Regulatory Assessment

The Access Board has prepared this final regulatory assessment (Final RA) in support of the agency’s final accessibility standards for medical diagnostic equipment (MDE Standards or final rule). The Board has developed these MDE Standards pursuant to Section 510 of the Rehabilitation Act, an amendatory provision enacted in 2010 that tasked the Access Board with establishment of minimum technical criteria to ensure the accessibility of medical diagnostic equipment for persons with disabilities.1 The MDE Standards lay out the minimum technical criteria necessary to ensure that medical diagnostic equipment is accessible to and usable by patients with mobility and communication disabilities. Examples of such diagnostic equipment include examination tables and chairs, weight scales, mammography equipment, and other imaging equipment.

Achieving actual accessibility for medical diagnostic equipment via regulatory means is a two-step process. The MDE Standards are the first step. The MDE Standards contain technical specifications to make the covered diagnostic equipment accessible; however, they do not impose any requirements on health care providers or medical device manufacturers because the Access Board has no statutory authority to implement or enforce the Standards. The second step of this two-step regulatory scheme would be when one or more federal agencies, through separate rulemakings, adopt the MDE Standards (whether in whole or in part) as mandatory for entities under their jurisdiction. Subsequent rulemakings by these “enforcing agencies” will identify the entities that must comply with the MDE Standards, and the extent to which medical diagnostic equipment must conform to the MDE Standards. Since the Access Board does not know if and how enforcing authorities will adopt the MDE Standards, it has no way of estimating what costs (if any) manufacturers, providers, or others will incur as a result of this rule, or what level of societal benefits will be accrued.

Instead, this Final RA offers a qualitative discussion of some of the possible future impact of the MDE Standards. First, the Final RA examines the barriers to health care facing individuals with disabilities due to inaccessible diagnostic equipment, and it explains how the barriers will be reduced when patients with disabilities can access and use medical diagnostic equipment complying with the MDE Standards. Second, the Final RA discusses the potential impacts on health care providers and medical device manufacturers in cases where enforcing agencies adopt the MDE Standards as mandatory for entities regulated under their jurisdiction.

In addition, the Final RA provides a brief overview of commonly used diagnostic equipment in the current U.S. market to give a sense of how technical requirements in the MDE Standards are or are not met among the products sold at present. Building on the market information provided in the Preliminary Regulatory Assessment (Preliminary RA), as well as a search of online information from manufacturers, the Final RA presents product and price information for select diagnostic equipment. It indicates the extent to which different types of diagnostic equipment are already available with features similar to those required by the technical specifications of this final rule, and it notes where products do not currently offer similar features, meaning that they would require redesign should an enforcing authority adopt these MDE Standards in the future.