Having a data breach response plan on paper isn't enough. Practice staff expected to implement it must understand and be equipped to execute their tasks.
In the last 18 months, there have been three massive data breaches involving the healthcare industry, scores of smaller breaches, and a growing trend of insider threats posed by employees who have sold protected health information (PHI) for their own personal gain. Unlike stolen credit card numbers that can be deactivated, the personal identifying information needed to commit identity-theft type crimes, such as name, address, Social Security number, and date of birth, cannot be changed easily, if at all. Because of the permanent nature of the information that they contain, health records are approximately 10 times more valuable than stolen credit card numbers on Internet black markets where they can be bought and sold in bulk.
Now more than ever, because of new threats posed by such cybercriminals, any organization that collects, uses, discloses, or stores PHI is a potential breach victim. Covered Entities and their Business Associates subject to HIPAA who suffer a data breach must act quickly and correctly in assessing the situation. They must thoroughly investigate and mitigate risks caused by the breach, attempt recovery of the lost information, and provide required notifications to affected individuals and others. Throughout this process, organizations experiencing a breach should strive to demonstrate publicly that the data loss is being handled responsibly and appropriately.
Defining a "Breach"
HIPAA defines a breach as the acquisition, access, use, or disclosure of PHI in a manner inconsistent with the Privacy Rule that compromises its security or privacy. In most cases, a breach is presumed to have occurred unless it can be demonstrated that there is a "low probability" that the PHI has been compromised. When performing this initial inquiry, an organization must consider:
1. The nature and extent of the PHI involved, including the types of identifiers and likelihood of re-identification;
2. The unauthorized person who used the PHI or to whom the disclosure was made;
3. Whether the PHI was actually acquired or viewed; and
4. The extent to which the risk to the PHI has been mitigated.
Plan Ahead for Breach Notification
Every Covered Entity and Business Associate that handles PHI should develop its own unique breach response plan, built upon its most recent Security Risk Assessment (SRA), itself a fundamental step in the development of a comprehensive HIPAA security program. This security program should include a complete inventory of all devices containing sensitive data and policies and procedures requiring the immediate reporting of any lost, stolen, or compromised devices or media.
Using the most critical vulnerabilities identified in the SRA as a blueprint, the "worst case" scenario should be used to develop a detailed response plan. This discussion and handling of the "crisis" in a benign environment should be memorialized and refined into a formal breach response plan that identifies clear lines of communication and responsibility, including what gets done, who does it, and when they are supposed to do it.
Merely having a breach response plan on paper is not enough. Individuals who are expected to implement the plan must understand and be equipped to execute their responsibilities.
Whether through a medical practice's in-house counsel or an outside law firm, there are important reasons to integrate counsel into a breach response plan. Privacy counsel with breach response experience can bring valuable insight and steadying presence to an unfamiliar and sometimes chaotic situation. In the event of a follow-up investigation by HHS' Office for Civil Rights (OCR) (which is mandated in breaches affecting 500 or more individuals) or civil litigation, an organization's deliberative processes and internal communications and/or actions involving their counsel regarding breach response may be kept confidential through these doctrines. Without the involvement of counsel, the entirety of an organization's actions and communications would be potentially discoverable in the now familiar class-action lawsuits that inevitably follow data breaches.
Activating the Breach Response Plan
If it is determined that a breach has occurred, an organization should immediately take all possible steps to minimize or limit the impact of the breach while documenting its efforts to do so. Mitigation often occurs parallel with an investigation, and its own document trail, into the cause of the breach. In some cases, such as when a device is physically lost or stolen, mitigation may be impossible unless there is a way to remotely wipe the data contained on it. If the breach involves media or paper that can be tracked or retrieved, every effort should be made to recover it. Law enforcement should be contacted if criminal activity such as theft or intrusion is suspected.
Like other aspects of breach response, a medical practice's internal investigation into a breach should be thoroughly documented. The Privacy Officer, in consultation with privacy counsel for the organization, should collect and preserve evidence in accordance with established policies and procedures. This information may include interviews, e-mails, chat logs, voicemails, cellular calling records, computer logs, and any other information regarding the data loss.
If the breach involves cyber intrusion, the Privacy Officer will likely require the assistance of IT vendors or others such as specially-trained law enforcement divisions. Expert forensic assistance from these individuals can be invaluable when investigating a possible breach or determining the scope of known breach.
Formal Notification to Individuals, HHS, and Others
Once a breach has been internally confirmed, HIPAA requires official notification to all affected individuals and the OCR. If the breach involves 500 or more individuals, media organizations in the area where the affected individuals live must also be notified. Most times, these notifications must occur within 60 days of when the breach actually was, or should have been, discovered.
This does not necessarily mean that the breach will remain private until further disclosure. In many instances, breaches become public knowledge long before formal notification is made. To prevent such situations from spiraling out of control, it is imperative that an organization's breach response team be prepared to make public limited information in which there is a high degree of confidence, while stressing that the investigation is ongoing and this information may evolve. Scrambling to figure out a breach response strategy while trying to investigate and mitigate the possible harm can easily lend to inaccurate and/or harmful information being disseminated. Responding with silence will only intensify the scrutiny in such situations. A breach response plan will help a practice follow a "script" through an otherwise unfamiliar and potentially high-stakes crisis.
Poor breach notifications can take many shapes. Some fail to acknowledge the seriousness of the situation. Others provide incomplete or incorrect information. Another poor "response strategy" is complete silence or other tone-deaf actions which demonstrate organizational discord or a misunderstanding of the severity of the situation. Any of these missteps can be severely damaging, not only from a reputational point of view, but also during later phases if there is a formal investigation by OCR.
After the required notifications have been made, the organization should update its current risk management plan to reflect lessons learned and vulnerabilities addressed as a result of the breach.
Most cyber intrusions are not brutish acts of virtual "smash and grab" thuggery, but well-planned and strategic, with the hallmarks of stealth and patience. As data collection and information sharing among healthcare providers and their affiliates grows in the future, the threats to the security and integrity of this information will continue to increase.
Failing to prepare for a breach is the same as preparing to fail at responding to one. As electronic health information continues to multiply along with data sharing among multiple providers and affiliates, preparing for this threat must become an organizational priority for everyone.
Leonardo M. Tamburellois counsel for McElroy, Deutsch, Mulvaney & Carpenter, LLP. He has been designated a Certified Information Privacy Professional by the International Association of Privacy Professionals, and serves as co-chair of the American Health Lawyers Association’s Health Information Technology/ Electronic Health Record Affinity Group. He can be contacted at email@example.com.