HIPAA Omnibus Rule: Part 8 (Breach Analysis)

The HIPAA Omnibus rule makes a number of additional important changes to breach analysis in case of a breach of unsecured PHI.

The Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules under the Health Information Technology for Economic and Clinical Health Act and the Genetic Information Nondiscrimination Act, 78 Fed. Reg. 5566 (Jan. 25, 2013), notes that:

  • Section 13402 of the HITECH Act requires HIPAA covered entities to provide notification to affected individuals and to the Secretary of HHS following the discovery of a breach of unsecured protected health information. In some cases, the Act requires covered entities also to provide notification to the media of breaches. In the case of a breach of unsecured protected health information at or by a business associate of a covered entity, the Act requires the business associate to notify the covered entity of the breach. Finally, the Act requires the Secretary to post on an HHS Web site a list of covered entities that experience breaches of unsecured protected health information involving more than 500 individuals.
  • Section 13400(1) of the Act defines “breach” to mean, generally, the unauthorized acquisition, access, use, or disclosure of protected health information which compromises the security or privacy of such information.
  • The Act includes three exceptions to this definition to encompass situations Congress clearly intended not to constitute breaches: (1) Unintentional acquisition, access, or use of protected health information by an employee or other person acting under the authority of a covered entity or business associate if such acquisition, access, or use was made in good faith and within the course and scope of the employment or other professional relationship of such person with the covered entity or business associate and such information is not further acquired, accessed, used, or disclosed by any person (section 13400(1)(B)(i)); (2) inadvertent disclosure of protected health information from one person authorized to access protected health information at a facility operated by a covered entity or business associate to another person similarly situated at the same facility and the information received is not further acquired, accessed, used or disclosed without authorization by any person (section 13400(1)(B)(ii) and (iii)); and (3) unauthorized disclosures in which an unauthorized person to whom protected health information is disclosed would not reasonably have been able to retain the information (section 13400(1)(A)).
  • The Omnibus Rule amends 45 CFR 164.402 (and changes the interim final rule). The definition will “clarify that an impermissible use or disclosure of protected health information is presumed to be a breach unless the covered entity or business associate, as applicable, demonstrates that there is a low probability that the protected health information has been compromised.”
  • A covered entity or business associate must overcome the presumption that the breach must be reported, by performing a four-factor risk assessment to determine whether or not PHI has been compromised:

Instead of assessing the risk of harm to the individual, covered entities and business associates must assess the probability that the protected health information has been compromised based on a risk assessment that considers at least the following factors: (1) The nature and extent of the protected health information involved, including the types of identifiers and the likelihood of re-identification; (2) the unauthorized person who used the protected health information or to whom the disclosure was made; (3) whether the protected health information was actually acquired or viewed; and (4) the extent to which the risk to the protected health information has been mitigated.

The rule contains additional detail with regard to each factor.

  • There are additional specific rules as to who to notify (and when) regarding a breach. This eliminates covered entity’s discretion regarding whether or not a breach must be disclosed to affected individuals, the government, and potentially the media.

Under 45 CFR 164.402, “breach” means the acquisition, access, use, or disclosure of protected health information in a manner not permitted under subpart E of this part which compromises the security or privacy of the protected health information. There are some exclusions, but the breach rule makes clear that:

Except as provided in [the existing exceptions to the definition of breach], an acquisition, access, use, or disclosure of protected health information in a manner not permitted under subpart E is presumed to be a breach unless the covered entity or business associate, as applicable, demonstrates that here is a low probability that the protected health information has been compromised based on a risk assessment of at least the following factors: (i) The nature and extent of the protected health information involved, including the types of identifiers and the likelihood of re-identification; (ii) The unauthorized person who used the protected health information or to whom the disclosure was made; (iii) Whether the protected health information was actually acquired or viewed; and (iv) The extent to which the risk to the protected health information has been mitigated.

Under 45 CFR 164.404(a), the Standard is:

General rule. A covered entity shall, following the discovery of a breach of unsecured protected health information, notify each individual whose unsecured protected health information has been, or is reasonably believed by the covered entity to have been, accessed, acquired, used, or disclosed as a result of such breach.

Breaches treated as discovered. For purposes of paragraph (a)(1) of this section, §§ 164.406(a), and 164.408(a), a breach shall be treated as discovered by a covered entity as of the first day on which such breach is known to the covered entity, or, by exercising reasonable diligence would have been known to the covered entity. A covered entity shall be deemed to have knowledge of a breach if such breach is known, or by exercising reasonable diligence would have been known, to any person, other than the person committing the breach, who is a workforce member or agent of the covered entity (determined in accordance with the federal common law of agency).

Below are additional Breach and Breach Notification rules from Subpart D: Notification in Case of Breach of Unsecured Information.

164.404(b) – Implementation specification: Timeliness of notification. Except as provided in § 164.412, a covered entity shall provide the notification required by paragraph (a) of this section without unreasonable delay and in no case later than 60 calendar days after discovery of a breach.

164.404(c) – Implementation specifications: Content of notification.

  1. Elements. The notification required by paragraph (a) of this section shall include, to the extent possible:
    1. A brief description of what happened, including the date of the breach and the date of the discovery of the breach, if known;
    2. A description of the types of unsecured protected health information that were involved in the breach (such as whether full name, social security number, date of birth, home address, account number, diagnosis, disability code, or other types of information were involved);
    3. Any steps individuals should take to protect themselves from potential harm resulting from the breach;
    4. A brief description of what the covered entity involved is doing to investigate the breach, to mitigate harm to individuals, and to protect against any further breaches; and
    5. Contact procedures for individuals to ask questions or learn additional information, which shall include a toll-free telephone number, an e-mail address, Web site, or postal address.
  2. Plain language requirement. The notification required by paragraph (a) of this section shall be written in plain language.

164.404(d) – Implementation specifications: Methods of individual notification. The notification required by paragraph (a) of this section shall be provided in the following form:

  1. Written notice.
    1. i. Written notification by first-class mail to the individual at the last known address of the individual or, if the individual agrees to electronic notice and such agreement has not been withdrawn, by electronic mail. The notification may be provided in one or more mailings as information is available.
    2. ii. If the covered entity knows the individual is deceased and has the address of the next of kin or personal representative of the individual (as specified under § 164.502(g)(4) of subpart E), written notification by first-class mail to either the next of kin or personal representative of the individual. The notification may be provided in one or more mailings as information is available.
  2. Substitute notice. In the case in which there is insufficient or out-of-date contact information that precludes written notification to the individual under paragraph (d)(1)(i) of this section, a substitute form of notice reasonably calculated to reach the individual shall be provided. Substitute notice need not be provided in the case in which there is insufficient or out-of-date contact information that precludes written notification to the next of kin or personal representative of the individual under paragraph (d)(1)(ii).
    1. i. In the case in which there is insufficient or out-of-date contact information for fewer than 10 individuals, then such substitute notice may be provided by an alternative form of written notice, telephone, or other means.
    2. ii. In the case in which there is insufficient or out-of-date contact information for 10 or more individuals, then such substitute notice shall:
      1. Be in the form of either a conspicuous posting for a period of 90 days on the home page of the web site of the covered entity involved, or conspicuous notice in major print or broadcast media in geographic areas where the individuals affected by the breach likely reside; and
      2. Include a toll-free phone number that remains active for at least 90 days where an individual can learn whether the individual’s unsecured protected health information may be included in the breach.
  3. Additional notice in urgent situations. In any case deemed by the covered entity to require urgency because of possible imminent misuse of unsecured protected health information, the covered entity may provide information to individuals by telephone or other means, as appropriate, in addition to notice provided under paragraph (d)(1) of this section.

164.404(d) – Notification to the Media:

  1. Standard. For a breach of unsecured protected health information involving more than 500 residents of a State or jurisdiction, a covered entity shall, following the discovery of the breach as provided in §164.404(a)(2), notify prominent media outlets serving the State or jurisdiction.
  2. Implementation specification: Timeliness of notification. Except as provided in § 164.412, a covered entity shall provide the notification required by paragraph (a) of this section without unreasonable delay and in no case later than 60 calendar days after discovery of a breach.
  3. Implementation specifications: Content of notification. The notification required by paragraph (a) of this section shall meet the requirements of § 164.404(c).

164.408 – Notification to the Secretary of HHS

  1. Standard. A covered entity shall, following the discovery of a breach of unsecured protected health information as provided in § 164.404(a)(2), notify the Secretary.
  2. Implementation specifications: Breaches involving 500 or more individuals. For breaches of unsecured protected health information involving 500 or more individuals, a covered entity shall, except as provided in § 164.412, provide the notification required by paragraph (a) of this section contemporaneously with the notice required by §164.404(a) and in the manner specified on the HHS web site.
  3. Implementation specifications: Breaches involving less than 500 individuals. For breaches of unsecured protected health information involving less than 500 individuals, a covered entity shall maintain a log or other documentation of such breaches and, not later than 60 days after the end of each calendar year, provide the notification required by paragraph (a) of this section for breaches discovered during the preceding calendar year, in the manner specified on the HHS web site.

164.410 – Notification by Business Associates

  1. Standard.

1. General rule. A business associate shall, following the discovery of a breach of unsecured protected health information, notify the covered entity of such breach.

2. Breaches treated as discovered. For purposes of paragraph (a)(1) of this section, a breach shall be treated as discovered by a business associate as of the first day on which such breach is known to the business associate or, by exercising reasonable diligence, would have been known to the business associate. A business associate shall be deemed to have knowledge of a breach if the breach is known, or by exercising reasonable diligence would have been known, to any person, other than the person committing the breach, who is an employee, officer, or other agent of the business associate (determined in accordance with the Federal common law of agency).

  1. Implementation specifications: Timeliness of notification. Except as provided in § 164.412, a business associate shall provide the notification required by paragraph (a) of this section without unreasonable delay and in no case later than 60 calendar days after discovery of a breach.
  2. Implementation specifications: Content of notification.

1. The notification required by paragraph (a) of this section shall include, to the extent possible, the identification of each individual whose unsecured protected health information has been, or is reasonably believed by the business associate to have been, accessed, acquired, used, or disclosed during the breach.

2. A business associate shall provide the covered entity with any other available information that the covered entity is required to include in notification to the individual under §164.404(c) at the time of the notification required by paragraph (a) of this section or promptly thereafter as information becomes available.

164.412 – Law Enforcement Delay

If a law enforcement official states to a covered entity or business associate that a notification, notice, or posting required under this subpart would impede a criminal investigation or cause damage to national security, a covered entity or business associate shall:

  1. If the statement is in writing and specifies the time for which a delay is required, delay such notification, notice, or posting for the time period specified by the official; or
  2. If the statement is made orally, document the statement, including the identity of the official making the statement, and delay the notification, notice, or posting temporarily and no longer than 30 days from the date of the oral statement, unless a written statement as described in paragraph (a) of this section is submitted during that time.

164.414 – Administrative Requirements and Burden of Proof

  1. Administrative requirements. A covered entity is required to comply with the administrative requirements of §§ 164.530(b), (d), (e), (g), (h), (i), and (j) with respect to the requirements of this subpart.
  2. Burden of proof. In the event of a use or disclosure in violation of subpart E, the covered entity or business associate, as applicable, shall have the burden of demonstrating that all notifications were made as required by this subpart or that the use or disclosure did not constitute a breach, as defined at § 164.402.

See also the Unsecured PHI Guidance which, HHS notes, “continues to specify encryption and destruction as the two methods for rendering protected health information unusable, unreadable, or indecipherable to unauthorized individuals—or “secured”—and thus, exempt from the breach notification obligations.”

See our full series of articles:

HIPAA Omnibus Rule: Part 1 (Overview)

HIPAA Omnibus Rule: Part 2 (Business Associates & Subcontractors)

HIPAA Omnibus Rule: Part 3 (Enforcement & Penalties)

HIPAA Omnibus Rule: Part 4 (Security Rule Changes)

HIPAA Omnibus Rule: Part 5 (Privacy Rule Changes)

HIPAA Omnibus Rule: Part 6 (Business Associate Agreements)

HIPAA Omnibus Rule: Part 7 (Notice of Privacy Practices & Other Provisions)

HIPAA Omnibus Rule: Part 8 (Breach Analysis)

 

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The healthcare privacy and security requirements of HIPAA and HITECH can be daunting. Even small healthcare offices can be subject to federal and state privacy and confidentiality compliance rules. For healthcare legal and regulatory expertise, contact the HIPAA and HITECH legal team at the Cohen Healthcare Law Group.

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Michael H Cohen Healthcare & FDA Lawyers

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