ARCHITECTURAL AND TRANSPORTATION BARRIERS COMPLIANCE BOARD 

Statement of Regulatory and Deregulatory Priorities 

 The Architectural and Transportation Barriers Compliance Board (Access Board) is an Independent 

Federal agency established by section 502 of the Rehabilitation Act (29 U.S.C. 792). The Access Board 

is responsible for developing accessibility guidelines and standards under various laws to ensure that 

individuals with disabilities have access to and use of buildings and facilities, transportation vehicles, and 

information and communication technology. Other Federal agencies adopt the accessibility guidelines 

and standards issued by the Access Board as mandatory requirements for entities under their jurisdiction. 

 The item in this regulatory plan is entitled “Accessibility Standards for Medical Diagnostic Equipment.” 

Section 4203 of the Patient Protection and Affordable Care Act (Pub. L. 111-148, 124 Stat. 570) amended 

title V of the Rehabilitation Act, which establishes rights and protections for individuals with disabilities, by 

adding section 510. Section 510 of the Rehabilitation Act (29 U.S.C. 794f) requires the Access Board, in 

consultation with the Commissioner of the Food and Drug Administration, to issue standards that contain 

minimum technical criteria to ensure that medical diagnostic equipment, used in or in conjunction with 

medical settings such as physicians’ offices, clinics, emergency rooms, and hospitals, are accessible to 

and usable by individuals with disabilities. The statute provides that the standards must allow for 

independent access to and use of the equipment by individuals with disabilities to the maximum extent 

possible. The statute lists examination tables, examination chairs, weight scales, mammography 

equipment, and other imaging equipment as examples of equipment to which the standards will apply. 

However, this list is not exclusive and the statute covers any equipment commonly used by health 

professionals for diagnostic purposes. The statute does not cover medical devices used for monitoring or 

treating medical conditions such as glucometers and infusion pumps. 

 Section 510 of the Rehabilitation Act requires the standards to be issued not later than 24 months after 

the enactment of the Patient Protection and Affordable Care Act. The Patient Protection and Affordable 

1

Regulations.gov Friday, January 20, 2012 The Regulatory Plan
Care Act was enacted on March 23, 2010. Accordingly, the statutory deadline for issuing the standards is 

March 23, 2012.

 The Access Board has considered alternatives proposed by stakeholders at public hearings and 

identified in research. In addition, the Access Board has consulted closely with the Department of Justice 

and the Food and Drug Administration in the development of these draft standards. The Access Board 

has also considered approaches contained in the Association for the Advancement of Medical 

Instrumentation’s ANSI/AAMI HE 75:2009, “Human factors engineering—Design of medical devices” in 

developing the proposed standards. ANSI/AAMI HE 75 is a recommended practice that provides 

guidance on human factors design principles for medical devices. Chapter 16 of ANSI/AAMI HE 75 

provides guidance on accessibility for patients and health care professionals with disabilities. Chapter 16 

of ANSI/AAMI HE 75 is available at: http://www.aami.org/he75/. The proposed standards do not 

reference the guidance in chapter16 of ANSI/AAMI HE 75 because the guidance is not mandatory. The 

Access Board seeks to promote harmonization of its standards and guidelines with voluntary consensus 

standards and plans to participate in future revisions to ANSI/AAMI HE 75. 

 The Access Board is seeking input from the public on costs and benefits associated with these 

standards. Section 510 of the Rehabilitation Act does not address who is required to comply with the 

standards. Compliance with the standards is not mandatory unless other agencies adopt the standards 

as mandatory requirements for entities under their jurisdiction. In July 2010, the Department of Justice 

issued an advance notice of proposed rulemaking (ANPRM) announcing that it was considering 

amending its Americans With Disabilities Act (ADA) regulations to ensure that equipment and furniture 

are accessible to individuals with disabilities. See 75 FR 43452 (July 26, 2010). The ANPRM noted that 

the ADA has always required the provision of accessible equipment and furniture, and that the 

Department has entered into settlement agreements with medical care providers requiring them to 

provide accessible medical equipment. The ANPRM stated that when the Access Board has issued 

accessibility standards for medical diagnostic equipment, the Department would consider adopting the 

standards in its ADA regulations. The ANPRM also stated that if the Department adopts the Access 

2

Regulations.gov Friday, January 20, 2012 The Regulatory Plan
Board’s accessibility standards for medical diagnostic equipment, it would develop scoping requirements 

that specify the minimum number of accessible types of equipment required for different medical settings.

 The rule is intended to reduce health and safety risks to individuals with disabilities by making medical 

diagnostic equipment accessible. 

3

Regulations.gov Friday, January 20, 2012 The Regulatory Plan
The 1 Actions Described in the Regulatory Plan

Title

Regulation 

Identifier 

Number

Rulemaking 

Stage

Accessibility Standards for Medical Diagnostic Equipment 3014-AA40 Proposed Rule Stage

Architectural and Transportation Barriers Compliance Board ( ATBCB ) RIN: 3014-AA40

 View Related Documents

Title: Accessibility Standards for Medical Diagnostic Equipment

Abstract: This regulation will establish minimum technical criteria to ensure that medical equipment used for diagnostic

purposes by health professionals in (or in conjunction with) physician's offices, clinics, emergency rooms, hospitals, and other

medical settings is accessible to and usable by individuals with disabilities.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed Rule

Major: No Unfunded Mandates: No

CFR Citation: 30 CFR 1197 (New) (To search for a specific CFR, visit the Code of Federal Regulations ) 

Legal Authority: 29 USC 794(f)

Legal Deadline: 

Action Source Description Date

Other Statutory 29 USC 794(f) 03/22/2012 

Regulatory Plan:

Statement of Need: The Access Board is required to issue accessibility standards for medical diagnostic equipment by

section 510 of the Rehabilitation Act. The standards will reduce health and safety risks to individuals with disabilities by making

medical diagnostic equipment accessible.

Legal Basis: Section 4203 of the Patient Protection and Affordable Care Act (Pub. L. 111-148, 124 Stat. 570) amended title

V of the Rehabilitation Act, which establishes rights and protections for individuals with disabilities by adding section 510.

Section 510 of the Rehabilitation Act (29 U.S.C. 794f) requires the Access Board, in consultation with the Commissioner of the

Food and Drug Administration, to issue standards that contain minimum technical criteria to ensure that medical diagnostic

equipment used in or in conjunction with medical settings such as physicians' offices, clinics, emergency rooms, and hospitals

are accessible to and usable by individuals with disabilities. The statute provides that the standards must allow for independent

access to and use of the equipment by individuals with disabilities to the maximum extent possible. The statute lists

examination tables, examination chairs, weight scales, mammography equipment, and other imaging equipment as examples of

equipment to which the standards will apply. However, this list is not exclusive and the statute covers any equipment commonly

used by health professionals for diagnostic purposes. The statute does not cover medical devices used for monitoring or treating

medical conditions such as glucometers and infusion pumps.

Alternatives: The Access Board has considered alternatives proposed by stakeholders at public hearings and identified in

research. In addition, the Access Board has consulted closely with the Department of Justice and the Food and Drug

Administration in the development of these draft standards. The Access Board has also considered approaches contained in the

Association for the Advancement of Medical Instrumentation's ANSI/AAMI HE 75:2009, "Human factors engineering--Design of

medical devices" in developing the proposed standards. ANSI/AAMI HE 75 is a recommended practice that provides guidance

on human factors design principles for medical devices. Chapter 16 of ANSI/AAMI HE 75 provides guidance on accessibility for

patients and health care professionals with disabilities. Chapter 16 of ANSI/AAMI HE 75 is available at:

http://www.aami.org/he75/. The proposed standards do not reference the guidance in chapter 16 of ANSI/AAMI HE 75 because

the guidance is not mandatory. The Access Board seeks to promote harmonization of its standards and guidelines with

voluntary consensus standards and plans to participate in future revisions to ANSI/AAMI HE 75.

Costs and Benefits: The Access Board is seeking input from the public on costs and benefits associated with these

standards. Section 510 of the Rehabilitation Act does not address who is required to comply with the standards. Compliance

with the standards is not mandatory unless other agencies adopt the standards as mandatory requirements for entities under

their jurisdiction. In July 2010, the Department of Justice issued an advance notice of proposed rulemaking (ANPRM)

announcing that it was considering amending its ADA regulations to ensure that equipment and furniture are accessible to

4

Regulations.gov Friday, January 20, 2012 The Regulatory Plan
individuals with disabilities. See 75 FR 43452 (Jul. 26, 2010). The ANPRM noted that the ADA has always required the

provision of accessible equipment and furniture, and that the Department has entered into settlement agreements with medical

care providers requiring them to provide accessible medical equipment. The ANPRM stated that when the Access Board has

issued accessibility standards for medical diagnostic equipment, the Department would consider adopting the standards in its

ADA regulations. The ANPRM also stated that, if the Department adopts the Access Board's accessibility standards for medical

diagnostic equipment, it would develop scoping requirements that specify the minimum number of accessible types of

equipment required for different medical settings.

Risks: The rule is intended to reduce health and safety risks to individuals with disabilities by making medical diagnostic

equipment accessible.

Timetable:

Action Date FR Cite

Notice of Public Information Meeting 06/22/2010 75 FR 35439 

NPRM 02/00/2012 

NPRM Comment Period End 04/00/2012 

Regulatory Flexibility Analysis

Required: Undetermined Government Levels Affected: Undetermined

Federalism: Undetermined

RIN Information URL: www.access-board.gov/medicalequipment.htm Public Comment URL: www.regulations.gov

Agency Contact: James Raggio 

General Counsel

Architectural and Transportation Barriers Compliance Board

1331 F Street NW. Suite 1000

Washington , DC 20004-1111 

Phone: 202 272-0040 

TDD Phone: 202 272-0062

FAX: 202 272-0081

E-Mail: raggio@access-board.gov

5

Regulations.gov Friday, January 20, 2012 The Regulatory Plan