Security breaches are now remarkably commonplace in healthcare; more than 55 were reported to the Department of Health and Human Services (HHS) in the first six months of 2010.  In fact, healthcare is the second most breached industry, according to the Identity Theft Resource Center.  And security breaches, whether digital- or paper-based, can happen at any given moment—physical theft of a laptop from an employee’s car, deliberate abuse of system access, misdirected faxes and emails, malware attacks, unintentional human error, unauthorized access, a lost backup drive.  Additionally, the future of healthcare dictates the use of electronic medical records, raising fresh concerns of protecting patient privacy, PHI threats and medical identity theft.

Dr. Larry Ponemon, chairman and founder of the Ponemon Institute, a leading researcher and voice in addressing data breach risks and issues, noted about RADAR that:

“Organizations may need guidance, especially when dealing with PHI breaches, so they cover their bases to protect individuals and follow all of the rules and laws. ID Experts’s RADAR new tool offers consistency and efficiency for evaluating and reporting a security breach, and provides the analysis and documentation required of a mandated risk assessment.”

Following any security breach, RADAR will guide the privacy or security officer to analyze the incident and exposed data to quantify the incident, determine whether the exposed information includes PHI, whether any exceptions apply, and the likelihood that the information could be misused.  The results will help companies determine the potential risk of harm to the individuals affected by each data breach incident and take appropriate steps to mitigate the potential harm to those affected, while fulfilling all of the HITECH requirements enforced by the HHS, including determining if notification is required.

RADAR is current in beta test with several leading US healthcare providers and will be generally available in August, 2010. RADAR is available as software-as-a-service on a subscription basis with pricing starting at $1,500 per user per year.

The handling of data breach incidents has become a way of life for healthcare providers and with other HIPAA covered entities. With the passage of the HITECH Act last year, there are now substantial penalties that can be levied, up to $1.5 million. This fact, combined with a requirement to notify the Department of Health and Human Services as well as the media for data breach incidents that affect over 500 individuals has, for the first time, resulted in public records being kept for such incidents.

If you oversee privacy, compliance, or IT for a hospital system, a group practice, a health insurance company, other covered entities, or even one of their business associates, the HITECH Act and its privacy and data breach provisions require your close attention. While many people know that HITECH generally creates requirements for data breach notification, there are at least four things you may not know about HITECH that you really should:

1. The requirement for a mandatory incident-specific risk assessment for every incident
2. The fact that HITECH notification provisions do not pre-empt state notification laws
3. Encryption of data does not necessarily alleviate the risk of data breach
4. If your business associate exposes your protected health information (PHI), you are responsible

1. Mandatory incident-specific risk assessment. When HHS issued its Interim Final Rule giving healthcare organizations guidance for complying with the HITECH Act data breach provisions, it added a new requirement.  The requirement is that the organization carry out an incident-specific risk assessment to determine the potential risk of harm to the individuals affected by each and every data breach incident.  The rules establish a “harm threshold” for notification, but unfortunately, don’t make the determination of risk and the potential of harm. It is essential to become well versed in these rules and be prepared to carry out a HITECH compliant data breach incident risk assessment.

2. HITECH doesn’t pre-empt state notification laws. While HITECH is the first national law for notification in the case of privacy information breaches, most U.S. states also have breach notification laws.  And while the intent of these laws is similar — to make individuals aware that their PHI may have been improperly disclosed — the specific details in all of these laws can actually vary a great deal.  But because HITECH is not “preemptive,” a healthcare organization that has experienced a data breach must ensure that it complies with both HITECH regulations as well as the regulations in every state where individuals are affected.  This can be daunting especially because HITECH and state laws in some cases are conflicting.

3.  Encryption not a silver bullet. There is a lot of advocacy for encryption of PHI as a means to avoid data breach incidents.  The general argument is that if data is encrypted, that data breaches will not occur.  Unfortunately, this is overly simplistic. While encryption will assist healthcare organizations in avoiding certain types of data breach incidents, it is not a panacea.  For instance, a common threat approach is for a criminal or organized crime entity to enlist an “insider” to assist in extracting PHI.  An insider with valid access credentials will not find encryption to be an obstacle in any way.  As a result, consider encryption one of many tools for information protection, not a silver bullet.

4.  You are responsible for your business associate. For the first time, HIPAA business associates are required to meet the HIPAA Privacy and Security Rule requirements based on HITECH.  While this is a good thing, a covered entity should not consider this a “free pass” if one of your business associates exposed PHI that was provided by your organization.  While you may be able to hold them financial accountable, if you’ve specified for such eventualities in your business associate agreements, the obligation for notification is still with the covered entity.  It is your responsibility to maintain the privacy for the PHI, no matter to whom you entrust it. And of course, the affected patients will hold you responsible as well.

As you put processes and procedures in place to meet HITECH obligations, consider also putting in place a comprehensive and current data breach incident response plan.  This will prevent a lot of headaches and last-minute scrambling, should you be faced with a data breach.

Titled “Three things you may not know about the HITECH Act…but should“, the article hones in on aspects of the rulemaking from the US Department of Health and Human Services that healthcare organizations must follow in determining whether a privacy breach incident meets the requirements to notification.

HITECH is known primarily for the manner in which it motivates healthcare providers to implement electronic health records (EHR) systems. But as more and more of our medical information is going online, the Act also wisely enhanced the privacy and security provisions that are required of healthcare providers and added penalties and enforcement mechanisms for the breach of private healthcare information.

One of the three things you may not know, per this article, is that when your organization experiences a potential privacy incident, that you are required to carry out a “risk assessment” in order to determine the nature of the protected health information (PHI) that was disclosed, and whether it poses a risk of harm to the affected patients.Based on the results of this risk assessment, your organization may or may not be obligated to notify the affected individuals, along with HHS and the media. So this assessment process is very important.

Unfortunately, the risk assessment process is not at as well defined or straightforward as might be hoped. And this gets to one of the 2nd items that you may not know about in HITECH. In carrying out a risk assessment, the goal is to determine whether there is a risk of financial, reputational or other harm to the patients affected. And in this process, not all PHI is created equally, and in fact, you must consider the nature of the information disclosed in a manner that is situationally aware.

For instance, disclosure of a persons name and their medical procedure may not be cause for any risk of harm if the procedure was having a bunion removed. However, if the procedure was for the diagnosis of AIDS, disclosure of this information could result in substantial harm. As a result, it is not just the data types that need to be considered, but the nature of the data and the environment of their release. Not at all straightforward.

And then the 3rd thing that you may not know about HITECH from this article is that its data breach notification provisions don’t “preempt” those of each of the states. In fact, if your organization experiences a data breach, you need to assess the requirement to notify and how to notify not just using not just the requirements of HITECH, but also the requirements as stated in state data breach notification laws.

For example, you may find that based on your risk assessment, that HITECH requires notification. But you may also find that in some states, the timeframe for notification is shorter than the 60 days from discovery of incident that is required by HITECH. In other words, you must look at your breach notification requirements both under HITECH as well as under each state law where you have patients that were affected by the incident.

Needless to say, this is a complex process and you would be well advised to document your processes and decisions very carefully. You really don’t want to be the target of one of those $1.5MM fines that are beginning to surface.

As noted by InformationWeek Healthcare:

“While advancements in security technology better protects patient data, and regulations like HIPAA aim to set rules for information security and privacy, some breaches boil down to humans making mistakes. ‘Everything in our environment is encrypted,’ said William Fandrich, senior VP and CIO at Blue Cross Blue Shield of Massachusetts. However, despite solid attempts at security protection and other precautions, healthcare organizations need to emphasize–and continue to remind–employees about simple things they need to do to prevent patient privacy breaches.”

We continue to find that organizations turn primarily to technology to solve the data breach “problem”. This is exemplified by the perspective that once all data is encrypted, that data breach risks will be eliminated. It is great to see the thoughtfulness of healthcare CIOs at this conference where there is a prominent recognition that human error (and of course, human fraud) is a weak link for data breach risks despite the best of technologies applied.

One of the keys to meeting the notification requirement is completing and documenting a data breach incident “risk assessment” for each and every incident that is detected. The “rules” for carrying out this mandated assessment are specified by the department of Health and Human Services (HHS) in their rulemaking. This webinar will assist information security, compliance and privacy officers and professionals at hospitals, health insurers, and other covered entities in understanding what they need to do and how to go about doing it, when faced with a potential data breach incident.

A description of the webinar follows.

The HITECH Act requires HIPAA-covered entities to carry out a careful risk assessment, including an evaluation of potential harm, for every potential data breach incident. This risk assessment will assist organizations in deciding whether they are obligated to then notify affected individuals, the Department of Health and Human Services (HHS) and the media about data breach incidents.

Kirk Nahra, CIPP, a partner at the premier healthcare law firm Wiley Rein LLP, and Rick Kam, president and founder of ID Experts, will review and discuss the HHS rules for completing these mandated data breach incident risk assessments in order to ensure compliance and utilize evolving best practices.

Learn about considerations for HIPAA-covered entities in carrying out mandated HITECH data security breach incident risk assessments. To enroll to attend the webinar, click here.

The passage of the Health Information Technology for Economic and Clinical Health (HITECH) Act earmarks over $19 billion in funds as incentives for healthcare providers to adopt EHR technologies. As these funds flow, the amount of medical data will grow exponentially into the petabytes over the next four years.

As recent article titled “As health data goes digital, security risks grow” published in Computerworld and Business Week highlights a significant issue with this trend, the fact that the security of your medical records is far from assured. It concludes that:

“Over the next four years, the amount of personal medical information online will increase exponentially, opening up new avenues for hackers to expose personal data that, unlike financial information, can result in a permanent violation of privacy.”

With the focus of healthcare providers being on securing HITECH stimulus funds for the implementation of EHR systems, there is the risk that the security systems and architecture for these systems, especially in areas of interchange with other entities, may increase risks of exposure of protected health information (PHI) of patients.

Dr. Taher Elgamal, the individual that led the development of  secure sockets layer (SSL network encryption) as the chief scientist at Netscape, and is now the chief security officer at Axway, highlights that the current solution path for this issue, encryption of the PHI data, isn’t a silver bullet for assuring patient privacy.

“The fact that you did encryption doesn’t mean you’ve protected medical information, because access control is the real issue,” Elgamal said. “New cybercriminals do not do what the old cybercriminals did. They realize you’ll be encrypting the data and instead access the application and steal access rights.”

The implications of this on healthcare providers is significant. The financial and patient benefit motivation associates with implementing EHR systems must be balanced by the security and privacy requirements that now have public and financial implications as well for non-compliance.  It isn’t clear to me that most covered entities are appropriately balancing both sides of this equation.

These include:

- Customer/patient/client churn rate, the tendency for a data breach event to cause them to “vote with their feet” and choose another provider, remains the key cost driver for data breach incidents. Such lost customer costs are typically 2/3rds the cost of a data breach. Industries that exhibit the highest churn rates are healthcare, pharmaceuticals and communications (all 6%).

- Almost half (44%) of organizations outsourced the data breach response effort to an expert third party consultant. When outsourced in this way, the costs per victim declined a huge 26% vs. companies that “go it alone”. The ability to reduce costs by outsourcing the response process is counterintuitive to some, but validates the value of an outside consultant that is knowledgeable and can execute using best practices

-  “Companies that notify too quickly may incur higher costs”. This was surprising to me. The study found that these “quick responders”, organizations that notified within one month of detection of the breach, ended up paying 12% more than their peers. The assumption was that moving too quickly through the process causes inefficiencies that can be avoided.

As always, the study and report is full of valuable and interesting data and perspective for privacy, information security,  legal and financial officers. It is a “must read” for anyone in a relevant role at an organization that is entrusted with PII and PHI, especially the CISOs who are most frequently the organizational members responsible for the handling of data breach incidents.

“Sadly, this lawsuit is historic — involving an unparalleled health care privacy breach and an unprecedented state enforcement of HIPAA,” Blumenthal said. “Protected private medical records and financial information on almost a half million Health Net enrollees in Connecticut were exposed for at least six months — most likely by thieves — before Health Net notified appropriate authorities and consumers. These missing medical records included some of the most personal, intimate patient information — exposing individuals to grave embarrassment and emotional distress, as well as financial harm and identity theft. The staggering scope of the data loss, and deliberate delay in disclosure, are legally actionable and ethically unacceptable. Even more alarming than the breach, Health Net downplayed and dismissed the danger to patients and consumers. Failing to protect patient privacy blatantly violates federal law and Health Net’s public trust. We are seeking a preliminary order to protect patients and consumers, and will fight for civil penalties.”

It is likely this while this is a first, that it is the beginning of a new era for healthcare organizations and the expectation that they will take the privacy obligations of their patients seriously.  While unfortunate, this situation illustrates that some healthcare organizations require stronger motivation to both protect patient information as well as to follow good sense and legal requirements to promptly notify individuals if there has been a breach of their information that may put them at risk.

“In 2009, PrivacyRights.org reports that there were 46 breaches of PHI representing nearly 80M records.  Note that 76M of those records were from the VA that inadvertently sent one of its RAID drives out for repair without cleansing it of those 76M records of veterans.  If you can’t trust the government to keep your PHI safe, who can you trust?”

Now I must admit, I would never have suggested that it is reasonable to assume that the government is good at maintaining privacy of personal information that they collect on American citizens. But it is reasonable to assume that as more protected health information (PHI) is collected, stored, shared and manipulated in computer systems at healthcare providers and payors, that the risk of exposure, and the subsequent number of data breach incidents, will rise.

So it really does make for an interesting thought, do I trust my doctor and hospital with my health data? Do I trust my health insurer with my health data? How about my pharmacy? Like it or not, I don’t have much choice but to provide them with or allow them to access my PHI.

But I do have a choice as to whether I should entrust Microsoft or Google with this sensitive information. Both companies have built systems “in the cloud” that allow consumers to centralize their personal health history. Microsoft HealthVault is designed to let us “collect, store, and share health information critical to our family’s well-being” and Google Health allows us to “organize our health information all in one place, gather our medical records from doctors, hospitals, and pharmacies, and share our information securely with a family member, doctors or caregiver.”

Microsoft has made HealthVault quite “open”,enabling organizations such as providers, payors, pharmacies and others to create applications for individuals to import information that they hold on us into our HealthVault account. I setup a HealthVault account, to see how this worked. Unfortunately, neither my national pharmacy chain nor my health insurer were on the list of those who make such information “exportable” to HealthVault.

Assuming that my trusted providers, insurer and pharmacy do provide such export capabilities in the future, it still leaves me with a nagging concern: do I really trust Microsoft to hold my entire medical life history? While I’d love to have all of this information in one place, and to be able to make it available to healthcare providers that I may wantto see in the future, the thought of entrusting this to anyone is daunting, not the least of which a company who’s software is a constant target for viruses, worms and malware of all kinds.

So for now, I probably won’t start trusting my medical history to either Microsoft or Google.  My health data will be remain somewhat safe with doctors, an insurer and a pharmacy, and numerous business associates of their that I don’t even know by name, that I hope I can trust. But given the number and scope of data breaches the last year or so in healthcare, I’m not really feeling very confident about my healthcare data privacy at this moment.

The HHS Rules require healthcare organizations (specifically HIPAA covered entities) to report to HHS any data breach incidents that have affected over 500 individuals, shortly after the breach is discovered.  I noticed that the Identity Theft Resource Center (ITRC) 2009 ITRC Breach Report, a terrific compendium of public information from numerous sources on data breach incidents, had captured numerous healthcare data breaches since the September 23rd effective date. And of course there have been several very high profile healthcare data breaches recently including the Blue Cross Blue Shield Assocation breach that affected over 850,000 of their medical providers, as well as the recent Health Net data breach affecting over 1.5MM individuals.

So with great anticipation I visited the HHS website where there is a section on the Breach Notification Rule and clicked on the following link: