Tag Archives: health information technology for economic and clinical health act

OCR Nails Hospice For $50K In First HIPAA Breach Settlement Involving Small Data Breach

Properly encrypt and protected electronic protected health information (ePHI) on laptops and in other mediums!

That’s the clear message of the Department of Health and Human Services (HHS) Office of Civil Rights (OCR) in its announcement of its first settlement under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule involving a breach of ePHI of fewer than 500 individuals by a HIPAA-covered entity, Hospice of North Idaho (HONI).

The settlement shows that the Office of Civil Rights stands ready to penalize these healthcare providers, health plans, healthcare clearinghouses and their business associates (covered entities) when their failure to properly secure and protect ePHI on laptops or in other systems results in a breach of ePHI even when the breach affects fewer than 500 individuals.

HIPAA Security & Breach Notification For ePHI
Under the originally enacted requirements of HIPAA, covered entities and their business associates are required to restrict the use, access and disclosure of protected health information and establish and administer various other policies and safeguards in relation to protected health information. Additionally, the Security Rules require specific encryption and other safeguards when covered entities collect, create, use, access, retain or disclose ePHI.

The Health Information Technology for Economic and Clinical Health (HITECH) Act amended HIPAA, among other things to tighten certain HIPAA requirements, expand its provisions to directly apply to business associates, as well as covered entities and to impose specific breach notification requirements. The HITECH Act Breach Notification Rule requires covered entities to report an impermissible use or disclosure of protected health information, or a “breach,” of 500 individuals or more (Large Breach) to the Secretary of HHS and the media within 60 days after the discovery of the breach. Smaller breaches affecting less than 500 individuals (Small Breach) must be reported to the Secretary on an annual basis.

Since the Breach Notification Rule took effect, the Office of Civil Rights’ announced policy has been to investigate all Large Breaches and such investigations have resulted in settlements or other corrective action in relation to various Large Breaches. Until now, however, the Office of Civil Rights has not made public any resolution agreements requiring settlement payments involving any Small Breaches.

Hospice Of North Idaho Settlement
On January 2, 2013, the Office of Civil Rights announced that Hospice of North Idaho will pay the Office of Civil Rights $50,000 to settle potential HIPAA violations that occurred in connection with the theft of an unencrypted laptop computer containing ePHI. The Hospice of North Idaho settlement is the first settlement involving a breach of ePHI affecting fewer than 500 individuals. Read the full HONI Resolution Agreement here.

The Office of Civil Rights opened an investigation after Hospice of North Idaho reported to the Department of Health and Human Services that an unencrypted laptop computer containing ePHI of 441 patients had been stolen in June 2010. Hospice of North Idaho team members regularly use laptops containing ePHI in their field work.

Over the course of the investigation, the Office of Civil Rights discovered that Hospice of North Idaho had not conducted a risk analysis to safeguard ePHI or have in place policies or procedures to address mobile device security as required by the HIPAA Security Rule. Since the June 2010 theft, Hospice of North Idaho has taken extensive additional steps to improve their HIPAA Privacy and Security compliance program.

Enforcement Actions Highlight Growing HIPAA Exposures For Covered Entities
While the Hospice of North Idaho settlement marks the first settlement on a small breach, this is not the first time the Office of Civil Rights has sought sanctions against a covered entity for data breaches involving the loss or theft of unencrypted data on a laptop, storage device or other computer device. In fact, the Office of Civil Rights’ first resolution agreement — reached before the enactment of the HIPAA Breach Notification Rules — stemmed from such a breach (see Providence To Pay $100000 & Implement Other Safeguards).

Breaches resulting from the loss or theft of unencrypted ePHI on mobile or other computer devices or systems has been a common basis of investigation and sanctions since that time, particularly since the Breach Notification rules took effect. See, e.g., OCR Hits Alaska Medicaid For $1.7M+ For HIPAA Security Breach. Coupled with statements by the Office of Civil Rights about its intolerance, the Hospice of North Idaho and other settlements provide a strong warning to covered entities to properly encrypt ePHI on mobile and other devices.

Furthermore, the Hospice of North Idaho settlement also adds to growing evidence of the growing exposures that health care providers, health plans, health care clearinghouses and their business associates need to carefully and appropriately manage their HIPAA encryption and other Privacy and Security responsibilities. See OCR Audit Program Kickoff Further Heats HIPAA Privacy Risks; $1.5 Million HIPAA Settlement Reached To Resolve 1st OCR Enforcement Action Prompted By HITECH Act Breach Report; and, HIPAA Heats Up: HITECH Act Changes Take Effect & OCR Begins Posting Names, Other Details Of Unsecured PHI Breach Reports On Website. Covered entities are urged to heed these warnings by strengthening their HIPAA compliance and adopting other suitable safeguards to minimize HIPAA exposures.

Office of Civil Rights Director Leon Rodriguez, in OCR’s announcement of the Hospice of North Idaho settlement, reiterated the Office of Civil Rights’ expectation that covered entities will properly encrypt ePHI on mobile or other devices. “This action sends a strong message to the health care industry that, regardless of size, covered entities must take action and will be held accountable for safeguarding their patients’ health information.” said Rodriguez. “Encryption is an easy method for making lost information unusable, unreadable and undecipherable.”

In the face of rising enforcement and fines, the Office of Civil Rights’ initiation of HIPAA audits and other recent developments, covered entities and their business associates should tighten privacy policies, breach and other monitoring, training and other practices to reduce potential HIPAA exposures in light of recently tightened requirements and new enforcement risks.

In response to these expanding exposures, all covered entities and their business associates should review critically and carefully the adequacy of their current HIPAA Privacy and Security compliance policies, monitoring, training, breach notification and other practices taking into consideration the Office of Civil Rights’ investigation and enforcement actions, emerging litigation and other enforcement data, their own and reports of other security and privacy breaches and near misses, and other developments to determine if additional steps are necessary or advisable.

New Office Of Civil Rights HIPAA Mobile Device Educational Tool
While the Office of Civil Rights’ enforcement of HIPAA has significantly increased, compliance and enforcement of the encryption and other Security Rule requirements of HIPAA are a special focus of the Office of Civil Rights.

To further promote compliance with the Breach Notification Rule as it relates to ePHI on mobile devices, the Office of Civil Rights and the HHS Office of the National Coordinator for Health Information Technology (ONC) recently kicked off a new educational initiative, Mobile Devices: Know the RISKS. Take the STEPS. PROTECT and SECURE Health Information. The program offers health care providers and organizations practical tips on ways to protect their patients’ health information when using mobile devices such as laptops, tablets, and smartphones. For more information, see here.

For more information on HIPAA compliance and risk management tips, see here.

Privacy Enforcement In The Healthcare Arena​

The Exposure
Organizations that deal with private health information (PHI) should know how to properly handle such data in absence of a breach as well as how to respond after a breach occurs. According to the 2011 Computer Security Institute Crime and Security Survey, 97% of organizations report using anti-virus software, 95% use firewalls, 85% use anti-spyware software, 66% use data encryption and 62% use intrusion detection systems.

The Open Security Foundation’s website, www.datalossdb.org, shows that despite taking meaningful steps to prevent security breaches, healthcare organizations accounted for 18% of the 1,032 data breaches reported in 2011 and 15% of all time. Further, according to the Ponemon Institute’s 2011 Cost of Breach Study, the per capita costs of a breach for healthcare organizations average around $240 per record. When compared to retail, which averages $174 per record, education which averages $142 per record, and an average of $194 per record for all industries, healthcare organizations clearly have cause to be concerned about breach response expenses.

A healthcare organization or business associate1 should also be aware of the increased standards that have been imposed by the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the Health Information Technology for Economic and Clinical Health Act (HITECH), the Privacy Rule and the Security Rule. One aspect of the Health Information Technology for Economic and Clinical Health Act act that may surprise many is the potential for the Office of Civil Rights (OCR) to fine an organization in absence of a breach.

In 2012, the Office of Civil Rights will conduct 150 audits of Covered Entities. If material security weaknesses are reported, a formal compliance review will follow. If that review uncovers blatant security violations, civil monetary fines could follow. Enforcement action around data breaches has been on the rise, and fines and penalties are being levied more frequently than in the past. The Department of Health & Human Services (DHHS) posts examples of resolutions including fines on their website. These initial audits are likely only the beginning of expanding regulatory oversight related to private health information.

Theodore Kobus III of Baker & Hostetler LLP, one of the national leaders of their Privacy, Security and Social Media Practice, advises the following regarding the current regulatory environment:

Data security extends beyond breach response and we are seeing an increasing number of regulatory investigations and fines stemming from how an organization responds to changes in its risks. A big part of being prepared includes understanding the nature and scope of the information you hold and how that data needs to be protected as risks in the organization evolve. For example, if you store data in an area that was once monitored by a security guard, but that area is now unoccupied, you may want to consider implementing other security measures.

Reducing The Exposure
In a previous article regarding lost laptops, we provided basic tips for handling a privacy breach.

With the type and volume of private health information that organizations in the healthcare arena touch, they are expected to take even more comprehensive steps to anticipate, prevent, respond to, and survive a breach. While many organizations are large enough to have entire departments dedicated to this issue, the complexity of the privacy laws means that, regardless of the organization’s ability to dedicate resources, it is important to work with legal counsel that is solely focused on privacy related issues. Similarly, healthcare providers should also seek out specialized network security risk management providers who can help answer important questions like:

  • Am I prepared to show that I took the proper steps before a data breach occurred?
  • Do I have an effective incident response plan in place when there is a problem?
  • Am I protecting digital records as well as paper records under the requirements of the Health Insurance Portability and Accountability Act of 1996 and the Health Information Technology for Economic and Clinical Health Act?
  • Are my vendors and business associates also in compliance with the proper standards?

Many insurers have existing relationships with computer forensic firms, notification vendors, credit monitoring providers, legal forensic firms, public relations firms and others to help navigate the huge distractions following a data breach. To this end, we have seen insureds purchase cyberliability coverage solely for the value-added services provided by the insurer. Many of these buyers feel that they can afford a security breach, but that they don’t have the time to line up all the necessary critical response vendors if a breach occurs.

Neeraj Sahni of Kroll Advisory Solutions points out:

The ease of access to electronic data, anywhere-anytime, makes security a challenge as negligence leads to recurring data breaches. Preventive preparation is the most important loss control mechanism for any organization that has sensitive data. Thus waiting for a breach to occur is reactive and may incur more liability for any company. An incident response plan potentially helps lessen the impact of a breach. Also note, being compliant with security and privacy regulations does not provide assurance to an organization against a data breach.

Contractual Risk Transfer May Not Be Enough
Contracts with business associates and other trading partners may be part of the solution, but not the whole solution, as observed by Theodore Kobus III:

Many organizations think that a contract shifting liability to a third party is all that you need to protect the organization in the event that a vendor causes a breach. This type of protection is good, but it does not solve all of the organization’s issues. Notwithstanding the public relations issues the organization may face after a breach by a vendor, laws such as HITECH and various state laws still hold the organization who owns the data ultimately responsible for the breach. Another consideration about shifting all responsibility for a breach to the vendor is the lack of control about the messaging after a breach occurs. Remember, even though the vendor may have caused the breach, these are still your customers and your reputation is at risk.

Mr. Kobus brings up a dangerous situation. If a healthcare provider has fully shifted post-breach responsibilities to a vendor that caused the breach, the treatment of its customers or patients is in the hands of the vendor. To shift financial responsibility is one thing, but the provision of post-breach services such as call centers and identity/credit services should remain in the healthcare provider’s control. When it comes to the handling of an organization’s reputation, the preferred approach is to proactively protect its reputation rather than scramble to restore it after a poorly handled data breach.

The Right Insurance To Survive A Breach
Healthcare providers and business associates should have their own policy to protect their organization. The company’s own employees are a significant cause of data breaches, as are external hacks. The organization will not be able to unfailingly transfer that risk to other parties.

Organizations should also ensure their vendors have the financial assets or insurance to back up their contractual promises. If an entity is going to rely on a third party vendor to hold on to private health information for which they are responsible, they should be reviewing the vendor’s professional liability insurance rather than just asking if they have a policy.

Types Of Risk Transfer Vehicles
Cyberliability is the generic description of the type of policy healthcare organizations will need. In a prior article, we went into some detail about what is available. Here are some of the typical insuring agreements in a Cyberliability policy:

  • 1st Party Business Interruption — Covers lost business income in the event a virus infection or hacker shuts down your network.
  • 1st Party Data Asset — Covers the expense to recover lost data and other expenses.
  • Cyberextortion — Covers expenses and ransom if a hacker threatens your network or data.
  • 3rd Party Network Security — Covers your liability when hackers use your system to inflict damage on others.
  • 1st Party Privacy
    • Notification Expenses — When data is lost, you must notify all potential victims within a very brief period of time and in accordance with the state laws where the potential victims reside.
    • Forensic Expenses — The insurer will cover the expenses associated with bringing in computer experts to determine the cause of a breach and list of potential victims. Some insurers also cover legal forensic experts.
    • Credit Monitoring — The insurer may cover one to two years of credit monitoring services for those exposed.
    • Credit or Identity Repair Services — The insurer will cover the expenses for up to one year to restore compromised identities and repair a victim’s credit rating following an actual identity theft.
    • Crisis Management — Public Relations expense coverage to protect the image of the organization.
  • Regulatory Defense and Expenses — Many new regulations exist related to the protection of confidential data. The insurance will provide defense cost coverage and in many cases cover fines, penalties and restitution funds levied by a regulatory body, where insurable. This coverage is designed to help healthcare organizations respond to actions brought by state agencies, state attorneys general, the Department of Health and Human Services, the Office of Civil Rights and other regulatory agencies.

There are now more than 30 different insurers with dedicated cyberliability policies, and no two insuring agreements are the same. It is important to be diligent in making sure the coverage sought is the coverage bought.

Conclusion
The current regulatory oversight and monetary implications surrounding a loss of private health information means that firms in the healthcare arena should be more aware than most of privacy enforcement and how to protect their clients, constituents, reputation, and organization.

1 A “business associate” is a person or entity that performs certain functions or activities that involve the use or disclosure of protected health information on behalf of, or provides services to, a covered entity. A member of the covered entity’s workforce is not a business associate. (For more information, see hhs.gov.)