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The U.S. Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) has imposed its first civil monetary penalty since the Privacy Rule of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) became effective in April 2003. HHS issued a Notice of Final Determination finding that Cignet Health of Prince George’s County, Md., (Cignet) violated the Privacy Rule and imposed $4.3 million in penalties for the violations. The penalty amount is based on the increased penalty amounts authorized by Section 13410(d) of the Health Information Technology for Economic and Clinical Health (HITECH) Act.

In a Notice of Proposed Determination issued Oct. 20, 2010, OCR found that Cignet violated 41 patients’ rights by denying them access to their medical records when requested between September 2008 and October 2009. These patients individually filed complaints with OCR, initiating investigations of each complaint. The HIPAA Privacy Rule requires that a covered entity provide a patient with a copy of their medical records within 30 (and no later than 60) days of the patient’s request. The penalty for these violations is $1.3 million.

During the investigations, Cignet refused to respond to OCR’s demands to produce the records. Additionally, Cignet failed to cooperate with OCR’s investigations of the complaints and produce the records in response to OCR’s subpoena. OCR filed a petition to enforce its subpoena in United States District Court and obtained a default judgment against Cignet on March 30, 2010. On April 7, 2010, Cignet produced the medical records to OCR, but otherwise made no efforts to resolve the complaints through informal means. When Cignet did produce the records, it included certain records of 4,500 unrelated patients.

OCR also found that Cignet failed to cooperate with OCR’s investigations on a continuing daily basis from March 17, 2009, to April 7, 2010, and that the failure to cooperate was due to Cignet’s willful neglect to comply with the Privacy Rule. Covered entities are required under law to cooperate with the Department’s investigations. The penalty for these violations is $3 million.

There are some important lessons from this case for covered entities and business associates (now subject to the same penalty provisions as covered entities):

  • HHS appears to have turned the corner – it is willing to impose substantial penalties for Privacy and Security Rule violations under HIPAA.
  • Each day that a violation continues can be treated as a separate violation, allowing penalties to add up quickly. Cignet’s failure to provide a patient timely access to his records was a violation, and each day that continued was a separate violation. 
  • When responding to an HHS investigation concerning patient or participant information, be sure to include only the information being requested, and not that of unrelated persons.
  • Most important, be responsive to the agency. The reason for the significance of the penalties was almost certainly due to Cignet’s level of cooperation HHS.  

 

As employees become more savvy with electronic communications and employers face increasing challenges with controlling vast amounts of data, the circumstances in this recent San Francisco Examiner story are likely being repeated all over the country – employee takes company information to support her wrongful termination case.

As reported by the Examiner, a Human Services Agency of San Francisco employee, after being terminated for performance issues, e-mailed caseload files, containing Medi-Cal beneficiaries’ names, Social Security numbers, and other personal identifying information belonging to 2400 individuals, to her personal computer, two attorneys and two union representatives.

While the facts are not entirely clear from the report, including why the former employee still had access to her former employer’s systems following termination, such a disclosure could have triggered the breach notification requirements under the HIPAA Privacy and Security Rules, and likely did trigger California’s own breach notification laws. With breach notification mandates in almost every state, few employers are immune from the risks of a data breach or the costs that are associated with responding to a breach when it occurs.

As this situation makes clear, employers need to implement written information security programs containing privacy and security policies. These policies should include data breach detection and response procedures and mandate training for all employees. While being mindful of applicable whistle blower protections, employers should remind employees that confidential company and personal information is not to be used or disseminated, except when consistent with the employee’s assigned job responsibilities. In this case, based on the information reported, the entire incident might have been avoided had the former employee’s access to the Agency’s systems been terminated.

Employers must continually assess their risks (e.g., examining what information the company has, the nature of that information, how it moves through the organization and to/from its vendors, and the company’s current set of safeguards), determine the best methods of protecting the sensitive information they possess, and create a culture of data security and privacy throughout their organizations. This can only be accomplished when data security and privacy are made a priority through clear policies with frequent training and attention. And, of course, when terminating or disciplining employees, employers should expect employees might begin using and disclosing information in a manner that is not permitted, and should take steps to prevent these kinds of disclosures.

On December 18, 2010 President Obama signed into law the Social Security Number Protection Act of 2010. The law has two key components. 

First, the law establishes that no Federal, State, or local agency may display the Social Security account number of any individuals or any derivative of such number, on any check issued for payment by said agency. 

Second, the law prohibits Federal, State, or local agencies from employing, or entering into a contract for the use or employment of, prisoners in any capacity that would allow such prisoners access to the Social Security account numbers of other individuals. 

As employers have been grappling with the recent uptick in state laws addressing safeguards for Social Security numbers, this new law tightens protections at the federal level.   Additionally, federal contractors may need to consider how this change impacts their other obligations under the Federal Information Security Management Act.

Welcome to the next advancement in the delivery of health services –

monitoring patients and promoting healthy behavior through mobile phones and other portable devices

The Washington Post reported today about a service offered through Voxiva whereby expectant mothers receive free text messages concerning prenatal health advice. The pilot program has been in place since February and since then more than 100,000 expectant mothers are reported to have participated in the program. These technologies clearly are in line with initiatives in this country to move to electronic health records. However, whether these methods for delivering health care take hold remains to be seen. As the WP notes, while these technologies are attractive, there are challenges:

  • As noted by WP reporter Steven Overly, communicating to a wide variety of patients through a "wide variety of mobile devices, operating systems and network speeds" raises significant challenges. 
  • Another issue, of course, is HIPAA and how these communications and devices will meet the privacy and security requirements under those regulations.
  • Human error easily could cause the wrong messages to be sent to the wrong patients creating data breach, malpractice and other risks.
  • One of our more recent posts highlights the concern about information maintained on cellphones and other mobile devices and what happens to that information when the phones are discarded. 
  • Employers who provide phones to their employees and have the right to review text messages, see recent U.S. Supreme Court decision in Quon v. City of Ontario, can easily find themselves with access to all kinds of medical information of employees and possibly their dependents who give their doctors their cell phone number. This risks here could be significant.   

As with the adoption of any new technology or new application of technology, companies and employers should be careful to think through all of the issues and take appropriate preventive steps toward minimizing risks.

Pursuant to the Fair Credit Reporting Act (pdf), the Federal Trade Commission has promulgated three notices (pdf): (i) A General Summary of Rights; (ii) A Notice to Furnishers of Information to Consumer Reporting Agencies; and (iii) A Notice to Users of Consumer Reports (such as employers). In late August, the FTC proposed revisions to the three current forms.

General Summary of Rights

The proposed revised General Summary of Rights, which needs to be provided by an employer if a pre-adverse action notice is issued, incorporates notice of the individual’s rights to contest the accuracy of information contained in a consumer report not only with the consumer reporting agency but also the entity that furnished the information to the consumer reporting agency. The proposed notice also is more streamlined and unlike the current notice refers to various government websites from which relevant information can be accessed rather than listing all relevant federal agencies responsible for the enforcing the FCRA.

Notice to Furnishers

The proposed Notice to Furnishers incorporates the recently imposed obligations on data furnishers to establish policies and procedures to ensure the accuracy of information provided to consumer reporting agencies, as well as the obligation to address disputes regarding accuracy raised by the subject of the report with the data furnisher.

Notice to Users

The proposed Notice to Users, which is provided by a consumer reporting agency to an employer along with an End User Certification, incorporates additional obligations imposed on users by, among others, the FTC’s Address Discrepancy and Medical Information rules.

The proposed notices are now subject to a public notice and comment period.

Indiana recently enacted a new law which grants authority to the Indiana Office of the Attorney General’s Identity Theft Unit to obtain and secure abandoned records with personally identifying information, including health records, and either destroy them or return them to their owners. Additionally, the new law sets fines and other legal ramifications for violations of the law by health care providers or licensed professionals who leave such records unsecured in violation of state law. In fact, the Attorney General has already utilized this authority to obtain personal records from four entities. 

This additional grant of authority to the Indiana Attorney General, is in addition to the authority previously granted by the Health Information Technology for Economic and Clinical Health (HITECH) Act to enforce the privacy and security protections of HIPAA for protected health information. As we have previously discussed, the Connecticut Attorney General has filed a civil action against Health Net, as well as instituted an investigation against Griffin Hospital for violations of HIPAA. 

The Indiana statute, as with the authority granted to Attorney Generals under HITECH, highlight the need for companies to develop and implement comprehensive data security polices to secure their records. 

Rite Aid Corporation and its affiliates have agreed to pay $1 million to settle potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule, the U.S. Department of Health and Human Services (HHS) announced today. At the same time, Rite Aid signed a consent order with the Federal Trade Commission (FTC) to settle potential violations of the FTC Act.

The lesson to be learned from this case:

Disposing of individuals’ health information in an industrial trash container accessible to unauthorized persons is not compliant with several requirements of the HIPAA Privacy Rule and exposes the individuals’ information to the risk of identity theft and other crimes.

The Office of Civil Rights, which enforces the HIPAA Privacy and Security Rules, opened its investigation of Rite Aid after television media videotaped incidents in which pharmacies were shown to have disposed of prescriptions and labeled pill bottles containing individuals’ identifiable information in industrial trash containers that were accessible to the public. These incidents were reported as occurring in a variety of cities across the United States. Rite Aid pharmacy stores in several of the cities were highlighted in media reports.

The investigation also indicated other potential concerns about Rite Aid’s policies related to safeguarding patient information during the disposal process, training employees, and a related sanction policy.

The Director of OCR noted:

It is critical that companies, large and small, build a culture of compliance to protect consumers’ right to privacy and safeguard health information. OCR is committed to strong enforcement of HIPAA.

The corrective action Rite Aid has agreed to includes improving policies and procedures to safeguard the privacy of its customers’ health information, and applies to all of its nearly 4,800 retail pharmacies. More specifically, the settlement requires Rite Aid to take a number of steps including

  • Revising and distributing its policies and procedures regarding disposal of protected health information and sanctioning workers who do not follow them;
  • Training workforce members on these new requirements;
  • Conducting internal monitoring; and
  • Engaging a qualified, independent third-party assessor to conduct compliance reviews and render reports to HHS and FTC.

The HHS corrective action plan will be in place for three years; the FTC order will be in place for 20 years. The length and scope of these plans show the seriousness these agencies are taking concerning compliance with requirements to safeguard personal information.  

Connecticut Attorney General Richard Blumenthal has commenced an investigation in a second case involving potential HIPAA violations by a worker at Griffin Hospital. This follows the suit commenced against Health Net for HIPAA violations following a data breach. As reported by George Gombossy of ctwatchdog.com, this would be the second time a state attorney general has used the enforcement authority granted under the Health Information Technology for Economic and Clinical Health Act (HITECH).

The Attorney General’s press release states:

My office is investigating allegations that a radiologist formerly affiliated with Griffin Hospital improperly accessed the medical information of almost 1,000 of the hospital’s patients.

These charges, if true, are deeply disturbing. Patients rightly expect and demand that their medical information remain secure and confidential, viewed only by authorized individuals.

Unauthorized accessing of patient information is a violation of the federal HIPAA law that my office is empowered to enforce. I will seek strong and significant sanctions, if warranted by the facts.

Griffin Hospital rightly informed my office of this alleged data breach and is cooperating with our investigation.

Efforts are underway to help state Attorneys General become more actively involved in HIPAA enforcement. For example, the Department of Health and Human Services (HHS) has awarded a $1.7 million contract to train attorneys general on enforcing HIPAA and, specifically, to assist the Office of Civil Rights (an arm of HHS) “in conceptualizing and implementing a training curriculum for state attorneys general staff and others affected by the HIPAA Privacy and Security Rules.”

It is important that HIPAA-covered entities and business associates focus on compliance so when there is a data breach, they will be better positioned to respond to a state attorney general inquiry.

Have you noticed that negotiating that business associate agreement has gotten a lot more difficult? Many companies that serve health care providers and health plans, generally known as business associates, have noticed. These companies include software vendors, benefits brokers, cloud computing providers, data storage/destruction companies, and accountants, among others.

The clients of these companies are citing HIPAA, ARRA, HITECH, data breach notification requirements, and state law mandates as they demand stricter contract language and additional rights and protections, such as the right to audit the business associate and to be held harmless in the event of any data mishap. Business associates that took HIPAA lightly in 2003 and 2004, when the HIPAA regulations first became effective (2005 and 2006 for the security regulations), are playing catch-up.

When President Obama signed the American Recovery and Reinvestment Act of 2009 (ARRA), “business associates” may not have expected the significant effects that law would have on their businesses. Chief among those effects are mainly due to four sentences in The Health Information Technology for Economic and Clinical Health (HITECH) Act (pdf), passed as part of ARRA, and which generally became effective on February 17, 2010 (the breach notification mandate became effective on September 23, 2009), one year after enactment:

  • “Sections 164.308, 164.310, 164.312, and 164.316 of title 45, Code of Federal Regulations, shall apply to a business associate of a covered entity in the same manner that such sections apply to the covered entity. The additional requirements of this title that relate to security and that are made applicable with respect to covered entities shall also be applicable to such a business associate and shall be incorporate[d] into the business associate agreement between the business associate and the covered entity.” ARRA Sec. 13401(a). This statement makes business associates directly subject to nearly all of the HIPAA security regulations, the HIPAA rules relating to electronic protected health information. Prior to the change, these obligations existed for business associates only as a matter of contract.
  • “A business associate of a covered entity that accesses, maintains, retains, modifies, records, stores, destroys, or otherwise holds, uses, or discloses unsecured protected health information shall, following the discovery of a breach of such information, notify the covered entity of such breach.” ARRA Sec. 13402(b). This statement creates a new obligation for business associates – report to covered entities breaches of unsecured protected health information.
  • “The additional requirements of this subtitle that relate to privacy and that are made applicable with respect to covered entities shall also be applicable to such a business associate and shall be incorporated into the business associate agreement between the business associate and the covered entity.” ARRA Sec. 13404(a). This statement makes business associates directly subject to nearly all of the HIPAA privacy regulations. Prior to the change, as with the security regulations, these obligations existed for business associates only as a matter of contract.

In response to these law changes, and in the absence of regulatory guidance, covered entities have been demanding modifications to existing business associate agreements or requesting new agreements. In both cases, covered entities are seeking greater assurances from their business associates concerning the handling of the covered entities’ protected health information.

On top of that, covered entities are weaving into business associate agreements and other agreements requirements under newly enacted state laws requiring protections for “personal information” in the hands of vendors (e.g., business associates) to curb identity theft. Given the cost and reputational harm that could come from a data breach, as well a growing enforcement activity, many covered entities are becoming more forceful in their negotiations, citing legal mandates and established company policies for their unwillingness to budge on many provisions, even those that go beyond statutory mandates.

What is a business associate to do? Here are some thoughts:

  1. Confirm your company is a business associate. (go to HHS HIPAA frequently asked questions and insert "business associate" for helpful guidance). In some cases, covered entities are blanketing all of their vendors with these agreements. If believe your company is not a business associate, raise it with your client. Of course, even if you avoid being considered a business associate, your customer/client still may demand written assurances under state law for the personal information you handle on its behalf.
  2. Become compliant. As noted above, the HIPAA privacy and security requirements are now directly applicable to business associates. While additional guidance is expected as to what this means precisely, there is enough existing guidance concerning covered entities for business associates to use to achieve compliance. Among other things, compliance means conducting a risk assessment, adopting a written set of policies and procedures concerning the safeguarding of protected health information, and training staff. Being compliant not only reduces risk, but in an environment of increasing attention to data privacy and security, compliance can be a competitive advantage.
  3. Review agreements carefully. Covered entities increasingly include contract provisions that provide the covered entity with greater protections than the law requires. To the extent possible, try to remove those provisions. In any event, it is important to know your obligations under these agreements; they can vary dramatically from covered entity to covered entity.
  4. Develop strategies for reviewing/complying with multiple contracts. Some business associates have many clients and, therefore, business associate agreements. Managing unique provisions multiple agreements can be daunting, although the ability to negotiate a uniform agreement across a client basis is increasingly unlikely. So, where possible, try to use similar provisions in all agreements and know ahead of time your approach to certain key provisions, such as handling data breaches.
  5. Understand the law. Even if you’ve mastered the determination of whether you are a business associate, the rules outlining your business’ obligations likely will be evolving under HIPAA over the next few years, particularly with the expected growth of electronic health records and the expansion of health care. The same is true of state laws concerning personal information. In many cases these laws might coexist peacefully, in other cases there will be conflict. You need to be aware of the conflicts and be prepared to act accordingly.

 

Keystroke logging (or “keylogging”) is the noting (or logging) of the keys struck on a computer keyboard. Typically, this is done secretly, so  the keyboard user is unaware his activities are being monitored.

Several cases throughout the country have examined an employer’s use of keylogging.  Recently, the Criminal Court of the City of New York held in New York v. Klapper  that an employer who installed keylogging software on office computers and subsequently monitored an employee’s e-mail activity did not, absent some showing of contrary e-mail protections or acceptable use policies, access a computer “without authorization” in violation of New York law. 

In some of the strongest language against the premise of e-mail privacy to date, the Court stated in its April 28, 2010 opinion:

[t]he concept of internet privacy is a fallacy upon which no one should rely. It is today’s reality that a reasonable expectation of internet privacy is lost, upon your affirmative keystroke. 

The Court found that e-mails are more akin to a postcard than a letter, as they are less secure and can easily be viewed by a passerby. An employee who sends an e-mail from a work computer sends a communication that will travel through the employer’s central computer and will be commonly stored on the employer’s server even after it is received and read. Once stored on the server, the employer can easily scan or read all stored e-mails or data. The same holds true once the e-mail reaches its destination, as it travels through the Internet via an Internet service provider. Accordingly, this process diminishes an individual’s expectation of privacy in e-mail communications.

In contrast to the strong language from New York, the U.S. District Court for the Northern District of California ruled in Brahmana v. Lembo that a plaintiff could proceed to trial in his case alleging his employer committed an impermissible “interception” under the Electronic Communications Privacy Act (ECPA) by using keylogging to discover the password to his personal e-mail account, and using the logged password, accessed his personal e-mail.  However, another California District Court found in United States v. Ropp that because the keylogger recorded the keystroke information in transit between the keyboard and the CPU, the system transmitting the information did not affect interstate commerce as the required by the ECPA.  Further complicating the issue, a federal court in Ohio questioned Ropp, suggesting in Porter v. Havlicek that it read the statute too narrowly by requiring the communication to be traveling in interstate commerce as opposed to merely “affecting interstate commerce.”

Because of the numerous issues arising from the use of electronic communications, and the varying court opinions on these questions, employers would do well to reexamine their use of keystroke monitoring or logging technology on a regular basis.