-based platforms.
There is a need for more research on how health information technologies can support collaborative home care teams. Pinelle and Gutman (2001, 2002) point out: “Home care teams have different collaboration needs than workers in inpatient settings because they are widely distributed, they are mobile, and they maintain separate care recipient records. Interviews with several home care workers identified five specific areas where team members need to collaborate with one another: scheduling visits, disseminating information, finding answers to questions, short-term treatment coordination, and longer-term treatment planning.”
Impact of “Meaningful Use”
On February 17, 2009, President Obama signed the American Recovery and Reinvestment Act of 2009 (ARRA). This statute includes the Health Information Technology for Economic and Clinical Health Act (the HITECH Act) that sets forth a plan for advancing the “meaningful use” of health information technology to improve quality of care and establish a foundation for health care reform. Among its provisions, the HITECH act requires the Office of the National Coordinator for Health Information Technology, in consultation with other appropriate federal agencies, to update the Federal Health Information Technology Strategic Plan published in June 2008. This update will include specific objectives, milestones, and metrics with respect to achieving the goal of enabling the use of an electronic health record for each person in the United States by 2014.
The ARRA authorized the Centers for Medicare & Medicaid Services to provide reimbursement incentives for eligible professionals and hospitals that are successful in becoming “meaningful users” of certified EHR technology. The objective of the incentive program is to encourage use of
information technology by health care providers and create a better health care delivery system. Specific to health care in the home, the objective of meaningful use of health information technologies is to improve clinical decision making and enhance care coordination among caregivers. In order to receive funds, which will become available in 2011, hospitals and eligible providers have to meet more than 20 benchmarks, including being able to write electronic prescriptions, provide care recipients with access to their own electronic medical records on request, provide clinical summaries for care recipients for each office visit, and send reminders to care recipients for follow-up or preventive care.
In response, many vendors are augmenting their EHR applications with online care recipient portals, including personal health records. These portals allow care recipients to review their records and to record significant health and medical events that their primary care physician may be unaware of. Many EHRs also contain patient discharge information or instruction modules. These instructions form an important link between what the care recipient heard during a visit or hospital stay and what he or she will be required to do at home. Given the importance of the information contained in EHRs, it is incumbent upon vendors to make this information useful and usable. If the content and form of these instructions are not clear, the care recipient is at risk. Electronic health records are expensive to implement and a challenge for health care providers to adjust to, but they have substantial promise. Therefore, while the short-term impact of EHR adoption and meaningful use remain uncertain, over the long term, digitizing health records is expected to return benefits for health care in the home relative to improved coordination of care, enhanced communications, and better guidance and support for care recipients.
Personal Health Records
Although there has been debate about public adoption of personal health records (Kahn, Aulakh, and Bosworth, 2009), some health care providers are realizing that care recipients will use online health records if they are perceived to be helpful in accessing information and/or services, such as recent lab test results, summaries of appointments, e-mail contact with their physicians, and the ability to schedule appointments (Liang, 2010). However, personal health records are becoming more than electronic repositories of care recipients’ administrative and clinical data. While these data constitute the core of a PHR, in the future, care recipients will have the opportunity to have more interaction with and control over these systems, which will become aggregations of different types of data and functions that enable a range of data storage, exchange, and transactions among health care stakeholders.
Care recipients can gather and analyze their own data (so-called observations of daily living or ODLs) via PHRs to determine ways to live healthier, rather than simply to manage their illnesses. Daily living data can take many forms—from quantitative measures of sleep (e.g., sensors indicating how long the care recipient slept and how much the care recipient moved during the night) to qualitative self-reports (e.g., the care recipient reporting his or her own mood). Some PHRs are experimenting with ways to convert typically qualitative metrics into numeric values. Collection of daily living data through PHRs gives both clinicians and care recipients insights for improving health care and health outcomes that are unattainable if records contain only data captured in clinical settings.
Recording observations of daily living in a health record is not a new concept. The traditional health record contained information that was not always quantitative; it could and often did capture qualitative information obtained during a clinical encounter. But PHRs are demonstrating new ways of collecting, organizing, displaying, and using that information. The ultimate goal is to use data to understand the experience of an individual as he or she goes about daily living and how personal choices affect one’s health. Human factors considerations in the design of PHRs will be critical for the development of high-quality tools and for putting care recipients in greater control of their own health care management.
Many PHRs and care recipient portals have been constructed, often based on the continuity of care record (CCR).3 A recent study (Alkhatlan, 2010) investigated the understandability of the standard CCR terminology used in PHRs and explored users’ needs and preferences for data content. The participants were 30 undergraduate and graduate students in nonhealth fields. The study found that some terms (e.g., medications, immunizations, procedures/surgeries) were “easy to understand,” some terms (e.g., vital signs, health care provider information, plan of care) were “understandable with a short definition,” some terms (e.g., support sources, functional status, alerts) were “understandable with a long definition,” and one term (advance directives) was “difficult to understand.” Of the 17 CCR terms tested, using a scale of understandability from 0 to 3.5 (low to high), all but four of the terms had a score of less than 2.0, and nearly half (8) had a score of 1.5 or lower. The study also elicited from the participants suggestions for simple terms that might be used in place of the CCR terms (see Table 5-2). The author commented that vendors design PHRs primarily on the basis
3The CCR is a health record standard specification developed jointly by ASTM International, the Massachusetts Medical Society, the Healthcare Information and Management Systems Society, the American Academy of Family Physicians, the American Academy of Pediatrics, and other vendors of health information technologies. For more information, see http://www.astm.org/Standards/E2369.htm [February, 8, 2011].
TABLE 5-2 Continuity of Care Record (CCR) Terms Versus Participants’ Suggested Simple Terms, in Order of Increasing Difficulty to Understand
|Continuity of Care Record Term||Term Suggested by Participants|
|Health care professional visits|
|Health care provider information||Health care practitioners|
|Health care professionals|
|Health care personnel|
|Plan of care||Treatment plan|
|Health status||Description of current health|
|Problems||Major medical problems|
|Health problem history|
|Current/past medical problems|
|Medical equipment||Personalized medical devices|
|Internal or external medical devices used|
|Support sources||Emergency contact information|
|Functional status||Functional ability|
|Advance directives||Legal documents|
|Power of attorney|
of data needed from the perspective of health care providers, which results in interfaces that may be neither suitable nor desirable for care recipients (Alkhatlan, 2010).
Consumer Health Informatics
Increasingly, health information technology tools, applications, and devices are being produced for and used by healthy consumers, not just for individuals with suspected or diagnosed illness. They are also being used by informal caregivers to provide health information or obtain health management support, often without the involvement of formal caregivers. This
new genre of health applications, known as consumer health informatics tools, was defined in 2000 by Eysenbach, and more recently revised by the Agency for Healthcare Research and Quality, to include any electronic tool, technology, or system that (Gibbons et al., 2009)
- Is primarily designed to interact with health information users or consumers;
- Both uses and provides personal health information; and
- Is used for the purpose of helping consumers manage their health or health care maybe with, but is not dependent on, a health care professional and is not considered a tool within the context of routine clinical care.
Popular consumer health informatics devices include interactive, personal monitoring devices and decision support aids loaded onto cell phones, personal digital assistants, laptop computers, wireless-enabled devices (e.g., weight scales), personal health records, text messaging, discussion/chat groups, and online websites.
Because consumers often cite cost, convenience, and anonymity among the most important benefits of using the Internet to obtain health information and support, growth in societal interest in these tools and applications is likely to continue. In addition, because approximately 30 million newly insured Americans will enter the health care system over the next few years, the need, interest, and demand for ever more powerful consumer health informatics tools are expected to continue to grow well into the future.
Importantly, interactions between the consumer health informatics tools available to care recipients and the electronic health records that primary care providers and hospitals use raise issues that have a direct impact on health care in the home. Two of these issues are data ownership and data reliability. There is controversy about who should own the data in an EHR, whether the care recipient can simply annotate the data or should have the right to demand that items be expunged. The reliability of data that a care recipient enters into a PHR or care recipient portal is unknown, since data input can be affected by interface design, guidance, instructions, definitions, etc. This in turn will affect how much weight primary care providers should give to the data. These practical issues will have to be addressed as adoption of new technologies increases.
Health Information-Seeking Behaviors
Much has been written about health information-seeking behavior, although the term is used in various ways, and clear definitions, theoretical frameworks, and consensus on the meaning of the term are all lacking.
Lambert and Loiselle (2007) conducted a review of approximately 100 articles and five books and studied the topic as related to three issues: (1) coping with a health-threatening situation, (2) participation and involvement in medical decision making, and (3) behavior change and prevention behavior. They found that patterns of health information-seeking behavior reflected individuals’ selectivity in the type and amount of information needed and the sources and actions used.
Estimates of the use of the Internet for finding medical information vary significantly. One reason for this seems to be the time frame referents used in different studies. Those that asked if respondents had “ever” used the Internet to find health information found prevalence rates of 70 percent to more than 80 percent. Studies that asked about a narrower time frame (e.g., in the past year) found rates of 40 to 60 percent. One large study (n = 6,119) that asked about searching in the previous 30 days found rates of 13 percent among all respondents and 21 percent among respondents with Internet access (n = 3,829) (Weaver et al., 2009).
Use of the Internet is limited if the content is not retrievable by the user. This can be the case for individuals with disabilities who have to rely on special devices or technologies to process online information due to their sensory, mobile, or mental limitations. One study (Zeng and Parmanto, 2003) found that none of the 108 consumer health information websites examined satisfied all of the web accessibility requirements. In determining web accessibility, the authors constructed a measurement framework and scoring system based on specifications4 that offer checkpoints to determine content access for people with disabilities. In a 2009 examination of health care websites (Parmanto, 2010), the author determined there was still a long way to go to remove barriers to accessibility for people with disabilities.
The preferred medium for receiving health information varies significantly by age, gender, and ethnicity. For example, when seeking information specifically about cancer, Americans ages 65 and older are almost 10 times more likely to say they prefer going to health care providers first, before looking on the Internet, than people ages 18-64. Women are more likely than men to seek cancer information from sources other than the Internet. Compared with all other racial/ethnic groups, a higher percentage of Hispanics seek cancer information from health care providers and friends or family, and more blacks seek information from printed materials; more
4The widely referenced specifications included the World Wide Web Consortium (W3C) Web Content Accessibility Guideline 1.0 (WCAG), a stable international specification developed through a voluntary industry consensus, and the Electronic and Information Technology Accessibility Standards, published by the U.S. Access Board in December 2000 as required by Section 508 of the Rehabilitation Act Amendments of 1998.
whites and non-Hispanic others seek information on the Internet (National Cancer Institute, 2005).
Consumers are increasingly comfortable using the Internet as a research tool to obtain information on medical conditions, treatments, and wellness (Fox and Jones, 2009). This may be fueled in part by health care providers. Recent evidence suggests that nurses are very savvy when it comes to using information technology for health, and approximately three out of four U.S. nurses recommend health websites to care recipients. The average nurse spends eight hours per week online for professional purposes, the same amount as physicians, and almost all of them use the Internet between care recipient consultations. Nurses are also proactive in researching medical product information specifically online—over 80 percent have visited a pharmaceutical, biotechnology, or medical device company website in the past year (Manhattan Research, 2009).
User-centered design methods incorporate the needs of care recipients and caregivers, who are the intended users of a technology, into product design and evaluation. For example, these methods may be used by designers to address the needs of racial/ethnic minorities related to experiences with the mismatch of power between care recipient and health care provider, varying mental models of illness, and language barriers. Input and feedback obtained from users about these issues may be used to inform the design of care recipient–focused technologies.
The user-centered process has been effectively applied in the design of the Comprehensive Health Enhancement Support System (CHESS). CHESS was developed by a team of decision, information, education, and communication scientists at the University of Wisconsin–Madison’s Center for Health Enhancement Systems Studies, who used user-centered approaches in the design and evaluation of the system (Shaw et al., 2006). Through needs assessment surveys, users were asked to evaluate both the relevance and feedback provided by content that was created by clinical experts. Use of CHESS has been shown to improve care recipients’ quality of life, reduce demands on physician time, and in some cases even reduce the cost of care. Although the impact of user-centered design was not tested directly, the high levels of CHESS usage reported across racial, socioeconomic, gender, and age lines suggest that these methods had a positive effect on the design of this care recipient–focused information technology (Gustafson et al., 2002).
STANDARDS AFFECTING MEDICAL DEVICES AND HEALTH INFORMATION TECHNOLOGIES
A number of design standards and guidelines have been developed to guide the medical device and system design process (see Table 5-3). The Association for the Advancement of Medical Instrumentation (AAMI) developed many of the existing U.S. medical device standards, and, in response to the emergence of home health care as an important standardization area, recently established a new committee to focus on home health care. This group, called Medical Devices and Systems in Home Care Applications, will focus on health care devices specifically intended for use in the home environment. The efforts of this AAMI committee are intended to complement the FDA’s recent Medical Device Home Use Initiative (U.S. Food and Drug Administration, 2010), designed to support the safe use of medical devices in a residential setting, and, in turn, AAMI anticipates that the FDA initiative will augment the committee’s efforts (Association for the Advancement of Medical Instrumentation, 2010).
A number of user-interface standards and guidelines focus on various types of information technologies that play a role in health care in the home. Some standards and guidelines cover websites, some cover web and software applications, and some provide guidance for the design of hardware, including medical devices (see Table 5-4). However, standards and guidelines specific to health information technology applications are few.
Medical devices are migrating into the home with increasing frequency, and health information technologies are playing an ever-growing role in home-based health care, but useful guidance and regulatory oversight are not keeping pace. There is insufficient guidance regarding labeling for medical devices and regarding the content, structure, accessibility, and usability of health information technologies. The FDA’s postmarket surveillance system is insufficient to capture data to assist in the understanding of problems with medical devices in the home. Despite the proliferation of health information and integrated technologies for health care in the home, guidance and standardization are lacking for these new products regarding their content, format, structure, and usability, especially for untrained users (Karsh et al., 2011).
INTEGRATED TECHNOLOGIES IN THE HOME
A variety of health care applications and systems that integrate medical devices and health information technologies promise to facilitate practice of health care in the home in the future. Integrated technologies include context-aware medication dispensing systems, infusion pumps, mobility assistive devices, wearable monitoring and reminding devices, stationary
TABLE 5-3 Key Standards for Medical Device Design
|ANSI/AAMI HE74:2001 Human Factors Design Process for Medical Devices||The document describes “a recommended human factors engineering process for use in fulfilling user interface design requirements in the development of medical devices and systems, including hardware, software, and documentation.” 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 Human Factors Engineering—Design of Medical Devices||This document’s 25 sections provide requirements and recommendations for nearly all human factors aspects of medical device design, including visual display, controls, alarms, connectors and connections, device software, 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 Medical Devices—Application of Usability Engineering to Medical Devices||This standard: “Specifies a process for a manufacturer to analyse [sic], specify, design, verify and validate usability, as it relates to safety of a medical device. This usability engineering process assesses and mitigates risks caused by usability problems associated with correct use and use errors, i.e. normal use. It can be used to identify but does not assess or mitigate risks associated with abnormal use.”|
|IEC 60601-1-11:2010 Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment||This standard addresses some of the issues related to electrical medical devices used in the home. Although it offers significant guidance with respect to electrical power considerations for home use devices, as well as some guidance on instructions for use, remotely audible alarms (since untrained caregivers may not always be in close proximity to 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.|
TABLE 5-4 Standards and Guidelines for User Interfaces
|Microsoft Common Health User Interface||By far the most developed and rich set of standards 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 for the Presentation of Health Data—Australia HB 306-2007||This document provides guidelines for the design of effective user interfaces for health information 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 Guidelines-W3C||Primarily intended for people who develop web 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.|
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 physical, 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 abilities, 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 technologies 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 proliferate, 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 prosthetics (Bogue, 2009).
Future technological advances will bring new devices, such as improved pacemakers, cochlear implants, and medicine delivery systems. Miniaturization of various components, including microprocessors and nanotechnology, will make possible advances in many types of medical devices used inside
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 imaging 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 (electroencephalography), 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 measures, 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
to reach a goal than does individual participation. But the application of personal motion technologies extends far beyond measuring and reporting 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 oximeters, 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 connection. 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 professional, more continuous monitoring of caregiver performance and providing 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 adoption 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
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 usability. 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 important to consider the full range of users’ functional abilities, health literacy, self-efficacy, readiness to change, and motivations for and barriers to changing health behaviors. It is also important to honor the users’ cultural norms and their preferences for how and with whom to share data, action recommendations, 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 confidential 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 information 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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