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 Issues HIPAA Guidance For Mental Health

February 21, 2014 By

HHS recently issued HIPAA guidance for mental health practitioners, in an effort to help providers wade through complicated decisions of when disclosures of patient information are permissible.  This guidance, set up in a FAQ format, is designed to incorporate common questions related to the intersection of mental health and privacy laws.  The guidance addresses when healthcare providers are permitted to:

  • Communicate with a patient’s family members, friends, or others involved in the patient’s care;
  • Communicate with family members when the patient is an adult;
  • Communicate with the parent of a patient who is a minor;
  • Consider the patient’s capacity to agree or object to the sharing of their information;
  • Involve a patient’s family members, friends, or others in dealing with patient failures to adhere to medication or other therapy;
  • Listen to family members about their loved ones receiving mental health treatment;
  • Communicate with family members, law enforcement, or others when the patient presents a serious and imminent threat of harm to self or others; and
  • Communicate to law enforcement about the release of a patient brought in for an emergency psychiatric hold.

The guidance also addresses FERPA (privacy laws in a school setting), Federal alcohol and drug abuse confidentiality (42 CFR Part 2 Programs) and the rights of parents to have access to a minor child’s information.    Though not addressed in the guidance, those mental health practitioners practicing in Washington State should also be aware of  the new statutes regulating mental health record disclosures which take effect on July 1, 2014.

For assistance in navigating these privacy rules please contact Elana Zana or Dave Schoolcraft.

Filed Under: Compliance, HIPAA, Mental Health, Washington 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: , ,

Proposed HIPAA Rule to Enhance Criminal Background Check System

January 13, 2014 By

On January 7, the U.S. Department of Health & Human Services (HHS) published a notice of proposed rulemaking (NPRM) to revise the HIPAA Privacy Rule expressly permitting certain covered entities to disclose specific information about individuals who are subject to the federal mental health prohibitor to the National Instant Criminal Background Check System (NICS). HHS stated the purpose of this amendment is to help “strengthen the federal background check system to keep guns out of potentially dangerous hands” by removing legal barriers under HIPAA that may prevent reporting relevant information to the NICS.

The NICS is a national system used to conduct background checks on individuals who may be disqualified from purchasing or receiving firearms based on federally prohibited categories or state law. One such category is the federal “mental health prohibitor,” which includes individuals who have been (1) involuntarily committed to a mental institution; (2) found incompetent to stand trial or not guilty by reason of insanity; or (3) determined by a court, board, commission, or other lawful authority to be a danger to themselves or others or to lack the mental capacity to contract or manage their own affairs.

The proposed amendment would permit HIPAA covered entities that perform the commitments or adjudications that make individuals subject to the federal mental health prohibitor, or that act as repositories of NICS records on behalf of a state, to use and disclose certain information for NICS reporting purposes. These select covered entities would be permitted to disclose only  the “individual’s name; date of birth; sex; a code or notation indicating that the individual is subject to the Federal mental health prohibitor; a code or notation representing the reporting entity; and a code identifying the agency record supporting the prohibition.” Covered entities would not be permitted to disclose clinical or diagnostic information, medical records, or other identifiable health information. Covered entities could disclose the information directly to the NICS or to an entity designated by a state as a data repository for NICS reporting purposes.

Because the proposed rule focuses on covered entities that actually are responsible for ordering involuntary commitments or conducting adjudications, or that act as a designated repository of NICS records, it does not affect most treating providers or covered entities that only engage in treatment functions. Further, this modification would permit, not require, the specified covered entities to disclose information.  The proposed amendment would not include any additional notification requirements to individuals whose information was disclosed and would not require covered entities to change their notice of privacy practices.

HHS is seeking comments, which are due on March 10, on various issues addressed in the NPRM, including whether the permission should be broadened to include reporting on individuals subject to state firearms prohibitions and additional (non-clinical) identifying information.

For more information about the proposed rule or HIPAA in general, please contact Jefferson Lin.

Filed Under: HIPAA, Mental Health 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: , ,

Meaningful Use Audits – Security Risk Analysis

December 13, 2013 By

‘Tis the season for Meaningful Use, the time of year when eligible professionals (EPs) and eligible hospitals (EHs) compile their data from the meaningful use measures and prepare for attestation.  It is also the season of meaningful use audits.  A lesson learned from recent audits: CMS means what it says – EPs and EHs must conduct a security risk analysis.  This measure is not one to be taken lightly – it’s a HIPAA requirement, and CMS auditors are on the lookout for documentation (remember, all documentation must be retained for 6 years).

Regardless of whether EPs or EHs are attesting to Stage 1 or Stage 2, or the fact that they performed a security risk analysis last year, this objective and measure must be fulfilled each year:

 

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.

The HIPAA requirement for a Security Risk Analysis pursuant to 45 CFR 164.308(a)(1) is as follows:

“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.”

CMS Meaningful Use audits have specifically called out this objective and measure and are requiring participants to prove that a Security Risk Analysis has actually occurred.  Though the HIPAA Security Officer should have conducted a security risk analysis for the entire practice/hospital, EPs and EHs should maintain a copy of this assessment with their meaningful use documentation and should review the assessment to make sure that the risk analysis complies with the meaningful use requirements (note: the Stage 2 requirements are significantly broader).

Below is the audit question that was sent to some Stage 1 EPs:

“Provide proof that a security risk analysis of Certified EHR Technology was performed prior to the end of the reporting period (i.e. report which documents the procedures performed during the analysis and the results of the analysis).  If deficiencies are identified in this analysis, please supply the implementation plan; this plan should include the completion dates.”

Note that the audit request indicates that further documentation is needed to satisfy the auditors.  EPs must show the implementation plan and the completion dates.  As per the measure itself, the requirement is not merely to conduct a security risk analysis, but the EPs and EHs must implement security updates and correct security deficiencies.  EPs and EHs should document these steps as well in order to appropriately respond to an audit request.

CMS has recently issued a new tip sheet to assist EPs and EHs in fulfilling the security risk analysis requirement.  In addition ONC has published guidance on HIPAA Security Risk Analysis requirements.  The CMS tip sheet includes some common myths surrounding risk analysis such as:

  • “I only need to do a risk analysis once.”

False. To comply with HIPAA, you must continue to review, correct or modify, and update security protections.

  • “My EHR vendor took care of everything I need to do about privacy and security.”

False. Your EHR vendor may be able to provide information, assistance, and training on the privacy and security aspects of the EHR product. However, EHR vendors are not responsible for making their products compliant with HIPAA Privacy and Security Rules. It is solely your responsibility to have a complete risk analysis conducted.

  • “The security risk analysis is optional for small providers.”

False. All providers who are “covered entities” under HIPAA are required to perform a risk analysis. In addition, all providers who want to receive EHR incentive payments must conduct a risk analysis.

  • “Simply installing a certified EHR fulfills the security risk analysis MU requirement.”

False. Even with a certified EHR, you must perform a full security risk analysis. Security requirements address all electronic protected health information you maintain, not just what is in your EHR.

Responding to a Meaningful Use audit can be time consuming and very detailed oriented — thus, maintaining the appropriate documentation is essential.  For assistance with Meaningful Use or HIPAA security risk assessments, please contact Elana Zana.

Filed Under: EHR, HIPAA, HITECH, Hospitals, Incentive Payments, Meaningful Use Tagged With: , , ,

Reducing the Risks of Third-Party Access to EHR Systems

October 4, 2013 By

UnityPoint Health, a health system located in Iowa, recently informed 1,800 patients of a breach of their health information.  UnityPoint learned of the breach after an audit discovered that a third party contractor’s employee had improperly gained access to the UnityPoint electronic health record (EHR) system and viewed the records of the 1,800 patients.

The UnityPoint breach shows the risks of allowing a third party contractors, known as “business associates,” to access health information in an EHR system  While such access may be required for certain activities, including billing, claims management, or utilization review, providers must be certain that the business associate agreements with such contractors include strong protections for the provider.

For example, business associate agreements should include requirements for the business associate to indemnify the provider for expenses resulting from HIPAA breaches, pay all notification costs associated with such breaches, and maintain insurance policies that provide coverage for a large breach.

Although strong language in a business associate agreement provides legal protection for a provider, it will do nothing to counteract the public relations fallout that results from notifying patients of a breach.  Therefore, providers should make every effort to contract with legitimate entities that understand HIPAA compliance.

If you would like more information about HIPAA compliance, please contact Casey Moriarty.

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

Increase in Costs for Copies – But Don’t Forget HIPAA (Updated)

July 11, 2013 By

Effective July 1, 2013, medical providers in Washington may increase their charges for searching and duplicating medical records.  The Department of Health (“DOH”) recently released the updated fee schedule for providers. The revised charges are as follows:

 

Current Fee Schedule

Fee Schedule Effective
July 1, 2013

Copying for First 30 Pages

$1.04/page

$1.09/page

Additional Pages

$0.79/page

$0.82/page

Clerical Fees
(for searching and handling records)

$23.00

$24.00

 

Providers who personally edit confidential information from the record are allowed to charge their usual fee for a basic office visit.  Pursuant to HIPAA, this fee may be charged when the medical record is validly requested by someone other than the individual.

HIPAA Limitations Relating to Medical Record Requests by Patients

Though the WAC allows certain charges, HIPAA limits these charges when a patient requests duplication of his/her medical record.  Fees charged by providers may only include:

  1. Labor for copying the protected health information (whether electronic or paper form);
  2. Supplies for creating the paper copy or electronic media;
  3. Postage fees (when the individual has requested the copy by mail); and
  4. If, agreed to in advance by the patient, the cost of preparing an explanation or summary of the protected health information.

Applying both the WAC and HIPAA in combination, the clerical fee of $24.00 cannot be charged to a patient requesting a copy of his/her medical record; but a reasonable clerical fee for the labor of copying the medical record may be assessed.  Providers may not charge a fee equal to a basic office visit to the patient, but may charge a reasonable fee if a summary is provided.  Copying fees up to the maximum allowed by the WAC are permissible.  In addition, the HITECH Act amends HIPAA to allow a provider to impose a fee for the labor costs associated with copying an electronic medical record.

Filed Under: HIPAA, HITECH, Washington 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: , , ,

The HITECH Act Final Rule’s GINA-Related Modifications to HIPAA

April 12, 2013 By

The Genetic Information Nondiscrimination Act of 2008 (GINA) prohibits health insurers and health plans from discriminating against beneficiaries on the basis of genetic information.  The HITECH Act Final Rule makes some important GINA-related changes to HIPAA.

In general, the changes related to genetic information are solely of interest to health insurers and health plans.  With that said, the Final Rule’s amendment to the definition of “health information” to include genetic information is relevant to all covered entities.  Under this new definition, all HIPAA covered entities must ensure that the following information is protected and secured under the HIPAA Privacy and Security Rules:

1. Any information related to genetic tests of an individual.

2. The genetic tests of family members of an individual.

3. The manifestation of a disease or disorder in family members of an individual. “Manifestation” means a disease, disorder, or pathological condition that an individual has been or could reasonably be diagnosed with by a health care professional with appropriate training and expertise in the field of medicine involved.

4. Any request for, or receipt of, genetic services, or participation in clinical research which includes genetic services, by an individual or any family member of the individual.

Additional GINA-related changes to HIPAA under the Final Rule include an explicit prohibition on the use or disclosure of genetic information for a health insurer’s or health plan’s underwriting purposes. There is an exception for underwriting performed by issuers of long-term care policies.

The Final Rule also requires a health plan or health insurer to include a statement in its notice of privacy practices that it will not use or disclose genetic information of an individual for underwriting purposes. Again, there is an exception for issuers of long-term care policies.

If you would like more information about the Final Rule’s GINA-related modifications to HIPAA, please contact Casey Moriarty.

Filed Under: HIPAA, HITECH Tagged With: ,
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