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Title: Breach Notification Policy
Subject: Office of Compliance & Corporate Integrity (OCCI)
Policy No: OCCI:2013:P11
Applies: Rowan University & Rowan University School of Osteopathic Medicine (RowanSOM)
Issuing Authority: Rowan President & RowanSOM Dean
Responsible Officer: Chief Audit, Compliance and Privacy Officer & ; Director of Information Security
Date Adopted: 07/01/2013
Last Revision:  03/256/20202024
Last Reviewed: 03/256/20202024

I.    PURPOSE

To facilitate compliance with the Health Information Technology for Economic and Clinical Health Act (HITECH) component of the American Recovery and Reinvestment Act of 2009 (ARRA) and Omnibus Privacy Final Rule 2013 breach notification of unsecured protected health information (PHI), Personal Identifiable Information (PII), Family Educational Rights and Privacy Act (FERPA), and other federal or state notification law requirements.

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Under the direction of the Dean of RowanSOM, Chief Audit, Compliance & Privacy Officer, RowanSOM General Counsel and Executive Management shall implement and ensure compliance with this policy.

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1. Access to University Records
2. M. Media Release: Academic, Clinical 
3. Identity Theft Prevention Program
4. Standards for Privacy of Individually Identifiable Health Information
5. Access of Individuals to Protected Health Information
6. Uses and Disclosures of Health Information With and Without an Authorization
7. Protection of Sensitive Electronic Information (SEI)
8. Reporting Compliance and Ethics Concerns
9. Information Technology Incident Management Policy and Standards
10. Omnibus Final Privacy Rule of 2013

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By Direction of the President:

Signature on File

________________________________
Chief Audit, Compliance & Privacy Officer

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1. Discovery of an Alleged Breach: A breach of PHI shall be treated as "discovered" as of the first day on which such breach is known to RowanSOM, or, by exercising reasonable diligence would have been known to RowanSOM (includes breaches by RowanSOM's business associates). RowanSOM 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 (business associate) of RowanSOM. Following the discovery of a potential breach, RowanSOM will begin an investigation which includes a risk assessment of harm. If the results of the risk assessment warrant the process will begin to notify each individual who's PHI has been, or is reasonably believed by RowanSOM to have been, accessed, acquired, used, or disclosed as a result of the breach. RowanSOM shall also begin the process of determining what external notifications are required or should be made (e.g., Secretary of Department of Health & Human Services (HHS), media outlets, law enforcement officials, etc.).
2. Breach Investigation: The Chief Audit, Compliance & Privacy Officer should manage the investigation unless otherwise directed by Rowan General Counsel and Senior Management. The management of the breach investigation will include the completion of a risk of harm assessment in coordination with others in RowanSOM as appropriate (e.g., administration, security incident response team, human resources, risk management, public relations, legal counsel, etc.) The Chief Audit, Compliance & Privacy Officer and Rowan General Counsel shall be the key facilitators for all breach notification processes to the appropriate entities (e.g., HHS, media, law enforcement officials, etc.). All documentation related to the breach investigation, including the risk of harm assessment, shall be retained by the OCCI for a minimum of six years.
3. Probability that the PHI has been compromised: For an acquisition, access, use or disclosure of PHI to constitute a breach, it must constitute a violation of the Privacy Rule. A use or disclosure of PHI that is incident to an otherwise permissible use or disclosure and occurs despite reasonable safeguards and proper minimum necessary procedures would not be a violation of the Privacy Rule and would not qualify as a potential breach. To determine if an impermissible use or disclosure of PHI constitutes a breach and requires further notification to individuals, media, or the HHS secretary under breach notification requirements, the investigator will need to perform a risk assessment to determine if there is significant probability that PHI has been compromised as a result of the impermissible use or disclosure. RowanSOM shall document the probability of PHI has been compromised as part of the investigation, noting the outcome of the assessment process. RowanSOM has the burden of proof for demonstrating that all notifications were made as required or that the use or disclosure did not constitute a breach. Based on the outcome of the assessment, RowanSOM will determine the need to move forward with breach notification. The probability of PHI being compromised assessment and the supporting documentation shall be fact-specific and address:
   1. The nature and extent of the PHI involved, which includes type of identifiers and the probability of re-identification;
   2. The unauthorized person who used the PHI or to who the PHI was disclosed to; and
   3. Whether the PHI was acquired or just viewed and the extent to which the risk to the PHI has been mitigated
4. Timeliness Notification: Upon determination that breach notification is required, the notice shall be made without unreasonable delay and in no case later than 60 calendar days after the discovery of the breach by RowanSOM or the business associate involved. It is the responsibility of RowanSOM to demonstrate that all notifications were made as required, including evidence demonstrating the necessity of delay
5. Delay of Notification Authorized for Law Enforcement Purposes: If a law enforcement official states to RowanSOM that a notification, notice, or posting would impede a criminal investigation or cause damage to national security, RowanSOM shall:
   1. If the statement is in writing and specifies the time for which a delay is required, delay such notification, notice, or posting of 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 above is submitted during that time.
6. Content of the Notice: The notice shall be written in plain language and must contain the following information:
   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 the individual should take to protect themselves from potential harm resulting from the breach.
   4. A brief description of what steps RowanSOM is performing to investigate the breach, to mitigate harm to individuals, and to protect against further breaches.
   5. Contact procedures for individuals to ask questions or learn additional information, which includes providing them a toll-free telephone number, an e-mail address, information on the RowanSOM website home page, or postal address.
7. Methods of Notification: The method of notification will depend on the individuals/entities to be notified. The investigator will utilize the following methods accordingly:
   Notice to Individual(s): Notice shall be provided promptly and in the following form:
   1. 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 shall be provided in one or more mailings as information is available. If RowanSOM knows that the individual is deceased and has the address of the next of kin or personal representative of the individual, written notification by first-class mail to the next of kin or personal representative shall be carried out.
   2. Substitute Notice: In the case where there is insufficient or out-of-date contact information (including a phone number, email address, etc.) that precludes direct written or electronic notification, a substitute form of notice reasonably calculated to reach the individual shall be provided. A 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.
   3. In a case in which there is insufficient or out-of-date contact information for fewer than 10 individuals, then the substitute notice may be provided by an alternative form of written notice, telephone, or other means.
   4. In the case in which there is insufficient or out-of-date contact information for 10 or more individuals, then the substitute notice shall be in the form of either a conspicuous posting for a period of 90 days on the home page of RowanSOM's website, or a conspicuous notice in a major print or broadcast media in RowanSOM's geographic areas where the individuals affected by the breach likely reside. The notice shall include a toll-free number that remains active for at least 90 days where an individual can learn whether his or her PHI may be included in the breach.
8. Notice to Risk Management: Upon notice of a PHI breach incident, the Chief Audit, Compliance & Privacy Officer and Rowan General Counsel shall take the steps needed to protect RowanSOM's interest under any policies of insurance that may offer coverage.
9. Notice to Media: Notice shall be provided to prominent media outlets serving the state and regional area when the breach of unsecured PHI affects more than 500 patients. The Notice shall be provided in the form of a press release.
10. Notice to Secretary of HHS: Notice shall be provided to the Secretary of HHS as follows below. The Secretary shall make available to the public on the HHS Internet website a list identifying covered entities involved in all breaches in which the unsecured PHI of more than 500 patients is accessed, acquired, used, or disclosed. 
    1. For breaches involving 500 or more individuals, RowanSOM shall notify the Secretary of HHS as instructed at www.hhs.gov at the same time notice is made to the individuals.
    2. For breaches involving less than 500 individuals, RowanSOM will maintain a log of the breaches and annually submit the log to the Secretary of HHS during the year involved (logged breaches occurring during the preceding calendar year to be submitted no later than 60 days after the end of the calendar year). Instructions for submitting the log are provided at www.hhs.gov. 
11. Maintenance of Breach Information/Log: As described above and in addition to the reports created for each incident, RowanSOM shall maintain a process to record or log all breaches of unsecured PHI regardless of the number of patients affected. The following information should be collected/logged for each breach:
    1. A description of what happened, including the date of the breach, the date of the discovery of the breach, and the number of patients affected, if known. 
    2. A description of the types of unsecured protected health information that were involved in the breach (such as full name, Social Security Number, date of birth, home address, account number, etc.).
    3. A description of the action taken with regard to notification of patients regarding the breach.
    4. Resolution steps taken to mitigate the breach and prevent future occurrences.
12. Business Associate Responsibilities: The business associate (BA) of RowanSOM that accesses, maintains, retains, modifies, records, stores, destroys, or otherwise holds, uses, or discloses unsecured protected health information shall, without unreasonable delay and in no case later than 10 calendar days after discovery of a breach, notify RowanSOM of such breach using RowanSOM notification form. Such notice shall include the identification of each individual whose unsecured protected health information has been, or is reasonably believed by the BA to have been, accessed, acquired, or disclosed during such breach. The BA shall provide RowanSOM with any other available information that RowanSOM is required to include in notification to the individual at the time of the notification or promptly thereafter as information becomes available. Upon notification by the BA of discovery of a breach, RowanSOM will be responsible for notifying affected individuals, unless otherwise agreed upon by the BA to notify the affected individuals (note: it is still the burden of the Covered Entity to document this notification).
13. Workforce Training: RowanSOM shall train all members of its workforce on the policies and procedures with respect to PHI as necessary and appropriate for the members to carry out their job responsibilities (refer to Policies; HIPAA Policies; Standards for Privacy of Individually Identifiable Health Information). Workforce members shall also be trained as to how to identify and report breaches within RowanSOM.

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