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

California led the way in 2002 when it enacted the nation’s first data breach notification law. Last week, the State’s lawmakers sent Governor Arnold Schwarzenegger S.B. 1166 (pdf), which would mandate that data breach notification communications include more detailed information about the breach and that businesses experiencing data breaches affecting more than 500 Californians notify the State’s Attorney General.

Since California enacted its data breach notification law, lawmakers have been trying to make changes to it, with mixed results. Assembly Bill 1298 ("A.B. 1298"), which became effective January 1, 2008, expanded the application of the existing law to include medical and health information. However, to date, attempts to add content requirements to the notice and require notification to the State’s Attorney General have failed, despite similar requirements in the laws of a number of other states, such as Massachusetts, New York, North Carolina.

S.B. 1166 marks the third attempt by Senator Joe Simitian to amend the law in this manner. Both prior attempts were vetoed by the Governor Schwarzenegger. In addition to requiring notice to the State’s Attorney General for certain breaches, his current effort would require notices stating:

• a general description of the breach incident;
• the type of information breached;
• the date and time of the breach;
• whether the notification was delayed because of a law enforcement investigation; and
• a toll-free number of major credit reporting agencies if the breach exposed Social Security numbers, driver's license numbers, or state identification card numbers.

Because many states have similar content requirements and there are a number of websites that report on data breaches, passage of S.B. 1166 should not impose a significant burden in breaches involving individuals in multiple states. Nonetheless, companies should be alert to developments in California and be prepared to update their California data breach notification policies should the measure pass.
 

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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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With Mississippi enacting its own data breach notification law on April 7, Alabama, Kentucky, New Mexico, and South Dakota remain the only states without such a law. Mississippi Gov. Haley Barbour signed H.B. 583 making his state the 46th to enact a breach notification law. The law becomes effective July 1, 2011.

Like many breach notification statutes:

• the notification obligation falls on any business in the state which owns or licenses personal information,
• personal information generally includes name plus either Social Security number, drivers license number, or financial account number,
• encrypted personal information is not subject to the breach notification requirement, and
• the notification obligation applies only when there is a risk of harm to affected state resident in connection with a breach of security.

The law will be enforced by Mississippi’s Attorney General, however, the law prohibits individuals from commencing a privacy lawsuit under the new law.

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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 we have discussed before, data breach notification is one of the most rapidly emerging areas of law. Good security incident procedures as well as effective training can help avoid the risk of data breach. (Sample data breach training). 

A case in point: Connecticut's Attorney General has filed a civil action against Health Net of the Northeast Inc. (“Health Net”) for failing to secure approximately 446,000 individuals’ patient information on a missing portable computer disk drive, and for failing to provide prompt notice of the breach. Among other things, the suit alleges Health Net violated the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as amended by the Health Information Technology for Economic and Clinical Health (HITECH) Act, when it failed to provide prompt notice, failed to encrypt the data, failed to provide for and implement appropriate policies to safeguard the information, and failed to supervise and train its workforce on safeguarding protected health information and personal information. 

As this suit demonstrates, state Attorneys General will use the authority granted by HITECH to enforce the privacy and security protections of HIPAA for protected health information, as many breaches involving such information may not be covered by state data breach laws. Such enforcement will only add to the cost of a data breach, which, according to the 2009 Ponemon Institute Annual Cost of a Data Breach study, continues to rise.

While a company’s first line of defense always should be a comprehensive data security policy, preparation should include an effective security incident procedure. Several key questions, some of which will form the foundation for any good security incident procedure, must be answered immediately following a breach: 

• How did the breach occur?
• Are measures in place to contain the breach?
• What information was compromised? 
• Whose information was compromised?
• Will the local authorities be alerted?
• What potential breach notice laws are implicated?
• Does notice of the breach have to be provided?
• If so, to whom and how will notice be provided?
• Does the company have applicable insurance to cover the notification process?
• Will any monitoring service be provided for affected individuals?
• Are measures in place for public relations implications?

However, a security incident procedure is only as strong as the awareness you create among your employees as to what constitutes a data breach and who to notify in the event of a possible breach. Therefore, in addition to an effective security incident procedure, it is essential that training, like the sample above, be provided to employees on a regular basis.   

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Less than one month into 2010 the trend to address data security, destruction, and encryption has continued among state lawmakers. Specifically, Florida, Michigan, Kentucky, Kansas, Pennsylvania, and New York all have introduced, reintroduced, or amended legislation of this kind. 

• The Florida and Michigan laws would amend personal data destruction rules for companies.
• The New York law would mandate data security and encryption measures.
• The Kentucky bill would require government agencies to protect all personal data under the Gramm-Leach-Bliley Act.
• The Michigan bill includes a state version of the Federal Trade Commission's Red Flags Rule and would require creditors in the state to implement programs aimed at spotting “red flags” of possible identity theft and put in place mitigation measures. Michigan is also considering a number of other measures. 
• The Kansas law would require state agencies to engage in periodic network security reviews.
• The Pennsylvania bill would require public agencies to notify state residents of a breach of their personal information within seven days of the discovery of the breach.

While 5 states remain without data breach notice bills (Alabama, Kentucky, Mississippi, New Mexico, and South Dakota), Congress is considering legislation, the Data Accountability and Trust Act (DATA) (H.R. 2221), that would preempt all state notification laws and instead establish a national breach notice standard.

As we have previously mentioned, we anticipate data privacy and security legislation and case law to be at the forefront of legal issues in 2010. Employers should begin by reading the Data Security Primer and consider implementing comprehensive data security policies and procedures that would allow them to comply with the various state laws that may impact their business. 

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As passed by the House of Representatives on December 8, 2009, the Data Accountability and Trust Act would create federal data security standards, a national breach notification requirement, data destruction mandates, and special requirements for "information brokers." 

The Act will now move to the Senate, where it likely will be considered together with recent bills from various Senate Committees, two such bills we discussed in a recent post.

The Act would apply to each person engaged in interstate commerce that owns or possesses data in electronic form containing personal information (or contracts to have any third party entity maintain such data). In short, most businesses in the United States would be subject to the Act and required to establish and implement data security policies and procedures. Like other data security regulations, the Act would permit covered persons, when developing their policies and procedures, to take into account:

• the size of, and the nature, scope, and complexity of the activities engaged in by, such person;
• the current state of the art in administrative, technical, and physical safeguards for protecting such information; and
• the cost of implementing such safeguards.

These new standards will be regulated by the Federal Trade Commission (FTC). Violations of the Act would be enforced primarily by state Attorneys General, although the FTC maintains a right to intervene in those actions. Penalties can be substantial. For example, in the case of a violation of the breach notification requirement, the penalty amount would be calculated by multiplying the number of violations by an amount not greater than $11,000. Each failure to send notification would be treated as a separate violation, with a maximum civil penalty of $5,000,000.

Of course, it will be some time before the Act would become effective, if at all, and it may be substantially modified prior to enactment. Still, recent actions by Congress (for example the enhancements to HIPAA under the American Recovery and Reinvestment Act of 2009) and the states suggest a national standard for protecting personal information is only a matter of time. Companies should be gearing up to deal with these emerging information risks.

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Co-Author:  Joseph J. Lazzarotti, Esq.

Health Net Inc., one of the nation’s largest publicly traded managed health care companies, recently notified authorities and informed affected persons, with a statement on its website, that the unencrypted personal information of 1.5 million current and former members, stored on a portable disk drive, is missing from the company's Connecticut office. The company is now working to send written notices to affected individuals in four states—Arizona, New York, New Jersey and Connecticut.

Coordinating a data breach response, responding to the questions and complaints of affected persons, and negotiating with vendors to provide monitoring services are time-consuming, tedious tasks that require a strong sense of an organization’s public image, good judgment and excellent communication skills. Having the right person to drive this effort internally is critical. 

Additionally, companies that experience data breaches increasingly are becoming subject to federal and state agency inquiries. In this case, at least two states have announced investigations. Connecticut Attorney General Richard Blumenthal said his office will investigate the loss of the portable disk drive that he believed held the unencrypted health, personal, and financial information of some 450,000 Connecticut residents. Blumenthal also vowed to probe a six-month lag in notifying affected individuals of the breach. In a letter dated November 19, 2009, Arizona Attorney General Terry Goddard’s office requested information about the breach from Health Net, also noting the time between the breach and when affected persons were notified. It is critical that an organization’s Privacy Officer be prepared to respond to these inquiries, with the assistance of internal or external counsel when appropriate.

A breach of personal information, particularly one of this size, reminds us of the need for companies to take steps to implement policies and practices that safeguard sensitive personal and company confidential information. The first step is to appoint a person to spearhead a data breach response– typically the Chief Privacy or Information Officer. Among the duties and responsibilities of a Privacy Officer is being the company’s first line of defense when responding to a data breach, including directing the investigation of the breach, coordinating the notification process, addressing the concerns of affected persons and responding to government agency inquiries. For a sample Privacy Officer job description, click here.  

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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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Based on recent events, the University of East Anglia likely will agree that data privacy and security requires a comprehensive approach, as data breaches are not limited to incidents involving personal information and identity theft. In fact, the effects of a breach to an organization's information systems involving confidential company information can be far worse on the organization as a whole than if the breach involved personal information.

Take, for example, a report by The New York Times reporter Lauren Morello concerning a breach involving thousands of emails and documents of the Climatic Research Unit (CRU) at University of East Anglia. Apparently, hackers obtained and posted on the Internet emails and documents calling into question some of the positions about climate change and global warming held by the CRU. Whatever the truth or perception of the information contained in the posted emails and documents, the CRU surely is in an uncomfortable position of having to defend its statements and address their context. 

Last month we reported a data breach involving personal information of a different kind - ethics investigations of members of the United States Congress. Again, while not the kind of personal information that would lead to identity theft, or require notification be sent to the affected individuals, it is the kind of information that could have significant adverse consequences for the institution and the persons affected.

For this reason, organizations need to address "information risk" on an organization-wide basis, making sure that their written information security programs take into account how information of any kind, maintained in any medium by the organization, can, if misused, caused the organization harm. While remedies may be available through the criminal justice system or civil litigation under such laws as the Computer Fraud and Abuse Act, avoiding the breach in the first place obviously is preferred.

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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 Baltimore Sun reports that Baltimore police are investigating a security breach at Mercy Medical Center that left certain patient records open to possible identity theft. According to the article, affected former patients were sent a letter informing them that their personal patient records may have been accessed by a former employee in order to apply for credit cards and loans. A Maryland state law that became effective in 2008 would require Mercy Medical Center to notify these individuals promptly in the event of such a breach. 

This case is yet another example of personal information being accessed for improper purposes by hospital staff and demonstrates the need for hospitals to establish strict privacy controls and notification procedures.

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Today, Connecticut Attorney General Richard Blumenthal announced his office will investigate a data breach that occurred in late August that affected approximately 18,817 Connecticut health care professionals. The American Medical Association reported earlier that this breach involved the personal information, including Social Security numbers, of an estimated 850,000 physicians nationwide. What is most troubling about this breach is that it probably was avoidable.

Like many data breaches, this one involved a stolen laptop, in this case from the employee’s car. However, as NewsTimes.com reported, despite the employer’s encryption policy, the employee downloaded the file to a laptop, without the required encryption, in order to work from home.

Even the best firewalls and other technology-based information system protections cannot save us from ourselves. It was possible here that not only did the employee violate the company’s encryption policy, but he or she also may have exercised poor judgment in leaving the laptop in a car. The ease with which employees acquire, handle and transport massive amounts of sensitive personal information make it critical that businesses ensure their employees have greater awareness of the sensitivity of this information and receive regular training about how to be more cautious handling it. This should be a part of any written information security plan. 

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Joining the growing number of states which have enacted laws regulating the destruction of records to prevent possible identity theft, the Rhode Island Legislature passed H. 5092 on October 29, 2009. The bill requires businesses and government agencies to completely destroy records containing personal information, or render the personal information unusable, before disposing of records whether in electronic and paper form. Not surprisingly, H. 5092 comes on the heels of Texas’s Attorney General settling related violations for nearly $1,000,000 with Select Medical, and over $600,000 with Radio Shack.

As with most legislation of this nature, including the FTC’s data disposal rule, the law provides two means by which covered entities may destroy records: either by modifying the personal data to make it entirely unreadable or indecipherable through any means, or by taking reasonable steps to shred, erase, or otherwise destroy records. The bill also exempts certain covered entities whose destruction practices are covered by federal law or who contract with data disposal firms (who would be subject to the data disposal law). The need for such measures is further underlined by the overzealous office workers who used documents containing personal information as “confetti” during the New York Yankees World Series parade. 

Underlying the consequential nature of proper destruction, this bill permits individuals to sue to recover actual damages, and permits the state attorney general to seek fines or sue on behalf of individuals, with each record not properly disposed of being counted as a separate violation.

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Yesterday, the U.S. Senate Judiciary Committee again approved two pieces of legislation that would require certain entities to safeguard personal information and notify individuals of breaches of that information. Over the last few years, similar legislation made it out of various Committees, but failed to go any further. Could this time be different?

The Committee voted in favor of the Personal Data Privacy and Security Act of 2009 (S.1490) and the Data Breach Notification Act (S.139), sponsored by Senators Patrick Leahy and Dianne Feinstein, respectively.  In its current form, S. 1490 would require that covered entities, among other things, perform risk assessments, limit access to sensitive information, train their work force, and require vendors by contract to implement appropriate safeguards. The Data Breach Notification Act would establish a national standard for federal agencies and businesses engaged in interstate commerce to report data breaches.

There are a number of circumstances that suggest this legislation is more likely to move forward than in years past:

• The Judiciary Committee approved both measures by significant majorities.
• The number of data breaches and complaints about them continue to mount.
• Congress recently had its own data breach (reported here), affecting personal information not likely to lead to identity theft, but which could hurt some members' reelection efforts.
• The change in administration which arguably is more focused on privacy concerns given the push for electronic health records.

Stay tuned. . . 

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In good and not-so-good economic times, the on-boarding process – recruiting, application, hiring and orientation – is critical for employers to attract and welcome new talent. In recent years, technology has enabled employers to perform all or a part of this process on-line, significantly increasing efficiency and reducing costs. Moving to a web-based on-boarding system, however, raises many workplace challenges and considerations, including the privacy, security and management of personal data collected in the process.

Following are some of the key challenges and considerations employers should think about when moving to electronic on-boarding:

• Can the on-line process be the exclusive method for applying and on-boarding? Consider, for example, applicants who cannot access or view the site because of a disability.
• Are there laws limiting the personal information that may be collected from applicants? See, for example, Utah Employment Selection Procedures Act discussed in our article and the Utah law. 
• How must personal information collected during the process be safeguarded, retained, preserved, and ultimately destroyed? A recent class action was filed alleging failure to safeguard on-line job application information. 
• Is the process subject to collective bargaining?
• Are there special rules for government contractors? See Office of Federal Contract Compliance Programs (OFCCP) guidance. 
• Are on-line consents for fitness-for-duty examinations, background checks, and drug testing valid? Can non-compete agreements be executed electronically?
• Are there any specific issues/disclosures for public sector employees/applicants?
• Can the I-9 verification/e-verify process be completed on-line?
• Do the rules change for applicants from other countries?
• If an applicant is hired, how does collected information about the person transfer accurately and securely for benefit plan enrollment, payroll, personnel, and other purposes?
• Has the on-boarding vendor been vetted and shown capable of safeguarding personal data and preserving the integrity of that data? Where is data stored by the vendor? Are appropriate contract provisions in place?
• Can benefit plan enrollment forms be completed on-line?
• Can handbooks and benefit plan documents be provided on-line as part of the on-boarding process? See ERISA electronic disclosure regulations.

Employers implementing an electronic on-boarding process will certainly realize significant savings of time and money. However, those savings can be short-lived if the on-line process is not designed to address the risks inherent in the new medium.
 

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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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The Washington Post is reporting another inadvertent disclosure of sensitive information involving "peer-to-peer" or "P2P" technology. This time, the disclosure exposed a House Ethics Committee document outlining ongoing ethics investigations for an uncomfortably large number of House members. The same technology raises serious issues for employers.

According to the Washington Post, the now-terminated, junior committee staff member saved a copy of the document summarizing the ethics investigations to her personal computer where her peer-to-peer file-sharing software allowed it to be shared.

Besides the difficult political questions that are sure to follow, this incident makes clear that strong data security requires more than a strong firewall and encryption. Administrative policies, training and vigilance are essential, particularly where working remotely and from home is the norm.

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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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