[Federal Register Volume 65, Number 3 (Wednesday, January 5, 2000)]
[Proposed Rules]
[Pages 427-429]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-124]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
45 CFR Parts 160 and 164
[RIN 0991-AB08]
Standards for Privacy of Individually Identifiable Health
Information
AGENCY: Office of the Assistant Secretary for Planning and Evaluation,
DHHS.
ACTION: Proposed rule; correction.
-----------------------------------------------------------------------
SUMMARY: This document corrects the preamble and proposed regulatory
text published in the Federal Register of November 3, 1999, regarding
the Standards for Privacy of Individually Identifiable Health
Information.
FOR FURTHER INFORMATION CONTACT: Roxanne Gibson, (202) 260-5083.
SUPPLEMENTARY INFORMATION:
Corrections
In the proposed rule 45 CFR Parts 190 through 164, beginning on
page 59918
[[Page 428]]
in the issue of November 3, 1999, make the following corrections.
On page 59919 in the first column, C.3. currently says, ``Right to
restrict uses and disclosures.'' It should read, ``Right to request
restrictions on uses and disclosures.''
On page 59919 in the first column, D.6. currently says, ``Inclusion
in the accounting for uses and disclosures.'' This should be changed to
say, ``Inclusion in the accounting for disclosures.''
On page 59919 in the second column, III.3. currently says,
``Accounting for uses and disclosures.'' This should be changed to say,
``Accounting for disclosures.''
On page 59919 in the second column, IV.G.5. currently says, ``Right
to restrict uses and disclosures.'' It should read, ``Right to request
restrictions on uses and disclosures.''
On page 59942 in the second full paragraph of the second column
currently reads, ``We considered including other disclosures permitted
under proposed Sec. 164.510 within the prohibition described in this
provision, but were unsure if psychotherapy notes were ever relevant to
the public policy purposes underlying those disclosures. For example,
we would assume that such notes are rarely disclosed for public health
purposes or to next of kin. We solicit comment on whether there are
additional categories of disclosures permitted under proposed
Sec. 164.510 for which the disclosure of psychotherapy notes by covered
entities without specific individual authorization would be
appropriate.'' That paragraph should read, ``We considered including
the disclosures permitted under proposed Sec. 164.510 within the
prohibition described in this provision, but were unsure if
psychotherapy notes were ever relevant to the public policy purposes
underlying those disclosures. For example, we would assume that such
notes are rarely disclosed for public health purposes or to next of
kin. We solicit comment on whether there are categories of disclosures
permitted under proposed Sec. 164.510 for which the disclosure of
psychotherapy notes by covered entities without specific individual
authorization would not be appropriate.''
On page 59943 in the second full paragraph of the first column
currently reads, ``We considered including other of the uses and
disclosures that would be permitted under Sec. 164.510 within the
prohibition described in this provision, but were unsure if research
information unrelated to treatment would ever be relevant to the public
policy purposes underlying those disclosures. We solicit comment on
whether there are additional categories of uses or disclosures that
would be permitted under proposed Sec. 164.510 for which the use or
disclosure of such information by covered entities without specific
individual authorization would be appropriate.'' That paragraph should
read, ``We considered including the uses and disclosures that would be
permitted under Sec. 164.510 within the prohibition described in this
provision, but were unsure if research information unrelated to
treatment would ever be relevant to the public policy purposes
underlying those disclosures. We solicit comment on whether there are
categories of uses or disclosures that would be permitted under
proposed Sec. 164.510 for which use or disclosure of such information
by covered entities without specific individual authorization would not
be appropriate.''
On page 59945 in the second column, 3 currently says, ``Right to
Restrict Uses and Disclosures.'' It should read, ``Right to Request
Restrictions on Uses and Disclosures.''
On page 59945 in the second column, under 3 currently says,
``[Please label comments about this section with the subject: ``Right
to restrict''].'' It should read, ``[Please label comments about this
section with the subject: ``Right to request restrictions''].''
On page 59946 in the first column paragraph four, the sentence,
``Limiting the right to restrict to self-pay patients also would reduce
the number of requests that would be made under this provision.,''
should read, ``Limiting the right to request restrictions to self-pay
patients also would reduce the number of requests that would be made
under this provision.''
On page 59958 in the second line of the first column, the phrase
``(often refereed to as ``deemed status'')'' should be deleted.
On page 59987 in the second column section b. Grounds for denial of
request for amendment, the first sentence currently reads, ``We are
proposing that a covered plan or provider would be permitted to deny a
request for amendment or correction if, after a reasonable review, the
plan or provider determines that it did not create the information at
issue, the information would not be available for inspection and
copying under proposed Sec. 164.514, the information is accurate and
complete, or if it is erroneous or incomplete, it would not be
adversely affect the individual.'' We are correcting this sentence to
read, ``We are proposing that a covered plan or provider would be
permitted to deny a request for amendment or correction if, after a
reasonable review, the plan or provider determines that it did not
create the information at issue, the information would not be available
for inspection and copying under proposed Sec. 164.514, or the
information is accurate and complete.''
On page 60004 in the first column, 3. currently says, ``Accounting
for uses and disclosures.'' This should be changed to say, ``Accounting
for disclosures.''
On page 60004 in the first column, the preamble text under 3.
currently says, ``Covered plans and providers would have to be able to
provide an accounting for the uses and disclosures of protected health
information for purposes other than treatment, payment, or health care
operations.'' This should be changed to say, ``Covered plans and
providers would have to be able to provide an accounting for
disclosures of protected health information for purposes other than
treatment, payment, or health care operations.''
On page 60007 in table 1, the cost of notice development for all
entities in the initial or first year cost (2000) column should be
30,000,000 rather than 20,000,000.
On page 60007 in table 1, the total cost of the regulation in the
initial or first year cost (2000) column should be $1,185,230,000
rather than $1,165,230,000.
On page 60012 in the second column the third full paragraph begins,
``It is also important to point out that none of the States appear to
offer individuals the right to restrict disclosure of their protected
health information for treatment.'' It should read, ``It is also
important to point out that none of the States appear to offer
individuals the right to request restrictions on disclosure of their
protected health information for treatment.''
On page 60016 in the first column in the first paragraph under the
heading Notice of Privacy Practices, the sentences that currently read,
``Data from the 1996 Medical Expenditure Panel Survey shows that there
are approximately 200 million ambulatory care encounters per year,
nearly 20 million persons with a hospital episode, 7 million with home-
health episodes, and over 170 million with prescription drug use (350
million total). For the remaining four years of the five year period,
we have estimated that, on average, a quarter of the remaining
population will enter the system, and thus receive a notice.'' are
changed to read, ``Data from the 1996 Medical Expenditure Panel Survey
shows that there are approximately 200 million ambulatory care
encounters per year,
[[Page 429]]
nearly 20 million persons with a hospital episode, 7 million with home-
health episodes, and over 170 million with prescription drug use (397
million total). For the remaining four years of the five year period,
we have estimated that one-quarter to three-quarters of patients
without an encounter in the first year will enter the system.''
On page 60016 in the second column, the sentence starting on line
five currently reads, ``The cost for this would be $0.75 over five
years.'' This sentence should read, ``The cost for health plans to
issue notice would be $0.75 over five years.''
On page 60017 in table 2, the cost of notice development for all
entities in the initial or first year cost (2000) column should be
30,000,000 rather than 20,000,000.
On page 60018 in table 2, the total cost of the regulation in the
initial or first year cost (2000) column should be $1,185,230,000
rather than $1,165,230,000.
On page 60024 in the first column, 5 currently says, ``Right to
Restrict Uses and Disclosures.'' It should read, ``Right to Request
Restrictions on Uses and Disclosures.''
On page 60024 in the second full paragraph in the second column,
the sentence, ``Limiting the right to restrict to self-pay patients
also would reduce the number of requests that would be made under this
provision,'' should read, ``Limiting the right to request restrictions
to self-pay patients also would reduce the number of requests that
would be made under this provision.''
On page 60037 in the first paragraph of the first column, the
sentence that currently reads, ``These small businesses represent 83.8%
of all health entities we have examined,'' should read, ``These small
businesses represent 84.9% of all health entities we have examined.''
On page 60039 in the second column, c. currently says, ``Right to
restrict.'' It should read, ``Right to request restrictions on uses and
disclosures.''
On page 60041 in the first column under ``i. Documentation
requirements for covered entities,'' the sentence that currently reads,
``These areas would include use within the entity; informing business
partners; disclosures with and without authorizations; limitations on
use and disclosure for self-pay; inspection and copying; amendment or
correction; accounting for uses and disclosure; notice development,
maintenance, and dissemination; sanctions; and complaint procedures.,''
should read, ``These areas would include use within the entity;
informing business partners; disclosures with and without
authorization; inspection and copying; amendment or correction;
accounting for disclosure; notice development, maintenance, and
dissemination; sanctions; and complaint procedures.''
On page 60045 in the table summarizing the PRA burden hours, the
line that says, ``Sec. 164.515 Accounting for uses and disclosures of
protected health information,'' should read, ``Sec. 164.515 Accounting
for disclosures of protected health information.''
On page 60046 column three the heading ``Section 164.515 Accounting
for Uses and Disclosures of Protected Health Information'' should be
changed to ``Section 164.515 Accounting for Disclosures of Protected
Health Information.''
On page 60049 in the first column, the title Appendix to the
Preamble: Sample Contact of Provider Notice should read Appendix to the
Preamble: Sample Content of Provider Notice.
On page 60053 in the third column, under 164.506(a)(1), (i)
currently reads, ``Except for research information unrelated to
treatment, to carry out treatment, payment, or health care
operations;.'' It should read, ``Except for research information
unrelated to treatment and psychotherapy notes, to carry out treatment,
payment, or health care operations;''
On page 60055 in the third column, (3)(iii) currently reads, ``A
covered entity may not condition treatment, enrollment in a health
plan, or payment on a requirement that the individual authorize use of
disclosure of psychotherapy notes relating to the individual.'' It
should read, ``A covered entity may not condition treatment, enrollment
in a health plan, or payment on a requirement that the individual
authorize use or disclosure of research information unrelated to
treatment or psychotherapy notes relating to the individual.''
On page 60057 in the third column, the following should be deleted
because it duplicates information in the second column:
(5) Urgent circumstances. The disclosure is of the protected health
information of an individual who is or is suspected to be a victim of a
crime, abuse, or other harm, if the law enforcement official represents
that:
(i) Such information is needed to determine whether a violation of
law by a person other than the victim has occurred; and
(ii) Immediate law enforcement activity that depends upon obtaining
such information may be necessary.
Dated: December 27, 1999.
Brian P. Burns,
Deputy Assistant Secretary for Information Resources Management.
[FR Doc. 00-124 Filed 1-4-00; 8:45 am]
BILLING CODE 4150-04-M
