Workplace Privacy, Data Management & Security Report : Privacy Lawyers & Attorneys : Jackson Lewis Law Firm : Data Security, HIPAA & Confidentiality Issues

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.  

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U.S. Department of Health and Human Services Secretary Kathleen Sebelius has announced final rules for eligible health care professionals and hospitals to qualify for a portion of the $27 billion or so in Medicare and Medicaid incentive payments for implementation and meaningful use of certified electronic health records (EHR). Many are concerned these incentives will increase the risks for data privacy and security that will come with more health data being maintained, used and disclosed in electronic format. Under the rules, eligible professionals may receive as much as $44,000 under Medicare and $63,750 under Medicaid, and hospitals may receive millions of dollars under both Medicare and Medicaid.
 

"We will make the immediate investments necessary to ensure that within five years, all of America's medical records are computerized."

President Barack H. Obama, January 8, 2009 

HHS’s July 13 action is consistent with the agenda of President Obama and some of his predecessors to help improve Americans’ health, increase safety and reduce health care costs through expanding use of EHRs and simplifying the administrative costs of healthcare. The enactment of the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009 significantly advanced this agenda by establishing the statutory structure for eligible health care professionals and hospitals to receive government subsidies to adopt certified EHR technology. The HITECH Act, however, also expanded and tightened the HIPAA privacy and security regulations to address, in part, concerns about improper access and use of EHRs.

HHS’s regulations (consisting of more than 1,000 pages) define the minimum requirements and “meaningful use” objectives to qualify for the bonus payments (pdf) and identify the technical capabilities required for certified EHR technology (pdf). At the same time, providers and hospitals will need to focus on the evolving privacy and security mandates under HITECH, as well as under state law, to minimize the risks to protected health information and other personal information. So, as providers and hospitals look to Medicare and Medicaid funds to jumpstart their move to EHR systems, it will be important for them to be sure to have in place the appropriate policies, procedures and agreements to safeguard those records, which should include the careful handling and/or disposition of the mountains of paper records they currently maintain.

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Further to our discussions of the proposed regulations to implement statutory amendments under the Health Information Technology for Economic and Clinical Health Act (the “HITECH Act”), we summarize here a proposed changed to the definition of “business associate.” A significant part of the “HIPAA community” (covered entities, business associates and their agents and subcontractors) already is aware of the expanded application of HIPAA to business associates under HITECH. This expansion went into effect February 18, 2010, and, in fact, many business associate agreements currently are being modified in an attempt to reflect the statutory provisions. The HIPAA community, however, may not yet be aware of the proposal to further expand the direct application of the privacy and security rules under HIPAA to subcontractors performing functions for business associates.

A New Class of Business Associate

Prior to the HITECH Act changes, business associates and their agents and subcontractors were not directly subject to HIPAA. Instead, HIPAA required covered entities to obtain certain written assurances from their business associates. One of those written assurances was that business associates would ensure that their agents and subcontractors would agree to be subject to the same conditions and restrictions contained in the business associate agreement entered into with the covered entity.

The proposed regulations would include subcontractors in the group of “business associates” to the extent that they require access to protected health information. Such subcontractors are those persons who are not members of the business associate’s workforce, but perform functions for or provide services to a business associate. This would be the case even if the business associate has failed to enter into a business associate contract with the subcontractor. The regulator’s goal is to ensure the privacy and security protections will not lapse merely because a function is performed by an entity with no direct relationship with a covered entity, although the regulations seek public comments on the definition of subcontractor.

The proposed regulations state (emphasis added):

[W]e propose that downstream entities that work at the direction of or on behalf of a business associate and handle protected health information would also be required to comply with the applicable Privacy and Security Rule provisions in the same manner as the primary business associate, and likewise would incur liability for acts of noncompliance. We note, and further explain below, that this proposed modification would not require the covered entity to have a contract with the subcontractor; rather, the obligation would remain on each business associate to obtain satisfactory assurances in the form of a written contract or other arrangement that a subcontractor will appropriately safeguard protected health information. For example, under this proposal, if a business associate, such as a third party administrator, hires a company to handle document and media shredding to
securely dispose of paper and electronic protected health information, then the shredding company would be directly required to comply with the applicable requirements of the HIPAA Security Rule (e.g., with respect to proper disposal of electronic media) and the Privacy Rule (e.g., with respect to limiting its uses and disclosures of the protected health information in accordance with its contract with the business associate).

As the example above shows, if made final, the proposed regulation would further HIPAA’s reach and affect many businesses that may not currently view themselves as directly subject to the requirements or penalties under HIPAA. Many companies, including those that service the healthcare industry, such as health plans, likely will need to revisit their HIPAA-compliance measures.

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We recently reported here that the Department of Health and Human Services (HHS) is issuing proposed regulations to implement statutory amendments under the Health Information Technology for Economic and Clinical Health Act (the “HITECH Act”). These proposed regulations contain a number of important points to think about for HIPAA covered entities (and business associates), even though these rules are in proposed form. One is avoiding HIPAA violations involving “willful neglect," which under the HITECH Act will require a formal investigation and civil penalties.

To date, the Secretary of HHS has attempted to resolve complaints and certain violations by informal means, as required by § 160.312 of the current regulations. A significant change to the HIPAA enforcement scheme in the HITECH Act requires that if a preliminary investigation of the facts of a complaint indicates a possible violation due to willful neglect, the Secretary is required to commence a formal investigation. If the formal investigation finds a HIPAA violation involving willful neglect, the Secretary must impose a civil money penalty.

What is “willful neglect”?

Willful neglect is defined at § 160.401 as the “conscious, intentional failure or reckless indifference to the obligation to comply with the administrative simplification provision violated.” The term not only presumes actual or constructive knowledge on the part of the covered entity that a violation is virtually certain to occur, but also encompasses a conscious intent or degree of recklessness with regard to the entity’s compliance obligations.

So what does that mean, what are some examples? The proposed regulations provide the following examples:

1. A covered entity disposed of several hard drives containing electronic protected health information in an unsecured dumpster, in violation of § 164.530(c) and § 164.310(d)(2)(i). HHS’s investigation reveals that the covered entity had failed to implement any policies and procedures to reasonably and appropriately safeguard protected health information during the disposal process.
2. A covered entity failed to respond to an individual’s request that it restrict its uses and disclosures of protected health information about the individual. HHS’s investigation reveals that the covered entity does not have any policies and procedures in place for consideration of the restriction requests it receives and refuses to accept any requests for restrictions from individual patients who inquire.
3. A covered entity’s employee lost an unencrypted laptop that contained unsecured protected health information. HHS’s investigation reveals the covered entity feared its reputation would be harmed if information about the incident became public and, therefore, decided not to provide notification as required by § 164.400 et seq.

In addition to having actual or constructive knowledge of one or more violations, the covered entities in the examples above, particularly Example 1, failed to develop or implement compliant policies and procedures and, thus, demonstrated either conscious intent or reckless disregard with respect to the compliance obligations under HIPAA.

Based on the proposed regulations, covered entities can no longer expect the velvet hand of the regulators to resolve a violation informally in all cases. Covered entities that fail to have policies and procedure and make a good faith compliance effort likely will find themselves subject to mandatory formal investigations and penalties.

Covered entities like the one in example 1 above might want to consider certain precautions, including:

• maintaining a record retention policy,
• maintaining media re-use policy,
• maintaining a data destruction policy,
• maintaining an e-discovery policy, and
• and engaging a good data destruction/shredding company.
 

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The Department of Health and Human Services announced this morning that it will be issuing a notice of proposed rulemaking to begin implementing the recent statutory amendments under the Health Information Technology for Economic and Clinical Health Act (“the HITECH Act”). According to HHS, the proposed regulations (pdf), set to be published July 14, 2010, are designed to strengthen the privacy and security protection of health information, and to improve the workability and effectiveness of the existing HIPAA privacy and security rules. 

More specifically, the proposed rules would modify the Standards for Privacy of Individually Identifiable Health Information (Privacy Rule), the Security Standards for the Protection of Electronic Protected Health Information (Security Rule), and the rules pertaining to Compliance and Investigations, Imposition of Civil Money Penalties, and Procedures for Hearings (Enforcement Rule) issued under HIPAA.

We will be reviewing these regulations and reporting on them further as appropriate.

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As companies struggle with the risks and exposures related to data breaches, insurance can be an important part of an overall risk management strategy – so long as it is the right insurance.

Insurance carriers are offering products that purport to address this type of risk. Such insurance can be particularly important to businesses for which the handling of personal information or protected health information, such as some HIPAA “business associates,” is their lifeblood. However, as an ongoing litigation in a Utah federal district court makes clear, it is critical for businesses to be cautious and thorough when assessing insurance coverage, if only to avoid litigation about the scope of the coverage.

Court filings show that Perpetual Storage, a data storage company, had purchased certain insurance coverage through Colorado Casualty Insurance. One of Perpetual’s clients, University of Utah Hospitals and Clinics, stores significant amounts of its data with Perpetual, including personal information and protected health information. The University experienced a data breach on June 1, 2008, when storage disks were stolen from the car of a Perpetual employee who had picked up the disks from the University. The University claims the breach affected 1.7 million people. Claims expenses totaling approximately $3,354,753 were incurred in the course of responding to the breach. The specific costs alleged are $2,483,057 for credit monitoring expenses, $646,149 in printing and mailing costs, $81,389 in phone bank costs, and $144,158 in additional miscellaneous costs.

Naturally, the University is looking to Perpetual to reimburse it for these costs. In turn, Perpetual is looking to its insurance carrier, Colorado Casualty, to back it up. The insurer, however, has denied coverage. Colorado Casualty seems to be asserting that the claims do not constitute certain “bodily damages” or “property damages” as those terms are defined in the applicable policy. The insurer also claims that a number of policy exclusions support its decision to deny coverage.
At the same time, the University is seeking in its lawsuit to bring its insurance broker and adviser into the litigation, alleging they were "careless, negligent, and made various negligent misrepresentations about Perpetual's insurance coverage from Colorado Casualty."

A ruling in favor of Colorado Casualty likely would make it more difficult to seek reimbursement under commercial liability policies in connection with data breaches. Such a ruling also should be a wake-up call to businesses relying on their current commercial liability policies to deal with data breach issues.

The moral of the story for businesses - review your coverage with your insurance brokers or other insurance advisers to ensure appropriate coverage.

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On June 10, 2010, the California Department of Public Health (CDPH) announced  issuing administrative penalties and fines totaling $675,000 against five hospitals in the state. CDPH cites the facilities’ failure to prevent unauthorized access to confidential patient medical information as required under new legislation (Section 1280.15 of California’s Health and Safety Code) (pdf) as the basis for the penalties and fines.

Relevant portions of Section 1280.15 of California’s Health and Safety Code provide:

A clinic, health facility, home health agency, or hospice . . . shall prevent unlawful or unauthorized access to, and use or disclosure of, patients' medical information . . . The department, after investigation, may assess an administrative penalty for a violation of this section of up to twenty-five thousand dollars ($25,000) per patient whose medical information was unlawfully or without authorization accessed, used, or disclosed, and up to seventeen thousand five hundred dollars ($17,500) per subsequent occurrence of unlawful or unauthorized access, use, or disclosure of that patients' medical information. For purposes of the investigation, the department shall consider the clinic's, health facility's, agency's, or hospice's history of compliance with this section and other related state and federal statutes and regulations, the extent to which the facility detected violations and took preventative action to immediately correct and prevent past violations from recurring, and factors outside its control that restricted the facility's ability to comply with this section. The department shall have full discretion to consider all factors when determining the amount of an administrative penalty pursuant to this section.

CDPH Director Dr. Mark Horton commented, “medical privacy is a fundamental right and a critical component of quality medical care in California.” His position and the actions taken by the agency highlight the need for health care providers to do more to safeguard patient records. In most of these cases, according to the CDPH announcement, multiple hospital employees accessed confidential patient medical information without authority to do so.

However, California hospitals should not be the only entities concerned about exposure relating to unauthorized access to confidential personal information, nor is California’s Health and Safety Code the only statutory obligation to safeguard such information. Mandates to protect personal information are growing and apply to industries beyond healthcare and persons other than patients. In short, businesses in all states and industries should be reviewing, at a minimum:

1. how they safeguard personal information, whether it be that of customers, patients, employees, or their dependents,
2. who they permit to access personal information, and
3. what their plan is in the event of unauthorized access or acquisition.

We’ve written about a number of these areas of concern:

• Pending Federal Legislation
• State Attorneys General enforcing (i) HIPAA, (ii) Deceptive and Unfair Trade Practices Laws, (iii) record destruction laws.
• Risks if You Are a Business Associate
• Criminal Penalties Under HIPAA
• State Laws Mandating Protections for Personal Information, not just medical information.
• HHS Enforcing HIPAA Following Data Breach
• Developing a Plan

Like most things, "an ounce of prevention is worth a pound of cure."

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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.

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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.

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Health care providers beware – curiosity about patients can put you in jail.

According to NBC News, Huping Zhou, a licensed cardiothoracic surgeon in China, who worked at the UCLA School of Medicine as a researcher, will serve four months in prison for snooping into medical records back in 2003. This follows Mr. Zhou’s guilty pleas earlier this year to criminal charges under the Health Insurance Portability and Accountability Act (HIPAA).

In many cases, the snooping incidents involved celebrities. According to the NBC story, investigators claim Zhou “accessed UCLA patient records at least 323 times during one three-week period in 2003.”

This case together with recent amendments to HIPAA highlight the need for HIPAA covered entities to be more thorough and recurrent in their training of employees and other workforce members, as well as in their monitoring of access to confidential information. While safeguards and policies cannot prevent all breaches, they can go a long way toward reducing these kinds of incidents and the reputational harm that follows. 

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We are honored that the National Association of Professional Employer Organizations (NAPEO), the largest national trade association for professional employer organizations (PEOs), recently published our article in its May 2010 edition of its PEO Insider publication, an important resource for any PEO.  

PEOs no doubt provide valuable services for businesses across the country. However, in doing so, they generally have access to and maintain vast amounts of personal information. Our article, "Key Data Privacy and Security Issues for PEOs," summarizes emerging data privacy and security laws and their effects on PEOs.

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In another example of a medical provider facing potential civil liability for providing medical records in response to a subpoena, a federal court in the Northern District of Ohio denied summary judgment for the Cleveland Clinic and other defendants in Turk v. Oiler, No. 09-CV-381 (N. D. Ohio Feb 1, 2010.  We previously discussed the decision in Kim v. St. Elizabeth's Hosp. in which a court allowed similar claims to proceed under an Illinois law protecting mental health records. In Turk, the claims were based in part on the Ohio physician-patient privilege codified at Ohio Rev. Code Section 2317.02.

Plaintiff James Turk was a private investigator accused of possessing a weapon while under a disability in violation of Ohio law.  The Cleveland Clinic received a grand jury subpoena from the Cuyahoga County Court of Common Pleas seeking Turk's medical records. The clinic complied with the subpoena and produced the records. Turk and his wife later brought suit against the clinic claiming damages for invasion of privacy, negligent disclosure of medical records, and violation of the First Amendment.

The clinic moved for summary judgment, arguing that it was required to respond to a grand jury subpoena and that Section 2317.02 was preempted by the Health Insurance Portability and Accountability Act ("HIPAA").  The federal district court denied the motion and allowed the claims to proceed, reasoning that Ohio law was not preempted by HIPAA where it provided greater protections than the federal law.  The case stands for the proposition that compliance with HIPAA by itself is not enough and reinforces yet again the caution which health care providers must exercise when responding to subpoenas or other requests for medical records without a proper release.

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On February 22, 2010, the Office of Civil Rights (OCR) posted on its website its first list of covered entities that have reported breaches of unsecured protected health information affecting more than 500 individuals. OCR acknowledged the HITECH Act requires HHS to make this information public by posting it on an HHS website.

The breach notification rule became effective on September 23, 2009. In short, as we reported previously, the rule requires covered entities to provide notification of breaches of unsecured protected health information directly to the Secretary of HHS, as well as to the affected individuals. Breaches that affect 500 or more individuals must be reported to HHS within 60 days, and covered entities must provide this notification via the online form on the OCR website.

Of course, covered entities need to be aware that breaches reported to HHS will be made public on its site. Some states, such as Maryland and New Hampshire, have had a similar policy in effect for some time for breaches of personal information affecting residents of their states.

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As reported by the December 23 Rochester, Minnesota Post Bulletin, the Mayo Clinic has terminated two medical professionals, a physician and another staff member, after determining that they had inappropriately accessed a patient’s confidential electronic health records (EHRs).

The access highlights what should be a growing concern for health care industry employers: the increased availability EHRs provide about patients’ private information that is otherwise protected by HIPAA. As reported in the Bulletin, according to the President of the Minnesota-based Citizens’ Council on Health Care, “the development of the electronic medical record has allowed all sorts of people to have access” that they would not have had before the advent of EHRs.

As previously reported here, the risks of data breaches and misuses of personal information rise significantly when the information is in electronic format. The trend toward putting more information in electronic format will only continue given the significant cost savings through technological advancements and, for health information, federal subsidies for the adoption of EHRs. Despite protections mandated by law, the portability and availability of EHRs nevertheless facilitate the improper viewing or misuse patients’ protected health information.

The Mayo Clinic terminations come on the heels of a string of employee terminations in 2008 by the UCLA Medical Center, which, through investigations dating back to 2004, found that at least 127 employees had improperly accessed the medical records of celebrities. One employee was even indicted in 2009 after she was found to have purposefully removed the social security numbers of celebrity patients and recorded actor Farah Fawcett’s medical records. Farah Fawcett subsequently sued her.

While most medical providers are well-aware of HIPAA’s requirements, the interest in all things celebrity may be too much for some to resist. We expect that the American Recovery and Reinvestment Act of 2009 (ARRA) [pdf] may only increase the risk of privacy breaches for it provides incentives to health care-related businesses to develop even more extensive uses of electronic health records. However, even famous celebrities have privacy rights under HIPAA, and health care employers should revisit their policies, procedures and training in the area of maintaining patient privacy and more closely monitor the use of electronic medical records.

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Like individuals, businesses have resolutions/goals for 2010, perhaps even this new decade. As information risk, such as HIPAA or the occurrence of a data breach, continues threaten companies and put individuals’ personal identities, finances and medical information in jeopardy, addressing this issue in the coming years is a worthy resolution for any business. With this January 28, 2010, being the second National Data Privacy Day, January is as good a time as any to begin thinking about your organization’s information risk. The following list, which is by no means exhaustive, provides ten critical areas businesses will need to consider when addressing this issue.

1. Risk Assessment. Many businesses remain unaware of how much personal and confidential information they maintain, who has access to it, how it is used and disclosed, how it is safeguarded, and so on. Getting a handle on a business' critical information assets must be the first step, and is perhaps the most important step to tackling information risk. You simply can’t adequately safeguard something you are not aware exists.
2. Develop a Written Information Security Program. Even if adopting a written information security program (WISP) to protect personal information is not an express statutory or regulatory mandate in your state, having one is critical to addressing information risk. Not only will a WISP better position a company when defending claims related to a data breach, but it will help the company manage and safeguard critical information, and may even help the company avoid whistleblower claims from employees. For companies, a WISP can be a competitive advantage. Of course, in states like Massachusetts, Maryland, Oregon, Connecticut and others, a WISP in one form or another is required.
3. Vendors/Business Partners. Businesses addressing their information risk cannot stop at their information systems, buildings, and employees. Very often, vendors of the business maintain significant amounts of sensitive company and personal information of that business. This list of vendors can be long and include service providers such as: employee benefits consultants/administrators/brokers, accountants, lawyers, record storage/destructions companies, office cleaning services, professional employer organizations, payroll companies, cloud computing or other information service providers, and so on. Businesses that turn over sensitive information to a vendor need to take steps to ensure the vendor has implemented appropriate safeguards to protect the information. If this information is personal information, a number of states mandate contract provisions requiring the vendor to safeguard the information.
4. HIPAA. The recent changes by the HITECH Act, under the American Recovery and Reinvestment Act of 2009, will drive increased focus on HIPAA in 2010, particularly for business associates which for the first time become directly subject to many of the same privacy and security requirements as covered entities. The addition of a HIPAA breach notification requirement, effective September 23, 2009, and the growth of electronic health records, already are driving covered entities to amend their business associate agreements. Plan sponsors, health care providers and business associates all need to refocus their attention on HIPAA in 2010.
5. Insurance. Like many other risks, information risk can be addressed in part through insurance. More carriers are developing products dealing with personal information risk, and specifically data breach response. This kind of coverage should be a part of any CIO, privacy officer or risk manager’s plan for safeguarding information.
6. Identify “Red Flags”. Identifying “red flags” is the next step after implementing a WISP, beyond safeguarding sensitive information. The concept of “red flags” is to have policies and procedures designed to detect, prevent, and mitigate instances of identity theft – that is, with safeguards already in place, businesses need to be able to identify circumstances (“red flags”) which indicate incidents of identity theft could be occurring, and then take steps to prevent the identity theft or mitigate its effects. After a number of extensions, on June 1, 2010, the Federal Trade Commission will begin enforcing its “red flag” regulations that apply to financial institutions and creditors.
7. Training. A necessary component of any WISP and a required element under most federal and state laws mandating data security, training deserves special mention if only to remind businesses to remind employees how powerful the small devices are that they carry around.
8. Develop a Plan for Responding to a Breach Notification. All state and federal data breach notification requirements currently in effect require notice be provided as soon as possible. Delays in notification viewed as unreasonable could trigger an inquiry by the state’s Attorney General, or in the case of HIPAA protected health information, the Office of Civil Rights.
9. Carefully Integrate New Technologies. As businesses look for new technologies to increase productivity, cut costs, and gain a competitive advantage, how those technologies address information risk must be a factor in the decision whether to adopt the technology. For example, cloud computing is fast becoming a popular tool used by businesses to enhance their computing capabilities, at substantially reduced costs in some cases, but it raises a number of issues concerning information risk.
10. Watch for New Legislation. Today, managing data and ensuring its privacy, security and integrity is critical for businesses and individuals, and is increasingly becoming the subject of broad, complex regulation. It seems to be only a matter of time before U.S. companies are subject to a national law requiring the protection of personal information. Companies therefore need to stay tuned in order to continue to remain compliant and competitive in this regard.

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New Hampshire’s new breach notification law builds on the breach notification requirements under the HITECH Act by requiring health care providers and business associates to notify individuals of disclosures of their protected health information that are prohibited by New Hampshire law, even if such disclosures are permitted under HIPAA or other federal law. This new health information protection was enacted with other measures relating to privacy of electronic medical records and allowing individuals to opt out of sharing their names, addresses, and protected health care information with e-health data exchanges.

H.B. 619 becomes effective for data breaches occurring on and after January 1, 2010. Individuals may sue for violations of the notification requirement and, significantly, seek damages of not less than $1,000 per violation. The law also expressly requires business associates to cover the costs of notification if the use or disclosure triggering notification was made by the business associate.

Now, when New Hampshire health care providers and business associates experience a possible data breach, they will have to consider a number of laws to determine the appropriate response. These include H.B. 619, the state’s general breach notification statute, and the breach notification rules under the HITECH Act and implementing regulations. This is even more complex for health care providers and business associates operating in multiple states as at least five other states (Arkansas, California, Delaware, Missouri, Texas) and Puerto Rico require notification in the event some form of medical information is breached.
 

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Continuing our thoughts on how disclosures of private or confidential information may adversely impact the institution and the persons affected by such disclosure, we now focus on something near and dear to lawyers’ hearts: paper shredding.

Many businesses regularly shred documents they no longer need to protect them from disclosure. While this may secure the information contained in those documents, an additional concern exists for HIPAA-covered entities, such as hospitals, medical providers or their business associates. Often, those documents might consist of old medical records, charts, notes, or other information containing protected health information (“PHI”) specifically protected from disclosure under HIPAA.  

Shredding frequently is done by outsourced vendors.  They shred what is provided to them and then resell it as fill, packaging material or for other recyclable-type uses. But shredding alone may not be sufficient to secure data under HIPAA. This can cause a HIPAA headache, as suggested by recent occurrences overseas.  A gift-wrapping company owner in England discovered protected health data (including names of patients) from a local hospital on the shredding she used for work. In another situation being investigated by British authorities, an outsourced medical transcription company in India disclosed shredded health data. Although those situations occurred abroad, they could just as easily happen in the U.S., or occur outside the U.S. but affect information involving U.S. citizens.

If a data breach is discovered by the unauthorized disclosure of PHI through shredding or otherwise, under the American Recovery and Reinvestment Act of 2009 (“ARRA”), covered-entities and business associates must notify those affected by the disclosure of unsecured PHI within 60 days after a breach. If the breach involves disclosure of PHI for over 500 persons, a covered-entity and/or a business associate must also notify Department of Health and Human Services and the media. “Unsecured” under ARRA means any data not rendered unusable, unreasonable or indecipherable. Thus, an individual’s name legible on a snippet of shredded paper together with some health information may be enough to trigger ARRA’s disclosure requirements and constitute a HIPAA violation. For more information about data breaches under HIPAA, click here.

We therefore remind HIPAA-covered entities to ensure that their vendors are compliant with the HIPAA security requirements, that they have appropriate business associate agreements where necessary, and that they actively monitor compliance with those agreements.

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Co-Author:  V. John Ella, Esq.

In a key step toward developing a proposed U.S. health information technology (HIT) infrastructure, the Centers for Medicare & Medicaid Services has announced that Iowa’s Medicaid program is the first to receive federal matching funds for planning activities necessary to implement the electronic health record (EHR) incentive program established by the American Recovery and Reinvestment Act of 2009 (ARRA). 

ARRA was signed into law by President Obama on February 17, 2009. Among its various parts, ARRA includes provisions for the improvement of our nation’s health care through health information technology (also known as Health IT or HIT), Medicare and Medicaid Health IT provisions which provide incentives and support for the adoption of certified electronic health records (EHRs); and provisions to expand, enforce, and enhance the privacy and security safeguards required by HIPAA. The proposed goal of a switch to EHRs is to improve the quality of health care for individuals, make care more efficient by making it easier for providers treating a patient to coordinate care, and make it easier for individual patients to access the information they need to make decisions about their own health care. Responsibility for implementing this program falls to the National Coordinator for Health Information Technology, a position currently filled by Dr. David Blumenthal at the Department of Health and Human Services (“HHS”). In furtherance of this goal, Mr. Blumenthal recently announced $80 million in grants to develop a HIT workforce. Additionally, the HHS has created a helpful website on the topic of health information technology with links to resources on privacy issues.

In discussing the approximately $1.16 million in federal matching funds Iowa will receive, Cindy Mann, director of the Center for Medicaid and State Operations at CMS said, “While Iowa is the first state to receive approval of its plan for implementing the Recovery Act’s EHR incentive program, a number of other states have submitted plans as well, meaningful and interoperable use of EHRs in Medicaid will increase health care efficiency, reduce medical errors and improve quality-outcomes and patient satisfaction within and across the states.”   As the first state to receive federal funding, Iowa will use the funds to focus on planning, information gathering, analysis, and assessment with respect HIT and the use of EHR within the state.  

A HIT Infrastructure is likely to raise a range of new issues involving the handling of sensitive personal information. For instance, anytime extensive personal and medical information is placed in electronic form, the chance of a data breach or information misuse rises significantly. This is especially true given the recent growth in the area of medical identity theft. Additionally, as some commentators have reported, physicians, hospitals, and clinics have all expressed concerns regarding the technical feasibility of the system, potential for patient mix-ups, as well as the extensive cost to make the switch to EHR. How such a system would affect employers and group health plan administration remains unclear.  

With such an emphasis on a switch to EHR, and billions of federal dollars fueling the conversion, all businesses, particularly health care providers, need to be consider how they will be affected by the new HIT infrastructure. 

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“Cloud computing” takes many forms, but, fundamentally, it is a computer network system that allows consumers, businesses, and other entities to store data off-site and manage it with third-party-owned software accessed through the Internet. Files and software are stored centrally on a network to which end users can connect to access their files using computers that are less powerful and sophisticated than those we use today.  This technology reduces the need for expensive multiple servers and PCs with enough capacity to store massive data and application files. Some believe the PC of the future will need simply the capacity to connect to a web browser for the user to access his or her applications and files.

For more information on how cloud computing works, click here. For information on the FTC investigation of cloud computing, click here.

If you are not already computing in a cloud, you likely will be hearing more about “cloud computing” soon. Last month, for example, the City Council for the City of Los Angeles voted to move city employee e-mail and other applications from city computer networks to a cloud service provider – in this case, Google Inc. City officials cite significant cost savings (which they estimate to be in the millions) as one of the reasons for the switch. They acknowledged that concerns over data privacy, security and management remain.

We’ll agree that significant cost savings can be achieved through, among other things, reduced infrastructure. Questions and concerns many have with cloud computing, however, relate to the privacy, security and management of the information in the cloud. These include:

• What if the cloud starts to rain – a cloud computing data breach – who is responsible for notifying affected persons (and bearing the costs)?
• Which company owns the data placed in the cloud?
• If the data in the cloud is employee e-mail, is the employer still permitted to access and monitor email communications? Will new policies/notices be needed?
• Will company proprietary information be safe?
• Who has access to the data? Who should have access?
• Is the cloud service provider a business associate under HIPAA, prepared to comply with the HITECH Act? What other legal compliance requirements are there?
• Do we still need to maintain a back-up of data in the cloud?
• Where is the data stored? Is it in the United States, or in a foreign country subject to different data security standards? Does one location as opposed to another provide better access or security? What if data is stored in multiple places, will we be able to locate what we need when we need it?
• How big is the cloud? How much can we store?
• What if the cloud goes down? How do we get our data and access the applications needed to run our business?
• How do we move between clouds? Can our data be held captive when contract negotiations fall through?
• Can we put our clients’ data in the cloud? Do we have to tell them where it is?
• What happens to the data if the cloud service provider or the cloud customer goes out of business?
• Will applications in the cloud work the same way, be as flexible, and respond with the same speed as those on current PCs?

Organizations such as the Cloud Security Alliance have been formed to grapple with some of these issues. Indeed, the City of Los Angeles has had to respond to some of these concerns. So, while cloud computing may yield substantial cost savings and appear tempting, these and other questions and concerns should be addressed before moving in that direction.

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The Department of Health and Human Services (HHS) published interim final regulations on October 30, 2009, to update existing enforcement regulations under HIPAA for statutory revisions made by the Health Information Technology for Economic and Clinical Health (HITECH) Act. These regulations become effective November 30, 2009, and only address the provisions of the HITECH Act already in effect.

The interim final regulations, among other things, implement the increases in civil penalties and the four categories of violations and corresponding penalties established by the HITECH Act. Also, under the Act and the regulations, penalties will apply even where the covered entity did not know (and with the exercise of reasonable diligence would not have known) of the violation. However, HHS has the authority to reduce penalties in certain circumstances.

There have been a number of recent changes that enhance and strengthen HIPAA's enforcement provisions - the HITECH Act, the interim final regulations discussed above and agency reorganization. These measures suggest an increasing likelihood of enforcement concerning the HIPAA privacy and security regulations.  As a result, health care providers and health plans should be reviewing their compliance with HIPAA and preparing for additional guidance expected to be issued shortly.

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A British TV station investigation into India's medical transcription industry, known as Business Process Outsourcing (BPO), uncovered unsettling news for British subjects, as well as American citizens. Medical records sent to India to be transcribed and computerized are being sold. The Economic Times report on the investigation out of New Delhi suspects a "hardening of stance on the outsourcing industry by the western world." The article states:

The revelation has forced police of the two countries to join hands to launch an official investigation into the data pilferage of the records stored by the Indian BPOs. If found true, the allegations could hit the flourishing BPO sector in India hard, fueling doubts about their integrity and efficiency.

Security breaches of this kind can have far reaching effects beyond the businesses and individuals directly impacted. The hopes for funding U.S. healthcare reform rest, in part, on administrative cost savings. Under the HITECH Act, enacted as part of the 2009 federal stimulus bill, the U.S. will spend 36 billion to spur the health care industry to purchase and create systems and equipment, including electronic health records systems, to better network the healthcare industry. Reluctance to outsource and increased security are likely to chip away at whatever cost savings can be achieved through enhanced technology in healthcare. 

In the short run, businesses must be more vigilant in vetting their vendors, as well as the vendors of their vendors. These efforts should include stronger agreements, deeper examinations of security protocols, knowing where information is ultimately stored and processed, and having a better understanding of the applicable legal and industry standards concerning data security. These efforts can not stop at the water's edge.

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Little more than one month after the HIPAA breach notification regulations became effective (September 23, 2009), covered entities (health care providers, health plans) and their business associates are struggling with the effects of these new rules. Many are asking:

• What is a breach?
• Do we have to notify in all cases, what are the exceptions?
• Who do we notify?
• Do we have to notify the government?
• Do we have to modify our business associate agreements?
• Do we have to create, update our policies and procedures?

Indeed, it is important to learn about these issues before a breach happens. However, if a reportable breaches happens, covered entities will need to know how and when to notify the Department of Health and Human Services (HHS). For breaches involving 500 or more individuals, the covered entity must notify HHS at the same time as the affected individuals. For breaches involving fewer than 500 individuals, the covered entity must maintain a log of the breaches during the calendar year and report them to the Secretary within 60 days following the end of that year.

HHS established a website for reporting breaches, with separate links for immediate and annual notifications. Note that in addition to gathering information specific to the breach, both forms ask about the safeguards in place prior to the breach and steps taken following the breach. Also, the instructions require covered entities to complete a separate on-line form for each breach.

Remember: Breaches triggering a notification requirement under HIPAA also may require notice under state law, including notice to certain state agencies and officials.

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