To provide guidance for breach notification when impressive or unauthorized access, acquisition, use and/or disclosure of the ePHI occurs. Breach notification will be carried out in compliance with the American Recovery and Reinvestment Act (ARRA)/Health Information Technology for Economic and Clinical Health Act (HITECH) as well as any other federal or state notification law.
The Federal Trade Commission (FTC) has published breach notification rules for vendors of personal health records as required by ARRA/HITECH. The FTC rule applies to entities not covered by HIPAA, primarily vendors of personal health records. The rule is effective September 24, 2009 with full compliance required by February 22, 2010.
The American Recovery and Reinvestment Act of 2009 (ARRA) was signed into law on February 17, 2009. Title XIII of ARRA is the Health Information Technology for Economic and Clinical Health Act (HITECH). HITECH significantly impacts the Health Insurance Portability and Accountability (HIPAA) Privacy and Security Rules. While HIPAA did not require notification when patient protected health information (PHI) was inappropriately disclosed, covered entities and business associates may have chosen to include notification as part of the mitigation process. HITECH does require notification of certain breaches of unsecured PHI to the following: individuals, Department of Health and Human Services (HHS), and the media. The effective implementation for this provision is September 23, 2009 (pending publication HHS regulations).
In the case of a breach, FlowTrack shall notify all affected Customers. It is the responsibility of the Customers to notify affected individuals.
FlowTrack policy requires that:
(a) Breach notification procedures are invoked upon confirmation of security breach that results in unauthorized disclosure of unprotected/unencrypted sensitive data.
(b) Individuals impacted by a confirmed data breach must be notified within 60 days of discovery of such breach.
(c) In the event of a data breach that involves unencrypted ePHI, FlowTrack must report the breach to individuals impacted following the HIPAA Breach Notification requirements (45 CFR Part 164, Subpart D).
Discovery of Breach: A data breach shall be treated as "discovered" as of the first day on which such breach is known to the organization, or, by exercising reasonable diligence would have been known to FlowTrack (includes breaches by the organization's Customers, Partners, or subcontractors). FlowTrack 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 Partner of the organization. Following the discovery of a potential breach, the organization shall begin an investigation (see organizational policies for security incident response and/or risk management incident response) immediately, conduct a risk assessment, and based on the results of the risk assessment, begin the process to notify each Customer affected by the breach. FlowTrack 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.)
Breach Investigation: The FlowTrack Security Officer shall name an individual to act as the investigator of the breach (e.g., privacy officer, security officer, risk manager, etc.). The investigator shall be responsible for the management of the breach investigation, completion of a risk assessment, and coordinating with others in the organization as appropriate (e.g., administration, security incident response team, human resources, risk management, public relations, legal counsel, etc.) The investigator shall be the key facilitator 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 assessment, shall be retained for a minimum of seven years. A breach log is kept and maintained by the Security and Privacy Officer.
Risk Assessment: A risk assessment is performed in accordance to applicable laws and regulations.
For an acquisition, access, use or disclosure of ePHI to constitute a breach, it must constitute a violation of the HIPAA Privacy Rule. A use or disclosure of ePHI 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 ePHI constitutes a breach and requires further notification, the organization will need to perform a risk assessment to determine if there is significant risk of harm to the individual as a result of the impermissible use or disclosure. The organization shall document the risk assessment as part of the investigation in the incident report form noting the outcome of the risk assessment process. The organization has the burden of proof for demonstrating that all notifications to appropriate Customers or that the use or disclosure did not constitute a breach. Based on the outcome of the risk assessment, the organization will determine the need to move forward with breach notification. The risk assessment and the supporting documentation shall be fact specific and address:
Timeliness of Notification: Upon discovery of a breach, notice shall be made to the affected FlowTrack Customers, usually within 24-48 hours but no later than 10 calendar days after the discovery of the breach. It is the responsibility of the organization to demonstrate that all notifications were made as required, including evidence demonstrating the necessity of delay.
Delay of Notification Authorized for Law Enforcement Purposes: If a law enforcement official states to the organization that a notification, notice, or posting would impede a criminal investigation or cause damage to national security, the organization shall:
Content of the Notice: The notice shall be written in plain language and must contain the following information:
Methods of Notification: FlowTrack Customers will be notified via email and phone within the timeframe for reporting breaches, as outlined above.
Maintenance of Breach Information/Log: As described above and in addition to the reports created for each incident, FlowTrack shall maintain a process to record or log all breaches of unsecured sensitive data regardless of the number of records and Customers affected. The following information should be collected/logged for each breach (see sample Breach Notification Log):
Workforce Training: FlowTrack shall train all members of its workforce on the policies and procedures with respect to sensitive data as necessary and appropriate for the members to carry out their job responsibilities. Workforce members shall also be trained as to how to identify and report breaches within the organization.
Complaints: FlowTrack must provide a process for individuals to make complaints concerning the organization's patient privacy policies and procedures or its compliance with such policies and procedures. Individuals may do so by emailing [email protected]
Sanctions: The organization shall have in place and apply appropriate sanctions against members of its workforce, Customers, and Partners who fail to comply with privacy policies and procedures.
Retaliation/Waiver: FlowTrack may not intimidate, threaten, coerce, discriminate against, or take other retaliatory action against any individual for the exercise by the individual of any privacy right. The organization may not require individuals to waive their privacy rights under as a condition of the provision of treatment, payment, enrollment in a health plan, or eligibility for benefits.
The following requirements and guidelines shall be provided to and agreed upon by a client organization using FlowTrack platform to host sensitive data such as ePHI and PII.
The agreement may be in the form of a contract or acceptance of terms and conditions.
The FlowTrack Customer that accesses, maintains, retains, modifies, records, stores, destroys, or otherwise holds, uses, or discloses unsecured sensitive data shall, without unreasonable delay and in no case later than 72 hours after discovery of a breach, notify FlowTrack of such breach. The Customer shall provide FlowTrack with the following information:
Depending on the nature of the breach, an investigation may be conducted by FlowTrack or the Customer or jointly to determine the cause of breach.
Notice to Media: Unless FlowTrack is directly at fault for the cause of breach, FlowTrack Customers are responsible for providing notice to prominent media outlets at the Customer's discretion. Where FlowTrack is not at fault Company shall not name FlowTrack in any notice or media unless otherwise required by law to do so. In such event copies of such notice and media will be sent by Customer to FlowTrack before the release of any material to ensure accuracy and provide Company and FlowTrack the opportunity to avoid reputational damages and other types of damges.
Notice to Authorities: Unless FlowTrack is directly at fault for the cause of breach, FlowTrack Customers are responsible for providing notice to the appropriate authorities, including the Secretary of Health and Human Services (HHS) and your Lead Supervisory Authority (LSA) under GDPR, at the Customer's discretion.
[Name] [Name of Customer] [Address 1] [Address 2] [City, State Zip Code]
Dear [Name of Customer]:
I am writing to you from FlowTrack.co, with important information about a recent breach that affects your account with us. We became aware of this breach on [Insert Date] which occurred on or about [Insert Date]. The breach occurred as follows:
Describe event and include the following information:
Other Optional Considerations:
We will assist you in remedying the situation.
Fincosa LLC, 220 Calle Manuel Domenech #2012, San Juan, PR, 00918, USA