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ATBCB | RIN: 3014-AA40 | Publication ID: 2012 |
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. | |
Agency: Architectural and Transportation Barriers Compliance Board(ATBCB) | Priority: Other Significant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Final Rule Stage |
Major: No | Unfunded Mandates: No |
CFR Citation: 30 CFR 1197 (New) | |
Legal Authority: 29 USC 794(f) |
Legal Deadline:
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Statement of Need: Under section 510 of the Rehabilitation Act (29 U.S.C.794f), the Access Board, in consultation with the Commissioner of the Food and Drug Administration, is required 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 medical diagnostic equipment by individuals with disabilities to the maximum extent possible. 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 (Pub. L. 111-148, 124 Stat. 570).The statutory deadline for issuing the standards was March 23, 2012. |
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Summary of the 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. |
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Alternatives: In developing the NPRM, the Access Board has considered and will continue to consider alternatives proposed by a variety of stakeholders. First, the Access Board 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. In particular, 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 Access Board's 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 harmonize its standards and guidelines with voluntary consensus standards and plans to participate in future revisions to ANSI/AAMI HE 75. In addition, the Access Board has consulted closely with the Department of Justice and the Food and Drug Administration in the development of the proposed standards, and plans to continue to work closely with them in the development of the final rule. The Access Board has also established an Advisory Committee to make recommendations to the Board on how to address issues raised in the public comments on the proposed rule. |
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Anticipated Costs and Benefits: The proposed standards address many of the barriers that have been identified as affecting the accessibility and usability of diagnostic equipment by individuals with disabilities. For example, the proposed standards would facilitate independent transfers by individuals with disabilities onto and off of diagnostic equipment, and enable them to maintain their independence, confidence, and dignity, lessening the need for health care personnel to assist individuals with disabilities when transferring on and off of diagnostic equipment. The proposed standards would improve the quality of health care for individuals with disabilities and ensure that they receive examinations, diagnostic procedures, and other health care services equal to those received by individuals without disabilities. The Access Board has prepared a preliminary regulatory assessment for the proposed standards, which is available on the Access Board's web site at: http://www.accessboard.gov/medical-equipment.htm. The preliminary assessment compares costs of select medical diagnostic equipment with and without accessibility features in the market. The Access Board is seeking input from the public on costs and benefits associated with these proposed standards to support a final regulatory impact assessment that will accompany the final rule. Section 510 of the Rehabilitation Act does not address who is required to comply with the standards. Compliance with the standards would not be 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 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. At that time, the impact of scoping and application of the proposed standards can be more fully assessed. |
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Timetable:
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Regulatory Flexibility Analysis Required: Undetermined | Government Levels Affected: Undetermined |
Federalism: No | |
Included in the Regulatory Plan: Yes | |
RIN Information URL: www.access-board.gov/medical-equipment.htm | Public Comment URL: www.regulations.gov |
RIN Data Printed in the FR: No | |
Agency Contact: James Raggio General Counsel Architectural and Transportation Barriers Compliance Board Suite 1000, 1331 F Street NW., Suite 1000, Washington, DC 20004-1111 Phone:202 272-0040 TDD Phone:202 272-0062 Fax:202 272-0081 Email: raggio@access-board.gov |