1. What is Section 510?
Section 510 was added to the Rehabilitation Act of 1973 by section 4203 of Patient Protection and Affordability Act (Public Law 111-148, 124 Stat. L. 119), which the President signed into law on March 23, 2010. Section 510 requires the Access Board, in consultation with the Food and Drug Administration, to issue regulatory standards for medical diagnostic equipment to ensure that the equipment is accessible to, and usable by, individuals with disabilities.
2. What is "medical diagnostic equipment?"
Section 510 describes "medical diagnostic equipment" as equipment that is:
• used by health care professionals
• in medical settings, such as physician's offices, clinics, emergency rooms, and hospitals,
• for diagnostic purposes.
Medical diagnostic equipment used by health care professionals in conjunction with a medical setting, such as a mobile health unit or trailer operated by a clinic, is also covered by Section 510. Examination tables, examination chairs, mammography equipment, x-ray machines, radiological equipment, and weight scales are examples of medical diagnostic equipment covered by Section 510.
Medical equipment used solely for treatment purposes is not covered by Section 510. However, medical equipment, such as dental chairs, that are used for both examination and treatment procedures are covered by Section 510.
3. What will the regulatory standards do?
Section 510 requires the regulatory standards to set forth minimum technical criteria that will allow patients with disabilities independent entry to, use of, and exit from medical diagnostic equipment to the maximum extent possible. Section 510 recognizes that independent access to medical diagnostic equipment may not be possible for some patients with disabilities or in some situations. Other means such as patient lifts or assisted transfer techniques may have to be used to provide access to medical diagnostic equipment for some patients with disabilities or in some situations.
4. Will the regulatory standards include scoping provisions?
No. Section 510 does not authorize the Access Board to issue scoping provisions for medical diagnostic equipment. Scoping provisions specify the minimum number of accessible features to be provided in facilities.
5. Who is required to follow the regulatory standards?
Section 510 does not address who is required to follow the regulatory standards. However, other Federal agencies may adopt or reference the regulatory standards in regulations, and address who is required to follow them.
6. What other Federal agencies may adopt or reference the regulatory standards in regulations?
The U.S. Department of Justice may adopt or reference the regulatory standards in its regulations implementing the Americans with Disabilities Act (ADA). The ADA is a federal civil rights law that prohibits discrimination against individuals with disabilities, including in the provision of medical care services. Public hospitals, clinics, and medical offices operated by state and local governments are covered by Title II of the ADA. Private hospitals, clinics, and medical offices are covered by Title III of the ADA as places of public accommodation. The U.S. Department of Justice issued an advance notice of proposed rulemaking (ANPRM) on July 26, 2010 announcing that it is considering revisions to its ADA Titles II and III regulations to ensure accessibility of equipment and furniture, including medical equipment and furniture.
7. When will the regulatory standards be issued?
Section 510 sets a deadline for issuing the regulatory standards. The regulatory standards must be issued not later than March 22, 2012, which is two years after the date the Patient Protection and Affordability Act was signed into law.
8. How will the regulatory standards be developed?
Section 510 requires the regulatory standards to be issued in accordance with the Administrative Procedure Act (APA). The APA requires federal agencies to issue a notice of proposed rulemaking (NPRM) in the Federal Register, which includes the text of the proposed rule, and to give the public an opportunity to submit written comments on the proposed rule. Federal agencies consider the written comments on the proposed rule in developing the final rule. The Access Board usually takes additional steps, including public information meetings and hearings, to solicit input from the public when developing rules.
9. Will the regulatory standards be updated periodically?
Yes. Section 510 requires the Access Board, in consultation with the Food and Drug Administration, to periodically review and update the regulatory standards.