1.3 General Guidance for Telecommunications and Personalized Access Strategies Using Web-Based, Mobile, and Home-Based Interface Technologies in Healthcare
Overview
With the emergence of e-health products and services, Internet-enabled web services infrastructure, and telehealth, many medical devices have become (or soon will become) web-enabled and/or part of integrated telecommunications-enabled healthcare services. Multiple forms of wireless infrastructure have also emerged, and computing capabilities are becoming ubiquitous within environments such as the home (and in hospitals and clinics when HIPAA considerations can be addressed). The guidance that follows can be applied to many different medical devices, and it is not possible to provide guidance for all categories of devices. Where noted this guidance is based on Section 508 of the Rehabilitation Act as well as the W3C Web Content Accessibility Guidelines, as targeted to healthcare applications. It is also intended to be consistent with the emerging vision of universal access, which addresses not only the area of interface accessibility but also access barriers related to distance and cost; interestingly, all three have historic claims to this concept, with different federal agencies involved in implementation (Winters, 2007). There are also other areas of technological convergence, most notably between the traditional consumer electronics and medical device industries for certain classes of home and mobile products, and between the aging of the “baby boomer” generation and the push for better usability engineering for consumer electronics and web-based home products. It is reasonable to assume that consumers will demand more accessible products in the future, and that the risk associated with “old style” interfaces that are less accessible will be problematic if they proliferate.
These trends affect when and how medical devices are used, and indeed the nature of the interface, especially as related to home and mobile use. This in turn has human factors implications. Interfaces for medical products can and should take advantage of an existing, and growing, infrastructure of protocols and processes that relate to, for instance, accessible web design. Telecommunications and web-based capabilities can change the nature of interaction by opening up new alternatives for timely access to healthcare products and services (Winters, 2002), which can have significant effects on medical devices used for diagnosis and therapy. Guidance is needed to help navigate through the maze of possible design solutions to assure that accessible and usable design principles are followed.
Recently revised guidance from the FDA for medical device software makes such software subject to a regulatory pre-market review by the FDA if the software impacts any medical diagnosis, therapeutic intervention, life-supporting or life-sustaining functions, or delivery of potentially harmful levels of energy in a way that is considered a major or moderate level of concern to health and safety (FDA, 2005). Telecommunications and information technology that is integrated with (or into) medical devices needs to follow a similar process.
This guidance on telecommunications and information access design strategies. It builds on the considerable amount of usability analysis and ad hoc guidance that is available for designing web pages, consumer products that often include a wireless remote, and teleconferencing systems that are accessible to people with disabilities.
Finally, this guidance also relates to future possibilities for universal access for certain types of medical product interfaces, specifically related to technical innovation in the areas of personalized access and tele-access. An operational definition of universal access is: The ability to access a product or service by all who can benefit from the healthcare intervention or assessment, by overcoming barriers related to the accessibility of the interface, to distance and to cost. A key concept is that of transparently personalizing (customizing) the interface by a user agent that is based on the abilities and preferences of a specific user. For personalized access, the "standards" focus is on carefully defining a protocol that expresses the content of a target device or service in a way that enables a user agent to create and maintain a personalized interface that the client can use for access to the product or service.
General Guidance for 1.3
1.3.1 The W3C Web Content Accessibility Guidelines (WCAG) should be satisfied for all web-based medical products.
There has been a trend towards wider use of software-based interfaces for medical devices (see also Section 19, Software User Interface). The World Wide Web Consortium (W3C) Web Content Accessibility Guidelines (WCAG) Version 1.0 (W3C, 1999) have been successfully implemented on a broad scale by federal government web pages, including those of Department of Veterans Affairs and those associated with federal health programs such as Medicare (see http://www.w3.org/TR/WAI-WEBCONTENT/). These guidelines should also be fully implemented for all web-enabled medical products. Of note is that the W3C is in the final stages of implementing the Web Accessibility Guidelines Version 2 recommendation (W3C, 2006; see http://www.w3.org/TR/WCAG20/). The reader is encouraged to consult these newest recommendations for guidance. Also of note is the considerable collaborative effort that is underway to have the Version 2 guidelines adopted by governments around the world; thus these guidelines have international applicability. Dr. Judy Brewer, coordinator of the W3C Web Accessibility Initiative (WAI), envisions innovative possibilities for using the WAI principles for designing future medical devices and interfaces that are both more accessible and usable (Brewer, 2007). While initially developed for web accessibility, the authors of the W3C Web Content Accessibility Guidelines encourage use of the guidelines for making all software-based interfaces more usable and accessible.
1.3.2 Existing videoconferencing and multimedia standards should be supported to the greatest extent possible.
Since the International Telecommunications Union (ITU) introduced the H.32x suite of videoconferencing standards in 1996, their impact has been considerable: dramatic reductions in cost have been realized, with considerable improvements in both product usability and quality. These standards address issues such as conferencing protocols, voice and audio codecs (compression algorithms), remote device control, security/encryption, shared whiteboards, support for data channels (including medical device data), and so on. In a parallel development coming from the information technology software community, since the late 1990’s the Internet Engineering Task Force (IETF) has been systematically developing a multimedia infrastructure that builds on the lighter-weight Session Initiation Protocol (SIP). Collectively, these standards span both the classic phone line infrastructure (H.320 for moderate and higher bandwidth, H.324 for lower bandwidth videophones) and the packet-based Internet Protocol (IP) infrastructure (H.323, SIP), and apply to video, voice, images and data. Compression algorithms, audio and video protocols, and security continue to improve and get embedded into these standards. The approach toward consensus also helps assure that these protocols provide telecommunications information in an accessible format. Additionally, video feeds that include audio that are compliant with common multimedia standards helps to assure lip synching, as well as to accommodate the transfer of video feeds to larger displays.
Often these capabilities can be extended into the home, and a number of phone- or web-enabled conferencing/multimedia telehealth products are on the market, with digital phones (originally commonly called Voice over IP) now commonplace. Instant messaging “chat” programs also use these standards, usually either H.323 or SIP. Importantly, such multimedia is inherently multimodal, because it transmits audio (voice), video and data. Data includes text exchange (standard instant messaging, which is important for many people with disabilities), shared whiteboards, and shared signals. Standards-based capabilities include control of zoom-pan-tilt of a remote camera, which is often a requirement for Medicare reimbursement of a tele-health encounter.
Designers who use these standards provide the user with multimodal flexibility. As an example, there are many possible strategies for augmenting an existing vital signs monitoring device with videoconferencing capabilities, including ad hoc approaches. This guidance strongly encourages the designer to consider implementation paths that take advantage of and support one or more of the existing circuit-based (H.320, H.324) or Internet-based (H.323, SIP) standards.
1.3.3 Existing consumer electronics and wireless standards should be supported and applied to the greatest extent possible.
Proprietary medical device electronic and information technology capabilities tend to lag about 3-5 years behind consumer technologies; for instance, many medical devices have been slow to support the USB port, and few, if any, medical device manufacturers are involved in the development of emerging standards such as Universal Plug and Play (UP&P, see http://www.upnp.org), the various World Wide Web Consortium working groups (see http://www.w3.org for various W3C activities), or the various wireless standards. While some of this may be related to regulatory issues, the effect of this is that many medical devices are technologically outdated and are not able to take advantage of the latest accessibility features that tend to be available in current consumer and business products.
In recent years there has been profound improvement in technical protocols and infrastructure for wireless communications, such as provided by the IEEE 802.11x standards (for example WiFi is 802.11b) for local area networks (LANs), the Bluetooth and ZigBee (IEEE 802.15.4) protocols for personal area networks (PANs), cell phone protocols for wide-area networks (WANs), and IRDA for infrared line-of-sight transmission. All of these are in use for current medical products. Note that these medical products may integrate with, and potentially even use, home-based consumer products such as using a television as a monitor (subject to addressing HIPAA considerations and FDA regulatory approval). In contrast, from both an innovation and accessibility perspective, the medical-specific Wireless Medical Telemetry Service (WMTS) network, where companies write their own proprietary code for connectivity rather than building on the multi-billion dollar societal investment in wireless standards, is best avoided. For instance, hospital informatics systems use the consumer-oriented wireless LAN (IEEE 802.11x), and therefore have access to better commercial technology for robust signaling and security, and also standards-based wireless products commonly used by persons with disabilities; ideally, medical devices would as well.
1.3.4 Built-in multimodal capabilities should be recognized and used.
Multimedia technical capabilities continue to improve. For many computer-based, in-home and mobile products, a multimodal infrastructure is available that includes intrinsic support for voice, video, text exchange and time-based signals. Additionally, many of the security/confidentiality challenges of the past have been addressed. This can make support for multimodal interfaces that can help address guidance provided in Section 10.3.1 more readily achievable.
1.3.5 Basic electronic and information technology accessibility requirements should be integrated into medical devices that use home-based technologies.
Although many individuals still lack these devices, home-based infrastructures such as televisions, computers and wireless networks offer ready platforms for providing in-home telehealthcare. For example, if televisions are used as a monitor display, because of Section 508 most television tuners are likely already equipped with secondary audio program caption decoder circuitry which appropriately receives, decodes, and displays closed captions from broadcast, cable, videotape, and DVD signals (Section 508 §1194.24 (b)). Most televisions also come with wireless remote controls that include volume control.
1.3.6 Medical devices with audio interfaces should consider compliance with existing laws related to use of telecommunication products with hearing aids.
The compatibility problems between hearing aids used by persons who are hard of hearing and audio-based technologies such as telephones have been address by Access Board regulations, and solutions are readily achievable. For medical devices with such interfaces, the specific guidance provided in Section 508 under the title Telecommunications Products (1194.23) may be helpful (see http://www.access-board.gov/sec508/guide/1194.23.htm).
1.3.7 Modern infrastructure with accessibility capabilities should be used for training and informational materials.
To ensure access, all training, documentation and other informational materials should be accessible in multiple formats. Note that in meeting such a requirement, the designer can take advantage of modern infrastructures for direct access, and also common assistive technology products for indirect access. For instance, the following guidance is based on existing development tools:
1.3.7.1 All training and informational video and multimedia productions, regardless of format, that contain speech or other audio information necessary for the comprehension of the content, should be open- or closed-captioned (based on Section 508 §1194.24 (c)).
1.3.7.2 All training and informational video and multimedia productions, regardless of format, that contain visual information necessary for the comprehension of the content, should be able to be audio described (based on Section 508 §1194.24 (b)).
1.3.7.3 Display or presentation of alternate text presentation or audio descriptions should be user-selectable unless permanent (based on Section 508, §1194.24 (e)).