Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule and the National Instant Criminal Background Check System (NICS)
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Notice of proposed rulemaking.
CFR Part: "45 CFR Part 164"
Citation: "79 FR 784"
"Proposed Rules"
SUMMARY:
   DATES: Submit comments on or before
   ADDRESSES: Written comments may be submitted through any of the methods specified below. Please do not submit duplicate comments.
    * Federal eRulemaking Portal: You may submit electronic comments at http://www.regulations.gov. Follow the instructions for submitting electronic comments. Attachments should be in Microsoft Word, WordPerfect, or Excel; however, we prefer Microsoft Word.
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    * Hand Delivery or Courier: If you prefer, you may deliver (by hand or courier) your written comments (one original and two copies) to the following address only:
   Inspection of Public Comments: All comments received before the close of the comment period will be available for public inspection, including any personally identifiable or confidential business information that is included in a comment. We will post comments received before the close of the comment period at http://www.regulations.gov. Because comments will be made public, they should not include any sensitive personal information, such as a person's social security number; date of birth; driver's license number, State identification number or foreign country equivalent; passport number; financial account number; or credit or debit card number. Comments also should not include any sensitive health information, such as medical records or other individually identifiable health information, or any non-public corporate or trade association information, such as trade secrets or other proprietary information.
   FOR FURTHER INFORMATION CONTACT:
   SUPPLEMENTARY INFORMATION:
I. Background
   On
The National Instant Criminal Background Check System (NICS)
   The Brady Handgun Violence Prevention Act of 1993, Public Law 103-159, and its implementing regulations, are designed to prevent the transfer of firearms by licensed dealers to individuals who are not allowed to possess or receive them as a result of restrictions contained in either the Gun Control Act of 1968, as amended (Title 18, United States Code, Chapter 44), or State law. The Gun Control Act identifies several categories (known as "prohibitors") of individuals /1/ who are prohibited from engaging in the shipment, transport, receipt, or possession of firearms, including convicted felons and fugitives. Most relevant for the purposes of this NPRM is the Federal mental health prohibitor, which, pursuant to
   FOOTNOTE 1 See 18 U.S.C. 922(g) and (n) and implementing regulations at 27 CFR 478.11 and 27 CFR 478.32. END FOOTNOTE
   FOOTNOTE 2 The regulation, at 27 CFR 478.11, defines "Committed to a mental institution" as: A formal commitment of a person to a mental institution by a court, board, commission, or other lawful authority. The term includes a commitment to a mental institution involuntarily, commitment for mental defectiveness or mental illness, as well as commitments for other reasons, such as for drug use. The term does not include a person in a mental institution for observation or a voluntary admission to a mental institution. Note that DOJ has proposed clarifications to this regulatory language, which are published elsewhere in this issue of the
   FOOTNOTE 3 The term used in the statute, "adjudicated as a mental defective," is defined by regulation to include: "(a) A determination by a court, board, commission, or other lawful authority that a person, as a result of marked subnormal intelligence, or mental illness, incompetency, condition, or disease: (1) Is a danger to himself or to others; or (2) lacks the mental capacity to contract or manage his own affairs." The term includes a finding of insanity in a criminal case, and a finding of incompetence to stand trial or a finding of not guilty by reason of lack of mental responsibility pursuant to the Uniform Code of Military Justice. 27 CFR 478.11. Note that DOJ has proposed clarifications to this regulatory language, which are published elsewhere in this issue of the
   The Brady Act established the
   FOOTNOTE 4 See 28 CFR 25.1 through 25.11 (establishing
   FOOTNOTE 5 Additionally, in 2012 the NICS Index began to include the identities of persons who are prohibited from possessing or acquiring firearms by State law, which in some cases may be more restrictive than Federal law. See Statement Before the
   FOOTNOTE 6 The other databases include the Interstate Identification Index, which contains criminal history record information; and the
   The potential transfer of a firearm from a Federal Firearms Licensee (FFL) to a prospective buyer proceeds as follows: First, the prospective buyer is required to provide personal information on a Firearms Transaction Record (ATF Form 4473). Unless the prospective buyer has documentation that he or she qualifies for an exception to the
   FOOTNOTE 7 These exceptions are listed in the ATF regulation at 27 CFR 478.102(d). For example, a
   FOOTNOTE 8 The form collects the prospective buyer's name; demographic information such as address, place and date of birth, gender, citizenship, race and ethnicity; and "yes" or "no" answers to questions about the person's criminal history and other potential prohibitors. The form is available at http: //www.atf.gov/forms/download/atf-f-4473-1.pdf. END FOOTNOTE
   FOOTNOTE 9 For example, a "delay" response may mean that further research is required because potentially prohibitive criteria exist, but the matched records are incomplete,
   FOOTNOTE 10 Some States have waiting periods that also must be complied with before a firearm may be transferred, regardless of whether a proceed response from
   Although FFLs are required in most cases to request a background check through the
   FOOTNOTE 11 See 27 CFR 478.102. Exceptions to this requirement are referenced in FN 7 above, and listed in the regulation at 27 CFR 478.102(d). END FOOTNOTE
   FOOTNOTE 12 Eligibility for these grants is limited to States that have implemented a relief from disabilities program for individuals who are prohibited from possessing or receiving firearms for mental health reasons. Such programs must provide that a State court, board, commission, or other lawful authority shall grant the relief if, based on the circumstances regarding the disabilities and the person's record and reputation, the person is not likely to pose a danger to public safety, and granting the relief would not be contrary to the public interest.
   FOOTNOTE 13 The same is true of the other two databases accessed during a NICS Check, the III and NCIC. State participation and reporting to those databases is also not required. END FOOTNOTE
The HIPAA Privacy Rule and NICS Reporting
   The Privacy Rule, promulgated under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), Title II, Subtitle F--Administrative Simplification, Public Law 104-191, establishes federal protections to ensure the privacy and security of protected health information and establishes an array of individual rights with respect to one's own health information. HIPAA applies to covered entities, which include health plans, health care clearinghouses, and health care providers that conduct certain standard transactions (such as billing insurance) electronically. HIPAA covered entities may only use and disclose protected health information with the individual's written authorization, or as otherwise expressly permitted or required by the HIPAA Privacy Rule.
   The Privacy Rule seeks to balance individuals' privacy interests with important public policy goals including public health and safety. In doing so, the Privacy Rule allows, subject to certain conditions and limitations, uses and disclosures of protected health information without individuals' authorization for certain law enforcement purposes, to avert a serious threat to health or safety, and where required by State or other law, among other purposes. See 45 CFR 164.512.
   As stated above, individuals who are subject to the Federal mental health prohibitor are ineligible to purchase a firearm because they have been "committed to a mental institution" or "adjudicated a mental defective", 18 U.S.C. 922(g)(4). DOJ regulations define these categories to include persons who have been involuntarily committed to a mental institution for reasons such as mental illness or drug use; have been found incompetent to stand trial or not guilty by reason of insanity; or otherwise have been adjudicated by a court, board, commission, or other lawful authority to be a danger to themselves or others or unable to manage their own affairs, as a result of marked subnormal intelligence, or mental illness, incompetency, condition, or disease. /14/ Records of individuals adjudicated as incompetent to stand trial, or not guilty by reason of insanity, originate with entities in the criminal justice system, and these entities are not HIPAA covered entities. Likewise, involuntary civil commitments usually are made by court order, and thus, records of such formal commitments typically originate with entities in the justice system. In addition, many adjudications determining that individuals pose a danger to themselves or others, or are incapable of managing their own affairs, occur through a legal process in the court system.
   FOOTNOTE 14 As noted above, DOJ has proposed clarifications to the regulatory language relevant to these two categories; the DOJ proposal is published elsewhere in this issue of the
   However, because of the variety of State laws, there may be State agencies, boards, commissions, or other lawful authorities outside the court system that are involved in some involuntary commitments or mental health adjudications that make an individual subject to the Federal mental health prohibitor. Moreover, we understand that some States have designated repositories to collect and report to the
   Even in circumstances where records are subject to HIPAA--for example, where the record of an involuntary commitment or mental health adjudication originates with a HIPAA covered entity, or the HIPAA covered entity is the State repository for such records--there are ways in which the Privacy Rule permits the reporting to the
   FOOTNOTE 15 See 45 CFR 164.512(a). Note that disclosures for
   FOOTNOTE 16 See 45 CFR 164.103, 164.105. END FOOTNOTE
   However, many States still are not reporting to the
   FOOTNOTE 17 See GAO-12-684, Gun Control: Sharing Promising Practices and Assessing Incentives Could Better Position Justice to Assist States in Providing Records for Background Checks. END FOOTNOTE
   FOOTNOTE 18 We note that the GAO Report uses the term "mental health records" to refer to identifying information on individuals who are subject to the Federal mental health prohibitor. To avoid implying that mental health records are collected by
II. The ANPRM
Background
   On
   The ANPRM stated that, in crafting the elements of an express permission, the Department would consider limiting the information to be disclosed to the minimum information necessary for
   To inform our efforts to address any issues in this area, we requested comments on a series of questions concerning the nature and scope of the problem of underreporting. The questions included:
    * The nature and extent of States' participation in
    * To what extent HIPAA is perceived as a barrier to reporting, and specific examples of situations in which reporting to the
    * Steps States may have taken to address HIPAA challenges for reporting, including any statutory or regulatory changes at the State level;
    * Whether States had designated any HIPAA covered agencies as repositories of information for
    * Whether certain HIPAA covered entities in the States have authority to order involuntary commitments or perform other adjudications that make an individual subject to the Federal mental health prohibitor;
    * Whether additional, non-HIPAA related barriers to reporting exist;
    * Whether there are privacy protections in place for data collected for
    * Whether creating an express permission would have implications for treatment, and whether there would be ways to mitigate any unintended consequences of creating such a permission; and
    * How HHS could disseminate information or provide additional guidance on the HIPAA Privacy Rule to address confusion about HIPAA that may affect reporting to the
   We requested comments from all stakeholders on these issues, including HIPAA covered entities; agencies of State, territorial, and tribal governments; law enforcement officials; individuals; and consumer advocates and groups.
III. Public Comments on the ANPRM
Introduction
   The Department received over 2,050 comments in response to the ANPRM. Commenters included individuals, State agencies, health care providers, professional organizations, consumer advocacy groups, and other stakeholders.
   Individuals generally expressed concern that the
   Many individual commenters, as well as health care providers, organizations representing providers, and consumer advocacy groups, emphasized the importance of protecting individuals' health information privacy and raised concerns regarding the possible adverse consequences an express permission could have on the patient-provider treatment relationship and individuals' willingness to seek needed mental health care. Other commenters supported the proposal as removing a perceived barrier to an important and necessary public safety measure. Four State agencies and several organizations representing State officials and State-based professional organizations responded to the specific questions in the ANPRM regarding how
Summary of Comments and Responses
A. Concerns Regarding the
   As noted above, a majority of individual commenters voiced general concern that
   Many commenters raised concerns with the Federal mental health prohibitor category itself. Some, while supportive of the general proposition that individuals who pose a risk of harm to themselves or others should not have access to firearms, expressed concern that the Federal mental health prohibitor was overly broad and would result in individuals being reported to the NICS Index who do not pose a threat to society. A number of these commenters expressed concern regarding the standard used to determine whether individuals should be reported to the
   Further, many commenters asserted that mental illness is not an effective predictor of gun violence, and that there is no direct correlation between reporting individuals with mental illnesses to the NICS Index and a reduction in gun violence. Several commenters added that studies have shown that individuals with mental disorders are more likely to be the victims of violent crime by others than the perpetrators. In addition, some commenters specifically objected to individuals that fall within the Federal mental health prohibitor being reported to the
   Many commenters expressed concerns about whether individuals who are subject to the Federal mental health prohibitor receive due process. For example, many individuals were concerned that an individual would be reported to the
   State officials and many other commenters emphasized the importance of establishing mechanisms to remove an individual's name from the
   A few commenters suggested that, in addition to the minimum information currently needed to report an individual to the
   We acknowledge the concerns of these commenters. However, this proposed rule would not affect the scope of the
   Further, the Department clarifies that the proposed HIPAA permission for
   FOOTNOTE 19 DOJ has proposed clarifications to 27 CFR 478.11. The DOJ proposal is published elsewhere in this issue of the
   We acknowledge the commenters' concerns with respect to opportunities for remediation and note that individuals who believe they are wrongly denied the purchase of a firearm can visit https://forms.fbi.gov/nics-appeals-request-form to find out more information and appeal their denial. Further, some States have implemented programs providing for relief from disabilities under the Federal mental health prohibitor. Relief from disabilities is a process by which an individual, who would otherwise be prohibited from purchasing a firearm under the Federal mental health prohibitor, may apply to the lawful authority in the State where the commitment or adjudication occurred for relief. The lawful authority must grant relief if it can be established that the circumstances regarding the disability and the applicant's record and reputation are such that the applicant will not be likely to act in a manner dangerous to public safety, and the granting of relief would not be contrary to the public interest. States' processes for granting relief vary.
B. Comments Regarding NICS Reporting Barriers and Creating an Express Permission in the HIPAA Privacy Rule
1. State Processes for Reporting to the
   Health agencies from three States responded to the ANPRM's specific questions regarding
2. Creating an Express Permission
   Two of the State agency commenters agreed with our statement in the ANPRM that creating an express permission in HIPAA for disclosures to the
   In addition, the Law Center to Prevent Gun Violence reported that, while a majority of States have enacted laws relating to reporting information to the
   Some commenters agreed that, if a permission were created, HIPAA's minimum necessary provisions should apply to any disclosures for reporting to the
   In addition, several commenters urged that any HIPAA exception be limited to reporting of "commitments" as defined by 27 CFR 478.11, as these commenters noted, there exists a great variance under State law as to what constitutes a commitment. Several commenters requested clarification on what constitutes a commitment under the Federal mental health prohibitor. One commenter specifically urged the Department to not amend the HIPAA Privacy Rule until the DOJ revises the Gun Control Act regulations to clarify the standards under which an individual becomes subject to a statutory prohibitor. /20/
   FOOTNOTE 20 We note that DOJ has proposed clarifications to the relevant regulations defining the categories of persons who are prohibited from possessing firearms. The DOJ proposal is published elsewhere in this issue of the
   A number of commenters argued that the proposed permission was unnecessary, some agreeing with the ANPRM's statement that HIPAA's existing permissions (e.g., for uses and disclosures required by State law) largely permit
   Many commenters believed a change to the Privacy Rule to be unnecessary because the information generally is reported to the
   Some commenters were opposed to the creation of any express permission. Many mental health advocates and individual commenters voiced concern that an express HIPAA permission for reporting to the
   After considering the comments we received, we agree that the creation of an express permission in the HIPAA Privacy Rule to disclose information relevant to the Federal mental health prohibitor for
   It is important to note that a mental health diagnosis does not, in itself, make an individual subject to the Federal mental health prohibitor, which requires an involuntary commitment or adjudication that the individual poses a danger to self or others or lacks the mental capacity to contract or manage their own affairs. For example, with respect to the Federal mental health prohibitor, concerns about veterans being reported to the
   The Department has carefully tailored the proposed permission to generally apply to entities that are not directly involved in treatment to minimize any potential adverse unintended consequences, such as discouraging individuals from seeking mental health treatment due to concerns that their provider might report them to the
   FOOTNOTE 21 We note that other provisions of the HIPAA Privacy Rule that permit covered entities to disclose information for public policy purposes remain in effect. Thus, where a HIPAA covered entity, including an entity not falling within the proposed provision, is required by law to disclose to the
   The Department is soliciting comment on whether the permission should instead be broad enough to also include reporting of persons to the
   In addition, the proposed provision would permit those entities to disclose only the minimum necessary information for
   We believe that the proposed change would appropriately protect and preserve individuals' privacy interests, the patient-provider relationship, and the public's health and safety. We emphasize that most covered entities, including treating providers who do not also perform formal involuntary commitments or other adjudications that make an individual subject to the Federal mental health prohibitor, as well as business associates, will not be disclosing information about individuals directly to the
C. Other Comments
1. Privacy, Security, and Uses of NICS Information
   A few commenters requested information on whether information in the
   The relevant regulations permit
   FOOTNOTE 22 See Gun Control Act, 18
   The DOJ regulations make clear that FFLs can initiate
   With respect to the privacy and security of information reported for
   Finally, in response to a question in the ANPRM about the confidentiality of information that has been collected by a repository for
2. Improving the
   Several commenters recommended better tracking of firearms and better enforcement of existing laws in place of a HIPAA modification. Other commenters urged the Department to focus on improving the current mental health care system in order to reduce gun violence associated with mental illness.
   The Department continues to support efforts by the Administration to dispel stigmas relating to mental illness and to encourage individuals to seek voluntary mental health treatment. With the implementation of the Affordable Care Act, millions of Americans who did not previously have coverage will receive coverage for mental health services. Additionally, the Administration has improved access to mental health services for veterans and has supported initiatives to train more mental health professionals and help educators recognize students showing signs of mental illness and refer them to appropriate services.
3. Application of a HIPAA Permission to Other Prohibitors
   Several commenters requested clarification on whether disclosures for
   The Department does not propose to expand the proposed permission to apply to information about individuals who are subject to the other prohibitors listed at 18 U.S.C. 922. HIPAA covered entities are unlikely to have information related to the other Federal prohibitors, with the possible exception of the drug use prohibitor, for which we understand criminal records to be the primary source of information for the
   Some States have enacted their own laws prohibiting the possession or receipt of firearms for reasons related to mental health and may prohibit the purchase or possession of a firearm by additional individuals who are not otherwise subject to the Federal mental health prohibitor. For example, some States may temporarily prohibit firearm possession by individuals who have voluntarily committed themselves to inpatient treatment, which currently does not make an individual subject to the Federal mental health prohibitor. As noted above, some States currently collect and report to the
   Although the
4. Notice
   A few commenters asked whether individuals would be notified if their provider disclosed their protected health information for
   We are not proposing new notification requirements. /23/ Further, the Department would not require covered entities to revise their Notices of Privacy Practices to specifically reference this new provision. Existing notices that more generally refer to the types of disclosures each covered entity is permitted to make, including disclosures for the public policy purposes under 45 CFR 164.512, would suffice.
   FOOTNOTE 23 We note that individuals who have tried to purchase a firearm and been denied can appeal to the
5. HHS Authority
   Several commenters argued that any amendment to HIPAA to provide an express permission for reporting to the
   We note that
6. Additional Guidance
   Several commenters asked for additional guidance materials, training, and other outreach efforts from the Department to help covered entities, State agency officials, State legislatures, and State judiciaries better understand HIPAA's permitted and required disclosures. Some commenters specifically cited HIPAA as a perceived barrier to State legislatures passing laws requiring
   The Department anticipates issuing guidance to both address misconceptions (e.g., such as the perception that HIPAA is a barrier to State legislatures passing laws requiring reporting) and to help covered entities comply with the rule. With respect to the latter, we intend to work with DOJ to issue additional guidance on the categories within the Federal mental health prohibitor, /24/ variations in State law, and when and how the HIPAA permission would apply. We will continue to evaluate additional areas that may benefit from further guidance.
   FOOTNOTE 24 We note that DOJ has proposed clarifications to the regulatory definitions relevant to the Federal mental health prohibitor. The DOJ proposal is published elsewhere in this issue of the
   Finally, the Department will continue its efforts to increase access to, and utilization of, needed mental health care services.
IV. Overview of the Proposed Rule
   We are proposing to revise 45 CFR 164.512 of the Privacy Rule by adding a new category of permitted disclosures to 45 CFR 164.512(k), which addresses uses and disclosures for specialized government functions. The new provisions at (k)(7) would permit certain covered entities to disclose the minimum necessary demographic and other information for
   There is a strong public safety need for this information to be accessible to the
   We note that the proposed modification to the Privacy Rule would merely permit, and not require, covered entities to report to the
V. Description of the Proposed Rule
   The following describes the specific provisions of the proposed rule. Those interested in commenting on the proposed rule can assist the Department by preceding discussion of any particular topic with a citation or reference to the aspect of the proposed rule being discussed. While we request comment on several specific questions, we welcome comments on any aspect of the proposed rule.
   Paragraph (k)(7) would permit uses and disclosures of protected health information for purposes of reporting to the
   The proposed permission would not permit covered entities to use or disclose the protected health information of individuals who are subject to one or more of the other prohibitors listed at 18 U.S.C. 922(g), as the lack of an express HIPAA permission for reporting information relevant to the Federal mental health prohibitor is a limited problem and we have not heard that there is a similar issue with respect to the other prohibitors. Thus, for example, a covered entity would not be able to use this permission to use or disclose information about an individual who is an unlawful user of or addicted to any controlled substance (18 U.S.C. 922(g)(3)), except to the extent the individual is also subject to the Federal mental health prohibitor. We note that other laws may impact disclosures related to the other prohibitors, including 18 U.S.C. 922(g)(3).
   We propose to limit the permission to uses and disclosures about individuals who are subject to the Federal mental health prohibitor. As discussed above, we request comment on the scope of the permission, specifically with regard to whether the permission should be broadened to allow covered entities to disclose the identities of individuals who are prohibited by Federal or State law from possessing or receiving firearms for reasons related to mental health.
Applicability
   Paragraph (k)(7)(i) would apply the express permission only to covered entities that function as repositories of information relevant to the Federal mental health prohibitor on behalf of a State, or that are responsible for ordering the involuntary commitments or other adjudications that make an individual subject to the Federal mental health prohibitor. The Federal prohibitor regulations define an involuntary commitment as a formal commitment of a person to a mental institution by a court, board, commission, or other lawful authority. It does not apply to individuals in a psychiatric facility for observation or who have been admitted voluntarily. The other applicable adjudications include determinations by a court, board, commission, or other lawful authority that persons are a danger to themselves or others, or lack the mental capacity to contract or manage their own affairs, as a result of marked subnormal intelligence, or mental illness, incompetency, condition, or disease. See 27 CFR 478.11 (Definitions). /25/ This NPRM refers to the involuntary commitments and other applicable adjudications as, collectively, "adjudications that make an individual subject to the Federal mental health prohibitor."
   FOOTNOTE 25 Note that DOJ has proposed clarifications to this regulation; the DOJ proposal is published elsewhere in this issue of the
   Our understanding is that lawful authority for performing such adjudications and repository functions rests, for the most part, with entities that operate outside the scope of HIPAA. However, in the interest of public safety, we want to ensure that relevant adjudications can be reported in the small subset of States in which HIPAA covered entities may make, or collect and report records of, these determinations.
   In permitting only entities involved in these adjudicatory or repository/reporting functions to use or disclose Federal mental health prohibitor information for
   We request public comment on the extent to which some States may have vested responsibility for Federal mental health prohibitor reporting in HIPAA covered entities, to what extent records needed for
Recipients of Information Disclosures
   Paragraph (k)(7)(ii) would provide that a covered entity identified in (k)(7)(i) may use or disclose Federal mental health prohibitor information for
Limitations on the Information Used or Disclosed
   Paragraph (k)(7)(iii) would strictly limit the information used or disclosed for
   We are also considering permitting the disclosure of some or all the following additional data elements, which are optional fields for a NICS Index entry, as part of the minimum necessary for
VI. Regulatory Analyses
A. Introduction
   We have prepared a regulatory impact statement in compliance with Executive Order 12866 (
1. Executive Order 12866 and Executive Order 13563
   Executive Orders 12866 and 135643 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 135634 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been designated a "significant regulatory action" although not economically significant, under section 3(f) of Executive Order 12866. Accordingly, this rule has been reviewed by the
   A regulatory impact analysis must be prepared for all major rules that have economically significant effects (
   Although we expect the economic impact of the rule, including non-quantifiable costs and savings discussed in the regulatory analysis below, to be less than
2. Entities Subject to the Rule
   This proposed rule would apply only to covered entities that are responsible for ordering involuntary commitments or conducting other adjudications that make individuals subject to a Federal prohibition against possessing firearms under 18 U.S.C. 922(g)(4) (the Federal mental health prohibitor), or that are otherwise designated by a State to report the identities of such individuals to the
   This proposed rule is needed to ensure that, where HIPAA covered entities make adjudications causing individuals to become subject to the Federal mental health prohibitor, or serve as repositories of records of such adjudications on behalf of States, those covered entities can report the identities of those individuals to the
C. Qualitative Analysis of Unquantified Costs
   The rule would be cost neutral with respect to HIPAA covered entities. The rule would not require entities that already have a
   To the extent that the rule would permit some covered entities to report to the
   As explained above, we have carefully and narrowly tailored the proposed rule to apply only to a small number of covered entities that may be responsible for the adjudications that make an individual subject to the Federal mental health prohibitor, or that serve as repositories of data about such adjudications. As such, the proposed rule generally would maintain a separation between treatment functions and
   Finally, we recognize the intangible burden to individuals of the stigma associated with mental health conditions. We again emphasize, as we did in the ANPRM, that individuals with treated mental health conditions as a group have not been shown to pose an increased risk of gun violence against others compared with the general population, and are in fact more likely to be victims of violence than other members of the general population. We note further that the Federal mental health prohibitor does not apply to all individuals with mental health conditions, but instead a subset of individuals who have been involuntarily committed or otherwise adjudicated to be a danger to themselves or others, or unable to manage their own affairs, as a result of marked subnormal intelligence, or mental illness, incompetency, condition, or disease. With this proposed rule, the Department is not adopting or endorsing the idea that individuals with mental health conditions pose a danger to society. Rather, the rule would permit a limited number of HIPAA covered entities to report to the
   We request comment on this assumption and on any other costs that may be associated with the rule.
D. Qualitative Analysis of Unquantified Benefits
   While we believe that there may be benefits to public safety as a result of the rule, we are not able to monetize the value of such benefits.
   For example, the rule may result in increased reporting to the
   An additional benefit of the rule would be to alleviate the concerns of State lawmakers who, according to a handful of commenters, may be reluctant to pursue legislation requiring entities to report Federal mental health prohibitor information for
   We welcome comment on any of these issues.
E. Additional Regulatory Analyses
1. Regulatory Flexibility Act
   The RFA requires agencies to analyze and consider options for reducing regulatory burden if a rule will impose a significant burden on a substantial number of small entities. The act requires the head of the agency to either certify that the rule would not impose such a burden or perform a regulatory flexibility analysis and consider alternatives to lessen the burden. For the reasons explained more fully above in the summary of costs and benefits, it is not expected that the rule would result in compliance costs for covered entities of any size because the rule would not impose new requirements.
2. Unfunded Mandates Reform Act
   Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates would require spending in any one year
3. Federalism
   Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a rule that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications.
   The Federalism implications of the HIPAA Privacy and Security Rules were assessed as required by Executive Order 13132 and published as part of the preambles to the final rules on
F. Accounting Statement
   Whenever a rule is considered a significant rule under Executive Order 12866, we are required to develop an accounting statement indicating the costs associated with the rule. As explained above in the RIA, we expect that the rule would be cost neutral. However, we invite comment on potential costs associated with the rule, including costs to covered entities that choose to amend written HIPAA policies and procedures or train staff.
VII. Collection of Information Requirements
   This proposed rule does not contain new requirements for information collections (i.e., reporting, recordkeeping, and third-party disclosures) under the Paperwork Reduction Act.
List of Subjects in 45 CFR Part 164
   Administrative practice and procedure, Computer technology, Electronic information system, Electronic transactions, Employer benefit plan, Health, Health care, Health facilities, Health insurance, Health records, Hospitals,
   For the reasons set forth in the preamble, the
PART 164--SECURITY AND PRIVACY
   1. The authority citation for part 164 continues to read as follows:
   Authority: 42 U.S.C. 1302(a); 42 U.S.C. 1320d-1320d-9; sec. 264, Pub. L. 104-191, 110
   2. Amend
* * * * *
   (k) * * *
   (7) National Instant Criminal Background Check System. A covered entity may use or disclose protected health information for purposes of reporting to the National Instant Criminal Background Check System the identity of an individual who is prohibited from possessing a firearm under 18 U.S.C. 922(g)(4), provided the covered entity:
   (i) Is a State agency or other entity that is, or contains an entity that is:
   (A) An entity designated by the State to report, or which collects information for purposes of reporting, on behalf of the State, to the National Instant Criminal Background Check System; or
   (B) A court, board, commission, or other lawful authority that makes the commitment or adjudication that causes an individual to become subject to 18 U.S.C. 922(g)(4).
   (ii) Discloses the information to:
   (A) The National Instant Criminal Background Check System; or
   (B) An entity designated by the State to report, or which collects information for purposes of reporting, on behalf of the State, to the National Instant Criminal Background Check System; and
   (iii) (A) Discloses only the limited demographic and certain other information needed for purposes of reporting to the National Instant Criminal Background Check System; and
   (B) Does not disclose diagnostic or clinical information for such purposes.
* * * * *
   Dated:
Secretary.
[FR Doc. 2014-00055 Filed 1-3-14;
BILLING CODE 4153-01-P
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