Guest Post from Pat Yu* of Accero. We are happy to make Mr. Yu’s insights available to our readers as they are important considerations for companies considering alternative data and systems management strategies. Enjoy this post: 

To host or not to host . . . That’s ultimately the critical question when it comes to major internal system deployments, such as human capital management (HCM) solutions. To help you move toward a smart, strategic decision, here is a high-level overview of each model:

Licensed

Still widely used by most companies, licensed software delivery often provides user’s more control. You purchase a license, install the software and use your internal resources to manage and configure or customize the solution. When companies purchase licenses for a major software solution, they are ultimately responsible for all aspects of application management, including: installing upgrades, troubleshooting issues and hardware maintenance.

Hosted
 

Hosting is most often provided today in the form of Software as a Service, or SaaS. In this model, the vendor hosts the solution and users access it via the web. One of the key benefits of selecting a hosted model, besides the scalability and convenience of 24×7 web access, is the fact that the software provider is responsible for:

  • Managing both the software and hardware components of the application
  • Network issues such as redundancy, data backup and disaster recovery planning
  • Managing the data center or centers that deliver the application
  • Upgrading the software automatically for customers on a regular schedule

A checklist for decision makers

Hosting in and of itself is simply a delivery model. A software application must meet your business requirements; how it is delivered (licensed vs. SaaS) may be part of your requirement, but it should not be the primary factor. Follow the checklist below to help your organization determine which solution best fits your needs:

  • Clearly define your business requirements
  • Inventory solution providers (licensed and hosted)
  • Evaluate systems to ensure they meet your high priority requirements
  • Consider growth strategies and make sure the solution will scale to match
  • Prepare a minimum four-year cost analysis to evaluate cost of ownership (this should include the cost to host the solution in house if you are considering a traditional license – and the IT resources needed to manage it)
  • Review implementation timeframe (SaaS is often faster to deploy)
  • Consider other costs – IT resources, hardware, software, time, etc.

*Pat Yu is the Director of Product Development at Accero, a Payroll, Human Resources and Human Capital Management software and service provider. Visit www.accero.com or call 800.429.2674.
 

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.

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.

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.
 

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.

Effective May 1, 2010, Alberta amended its Personal Information Protection Act (PIPA) to require breach reporting and notification requirements. U.S. businesses with a presence in Alberta should take note of the new law as it is a bit different than most of the state data breach notification laws in the United States. 

PIPA governs the collection, use and disclosure of personal information by businesses. Under the amendment to PIPA that adds the mandatory breach notification requirement, organizations that experience a breach will be required to report the incident to the Privacy Commissioner where there exists “a real risk of significant harm” to an individual. The Commissioner can, in turn, require the organization to notify the affected individuals.

Alberta’s Privacy Commissioner Frank Work commented on the new law:

Now an organization has to report significant losses to my Office. I can then require notification of affected individuals. Our experience has been that most businesses already notify people affected by losses and we encourage this. This is not necessarily a matter of making businesses liable for losses of information; it is about warning people so that they can take precautions. Hopefully it will make businesses more aware of the need for reasonable security measures.”

Of course, the challenge for multi-national companies will be to consider and coordinate the laws in various jurisdictions.

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.

The Supreme Court today issued its decision in City of Ontario, California v. Quon.  In a unanimous decision, the Court held that the search of Quon’s text messages, sent or received on his department issued pager, was reasonable and did not violate Quon’s Fourth Amendment rights. 

As set forth in the opinion, the Court did not resolve the parties disagreement over Quon’s privacy expectations, and instead disposed the case on the narrower grounds of the reasonableness of the search.  While the Court chose not to utilize the facts of this case to establish far-reaching premises that define the existence, and extent, of privacy expectations of employees using employer-provided communication devices, the Court did note that 

Employer policies concerning communications will of course shape the reasonable expectations of their employees, especially to the extent that such policies are clearly communicated.

Click here for a more in depth analysis of the decision. See our previous posts on Quon, here and here

All information from plaintiffs’ social networking profiles and postings that relate to their general emotions, feelings, and mental states must be produced in discovery when they allege severe emotional trauma and harassment against their employer, a federal court in Indiana has ruled. (EEOC v. Simply Storage Management LLC, S.D. Ind., No. 1:09-cv-1223, discovery order 5/11/10).

Social networking sites (SNS) such as Facebook and MySpace are fast becoming a hot topic in litigation as they may contain a wealth of potentially relevant information. In Simply Storage, the Equal Employment Opportunity Commission brought suit on behalf of plaintiffs and other similarly situated employees who claimed their employers were liable for a supervisor’s alleged sexual harassment. The EEOC requested a discovery conference because counsel for the parties disagreed as to whether the two named plaintiffs must produce the Internet social networking site profiles, including postings, pictures, blogs, messages, personal information, lists of “friends,” and of causes joined that the user has placed or created online.

The EEOC objected to production of all SNS content (and to similar deposition questioning). It argued the requests were overbroad, not relevant, unduly burdensome (because they improperly infringe on claimants’ privacy), and would harass and embarrass the claimants. Simply Storage countered that discovery of these matters was proper because certain EEOC discovery responses placed the emotional health of particular claimants at issue, beyond that typically encountered in “garden variety emotional distress claims.”

The court weighed ordering complete discovery of the plaintiffs’ Facebook and MySpace account information against limiting discovery to content specifically related to the alleged injury.  It found neither alternative satisfactory. According to the court, limiting discovery to posts that specifically referenced the mental issues and harassment alleged by the plaintiffs would be too narrow, while admitting the full profiles would include likely irrelevant—and potentially inflammatory—content. The court held, “It is reasonable to expect severe emotional or mental injury to manifest itself in some SNS content, and an examination of that content might reveal whether onset occurred, when, and the degree of distress. Further, information that evidences other stressors that could have produced the alleged emotional distress is also relevant.”

The court therefore defined the relevant scope of discovery as including “any profiles, postings, or messages (including status updates, wall comments, causes joined, groups joined, activity streams, blog entries) … that reveal, refer, or relate to any emotion, feeling, or mental state, as well as communications that reveal, refer, or relate to events that could reasonably be expected to produce a significant emotion, feeling, or mental state.”

The court rejected the EEOC’s assertion that broad discovery of this kind would violate the plaintiffs’ right to privacy and held that, while potentially relevant content may be embarrassing to the plaintiffs, “this is the inevitable result of alleging these sorts of injuries.” In addressing the argument that the profiles were “private” and password protected, the court held that these protections were insufficient to circumvent discovery. “[A] person’s expectation and intent that her communications be maintained as private is not a legitimate basis for shielding those communications from discovery.”

This case illustrates the importance of expanding the traditional thinking behind discoverable information to cover social media. Employers, upon advice of counsel, should consider requesting information of this nature. 

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:

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