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The most common HIPAA violations that have resulted in financial penalties are the failure to perform an organization-wide risk analysis to identify risks to the confidentiality, integrity, and availability of protected health information (PHI); the failure to enter into a HIPAA-compliant business associate agreement; impermissible disclosures of PHI; delayed breach notifications; and the failure to safeguard PHI.
The settlements pursued by the Department of Health and Human Services’ Office for Civil Rights (OCR) are for egregious violations of HIPAA Rules. Settlements are also pursued to highlight common HIPAA violations to raise awareness of the need to comply with specific aspects of HIPAA Rules.
This article covers five of the most common HIPAA violations that have resulted in settlements with covered entities and their business associates over the past few years.
Are Data Breaches HIPAA Violations?
Data breaches are now a fact of life. Even with multi-layered cybersecurity defenses, data breaches are still likely to occur from time to time. OCR understands that healthcare organizations are being targeted by cybercriminals and that it is not possible to implement impregnable security defenses.
Being HIPAA compliant is not about making sure that data breaches never happen. HIPAA compliance is about reducing risk to an appropriate and acceptable level. Just because an organization experiences a data breach, it does not mean the breach was the result of a HIPAA violation.
The OCR breach portal now reflects this more clearly. Many data breaches are investigated by OCR and are found not to involve any violations of HIPAA Rules. Consequently, the investigations are closed without any action being taken.
How are HIPAA Violations Discovered?
HIPAA violations can continue for many months, or even years, before they are discovered. The longer they are allowed to persist, the greater the penalty will be when they are eventually discovered. It is therefore important for HIPAA-covered entities to conduct regular HIPAA compliance reviews to make sure HIPAA violations are discovered and corrected before they are identified by regulators.
There are three main ways that HIPAA violations are discovered:
- Investigations into a data breach by OCR (or state attorneys general)
- Investigations into complaints about covered entities and business associates
- HIPAA compliance audits
Even when a data breach does not involve a HIPAA violation, or a complaint proves to be unfounded, OCR may uncover unrelated HIPAA violations that could warrant a financial penalty.
What are the 10 Most Common HIPAA Violations?
Listed below are 10 of the most common HIPAA violations, together with examples of HIPAA-covered entities and business associates that have been discovered to be in violation of HIPAA Rules and have had to settle those violations with OCR and state attorneys general. In many cases, investigations have uncovered multiple HIPAA violations. The settlement amounts reflect the seriousness of the violation, the length of time the violation has been allowed to persist, the number of violations identified, and the financial position of the covered entity/business associate.
Snooping on Healthcare Records
Accessing the health records of patients for reasons other than those permitted by the Privacy Rule – treatment, payment, and healthcare operations – is a violation of patient privacy. Snooping on healthcare records of family, friends, neighbors, co-workers, and celebrities is one of the most common HIPAA violations committed by employees. When discovered, these violations usually result in termination of employment but could also result in criminal charges for the employee concerned. Financial penalties for healthcare organizations that have failed to prevent snooping are relatively uncommon, but they are possible as University of California Los Angeles Health System discovered.
University of California Los Angeles Health System was fined $865,000 for failing to restrict access to medical records. The healthcare provider was investigated following the discovery that a physician had accessed the medical records of celebrities and other patients without authorization. Dr. Huping Zhou accessed the records of patients without authorization 323 times after learning that he would soon be dismissed. Dr. Zhou became the first healthcare employee to be jailed for a HIPAA violation and was sentenced to four months in federal prison.
Failure to Perform an Organization-Wide Risk Analysis
The failure to perform an organization-wide risk analysis is one of the most common HIPAA violations to result in a financial penalty. If the risk analysis is not performed regularly, organizations will not be able to determine whether any vulnerabilities to the confidentiality, integrity, and availability of PHI exist. Risks are therefore likely to remain unaddressed, leaving the door wide open to hackers.
HIPAA settlements with covered entities for the failure to conduct an organization-wide risk assessment include:
- Oregon Health & Science University– $2.7 million settlement for the lack of an enterprise-wide risk analysis.
- Cardionet – $2.5 million settlement for an incomplete risk analysis and lack of risk management processes.
- Cancer Care Group – $750,000 settlement for the failure to conduct an enterprise-wide risk analysis.
- Lahey Hospital and Medical Center – $850,000 settlement for the failure to conduct an organization-wide risk assessment and other HIPAA violations.
Failure to Manage Security Risks / Lack of a Risk Management Process
Performing a risk analysis is essential, but it is not just a checkbox item for compliance. Risks that are identified must then be subjected to a risk management process. They should be prioritized and addressed in a reasonable time frame. Knowing about risks to PHI and failing to address them one of the most common HIPAA violations penalized by the Office for Civil Rights.
HIPAA settlements with covered entities for the failure to manage identified risks include:
- Alaska Department of health and Social Services – $1.7 million penalty for the failure to perform risk analysis and risk management failures.
- University of Massachusetts Amherst (UMass) – $650,000 penalty for risk management failures.
- Metro Community Provider Network – $400,000 penalty for risk management failures.
- Anchorage Community Mental Health Services – $150,000 penalty for the failure to manage risk to ePHI.
Failure to Enter into a HIPAA-Compliant Business Associate Agreement
The failure to enter into a HIPAA-compliant business associate agreement with all vendors that are provided with or given access to PHI is another of the most common HIPAA violations. Even when business associate agreements are held for all vendors, they may not be HIPAA compliant, especially if they have not been revised after the Omnibus Final Rule.
Notable settlements for these common HIPAA violations include:
- Raleigh Orthopaedic Clinic, P.A. of North Carolina – $750,000 settlement for the failure to execute a HIPAA-compliant business associate agreement.
- North Memorial Health Care of Minnesota – $1.55 million settlement for failing to enter into a BAA with a major contractor and other HIPAA violations.
- Care New England Health System– $400,000 settlement for the failure to update business associate agreements
Insufficient ePHI Access Controls
The HIPAA Security Rule requires covered entities and their business associates to limit access to ePHI to authorized individuals. The failure to implement appropriate ePHI access controls is also one of the most common HIPAA violations and one that has attracted several financial penalties.
Financial penalties issued to covered entities for ePHI access control failures include:
- Anthem Inc. – $16,000,000 penalty for access control failures and other serious HIPAA violations.
- Memorial Healthcare System – $5,500,000 penalty for insufficient ePHI access controls.
- Texas Department of Aging and Disability Services – $1,600,000 penalty for risk analysis failures, access control failures, and information system monitoring failures.
- University of California Los Angeles Health System – $865,500 penalty for the failure to restrict access to medical records.
- Pagosa Springs Medical Center – $111,400 penalty for the failure to terminate access to ePHI after an employee termination and a lack of a business associate agreement.
Failure to Use Encryption or an Equivalent Measure to Safeguard ePHI on Portable Devices
One of the most effective methods of preventing data breaches is to encrypt PHI. Breaches of encrypted PHI are not reportable security incidents unless the key to decrypt data is also stolen. Encryption is not mandatory under HIPAA Rules, but it cannot be ignored. If the decision is taken not to use encryption, an alternative, equivalent security measure must be used in its place.
Recent settlements for the failure to safeguard PHI include:
- Children’s Medical Center of Dallas – $3.2 million civil monetary penalty for failing to take action to address known risks, including the failure to use encryption on portable devices.
- Catholic Health Care Services of the Archdiocese of Philadelphia– $650,000 settlement for the failure to use encryption, the failure to conduct an enterprise wide risk analysis, and to manage risks.
Exceeding the 60-Day Deadline for Issuing Breach Notifications
The HIPAA Breach Notification Rule requires covered entities to issue notifications of breaches without unnecessary delay, and certainly no later than 60 days following the discovery of a data breach. Exceeding that time frame is one of the most common HIPAA violations, which has seen two penalties issued this year:
- Presence Health – $475,000 settlement for delaying the issuing of breach notifications by a month.
- CoPilot Provider Support Services Inc. – $130,000 settlement with NY Attorney General for delayed breach notifications.
Impermissible Disclosures of Protected Health Information
Any disclosure of protected health information that is not permitted under the HIPAA Privacy Rule can attract a financial penalty. This violation category includes disclosing PHI to a patient’s employer, potential disclosures following the theft or loss of unencrypted laptop computers, careless handling of PHI, disclosing PHI unnecessarily, not adhering to the ‘minimum necessary’ standard, and disclosures of PHI after patient authorizations have expired.
Settlements for impermissible disclosures of PHI include:
- Memorial Hermann Health System – $2.4 million settlement for disclosing a patient’s PHI in a press release.
- New York Presbyterian Hospital – $2,200,000 penalty for filming patients without consent.
- Massachusetts General Hospital– $515,000 penalty for filming patients without consent.
- Luke’s-Roosevelt Hospital Center – $387,000 settlement for careless handling of PHI/Disclosure of a patient’s HIV status to their employer.
- Brigham and Women’s Hospital– $384,000 penalty for filming patients without consent.
- Boston Medical Center – $100,000 penalty for filming patients without consent.
Improper Disposal of PHI
When physical PHI and ePHI are no longer required and retention periods have expired, HIPAA Rules require the information to be securely and permanently destroyed. For paper records this could involve shredding or pulping and for ePHI, degaussing, securely wiping, or destroying the electronic devices on which the ePHI is stored to prevent impermissible disclosures.
Financial penalties issued to covered entities for improper disposal of PHI/ePHI include:
- Parkview Health – $800,000 penalty for the failure to securely dispose of paper records containing PHI.
- Cornell Prescription Pharmacy – $125,000 penalty for the improper disposal of PHI.
- FileFax Inc. – $100,000 penalty for a defunct business over improper disposal of medical records.
Denying Patients Access to Health Records/Exceeding Timescale for Providing Access
The HIPAA Privacy Rule gives patients the right to access their medical records and obtain copies on request. This allows patients to check their records for errors and share them with other entities and individuals. Denying patients copies of their health records, overcharging for copies, or failing to provide those records within 30 days is a violation of HIPAA. While this is not one of the most common HIPAA violations to attract a financial penalty, OCR has stated it will be cracking down on this aspect of noncompliance in 2019.
HIPAA settlements with covered entities for denying patients access to their records or unnecessary delays in providing access include:
Cignet Health of Prince George’s County – $4,300,000 penalty for denying patients access to their medical records.
Common HIPAA Violations by Healthcare Employees
Snooping on healthcare records is a fairly obvious HIPAA violation and one that all healthcare employees who have received HIPAA training should know is a violation of their employer’s policies and HIPAA Rules.
Other common HIPAA violations often come about as a result of misunderstandings about HIPAA requirements. While each of these common HIPAA violations affect far fewer numbers of patients than the above violations, they can still cause a significant amount of harm: To the patient(s) involved and their employer. They can also result in disciplinary action against the employee responsible including termination.
Listed below are some of the common HIPAA violations committed by healthcare employees. These common HIPAA violations should be covered as part of the HIPAA training given to employees to raise awareness to these frequent areas of noncompliance.
Emailing ePHI to Personal Email Accounts and Removing PHI from a Healthcare Facility
It can be difficult to find the time to complete all the necessary tasks within working hours and it can be tempting to take work home to complete. Removing protected health information from a healthcare facility places that information at risk of exposure. This is a common employee HIPAA violation and may even be routine practice at a healthcare facility that is understaffed. That does not mean it is an acceptable practice.
The same applies to emailing ePHI to personal email accounts. Regardless of the intentions, whether it is to get help with spreadsheets, complete work at home to get ahead for the next day, or to catch up on a backlog, it is a violation of HIPAA Rules. Further, any emailing of ePHI to a personal email account could be considered theft, the repercussions of which could be far more severe than termination of an employment contract.
Leaving Portable Electronic Devices and Paperwork Unattended
The HIPAA Security Rule requires PHI and ePHI to be secured at all times. If paperwork is left unattended it could be viewed by an unauthorized individual, be that a member of staff, patient, or visitor to the healthcare facility. Were that to happen it would be considered an impermissible disclosure of PHI.
Electronic devices that contain ePHI must similarly be secured at all times. Electronic devices are portable and valuable. Opportunistic thieves could easily steal an unattended device and gain access to ePHI. There have been many cases of healthcare employees removing unencrypted devices from healthcare facilities, only for them to be stolen from vehicles or homes. Theft can also easily occur within a healthcare facility if devices are not secured. Healthcare employees must ensure that their employer’s policies are followed, and HIPAA Rules are not violated by leaving devices and paperwork unattended.
Releasing Patient Information to an Unauthorized Individual
An authorization form must be obtained from a patient before any of their PHI can be disclosed to a third party for a purpose other than one expressly permitted by the HIPAA Privacy Rule. Disclosing PHI for purposes other than treatment, payment for healthcare, or healthcare operations (and limited other cases) is a HIPAA violation if authorization has not been received from the patient in advance.
Healthcare employees must ensure that prior to disclosing PHI to a third party that authorization has been obtained from the patient and information is not disclosed to any individual or company that is not included on the authorization form. Authorization forms are only valid if they have been signed by the patient or their nominated representative.
Releasing Patient Information Without Authorization
In a similar vein to the previous point, healthcare employees must also exercise caution about the types of information that are released to third parties, even if an authorization form has been received allowing a specific individual, company, or organization to receive PHI.
The authorization form should include what types of information have been authorized to be released. Any information that is not detailed on the authorization form must remain private and confidential and should not be shared. The disclosure of additional information would violate the HIPAA Privacy Rule.
Disclosures of PHI to Third Parties After the Expiry of an Authorization
All HIPAA authorization forms must include the names or classes of individuals who are being authorized to receive PHI, the types of PHI that will be disclosed, and the reasons for the disclosures. They must also include an expiry date for the authorization.
PHI must not be disclosed to any individual listed on the authorization form after the expiry date has passed, even if authorization has previously been given to that entity to receive PHI. A new authorization form is required before any further disclosure takes place. It should also be noted that an authorization form without an expiry date is not HIPAA compliant.
Impermissible Disclosures of Patient Health Records
The HIPAA Privacy Rule permits patients to obtain a copy of their health records on request or have their records provided to a nominated third party such as a personal representative or other individual. If not collected in person by the patient, the third party must have been given authorization by the patient – on a HIPAA authorization form – to receive the records before they can be released.
Prior to providing copies of patient health records, healthcare employees must verify the identity of the patient or the person collecting the records and must ensure records are only released to an individual authorized to receive them. Care must also be taken to ensure that the correct patient’s records are released.
Downloading PHI onto Unauthorized Devices
It can be difficult for healthcare IT departments to keep track of all devices that connect to the network, given how many different devices have network access. Ensuring those devices are secured can be an even bigger problem, yet this is a requirement for HIPAA compliance.
Employees need to be aware that there are privacy and security risks associated with downloading ePHI to unauthorized portable electronic devices. Not only does this increase the risk of an accidental disclosure of ePHI – in the event that the device is lost or stolen – it could also be viewed as theft and a HIPAA violation.
Providing Unauthorized Access to Medical Records
It is the responsibility of the covered entity to ensure that access to patient health information and medical records is only given to authorized individuals. This is achieved by implementing access controls via unique logins.
Employees have a responsibility to ensure that they do not give access to health information to co-workers who many not have the same access rights. The sharing of login credentials could not only result in an impermissible disclosure of ePHI, any actions taken by that employee would be attributed to the individual whose login credentials were used to gain access.
What does it mean to “reduce risk to an appropriate and acceptable level”?
When potential risks and vulnerabilities are identified, covered entities and business associates have to decide what measures to implement according to the size, complexity, and capabilities of the organizations, the existing measures already in place, and the cost of implementing further measures in relation to the likelihood of a data breach and the scale of injury it would cause.
How is it possible to prevent employees snooping on healthcare records?
Although many cases of healthcare snooping are attributable to curiosity rather than malicious intent, all cases of healthcare snooping are HIPAA violations. To prevent employees snooping on healthcare records, covered entities should implement a program of training, ensure access privileges comply with the Minimum Necessary Standard, activate audit logs, and enforce sanctions.
If encryption is not mandatory, how can it be a HIPAA violation if records are unencrypted?
Although encryption is not mandatory, it is an addressable implementation specification of the Security Rule. This means organizations can only avoid implementing the requirement if it is not reasonable and appropriate in the circumstances, or if an alternative security measure is equally as effective. If organizations fail to implement encryption, they have to document the reasons why.
Why was the fine for denying patients access to health records so high?
In this particular case, the non-cooperation of the covered entity contributed to the size of the fine (you can read about the case here). Since this case, the CMS´ Meaningful Use program has evolved into the Promoting Interoperability program, and – in addition to being sanctioned for a HIPAA violation – any covered entity failing to provide health records in a timely manner could now also lose a percentage of their Medicare payments.