HIPAA Compliance News

Sen. Warner Demands Answers from HHS Over Apparent Lack of Response to Major PACS Data Breach

U.S. Senator, Mark. R. Warner (D-VA) has written to the Director of the HHS’ Office for Civil Rights, Roger Severino, expressing concern over the HHS response to the mass exposure of medical images by U.S. healthcare organizations.

Sen. Warner is the Vice Chairman of the Senate Intelligence Committee and co-founder of the Senate Cybersecurity Caucus. This is the latest in a series of communications in which he has voiced concerns about cybersecurity failures that have compromised the personal and private information of Americans. In February, Sen. Warner demanded answers from HHS agencies, NIST, and healthcare associations about healthcare cybersecurity following the continued increase in healthcare data breaches.

His recent letter to OCR was in response to a September 17, 2019 report about the exposure of millions of Americans’ medical images that were stored in unsecured picture archiving and communications systems (PACS).

The report detailed the findings of an investigation by ProPublica, German public broadcaster Bayerischer Rundfunk, and vulnerability and analysis firm, Greenbone Networks, which revealed almost 400 million medical images could be freely downloaded from the internet without authentication.  Sen. Warner pointed out that at the time of writing the letter, “for all U.S. territories there are 114.5 million images accessible, 22.1 million patient records, and 400,000 Social Security numbers, impacting an estimated 5 million patients in 22 states.”

Sen. Warner stated in the letter that the exposure of the medical images not only has potential to cause harm to individuals, it is also damaging to national security. The types of exposed information could potentially be used by cybercriminals in phishing campaigns and for other malicious attacks, such as those aimed at spreading malware. Flaws in the DICOM protocol could be exploited to incorporate malicious code into medical images. Nation state actors or cybercriminal groups could have downloaded the images, inserted malicious code, and then uploaded the images without being detected.

One of the U.S. firms implicated in the ProPublica report was TridentUSA Health Services and one of its affiliates, MobileX USA. In September 2019, following publication of the report, Sen. Warner wrote to TridentUSA Health Services demanding answers about its cybersecurity practices and how the data of millions of Americans, which the company was responsible for keeping private, came to be exposed online and required no password or other means of authentication to access.

In his letter to OCR, Sen. Warner explained that TridentUSA Health Services, a HIPAA-covered entity, responded to his letter and stated it had passed an HHS Security Rule audit in March 2019. That audit was passed even though at the time of the audit medical images under its control were exposed online and could be freely accessed over the internet.

“As your agency aggressively pushes to permit a wider range of parties (including those not covered by HIPAA) to have access to the sensitive health information of American patients without traditional privacy protections attaching to that information, HHS’s inattention to this particular incident becomes even more troubling,” wrote Warner.

The exposure of PACS data was reported to US-CERT by the German Federal Office for Information Security. US-CERT made contact with Greenbone Networks and confirmed the exposed data had been received and said that the matter would be reported to the HHS. Greenbone Networks had no contact from HHS and no further contact from US-CERT.

The researchers in Germany also demonstrated to Sen. Warner that even on October 15, 2019, several US-based PACS have open ports that support unencrypted communications protocols. Those unsecured PACS could be accessed without authentication and a wide range of medical images could be viewed and downloaded, including X-rays and mammograms that contain sensitive patient information such as names and Social Security numbers. Those images and personal information were still accessible freely online on the date of writing the letter (Nov 8, 2019).

“As of writing this letter, TridentUSA Health Services is not included on your breach portal website and I have seen no evidence that, once contacted by US-CERT, you acted on that information in a meaningful way,” wrote Sen. Warner.

Sen. Warner has demanded answers to 5 questions:

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HHS Increases Civil Monetary Penalties for HIPAA Violations in Line with Inflation

The U.S Department of Health and Human Services’ has increased the civil monetary penalties for HIPAA violations to take inflation into account, in accordance with the Inflation Adjustment Act.

The final rule was issued and took effect on Tuesday November 5, 2019. This rule increases the civil monetary penalties for HIPAA violations that occurred on or after February 18, 2019. Under the new penalty structure, the increases from 2018 to 2019 are detailed in the table below:

Penalty Tier Level of Culpability Minimum Penalty per Violation

(2018 » 2019)

Maximum Penalty per Violation

(2018 » 2019)

New Maximum Annual Penalty

(2018 » 2019)*

1 No Knowledge $114.29 » $117 $57,051 » $58,490 $1,711,533 » $1,754,698
2 Reasonable Cause $1,141 » $1,170 $57,051 » $58,490 $1,711,533 » $1,754,698
3 Willful Neglect – Corrective Action Taken $11,410 » $11,698 $57,051 » $58,490 $1,711,533 » $1,754,698
4 Willful Neglect – No Corrective Action Taken $57,051 » $58,490 $1,711,533 » $1,754,698 $1,711,533 » $1,754,698

Penalties for HIPAA violations that occurred prior to February 18, 2019 have increased to $159 per violation, with an annual cap of $39,936 per violation category.

Earlier this year, the HHS’ Office for Civil Rights announced that it had reduced the penalties for HIPAA violations in certain tiers after a review of the wording of the HITECH Act. The maximum penalty for a HIPAA violation in the highest tier remained at $1.711 million, per violation category per year. Prior to the review, the maximum HIPAA violation penalty was $1.711 million in all four penalty tiers.

*The notice of enforcement discretion, announced on April 30, 2019, capped the maximum annual penalties at $10,000 (Tier 1), $100,000 (Tier 2), $250,000 (Tier 3), and $1,711,533 (Tier 4). The notice of enforcement discretion stated that the reviewed penalty tiers would also be adjusted in line with inflation. The multiplier used by OCR to calculate the cost-of-living increases was based on the Consumer Price Index for all Urban Consumers (CPI–U) for October 2019, which was 1.02522. That would make the new maximum penalties under the notice of enforcement discretion $10,252.20 (Tier 1), $102,522 (Tier 2), $256,305 (Tier 3), and $1,754,698 (Tier 4).

While OCR’s notice of enforcement discretion states that OCR will be adopting the new, revised penalties, this has yet to be made official and is pending further rulemaking. The notification of enforcement discretion creates no legal obligations and no legal rights, so OCR could therefore legally use the above maximum penalty amount of $1,754,698 per violation category, per year across all penalty tiers.

Full details of the new penalty structures have been published in the Federal Register for all agencies, including the FDA, ACF, HRSA, AHRQ, OIG, CMS, and OCR and can be viewed here (PDF).

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Texas Health and Human Services Commission Pays $1.6 Million HIPAA Penalty

The Department of Health and Human Services’ Office for Civil Rights (OCR) has imposed a $1.6 million civil monetary penalty (CMP) on Texas Health and Human Services Commission (TX HHSC) for multiple violations of Health Insurance Portability and Accountability Act (HIPAA) Rules.

TX HHSC is a state agency that operates supported living centers, regulates nursing and childcare facilities, provides mental health and substance abuse services, and administers hundreds of state programs for people in need of assistance, such as individuals with intellectual and physical disabilities.

OCR launched an investigation following receipt of a breach report from the Department of Aging and Disability Services (DADS), a state agency that was reorganized into TX HHSC in September 2017. On June 11, 2015, DADS reported a security incident to OCR which stated that the electronic protected health information (ePHI) of 6,617 individuals had been exposed over the internet. The exposed information included names, addresses, diagnoses, treatment information, Medicaid numbers, and Social Security numbers.

The information was exposed during the migration of an internal CLASS/DBMD application from a private server to a public server. A flaw in the software of the application allowed ePHI to be accessed over the internet without any authentication. As a result of the flaw, private and highly sensitive information could be found and accessed through a Google search.

TX HHSC was unable to provide documentation to demonstrate compliance with three important provisions of HIPAA Rules. OCR determined that TX HHSC had violated four HIPAA provisions.

  • 45 C.F.R. § 164.308(a)(1 )(ii)(A) – Failure to conduct a comprehensive organization-wide risk analysis to identify all risks to the confidentiality, integrity, and availability of PHI
  • 45 C.F.R. § 164.312(a)(1) – Failure to implement access controls. Credentials were not required to access ePHI contained in its CLASS/DBMD
  • 45 C.F.R. § 164.312(b) – Failure to implement audit controls that recorded user access on the public server, which prevented TX HHSC from determining who had accessed ePHI in the application during the time it was exposed.
  • 45 C.F.R. § 164.502(a) – The above failures resulted in an impermissible disclosure of the ePHI of 6,617 individuals.

Under HIPAA, financial penalties are determined based on the level of culpability. OCR determined that the violations fell short of willful neglect and constituted reasonable cause – the second penalty tier. For each of the above classes of HIPAA violation, the minimum penalty for a violation is $1,000 up to a maximum financial penalty of $100,000 per year. The risk analysis failures, access controls failures, and audit control failures spanned from 2013 to 2017, hence the $1.6 million penalty.

“Covered entities need to know who can access protected health information in their custody at all times,” said OCR Director Roger Severino. “No one should have to worry about their private health information being discoverable through a Google search.”

We initially reported on the HIPAA penalty in March 2019 when it appeared that a settlement had been reached between TX HHSC and OCR over the HIPAA violations. The 86th Legislature of the State of Texas had voted to approve the settlement; however, it would appear that the proposed settlement was rejected. OCR issued a Notice of Proposed Determination on July 29, 2019.

TX HHSC did not contest the findings of OCR’s Notice of Proposed Determination and waived the right to a hearing. OCR imposed the CMP on TX HHSC on October 25, 2019.

This is the second HIPAA penalty to be announced by OCR this week. A few days ago, OCR announced a $3 million settlement had been reached with the University of Rochester Medical Center to resolve HIPAA violations related to the loss of unencrypted devices containing ePHI.

The TX HHSC CMP is the seventh HIPAA penalty of 2019. The latest CMP brings the total HIPAA fines for 2019 up to $9,949,000.

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Webinar: Your 2019 MIPS Security Risk Analysis: 6 Steps to Compliance (11/14/19)

Healthcare organizations often struggle with risk analyses, as OCR’s HIPAA enforcement actions clearly show. The risk analysis is the most common HIPAA violation cited in OCR’s enforcement actions.

The risk analysis is essential as it allows healthcare organizations to identify all risks to the confidentiality, integrity, and availability of ePHI. Those risks can then be reduced to a reasonable and acceptable level. A risk assessment should be completed regularly, with the frequency determined by the circumstances of their environment. For many healthcare organizations, this will be annually.

An annual security risk analysis (SRA) is a requirement of the 2019 MIPS Performance Year to comply with Promoting Interoperability. The SRA makes up 25% of the performance score so it is essential that this critical process is completed. The deadline for completing the SRA is December 31, 2019.

If you have yet to conduct your SRA for 2019 and are not yet ready to attest to meeting this objective, help is at hand. HIPAA Journal sponsor, Compliancy Group, is hosting a webinar in conjunction with Compulink Healthcare Solutions which covers this important aspect of compliance.

At the webinar, Compliancy Group and Compulink Healthcare Solutions’ Director of Professional Relations and Government Programs, Dr. Karen Perry, will be discussing the security risk analysis and how you can implement appropriate safeguards to satisfy the MIPS SRA requirement.

At the end of the event you will have access to the tools you need to confidently achieve your mission-critical priorities, ensure compliance, and help your organization thrive in a fast-evolving digital landscape.

Webinar Details:

Your 2019 MIPS Security Risk Analysis: 6 Steps to Compliance

Date: Thursday, November 14, 2019

Time: 14:00 ET

Registration Link

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Lack of Encryption Leads to $3 Million HIPAA Penalty for New York Medical Center

The University of Rochester Medical Center (URMC) has paid a $3 million HIPAA penalty for the failure to encrypt mobile devices and other HIPAA violations.

URMC is one of the largest health systems in New York State with more than 26,000 employees at the Medical Center and various other components of the health system, including Strong Memorial Hospital and the School of Dentistry.

The Department of Health and Human Services’ Office for Civil Rights (OCR) launched an investigation following receipt of two breach reports from UMRC – The loss of an unencrypted flash drive and the theft of an unencrypted laptop computer in 2013 and 2017.

This was not the first time OCR had investigated URMC. An investigation was launched in 2010 following a similar breach involving a lost flash drive. In that instance, OCR provided technical compliance assistance to URMC. The latest investigation uncovered multiple violations of HIPAA Rules, including areas of noncompliance that should have been addressed after receiving technical assistance from OCR in 2010.

Under HIPAA, data encryption is not mandatory. Following a risk analysis, as part of the risk management process, covered entities must assess whether encryption is an appropriate safeguard. An alternative safeguard can be implemented in place of encryption if it provides an equivalent level of protection.

In this case, URMC had assessed risk and determined that the lack of encryption posed a high risk to the confidentiality, integrity, and availability of ePHI, yet failed to implement encryption when it was appropriate and continued to use unencrypted mobile devices that contained ePHI, in violation of 45 C.F.R. § 164.31 2(a)(2)(iv).

OCR’s investigation confirmed that the ePHI of 43 patients was contained on the stolen laptop and as a result of the theft, that information was impermissibly disclosed – 45 C.F.R. §164.502(a). OCR also determined that URMC had failed to conduct a comprehensive, organization-wide risk analysis – 45 C.F.R. § 164.308(a)(1)(ii)(A) – that included all risks to the confidentiality, integrity, and availability of ePHI, and covered ePHI stored on the lost and stolen devices.

Risks had not been sufficiently managed and reduced to reasonable and acceptable level – 45 C.F.R. §164.308(a)(l)(ii)(B) – and policies and procedures governing the receipt and removal of hardware and electronic media in and out of its facilities had not been implemented – 45 C.F.R. § 163.310(d).

In addition to the $3,000,000 financial penalty, URMC is required to adopt a robust corrective action plan to address all aspects of noncompliance identified by OCR. URMC’s compliance efforts over the next two years will be scrutinized by OCR to ensure continuing compliance.

“Because theft and loss are constant threats, failing to encrypt mobile devices needlessly puts patient health information at risk,” said OCR Director Roger Severino. “When covered entities are warned of their deficiencies, but fail to fix the problem, they will be held fully responsible for their neglect.”

This is the sixth financial penalty of 2019 that OCR has issued to resolve violations of the Health Insurance Portability and Accountability Act and it is the fourth enforcement action to cite a risk analysis failure.

The risk analysis is one of the most important elements of HIPAA compliance and a risk analysis failure is the most common HIPAA violation cited in OCRs enforcement actions.

OCR has released a risk assessment tool to help covered entities and business associates comply with this aspect of HIPAA. Further information on the HHS risk assessment tool is available on this page.

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Common Office 365 Mistakes Made by Healthcare Organizations

An Office 365 phishing campaign has been running over the past few weeks that uses voicemail messages as a lure to get users to disclose their Office 365 credentials. Further information on the campaign is detailed below along with some of the most common Office 365 mistakes that increase the risk of a costly data breach and HIPAA penalty.

Office 365 Voicemail Phishing Scam

The Office 365 voicemail phishing scam was detected by researchers at McAfee. The campaign has been running for several weeks and targets middle management and executives at high profile companies. A wide range of industries have been attacked, including healthcare, although the majority of attacks have been on companies in the service, IT services, and retail sectors.

The emails appear to have been sent by Microsoft and alert users to a new voicemail message. The emails include the caller’s telephone number, the date of the call, the duration of the voicemail message, and a reference number. The emails appear to be automated messages and tell the recipient that immediate attention is required to access the message.

The phishing emails include an HTML attachment which will play a short excerpt from the voicemail message if opened. Users will then be redirected to a spoofed Office 365 web page where they must enter their Office 365 credentials to listen to the full message. If credentials are entered, they will be captured by the attacker. Users are then redirected to the Office.com website. No voicemail message will be played.

This is not the first time that voicemail and missed call notifications have been used as a lure in phishing attacks, but the inclusion of audio recordings in phishing emails is unusual. The partial voicemail recording comes from an embedded .wav file in the HTML attachment.

McAfee reports that three different phishing kits are being used to generate the spoofed Microsoft Office 365 websites, which suggests three different threat groups are using this ploy.

While there are red flags that should alert security-aware employees that this is a scam, unfamiliarity with this type of phishing scam and the inclusion of Microsoft logos and carbon-copy Office 365 login windows may be enough to convince users that the voicemail notifications are genuine.

Common Office 365 Mistakes to Avoid and HIPAA Best Practices

This is just the latest of several recent phishing campaigns targeting Office 365 users and attacks on Office 365 users are increasing. Listed below are some steps that can be taken to reduce risk along with some of the common Office 365 mistakes that are made which can increase the risk of account compromises, data breaches and HIPAA penalties.

Consider Using a Third-Party Anti-Phishing Solution on Top of Office 365

Office 365 incorporates anti-spam and anti-phishing protections as standard through Microsoft Exchange Online Protection (EOP). While this control is effective at blocking spam email (99%) and known malware (100%), it doesn’t perform so well at stopping phishing emails and zero-day threats. Microsoft is improving its anti-phishing controls but EOP is unlikely to provide a sufficiently high level of protection for healthcare organizations that are extensively targeted by cybercriminals.

Microsoft’s anti-phishing protections are better in Advanced Threat Protection (APT), although this solution cannot identify zero-day threats, does not include sandboxing for analyzing malicious attachments, and email impersonation protection is limited. For advanced protection against phishing and zero-day threats, consider layering a third-party anti-phishing solution on top of Office 365.

Implement Multi-Factor Authentication

A third-party solution will block more threats, but some will still be delivered to inboxes. The Verizon Data Breach Investigations Report revealed 30% of employees open phishing emails and 12% click links in those messages. Security awareness training for employees is mandatory under HIPAA and can help to reduce susceptibility to phishing attacks, but additional anti-phishing measures are required to reduce risk to a reasonable and acceptable level. One of the most effective measures is multi-factor authentication. It is not infallible, but it will help to ensure that compromised credentials cannot be used to access Office 365 email accounts.

Check DHS Advice Prior to Migrating from On-Premises Mail Services to Office 365

There are risks and vulnerabilities that must be mitigated when migrating from on-premises mail services to Office 365. The DHS’ Cybersecurity and Infrastructure Security Agency has issued best practices that should be followed. Check this advice before handling your own migrations or using a third-party service.

Ensure Logging is Configured and Review Email Logs Regularly

HIPAA requires logs to be created of system activity and ePHI access attempts, including the activities of authorized users. Those logs must also be reviewed regularly and checked for signs of unauthorized access and suspicious employee behavior.

Ensure Your Emails are Encrypted

Email encryption will prevent messages containing ePHI from being intercepted in transit. Email encryption is a requirement of HIPAA if messages containing ePHI are sent outside your organization.

Make Sure You Read Your Business Associate Agreement

Just because you have obtained a signed business associate agreement from Microsoft it does not mean your email is HIPAA-compliant. Make sure you read the terms in the BAA, check your set up is correct, and you are aware of your responsibilities for securing Office 365 and you are using Office 365 in a HIPAA compliant manner.

Backup and Use Email Archiving

In the event of disaster, it is essential that you can recover your email data. Your Office 365 environment must therefore be backed up and emails containing ePHI and HIPAA-related documents must be retained for a period of 6 years. An archiving solution – from Microsoft or a third-party – is the best way of retaining emails as archives can be searched and emails quickly recovered when they are required, such for legal discovery or a compliance audit.

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HHS Releases Updated HIPAA Security Risk Assessment Tool

The HHS has updated its HIPAA Security Risk Assessment Tool and has added several new features that have been requested by users to improve usability.

The HIPAA Security Risk Assessment Tool was developed by the HHS Office of the National Coordinator for Health Information Technology (ONC) in collaboration with the HHS’ Office for Civil Rights.

The Security Risk Assessment Tool can help small to medium sized healthcare organizations conduct a comprehensive, organization-wide risk assessment to identify all risks to the confidentiality, integrity, and availability of protected health information (PHI).

By using the tool, healthcare organizations will be able to identify and assess risks and vulnerabilities and use that information to improve their defenses against malware, ransomware, viruses, botnets and other types of cyberattack.

The risk assessment is a foundational element of compliance with the Health Insurance Portability Act Security Rule. By conducting a risk assessment, healthcare organizations can identify areas where PHI may be at risk. Any risks can then be assessed, prioritized, and reduced to a reasonable and acceptable level.

Since its initial release, the tool has been updated several times to improve usability and add additional functions. The latest version of the Risk Assessment Tool – Version 3.1 – has been released to coincide with National Cybersecurity Awareness Month and includes several user-requested improvements:

  • Threat and vulnerability validation
  • Incorporation of NIST Cybersecurity Framework references
  • Improved asset and vendor management
  • Question flagging and a new Flagged Report
  • Ability to export Detailed Reports to Excel
  • Fixes for several reported bugs to improve stability

The tool can be downloaded from the HHS for Windows devices, although the latest version is not available for Mac OS.

The HHS points out that the tool is only as useful as the work that goes into conducting and documenting a risk assessment. Use of the tool does not guarantee compliance with the risk assessment requirements of the HIPAA Security Rule and will only help HIPAA-covered entities and their business associates conduct periodic risk assessments.

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Slew of HIPAA Violations Leads to $2.15 Million Civil Monetary Penalty for Jackson Health System

The Department of Health and Human Services’ Office for Civil Rights has imposed a $2.15 million civil monetary penalty against the Miami, FL-based nonprofit academic medical system, Jackson Health System (JHS), for a slew of violations of HIPAA Privacy Rule, Security Rule, and Breach Notification Rule.

In July 2015, OCR became aware of several media reports in which the PHI of a patient was impermissibly disclosed. The individual was a well-known NFL football player. Photographs of an operating room display board and schedule had also been shared on social media by a reporter. OCR launched an investigation in October 2015 and opened a compliance review in relation to the impermissible disclosure.

JHS investigated and submitted a report confirming a photograph was taken in which two patients PHI was visible, including the PHI of a well-known person in the community. The internal investigation revealed an employee had been accessing patient information without authorization since 2011. During that time, the employee had accessed the records of 24,188 patients without any legitimate work reason for doing so and had been selling that information.

HIPAA requires covered entities to implement policies and procedures to prevent, contain, and correct security violations – 45 C.F.R. § 164.308(a)(l) – however, before risks can be managed and reduced to a reasonable and acceptable level, a covered entity must conduct a comprehensive risk analysis – 45 C.F .R. §164.308(a)(l)(ii){A) – to ensure that all risks to the confidentiality, integrity, and availability of PHI are identified.

On several occasions, OCR requested documentation on risk analyses at JHS. JHS supplied documentation on internal assessments from 2009, 2012, and 2013, and risk analyses conducted by third parties in 2014, 2015, 2016, and 2017.

OCR discovered that prior to 2017, JHS had erroneously marked several aspects of the HIPAA Security Rule as non-applicable in the risk analyses. A risk analysis failure occurred in 2014 as it had failed to cover all ePHI and did not identify all risks to ePHI contained within JHS systems. JHS had also failed to provide documentation confirming measures had been implemented to reduce all risk to ePHI to a reasonable and appropriate level, even though recommendations had been made by the company that performed the 2014 risk analysis.

Similar risk analysis failures occurred in 2015. Some sections of the risk analysis conducted by a third party had not been completed, the risk analysis failed to cover all ePHI, and documentation could not be supplied confirming risk management efforts had taken place. It was a similar story in 2016, and the 2017 risk analysis was not comprehensive.

OCR investigators also discovered reviews of information system activity such as audit logs had not been regularly reviewed, in violation of 45 C.F.R. § 164.308(l)(ii)(D).

OCR also determined that between July 22, 2013 and January 27, 2016, policies and procedures had not been implemented to prevent, detect, contain, and correct security violations. The HIPAA Privacy Rule had also been violated, as reasonable efforts were not made to limit certain employees’ access to PHI, which had led to unauthorized access and impermissible disclosures. Access to PHI was also not limited to the minimum necessary information, in violation of 45 C.F.R. §164.308(a)(4) and 45 C.F.R. § 164.514(d).

On multiple occasions employees had accessed records without authorization when there was no treatment relationship with a patient, and also after a treatment relationship had come to an end.

JHS had also violated the HIPAA Breach Notification Rule by failing to report a breach within 60 days of discovery in violation of 45 C.F.R. § 164.408(b). The loss of boxes of files in 2013 was not reported for 160 days. JHS also admitted that it did not have policies in place covering PHI breaches prior to October 2013.

OCR attempted to resolve the HIPAA violations via informal means, but JHS failed to comply, which led to OCR issuing a Notice of Proposed Determination. JHS waived its right to a hearing and OCR issued a Notice of Final Determination, which was not contested and JHS paid the full financial penalty of $2,154,000.

“OCR’s investigation revealed a HIPAA compliance program that had been in disarray for a number of years,” explained OCR Director Roger Severino. “This hospital system’s compliance program failed to detect and stop an employee who stole and sold thousands of patient records; lost patient files without notifying OCR as required by law; and failed to properly secure PHI that was leaked to the media.”

This is the second financial penalty for a HIPAA covered entity to be announced this month and the fifth penalty to be issued in 2019. Earlier this month, Elite Dental Associates settled its HIPAA case with OCR for $10,000 following disclosures of patients’ PHI on the Yelp review site.

Settlements were also agreed with Bayfront Health St Petersburg ($85,000), Medical Informatics Engineering ($100,000), and Touchstone Medical Imaging ($3,000,000) earlier in the year.

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September 2019 Healthcare Data Breach Report

September saw 36 healthcare data breaches of more than 500 records reported to the Department of Health and Human Services’ Office for Civil Rights, which represents a 26.53% decrease in breaches from the previous month.

1,957,168 healthcare records were compromised in those breaches, an increase of 168.11% from August. The large number of breached records is largely down to four reported incidents, each of which involved hundreds of thousands of healthcare records. Three of those incidents have been confirmed as ransomware attacks.

Largest Healthcare Data Breaches in September 2019

The largest breach of the month was due to a ransomware attack on Jacksonville, FL-based North Florida OB-GYN, part of Women’s Care of Florida. 528,188 healthcare records were potentially compromised as a result of the attack. Sarrell Dental also experienced a ransomware attack in which the records of 391,472 patients of its Alabama clinics were encrypted. 320,000 records of patients of Premier Family Medical in Utah were also potentially compromised in a ransomware attack. The University of Puerto Rico reported a network server hacking incident involving 439,753 records of Intramural Practice Plan members. The exact nature of the breach is unclear.

Those four breaches accounted for 85.80% of the healthcare records breached in September.

Name of Covered Entity Covered Entity Type Individuals Affected Type of Breach Location of Breached Information
Women’s Care Florida, LLC Healthcare Provider 528188 Hacking/IT Incident Network Server
Intramural Practice Plan – Medical Sciences Campus – University of Puerto Rico Healthcare Provider 439753 Hacking/IT Incident Network Server
Sarrell Dental Healthcare Provider 391472 Hacking/IT Incident Network Server
Premier Family Medical Healthcare Provider 320000 Hacking/IT Incident Network Server
Magellan Healthcare Business Associate 55637 Hacking/IT Incident Email
CHI Health Orthopedics Clinic -Lakeside Healthcare Provider 48000 Hacking/IT Incident Desktop Computer, Electronic Medical Record, Network Server
Kilgore Vision Center Healthcare Provider 40000 Hacking/IT Incident Network Server
Peoples Injury Network Northwest Healthcare Provider 27000 Hacking/IT Incident Network Server
Sweetser Healthcare Provider 22000 Hacking/IT Incident Email
Perfect Teeth Yale, P.C. Healthcare Provider 15000 Loss Other Portable Electronic Device

Causes of September 2019 Healthcare Data Breaches

Hacking/IT incidents dominated the breach reports in September with 24 incidents reported. There were 9 unauthorized access/disclosure incidents and three cases of loss/theft of physical and electronic records.

1,917,657 healthcare records were compromised in the 24 hacking/IT incidents which accounted for 97.98% of breached records in September. The mean breach size was 958,829 records and the median breach size was 5,255 records.

Unauthorized access/disclosure incidents in September accounted for 1% or 19,741 breached records. The mean breach size was 2,193 records and the median breach size was 998 records. There were two reported theft incidents involving 4,770 physical and electronic records and a single loss incident involving 15,000 records stored on a portable electronic device.

Location of Breached Protected Health Information

Phishing continues to be a major problem area for the healthcare industry. In September, 44.44% of all breaches – 16 incidents – involved PHI stored in email accounts. There were 13 network server incidents, a large percentage of which were ransomware attacks.

September 2019 Healthcare Data Breaches by Covered Entity Type

28 data breaches were reported by healthcare providers in September, four incidents were reported by health plans/health insurers, and four incidents were reported by business associates of HIPAA covered entities. A further four breaches had some business associate involvement but were reported by the covered entity.

States Affected by September 2019 Healthcare Data Breaches

September’s data breaches were reported by entities in 23 states and Puerto Rico. California, Maryland, and Washington were the worst affected with three breaches each. There were two breaches reported by entities based in Arkansas, Arizona, Colorado, Georgia, Indiana, and South Carolina, and one breach was reported in each of Alabama, Florida, Iowa, Illinois, Maine, Michigan, Nebraska, New Jersey, Ohio, Oklahoma, Tennessee, Texas, Utah, West Virginia, and Puerto Rico.

HIPAA Enforcement Activity in September 2019

In September 2019, the HHS’ Office for Civil Rights announced its third HIPAA violation penalty of the year. Bayfront Health St Petersburg in Florida was issued with an $85,000 financial penalty for the failure to provide a patient with a copy of her child’s fetal heart monitor records within a reasonable time frame. It took 9 months and multiple attempts by the patient before she was provided with the records.

This month, OCR Director Roger Severino gave an update on OCR’s main enforcement priorities and confirmed that noncompliance with the HIPAA right of access is still a major focus for OCR. Further financial penalties can be expected over the coming weeks and months for healthcare organizations that fail to provide individuals with copies of their health information within a reasonable time frame and at a reasonable cost.

There were no financial penalties issued by state attorneys general in September over HIPAA violations.

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