Large Data Breach Highlights Risks from Foreign Hackers

Community Health Systems (CHS) has announced that the personal information of approximately 4.5 million patients has been breached.  According to CHS, the information includes patient names, addresses, social security numbers, telephone numbers, and birthdates.

Although the breached records do not contain the details of the patients’ treatment at CHS’ hospitals, the identifying information in the records still meets the HIPAA definition of “protected health information.”  Therefore, CHS will have to follow the HIPAA breach notification requirements.

According to CHS’ filing with the Securities and Exchange Commission, CHS has hired the data security firm, Mandiant, to investigate the breach.  Mandiant has pointed blame at a group originating from China who apparently orchestrated the breach through the use of sophisticated malware.

This large breach should be another reminder for health care providers to safeguard their electronic systems and educate staff members on security policies and procedures.  The type of malware that contributed to the CHS breach can often be installed by a staff member who clicks on a link in an e-mail, or responds to an e-mail from hackers who pose as security personnel.  In addition, health care providers should consider the use of encryption technology that meets the HIPAA breach safe harbor standards.

When in doubt about a suspicious e-mail, phone call, or other communication, staff members should always check with the provider’s information technology personnel and the HIPAA Privacy Officer before taking any action.

If you have any questions about the HIPAA breach notification requirements, please contact Casey Moriarty.

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

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.

 

 

Rady HIPAA Breach – Access Controls & Training

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.

 

$4.8 Million HIPAA Settlement – Patient Data on the Web

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.

 

Stolen Laptops Lead to $2 Million in HIPAA Settlements

Last week HHS announced close to $2 Million dollars in HIPAA settlements with Concentra and QCA Health Plan due to the theft of unencrypted laptops.  However, the message from HHS is not just the importance of data encryption, rather its performance and follow through with security risk analysis and implementation of security policies and procedures.  Further, the close to $2 million in fines do not include the additional costs and time it will take both of these health care organizations to comply with the OCR corrective action plans.

Concentra

The larger settlement and corrective action plan involved Concentra Health Services, a subsidiary of Humana, Inc., which operates more than 300 medical clinics nationally, including urgent care, occupational and physical therapy, and wellness services.  Concentra agreed to a $1,725,220 settlement with HHS for potential violations resulting from the breach notification associated with a stolen unencrypted laptop.  Specifically, the Resolution Agreement identified the following two deficiencies:

(1) Concentra failed to adequately remediate and manage its identified lack of encryption or, alternatively, document why encryption was not reasonable and appropriate and implement an equivalent alternative measure to encryption, if reasonable and appropriate, from October 27, 2008, until June 22, 2012 (date on which a complete inventory assessment was completed and Concentra immediately took action to begin encrypting all unencrypted devices) (see 45 C.F.R. § 164.312(a)(2)(iv)).

(2) Concentra did not sufficiently implement policies and procedures to prevent, detect, contain, and correct security violations under the security management process standard when it failed to adequately execute risk management measures to reduce its identified lack of encryption to a reasonable and appropriate level from October 27, 2008, (date of Concentra’s last project report indicating that 434 out of 597 laptops were encrypted) until June 22, 2012 (date on which a complete inventory assessment was completed and Concentra immediately took action to begin encrypting all unencrypted devices) (see 45 C.F.R. § 164.308(a)(1)(i)).

Interestingly, while the Security Rule allows for flexibility in implementation for certain measures, including data encryption under 45 CFR 164.312, this high settlement amount indicates that healthcare organizations (including now business associates) who choose not to implement encryption standards must be able to explain themselves.  HHS, in the Resolution Agreement, faults Concentra not only for failing to encrypt the data, but in light of a decision not to encrypt, Concentra was faulted for failing to implement an alternative to encryption (though unclear what a reasonable alternative to encryption would be).  Now, not only does Concentra have this large settlement payment due to HHS, but it has to comply with the corrective action plan, which includes the implementation of a security management plan (with a security risk analysis baked in), encryption obligations, security awareness training, and annual reports to HHS.  And if Concentra fails to comply, HHS has reserved its right to impose civil monetary penalties (which were significantly increased under the HITECH Act).

QCA Health Plan of Arkansas

The smaller settlement of $250,000 was with QCA Health Plan of Arkansas, a healthcare insurance provider.  The impetus for this settlement and corrective action plan was the theft of an unencrypted laptop from an employee’s car which contained PHI belonging to 148 individuals (note that this breach affected less than 500 individuals).  The Resolution Agreement determined that:

A.  QCA did not implement policies and procedures to prevent, detect, contain, and correct security violations, including conducting an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of ePHI it held, and implementing security measures sufficient to reduce risks and vulnerabilities to a reasonable and appropriate level to comply with 45 C.F.R. § 164.306 from the compliance date of the Security Rule to June 18, 2012.

B. QCA did not implement physical safeguards for all workstations that access ePHI to restrict access to authorized users on October 8, 2011.

C. QCA impermissibly disclosed the ePHI of 148 individuals on October 8, 2011.

Unlike Concentra, QCA was not directly faulted for failing to encrypt its laptops, or failing to implement a reasonable alternative. Rather, this settlement focused instead on the lack of sufficient HIPAA Security policies and procedures, inadequacy in conducting a security risk assessment, and the failure to implement security measures, most specifically physical safeguards. The corrective action plan is also noticeably different, with a focus instead on workforce training and reporting of workforce non-compliance, rather than on encryption requirements (the press release notes that QCA encrypted its laptops following the breach).

Though like most breach cases the simple solution is to encrypt the data to avoid an actual breach, these settlements expose the depth of compliance obligations and monetary consequences associated with the failure to securely protect the PHI.  Concentra and QCA, like other health care organizations who have settled with HHS, will have years of compliance reporting obligations and security management requirements that will likely create significant cost burdens in addition to the monetary settlement obligations.  HHS has made it quite clear in its press releases and corrective action plans, healthcare organizations and business associates must create and implement Security policies and procedures, and must engage in a security management process that ensures the security of patient data post the initial implementation.

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

HHS Security Risk Assessment Tool Webinar

The Office of the National Coordinator announced today that it will host a webinar to discuss its Security Risk Assessment Tool.

This webinar is designed to review the current state of the tool, discuss some of the known issues and ONC’s plan to address those identified issues, and answer questions from users across the country.

The webinar will be on April 29th at 2:00 PM Eastern (11:00 AM Pacific).  To register click here.

To learn more about the Security Risk Assessment Tool and using it for HIPAA and meaningful use compliance read our previous article here.

Want to Make HIPAA More Interesting? Try Playing Web Games

Many healthcare providers understand the importance of HIPAA compliance, but are not interested in reading detailed regulations and agency commentary to understand the rules.  If this describes any of your staff members, the Office of National Coordinator (ONC) for Health Information Technology may have a solution: play an online game.

In an effort to make HIPAA compliance a bit more fun, ONC has developed web games for both the HIPAA Privacy and Security Rules.  Each game provides a number of real-life patient privacy scenarios and asks the player to choose the correct course of action.

Sample scenarios include an employee’s access to unencrypted PHI on a home laptop, the purpose of an entity’s “contingency plan” under the Security Rule, and the use of e-mail to send unencrypted PHI.

The games might be something to try if you have found it difficult to make HIPAA compliance engaging for staff members.  Although the games are simple and fun, the issues that they address have huge significance for all covered entities and business associates.

You can access the games here.  What is your highest score?

For more information about HIPAA compliance, contact Casey Moriarty.

HHS Releases Security Risk Assessment Tool

Need help performing your HIPAA/Meaningful Use Security Risk Assessment?  Good news, HHS has released a tool to help!  In partnership with the Office of the National Coordinator, HHS created a tool, user guide, software, tutorial, videos and even an iOS App to help HIPAA covered entities and business associates perform the required HIPAA Risk Analysis.

The HIPAA Security Rule specifically requires (this is not an addressable specification) a Security Risk Analysis:

“Risk analysis (Required). Conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of electronic protected health information held by the covered entity or business associate.”  45 CFR 164.308(a)(1)

In addition, those hospitals and eligible professionals seeking to meet meaningful use in order to receive the EHR Incentive dollars or avoid the Medicare payment adjustments must fulfill a HIPAA Security Risk Assessment.

Stage 1

Stage 2

Objective. Protect electronic health information created or maintained by the certified EHR technology through the implementation of appropriate technical capabilities.Measure. Conduct or review a security risk analysis in accordance with the requirements under 45 CFR 164.308(a)(1) and implement security updates as necessary and correct identified security deficiencies as part of its risk management process. Objective. Protect electronic health information created or maintained by the Certified EHR Technology through the implementation of appropriate technical capabilities.Measure. Conduct or review a security risk analysis in accordance with the requirements under 45 CFR 164.308(a)(1), including addressing the encryption/security of data stored in Certified EHR Technology in accordance with requirements under 45 CFR 164.312(a)(2)(iv) and 45 CFR 164.306(d)(3), and implement security updates as necessary and correct identified security deficiencies as part of the EP’s risk management process.

For those hospitals and eligible professionals looking to meet meaningful use, the Security Risk Assessment tool will generate a report that can be provided to auditors.  However, the report alone is likely insufficient because both the auditors and the  meaningful use requirements (above) require the correction of security deficiencies – so merely running a Security Risk Assessment without taking actions to remedy the problem will not suffice.  To read more about meaningful use audits and security risk assessments click here

In addition to releasing the Security Risk Assessment tool, HHS has created a helpful true/false statement with the Top 10 Myths of Security Risk Analysis.  This document highlights the misconceptions regarding the risk assessment requirements, including that all covered entities and business associates (regardless of the size) must conduct a risk assessment pursuant to HIPAA.  Importantly, though only eligible professionals & hospitals are eligible for meaningful use incentives and Medicare payment adjustments, business associates must also comply with the HIPAA Security Rule pursuant to the HITECH Act.  Therefore, business associates must also conduct security risk assessments, and per recent guidance from HHS, business associates are likely part of the next round of HIPAA audits.

For more information about HIPAA, security risk assessments, and meaningful use please contact Elana Zana.

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

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.

Upcoming HIPAA Audits Will Include Business Associates

On February 24, 2014, the Department of Health and Human Services (“HHS”) published a notice of its proposed collection of information in connection with its HIPAA audit efforts.  Comments on the proposed collection request must be submitted by April 25, 2014.

The notice indicates HHS’s intent to survey up to 1,200 organizations, including both covered entities and business associates, to determine the organizations’ suitability for HIPAA audits by HHS.  The survey will seek information about an organization’s patient visits, use of electronic information, revenue, and business locations, among other things.  The notice hints that some sort of technology will be used to complete the survey, as HHS’s time estimate of 30-60 minutes to complete the survey includes the time needed to “develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information…”. The notice does not include details on the criteria HHS will use to select an organization for an audit.

One of the notable items of this notice is HHS’s announcement that this round of HIPAA surveys will include business associates as well as covered entites.  This is a clear signal that HHS is getting serious about HIPAA compliance by all organizations who handle protected health information.

For more information about HIPAA audits and HIPAA enforcement, please contact Lee Kuo.