Pursuant to Section 510 of the Rehabilitation Act, as amended by the Patient Protection and Affordable Care Act (29 U.S.C. § 794f), the Access Board has developed the MDE Standards to ensure that people with disabilities can access and use independently medical diagnostic equipment. The MDE Standards contain technical specifications to make diagnostic equipment accessible; however, the Standards impose no requirements on health care providers or medical device manufacturers, because the Board has no statutory authority to enforce them. At present, little is known regarding what next step the agencies with enforcing authority will take to make any or all of the MDE Standards mandatory. For this reason, this Final RA does not present any quantitative impacts of the MDE Standards on individuals with disabilities, health care providers, and medical device manufacturers.

This Final RA, instead, has discussed some of the potential ultimate impacts of these Standards in qualitative terms if these standards are adopted in the future by an enforcing agency. Given the many barriers to health care that patients with disabilities encounter due to inaccessible medical diagnostic equipment, individuals with disabilities will benefit from access to and use of diagnostic equipment meeting the MDE Standards. Equipment complying with the Standards will facilitate independent transfers by many patients with mobility and communication disabilities onto and off of diagnostic equipment and enable them to maintain their independence, confidence, and dignity. Accessible diagnostic equipment could contribute to more positive health care experiences for individuals with disabilities and enable them to receive health care comparable to that received by their non-disabled counterparts, but only once these standards are adopted by an enforcing agency.

If the MDE Standards are adopted by other agencies as mandatory for entities regulated under their jurisdiction, the Standards could affect health care providers and medical device manufacturers. 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.

In addition, the Standards could yield some immediate benefits, even before any adoption by enforcing agencies through 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 pertaining to the 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 the population – one that includes more people with disabilities and older adults.

The Access Board thus concludes that the benefits of the MDE Standards justify the costs of the final rule; that the Standards will impose the least burden on society, consistent with achieving the regulatory objectives; and that the regulatory approach selected will maximize net benefits. This Final RA has met the requirements of Executive Order 13563 (Improving Regulation and Regulatory Review) and Executive Order 12866 (Regulatory Planning and Review). Among other things, Executive Order 13563 directs agencies to: propose or adopt a regulation only after reaching a reasoned determination that its benefits justify its costs; tailor the regulation to impose the least burden on society possible while obtaining the regulatory objectives; and, in choosing among alternative regulatory approaches, select those approaches that maximize net benefits. Executive Order 13563 recognizes that some benefits and costs are difficult to quantify and provides that, where appropriate and permitted by law, agencies may consider and discuss qualitatively values that are difficult or impossible to quantify; such values include equity, human dignity, and fairness.