36 CFR Part 1195 Proposed Accessibility Standards for Medical Diagnostic Equipment NPRM - Preamble

B. Patient Protection and Affordable Care Act and Section 510 of the Rehabilitation Act

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 USC 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 is 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 used by health care providers 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 statute also requires the Access Board, in consultation with the Commissioner of the Food and Drug Administration, to periodically review and amend the standards, as appropriate. Section 510 of the Rehabilitation Act does not require any entity to comply with the standards that the Access Board issues under this law. Compliance with the standards becomes mandatory only when an enforcing authority adopts the standards as mandatory requirements for entities subject to its jurisdiction. As discussed below, the Department of Justice (DOJ) may adopt the 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.