HIPAA Compliance News

Cottage Health Fined $2 Million By California Attorney General’s Office

Posted by HIPAA Journal

Santa Barbara-based Cottage Health has agreed to settle a data breach case with the California attorney general’s office. Cottage Health will pay $2 million to resolve multiple violations of state and federal laws.

Cottage Health was investigated by the California attorney general’s office over a breach of confidential patient data in 2013. The breach was discovered by Cottage Health on December 2, 2013, when someone contacted the healthcare network and left a message on its voicemail system warning that sensitive patient information had been indexed by the search engines and was freely available via Google.

The sensitive information of more than 50,000 patients was available online, without any need for authentication such as a password and the server on which the information was stored was not protected by a firewall. The types of information exposed included names, medical histories, diagnoses, prescriptions, and lab test results. In addition to the individual who alerted Cottage Health to the breach, the server had been accessed by other individuals during the time that it was unsecured.

As is required under state laws, the incident was reported to state attorney general Kamala D. Harris. Two years later, while the attorney general’s office was investigating the incident, Cottage Health experienced a second breach. The second breach involved the records of 4,596 patients, and similarly, were left exposed and accessible online without any need for authentication.

The information was accessible for almost two weeks before the error was identified and protections put in place to prevent unauthorised access. The information exposed in the second breach included personally identifiable information and protected health information such as names, addresses, medical record numbers, account numbers, employment information, Social Security numbers, and admission and discharge dates.

Cottage Health claims that while both incidents resulted in the exposure of patient data, there are no indications to suggest any patient information was used inappropriately. The breaches prompted Cottage Health to review its information security controls and strengthen its policies, procedures, and security protections to prevent similar breaches from occurring in the future. In each case, the health network’s security teams acted quickly to limit harm and secure the exposed information. New system monitoring tools have now been implemented, and advanced security solutions are in place that allow vulnerabilities to be identified and mitigated much more rapidly.

The response to the breach may have been reasonable and appropriate, and protections now far better, but it is the lack of protections leading up to the data breaches that warranted a financial penalty. The California state attorney general’s office alleges that Cottage Health breached California’s Confidentiality of Medical Information Act, its Unfair Competition Law, and HIPAA Rules were also violated. According to the complaint, “Cottage failed to employ basic security safeguards.” Cottage Health was running outdated software, patches were not applied promptly, default configurations had not been changed, strong passwords were not used, access to sensitive PII was not limited, and regular risk assessments were not conducted.

Announcing the settlement, California Attorney General Xavier Becerra said, “When patients go to a hospital to seek medical care, the last thing they should have to worry about is having their personal medical information exposed,” Becerra explained that “The law requires health care providers to protect patients’ privacy. On both of these counts, Cottage Health failed.”

In addition to the $2 million settlement, Cottage Health is required to update and maintain information security controls and ensure security practices and procedures match industry standards.

Specifically, the judgement requires Cottage Health to:

  • Assess hardware and software for vulnerabilities to the confidentiality, integrity, and availability of patients’ medical information.
  • Update access controls and security settings as appropriate
  • Evaluate the response to and protections from external threats, including firewall security
  • Encrypt patients’ medical information in transit to industry standards
  • Maintain reasonable policies and protocols for all information practices regarding data retention, internal audits, security incident tracking reports, risk assessments, incident management, and remediation plan
  • Conduct periodic vulnerability scans and penetration tests to identify and assess vulnerabilities, and remediate any vulnerabilities discovered
  • Conduct employee training on the correct use and storage of patients’ medical information.

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Is Slack HIPAA Compliant?

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Slack is a powerful communication tool for improving collaboration, but is Slack HIPAA compliant? Can Slack be used by healthcare organizations for sharing protected health information without risking a HIPAA violation?

Is Slack HIPAA Compliant?

There has been considerable confusion about the use of Slack in healthcare and whether Slack is HIPAA compliant.

Since its launch, Slack has not been HIPAA compliant, although steps have been taken to develop a version of the platform that can be used by healthcare organizations. That version is called Slack Enterprise Grid.

In 2017, Geoff Belknap, Chief Security Officer at Slack, said “our team has spent over a year investing our time and effort into meeting the rigorous security needs of our customers who work in highly regulated industries.”

Slack Enterprise Grid was announced at the start of 2017. It should be noted that Slack Enterprise Grid is not the same as Slack. It has been built on different code, and has been developed specifically for use by companies with more than 500 employees.

Slack Enterprise Grid incorporates several security features that support HIPAA compliance. Those features include data encryption at rest and in transit, customer message retention to create an audit trail, and support for data loss prevention to ensure that audit trail is maintained.

Slack Enterprise Grid creates detailed access logs, and administrators can remotely terminate connections and sign users out from all connected devices. Team owners can delete all customer data within 24 hours – useful for when users leave the company. Slack also includes team-wide two-factor authentication, creates offsite backups, and is compliant with NIST standards, as well as SOC2 and SOC3.

As Slack explains on its website, “Slack Enterprise Grid customers in regulated industries can benefit from our DLP and eDiscovery support to become HIPAA and FINRA compliant.”

On February 4, 2018, Slack confirmed on Twitter that the only version of the platform that supports HIPAA compliance is Enterprise Grid. Slack has also recently updated its website to confirm that it supports HIPAA compliance and can be used to share patients’ protected health information securely.

is Slack HIPAA compliant

At present (February 2019), the platform only supports HIPAA compliance for file uploads. Use of its direct messaging and channel communications features are not compliant and cannot be used in connection with PHI. Those features are expected to be made HIPAA compliant later in 2019.

So is Slack HIPAA compliant? No. Is Slack Enterprise Grid HIPAA compliant? It can be.

However, before Slack Enterprise Grid can be used by healthcare organizations for any activities involving PHI, there is the matter of the HIPAA business associate agreement (BAA).

Will Slack Sign a Business Associate Agreement?

A business associate agreement must be signed with a company prior to its platform being used to send or receive protected health information (PHI). And as Slack points out on its website, “Customer must not use, disclose, transmit or otherwise process any “Protected Health Information” as defined in HIPAA.”

Slack also states that, “Unless Customer has entered into a written agreement with Slack to the contrary, Customer acknowledges that Slack is not a “Business Associate,” suggesting Slack is prepared to sign a BAA for Slack Enterprise Grid.

However, the BAA is not universally offered and is not available on the Slack website. Healthcare organizations considering using Slack Enterprise Grid must contact Slack and request a copy, and scrutinize the BAA – if one is offered.

With a signed BAA, healthcare organizations must then carefully configure the platform. An audit trail must be maintained, user logins carefully set up, policies and procedures developed covering the use of the platform, and staff must be trained. The eDiscovery function must also be activated.

Even with a BAA in place, it will be possible for Slack Enterprise Grid to be used in a manner that is not HIPAA compliant.

 

 

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October 2017 Healthcare Data Breaches

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In October 2017, there were 27 healthcare data breaches reported to the Department of Health and Human Services’ Office for Civil Rights. Those data breaches resulted in the theft/exposure of 71,377 patient and plan member records. October saw a significant fall in the number of reported breaches compared to September, and a major fall in the number of records exposed.

Healthcare data breaches by month (July-October 2017)

October saw a major reduction in the number of breached records, with the monthly total almost 85% lower than September and almost 88% lower than the average number of records breached over the preceding three months.

healthcare records breached July-October 2017

Healthcare providers were the worst hit in October with 19 reported data breaches. There were six data breaches reported by health plans and at least two incidents involved business associates of HIPAA-covered entities.

October 2017 Healthcare Data Breaches by Covered Entity Type

October 2017 healthcare data breaches by covered entity type

Main Causes of October 2017 Healthcare Data Breaches

Unauthorized access/disclosures were the biggest causes of healthcare data breaches in October. There were 14 breaches reported involving unauthorized access/disclosures, 8 hacking incidents, four cases of theft, and one unencrypted laptop computer was lost.

cause of october 2017 healthcare data breaches

Unauthorized access/disclosures were the leading causes of October 2017 healthcare data breaches, although hacking/IT incidents exposed more records – Over twice the number of records exposed by unauthorized access/disclosures and hacking/IT incidents exposed more records than all other breach types combined.

october 2017 healthcare data breaches - records exposed

Location of Exposed and Stolen Protected Health Information

Email was the most common location of breached PHI in October. Five of the nine incidents involving email were the result of hacking/IT incidents such as phishing. The remaining four incidents were unauthorized access/disclosures such as healthcare employees sending emails containing PHI to incorrect recipients. Five incidents involved paper records, highlighting the importance of securing physical records as well as electronic protected health information.

october 2017 healthcare data breaches - location of breached PHI

October 2017 Healthcare Data Breaches by State

In October, healthcare organizations based in 22 states reported data breaches. The state that experienced the most data breaches was Florida, with 3 reported breaches. Maryland, Massachusetts, and New York each had two breaches.

Alabama, Arizona, California, Connecticut, Georgia, Iowa, Illinois, Kansas, Kentucky, Louisiana, Missouri, North Carolina, Ohio, Rhode Island, Tennessee, Texas, Virginia, and Washington each had one reported breach.

Largest Healthcare Data Breaches in October 2017

 

Breached Entity Entity Type Breach Type Individuals Affected
Chase Brexton Health Care Healthcare Provider Hacking/IT Incident 16,562
East Central Kansas Area Agency on Aging Business Associate Hacking/IT Incident 8,750
Brevard Physician Associates Healthcare Provider Theft 7,976
MHC Coalition for Health and Wellness Healthcare Provider Theft 5,806
Catholic Charities of the Diocese of Albany Healthcare Provider Hacking/IT Incident 4,624
MGA Home Healthcare Colorado, Inc. Healthcare Provider Hacking/IT Incident 2,898
Orthopedics NY, LLP Healthcare Provider Unauthorized Access/Disclosure 2,493
Mann-Grandstaff VA Medical Center Healthcare Provider Theft 1,915
Arch City Dental, LLC Healthcare Provider Unauthorized Access/Disclosure 1,716
John Hancock Life Insurance Company (U.S.A.) Health Plan Unauthorized Access/Disclosure 1,715

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5 Year Jail Term Upheld for Clinic Worker Who Stole PHI

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A clinic worker who stole the protected health information of mentally ill patients and sold the data to identity thieves has failed to get his 5-year jail term reduced.

Jean Baptiste Alvarez, 43, of Aldan, PA, stole daily census sheets from the Kirkbride Center, a 267-bed behavioral health care facility in Philadelphia. The census sheets contained all the information needed to steal the identities of patients and submit fraudulent tax returns in their names – Names, Social Security numbers, dates of birth and other personally identifiable information.

Alvarez had the opportunity to steal the data undetected, as the floor where the sheets were kept did not have security cameras.

Alvarez was paid $1,000 per census sheet by his to-co-conspirators, who used the information to submit 164 fraudulent tax returns in the names of the patients, resulting in a loss of $232,612 in tax revenue for the IRS.

In early 2016, Alvarez was found guilty of conspiracy to defraud, misuse of Social Security numbers, and aggravated identity theft. The latter carried a minimum sentence of 2 years. The maximum sentence for all counts was 24 years in jail, a maximum of three years of supervised release, and potentially a fine.

Judge Michael M. Baylson invoked the vulnerable victim enhancement, and Alvarez was sentenced to 5 years in jail for his crimes, 3 years of supervised release, was ordered to pay $266,985 in restitution, and a $500 special assessment fine.

Alvarez appealed the sentence claiming it was excessively harsh as his victims were not “vulnerable.” He also explained that he did not target the patients because they were mentally ill and had drug addiction issues. He only stole the information because he had access to it.

However, the U.S. Court of Appeals for the Third Circuit rejected his appeal to have the sentence reduced, ruling that Alvarez’s argument was without merit. The victims were suffering from mental health and addition issues and were vulnerable.  Judge D. Michael Fisher also noted that since the patients were not working, the IRS was unlikely to detect the fraud as there would not be any duplicate claim. The patients would similarly be unlikely to discover they had been defrauded due to their mental health issues. The 5-year jail term stands.

The case serves as a warning to healthcare workers that the theft of patients’ personal information can result in lengthy jail terms. The Department of Justice is aggressively pursuing cases of PHI theft, identity theft, and tax fraud, and is punishing criminals to the full extent of the law.

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How to Handle A HIPAA Privacy Complaint

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Healthcare providers need to be prepared to deal with a HIPAA privacy complaint from a patient. In order for an efficient response to be conducted, policies should be developed covering the complaints procedure and staff must be trained to handle HIPAA privacy complaints correctly.

Patients must also be clearly informed how they can make a HIPAA privacy complaint if they feel that their privacy has been violated or HIPAA Rules have been breached. This should be clearly stated in your Notice of Privacy Practices.

A HIPAA Privacy Complaint Should be Taken Seriously

When a HIPAA privacy complaint is filed, it is important that it is dealt with quickly and efficiently. Fast action will help to reassure patients that that you treat all potential privacy and security violations seriously.

While patients may be annoyed or upset that an error has been made, in many cases, patients are not looking to cause trouble. They want the issue to be investigated, any risks to be mitigated, the problem to be addressed to ensure it does not happen again, and in many cases, they seek an apology. If the complaint is dealt with quickly and efficiently, it may not be taken any further.

If a verbal complaint is made, the patient should be asked to submit the complaint in writing. You should provide a form for the patient to do this. The HIPAA privacy complaint form can then be passed on to your Privacy Officer to investigate.

Investigate All Complaints and Take Prompt Action

All HIPAA privacy complaints should be investigated to determine who was involved, and how the privacy of the patient was violated. The privacy breach may not be a one-off mistake. It could be an indication of a widespread problem within your organization. The Privacy Officer must identify the root cause of the privacy violation and take action to ensure that any issues are corrected to prevent similar privacy breaches from occurring in the future.

All individuals involved in the breach must be identified and appropriate action taken – disciplinary action and/or additional training. A report of the incident should be given to law enforcement if a crime is suspected, and policies and procedures may need to be updated to introduce new safeguards to prevent a recurrence.

The Privacy Officer will need to determine whether there has been a HIPAA breach, and if the incident must be reported. The investigation must determine whether any other patients are likely to have had their privacy violated. If so, they will need to be notified within 60 days.

If a HIPAA breach has occurred, the Breach Notification Rule requires covered entities to report the breach to OCR without unnecessary delay. State laws may also require healthcare organizations to notify appropriate state attorneys general of the breach.

A breach impacting 500 or more individuals must be reported to OCR within 60 days of the discovery of the breach, and within 60 days of year end for smaller breaches. The failure to investigate promptly may see that deadline missed. In 2017, OCR issued its first HIPAA penalty solely for a Breach Notification Rule violation.

It is important that all stages of the complaint and investigation are documented. Those documents are likely to be requested in the event of an audit or investigation by OCR or state attorneys general. If any documents are missing, that aspect of the complaint investigation cannot be easily proven to have taken place.

Once the investigation into the HIPAA privacy complaint has been completed, it is important to report back to the complainant and explain that their complaint has been investigated, and the actions taken to mitigate harm and prevent similar incidents from occurring in the future should be explained.

Summary of How to Correctly Handle a HIPAA Complaint

  • Request the HIPAA privacy complaint is made in writing
  • Pass the compliant to the Privacy Officer
  • Privacy Officer should find out who was involved and what PHI was breached
  • The root cause of the breach must be established
  • Action should be taken to mitigate harm
  • Pass information to HR to take disciplinary action against employees (if appropriate)
  • Report the breach to law enforcement (if appropriate)
  • Policies and procedures should be updated to prevent a recurrence
  • Retrain staff
  • Determine whether the breach is a reportable incident
  • Collate all documentation in relation to the breach and investigation
  • Contact the complainant and explain the findings of the investigation

If the breach is determined to be a reportable incident

  • Submit a breach report to OCR
  • Submit breach reports to appropriate state attorneys general
  • Provide a toll-free number for patients to find out more information
  • Notify all affected individuals by mail
  • Post a breach notice in a prominent place on the home page of your organization’s website for 90 days if current contact information for 10 or more individuals is not held

If the breach is discovered to affect more than 500 individuals

  • Issue a press release to a prominent media outlet

Privacy Violations Can Result in Financial Penalties

When patients believe their privacy has been violated, or HIPAA Rules have been breached, they may report the incident to the Department of Health and Human Services’ Office for Civil Rights. Some patients may choose to take this course of action rather than contact the covered entity concerned.

OCR is likely to take an interest in an organization’s HIPAA policies covering privacy complaints. Financial penalties await organizations that do not have documented policies and procedures in place, and the penalties for HIPAA violations can be severe.

OCR wants to see that complaints are treated seriously, they are adequately investigated and resolved, and that prompt action is taken to ensure they do not happen again. A fast and efficient response to a HIPAA privacy complaint – and correction of any HIPAA violations uncovered – will reduce the risk of a HIPAA violation penalty, and the amount of the penalty if it cannot be avoided.

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Is Google Hangouts HIPAA Compliant?

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Is Google Hangouts HIPAA compliant? Can Google Hangouts be used by healthcare professionals to transmit and receive protected health information (PHI)?

Is Google Hangouts HIPAA Compliant?

Healthcare organizations frequently ask about Google services and HIPAA compliance, and one product in particular has caused some confusion is Google Hangouts. Google Hangouts is the latest incarnation of the Hangouts video chat system, and has taken the place of Huddle (Google+ Messenger). Google Hangouts is a cloud-based communication platform that incorporates four different elements: Video chat, SMS, VOIP, and an instant messaging service.

Google will sign a business associate agreement for G Suite, which currently covers the following Google core services

  • Gmail
  • Calendar
  • Google Drive (Includes Google Docs, Google Sheets, Google Slides, and Google Forms)
  • Apps Script
  • Keep
  • Sites
  • Jamboard
  • Google Cloud Search
  • Vault (If applicable)
  • Google Hangouts (Chat messaging)
  • Hangouts Meet

The Business Associate Agreement does not cover Google Groups, Google Contacts, and Google+, none of which can be used in conjunction with protected health information. Google also advises users to disable the use of non-core services in relation to G suite – for example YouTube, ​Blogger ​and Google ​Photos.

So, certain elements of Google Hangouts are HIPAA compliant and can be used by HIPAA covered entities without violating HIPAA Rules, provided that prior to the use of the services with PHI, the covered entity has entered into a business associate agreement with Google.

However, even with a BAA in place, not all elements of Google Hangouts are HIPAA compliant, so covered entities must exercise caution. Video chat for instance, is not covered by the BAA so cannot be used, and neither the SMS and VOIP options.

To help make Google Hangouts HIPAA compliant, Google has released a guide for healthcare organizations.

Google Hangouts HIPAA Compliance Depends on Users

If you decide to allow the use of Google Hangouts in your organization, it important to address the allowable uses of Google Hangouts with respect to PHI through policies and procedures. Staff must be trained on the correct use of the platform, and instructed which elements of Google Hangouts can be used and which are prohibited. If video chat is important for your organization, you should seek a HIPAA-compliant alternative platform.

As we have mentioned in a previous post, simply obtaining a BAA from Google is no guarantee of HIPAA compliance – that will depend on how Google services are configured and how they are used – See this page for further information of G Suite HIPAA Compliance.

Don’t Forget to Implement Additional Safeguards for Mobile Devices

One area where HIPAA-covered entities could easily violate HIPAA Rules is the use of Google Hangouts on mobile devices. Google does have excellent security controls that can alert users to potential unauthorized access of their Google account. These should be configured to ensure inappropriate access attempts are identified rapidly. Controls should also be implemented on mobile devices to ensure that the devices are protected in case of loss or theft.

Access controls on the device should be implemented to prevent the device, and any ePHI stored on it, from being easily accessed. Policies and procedures should also be developed to ensure lost and stolen devices are reported promptly, and actions taken to secure accounts. It is also recommended to implement controls that allow lost and stolen devices to be located, locked, and remotely wiped.

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President Trump Nominates Alex Azar for HHS Secretary

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Former Deputy Secretary of the Department of Health and Human Services, Alex Azar, is tipped to take over from former Secretary Tom Price after receiving the presidential nomination for the role. Azar previously served as general counsel to the HHS and Deputy Secretary during the George W. Bush administration.

President Trump confirmed on Twitter that he believes Azar is the man for the job, tweeting “Happy to announce, I am nominating Alex Azar to be the next HHS Secretary. He will be a star for better healthcare and lower drug prices!”

The position of Secretary of the Department of Health and Human Services was vacated by former Secretary Tom Price in September, following revelations about his controversial use of military aircraft and expensive charter flights to travel around the country.

While there were several potential candidates tipped to receive the nomination, including commissioner of the Food and Drug Administration, Scott Gottlieb, and administrator of the Centers for Medicare and Medicaid Services, Seema Verma, President Trump has made a controversial choice.

Alex Azar is a trained lawyer, but has spent the past ten years working in the pharmaceutical industry – an industry regulated by the HHS. In 2007, Azar joined pharmaceutical giant Eli Lilly taking on the role of senior vice president of corporate affairs and communications before becoming the head of the U.S. division of the firm until January 2017, when he left to start up his own consulting firm.

The nomination of Azar has raised many eyebrows. While President Trump has tweeted that he sees Azar as the man to help lower drug prices, Eli Lilly has attracted considerable criticism in the past for hikes in drug prices, notably for price rises to Insulin, one of the firm’s major pharmaceutical products. President Trump has previously claimed the pharmaceutical industry is ‘getting away with murder’ setting prices for their products.

Democrats have already expressed skepticism about how Azar would be able to help lower healthcare costs, not sharing Trump’s optimistic view that Azar can help drive prices down.

Azar has also been a harsh critic of the Affordable Car Act, sharing President’s Trump’s view that the ACA should be repealed. Despite repeated attempts, the failure to repeal ACA will mean that if appointed, Azar will be responsible for overseeing enforcement of the ACA.

Before Azar can take the helm of the Department of Health and Human Services, he must first be approved by Congress. Azar’s record while serving in the pharmaceutical industry is certain to be scrutinized, as will his commitment to enforcing the Affordable Care Act that he has previously strongly opposed.

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In What Year Was HIPAA Passed into Legislature?

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The Health Insurance Portability and Accountability Act or HIPAA was passed into legislature on August 21, 1996, when Bill Clinton added his signature to the bill.

Initially, the purpose of HIPAA was to improve portability and continuity of health insurance coverage, especially for employees that were between jobs. HIPAA also standardized amounts that could be saved in pre-tax medical savings accounts, prohibited tax-deduction of interest on life insurance loans, enforced group health plan requirements, simplified the administration of healthcare with standard codes and practices, and introduced measures to prevent healthcare fraud.

Many of the details of the five titles of HIPAA took some time to be developed, and several years passed before HIPAA Rules became enforceable. The HIPAA Enforcement Rule, which allows the Department of Health and Human Services’ Office for Civil Rights to impose financial penalties for noncompliance with HIPAA Rules, was not passed until February 16, 2006 – A decade after HIPAA was first introduced.

There have been several important dates in the past two decades since HIPAA was originally passed – Notably the introduction of the HIPAA Privacy Rule, HIPAA Security Rule, HIPAA Breach Notification Rule, and the HIPAA Omnibus Rule.

The HIPAA Privacy Rule introduced many provisions to better protect the privacy of patients. The Security Rule was primarily concerned with the security of electronic protected health information. The Breach Notification Rule ensures that all breaches of protected health information are reported, while the Omnibus Rule introduced a broad range of changes, including new requirements required by the Health Information Technology for Economic and Clinical Health (HITECH) Act.

Four key updates to HIPAA legislation are detailed below.

The Privacy Rule of HIPAA Passed into Legislature

The Privacy Rule of HIPAA was passed into legislature on December 28, 2000. The official name of the update to HIPAA is the “Standards for Privacy of Individual Identifiable Health Information.” The HIPAA Privacy Rule compliance date was April 14, 2003.

The HIPAA Privacy Rule details the allowable uses and disclosures of protected health information without first obtaining consent from patients. The HIPAA Privacy Rule also gives patients the right to obtain copies of their health data from HIPAA-covered entities.

The Security Rule of HIPAA Passed into Legislature

The Security Rule of HIPAA was passed into legislature on April 21, 2003, although the effective date was not until April 21, 2005. While the HIPAA Privacy Rule was concerned with all forms of protected health information, the HIPAA Security Rule is primarily concerned with the creation, use, storage and transmission of electronic PHI. The HIPAA Security Rule requires administrative, physical, and technical safeguards to be introduced to keep PHI secure. The Security Rule also introduced requirements for when PHI is no longer required.

The Breach Notification Rule of HIPAA Passed into Legislature

The HIPAA Breach Notification Rule came from the Health Information Technology for Economic and Clinical Health (HITECH) Act, which was passed on February 17, 2009. The HIPAA Breach Notification Rule took effect from August 24, 2009.

The Breach Notification Rule requires HIPAA-covered entities to submit notifications of breaches of protected health information to the Secretary of the Department of Health and Human Services within 60 days of the discovery of a breach if the breach involved 500 or more records. Smaller breaches must still be reported, no later than 60 days after the end of the year in which the breach was discovered. The Breach Notification Rule also requires notifications of a breach to be sent to affected patients within 60 days of the discovery of the breach.

The Omnibus Rule of HIPAA Passed into Legislature?

The HIPAA Omnibus Final Rule was issued on January 17, 2013. The HIPAA Omnibus Rule introduced several changes to the HIPAA Privacy, Security, and Breach Notification Rules.

One of the most important changes affected HIPAA business associates – individuals or entities that are contracted to HIPAA-covered entities to provide services that require access to PHI.

Since the passing of the HIPAA Omnibus Rule, business associates of HIPAA-covered entities, and their subcontractors, must implement safeguards to protect ePHI as required by the HIPAA Security Rule. Since the introduction of the Omnibus Rule, business associates of HIPAA-covered entities can be fined directly for HIPAA violations.

Another important update was clarification of “significant harm.” Prior to the introduction of the Omnibus Rule, many covered entities failed to report breaches as there was determined to have been no significant harm caused to patients as a result of the breach. After the Omnibus Rule, covered entities must be able to prove there was no significant harm if they decide not to report a breach.

Infographic Summary of Milestones in the History of HIPAA

In addition to the above major changes to HIPAA legislation, there have been numerous milestones in the history of HIPAA, which have been summarized in the infographic below. The infographic details legislation changes, clarifications of HIPAA Rules, major enforcement actions, and HIPAA audits – Click the image below to view the graphic in full size.

HIPAA History

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What is a Limited Data Set Under HIPAA?

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A limited data set under HIPAA is a set of identifiable healthcare information that the HIPAA Privacy Rule permits covered entities to share with certain entities for research purposes, public health activities, and healthcare operations without obtaining prior authorization from patients, if certain conditions are met.

In contrast to de-identified protected health information, which is no longer classed as PHI under HIPAA Rules, a limited data set under HIPAA is still identifiable protected information. Therefore it is still subject to HIPAA Privacy Rule regulations.

A HIPAA limited data set can only be shared with entities that have signed a data use agreement with the covered entity. The data use agreement allows the covered entity to obtain satisfactory assurances that the PHI will only be used for specific purposes, that the PHI will not be disclosed by the entity with which it is shared, and that the requirements of the HIPAA Privacy Rule will be followed.

The data use agreement, which must be accepted prior to the limited data set being shared, should outline the following:

  • Allowable uses and disclosures
  • Approved recipients and users of the data
  • An agreement that the data will not be used to contact individuals or re-identify them
  • Require safeguards to be implemented to ensure the confidentiality of data and prevent impermissible uses and disclosures
  • State the discovery of impermissible uses and disclosures must be reported back to the covered entity
  • State that any subcontractors who are required to access or use the data also enter into a data use agreement and agree to comply with its requirements.

In all cases, the HIPAA minimum necessary standard applies, and information in the data set must be limited to only the information necessary to perform the purpose for which it is disclosed.

What Information Must be Removed From a Limited Data Set Under HIPAA?

A limited data set under HIPAA cannot contain any of the following identifiers:

  • Names – including those of relatives, employers, and household members
  • Street addresses or postal address information with the exception of town/city, state, and zip code
  • Phone/Fax numbers
  • E-mail addresses
  • Social Security numbers
  • Medical record numbers
  • Health plan beneficiary numbers
  • Other account numbers
  • Certificate and license numbers
  • Vehicle identifiers and serial numbers, including license plate numbers
  • Device identifiers and serial numbers
  • URLs and IP addresses
  • Biometric identifiers such as fingerprints, retinal scans and voice prints
  • Full face photos and comparable images

Limited Data Sets: FAQs

What are the differences between a limited data set under HIPAA and de-identified protected health information?

The differences are that the content of a limited data set is still subject to Privacy Rule standards for uses and disclosures and it is necessary for a Covered Entity to enter into a data use agreement with the recipient of the limited data set prior to sharing the information with the recipient. De-identified protected health information has neither of these requirements because de-identified protected health information contains no individually identifiable health information.

What individually identifiable information can remain in a limited data set?

The list of identifiers in a limited data set can include the town, city, or state of the individual, their gender, and dates relating to the individual. Additionally, there is no requirement to remove “any other unique identifying number, characteristic, or code” as there is for de-identifying protected health information – notwithstanding that the list of identifiers for de-identifying protected health information is very out-of-date.

What is the purpose of a limited data set if most identifiers are removed?

As mentioned in the article, a limited data set under HIPAA can be used for research purposes, public health activities, and healthcare operations. Consequently, the set could be used to (for example) determine how many minors were treated in ED, establish the proportion of male vs female patients in geriatric care, or calculate what resources might be required to cope with a patient surge during a pandemic or other emergency.

Is the information left in a limited data set still protected health information?

Yes, as a limited data set includes information relating to an individual´s past, present, or future health conditions, treatments for the conditions, and payments for the treatments AND information that could be used to identify the individual, the information left in a limited data set meets the definition of protected health information in §160.103 of the Administrative Simplification Regulations.

What happens if the recipient of a limited data set misuses the information or impermissibly discloses the information?

As soon as the Covered Entity learns of any misuse or impermissible disclosure, it must conduct a risk assessment to determine whether the misuse/impermissible disclosure constitutes a notifiable data breach under the Breach Notification Rule. If so, the breach must be reported to the affected individual(s) and the HHS´ Office for Civil Rights.

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