See Modern Healthcare article at "Hackers breach Anthem; 80M exposed"
See Modern Healthcare article at "Hackers breach Anthem; 80M exposed"
HHS has announced a long-awaited omnibus final rule that implements a number of provisions of the HITECH Act, enacted as part of the American Recovery and Reinvestment Act of 2009, commonly known as the "Stimulus Bill," to strengthen the privacy and security protections for health information established under the Health Insurance Portability and Accountability Act of 1996 (HIPAA).
Via HHS Press Release:
The final rule also reduces burden by streamlining individuals’ ability to authorize the use of their health information for research purposes. The rule makes it easier for parents and others to give permission to share proof of a child’s immunization with a school and gives covered entities and business associates up to one year after the 180-day compliance date to modify contracts to comply with the rule.
The final omnibus rule is based on statutory changes under the HITECH Act, enacted as part of the American Recovery and Reinvestment Act of 2009, and the Genetic Information Nondiscrimination Act of 2008 (GINA) which clarifies that genetic information is protected under the HIPAA Privacy Rule and prohibits most health plans from using or disclosing genetic information for underwriting purposes.
In a sign that HHS is serious about small data breaches, the Office of Civil Rights (OCR) and The Hospice of North Idaho reached a settlement agreement to resolve allegations of a 2010 breach involving 441 patient records. OCR Director Leon Rodriguez reminded the industry that every covered entity, regardless of size, must implement the privacy and security safeguards - including, e.g., encryption of protected health information on mobile devices - required under HIPAA, as amended pursuant to the HITECH Act.
This settlement comes at the same time as the OCR rolls out its new educational initiative aimed at securing protected data on mobile devices. You can learn more about this initiative here.
Via HHS Press Release:
The Hospice of North Idaho (HONI) has agreed to pay the U.S. Department of Health and Human Services’ (HHS) $50,000 to settle potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule. This is the first settlement involving a breach of unprotected electronic protected health information (ePHI) affecting fewer than 500 individuals.
The HHS Office for Civil Rights (OCR) began its investigation after HONI reported to HHS that an unencrypted laptop computer containing the electronic protected health information (ePHI) of 441 patients had been stolen in June 2010. Laptops containing ePHI are regularly used by the organization as part of their field work. Over the course of the investigation, OCR discovered that HONI had not conducted a risk analysis to safeguard ePHI. Further, HONI did not have in place policies or procedures to address mobile device security as required by the HIPAA Security Rule. Since the June 2010 theft, HONI has taken extensive additional steps to improve their HIPAA Privacy and Security compliance program.
“This action sends a strong message to the health care industry that, regardless of size, covered entities must take action and will be held accountable for safeguarding their patients’ health information.” said OCR Director Leon Rodriguez. “Encryption is an easy method for making lost information unusable, unreadable and undecipherable.”
The Health Information Technology for Economic and Clinical Health (HITECH) Breach Notification Rule requires covered entities to report an impermissible use or disclosure of protected health information, or a “breach,” of 500 individuals or more to the Secretary of HHS and the media within 60 days after the discovery of the breach. Smaller breaches affecting less than 500 individuals must be reported to the Secretary on an annual basis.
A new educational initiative, Mobile Devices: Know the RISKS. Take the STEPS. PROTECT and SECURE Health Information, has been launched by OCR and the HHS Office of the National Coordinator for Health Information Technology (ONC) that offers health care providers and organizations practical tips on ways to protect their patients’ health information when using mobile devices such as laptops, tablets, and smartphones. For more information, visit www.HealthIT.gov/mobiledevices.
The Resolution Agreement can be found on the OCR website at http://www.hhs.gov/ocr/privacy/hipaa/enforcement/examples/honi-agreement.pdf
“HHS announces first HIPAA breach settlement involving less than 500 patients:
Hospice of North Idaho settles HIPAA security case for $50,000,” HHS Press Release (January 2, 2013)
Hackers recently infiltrated South Carolina's state tax records, absconding with the largest haul to date of Social Security numbers, credit and debit card numbers from a state agency. State officials describe how the theft was worked, and list enhanced security measures that could have prevented the attack.
See New York Times article at "South Carolina Offers Details of Data Theft and Warns It Could Happen Elsewhere".
South Shore Hospital in Weymouth, Massachusetts agreed this week to pay $475,000 to settle allegations connected with a 2010 data breach affecting the confidential health records of more than 800,000 patients. The hospital has already spent $275,000 on new security measures, since the breach, bringing the total cost of the breach up to $750,000.
The settlement resulted from a data breach reported to the attorney general's office in July 2010 that included individual's names, Social Security numbers, financial account numbers, and medical diagnoses, the news release said.
South Shore Hospital shipped three boxes containing 473 unencrypted back-up computer tapes with the personal information and health information from 800,000 individuals, the release said. The tapes were being shipped to a remote location so that Archive Data Solutions could erase the tapes and resell them, according to the release. Only one of the boxes arrived to its destination in Texas, the press release said, and the missing boxes have not been recovered. There are no reports of unauthorized use of the personal information.
Approved in Suffolk Superior Court, the settlement includes a $250,000 civil penalty and a payment of $225,000 for an education fund to be used by the attorney general's office to promote education related to protecting personal information and health information. The total amount of the settlement was $750,000, but the settlement credits South Shore Hospital for $275,000 to reflect security measures it has taken subsequent to the breach.
As a result of the settlement, South Shore Hospital will be required to take steps to ensure compliance with data security laws and regulations, as well as to undergo an audit of its security measures, the news release said.
“South Shore Hospital to pay $475K over patient data breach,” Boston Business Journal (May 9, 2012)
A surge in data privacy breaches and the accompanying string of recent HHS enforcement actions should serve as an important reminder to healthcare providers regarding the importance of data privacy protection and the skyrocketing costs of failures to comply. 2011 saw a 97% increase in the number of data breaches, as reported by the Salt Lake Tribune in the context of the massive breach of health information privacy in Utah earlier this month.
At the same time, HHS has stepped up its enforcement actions. Last week, we touched on the $100,000 OCR settlement with a cardiology practice in Arizona. Last month, HHS reached a $1.5 million settlement with Blue Cross Blue Shield of Tennessee (BCBST) for a breach of about 1 million unencrypted patient records which resided on over 50 stolen hard-drives. However, the $1.5 million settlement amount was dwarfed by the $17 million BCBST had to spend on notification and credit monitoring expenses, as well as investigating and correcting the breach.
The BCBST settlement is a good reminder that breaches and noncompliance can be extraordinarily expensive, even without the federal and/or state regulatory fines. A December 2011 Ponemon Institute study found that data security breaches cost the healthcare industry $6.5 billion in the year leading up to that study. Just last month, a medical records company filed for bankruptcy after its offices were burglarized and medical records of over 14,000 people were stolen. The costs and expenses associated with that breach were so high that the firm had no choice but to go out of business.
These cases also demonstrated that OCR will investigate a breach regardless of the organization's size or reach. In fact, smaller practices should pay particular attention to these developments because a recent study showed that smaller healthcare providers are more likely to suffer a breach because their Internet and sharing practices are not likely as secure as those implemented at large healthcare provider organizations.
Basic compliance with HIPAA and the related regulations is, of course, required, but it is not a panacea. A study by the American National Standards Institute found that insufficient funding and lack of managerial support were among the key causes of security breaches of protected health information.
A HIMSS/Kroll study showed that while most of the surveyed healthcare providers are compliant with the applicable laws, regulations, and industry standards, significant security challenges remain. Employees' compliance with the organization's policies was the primary concern, reported by nearly half of all respondents to that survey. Constant evolution of tech devices and the way doctors and patients interact using such devices is another huge challenge, since regulations cannot keep up with the exponential rate of change in this market.
Finally, the HIMSS/Kroll study showed that healthcare providers are also concerned about third parties (e.g., contractors, business associates, et al) who have access to such providers' patient information. As we have written previously, it is absolutely crucial to have the right contractual protections in your license and services agreements with such third parties, including indemnification or cost reimbursement provisions in the applicable Business Associate Agreements. A hacker or an intentional theft or disclosure by an employee may be difficult to control or prevent; but each healthcare provider can protect themselves contractually for the costs associated with a data breach, if such such breach was caused by the negligence of a business associate or a third party contractor.
On April 17, 2012, HHS announced that its Office for Civil Rights (OCR) settled a HIPAA violation case against a surgery practice in Arizona, for $100,000 and a Corrective Action Plan (CAP), which requires implementation of policies and procedures to prevent such HIPAA violations and breaches in the future.
Via HHS Press Release:
The incident giving rise to OCR’s investigation was a report that the physician practice was posting clinical and surgical appointments for its patients on an Internet-based calendar that was publicly accessible. On further investigation, OCR found that Phoenix Cardiac Surgery had implemented few policies and procedures to comply with the HIPAA Privacy and Security Rules, and had limited safeguards in place to protect patients’ electronic protected health information (ePHI).
'This case is significant because it highlights a multi-year, continuing failure on the part of this provider to comply with the requirements of the Privacy and Security Rules,' said Leon Rodriguez, director of OCR. 'We hope that health care providers pay careful attention to this resolution agreement and understand that the HIPAA Privacy and Security Rules have been in place for many years, and OCR expects full compliance no matter the size of a covered entity.'
OCR’s investigation also revealed the following issues:
- Phoenix Cardiac Surgery failed to implement adequate policies and procedures to appropriately safeguard patient information;
- Phoenix Cardiac Surgery failed to document that it trained any employees on its policies and procedures on the Privacy and Security Rules;
- Phoenix Cardiac Surgery failed to identify a security official and conduct a risk analysis; and
- Phoenix Cardiac Surgery failed to obtain business associate agreements with Internet-based email and calendar services where the provision of the service included storage of and access to its ePHI.
Under the HHS resolution agreement, Phoenix Cardiac Surgery has agreed to pay a $100,000 settlement amount and a corrective action plan that includes a review of recently developed policies and other actions taken to come into full compliance with the Privacy and Security Rules.
"HHS settles case with Phoenix Cardiac Surgery for lack of HIPAA safeguards," HHS Press Release (April 17, 2012).
The Department of Health and Human Services' Office for Civil Rights has set a March target date for release of the long-delayed final version of Health Insurance Portability and Accountability Act modifications and the HIPAA breach notification rule.
Although an HHS semi-annual regulatory agenda published Feb. 13 in the Federal Register did not mention these regulations, a January 'unified agenda' document, with far more details, shows a March target date, notes Susan McAndrew, OCR's deputy director for health information privacy.
The HHS regulatory agenda sets target dates, which, historically, aren't necessarily met. And the rules don't yet appear on the list of regulations under review by the Office of Management and Budget. OMB review is the final step before publishing a rule in the Federal Register.
'OCR is making every effort to publish the final rules on all of the remaining HITECH Act provisions so these important protections and expansions of individual rights under the HIPAA privacy and security rules can be made available uniformly to consumers across the country,' McAndrew told HealthcareInfoSecurity. 'OCR is proceeding with all deliberate speed to ensure the major impacts of these regulations are fully understood and addressed.'
In mid-2010, OCR issued a proposed version of the HIPAA modifications, which would, among other things, require business associates to comply. An interim final version of the HIPAA breach notification rule is now in effect until the final version is released. OCR submitted a final version for review by the Office of Management and Budget in 2010 and then withdrew it (see: Final Breach Notification Rule on Hold). It's been on hold ever since.
The interim final version of the breach rule contains a controversial harm standard that enables organizations to conduct a risk assessment to determine whether a breach represents a significant risk of harm to individuals and thus merits reporting.
"March Target for HIPAA Modifications," Healthcare Info Security (February 15, 2012).
Nemours, a children's health system with hospitals in Pennsylvania, Delaware, Florida and New Jersey, reported a massive breach affecting 1.6 million people, including patients, employees, and vendors. Via Health Data Management:
'On September 8, 2011, we learned that a locked tape storage cabinet containing computer backup tapes was missing,' the delivery system said in a notice to patients. 'We immediately began an investigation and now believe the cabinet was removed from our Wilmington facility on or about August 10, 2011, during a remodeling project. To date, we have been unable to locate the storage cabinet. We believe the cabinet contained three unencrypted backup tapes from a computer system we stopped using in 2004. No medical records were on the backup tapes, but they did contain patient billing information, including name, date of birth, insurance information, medical treatment information, and Social Security number.' Some employee payroll data and vendor information, such as direct deposit bank account information, also was on the tapes.
Nemours began encrypting its back up data tapes and moved its rarely-used tapes to a more secure off-site facility. The health system is offering a year's worth of credit-monitoring to affected individuals, which considering the numbers involved in this breach, could be a massive, seven-figure expense.
"Nemours Notifying 1.6 Million Individuals About Breach," Health Data Management (October 18, 2011).
A spreadsheet containing personal data of 20,000 emergency room patients of Stanford Hospital appeared on Student of Fortune, a Web site which "crowdsources" homework to other students online. The lost data included names, admission dates, diagnoses and other sensitive information. According to the New York Times, the spreadsheet was uploaded to this site by a billings contractor of Stanford Hospital, when an employee tried to solicit help on how to create a graph from the data in the spreadsheet. As Gawker reasonably speculated, a contractor's employee probably did not know how to create a graph and "so uploaded it to the homework helper website and offered, probably, a buck or two if someone could do it for them."
This breach stands out among the hundreds of others not because of its size (significantly larger breaches have been reported to HHS in the last year alone), but because this breach went undetected for almost a year and because, once again, a contractor of the healthcare provider caused a major data breach. According to a privacy expert quoted in the Times, "nearly 20 percent of breaches involved outside contractors, accounting for more than half of all the records exposed," which is a staggering number.
To protect our healthcare provider clients, we always include specific privacy protection warranties, indemnification clauses and limitation of liability carve-outs for vendor's own negligent acts or omissions which result in a data breach or loss. Stanford Hospital's example illustrates that providers must insist on such protections despite strenuous objections from vendors because, otherwise, providers may be exposed to a wide range of expenses and damages from third-party claims, fines, investigations and breach notification associated with a data breach or loss resulting from vendor's actions.
The Times correctly pointed out that contract language alone is not enough, and that significant due diligence by each provider is required. Certainly, employee training for both the hospital and the business associate-type contractors is absolutely essential. Relating the seriousness and gravity of health information privacy breaches should be a key element of such training. However, having a clear termination right and a strong contractual obligation to indemnify the provider in the event a vendor causes a major breach like the one at Stanford Hospital, is a good start.
We frequently see vendor agreements either without such an indemnification clause or with severe caps on vendor's liability. The latter is often limited to one year's worth of fees, or, in a better scenario, all fees paid by provider to vendor under the agreement. However, in case of a major breach caused by a vendor, such caps would not allow a provider to recover its costs and damages in dealing with the breach. Therefore, carve-outs to vendor's limitation of liability in connection with vendor's own breaches of PHI or other confidential information are crucial.
Stanford Hospital may be exposed to significant fines under both federal and state privacy laws. In fact, another Stanford hospital (Packard Children's) was slapped with a $250,000 fine under California law for failing to report a breach within 5 days. However, such regulatory expenses are just the tip of the iceberg: Stanford Hospital will have to spend a lot more on investigations, legal expenses, staff time, and, possibly, credit monitoring for the affected individuals.
For more information, please listen to or view the slides from our Webinar on negotiating "must-have" provisions in HIT contracts.
"Patient Data Posted Online in Major Breach of Privacy," The New York Times (September 8, 2011).
"Stanford Hospital Suffers Comically Stupid Patient Data Leak," Gawker.com (September 8, 2011).
A survey by Veriphyr, a provider of identity and access intelligence solutions, found that insiders were responsible for over 60% of data breaches of protected health information (PHI). Specifically, 35% of the PHI breaches were due to insiders' snooping into medical records of fellow employees, and 27% due to improper access to records of their friends and relatives.
Over 70% of surveyed entities, which included hospitals and other heathcare providers, reported suffering one or more breaches within the last 12 months. Veriphyr CEO estimated that data breaches cost healthcare organizations almost $6 billion annually, but found that an overwhelming majority of privacy and compliance officers within the surveyed group (79%) felt that they lacked "adequate controls to detect PHI breaches in a timely fashion."
It is worth noting that 45% of breaches in the survey were caused by loss or theft of medical records and/or equipment holding such records. We have recently seen HHS impose a $1 million fine on Massachusetts General Hospital in a case where, it seems, records were lost by an employee due to a simple mistake and with no malice. UCLA Health System also paid a high price for its employees' snooping into medical records of celebrities.
While it is difficult to anticipate or avoid all possible human error, certain best practices - including Board and executive-level support for privacy initiatives, staff training and updated privacy and security policies and procedures, will go a long way to help your organization protect itself from a disastrous and costly data breach.
"Insiders responsible for majority of privacy breaches, survey finds," Healthcare IT News (August 30, 2011).
After Health Net, Inc. in California announced Monday that several data servers containing sensitive health and personal information on its enrollees are unaccounted for, state officials said the security breach involves 'personal information for 1.9 million current and past enrollees nationwide.'
The California Department of Managed Health Care, the only stand-alone HMO watchdog agency in the nation, also provided further details beyond the plan's statement, saying that the missing records on nine servers are 'for more than 622,000 enrollees in Health Net products regulated by the DMHC, more than 223,000 enrolled in the California Department of Insurance products (another state agency that has oversight responsibility) and a number enrolled in Medicare.'
'The DMHC has opened an investigation into Health Net's security practices," said DMHC spokesperson Lynne Randolph. "Health Net has agreed to provide two years of free credit monitoring services to its California enrollees, in addition to identity theft insurance, fraud resolution and restoration of credit files, if needed.'
This may not be the last government investigation for the embattled insurer. For more information on the breach, please click here.
HealthNet, a California-based insurer, suffered another major data breach last month. Modern Healthcare reports that HealthNet lost data of almost two million employees, members and healthcare providers, including their medical information, Social Security numbers and other sensitive information. The loss was reportedly caused by a missing server drive from HealthNet's Rancho Cordova, CA data center. According to the insurance company's press release, HealthNet's IT vendor, IBM, notified HealthNet that it could not locate the drives.
As we noted previously, HealthNet suffered another major data breach in 2009, when the company lost a portable hard drive containing sensitive and protected information on 1.5 million people. As a result of that breach, HealthNet was sued by then-Connecticut Attorney General Richard Blumenthal, in a first such action under HIPAA, as modified by the HITECH Act. HealthNet and Connecticut settled this suit in 2010 for $250,000 fine, a $500,000 contingency fund and a corrective action plan aimed at enhancing the security of the data in HealthNet's possession.
In light of HHS stepping up enforcement of HIPAA and HIPAA Privacy and Security Rules, HealthNet will become a likely target of both federal and state investigations; and if such investigations reveal negligence or failure to implement or comply with their own corrective action plan referenced above, the fines could be much more severe than the $250,000 number from the Connecticut settlement in 2010.
This should also serve as a reminder about the importance of requiring IT vendors to indemnify healthcare providers against such losses. If HealthNet's investigation concludes that IBM and/or its personnel were responsible for this loss, the parties will likely look to their existing contracts and BAA to determine whether IBM will reimburse HealthNet for its costs in relation to this breach.
Via Modern Healthcare:
Woodland Hills, Calif.-based health insurer Health Net announced Monday that it had lost servers containing personal health information and demographic data for nearly 2 million current and past patients.
The breach, which affects approximately 1.9 million people nationwide, occurred in February. Health Net said it cannot account for server drives missing from a data center in Rancho Cordova, Calif. Those drives contain patients' names, Social Security numbers and sensitive health information. It's not the first time Health Net enrollees have experienced a breach. In 2009, 1.5 million people were affected when a portable hard drive containing patient data went missing.
According to the California Department of Managed Health Care, the breach will affect as many as 845,000 of the state's residents. In a news release, Connecticut Attorney General George Jepsen urged the insurer to provide adequate identity protections for the 25,000 state residents whose data has been compromised.
"Health insurance companies have access to very sensitive and personal information," Jepsen said in the release. “They have a duty to protect that information from unlawful disclosure.”
[In a press release,] Health Net said it would offer two years of credit monitoring and identity protection to affected customers. The insurer also has set up a hotline.
New York City's Health and Hospital Corporation notified its patients last week of a loss of electronic files containing personal data, including PHI of some 1.7 million people. Electronic files were stolen while the information management company's van was left unlocked and unattended.
This case should serve as a great reminder to:
- check your existing contracts - including Business Associate Agreements - with HIT and health information management vendors, to see if such agreements contain appropriate clauses indemnifying the provider against costs, losses, fines and other expenses incurred as a result of the vendor's loss or improper disclosure of protected personal data, including PHI;
- make sure that same contracts do not impose a cap on vendor's liability in the event of such breach;
- confirm that you have a proper breach response plan in place (which should include, e.g., where applicable, procedures for notifying patients in foreign languages); if not, bring together management, legal, IT and privacy and security offers to develop such a plan as soon as possible; and
- review your policies and procedures with respect to compliance with the HIPAA Privacy and Security Rules, especially as modified by the HITECH Act.
Via the New York Times:
On Wednesday, the agency started mailing notification letters to the victims, in 17 languages, announcing an information hot line and customer care centers at both hospitals, and offering free credit monitoring and fraud resolution services for one year. Those interested in the offer have 120 days to register. The notification text is also available online.
The hospitals corporation said it had taken “decisive steps to protect the individuals who are potentially affected,” even though there is no evidence the information, contained on computer backup tapes that were being delivered to “a secure storage location,” has been accessed or misused. It also said that the data is stored in a program “that would make it difficult for someone without technical knowledge to access the private information.”
The hospitals corporation has filed suit to hold the vendor, GRM Information Management Services, responsible for covering all damages related to the loss of the data.
For more information, please listen to or view the slides from our Webinar on negotiating "must-have" provisions in HIT contracts.
Post & Schell, in collaboration with Kroll Fraud Solutions, presented a free webinar examining the crucial changes and updates to the HIPAA Privacy and Security Rules included in the Notice of Proposed Rulemaking (NPRM) issued by the Office of Civil Rights of the U.S. Department of Health and Human Services on July 8, 2010. Post & Schell's Steve Fox and Vadim Schick highlighted the key provisions in the NPRM, including:
- New restrictions on use and disclosure of protected health information (PHI) for marketing, fundraising, and other commercial purposes
- Providing patients with e-copies of their PHI
- Extension of HIPAA Privacy and Security Rules to business associates
- Effect of new rules on business associate agreements
In addition, our guest presenter for this webinar, Alex Ricardo, CIPP of Kroll Fraud Solutions, discussed the practical implications of this new set of regulations on covered entities and business associates, including:
- Assessing an organization's policies, procedures and practices for compliance with the HIPAA Rules and these updates
- Reviewing current contractual agreements and relationships with business associates and their subcontractors
- Training staff of the organization
- Breach preparedness and breach response
You can view or download the slides from this presentation by clicking here.
For more information, contact Vadim Schick at firstname.lastname@example.org or 202-661-6945.
On July 7, 2010, HHS issued a notice of proposed rule making (NPRM) regarding the changes to the HIPAA Privacy, Security and Enforcement Rules, as provided in the HITECH Act, in order "to strengthen the privacy and security protections for health information and to improve the workability and effectiveness of the HIPAA Rules." Via HHS Press Release:
The proposed modifications to the HIPAA Rules include provisions extending the applicability of certain of the Privacy and Security Rules’ requirements to the business associates of covered entities, establishing new limitations on the use and disclosure of protected health information for marketing and fundraising purposes, prohibiting the sale of protected health information, and expanding individuals’ rights to access their information and to obtain restrictions on certain disclosures of protected health information to health plans. In addition, the proposed rule adopts provisions designed to strengthen and expand HIPAA’s enforcement provisions.
You can view the NPRM by clicking here.
"Notice of Proposed Rulemaking to Implement HITECH Act Modifications," HHS Press Release (July 7, 2010).
In November of 2009, health insurance provider HealthNet reported a loss of a portable disk drive (which occurred six months prior to HealthNet's report). The disk drive contained compressed, though not encrypted, data, including social security and bank account information, on nearly half a million persons. This loss outraged the Connecticut Attorney General Richard Blumenthal, eventually leading Connecticut to file suit against the insurer for HIPAA violations and noncompliance with HealthNet's own security policies by failing to encrypt the sensitive data.
However, on July 6, 2010, Blumenthal (who is currently running to replace Chris Dodd (D-CT) in the U.S. Senate) announced that Connecticut has reached a settlement with HealthNet and its parent companies over this breach. According to Blumenthal, this is the very first time a state Attorney General reached such a settlement for a HIPAA violation. The settlement included:
- $250,000 fine to be paid to Connecticut;
- $500,000 contingency fund, to be paid to the state in the event it is determined that someone accessed the protected data on the lost disks; and
- a "corrective action plan" which is aimed to enhance security of protected data in possession of HealthNet and its parent companies.
It is important to keep in mind that the penalties could have been even higher. Yet regardless of the amount of the fine, this breach cost much more to HealthNet than $250,000. The costs associated with investigations, breach notification, and possible legal fees almost certainly cost the organization more than the amount of the fine imposed by Connecticut. Thus, HealthNet's example should serve as a great reminder about the importance of doing everything possible to avoid a breach, and knowing how to handle a breach effectively if one does occur.
"Blumenthal wins $250,000 in Health Net settlement," TheDay.com (July 6, 2010).
Lincoln Medical and Mental Health Center (LMMHC) in New York suffered a major breach affecting 130,495 of its patients, according to a notice provided to HHS. The breach occurred when the hospital's contractor, Siemens Medical Solutions USA, shipped seven password-protected, but not encrypted, CDs containing patient information via FedEx; and these CDs were subsequently lost in transit. Via Bloomberg Business Week:
The CDs were sent by the hospital's billing processor, Siemens Medical Solutions USA, around March 16, but never arrived at their intended destination. They included sensitive health and personal information including Social Security numbers, addresses, dates of birth, health plan numbers, driver's license numbers and even descriptions of medical procedures, the hospital said on a note posted to its Web site.
<...> Siemens is no longer FedExing CDs to Lincoln, the hospital said. It is not aware of any of the data being improperly accessed.
LMMHC's breach should serve as a reminder for all healthcare providers currently negotiating health IT contracts to include proper protections in the event its vendor causes a breach or loss of protected data. This is particularly crucial in the post-HITECH Act era.
We always include specific compliance with privacy laws warranties, indemnification clauses and limitation of liability carve-outs for vendor's own negligent acts or omissions which result in a data breach or loss. LMMHC's example clearly illustrates that providers must insist on such protections -- often, over strenuous objections from vendors -- because, otherwise, providers may be exposed to a wide range of expenses and damages from third-party claims, fines, investigations and breach notification associated with a data breach or loss resulting from vendor's actions.
For more information, please listen to or view the slides from our Webinar on negotiating "must-have" provisions in HIT contracts.
"New York hospital loses data on 130,000 via FedEx," Bloomberg Business Week (June 29, 2010).
Breaches are not always caused by lost laptops or hackers. They often result from simple errors by the hospital's or another provder's own staff. In a very recent example, the California Department of Public Health found two instances of serious mishandling of protected patient information at Children's Hospital of Orange County. Via Orange County Register:
In the first instance, the state found that after a doctor called to give the hospital a new fax number, patient records were instead sent to an auto business. Six faxes with health care information were picked up from the business, the report says.
A month later, the auto shop again notified the hospital that it had received a fax with a patient's name, date of birth and details of visits. The hospital discovered that the wrong fax number had not been changed in a data base.
Hospital staff said the breach would have been prevented if a test fax had been sent as required by hospital policy, the report said.
The other privacy breach occurred when the name of an emergency room patient's doctor was incorrectly entered into the system. Records were then faxed to the wrong doctor who notified the hospital.
CHOC is auditing its database to make sure information is accurate.
"State blames CHOC in wrong-site surgery," Orange County Register (June 25, 2010).
The number of reported health information breaches is growing rapidly: 32 breaches were reported on the OCR web site from September 2009 to February 2010, but the number almost tripled, to 93 breaches, by June 11, 2010. Such significant increases in reported breaches may be attributed to the notification and reporting requirements in the HITECH Act, which went into effect this year. We cannot possibly report or list all of the relevant breaches, but we would like to highlight a few important ones:
- On May 28, 2010, Cincinnati.com reported that “Cincinnati Children's Hospital Medical Center is beefing up its computer security after a laptop computer containing more than 61,000 patient records was stolen.” Information lost included not only PHI, but also Social Security numbers and even credit card data. The records on the laptop were password protected, but they were not encrypted. The hospital reported the breach, hired a consulting company to deal with same, and offered affected individuals ID theft protection at no charge. The cost of this breach has already been extremely high, but it could be even higher if credit card companies go after Children's Hospital for losses associated with loss of improperly stored credit card information.
- Five hospitals in California were fined a combined total of $675,000 by the California Department of Public Health for patient privacy violations, failing to prevent unauthorized access to confidential patient medical information of 245 patients, which were improperly accessed by a total of 32 employees. On June 10, 2010, Press-Enterprise reported that the Community Hospital of San Bernardino was fined by the state of California a total of $325,000 for breaches of more than 200 patient records by two employees in 2009. Violations were significant, but, considering the fine, far from gruesome.
Please click here to read more.
In the first instance,
an unidentified radiology technician accessed 204 records for 177 patients between Jan. 10, 2009, and Feb. 22, 2009, without having a clinical reason to do so. The investigation report doesn't indicate whether the employee used the information she got or contacted the patients.
In a second investigation, inspectors found that a medical imaging department employee allowed a friend who was visiting her into a restricted access room where the employee worked. The visitor could overhear patients discuss their personal information with the employee, a report states.
This should serve as an important reminder about the far-reaching nature of medical information privacy laws -- both federal and local. California has a particularly strict medical privacy law, enacted in 2008. Breach does not mean just a lost laptop, hacking or intentional access of a celebrity's records, as we saw last year in California. It could be a wide range of activities, and hospitals and other providers should pay close attention to the fast-changing regulatory environment, create or modify their policies and procedures accordingly and, perhaps even more crucially, train their staff to comply with such necessary policies and procedures.
"Missing records on stolen laptop from Cincinnati Children's Hospital," Cincinnati.com (May 28, 2010).
"SB hospital fined $325,000 for breach of patient records," Press-Enterprise (June 10, 2010).
"Large Patient Information Breaches List Nears Century Mark," Health Leaders Media (June 16, 2010).
- HHS's Office of Civil Rights (OCR) filed a notice in the Federal Register lifting a requirement preventing OCR from posting names of sole practitioners who suffer breaches of patient data without first obtaining consent from such practitioners. Pursuant to the HITECH Act, any covered entity reporting a breach affecting over 500 individuals must report such breach to HHS, and HHS will post a notice of such breach on its web site. At the same time, HHS did not post names of individual physician practices (e.g., sole practitioners) without such physicians' consent because they deemed the name of the physician to be protected under the Privacy Act of 1974. Instead, HHS listed such breaches under "private practice." However, OCR announced on April 16, 2010, that "it will begin posting on its breach notification web site the names of entities they consider "individuals" regardless of whether or not those entities give consent." According to HealthLeaders Media, the rule will become effective after the comment period closes (about May 23, 2010).
- Government Health IT reports that OCR will issue more privacy and security rules mandated by the HITECH Act in May 2010, including rules regarding business associate liability; new limitations on the sale of protected health information, marketing, and fundraising communications; and stronger individual rights to access electronic medical records and restrict the disclosure of certain information. According to HHS, "OCR continues work on a Notice of Proposed Rulemaking (NPRM) regarding these provisions. Although the effective date (February 17, 2010) for many of these HITECH Act provisions has passed, the NPRM and the final rule that follows will provide specific information regarding the expected date of compliance and enforcement of these new requirements."
- On April 23, 2010 HIT Policy Committee's privacy and security workgroup revealed a draft technical framework for patient consent requirements, titled Basic Patient Privacy Consent (BPPC). According to Federal Computer Week, the draft framework includes "at least 12 types of patient consents, including implicit and explicit opt-out and opt-in, authorizations for specific research projects and authorizations for use of the document but not for republishing."
HealthImaging.com reported yesterday that a Connecticut radiologist, previously affiliated with the Griffin Hospital in Derby, Conn. "accessed patient radiology reports on the hospital's PACS using the passwords of other radiologists and an employee within the radiology department. The passwords were obtained and/or used without their knowledge." From HealthImaging.com:
From the investigation conducted by Griffin, it appears the radiologist who gained unauthorized access scanned the PACS directory listings of 957 patients who had radiology studies performed at Griffin during the period and selected and downloaded the image files of 339 of these patients.
On and after Feb. 26, Griffin received inquiries on behalf of patients regarding unsolicited contact by the physician who offered to perform professional services at another area hospital despite the patients' interest in having those services provided at Griffin. The inquiries prompted the investigation that revealed unauthorized intrusions into Griffin's PACS and, thereby, the breach of protected patient health information.
This should serve as a reminder for healthcare providers regarding maintaining the safeguards necessary to prevent wrongful access to patient data. For example, and there is no indication that this is what occurred in this case, clinicians and other hospital staff should not keep their system passwords on sticky notes next to or on their monitors. Even if you believe that everyone in your office is fully trustworthy, you never know who can get a hold of such restricted information as usernames and passwords. The reputational and financial damage to your organization could be very substantial; and your contract with the PACS system vendor is unlikely to indemnify or protect you from such losses.
"Radiologist breaches data, images of nearly 1,000 patients via PACS," HealthImaging.com (March 31, 2010).
As of February 22, 2010, HHS is expected to begin enforcing the new breach notification requirements created by the privacy and security provisions within the HITECH Act. Although such requirements went into effect last fall, HHS gave covered entities and business associates a few months to adapt to the new rules. That enforcement delay is now over, and, perhaps in a related move, on February 23, 2010, HHS's Office of Civil Rights, pursuant to the HITECH Act, posted a list of organizations which reported breaches of unsecured protected health information affecting 500 or more individuals on OCR's web site. This should serve as a good reminder to providers and HIT vendors alike to be keenly aware of the new regulations on breach notification.
The HITECH Act required a covered entity that “accesses, maintains, retains, modifies, records, stores, destroys, or otherwise holds, uses, or discloses unsecured protected health information” to notify each individual “whose unsecured protected health information has been, or is reasonably believed by the covered entity to have been, accessed, acquired, or disclosed” due to the breach. Business associates who discover a breach must notify the covered entity.
By regulation published in the Federal Register on August 24, 2009, HHS added a rather controversial "harm threshold" to this requirement: covered entities and business associates are required to notify the affected individual, the HHS, and, in some cases, the media, if such breach poses a significant risk of harm to the individual. This "harm threshold" essentially requires the organization which discovers a breach to undergo a risk assessment test to determine whether a breach would cause "significant harm" to the affected person.
The HITECH Act defines “breach” as “the unauthorized acquisition, access, use, or disclosure of protected health information which compromises the security or privacy of such information, except where an unauthorized person to whom such information is disclosed would not reasonably have been able to retain such information.” The Act includes two important (albeit vague) exceptions to this definition for cases in which: (1) “the unauthorized acquisition, access, or use of PHI is unintentional and made by an employee or individual acting under authority of a covered entity or business associate if such acquisition, access, or use was made in good faith and within the course and scope of the employment or other professional relationship with the covered entity or business associate, and such information is not further acquired, accessed, used, or disclosed”; or (2) “where an inadvertent disclosure occurs by an individual who is authorized to access PHI at a facility operated by a covered entity or business associate to another similarly situated individual at the same facility, as long as the PHI is not further acquired, accessed, used, or disclosed without authorization.
The HITECH Act imposes a similar notification requirement on a business associate “that accesses, maintains, retains, modifies, records, stores, destroys, or otherwise holds, uses, or discloses unsecured” PHI. In the event of a breach, the business associate shall provide notice to the covered entity, including “the identification of each individual whose unsecured protected health information has been, or is reasonably believed by the business associate to have been, accessed, acquired, or disclosed during such breach.”
The term “unsecured protected health information” refers to PHI that is not secured through the use of a “technology or methodology” specified by the Secretary in a “Guidance” issued as part of the breach notification regulation in the Federal Register on August 24, 2009 (see link above). The Guidance, which is to be updated annually, specifies two basic ways of rendering PHI “secure:” encryption and destruction. Electronic PHI must be properly encrypted “by ‘the use of an algorithmic process to transform data into a form in which there is a low probability of assigning meaning without use of a confidential process or key’ and such confidential process or key that might enable decryption has not been breached.” The Guidance provided an exhaustive list of technologies which would encrypt PHI, referencing “approved” processes and methods from the National Institute of Standards and Technology (NIST). Electronic PHI may be properly destroyed in the hard copy media (e.g., paper, tapes) on which the PHI is stored is shredded or destroyed “suchin such a way “that the PHI cannot be read or otherwise cannot be reconstructed;” electronic media containing PHI “must be cleared, purged, or destroyed consistent with NIST [Guidelines] such that the PHI cannot be retrieved.”
Securing PHI in accordance with this Guidance will be the safest way to protect a healthcare organization from a serious breach of patient data privacy. Organizations that suffer a breach involving disclosed, stolen or lost data that was not “secured” may be subject to a wide range of newly established breach notification requirements. It is important to note, however, that for both covered entities and business associates, the breach shall be deemed to have been discovered on the first day on which it is “known to such entity or associate.” The term “known” means that the circumstances of the breach are known by any “employee, officer, or other agent of such entity or associate,” other than the person who committed the breach. Furthermore, all notifications (by both covered entities and business associates) must be made “without unreasonable delay,” which, in Congressional time, means no later than 60 calendar days after discovery of the breach. The entity making the notification has the burden of demonstrating that all required notifications were made, as well as explaining the necessity of any delay.
There is a lot more information that covered entities and business associates must know about the new rules, including, for example, requirements regarding the content of breach notices. For more information on these matters, please do not hesitate to contact us.
There is little doubt that the healthcare industry must prepare for a growing number of - and expanding costs associated with - data breaches, particularly for breaches of protected health information. Here are just a few notable reports on this subject:
- Infosecurity.com reported on a striking increase in attempts to hack into healthcare organizations, while the rate of hacking in other economic sectors remained flat: "the last quarter of  saw an average of 13 400 attempts to hack healthcare organizations, compared to an average of 6,500 in the first nine months." According to researchers at SecureWorks, which produced the graph above, healthcare organizations are particularly vulnerable to such attacks because they "have to provide access to many external networks and web applications so as to stay connected with their patients, employees, insurers and business partners. This increases their risk to cyber attacks."
- Cnet News reported on similar findings by the Ponemon Institute, whose survey concluded that "Data breaches at U.S. companies attributed to malicious attacks and botnets doubled from 2008 to 2009 and cost substantially more than breaches caused by human negligence or system glitches." The cost per compromised record involving a criminal act averaged $215, about 40% higher than breaches from negligence and 30% higher than those from glitches, the Ponemon survey found.
There are also a couple of examples of individual healthcare organizations suffering from increasing costs associated with data breaches:
- According to Chattanooga Times Free Press (via iHealthBeat), BlueCross BlueShield of Tennessee announced that it has spent more than $7 million to respond to a security breach resulting from 57 hard drives having been stolen from its training facility, which may have compromised personal and health data of up to 500,000 members. $7 million tab does not appear to be the end of it:
The insurer has notified 220,000 BlueCross members about the data theft. The company also is offering no-cost credit-monitoring services for affected members. In addition, BlueCross is working to notify attorneys general in 32 states about the breach [pursuant to the HITECH Act]. <...>
BlueCross officials said 20,500 members already have signed up for the no-cost credit-monitoring services. In addition, the company has hired more than 700 contract and BlueCross employees to help determine what data the hard drives contained. The insurer said it might need to spend significantly more money to evaluate the missing data and provide additional identity protection services.
- Considering the experience of BCBS of Tennessee, the costs associated with HealthNet's infamous data breach must be even higher. On top of providing two years of free credit-monitoring for hundreds of thousands of affected members, HealthNet is being sued by the state of Connecticut for HIPAA violations and noncompliance with HealthNet's own security policies by failing to encrypt the sensitive data. The missing hard drive contained "27.7 million scanned pages of more than 120 different types of documents, including insurance claim forms, membership forms, appeals and grievances, correspondence and medical records." Further complicating HealthNet's situation is the fact that the company waited for six months to inform the affected customers of the possible breach.
"Healthcare hacks on the rise," Inforsecurity.com (January 26, 2010).
"Survey: Data breaches from malicious attacks doubled last year," cnet News (January 25, 2010).
"Tab for Response to Data Breach Hits $7 Million for BCBS of Tennessee," IHealthBeat (January 26, 2010).
"AG files suit in health data privacy breach," theday.com (January 13, 2010).
- According to LA Weekly, Huping Zhou, a former employee at the UCLA Healthcare System, pleaded guilty to federal charges of breaches of patient privacy. Zhou, 48, accessed the UCLA patient records system 323 times during the three-week period, mostly looking for the files of celebrities, after being let go by the hospital. Names of targeted celebrities have not been revealed. This case follows a similar breach at UCLA Medical Center, when Lawanda Jackson, a former nurse at the Center, plead guilty to wrongfully accessing information of Britney Spears and Farrah Fawcett.
- Delaware Online reports about a new unfortunate trend in medical identity theft -- searching for copies of discarded prescriptions: "In the latest crime trend to hit Delaware, police are reporting that people looking for drugs such as Oxycontin and Vicodin are stalking customers who throw away prescription bags containing paperwork with details about their pills and themselves. They use the personal information to call in prescriptions and charge them to the victims' insurance. Then they turn around and sell the drugs." According to Bruce DiVincenzo, chief agent of Delaware's Office of Narcotics and Dangerous Drugs:
They're making their own scripts by ordering paper from the Internet," he said. "It's the patient's name that they want, because that person is actively listed as a customer of the pharmacy and will not raise suspicion."
Pharmacies like CVS and Happy Harry's (a subsidiary of Walgreens) take certain precautions to prevent such identity theft, including checking ID's before filling prescriptions and reminding customers to be careful with their receipts and copies of prescriptions.
- According to Washington Technology, HHS is looking for a contractor to research the effectiveness of "de-identifying" PHI:
Under this new contract, HHS will research re-identifying the data and matching it to a specific individual.
'The contractor shall take one or more HIPAA Privacy Rule de-identified data sets and, using methods and technologies that exclude 'brute force' matching, demonstrate the ability or inability to re-identify the data,' the notice states.
The re-identification must be an accurate and unambiguous match to an individual.
"Former UCLA Health Worker Pleads Guilty To Accessing Celebrities' Medical Records," LA Weekly (January 8, 2010).
"Delaware crime: Trash-picking identity theft targets pharmacy customers," Delaware Online (January 6, 2009).
"HHS wants contractor to test privacy of 'anonymous' data," Washington Technology (January 5, 2010).
Health insurance provider Health Net reported a loss of a portable disk drive (which occurred six months ago). The disk drive contained compressed, though not encrypted, data, including social security and bank account information, on nearly half a million persons.
Connecticut Attorney General Richard Blumenthal was "outraged" the company waited this long to go public about this major data breach:
Health Net’s incomprehensible foot-dragging demonstrates shocking disregard for patients’ financial security, as well as loss of their highly sensitive and confidential personal health information <...> Personal information is like cash and should be guarded with equal care. Casual and cavalier attitudes toward data protection and breaches are intolerable and must stop.
This case provides yet another reminder about the importance of encrypting the sensitive and protected data, including PHI, in your possession.
According to NBC Connecticut:
Blumenthal is investigating and demanding that Health Net provide consumers with at least two years of identity theft protection, identity theft insurance, reimbursement for credit freezes and credit monitoring for at least two years for all 446,000 consumers.
The state Insurance Department is also investigating and looking for information, including what led to the disc drive disappearing, what information is missing, HealthNet’s security procedures and changes they plan.
In a statement, Health Net apologized for any "inconvenience or concern" this breach may cause. The company will provide credit monitoring for 2 years. Health Net did not receive any reports of misuse of lost data.
"Health Net Loses Information for 450,000 Clients," NBC Connecticut (November 19, 2008).
On August 19, 2009, pursuant to the HITECH Act, the Department of Health and Human Services (HHS) published the interim final regulations regarding breach notification requirements for health care providers and other entities covered by HIPAA.
According to the HHS press release:
The regulations, developed by the HHS Office for Civil Rights (OCR), require health care providers and other HIPAA covered entities to promptly notify affected individuals of a breach, as well as the HHS Secretary and the media in cases where a breach affects more than 500 individuals. Breaches affecting fewer than 500 individuals will be reported to the HHS Secretary on an annual basis. The regulations also require business associates of covered entities to notify the covered entity of breaches at or by the business associate.
You can find the text of the regulation here.
Stay tuned for more analysis of this important set of regulations on this blog. The interim final regulations are effective 30 days after publication in the Federal Register and include a 60-day public comment period.
Also, pursuant to Section 13403(a) of the HITECH Act, the HHS Secretary Kathleen Sebelius designated an individual in each regional office of HHS (Regional Office Privacy Advisors) in order "to offer guidance and education to covered entities, business associates, and individuals on their rights and responsibilities related to the HIPAA Privacy and Security Rules." The names, addresses, and contact information for each of the Regional Managers are listed here, together with a list of the States for which each Regional Manager has responsibility.
"HHS Issues Rule Requiring Individuals Be Notified of Breaches of Their Health Information," HHS Press Release (August 19, 2009).
" Designation of Regional Office Privacy Advisors," HHS Press Release (July 27, 2009).
Pursuant to the American Recovery and Reinvestment Act of 2009 (ARRA), the Federal Trade Commission (FTC) issued the final rule regarding notification requirements for breaches of electronic health information by vendors of personal health records and certain affiliated entities:
The rule applies to both vendors of personal health records – which provide online repositories that people can use to keep track of their health information – and entities that offer third-party applications for personal health records. These applications could include, for example, devices such as blood pressure cuffs or pedometers whose readings consumers can upload into their personal health records. Consumers may benefit by using these innovations, but only if they are confident that their health information is secure and confidential.
The Final Rule requires vendors of personal health records and related entities to notify consumers following a breach involving unsecured information. In addition, if a service provider to one of these entities has a breach, it must notify the entity, which in turn must notify consumers. The Final Rule also specifies the timing, method, and content of notification, and in the case of certain breaches involving 500 or more people, requires notice to the media. Entities covered by the rule must notify the FTC, and they may use a standard form, which can be found along with additional information about the rule at www.ftc.gov/healthbreach.
You can find the full text of the rule here.
"FTC Issues Final Breach Notification Rule for Electronic Health Information," FTC Press Release (August 17, 2009).
Healthcare providers are generally familiar with and are used to the complex network of state and federal data privacy protection laws (e.g., HIPAA and HIPAA Privacy and Security regulations). However, most providers may not be aware of another set of data security standards, the Payment Card Industry Data Security Standards (PCI DSS), imposed by a non-governmental, private organization representing the credit card industry.
Contrary to popular belief, PCI standards apply to any processor of credit cards, regardless of volume of credit card transactions. (However, PCI DSS differ based on each organization's transactions volume.) In other words, if your healthcare enterprise or practice accepts credit cards as payment for services (which virtually all practices do), your organization is subject to PCI DSS.
SC Magazine's recent contribution from Jim Lacy, CFO of healthcare IT company ZirMed, provides an excellent reminder for all healthcare providers accepting credit cards to take note of PCI DSS and begin the process of compliance with such standards.
A few lessons from Jim Lacy's piece and more after the jump.
Jim Lacy reminds healthcare providers of a few basic principles of PCI compliance:
- As mentioned above, PCI DSS applies to all entities processing credit card transactions, regardless of volume.
- PCI DSS compliance is not prohibitively expensive. Certain PCI-compliance services are available online for as little as $150 a year.
- If your organization is not compliant with PCI DSS, you may not be able to process credit card transactions in certain markets.
- Aside from suspension of one's ability to process credit card transactions, a data breach for non-compliant providers may cost hundreds of thousands of dollars in fines alone (VISA can impose fines up to $500,000 per incident).
- HIPAA compliance does not mean compliance with PCI DSS.
In addition to PCI DSS, at least one state, Minnesota, adopted most provisions of PCI DSS prohibiting storage of credit card data as state law, the Plastic Card Security Act (PCSA). PCSA essentially created a strict liability standard for entities processing over 20,000 credit card transactions a year for any losses or damages caused by a data breach of stored credit card data.
Thus, a Minnesota healthcare enterprise may be strictly liable to credit card companies or patients for losses or damages resulting from a security breach of stored credit card data, if such provider was not compliant with PCI DSS and the applicable provisions of Minnesota law.
"PCI-DSS: Not on health care provider's radar", SC Magazine (June 19, 2009).
A new study of 138 laptop-loss cases suffered over a recent 12-month period by 29 organizations, found that, on average, each lost or stolen laptop cost the employer $49,246. About 80% of the amount, or about $39,000 per laptop, are costs associated with data breaches, i.e., loss of personal data stored on the lost or stolen laptop. Significantly, the study found that:
The faster the company learns that a laptop is lost, the lower the average cost ... If a company discovers the loss in the same day, the average cost is $8,950. If it takes more than one week, the average cost rises significantly to approximately $115,849.
The study didn't endorse any particular brand of notebook protection gear, but noted that encryption on average can reduce the cost of a lost laptop by more than $20,000. (It is important to point out here that most data protection laws (both state and federal) exclude loss of encrypted or secured information from their definition of "breach.")
The study was conducted by the Michigan-based Ponemon Institute and commission by Intel.
("Typical lost or stolen laptop costs companies nearly $50,000, study finds", MercuryNews.com, April 22, 2009.)
On April 17, 2009, HHS issued guidance specifying the technologies and methodologies that render protected health information unusable, unreadable, or indecipherable to unauthorized individuals, as required by the Health Information Technology for Economic and Clinical Health (HITECH) Act passed as part of American Recovery and Reinvestment Act of 2009 (ARRA). This guidance was developed through a joint effort by OCR, the Office of the National Coordinator for Health Information Technology (ONC), and the Centers for Medicare and Medicaid Services (CMS).
This guidance relates to two forthcoming breach notification regulations – one to be issued by HHS for covered entities and their business associates under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) (Sec. 13402 of HITECH) and one to be issued by the Federal Trade Commission (FTC) for vendors of personal health records and other non-HIPAA covered entities (Sec. 13407 of HITECH). HITECH requires these regulations to be published within 180 days of enactment. If the entities subject to the regulations apply the technologies and methodologies specified in the guidance to secure information, they will not be required to provide the notifications required by the regulations in the event the information is breached.
The Guidance can be viewed (in PDF) here.
- After what has become a rather typical breach of patient privacy for Southern California, Kaiser Permanente fired fifteen employees (and disciplined eight additional employees) for looking at the medical records of Nadya Suleman, the mother of octuplets commonly referred to as "Octomom". Previously, similar breaches occurred at UCLA when that medical center's staff leaked celebrities' medical records to the tabloids. (MercuryNews.com, via AP, March 30, 2009.)
- Wall Street Journal reported last week that HIT stocks, especially smaller companies, like eClinicalWorks (which provide the software component of Wal-Mart's new EHR package) will benefit greatly from the billions of dollars in HIT funding included in the stimulus bill. Also, in another sure sign of a growing industry, Quality Systems, the maker of the NextGen EHR software, is "beefing up its sales force." ("Stimulus Funds for E-Records Augur Big Windfall for Small Health Firms", Wall Street Journal, March 24, 2009.)
- A new bill is introduced in the Pennsylvania Senate that would ban businesses from collecting personal data from driver's licenses. This should also serve as a good reminder for businesses not to collect or store more information than absolutely necessary. (Pennlive.com, March 30, 2009.)
- Perot Systems will launch a new service tomorrow (April 1, 2009) to help hospitals achieve "meaningful use" status under HITECH, geared towards meeting the interoperability and standardization of HIT use. (Healthcare IT News, March 30, 2009).
- Kaiser Permanente and IBM inked a $500 million, seven-year IT services deal. IBM will manage Kaiser's data center operations, storage and software, but IBM will not have access to patients' medical records. AP, San Francisco Chronicle (March 17, 2009).
- A new study expects that as much as three-quarters of prescribers will use e-prescribing by 2014 because of the incentives for adoption of e-prescribing technology included in the HITECH Act (though only about 15% of current prescribers use e-prescribing). This could result in a massive $22 billion reduction in drug and medical costs. Government Health IT (March 17, 2009).
- Wal-Mart is bringing its "high-volume, low-cost" approach to the medical records industry. Wal-Mart's Sam's Club division will produce a package that will include hardware from Dell, software from eClinicalWorks, as well as installation, maintenance and training services. According to the New York Times (March 11, 2009), the "Sam’s Club offering, to be made available this spring, will be under $25,000 for the first physician in a practice, and about $10,000 for each additional doctor. After the installation and training, continuing annual costs for maintenance and support will be $4,000 to $6,500 a year, the company estimates." This development has huge implications for the EHR market, and may actually aid the widespread adoption of EHR technology. Healthcare IT News (March 11, 2009) also covered this story.
More news after the jump.
- Health Information Security and Privacy Collaboration (HISPC) is working on an engine to help healthcare providers navigate through the complex labyrinth of interstate transfers of health information. Government Health IT (March 5, 2009).
- President & CEO of HIMSS Analytics, Dave Garetz, predicts a huge rush in 2009 to adopt HIT in order to qualify for government incentives as meaningful EHR users. There will likely be a significant shortage of competent HIT personnel and "change management experts" to help in this gigantic transition effort, which further underscores this Blog's urgent plea to begin planning for EHR adoption now. Healthcare IT News (March 4, 2009).
- Not everything is coming up roses: Scott Haig of Time has a thoughtful article outlining some of the major challenges for nationwide adoption of EHR technology. Time (March 5, 2009).
- Universities are (and have been for years) the leading sector for publicized data breaches. A new report examines the reasons. ComputerWorld (March 9, 2009). (The author of the article, Jay Cline, was only able 20 chief privacy officers at major U.S. universities, which is a clear sign that the academia - as institutions subject to numerous data privacy laws, including HIPAA, GLBA and FERPA - should be much more proactive and serious about data privacy protection.)