Preliminary Regulatory Assessment for Medical Diagnostic Equipment Accessibility Standards

Introduction

Section 510 of the Rehabilitation Act, as amended by the Patient Protection and Affordable Care Act, requires the Access Board, in consultation 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 useable by patients with disabilities. The statutory deadline for issuing the standards is March 23, 2012. The standards do not impose any mandatory requirements on health care providers or medical device manufacturers. However, other agencies, referred to as an enforcing authority in the standards, may issue regulations or adopt policies that require health care providers subject to their jurisdiction to acquire accessible medical diagnostic equipment that conforms to the standards.

The Access Board prepared this preliminary regulatory assessment to meet the requirements of Executive Order 13563 (Improving Regulation and Regulatory Review) and Executive Order 12866 (Regulatory Planning and Review) for the Notice of Proposed Rulemaking (NPRM) requesting public comment on the proposed standards. Among other things, Executive Order 13563 directs agencies to propose or adopt a regulation only upon a reasoned determination that its benefits justify its costs; tailor the regulation to impose the least burden on society, consistent with 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, including equity, human dignity, fairness, and distributive impacts.