Appendix 1: Chairs’ Perspectives on Workshop Breakout Theme C (Interfaces for Home Healthcare Devices)

This section summarizes the activity of the breakout theme of the Workshop on Accessible Interfaces for Medical Instrumentation that focused on interfaces for home healthcare devices (Theme C). It is authored by the co-chairs for this theme.

1. Status and Trends

Theme Group C co-chairs Daryle Gardner-Bonneau and Binh Tran gave short presentations summarizing the current status of standards work and medical technology user interfaces, respectively. With respect to standards, Dr. Gardner-Bonneau briefly described the lack of consistency in definitions of accessibility vs. usability, along with the differences in the way accessibility is defined in the U.S. and internationally. She also described the status of ongoing medical device and accessibility standards efforts (see Chapter 15, Gardner-Bonneau).

Dr. Tran discussed the state of the technology in the home healthcare area, and noted the chronic diseases that are the best candidates for management through home healthcare, the top four being diabetes, hypertension, congestive heart failure, and asthma. He showed a number of examples of the technologies being used to manage illnesses at home, and pointed out the increasing trend toward the design of small, compact or hand-held devices for monitoring and medication dosing. Dr. Tran also noted the increasing use of integrated telehealth systems for monitoring patients.

2. Vision Statements

There was not complete agreement about the status of all aspects of medical instrumentation user interface design among the participants. Some felt designers were addressing many usability and accessibility issues, while others felt that, currently, there were many challenges still to be addressed. Table 4 outlines the vision statements of this group, which reflect some of the challenges still to be met in the design of medical instrumentation for home healthcare. Most participants agreed that designers need additional guidelines and strategies for how to be more inclusive in designing for various end-users. Designers probably need to know more about the prevalence of disabilities and the nature of the functional deficits involved. The second vision statement reflects the need for adaptability and simplicity in devices designed for the home healthcare environment, emphasizing customizability, scalability, ease of operation, and interoperability of devices. Device designers also need to consider the variation in user skill levels, comfort with the technology, language issues, and variations in sensory and information processing capabilities that suggest the use of multi-modal, multisensory user interfaces.

The third vision statement reflects a longstanding need, not only in home care, but in the healthcare system generally, for connected, or integrated, care systems. There are too many individual and incompatible devices, and devices that don’t “talk” to each other. A worthy goal in home healthcare is to have integrated systems that can be remotely accessed, monitored, controlled and maintained. Inherent in the discussion of this vision statement was the need to empower patients, as components of the system, to take greater responsibility and control of their care (as opposed to perpetuating the MD-focused model of care). Medical equipment could also be “smarter,” not only in applying appropriate context-specific interpretations to data, but in adapting its interaction to the specific user (patient, lay caregiver, clinician). The need to consider not only clinicians, but also patients and lay caregivers, in the development of decision support systems, was highlighted. Finally, more and more healthcare is moving out of the hospital and into the home, but the reimbursement for home healthcare services, particularly telehealth services, needs to be modified in light of the capabilities of the technology that we have now, and that will become, no doubt, the norm in the future. New reimbursement policies should have a greater focus on preventive care.

3. Challenges and Barriers to Vision

Medical devices designers have been fairly far removed from the home healthcare equipment user. Devices have generally been designed for hospital use by trained professionals, and the movement of this equipment into the home environment reveals a gap in the knowledge of the home care environment among designers. In order to design appropriately, they need to understand that home environment, as well as the capabilities and limitations of this “new” user population. The first barrier listed in Table 4 identifies the narrowing of this knowledge gap as a significant challenge to be met in order to meet the goal of inclusive design. The second challenge reflects the limitations of current medical technology. Most devices and instrumentation rely on the visual user interface and manual control of devices. To meet the needs of users with disabilities, devices will need to have more flexible user interfaces with multi-modal, multi-sensory input and output options. The third challenge is similar: to meet the vision goal of scalable platforms, devices will need to address the requirement for flexibility and adaptability to different skills and ability levels of users, different comfort levels of users with the technology, and diversity of languages.

One of the barriers to having a connected care system is the current MD-focused healthcare model. Connected care will not be achieved until patients are empowered and have a specific and active role to play in the healthcare process. This concern is reflected in the fourth challenge listed in Table 4. Similarly, the final challenge in the table – the lack of focus on prevention – also implies that patients are not sufficiently involved in the process. The MD-focused model has always involved acute care – dealing with the current crisis, not preventing crises from occurring.

4. Knowledge Gaps and Action Items

The knowledge gaps and action items created by Theme Group C are also shown in Table 4, and relate closely to the vision statements and challenges/barriers statements. Many of the action items related to increasing the involvement of various stakeholders – mainly users and designers – in the tasks that must be carried out to make medical instrumentation accessible. Designers and manufacturers should become more actively involved in the standards process, to help establish both process and design guidance for achieving the accessible goal for medical instrumentation. Similarly, designers should be at the forefront of work to be done in enhancing the decision support capabilities of medical instrumentation for all expected users, as well as in increasing the flexibility and adaptability of medical device user interfaces to meet the needs of users in the home healthcare environment. This work will require research to ensure that the end results do, indeed, have the desired effect; in other words, the resulting designs should be tested for accessibility with appropriate samples of end-users. Ways to enhance patient empowerment towards self-management should be explored and validated. Finally, the complex relationships that exist among reimbursement, introduction of new technologies, and manufacturer profitability need to be better understood in order to meet accessibility goals in a way that is both feasible and financially sound.

5. Recommendations

The recommendations of Theme Group C (see Table 4) again relate closely to the original vision statements, but refer specifically to the roles that policymakers and granting agencies can play in the process of achieving accessibility goals for medical instrumentation used in the home healthcare arena. Policymakers and granting agencies can be key “cheerleaders” for accessibility by making changes and/or establishing programs that would mandate and enforce accessibility in the design of devices, provide reimbursement options for home healthcare that take advantage of telehealth technology for the management of chronic diseases, and by seriously promoting the prevention model of healthcare delivery. Granting agencies are encouraged to establish and support research programs that will help to fill the knowledge gaps that exist with respect to designing for accessibility, appropriately managing chronic disease through telehealth, and designing flexible and “smart” decision support systems for medical equipment. Research should also be supported that would better describe home healthcare clients in terms of their likely skills and abilities and their comfort with technology, and identify and ameliorate barriers to self-management. Finally, the medical instrumentation industry is encouraged to work towards the goals of interoperability, scalability, and customizability of systems and equipment designed for the home health market.

6. Discussion

Many of the user interface and accessibility problems in medical instrumentation stem from issues the plague the healthcare system as a whole. In fact, many would say that, in the U.S. at least, healthcare is fragmented and inefficient, and not really a “system” at all. The lack of a systems approach has, no doubt, created many of the problems we face in healthcare. We do not have a connected system of care, generally; therefore, a lack of technology integration is an expected byproduct of the fragmented care system itself.

Historically, the medical device industry has been a “cottage” industry; therefore it is not surprising that there are interoperability problems and a lack of integrated systems. In addition, as an industry that is regulated by the federal government through the U.S. Food and Drug Administration (FDA), the medical device industry places its priority where the government does – on the safety and effectiveness of individual medical devices. Only during the last ten years has the FDA emphasized usability as an additional goal, and the goal of accessibility is only now being placed on the table.

Further, much medical equipment that was designed for use by highly trained caregivers in the hospital environment has migrated to the home environment and into the hands of lay caregivers – a much more variable population of users across many dimensions. More medical devices are becoming, in effect consumer products, and the same levels of usability and accessibility we have come to expect from other consumer products should be applicable to these devices.

If we truly believe in patient empowerment and patient self-management of chronic illnesses, then we must also believe in and support usability and accessibility goals. Unless medical instrumentation is accessible and usable, patients cannot be empowered or manage their care. It’s as simple as that. The vision statements of Theme Group C – with words like scalable, customizable platforms, “smart” systems, a connected care system, strategies and guidelines for inclusive design, and reimbursement models that support telehealth and preventive care – will, if met, increase both the accessibility and usability of medical instrumentation and empower patients.