Violation of Privacy Rule Leads to $800,000 HIPAA Settlement

June 23, 2014 By

Indiana-based Parkview Health System (“Parkview”) has agreed to settle potential violations of the HIPAA Privacy Rule with the HHS Office for Civil Rights (“OCR”) by paying $800,000 and adopting a corrective action plan to address deficiencies in its HIPAA compliance program. The resolution agreement can be found here.

According to the HHS press release, the OCR opened an investigation after receiving a complaint from a retiring physician alleging that Parkview had violated the HIPAA Privacy Rule. In September 2008, Parkview took custody of medical records pertaining to approximately 5,000 to 8,000 patients while assisting the retiring physician to transition her patients to new providers, and while considering the possibility of purchasing some of the physician’s practice. On June 4, 2009, Parkview employees, with notice that the physician was not at home, left 71 cardboard boxes of these medical records unattended and accessible to unauthorized persons on the driveway of the physician’s home, within 20 feet of the public road and a short distance away from a heavily trafficked public shopping venue. It is unclear whether any of these medical records were actually viewed by anyone else.

In addition to the $800,000 payment, Parkview entered into a corrective action plan that requires them to:

  • Develop, maintain and revise, as necessary, written policies and procedures addressing requirements of the Privacy Rule and the corrective action plan (“Policies and Procedures”).  Specifically these Policies and Procedures must at a “minimum, provide for administrative, physical and technical safeguards (“safeguards”) to protect the privacy of non-electronic PHI to ensure that such PHI is appropriately and reasonably safeguarded from any intentional, unintentional or incidental use or disclosure that is in violation of the Privacy Rule.”
  • Provide Policies and Procedures to HHS within 30 days of Resolution Agreement’s Effective Date for HHS’s review and approval.
  • Distribute Policies and Procedures to all Parkview workforce members.
  • Periodically review the Policies and Procedures and update them to reflect changes in operations at Parkview, federal law, HHS guidance and/or any material compliance issues discovered by Parkview.
  • Notify HHS in writing within 30 days if Parkview determines that a workforce member has violated the Policies and Procedures (“Reportable Events”).
  • Provide general safeguards training to all workforce members who have access to PHI, as required by the Privacy Rule.
  • Provide training on its approved Policies and Procedures to all workforce members.
  • Submit to HHS a final report demonstrating Parkview’s compliance with the corrective action plan.

Organizations should pay careful attention to the transfer and disposal of both electronic and paper patient records. The OCR has provided helpful FAQs about HIPAA and the disposal of protected health information. For more information about complying with the HIPAA Privacy Rule, please contact Jefferson Lin or Elana Zana.

 

 

Filed Under: Breach Notification, Health Information Technology, HIPAA, HITECH Tagged With: , , ,

Rady HIPAA Breach – Access Controls & Training

June 19, 2014 By

Rady Children’s Hospital in San Diego announced this week that it has discovered two instances of impermissible disclosure of patient information – both disclosures arising from employees sending spreadsheets containing PHI to job applicants.  Surprisingly, Rady employees did not learn the lesson from their northern California neighbor, Stanford, which recently settled a lawsuit for $4 Million based on similar circumstances of a vendor releasing patient information to a job applicant.  In both the Rady situations (and at Stanford) identifiable patient information was sent to job applicants in order to evaluate those applicants’ skill sets.  The spreadsheets contained names, dates of birth, diagnoses, insurance carrier, claim information, and additional information.  Combined, the breach affected over 20,000 patients.

Rady has announced that it will take the following actions to prevent future events:

• Only commercially available and validated testing programs will be used to evaluate job applicants who will be tested onsite.
• We are increasing data security by further automating flagging of emails that may contain potential protected health or other sensitive information, and requiring an added level of approval before it can be sent.
• Rady Children’s is working with our email encryption provider to further strengthen our protection of sensitive data.
• Rady Children’s continually provides employees with education regarding privacy policies. We will be using these incidents as examples to better inform our leadership team and employees about the risks and the importance of the policies we have in place and train them in these new measures we are taking.

Though these steps are important, it is quite alarming that breaches such as these are still happening.  Why are job applicants receiving spreadsheets with patient information?  As Rady notes above, training exercises are commercially available.  Breaches, such as the one at Rady and at Stanford, reveal several flaws in HIPAA compliance – but two in particular rise to the surface.

1.  Access Controls.  The HIPAA Security Rule stresses the importance of access controls both internally and externally within a covered entity (and now business associates). Who gets access to the PHI, who gives that person access, and what access do they have?  The administrative, physical, and technical safeguard requirements all touch on whether access to PHI for workforce members is appropriate.  For example, a technical safeguard requirement specifically addressing access controls requires that covered entities, and business associates “implement technical policies and procedures for electronic information systems that maintain electronic protected health information to allow access only to those persons or software programs that have been granted access rights as specified in 164.308(a)(4).”  45 CFR 164.312.  Covered entities and business associates alike should evaluate who within their organizations actually need access to PHI to perform job functions.  Does the HR Department or an internal/external recruiter, arguably in charge of hiring new staff, need PHI in order to perform their job duties?  (Note, I do not opine here as to whether access to PHI was properly granted to the workforce members at Rady, as I lack sufficient information to make that judgment).  Determining if access to PHI is appropriate is both a requirement of the HIPAA Security Rule (though it is “addressable” you still need to address it!) and is a good mitigation tactic to avoid impermissible breaches, such as the one here.

2.  Training.  All covered entities and business associates are responsible for HIPAA Security training for all members of the workforce.  45 CFR 164.308.  Though training may vary depending on the workforce member’s use of PHI, all staff must be trained.  Training does not end following an initial session.  Periodic security updates are specifically identified in the Security Rule as an implementation specification.  These updates do not have to be limited to information about new virus protection software installed on the system. They can include valuable tidbits like case studies, HIPAA rule reminders, and HIPAA related headlines.  For some workforce members HIPAA may not be top of mind (specifically for those in business roles that may not deal with patients or patient information on a routine basis).  Providing periodic training updates and reminders, including examples of other HIPAA breaches (i.e. Stanford here) may be very useful in driving home how easy HIPAA breaches can be…and how expensive they are.

Avoidance of HIPAA breaches altogether is nearly impossible, but proper access controls and training can help mitigate against breaches such as the one that occurred here.

For more information about HIPAA Security contact Elana Zana.

 

Filed Under: Breach Notification, Compliance, Health Information Technology, HIPAA Tagged With: , , , ,

$4.8 Million HIPAA Settlement – Patient Data on the Web

May 13, 2014 By

On May 7, 2014, HHS announced that New York-Presbyterian Hospital (“NYP”) and Columbia University (“CU”) agreed to collectively pay $4.8 million in the largest HIPAA settlement to date. The organizations settled charges that they potentially violated the HIPAA Privacy and Security Rules by failing to secure thousands of patients’ electronic protected health information (“ePHI”).

NYP and CU operate a shared data network that links patient information systems containing ePHI. On September 27, 2010, the two entities submitted a joint breach report following the discovery that the ePHI of 6,800 individuals had been impermissibly disclosed due to a deactivated server, resulting in ePHI being accessible on internet search engines. The ePHI included patient statuses, vital signs, medications, and laboratory results.

HHS Office for Civil Rights’ (“OCR”) subsequent investigation determined that neither entity had conducted an accurate and thorough risk analysis or developed an adequate risk management plan to address potential threats and hazards to ePHI security. Further, OCR found that NYP failed to implement appropriate policies and procedures for authorizing access to its databases and failed to comply with internal policies on information access management.

NYP agreed to pay $3.3 million and CU agreed to pay $1.5 million. In addition, both entities agreed to Corrective Action Plans that require each entity to:

  • Conduct a comprehensive and thorough risk analysis;
  • Develop and implement a risk management plan;
  • Review and revise policies and procedures on information access management and device and media controls;
  • Develop an enhanced privacy and security awareness training program; and
  • Provide progress reports.

Additionally, CU must also “develop a process to evaluate any environmental or operational changes” that impact the security of ePHI it maintains.

This settlement again highlights the necessity for healthcare organizations and business associates to create and implement Security policies and procedures, and to engage in a security management process that ensures the security of patient data.

For assistance on the HIPAA Security Rule requirements, drafting and implementing Security policies and procedures, or general HIPAA assistance please contact Elana Zana or Jefferson Lin.

 

Filed Under: Breach Notification, Compliance, Health Information Technology, HIPAA, HITECH Tagged With: , , ,

Skagit County Agrees to Pay $215,000 for HIPAA Violations

March 14, 2014 By

On March 6, 2014, the U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”) reached a $215,000 settlement with Skagit County in northwest Washington state for violations of the HIPAA Privacy, Security and Breach Notification Rules, according to terms of the Resolution Agreement.  This represents the first OCR settlement with a county government for HIPAA non-compliance. For two weeks in September 2011, the electronic protected health information (“ePHI”) for 1,581 individuals was exposed after the ePHI had been inadvertently moved to a publicly accessible web server maintained by Skagit County.  The accessible files included protected health information about the testing and treatment of infectious diseases.

The OCR investigation revealed that Skagit County failed to provide notification to individuals as required by the Breach Notification Rule and that the county failed to implement sufficient policies and procedures to prevent, detect, contain, and correct security violations. Further, Skagit County failed to provide necessary and appropriate security awareness and training for its workforce members.  As part of the settlement, the county has agreed to enter into a Corrective Action Plan to address deficiencies in various HIPAA compliance areas, including written policies and procedures, documentation requirements, training, and other measures.

This settlement highlights the importance for all covered entities and business associates, whether in the government or private sector, to implement policies and procedures to safeguard ePHI and, in case of a breach, to respond promptly and effectively. For more information about this OCR settlement or for assistance with HIPAA compliance, please contact Jefferson Lin or David Schoolcraft.

Filed Under: Breach Notification, HIPAA, HITECH, Washington Tagged With: , ,

High Number of HIPAA Mobile Device Breaches – Time to Use Safe Harbor Encryption

February 24, 2014 By

Most breaches of electronic protected health information (ePHI) reported to the Department of Health and Human Services (HHS) have related to the theft or loss of unencrypted mobile devices. These breaches can lead to potentially hefty civil fines, costly settlements and negative publicity (e.g. Stanford and Idaho laptops or APDerm thumb drive). Given the increasing use of mobile devices and the significant costs of breach notification, healthcare organizations and their business associates would be wise to invest in encryption solutions that fall within the “safeharbor” for HIPAA breach notification.

Encryption and the “Safeharbor” for HIPAA Breach Notification

Under HHS guidance, ePHI is not considered “unsecured” if it is 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.  To avoid a breach of the confidential process or key, these decryption tools should be stored on a device or at a location separate from the data they are used to encrypt or decrypt.  Encryption processes “consistent with” (for data at rest) or which “comply, as appropriate, with” (for data in motion) the National Institute for Standards and Technology (“NIST”) guidelines are judged to meet the law’s standard for encryption.  If ePHI is encrypted pursuant to this guidance, then no breach notification is required following an impermissible use or disclosure of the information—this is known as the HIPAA breach notification “safeharbor”. [78 FR 5664]

NIST Guidelines for Data at Rest

The NIST guidelines for data at rest do not provide specific requirements for encryption technology– instead, it describes common storage encryption technologies (full disk, volume, virtual, and file/folder encryption) and offers recommendations for implementing a storage encryption solution. A main takeaway from this guide is that “the appropriate encryption solution for a particular situation depends primarily upon the type of storage, the amount of information that needs to be protected, the environments where the storage will be located, and the threats that need to be mitigated.” Despite the lack of bright-line rules, the NIST guide does offer some key recommendations, such as:

  • When selecting a storage encryption technology, consider solutions that use existing system features (such as operating system features) and infrastructure.
  • Use centralized management for all deployments of storage encryption except for standalone deployments and very small-scale deployments.
  • Select appropriate user authenticators for storage encryption solutions.
  • Implement measures that support and complement storage encryption for end user devices.

Encryption Technology for Apple iOS Devices: A Case Study

The good news is that the technology is available to properly encrypt ePHI without being too burdensome.  For instance, Apple’s popular iPhones and iPads fortunately have their own built-in encryption technology.  Every iOS device has a “dedicated AES (Advanced Encryption Standard) 256 crypto engine built into the DMA (Direct Memory Access) path between the flash storage and main system memory, making file encryption highly efficient.”  Setting a passcode turns on Data Protection, and the passcode becomes a key to encrypting mail messages and attachments (or other apps), using 256-bit AES encryption. Notably, Apple’s encryption technology (CoreCrypto Module and CoreCrypto Kernel Module) has been FIPS (Federal Information Processing Standards) certified, a standard that the NIST guide references and approves.

Based on the NIST guidelines for data at rest, the following are some basic steps for implementing a storage encryption technology solution specifically with Apple iOS devices:

  • Ensure that users have up-to-date devices and operating systems (e.g. iPhone 4 or higher running iOS 4 or higher).
  • Work with an IT administrator or security expert to manage deployment of iPhones.
  • Select appropriate passcode requirements to meet your security needs, including timeout periods, passcode strength and how often the passcode must be changed. The effectiveness of data protection depends on a strong passcode, so it is important to require and enforce a passcode stronger than 4 digits when establishing passcode policies.
  • Store/transmit the minimum amount of ePHI necessary to effectuate communication.
  • Disable access to Notification Center and Alerts from locked screen to prevent display of potentially sensitive data.
  • Revise and document organizational policies as needed to incorporate appropriate usage of the storage encryption solution.
  • Make users aware of their responsibilities for storage encryption, such as physically protecting mobile devices and promptly reporting loss or theft of devices.

For additional guidance on mobile device security, the HHS Office of the National Coordinator for Health Information Technology (“ONC”) has also provided helpful tips in “How Can You Protect and Secure Health Information When Using a Mobile Device?”.

As healthcare becomes more mobile, covered entities, business associates, and health information technology vendors should become familiar with the “safeharbor” for HIPAA breach notification and the NIST guidelines for encryption of data at rest and in transit.  For more information about the HIPAA “safeharbor”, encryption standards, or HIPAA in general, please contact Jefferson Lin, Lee Kuo or David Schoolcraft.

 

Filed Under: Breach Notification, Compliance, Health Information Technology, HIPAA, HITECH Tagged With: , ,

HHS Deadline for HIPAA Breach Notification Reporting

February 18, 2014 By

As part of the HITECH revisions to HIPAA, providers are required to report all HIPAA breaches, regardless of the number of individuals affected to HHS on an annual basis.  The deadline for this report is Saturday, March 1st, 2014.  This reporting requirement is pursuant to the Omnibus HIPAA Rule published in January of 2013.  Providers who have had breaches affecting less than 500 individuals can report the HIPAA breaches here.  This report needs to be filled out for each breach that occurred during the 2013 calendar year.  For example, if a covered entity had a breach in April of 2013 affecting three individuals and another breach in December 2013 affecting two individuals the report must be submitted for each breach but not for each individual (a total of two reports would be submitted in this example).  To fill out this form covered entities will need to submit the following information about the breach:

  • General information regarding the covered entity
  • Whether the breach occurred at or by a Business Associate and the associated contact information for that Business Associate
  • Date of the Breach
  • Date of Discovery
  • Approximate number of individuals affected by the Breach
  • Type of Breach (i.e. theft, loss, unauthorized access, etc.)
  • Location of breached information (i.e. laptop, e-mail, etc.)
  • Type of Protected Health Information involved in the Breach (i.e. demographic, financial, etc.)
  • Description of the Breach
  • Safeguards in place prior to the Breach (i.e. firewalls, physical security, etc.)
  • Date individuals were notified of the Breach
  • Whether substitute notice was required (this requirement is described in the rule)
  • Whether media notice was required (this requirement is described in the rule)
  • Actions taken in response to the Breach (sanctions, mitigation, etc.)
  • Any additional actions taken
  • Attestation

For those covered entities that have had a breach which affected more than 500 individuals, this report should have been submitted no later than 60 days following discovery of the breach in accordance with the Breach Notification Rule.

If you have questions regarding filling out this report or on Breach Notification in general please contact Elana Zana or Dave Schoolcraft.

Filed Under: Health Information Technology, HIPAA, HITECH Tagged With: , ,

Stolen Thumb Drive Proves Costly for Dermatology Practice

January 3, 2014 By

The Department of Health and Human Services (HHS) recently announced a $150,000 settlement with a dermatology practice in Massachusetts that arose out of a stolen thumb drive.  The unencrypted drive, which contained the health information of approximately 2,200 individuals, was stolen from a vehicle of one of the practice’s staff members.

Although HHS was concerned with the staff member’s failure to safeguard the health information, the large settlement amount resulted primarily from the practice’s lack of HIPAA policies and procedures.  Specifically, HHS determined that the practice: (1) had no breach notification policies, (2) had not conducted risk assessments for potential security vulnerabilities, and (3) did not adequately perform HIPAA training for its workforce.

This case provides an important warning to health care providers who do not have comprehensive HIPAA and HITECH policies and procedures.  Although the risk of being selected for an HHS HIPAA audit is still relatively low, it only takes one breach of health information for HHS to open an investigation that can result in costly penalties.

For more information about HIPAA and HITECH policies and procedures, please contact Casey Moriarty.

 

Filed Under: HIPAA, HITECH Tagged With: , ,

UW Medicine Notifies 90,000 Patients of HIPAA Breach

December 3, 2013 By

Just before the Thanksgiving holiday, UW Medicine reported a HIPAA security breach, affecting roughly 90,000 patients at Harborview and UW Medical Centers.  In early October, a UW Medicine employee opened an e-mail attachment containing malicious software.  The malware took control of the computer, which had patients’ data stored on it.  The information that was exposed was a subset or extraction of data that was used for billing purposes.  Patient information may have included names, medical record numbers, addresses, phone numbers, dates of service, charge amounts for services received, Social Security numbers or Medicare numbers.

This is the fourth biggest HIPAA security breach this year, according to data from the Department of Health and Human Services.  The other major breaches involved stolen unencrypted computers and laptops (Advocate Health System and AHMC Healthcare) and improper disposal of medical records (Texas Health Harris Methodist Hospital).

The recent UW Medicine incident highlights the need for hospitals, providers, and business associates to monitor and update their virus protection software and firewalls.  Additionally, organizations should implement security awareness and training programs for all workforce members– this may include periodic reminders addressing malicious software or guidance on opening suspicious e-mail attachments, e-mail from unfamiliar senders or hoax e-mail.

For assistance with HIPAA and/or the breach notification rules please contact Elana Zana or Jefferson Lin.

 

Filed Under: HIPAA, HITECH Tagged With: , , ,

Stolen Laptop Leads to Stanford’s Fifth HIPAA Breach

June 26, 2013 By

Earlier this month Stanford reported its 5th HIPAA breach since 2009.  This is Stanford’s third largest breach, affecting nearly 13,000 patients.   A broken laptop containing protected health information of pediatric patients was stolen from a restricted area of the Lucile Packard Children’s Hospital at Stanford.  The laptop was un-encrypted and contained patient information including: name, medical record number, age telephone numbers, surgical procedures and treating physicians.  Though the laptop had a broken screen, there is still the possibility of extracting the data from the computer.

Stanford’s other breaches include a disclosure  of 20,000 patient records when a subcontractor of a business associate placed patient information on the web seeking assistance with using Excel, the data was left on the website for nearly a year.  This breach has resulted in a $20 Million class action law suit under California law.

Earlier this year, Stanford announced its largest breach, affecting 57,000 patient records when an unencrypted laptop with patient information was stolen from a physician’s car.  In addition, Stanford reported a breach in 2012 of 2,500 patient records following the theft of an unencrypted laptop from a physician’s office.  Lastly, in 2010, Stanford was hit with a fine after failing to notify the state of California of the theft of a laptop by an employee containing over 500 patient records.

Considering Stanford’s previous breaches, encryption of its laptops would be a good course of action to prevent future HIPAA data breaches.  Stanford has reported that it now encrypts its laptops, but the one that was most recently stolen was unencrypted because the screen was broken.

Lessons learned from Stanford’s misfortunes:  encrypt all PHI and destroy broken devices (remember though broken, the data is still valuable to thieves).

For assistance with  HIPAA and/or the breach notification rules please contact Elana Zana.

Filed Under: Compliance, HIPAA, HITECH, Hospitals Tagged With: , , ,

Deadline to Report HIPAA Breach to HHS is Friday, March 1st

February 25, 2013 By

As part of the HITECH revisions to HIPAA, providers are required to report all HIPAA breaches, regardless of the number of individuals affected to HHS on an annual basis.  The deadline for this report is Friday, March 1st.  This reporting requirement is pursuant to the interim final rule on Breach Notification, the Omnibus HIPAA rule published in January does not impose any new requirements related to reporting of 2012 HIPAA breaches.  Providers who have had breaches affecting less than 500 individuals can report the HIPAA breaches here.  This report needs to be filled out for each breach that occurred during the 2012 calendar year.  For example, if a covered entity had a breach in March of 2012 affecting five individuals and another breach in August 2012 affecting two individuals the report must be submitted for each breach but not for each individual (a total of two reports would be submitted in this example).  To fill out this form covered entities will need to submit the following information about the breach:

  • General information regarding the covered entity
  • Whether the breach occurred at or by a Business Associate and the associated contact information for that Business Associate
  • Date of the Breach
  • Date of Discovery
  • Approximate number of individuals affected by the Breach
  • Type of Breach (i.e. theft, loss, unauthorized access, etc.)
  • Location of breached information (i.e. laptop, e-mail, etc.)
  • Type of Protected Health Information involved in the Breach (i.e. demographic, financial, etc.)
  • Description of the Breach
  • Safeguards in place prior to the Breach (i.e. firewalls, physical security, etc.)
  • Date individuals were notified of the Breach
  • Whether substitute notice was required (this requirement is described in the rule)
  • Whether media notice was required (this requirement is described in the rule)
  • Actions taken in response to the Breach (sanctions, mitigation, etc.)
  • Any additional actions taken
  • Attestation

For those covered entities that have had a breach which affected more than 500 individuals, this report should have been submitted no later than 60 days following discovery of the breach in accordance with the interim final rule on Breach Notification Rule.

If you have questions regarding filling out this report or on Breach Notification in general please contact Elana Zana or Dave Schoolcraft.

Filed Under: HIPAA, HITECH Tagged With: