A covered entity must maintain such policies and procedures in written or electronic form where policies or procedures with respect to protected health information are required by this subpart. Where a communication is required by this subpart to be in writing, a covered entity must maintain such writing, or an electronic copy, as documentation; and where an action or activity is required by this subpart to be documented, it must maintain a written or electronic record of such action or activity. While these requirements are subject to the PRA, we believe the burden associated with these requirements is exempt from the PRA as stipulated under 5 CFR 1320.3(b)(2).
We have submitted a copy of this rule to OMB for its review of the information collection requirements in Secs. 160.204, 160.306, 160.310, 164.502, 164.504, 164.506, 164.508, 164.510, 164.512, 164.514, 164.520, 164.522, 164.524, 164.526, 164.528, and Sec. 164.530. These requirements are not effective until they have been approved by OMB. If you comment on any of these information collection and record keeping requirements, please mail copies directly to the following: Health Care Financing Administration, Office of Information Services, Division of HCFA Enterprise Standards, Room N2-14-26, 7500 Security Boulevard, Baltimore, MD 21244-1850. ATTN: John Burke and to the Office of Information and Regulatory Affairs, Office of Management and Budget, Room 10235, New Executive Office Building, Washington, DC 20503. ATTN: Allison Herron Eydt, HCFA Desk Officer.