Source: http://www.hhhealthlawblog.com/2018/01/reporting-hipaa-breaches.html
Timestamp: 2018-01-16 07:12:19
Document Index: 207944406

Matched Legal Cases: ['§ 164', '§ 164', '§ 164', '§ 164', '§ 164', '§ 164', '§ 164', '§ 164', '§ 164', '§ 164', '§ 164', '§ 164', '§ 164']

Reporting HIPAA Breaches: Annual Deadline Approaches | Holland & Hart Health Law Blog
Is Your HIPAA Breach Reportable? Under the breach notification rule, covered entities are only required to self-report if there is a “breach” of “unsecured” PHI. (45 CFR § 164.400 et seq.).
1. Unsecured PHI. “Unsecured” PHI is that which is “not rendered unusable, unreadable, or indecipherable to unauthorized persons through the use of a technology or methodology” specified in HHS guidance. (45 CFR § 164.402). Currently, there are only two ways to “secure” PHI: (1) in the case of electronic PHI, by encryption that satisfies HHS standards; or (2) in the case of e-PHI or PHI maintained in hard copy form, by its complete destruction. (74 FR 42742). Breaches of “secured” PHI are not reportable. Most potential breaches will involve “unsecured” PHI.
2. Breach. The unauthorized “acquisition, access, use, or disclosure” of unsecured PHI in violation of the HIPAA Privacy Rule is presumed to be a reportable breach unless the covered entity or business associate determines that there is a low probability that the data has been compromised or the action fits within an exception. (45 CFR § 164.402; see 78 FR 5641). Thus, the covered entity or business associate must determine the following:
Was there a violation of the Privacy Rule? Breach notification is required only if the acquisition, access, use or disclosure results from a Privacy Rule violation; no notification is required if the use or disclosure is permitted by the Privacy Rule. (45 CFR § 164.402). For example, a covered entity may generally use or disclose PHI for purposes of treatment, payment, or healthcare operations without the individual’s authorization unless the covered entity has agreed otherwise. (45 CFR § 164.506). Disclosures to family members and others involved in the individual’s care or payment for their care is generally permitted if the patient has not objected and the provider otherwise determines that disclosure is in the patient’s best interest. (45 CFR § 164.510). HIPAA allows certain other disclosures that are required by law or made for specified public safety or government functions. (45 CFR § 164.512). Disclosures that are incidental to permissible uses or disclosures do not violate the Privacy Rule if the covered entity employed reasonable safeguards. (45 CFR §§ 164.402 and 164.502(a)(1)(iii)). When in doubt as to whether a disclosure violates the Privacy Rule, you should check with your privacy officer or a qualified attorney.
Does the violation fit within a breach exception? The following do not constitute reportable “breaches” as defined by HIPAA:
An unintentional acquisition, access, or use of PHI by a workforce member if such acquisition, access, or use was made in good faith and within the scope of the workforce member’s authority and does not result in further use or disclosure not permitted by the Privacy Rule. (45 CFR § 164.402). For example, no notification is required where an employee mistakenly looks at the wrong patient’s PHI but does not further use or disclose the PHI. (74 FR 42747).
if a covered entity improperly discloses protected health information that merely included the name of an individual and the fact that he received services from a hospital, then this would constitute a violation of the Privacy Rule, but it may not constitute a significant risk of financial or reputational harm to the individual. In contrast, if the information indicates the type of services that the individual received (such as oncology services), that the individual received services from a specialized facility (such as a substance abuse treatment program), or if the protected health information includes information that increases the risk of identity theft (such as a social security number, account number, or mother’s maiden name), then there is a higher likelihood that the impermissible use or disclosure compromised the security and privacy of the information.
(74 FR 42745). Although the Final Breach Notification Rule changed the “significant risk” test to the “low probability” standard, HHS’s commentary may still be helpful in evaluating whether there is a reportable breach.
The unauthorized person who impermissibly used the PHI or to whom disclosure was made. For example, disclosure to another health care provider or a person within the entity’s organization would presumably create a lower risk because such persons are more likely to comply with confidentiality obligations and are unlikely to misuse or further disclose the PHI. HHS offered the following example in the Omnibus Rule commentary:
Whether the risk to the PHI has been mitigated. For example, there may be a lower risk if a fax is directed to the wrong number, but the recipient confirms that they returned or destroyed the PHI; the PHI has not been and will not be further used or disclosed; and the recipient is reliable. (78 FR 5643). This factor highlights the need for covered entities and business associates to immediately identify and respond to potential breaches to reduce the probability that PHI is compromised and the necessity of breach reporting.The risk assessment should involve consideration of all of these factors in addition to others that may be relevant. One factor is not necessarily determinative, and some factors may offset or outweigh others, depending on the circumstances. (See 78 FR 5643). If you conclude that the risk assessment demonstrates a low probability that the PHI has been compromised, you should document your analysis and you may forego breach notification. On the other hand, if the risk assessment fails to demonstrate a low probability that the PHI has been compromised, you are required to report the breach to the affected individual and HHS as described below.
How Do I Report? If the breach is reportable, the covered entity and business associate must make the required reports; HHS has indicated that failure to do so will likely constitute “willful neglect”, thereby triggering mandatory penalties if discovered. (75 FR 40879).
2. Notice to the Individual. Covered entities must notify the affected individual or their personal representative without unreasonable delay, but in no event longer than 60 days following discovery. (45 CFR § 164.404(b)). In general, the notice must be sent by first class mail and contain the following information: a brief description of the breach, including the dates of the breach and its discovery; a description of the types of unsecured PHI involved; steps the individual should take to protect themselves from resulting harm; a description of the covered entity’s actions to investigate, mitigate and protect against future violations; and the procedures the individual may take to contact the covered entity for more information. (45 CFR § 164.404(c)-(d)). There are alternative notice procedures if the covered entity does not know the identity or contact information for affected persons. (Id.).
3. Notice to HHS. Breaches of unsecured PHI must also be reported to HHS: breach reports involving less than 500 persons must made within 60 days; breaches involving 500 or more must be reported within 60 days after the end of the calendar year. Covered entities submit the report electronically using the form available at http://www.hhs.gov/ocr/privacy/hipaa/administrative/breachnotificationrule/brinstruction.html. The OCR posts the names of entities with breaches involving more than 500 persons on the OCR’s wall of shame, https://ocrportal.hhs.gov/ocr/breach/breach_report.jsf.
Accounting Logs. Whether or not the breach is reportable to the individual or HHS, covered entities and business associates are still required to record impermissible disclosures in their accounting of disclosure logs as required by 45 CFR § 164.528. The log must record the date of the disclosure; name and address of the entity who received the PHI; a brief description of the PHI disclosed; and a brief statement of the reason for the disclosure. (45 CFR § 164.528(b)). If requested, the covered entity must disclose the log to the individual or the individual’s personal representative within 60 days. (Id. at 164.528(c)).
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