36 CFR Part 1195 Standards for Accessible Medical Diagnostic Equipment - Preamble

A. Purpose and Legal Authority

The 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. Pursuant to these laws, other federal agencies have adopted the Access Board’s guidelines and standards as mandatory requirements for entities subject to their jurisdiction.

On March 23, 2010, Section 4203 of the Patient Protection and Affordable Care Act (ACA) amended Title V of the Rehabilitation Act, which established the rights and protections for individuals with disabilities, by adding Section 510. Pub. L. 111-148, 124 Stat. 570). Section 510 of the Rehabilitation Act charges the Access Board, in consultation with the Commissioner of the Food and Drug Administration, with issuing standards that set forth the minimum technical criteria to ensure that medical diagnostic equipment (diagnostic equipment) used in (or in conjunction with) “physician’s offices, clinics, emergency rooms, hospitals, and other medical settings, is accessible to, and usable by, individuals with accessibility needs, and shall allow independent entry to, use of, and exit from the equipment by such individuals to the maximum extent possible.” 29 U.S.C. 794f.

The statute gives examples of diagnostic equipment, including “examination tables, examination chairs (including chairs used for eye examinations or procedures, and dental examinations or procedures), weight scales, mammography equipment, x-ray machines, and other radiological equipment commonly used for diagnostic purposes by health professionals.” 29 U.S.C. 794f. This list is not considered exhaustive, but is illustrative of types of medical diagnostic equipment.

Section 510 of the Rehabilitation Act instructs the Access Board to promulgate technical standards regarding accessibility of medical diagnostic equipment, but does not give the Access Board authority to enforce these standards. Compliance with the MDE Standards becomes mandatory only when an enforcing authority adopts the MDE Standards as mandatory for entities subject to its jurisdiction. Additionally, the enforcing agencies will determine the application and scope of these standards, such as who must comply and the extent to which medical diagnostic equipment used by covered entities must comply with these MDE Standards. As discussed below, the U.S. Department of Justice (DOJ) may adopt the MDE Standards as mandatory requirements for health care providers pursuant to its authority under Titles II and III of the Americans with Disabilities Act. Other federal agencies may adopt the standards as mandatory requirements for health care providers pursuant to their authority under Section 504 of the Rehabilitation Act.

Private parties, including individuals with disabilities, have also entered into settlement agreements with health care providers to enforce the ADA and Section 504 of the Rehabilitation Act.

The Commissioner of the Food and Drug Administration designated the Director of the Center for Devices and Radiological Health (FDA-CDRH) to consult with the Access Board on the development of the MDE Standards. The Access Board has worked throughout the process with the FDA-CDRH in developing these Standards.