2015 Edition Health Information Technology (Health IT)
Certification Criteria, 2015 Edition Base Electronic Health Record
(EHR) Definition, & ONC Health IT Certification Program
Modifications
§ 170.315(g)(8) (Accessibility-Centered Design)
Section § 170.315(g)(8) (Accessibility-Centered Design)
Excerpt of Proposed Rule
This is an excerpt from the 2015 Edition Health Information Technology (Health IT) Certification
Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, & ONC Health IT
Certification Program Modifications that is focused on section § 170.315(g)(8) on the topic of
accessibility-centered design. You can find the entire ONC document, including other sections
referenced both in the proposed rule and in its footnotes, here: http://federalregister.gov/a/201506612
Section § 170.315(g)(8) (Accessibility-Centered Design)
We propose to adopt a new 2015 Edition “accessibility-centered design” certification criterion that
would apply to all Health IT Modules certified to the 2015 Edition. This criterion would require the
identification of user-centered design standard(s) or laws for accessibility that were applied, or
complied with, in the development of specific capabilities included in a Health IT Module or,
alternatively, the lack of such application or compliance.
This proposed certification criterion would serve to increase transparency around the application of
user-centered design standards for accessibility to health IT and the compliance of health IT with
accessibility laws. We believe this transparency would be beneficial for those health care
providers, consumers, governments, and other stakeholders that have an interest in knowing the
degree to which heath IT, particularly certified health IT, meet health IT accessibility standards and
laws. This transparency may also encourage health IT developers to pursue the application of
more accessibility standards and laws in product development that could lead to improved usability
for health care providers with disabilities and health care outcomes for patients with disabilities.
We propose to model our approach and this criterion after the 2014 Edition “quality management
system” criterion (§ 170.314(g)(4) and see 77 FR 54270-54271). Therefore, as a first step, for each
capability that a Health IT Module includes and for which that capability’s
certification is sought, the use of a health IT accessibility-centered design standard or compliance
with a health IT accessibility law in the development, testing, implementation, and maintenance of
that capability must be identified. Working with our colleagues at NIST, we have identified an initial
list of health IT accessibility-centered design standards and accessibility laws below. However,
health IT developers may choose to use other health IT accessibility standards or laws in the
development, testing, implementation, and maintenance of capabilities, but must identify these
standards and/or laws for the purposes of certification. As with the 2014 Edition “quality
management system” criterion, we propose to permit a response that “no health IT accessibilitycentered design standard or law was applied to all applicable capabilities” as an acceptable means
of satisfy this proposed certification criterion. We note, however, that whatever method(s) is used
to meet this proposed criterion, it would be reported to the proposed open data CHPL.
We solicit comments on whether the standards and laws identified below are appropriate examples
and whether we should limit the certification criteria to which this criterion would apply. For
example, limiting it to a Health IT Module certified only to the certification criteria proposed in §
170.315(a), (b), (c), and (e), or otherwise. To note, we believe that, at a minimum, this criterion
would not apply to the certification criteria in § 170.315(g).
Example health IT accessibility-centered design standards and accessibility laws:
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ETSI ES 202 076 Human Factors (HF); User Interfaces; Generic spoken command vocabulary for ICT devices and
services;
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ETSI ETS 300 679 Terminal equipment (TE); Telephony for the hearing impaired; Electrical coupling of telephone sets to
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ETSI TR 102 068 (2002) Human Factors (HF): Requirements for assistive technology devices in ICT;
ETSI TS 102 511 (2007) Human Factors (HF): AT commands for assistive mobile device interfaces;
IEEE 802.11 IEEE standard for Information Technology; Telecommunications and information: Exchange between systems;
hearing aids;
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local and metropolitan area network; specific requirements - Part 11: Wireless LAN Medium Access Control (MAC) and
Physical Layer (PHY) Specification;
ISO 13406-1 (1999) Ergonomic requirements for work with visual displays based on flat panels. Part 1 – Introduction;
ISO 13406-2 (2001) Ergonomic requirements for work with visual displays based on flat panels. Part 2 - Ergonomic
requirements for flat panel displays;
IEC 80416-1 (2001) Basic principles for graphical symbols for use on equipment - Part 1: Creation of symbol originals;
ISO 80416-2 (2002) Basic principles for graphical symbols for use on equipment - Part 2: Form and use of arrows;
IEC 80416-3 (2002) Basic principles for graphical symbols for use on equipment - Part 3: Guidelines for the application of
graphical symbols;
ISO 80416-4 (2005) Basic principles for graphical symbols for use on equipment. Part 4 - Guidelines for the adaptation of
graphical symbols for use on screens and displays;
ISO 9241-151 (2008) Ergonomics of human-system interaction - Part 151: Guidance on World Wide Web user interfaces;
ISO 9355-1 (1999) Ergonomic requirements for the design of displays and control actuators. Part 1: Human interactions with
displays and control actuators;
ISO 9355-2 (1999) Ergonomic requirements for the design of displays and control actuators. Part 2: Displays;
ISO 9999 (2007) Assistive products for persons with disability - Classification and terminology;
ISO/CD 24500 Guidelines for all people, including elderly persons and persons with disabilities - Auditory signals on
consumer products;
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ISO/IEC 15411 (1999) Information technology - Segmented keyboard layouts;
ISO/IEC 15412 (1999) Information technology - Portable keyboard layouts;
ISO / IEC 24755 (2007) Information technology - Screen icons and symbols for personal mobile communication devices;
ISO/IEC CD 24786-1 Information Technology - User interfaces - Accessible user interface for accessibility setting on
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ISO/IEC TR 15440 (2005) Information Technology - Future keyboards and other associated input devices and related entry
information devices - Part 1: General and methods to start;
methods;
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ISO/IEC TR 19765 (2007) Information technology - Survey of icons and symbols that provide access to functions and
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facilities to improve the use of IT products by the elderly and persons with disabilities;
ISO/IEC TR 19766 (2007) Information technology - Guidelines for the design of icons and symbols accessible to all users,
including the elderly and persons with disabilities;
ITU-T E.902 (1995) Interactive services design guidelines;
ITU-T P.85 (1994) A method for subjective performance assessment of the quality of speech voice;
Section 504 of the Rehabilitation Act; and
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Section 508 of the Rehabilitation Act.
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Because we propose that Health IT Modules certified to the 2015 Edition would be required to be
certified to the 2015 Edition Accessibility-centered design criterion, we also propose to revise §
170.550 to require ONC-ACBs follow this proposed approach (please see section IV.C.2 of this
preamble for this proposal).
Transport Methods and Other Protocols
We propose two ways for providers to meet the 2015 Edition Base EHR definition using health IT
certified to transport methods. These ways serve to account for transport methods that we
understand are being used to readily exchange electronic health information and ensure that
providers have interoperable ways to exchange electronic health information. The first way to
meet the proposed 2015 Edition Base EHR definition requirement would be for a provider to
have health IT certified to § 170.315(b)(1) and (h)(1) (Direct Project specification). This would
account for situation where a provider uses a health IT developer’s product that acts as the
“edge” and the HISP. The second way would be for a provider to have health IT certified to §
170.315(b)(1) (ToC criterion) and (h)(2) (Direct Project, Edge Protocol, and XDR/XDM). This
would account for situations where a provider is using one health IT developer’s product that
serves as the “edge” and another health IT developer’s product that serves as a HISP.182 The
capabilities included in proposed § 170.315(h)(2) ensure interoperability by accounting for
various electronic health information exchange options using the Direct Project specification. To
fully implement this approach, we propose to revise § 170.550 to require an ONC-ACB to ensure
that a Health IT Module includes the certification criterion adopted at § 170.315(b)(1) in its
certification's scope in order to be certified to the certification criterion proposed for adoption at §
170.315(h)(1). We welcome comment on these proposed approaches and the transport
standards listed below in § 170.315(h)(1) through (3). Consistent with our proposed title of
“transport methods and other protocols” for §170.315(h), we proposed to revise the heading of §
170.202 from “transport standards” to “transport standards and other protocols.”
More information on the entire 2015 Edition Health Information Technology (Health IT)
Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, & ONC
Health IT Certification Program Modifications can be found here:
http://federalregister.gov/a/2015-06612
182 See the 2014 Edition Release 2 final rule for more discussion on such situations (79 FR 54436-38).