Download this file (mde-assessment.pdf)mde-assessment.pdf

Final Regulatory Assessment: Medical Diagnostic Equipment Accessibility Standards
(36 CFR Part 1195)


December 2016

Executive Summary

Section 510 of the Rehabilitation Act, as amended by the Patient Protection and Affordable Care Act, requires the Access Board, in coordination with the Food and Drug Administration, to issue accessibility standards that contain minimum technical criteria to ensure that medical diagnostic equipment is accessible to and usable by patients with disabilities. The U.S. Access Board (hereafter, “Access Board” or “Board”) is now issuing the final rule pursuant to this authority. The final rule includes technical standards for accessible medical diagnostic equipment (MDE Standards) that would allow individuals with mobility or communication disabilities to enter, use, and exit from medical diagnostic equipment independently, to the maximum extent possible. Examples of such diagnostic equipment include examination tables and chairs, weight scales, mammography equipment, and other imaging equipment.

The final rule does not directly impose any obligations on health care providers or medical device manufacturers, because the Board has no statutory authority to implement or enforce the accessibility requirements in the MDE Standards. Only when another federal agency, through separate rulemaking, adopts the MDE Standards (in whole or in part) as mandatory for entities under its jurisdiction will compliance be required. At this point, the Access Board does not know whether enforcing authorities will adopt the MDE Standards, nor (if they do) to what extent health care practices or particular types of medical diagnostic equipment will be required to comply with the Standards’ technical requirements. For this reason, the Access Board cannot estimate the incremental monetary or quantitative impact of the final rule.

Nevertheless, the Access Board is able to characterize qualitatively some of the potential impacts of these Standards. If and when the MDE Standards are adopted by enforcing agencies as mandatory for entities regulated under their jurisdiction, the Standards could affect health care providers, medical device manufacturers, and individuals with disabilities. Once health care providers and facilities are required to acquire accessible medical equipment, they could incur compliance costs, to the extent that their equipment is not already accessible. Medical device manufacturers would then decide whether to incur incremental costs to meet the demand for accessible equipment, and some or many manufacturers may have an economic incentive to produce accessible equipment. Finally, given the many barriers to health care that patients with disabilities encounter due to inaccessible medical diagnostic equipment, individuals with mobility and communication disabilities will benefit from access to and use of diagnostic equipment meeting the MDE Standards. As a consequence, they may be able to receive health care comparable to that received by their non-disabled counterparts.

In addition, the Standards could yield some more immediate benefits, even before any adoption by implementing agencies in formal rulemaking. First, the technical specifications for accessible MDE incorporated in the Standards will benefit enforcing agencies that are considering similar accessibility requirements for entities under their jurisdiction. Although enforcing agencies have full authority over whether to adopt the Access Board’s final rule (in whole or in part), the technical specifications in the MDE Standards reflect the input from a diverse set of stakeholders and provide solid groundwork for any future rulemaking in the area of accessibility in medical diagnostic equipment. Second, the Standards will serve as a best-practice document for the medical device industry and for health care providers and facilities. While the MDE Standards are non-binding, health care providers can use this final rule as guidance on how to provide equitable access to medical diagnostic equipment for people with mobility and communication disabilities. Manufacturers can also use the MDE Standards as they target their research and development efforts at producing diagnostic equipment that can be used by a larger segment of population – one that includes more people with disabilities and older adults.

The Access Board thus concludes that the potential benefits of the MDE Standards justify its potential costs; that the MDE Standards will impose the least burden on society, consistent with achieving the regulatory objectives; and that the regulatory approach selected will maximize net benefits.