Federal Register: January 5, 2000 (Volume 65, Number 3)

01/05/2000

[Federal Register: January 5, 2000 (Volume 65, Number 3)]

[Proposed Rules]

[Page 427-429]


DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary

45 CFR Parts 160 and 164

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 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 homehealth 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, nearly 20 million persons with a hospital episode, 7 million with homehealth 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

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