[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR21.33]
[Page 224]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 21 PROTECTION OF PRIVACY--Table of Contents
Subpart C Requirements for Specific Categories of Records
Sec. 21.33 Medical records.
(a) In general, an individual is entitled to have access to any
medical records about himself in Privacy Act Record Systems maintained
by the Food and Drug Administration.
(b) The Food and Drug Administration may apply the following special
procedures in disclosing medical records to an individual:
(1) The agency may review the records to determine whether
disclosure of the record to the individual who is the subject of the
records might have an adverse effect on him. If it is determined that
disclosure is not likely to have an adverse effect on the individual,
the record shall be disclosed to him. If it is determined that
disclosure is very likely to have an adverse effect on the individual,
he may be requested to designate, in writing, a representative to whom
the record shall be disclosed. Such representative may be a physician,
other health professional, or other responsible person who would be
willing to review the record and discuss it with the individual.
(2) The availability of the record may be subject to any procedures
for disclosure to an individual of medical records about himself under
part 20 of this chapter, in addition to or in lieu of the procedures in
paragraph (b)(1), that are not inconsistent with Sec. 21.41(f).
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