HIPAA Compliance News

1H 2022 Healthcare Data Breach Report

Posted by HIPAA Journal

Ransomware attacks are rife, hacking incidents are being reported at high levels, and there have been several very large healthcare data breaches reported so far in 2022; however, our analysis of healthcare data breaches reported in 1H 2022, shows that while data breaches are certainly being reported in high numbers, there has been a fall in the number of reported breaches compared to 1H 2021.

Between January 1, 2022, and June 30, 2022, 347 healthcare data breaches of 500 or more records were reported to the Department of Health and Human Services’ Office for Civil Rights (OCR) – the same number of data breaches reported in 2H, 2021. In 1H, 2021, 368 healthcare data breaches were reported to OCR, 21 fewer breaches than the corresponding period this year. That represents a 5.71% reduction in reported breaches.

Reported healthcare data breaches - 1H 2022

The number of healthcare records breached has continued to fall. In 1H, 2021, 27.6 million healthcare records were breached. In 2H, 2021, the number of breached records fell to 22.2 million, and the fall continued in 1H, 2022, when 20.2 million records were breached. That is a 9.1% fall from 2H, 2021, and a 26.8% reduction from 1H, 2021.

breached healthcare records - 1H 2022

While it is certainly good news that data breaches and the number of breached records are falling, the data should be treated with caution, as there have been some major data breaches reported that are not yet reflected in this breach report – Data breaches at business associates where only a handful of affected entities have reported the data breaches so far.

One notable breach is a ransomware attack on the HIPAA business associate, Professional Finance Company. That one breach alone affected 657 HIPAA-covered entities, and only a few of those entities have reported the breach so far. Another major business associate breach, at Avamere Health Services, affected 96 senior living and healthcare facilities. The end-of-year breach report could tell a different story.

Largest Healthcare Data Breaches in 1H 2022

1H 2022 Healthcare Data Breaches of 500 or More Records
500-1,000 Records 1,001-9,999 Records 10,000- 99,000 Records 100,000-249,999 Records 250,000-499,999 Records 500,000 – 999,999 Records 1,000,000+ Records
61 132 117 20 7 6 4

 

Name of Covered Entity State Covered Entity Type Individuals Affected Type of Breach Business Associate Data Breach Cause of Data Breach
Shields Health Care Group, Inc. MA Business Associate 2,000,000 Hacking/IT Incident Yes Unspecified cyberattack
North Broward Hospital District (Broward Health) FL Healthcare Provider 1,351,431 Hacking/IT Incident No Cyberattack through the office of 3rd party medical provider
Texas Tech University Health Sciences Center TX Healthcare Provider 1,290,104 Hacking/IT Incident Yes Ransomware attack on EHR provider (Eye Care Leaders)
Baptist Medical Center TX Healthcare Provider 1,243,031 Hacking/IT Incident No Unspecified cyberattack
Partnership HealthPlan of California CA Health Plan 854,913 Hacking/IT Incident No Ransomware attack
MCG Health, LLC WA Business Associate 793,283 Hacking/IT Incident Yes Unspecified hacking and data theft incident
Yuma Regional Medical Center AZ Healthcare Provider 737,448 Hacking/IT Incident No Ransomware attack
Morley Companies, Inc. MI Business Associate 521,046 Hacking/IT Incident Yes Unspecified hacking and data theft incident
Adaptive Health Integrations ND Healthcare Provider 510,574 Hacking/IT Incident No Unspecified hacking incident
Christie Business Holdings Company, P.C. IL Healthcare Provider 502,869 Hacking/IT Incident No Unauthorized access to email accounts
Monongalia Health System, Inc. WV Healthcare Provider 492,861 Hacking/IT Incident No Unspecified hacking incident
ARcare AR Healthcare Provider 345,353 Hacking/IT Incident No Malware infection
Super Care, Inc. dba SuperCare Health CA Healthcare Provider 318,379 Hacking/IT Incident No Unspecified hacking incident
Cytometry Specialists, Inc. (CSI Laboratories) GA Healthcare Provider 312,000 Hacking/IT Incident No Ransomware attack
South Denver Cardiology Associates, PC CO Healthcare Provider 287,652 Hacking/IT Incident No Unspecified hacking incident
Stokes Regional Eye Centers SC Healthcare Provider 266,170 Hacking/IT Incident Yes Ransomware attack on EHR provider (Eye Care Leaders)
Refuah Health Center NY Healthcare Provider 260,740 Hacking/IT Incident No Ransomware attack

Causes of 1H 2022 Healthcare Data Breaches

Hacking and other IT incidents dominated the breach reports in 1H 2022, accounting for 277 data breaches or 79.83% of all breaches reported in 1H. That represents a 7.36% increase from 2H, 2021, and a 6.44% increase from 1H, 2021. Across the hacking incidents in 1H, 2022, the protected health information of 19,654,129 individuals was exposed or compromised – 97.22% of all records breached in 1H, 2022.

That represents a 6.51% reduction in breached records from 2H, 2021, and a 26.56% reduction in breached records from 1H, 2021, showing that while hacking incidents are being conducted in very high numbers compared to previous years, the severity of those incidents has reduced.

The average hacking/IT incident breach size was 70,954 records in 1H, 2022 and the median breach size was 10,324 records. In 2H, 2022, the average breach size was 81,487 records with a median breach size of 5,989 records, and in 1H, 2021, the average breach size was 96,658 records and the median breach size was 6,635 records.

In 1H, 2022, there were 52 unauthorized access/disclosure breaches reported – 14.99% of all breaches in 1H, 2022. These incidents resulted in the impermissible disclosure of 278,034 healthcare records, 72.33% fewer records than in 2H, 2021, and 61.37% fewer records than in 1H, 2021. In 1H, 2022, the average breach size was 5,347 records and the median breach size was 1,421 records. In 1H, 2021, the average breach size was 14,778 records and the median was 1,946 records. In 1H, 2021, the average breach size was 9,725 records, and the median breach size was 1,848 records.

The number of loss, theft, and improper disposal incidents has remained fairly constant over the past 18 months, although the number of records exposed in these incidents increased in 1H, 2022 to 279,266 records, up 217.33% from 2H, 2021, and 422.53% from 1H, 2021.

Location of Breached Protected Health Information

Protected health information is stored in many different locations. Medical records are housed in electronic medical record systems, but a great deal of PHI is included in documents, spreadsheets, billing systems, email accounts, and many other locations. The chart below shows the locations where PHI was stored. In several security breaches, PHI was breached in several locations.

The data shows that by far the most common location of breached data is network servers, which is unsurprising given the high number of hacking incidents and ransomware attacks. Most data breaches do not involve electronic medical record systems; however, there have been breaches at electronic medical record providers this year, hence the increase in data breaches involving EHRs. The chart below also shows the extent to which email accounts are compromised. These incidents include phishing attacks and brute force attacks to guess weak passwords. HIPAA-regulated entities can reduce the risk of email data breaches by implementing multifactor authentication and having robust password policies and enforcing those policies. A password manager is recommended to make it easier for healthcare employees to set unique, complex passwords. It is also important not to neglect security awareness training for the workforce – a requirement for compliance with the HIPAA Security Rule.

Location of breached PHI

Where are the Data Breaches Occurring?

Healthcare providers are consistently the worst affected type of HIPAA-covered entity; however, the number of data breaches occurring at business associates has increased. Data breaches at business associates often affect multiple HIPAA-covered entities. These data breaches are shown on the OCR breach portal; however, they are not clearly reflected as, oftentimes, a breach at a business associate is self-reported by each HIPAA-covered entity. Simply tallying up the reported breaches by the reporting entity does not reflect the extent to which business associate data breaches are occurring.

This has always been reflected in the HIPAA Journal data breach reports, and since June 2021, the reporting of data breaches by covered entity type was adjusted further to make business associate data breaches clearer by showing graphs of where the breach occurred, rather than the entity reporting the data breach. The HIPAA Journal data analysis shows the rising number of healthcare data breaches at business associates.

1H 2022 Data Breaches by State

As a general rule of thumb, U.S. states with the highest populations tend to be the worst affected by data breaches, so California, Texas, Florida, New York, and Pennsylvania tend to experience more breaches than sparsely populated states such as Alaska, Vermont, and Wyoming; however, data breaches are being reported all across the United States.

The data from 1H 2022, shows data breaches occurred in 43 states, D.C. and Puerto Rico, with healthcare data safest in Alaska, Iowa, Louisiana, Maine, New Mexico, South Dakota, & Wyoming, where no data breaches were reported in the first half of the year.

State Number of Breaches
New York 29
California 23
New Jersey & Texas 18
Florida & Ohio 17
Michigan & Pennsylvania 15
Georgia 14
Virginia 13
Illinois & Washington 12
Massachusetts & North Carolina 10
Colorado, Missouri, & Tennessee 9
Alabama, Arizona, & Kansas 8
Maryland 7
Connecticut & South Carolina 6
Oklahoma, Utah, & West Virginia 5
Indiana, Minnesota, Nebraska, & New Hampshire 4
Wisconsin 3
Arkansas, Delaware, Mississippi, Montana, Nevada, & the District of Columbia 2
Hawaii, Idaho, Kentucky, North Dakota, Oregon, Rhode Island, Vermont, and Puerto Rico 1

HIPAA Enforcement Activity in 1H 2022

HIPAA Journal tracks HIPAA enforcement activity by OCR and state attorneys general in the monthly and annual healthcare data breach reports. In 2016, OCR started taking a harder line on HIPAA-regulated entities that were discovered to have violated the HIPAA Rules and increased the number of financial penalties imposed, with peak enforcement occurring in 2019 when 19 financial penalties were imposed.

2022 has started slowly in terms of HIPAA enforcement actions, with just 4 financial penalties imposed by OCR in 1H, 2022. However, that should not be seen as OCR going easy on HIPAA violators. In July 2022, OCR announced 12 financial penalties to resolve HIPAA violations, bringing the annual total up to 16. HIPAA Journal records show only one enforcement action taken by state attorneys general so far in 2022.

Limitations of this Report

The nature of breach reporting makes generating accurate data breach reports challenging. HIPAA-regulated entities are required to report data breaches to OCR within 60 days of a data breach occurring; however, the number of individuals affected may not be known at that point. As such, data breaches are often reported with an interim figure, which may be adjusted up or down when the investigation is completed. Many HIPAA-regulated entities report data breaches using a placeholder of 500 records, and then submit an amendment, so the final totals may not be reflected in this report. Data for this report was compiled on August 10, 2022.

While data breaches should be reported within 60 days of discovery, there has been a trend in recent years for data breaches to be reported within 60 days of the date when the investigation has confirmed how many individuals have been affected, even though the HIPAA Breach Notification Rule states that the date of discovery is the date the breach is discovered, not the date when investigations have been completed. Data breaches may have occurred and been discovered several months ago, but have not yet been reported. These will naturally not be reflected in this report.

This report is based on data breaches at HIPAA-regulated entities – healthcare providers, health plans, healthcare clearinghouses, and business associates of those entities. If an entity is not subject to HIPAA, they are not included in this report, even if they operate in the healthcare industry.

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Cloud Security Alliance Releases Third Party Vendor Risk Management Guidance for Healthcare Organizations

Posted by HIPAA Journal

Cyber actors are increasingly targeting business associates of HIPAA-covered entities as they provide an easy way to gain access to the networks of multiple healthcare organizations. To help healthcare delivery organizations (HDOs) deal with the threat, the Cloud Security Alliance (CSA) has published new guidance on third-party vendor risk management in healthcare. The guidance was drafted by the Health Information Management Working Group and includes examples and use cases and provides information on some of the risk management program tools that can be used by HDOs for risk management.

Third-party vendors provide invaluable services to HDOs, including services that cannot be effectively managed in-house; however, the use of vendors introduces cybersecurity, reputational, compliance, privacy, operational, strategic, and financial risks that need to be managed and mitigated. The guidance is intended to help HDOs identify, assess, and mitigate the risks associated with the use of third-party vendors to prevent and limit the severity of security incidents and data breaches.

Cyberattacks on vendors serving the healthcare industry have increased in recent years. Rather than attacking an HDO directly, a cyber actor can attack a vendor to gain access to sensitive data or to abuse the privileged access the vendor has to a HDO’s network. For example, a successful intrusion at a managed service provider allows a threat actor to gain access to the networks of all of the company’s clients by abusing the MSP’s privileged access to client systems. This is advantageous for a hacker as it means it is not necessary to hack into the networks of each MSP client individually.

When third-party vendors are used, the attack surface is increased significantly, and managing and reducing risk can be a challenge. While third-party vendors are used in all industry sectors, third-party vendor security risks are most prevalent in the healthcare sector. The CSA suggests that this is due to the lack of automation, extensive use of digital applications and medical devices, and the lack of fully deployed critical vendor management controls. Since healthcare organizations tend to use a large number of vendors, conducting comprehensive and accurate risk assessments for all vendors and implementing critical vendor management controls can be a very time-consuming and costly process.

“Healthcare Delivery Organizations entrust the protection of their sensitive data, reputation, finances, and more to third-party vendors. Given the importance of this critical, sensitive data, combined with regulatory and compliance requirements, it is crucial to identify, assess, and reduce third-party cyber risks,” said Dr. James Angle, the paper’s lead author and co-chair of the Health Information Management Working Group. “This paper offers a summary of third-party vendor risks in healthcare as well as suggested identification, detection, response, and mitigation strategies.”

If an HDO chooses to use a third-party vendor, it is essential that effective monitoring controls are implemented, but it is clear from the number of third-party or vendor-related data breaches that many healthcare organizations struggle to identify, protect, detect, respond to, and recover from these incidents, which suggests the current approaches for assessing and managing vendor risks are failing. These failures can have a major financial impact, not just in terms of the breach mitigation costs, but HDOs also face the risk of regulatory fines from the HHS’ Office for Civil Rights and state Attorneys General and there is also significant potential for long-lasting reputation damage.

The CSA makes several suggestions in the paper, including adopting the NIST Cybersecurity Framework for monitoring, measuring, and tracking third-party risk. The NIST Framework is mostly concerned with cybersecurity, but the same principles can also be applied for measuring other types of risk. The core functions of the framework are identify, protect, detect, respond, and recover. Using the framework, HDOs can identify risks, understand what data is provided to each, prioritize vendors based on the level of risk, implement safeguards to protect critical services, ensure monitoring controls are implemented to detect security incidents, and a plan is developed for responding to and mitigating any security breach.

“The increased use of third-party vendors for applications and data processing services in healthcare is likely to continue, especially as HDOs find it necessary to focus limited resources on core organizational objectives and contract out support services, making an effective third-party risk management program essential,” said Michael Roza, a contributor to the paper.

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NIST Updates Guidance on HIPAA Security Rule Compliance

Posted by HIPAA Journal

The National Institute of Standards and Technology (NIST) has updated its guidance for HIPAA-regulated entities on implementing the HIPAA Security Rule to help them better protect patients’ personal and protected health information.

The Security Rule of the Health Insurance Portability and Accountability Act established national standards for protecting the electronic protected health information (ePHI) that HIPAA-regulated entities create, receive, maintain or transmit. Ensuring compliance with the HIPAA Security Rule is more important than ever due to the increasing number of cyberattacks on HIPAA-regulated entities.

NIST published the first revision of its HIPAA Security Rule guidance in 2008, 6 years before the release of the NIST Cybersecurity Framework. Over the past 14 years, NIST has released other cybersecurity guidance and has regularly updated its Security and Privacy Controls (NIST SP 800-53). One of the main reasons for updating the HIPAA Security Rule guidance was to integrate it into NIST guidance that did not exist when Revision 1 was published in 2008.

“One of our main goals is to help make the updated publication more of a resource guide,” said Jeff Marron, a NIST cybersecurity specialist. “The revision is more actionable so that healthcare organizations can improve their cybersecurity posture and comply with the Security Rule.”

NIST has mapped the elements of the HIPAA Security Rule to the NIST Cybersecurity Framework subcategories, the controls in NIST SP 800-53, has increased the emphasis on the risk management component of the guidance, and has integrated enterprise risk management concepts. NIST has also factored in the feedback received from healthcare industry stakeholders in its pre-draft call for comments.

The latest revision is more of a refresh than an overhaul. The structure of the guidance has only changed slightly with the content updated to have an increased emphasis on assessment and management of risk to ePHI

“We provide a resource that can assist you with implementing the Security Rule in your own organization, which may have particular needs,” said Marron. “Our goal is to offer guidance and resources you can use in one readable publication.”

Comments will be accepted by NIST on the updated guidance – Implementing the Health Insurance Portability and Accountability Act (HIPAA) Security Rule: A Cybersecurity Resource Guide (NIST Special Publication 800-66, Revision 2) – until September 21, 2022.

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June 2022 Healthcare Data Breach Report

Posted by HIPAA Journal

June 2022 saw 70 healthcare data breaches of 500 or more records reported to the Department of Health and Human Services’ Office for Civil Rights (OCR) – two fewer than May and one fewer than June 2021. Over the past 12 months, from July 2021 to June 2022, 692 large healthcare data breaches have been reported and the records of 42,431,699 individuals have been exposed or impermissibly disclosed. The past two months have seen data breaches reported at well over the 12-month average of 57.67 breaches a month.

The past 6 months have seen data breaches reported at similar levels to the second half of 2021 (345 in 1H 2022 v 347 in 2H 2021), but data breaches are down 6.25% from the first half of 2021 (368 in 1H 2021 v 345 in 2H 2022).

Healthcare data breaches in the past 12 months

For the third successive month, the number of exposed or compromised records has increased. In June, 5,857,143 healthcare records were reported as breached. That is the highest monthly total so far in 2022. June saw 32.48% more records breached than the previous month and 65.64% more than the monthly average over the past 12 months.

While huge numbers of healthcare records are being breached, fewer records were breached in the first half of 2022 than were breached in either the first half or the second half of 2021. In 1H 2022, 20,191,930 records were breached – 26.84% fewer than the 27,600,651 records breached in 1H 2021 and 9.2% fewer than the 22,239,769 records breached in 2H 2021.

Breached healthcare records in the past 12 months

Largest Healthcare Data Breaches Reported in June 2022

There were 31 reported breaches of 10,000 or more healthcare records in June – the same number as May 2022  – two of which affected more than 1.2 million individuals. Several healthcare providers submitted breach reports in June 2022 due to the ransomware attack on the HIPAA business associate, Eye Care Leaders. At least 37 healthcare providers are now known to have been affected by that ransomware attack and more than 3 million records are known to have been exposed in the attack.

Name of Covered Entity State Covered Entity Type Individuals Affected Location of Breached Information Cause of Breach
Texas Tech University Health Sciences Center TX Healthcare Provider 1,290,104 Other Eye Care Leaders ransomware attack
Baptist Medical Center TX Healthcare Provider 1,243,031 Network Server Ransomware attack
MCG Health, LLC WA Business Associate 793,283 Network Server Unspecified hacking and data theft incident
Yuma Regional Medical Center AZ Healthcare Provider 737,448 Network Server Ransomware attack
Stokes Regional Eye Centers SC Healthcare Provider 266,170 Network Server Eye Care Leaders ransomware attack
Spectrum Eye Physicians CA Healthcare Provider 175,000 Network Server Eye Care Leaders ransomware attack
90 Degree Benefits, Inc. WI Business Associate 172,450 Network Server Unspecified hacking incident
Michigan Avenue Immediate Care IL Healthcare Provider 144,104 Network Server Unspecified hacking and data theft incident
Mattax Neu Prater Eye Center, Inc. MO Healthcare Provider 92,361 Electronic Medical Record Eye Care Leaders ransomware attack
Sight Partners Physicians, P.C. WA Healthcare Provider 86,101 Electronic Medical Record Eye Care Leaders ransomware attack
Clinivate LLC CA Business Associate 77,652 Network Server Unspecified hacking incident – No information publicly released
Kaiser Foundation Health Plan of Washington WA Healthcare Provider 69,589 Email Compromised email account
Carolina Eyecare Physicians, LLC SC Healthcare Provider 68,739 Electronic Medical Record Eye Care Leaders ransomware attack
Precision Eye Care, Ltd. MO Healthcare Provider 58,462 Electronic Medical Record Eye Care Leaders ransomware attack
Resolute Health Hospital TX Healthcare Provider 54,239 Network Server Ransomware attack
Aloha Laser Vision HI Healthcare Provider 43,263 Electronic Medical Record Eye Care Leaders ransomware attack
Center for Sight, Inc. MA Healthcare Provider 41,041 Electronic Medical Record Eye Care Leaders ransomware attack
McCoy Vision Center AL Healthcare Provider 33,930 Electronic Medical Record Eye Care Leaders ransomware attack
Chesapeake Eye Center PA MD Healthcare Provider 32,770 Network Server Eye Care Leaders ransomware attack
Kevin Wolf, DPM d/b/a Goldsboro Podiatry NC Healthcare Provider 30,669 Network Server Unspecified hacking incident
Long Vision Center TX Healthcare Provider 29,237 Electronic Medical Record Eye Care Leaders ransomware attack
Foxhall Ob Gyn Associates DC Healthcare Provider 27,000 Other No information
Alabama Eye &Cataract, P.C. AL Healthcare Provider 26,000 Network Server Eye Care Leaders ransomware attack
Lori A. Harkins MD, P.C. dba Harkins Eye Clinic NE Healthcare Provider 23,993 Electronic Medical Record Eye Care Leaders ransomware attack
DialAmerica Marketing, Inc. NJ Business Associate 19,796 Network Server Unspecified hacking incident
Central Florida Inpatient Medicine FL Healthcare Provider 19,625 Email Compromised email account
Yale New Haven Hospital CT Healthcare Provider 19,496 Other Data exposed on a public-facing website
Cherry Creek Eye Physicians and Surgeons, P.C. CO Healthcare Provider 17,732 Electronic Medical Record Eye Care Leaders ransomware attack
Bayhealth Medical Center, Inc. DE Healthcare Provider 17,481 Network Server Ransomware attack on business associate (Professional Finance Company)
Kernersville Eye Surgeons, P.C. NC Healthcare Provider 13,412 Electronic Medical Record Eye Care Leaders ransomware attack
Phelps County Regional Medical Center d/b/a Phelps Health MO Healthcare Provider 12,602 Network Server Data breach at business associate (MCG Health)

Causes of June 2022 Healthcare Data Breaches

As the above table shows, ransomware attacks on healthcare organizations continue to be reported in high numbers. 20 of the 31 affecting 10,000 or more individuals have been confirmed as involving ransomware. When these attacks occur at business associates they can affect many different HIPAA-covered entities. As mentioned, the Eye Care Leaders ransomware attack has affected at least 37 eye care providers, and a ransomware attack on Professional Finance Company affected 657 of its healthcare provider clients.

There is no sign that ransomware attacks on healthcare providers will slow. This month, CISA has warned the health and public health sector that North Korean state-sponsored hackers are known to be targeting the sector and are using ransomware for extortion.

Hacking incidents continue to dominate the breach reports, with all but two of the top 31 breaches involving hacking. 81% of the month’s breaches were reported as hacking/IT incidents, and across those 57 incidents, the records of 5,784,009 were breached – 98.75% of all the breached records in June. The average breach size was 101,474 records and the median breach size was 12,602 records.

There were 6 unauthorized access/disclosure data breaches reported involving 59,224 records. The average breach size was 9,871 records and the median breach size was 5,672 records. 5 loss theft incidents were reported (4 x theft, 1 x loss) involving 12,184 records. The average breach size was 2,437 records and the median breach size was 1,126 records. Finally, there were two improper disposal incidents reported, both of which involving paper/films. In total 1,726 records were exposed as a result of those incidents.

Causes of June 2022 healthcare data breaches

Location of Breached Protected Health Information

The bar graph below shows where the breached information was stored. The high number of network server breaches indicates the extent to which hackers are attacking healthcare organizations. Many of these attacks involved ransomware. Most data breaches reported by healthcare providers do not involve electronic health records, which are separate from other systems. The high number of breaches involving EHRs is due to the ransomware attack on Eye Care Leaders, which provides electronic medical record systems to eye care providers.

Location of breached PHI (June 2022)

Data Breaches by HIPAA-Regulated Entity Type

Healthcare providers were the worst affected HIPAA-covered entity in June, accounting for 55 data breaches of 500 or more records, with 4 data breaches reported by health plans. Business associates of HIPAA-covered entities self-reported 11 data breaches; however, 29 data breaches occurred at business associates but were reported by the affected covered entity rather than the business associate.

Taking this into account, the breakdown of the month’s data breaches by HIPAA-regulated entity type is shown in the chart below.

June 2022 Healthcare Data Breaches - HIPAA-regulated entity type

Geographic Distribution of Breached Entities

Data breaches of 500 or more records were reported by HIPAA-regulated entities in 29 states and the District of Columbia.

State Number of Data Breaches
Washington 5
California, New Jersey, North Carolina, Ohio, South Carolina, Texas, & Virginia 4
Alabama, Missouri, Nebraska, & New York 3
Delaware, Illinois, Kansas, Maryland, Michigan, Pennsylvania, Tennessee, & the District of Columbia. 2
Arizona, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Massachusetts, Mississippi, & Wisconsin 1

HIPAA Enforcement Activity in June 2022

There were no HIPAA enforcement actions announced by the OCR or state attorneys general in June; however, OCR announced this month (July) that a further 12 HIPAA penalties have been imposed, 11 of which were for violations of the HIPAA Right of Access.

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OCR Announces 11 Further Financial Penalties for HIPAA Right of Access Failures

Posted by HIPAA Journal

The Department of Health and Human Services’ Office for Civil Rights has sent a warning to healthcare providers about the importance of compliance with the HIPAA Right of Access with the announcement that a further 11 financial penalties for HIPAA-covered entities that have failed to provide patients with timely access to their medical records. The latest batch of enforcement actions brings the total number of financial penalties imposed under the HIPAA Right of Access enforcement initiative up to 38.

The HIPAA Right of Access gives people the right to inspect their protected health information that is held by a HIPAA-covered entity, check the information for errors, and request that any errors are corrected. People can also request a copy of their protected health information from healthcare providers and health plans. When such a request is made, the requested information must be provided in full within 30 days of the request being received. In very limited circumstances, an extension of 30 days is allowed. Requests can be submitted by patients or their nominated representatives, and parents and legal guardians of minors are permitted to obtain a copy of their minor’s records. Any individual requesting a copy of their records can only be charged a reasonable, cost-based fee for obtaining a copy of their records. The records should be provided in the format requested by the patient, provided the HIPAA-covered entity has the technical capability to provide records in that format.

OCR launched its HIPAA Right of Access enforcement initiative in the fall of 2019 in response to reports of widespread noncompliance with this important HIPAA right. “It should not take a federal investigation before a HIPAA-covered entity provides patients, or their personal representatives, with access to their medical records,” said OCR Director Lisa J. Pino.  “Health care organizations should take note that there are now 38 enforcement actions in our Right of Access Initiative and understand that OCR is serious about upholding the law and peoples’ fundamental right to timely access to their medical records.”

HIPAA Right of Access Penalties

The latest penalties were all imposed for the failure to provide timely access to an individual’s medical records, rather than for charging unreasonable fees for exercising the Right of Access. All but one of these cases was settled with OCR, with the covered entities also agreeing to a corrective action plan to address the non-compliance and prevent further violations.

One HIPAA-covered entity refused to cooperate with OCR’s requests, resulting in a civil monetary penalty. ACPM Podiatry had received a request from a former patient for a copy of his medical records. OCR was notified on April 8, 2019, that ACPM had refused to provide those records. OCR provided technical assistance to ACPM on April 18, 2019, confirming that the records must be provided under HIPAA. The investigation was closed. A second complaint was then filed with OCR a month later when the records had still not been provided.

OCR’s investigation revealed the records had been withheld as the complainant’s insurance company had not paid the bill, but the complainant said the records were required in order to appeal the unfavorable decision, and that the records were necessary to file that appeal. While there was contact between OCR and ACPM Podiatry, ACPM failed to respond to OCR’s data access requests, OCR’s notice of proposed determination of a financial penalty, nor the Letter of Opportunity to provide evidence of mitigating factors, resulting in a civil monetary penalty being imposed.

Three of the enforcement actions stemmed from a HIPAA-covered entity failing to provide a patient’s nominated representative with a copy of the requested records when HIPAA allows the release of records to a personal representative. Two cases involved the withholding of a patient’s medical records due to outstanding medical bills. A patient’s right to obtain a copy of their medical records is not conditional on whether payment for medical services has been made in full.

A summary of each financial penalty has been provided in the table below.

HIPAA Covered Entity State Penalty Type Penalty Amount Individuals Affected Alleged Violation Reason
ACPM Podiatry IL Civil Monetary Penalty $100,000 1 Untimely Access Records not provided
Memorial Hermann Health System TX Settlement $240,000 1 Untimely Access Records not provided in full for 564 days from the initial request
Southwest Surgical Associates TX Settlement $65,000 1 Untimely Access Records not provided for 13 months
Hillcrest Nursing and Rehabilitation MA Settlement $55,000 1 Untimely Access Records not provided to a personal representative for 7 months
MelroseWakefield Healthcare MA Settlement $55,000 1 Untimely Access Failure to provide records to a patient’s nominated representative for 4 months
Erie County Medical Center Corporation NY Settlement $50,000 1 Untimely Access Failure to provide the requested records to a patient’s nominated representative
Fallbrook Family Health Center NE Settlement $30,000 1 Untimely Access Unspecified delay in providing requested records
Associated Retina Specialists NY Settlement $22,500 1 Untimely Access Failure to provide patient with access to records for 5 months
Coastal Ear, Nose, and Throat FL Settlement $20,000 1 Untimely Access Failure to provide patient with access to records for 5 months
Lawrence Bell, Jr. D.D.S MD Settlement $5,000 1 Untimely Access Failure to provide records for more than 3 months
Danbury Psychiatric Consultants MA Settlement $3,500 1 Untimely Access Withheld records for 6 months as the patient had an outstanding medical bill

OCR has now imposed 122 financial penalties on HIPAA-regulated entities to resolve HIPAA violations since 2008. The latest batch of HIPAA penalties brings the total enforcement actions in 2022 involving a financial penalty up to 16, exceeding the financial penalties imposed in all of 2021 by 2.

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Oklahoma State University Settles HIPAA Case with OCR for $875,000

Posted by HIPAA Journal

The Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) has announced that Oklahoma State University – Center for Health Sciences (OSU-CHS) has agreed to settle a HIPAA investigation stemming from a web server hacking incident and has agreed to pay a financial penalty of $875,000 to resolve potential violations of the HIPAA Privacy, Security, and Breach Notification Rules.

OSU-CHS is a public land-grant research university that provides preventive, rehabilitative, and diagnostic care in Oklahoma. OCR launched a HIPAA investigation after receiving a breach report on January 5, 2018, in response to the hacking of an OSU-CHS web server. OSU-CHS determined that malware had been installed on the server which allowed the hacker(s) to access the electronic protected health information of 279,865 individuals.

The information exposed and potentially obtained by an unauthorized third party included names, Medicaid numbers, healthcare provider names, dates of service, dates of birth, addresses, and treatment information. OSU-CHS initially declared that the data breach occurred on November 7, 2017; however, it was later reported that the hackers first had access to the ePHI of patients 20 months earlier on March 9, 2016,

OCR investigators determined OSU-CHS had potentially violated the following provisions of the HIPAA Rules:

  • Impermissible disclosure of the ePHI of 279,865 individuals – 45 C.F.R. § 164.502(a)
  • Failure to conduct a comprehensive and accurate organization-wide risk analysis –45 C.F.R. § 164.308(a)(l)(ii)(A)
  • Failure to perform a periodic technical and nontechnical evaluation in response to environmental or operational changes affecting the security of ePHI – 45 C.F.R. 164.308(a)(8)
  • Failure to implement audit controls – 45 C.F.R. § 164.312(b)
  • A security incident response and reporting failure – 45 C.F.R. § 164.308(a)(6)(ii)
  • Failure to provide timely breach notification to affected individuals – 45 C.F.R. § 164.404
  • Failure to provide timely breach notification to the Secretary of the HHS – 45 C.F.R. § 164.408

In addition to the financial penalty, OSU-CHS has agreed to implement a corrective action plan to resolve all areas of non-compliance identified by OCR and will be closely monitored for compliance with the corrective action plan and the HIPAA Rules for two years. The case was settled with no admission of liability or wrongdoing.

“HIPAA-covered entities are vulnerable to cyber-attackers if they fail to understand where ePHI is stored in their information systems,” said OCR Director Lisa J. Pino. “Effective cybersecurity starts with an accurate and thorough risk analysis and implementing all of the Security Rule requirements.”

This is the fifth financial penalty to be imposed by OCR in 2022 to resolve HIPAA violations, and the 111th penalty to be imposed since OCR was given the authority to fine HIPAA-regulated entities for HIPAA violations.

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Senators Call for HIPAA Privacy Rule Change to Prohibit Disclosures of Reproductive Health Care Information to Law Enforcement

Posted by HIPAA Journal

The HHS’ Office for Civil Rights has recently issued guidance to healthcare organizations following the overturning of Roe v. Wade following the SCOTUS Dobbs v. Jackson Women’s Health Organization ruling, which removed the right to abortion at the federal level and allowed states to set their own laws. The guidance explained how the HIPAA Privacy Rule permits disclosures of protected health information – including reproductive health care information – to law enforcement but does not require such disclosures. OCR explained in the guidance when such disclosures of reproductive health care information would be considered HIPAA violations under the HIPAA Privacy Rule.

Two U.S. senators – Michael F. Bennet (D-Co) and Catherine Cortez Masto (D-NV) – recently wrote to the Secretary of the Department of Health and Human Services, Xavier Becerra, calling for the HHS to go further and make an update to the HIPAA Privacy Rule to ensure that the private and confidential health information of patients seeking reproductive healthcare is better protected.

“The [SCOTUS} decision has created profound uncertainty for patients concerning their right to privacy when making the deeply personal decision to have an abortion,” explained the senators in the letter. “We write to urge the Department of Health and Human Services (HHS) to take immediate steps to protect the privacy of Americans receiving reproductive health care services by updating the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule.”

The senators pointed out that at the time HIPAA was signed into law in 1996, Roe v. Wade had already upheld the right to abortion for more than two decades, and when the Privacy Rule was added to HIPAA in 2000, it was unthinkable that Roe v. Wade would be overturned two decades later. The senators praised the efforts of the HHS in issuing prompt guidance on the privacy of medical information relating to abortion and other sexual and reproductive health care and also for issuing guidance to consumers on protecting health information on mobile devices but believe that the HHS needs to go further.

“We urge HHS to immediately begin the process to update the Privacy Rule, following all requirements under the Administrative Procedure Act, to clarify who is a covered entity and to limit when that entity can share information on abortion or other reproductive health services,” explained the senators. The senators specifically requested the HHS clarify that reproductive health care information cannot be shared with law enforcement agencies who target individuals who have an abortion, and have requested the HHS rule that Pregnancy Care Centers (aka Crisis Pregnancy Centers) are required to comply with the HIPAA Privacy Rule.

“Following the Supreme Court’s decision in Dobbs, millions of Americans have lost a fundamental constitutional right to make their own health and reproductive decisions. We must do all that we can to protect their fundamental right to privacy,” concluded the senators.

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OCR Issues Guidance for Providers and Individuals Following Supreme Court Decision on Roe v. Wade

Posted by HIPAA Journal

President Biden and U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra recently called on HHS agencies to take action to protect access to sexual and reproductive health care, which includes abortion, pregnancy complications, and other related care, following the decision of the Supreme Court in Dobbs vs. Jackson Women’s Health Organization. The Supreme Court overruled Roe v. Wade and Planned Parenthood v. Casey and took away the right of women to have a safe and legal abortion.

Yesterday, the HHS Office for Civil Rights (OCR) issued new guidance for healthcare providers and patients seeking access to reproductive health care services to ensure patient privacy is protected. The guidance explains that the federal Health Insurance Portability and Accountability Act (HIPAA) requires individuals’ private medical information, which includes information about abortion and other sexual and reproductive health care, is required to be kept private and confidential. That information is classed as protected health information (PHI) under HIPAA and healthcare providers are not required to disclose PHI to third parties.

The guidance also explains the extent to which private medical information is protected on personal cell phones and tablets and includes advice for protecting individuals’ privacy when using period trackers and other health information apps. Concern has been raised by women that health apps on smartphones, such as period trackers, threaten privacy as they disclose geolocation data. That information could potentially be abused by individuals seeking to deny them access to medical care.

“How you access health care should not make you a target for discrimination,” explained HHS Secretary Xavier Becerra. “HHS stands with patients and providers in protecting HIPAA privacy rights and reproductive health care information.” Becerra is encouraging anyone who believes their privacy rights have been violated to file a complaint with OCR and explained that protecting access to health care, which includes abortion care and other forms of sexual and reproductive health care, is now an enforcement priority for OCR.

The guidance for healthcare providers explains that the HIPAA Privacy Rule allows HIPAA-covered entities, which includes healthcare providers, to disclose an individual’s PHI without obtaining authorization from that individual for the purposes of healthcare, payment, and healthcare operations, but other disclosures – to law enforcement officials for example – are only permitted in narrow circumstances, tailored to protect the individual’s privacy and support their access to health care, which includes abortion care. HIPAA-covered entities and their business associates are reminded that they can use and disclose PHI without an individual’s signed authorization, but only for reasons expressly permitted or required by the Privacy Rule. The guidance also explains the restrictions on disclosures of PHI under the HIPAA Privacy Rule when required by law, for law enforcement purposes, and to avert a serious threat to health or safety.

Separate guidance has been issued for individuals about protecting the privacy and security of their health information when using their personal cell phones or tablets. It is important for individuals to understand that most health apps, including period trackers, are not covered by the HIPAA Privacy or Security Rules. That means any personal healthcare data entered, collected, or transmitted by those apps or is stored on smartphones or tablets, is not protected and there are no restrictions on disclosures of that information.

The guidance explains best practices to adopt when using these health apps that will decrease the personal information collected by the apps and limit the potential for disclosures of personal information – including geolocation data – without the individual’s knowledge. The guidance explains how to turn off the location services on Apple and Android devices, and offers advice on selecting apps, browsers, and search engines that prioritize privacy and security.

Information on individuals’ rights to reproductive healthcare is available here.

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GAO: HHS Should Establish Mechanism for Obtaining Feedback on HIPAA Data Breach Reporting Process

Posted by HIPAA Journal

The Government Accountability Office (GAO) has recommended that the Department of Health and Human Services (HHS) establish a feedback mechanism to improve the effectiveness of its data breach reporting process.

The Health Information Technology for Economic and Clinical Health (HITECH) Act, part of the American Recovery and Reinvestment Act of 2009, called for the Secretary of the HHS to create and maintain a list of data breaches involving the unsecured protected health information of 500 or more individuals on its website.

The HHS’ Office for Civil Rights (OCR) Breach Portal includes breaches of the personally identifiable protected health information (PHI), such as unauthorized access and disclosures, exposures, and the loss and theft of PHI. The number of reported data breaches has been increasing each year, with 2021 seeing 714 data breaches of 500 or more records reported to OCR.

GAO explained in its report that between 2015 and 2021, the number of individuals affected by healthcare data breaches at healthcare providers, health plans, healthcare clearinghouses, and business associates of those entities has ranged from 5 million to 113 million each year.

OCR is the main enforcer of compliance with the Health Insurance Portability and Accountability Act (HIPAA). OCR investigates data breaches and complaints about potential HIPAA violations and seeks to establish whether the HIPAA Rules have been violated. To date, OCR has imposed 110 financial penalties on HIPAA-regulated entities that have been determined to have violated the HIPAA Rules.

In January 2021, the HITECH Act was amended to require OCR to consider the ‘recognized security practices’ that were continuously in place for the 12 months previously when making determinations about actions to take against HIPAA-regulated entities that have experienced breaches of PHI. OCR sought feedback from the public on the implementation of recognized security practices and is due to finalize that process this summer.

GAO said it was asked to conduct a review of the breach reporting process, determine the extent to which the HHS had established a review process to assess whether covered entities had implemented recognized security practices, and determine the extent to which improvements can be made related to the breach reporting requirements of the HHS.

As part of that process, GAO reviewed privacy and information security laws; analyzed HHS documentation, policies, and procedures; interviewed cognizant OCR officials; and surveyed HIPAA-regulated entities.

GAO said in its report that OCR has been charged with the development and management of the breach reporting process but has not established a method to allow HIPAA-regulated entities to provide feedback on the breach reporting process. Without such a mechanism, HIPAA-regulated entities could face challenges during the breach reporting process and have no clear way of reporting those issues to OCR. GAO has recommended such a process be established, as this would help OCR to improve aspects of the breach reporting process.

The HHS concurred with the single GAO recommendation and explained that OCR would establish a mechanism for regulated entities to provide feedback on the breach reporting and investigative process. This would be achieved by adding language and contact information to the confirmation emails that HIPAA-regulated entities receive when they report data breaches through the HHS Breach Portal. The HHS said it will also be issuing procedures to OCR’s regional offices that require them to regularly review and address emails received about the breach reporting process.

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