Justification for Nonsubstantive Change

DATE: November 3, 2011

FROM: Reports Clearance Officer, HRSA

TO: Office of Information and Regulatory Affairs, OMB

SUBJECT: HRSA Request for Non-Substantive Change to the Countermeasures Injury Compensation Program (OMB Control No. 0915-0334)

The Health Resources and Services Administration (HRSA) is requesting Office of Management and Budget (OMB) review and approval of a non-substantive change to the Countermeasures Injury Compensation Program. This change specifically relates to the Health Information Authorization Form that is included as an instrument in the package.

The Countermeasures Injury Compensation Program developed the Health Information Authorization form to facilitate the process of requesting and releasing medical records from healthcare providers.  The basis for this form was an existing Indian Health Service form.  Some language was removed that did not appear to be relevant for program’s purposes. However, by removing that language, the form technically became HIPAA noncompliant.  Several medical records departments have raised questions regarding the HIPAA compliance of this form. The HIPAA and privacy act specialists in OGC recently reviewed the form and provided the additional language that would squarely place this form in HIPAA compliance.

The changes made to this form are as follows:

• Sections IV and V were combined, and Section VI thus became V, VII became VI, etc.

• In Section IV, program removed “In some instances” from the sentence beginning “This information may be used…”. Also in section IV, program added “…and sharing de-identified” to “…e.g. gathering data…”.

• In Section V, program reworded “…in writing at any time to the Health Information Management (Health Records) Department of my facility/provider”, to instead say “…in writing at any time by contacting my facility/provider…”.

• In Section V, program added “Date of Termination or Expiration” to the Enter Date line so as to clarify what this is for.

• Program divided Section VII of the original form into three separate sections, VI, VII, and VIII.

• In the last box, program replaced the language “This information is to be released for the purposes stated above and may not be used by the recipient for any other purpose.” with the HIPAA mandated language, “Consenting to this authorization of disclosure of records is voluntary and health provider(s) shall not condition treatment upon the individual’s signature of such authorization for use or disclosure of health information. This information is subject to release for the purposes stated in Section IV and may not be used by the recipient for any other purpose unless permitted by federal law. I understand that information disclosed by this authorization, except for alcohol and drug abuse patient records as defined in 42 CFR Part 2,  may be subject to re-disclosure by the recipient and may no longer be protected by the Health Insurance Portability and Accountability Act Privacy Rule (45 CFR Part 164), and the Privacy Act of 1974 (5 USC 552a).”

Thank you.

Carla Haddad

Carla Haddad, MPH

Public Health Analyst

Office of Planning, Analysis and Evaluation

Health Resources and Services Administration

5600 Fishers Lane, Rm 10-49

Rockville, MD 20857

Phone: (301) 443-0165

Email: [email protected]