### 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 F ederal agencies adopt the accessibility guidelines and standards issued by the Access Board as mandator y 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 Affordabl e Care Act (Pub. L. 111-148, 124 Stat. 570) amended title V of the Rehabilitation Act, which establishes righ ts 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 Dr ug Administration, to issue standards that contain

minimum technical criteria to ensure that medical di agnostic 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 st atute provides that the standards must allow for independent access to and use of the equipment by i ndividuals 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 stat ute 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

### 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 alternativ es 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 t he Association for the Advancement of Medical Instrumentation’s ANSI/AAMI HE 75:2009, “Human fa ctors 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 medi cal 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.aa mi.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 benefit s 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 juri sdiction. In July 2010, the Department of Justice issued an advance notice of proposed rulemaki ng (ANPRM) announcing that it was considering amending its Americans With Disabilities Act (ADA) regul ations 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 fu rniture, and that the Department has entered into settlement agreements wi th medical care providers requiring them to provide accessible medical equipment. The ANPRM stated that when the Ac cess Board has issued accessibility standards for medical diagnostic equipm ent, the Department would consider adopting the standards in its ADA regulations. The ANPRM also stated that if the De partment adopts the Access

### Board’s accessibility standards for medical diagnost ic 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.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

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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 toindividuals 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/medical

equipment.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