HIPAA News

CMS Launches Review Program to Assess Compliance with the HIPAA Administrative Simplification Rules

Posted by HIPAA Journal

The HHS’ Centers for Medicare and Medicaid Services (CMS) has launched a compliance review program to assess whether HIPAA covered entities are complying with the HIPAA Administrative Simplification Rules for electronic healthcare transactions. The compliance reviews will commence in April 2019.

The HIPAA Administrative Simplification Rules

The HIPAA Administrative Simplification Rules were introduced to improve efficiency and the effectiveness of the health system in the United States. They require healthcare organizations to adopt national standards for healthcare transactions that are conducted electronically, including the use of standard code sets and unique health identifiers, in addition to complying with the requirements of the HIPAA Privacy and Security Rules.

The HHS’ Office for Civil Rights is responsible for enforcing the HIPAA Privacy, Security, and Breach Notification Rules. The CMS is responsible for administering and enforcing the rules covering transaction and code sets standards, the employer identifier standard, and the national provider identifier standard, as detailed in 45 CFR Parts 160, 162, and 164. The CMS-administered standards are required to be adopted whenever there is an exchange of health information. If the standards are not adopted, healthcare information cannot be exchanged efficiently.

The CMS Compliance Review Program

Starting in April 2019, the CMS will conduct compliance reviews on 9 randomly selected health plans and healthcare clearinghouses, including those that deal with Medicare and Medicaid and those that do not.

The compliance reviews will assess whether HIPAA -covered entities are in compliance with the standards set for:

  • Transaction formats;
  • Code sets; and
  • Unique identifiers

If covered entities selected for a review are found not to be in compliance with the HIPAA Administrative Simplification Rules, they will be provided with a corrective action plan to address any violations and will be given the opportunity to make changes and achieve compliance.

Any covered entity that fails to make the necessary changes and achieve compliance with the HIPAA Administrative Simplification standards will be subjected to “escalating enforcement actions”, which could include civil monetary penalties.

The 2019 CMS Compliance Review Program follows on from a pilot review program conducted in 2018 on three health plans and three healthcare clearinghouses that volunteered to participate. A separate program will take place in 2019 in which providers will also be able to volunteer for compliance reviews.

After the latest round of 9 compulsory compliance reviews have been completed, the CMS will conduct an ongoing campaign involving periodic reviews of randomly selected covered entities to assess compliance with the HIPAA Administrative Simplification Rules.

These will be in addition to the normal procedure for enforcing compliance, which currently operates on a complaint basis.

Organizations can use the web-based Administrative Simplification Enforcement and Testing Tool (ASETT) to test transactions to determine whether they are compliant and to submit complaints about HIPAA Administrative Simplification Rules violations.

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$1.6 Million Settlement Agreed with Texas Department of Aging and Disability Services Over 2015 Data Breach

Posted by HIPAA Journal

The Department of Health and Human Services’ Office for Civil Rights has agreed to settle a HIPAA violation case with the Texas Department of Aging and Disability Services (DADS) to resolve HIPAA violations discovered during the investigation of a 2015 data breach that exposed the protected health information of 6,617 Medicaid recipients.

The breach was caused by an error in a web application which made ePHI accessible over the internet for around 8 years. DADS submitted a breach report to OCR on June 11, 2015.

OCR launched an investigation into the breach to determine whether there had been any violation of HIPAA Rules. On July 2015, OCR notified DADS that the investigation had revealed there had been multiple violations of HIPAA Rules.

DADS was deemed to have violated the risk analysis provision of the HIPAA Security Rule – 45 C.F.R. § 164.308(a)(1)(ii)(A) – by failing to conduct a comprehensive, organization-wide risk analysis to identify potential risks to the confidentiality, integrity, and availability of ePHI.

There had also been a failure to implement appropriate technical policies and procedures for systems containing ePHI to only allow authorized individuals to access those systems, in violation of 45 C.F.R. § 164.308(a)(4) and 45 C.F.R. § 164.312(a)(1).

Appropriate hardware, software, and procedural mechanisms to record and examine information system activity had not been implemented, which contributed to the duration of exposure of ePHI – A violation of 5 C.F.R. § 164.312(b).

As a result of these violations, there was an impermissible disclosure of ePHI, in violation of 45 C.F.R. § 164.502(a).

The severity of the violations warranted a financial penalty and corrective action plan. Both were presented to the State of Texas and DADS was given the opportunity to implement the measures outlined in the CAP to address the vulnerabilities to ePHI.

The functions and resources that were involved in the breach have since been transferred to the Health and Human Services Commission (HHSC), which will ensure the CAP is implemented.

The State of Texas presented a counter proposal for a settlement agreement to OCR which will see the deduction of $1,600,000 from sums owed to HHSC from the CMS. The settlement releases HHSC from any further actions related to the breach and HHSC has agreed not to contest the settlement or CAP.

The settlement has yet to be announced by OCR, but it has been approved by the 86th Legislature of the State of Texas. This will be the first 2019 HIPAA settlement between OCR and a HIPAA covered entity.

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February 2019 Healthcare Data Breach Report

Posted by HIPAA Journal

Healthcare data breaches continued to be reported at a rate of more than one a day in February. February saw 32 healthcare data breaches reported, one fewer than January.

Healthcare data breaches by month

The number of reported breaches may have fell by 3%, but February’s breaches were far more severe. More than 2.11 million healthcare records were compromised in February breaches – A 330% increase from the previous month.

Records exposed in Healthcare data breaches by month

Causes of Healthcare Data Breaches in February 2019

Commonly there is a fairly even split between hacking/IT incidents and unauthorized access/disclosure incidents; however, in February, hacking and IT incidents such as malware infections and ransomware attacks dominated the healthcare data breach reports.

75% of all reported breaches in February (24 incidents) were hacking/IT incidents and those incidents resulted in the theft/exposure of 96.25% of all records that were breached. All but one of the top ten healthcare data breaches in February were due to hacks and IT incidents.

There were four unauthorized access/disclosure incidents and 4 cases of theft of physical or electronic PHI. The unauthorized access/disclosure incidents involved 3.1% of all compromised records and 0.65% of records were compromised in the theft incidents.

Causes of Healthcare data breaches in February 2019

Largest Healthcare Data Breaches in February 2019

The largest healthcare data breach reported in February involved the accidental removal of safeguards on a network server, which allowed the protected health information of more than 973,000 patients of UW Medicine to be exposed on the internet. Files were indexed by the search engines and could be found with simple Google searches. Files stored on the network server were accessible for a period of more than 3 weeks.

The second largest data breach was due to a ransomware attack on Columbia Surgical Specialist of Spokane. While patient information may have been accessed, no evidence was found to suggest any ePHI was stolen by the attackers.

The 326,629-record breach at UConn Health was due to a phishing attack that saw multiple employees’ email accounts compromised, and one email account was compromised in a phishing attack on Rutland Regional Medical Center that contained the ePHi of more than 72,000 patients.

Rank Name of Covered Entity Covered Entity Type Individuals Affected Type of Breach
1 UW Medicine Healthcare Provider 973,024 Hacking/IT Incident
2 Columbia Surgical Specialist of Spokane Healthcare Provider 400,000 Hacking/IT Incident
3 UConn Health Healthcare Provider 326,629 Hacking/IT Incident
4 Rutland Regional Medical Center Healthcare Provider 72,224 Hacking/IT Incident
5 Delaware Guidance Services for Children and Youth, Inc. Healthcare Provider 50,000 Hacking/IT Incident
6 Rush University Medical Center Healthcare Provider 44,924 Unauthorized Access/Disclosure
7 AdventHealth Medical Group Healthcare Provider 42,161 Hacking/IT Incident
8 Reproductive Medicine and Infertility Associates, P.A. Healthcare Provider 40,000 Hacking/IT Incident
9 Memorial Hospital at Gulfport Healthcare Provider 30,642 Hacking/IT Incident
10 Pasquotank-Camden Emergency Medical Service Healthcare Provider 20,420 Hacking/IT Incident

 

Location of Breached Protected Health Information

Email is usually the most common location of compromised PHI, although in February there was a major rise in data breaches due to compromised network servers. 46.88% of all breaches reported in February involved ePHI stored on network servers, 25% involved ePHI stored in email, and 12.5% involved ePHI in electronic medical records.

Location of breached PHI

Healthcare Data Breaches by Covered Entity Type

Healthcare providers were the worst affected by data breaches in February 2019 with 24 incidents reported. There were five breaches reported by health plans, and three breaches reported by business associates of HIPAA-covered entities. A further seven breaches had some business associate involvement.

February 2019 healthcare data breaches by covered entity

Healthcare Data Breaches by State

The healthcare data breaches reported in February were spread across 22 states. California and Florida were the worst affected states with three breaches apiece. Two breaches were reported in each of Illinois, Kentucky, Maryland, Minnesota, Texas, and Washington, and one breach was reported in each of Arizona, Colorado, Connecticut, Delaware, Georgia, Kansas, Massachusetts, Mississippi, Montana, North Carolina, Virginia, Wisconsin, and West Virginia.

HIPAA Enforcement Actions in February 2019

2018 was a record year for HIPAA enforcement actions, although 2019 has started slowly. The HHS’ Office for Civil Rights has not issued any fines nor agreed any HIPAA settlements so far in 2019.

There were no enforcement actions by state attorneys general over HIPAA violations in February. The only 2019 penalty to date is January’s $935.000 settlement between California and Aetna.

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Healthcare Associations Call for Safe Harbor for Breached Entities That Have Adopted Cybersecurity Best Practices

Posted by HIPAA Journal

Several healthcare associations have requested a safe harbor for healthcare organizations that would prevent OCR and state attorneys general from issuing financial penalties for breaches of protected health information if the breached entity has met certain standards for safeguarding protected health information (PHI).

The suggestions were made in response to the Department of Health and Human Services’ request for information (RFI) on potential changes to HIPAA to reduce the burden on healthcare organizations and improve data sharing for the coordination of patient care. The HHS received more than 1,300 comments on possible changes prior to the February 12, 2019 deadline.

The safe harbor was suggested by the College of Healthcare Information Management Executives (CHIME), the Association for Executives in Healthcare Information Technology (AEHIT), the Association for Executives in Healthcare Information Security (AEHIS), the American Medical Association (AMA), and the American Hospital Association (AHA).

Healthcare organizations can adopt cybersecurity frameworks, create layered defenses to keep their networks secure, provide security awareness training to employees, and adopt cybersecurity best practices, yet still experience a data breach.

OCR has already made it clear that its area of focus for enforcement is egregious violations of HIPAA Rules, such as widespread noncompliance and HIPAA-covered entities that have little regard for HIPAA Rules. However, all breaches of 500 or more records are investigated, and if HIPAA violations are discovered, financial penalties could be issued.

It has been argued that entities that have made reasonable efforts to keep patient information private and confidential should not be at risk of significant penalties.

CHIME suggested OCR should create “A safe harbor for providers who have demonstrated they are meeting a set of best practices such as those developed under the public-private effort known as the Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients (HICP).”

The AHA suggested healthcare organizations that experience cyberattacks should be provided with support and resources, and rather than punishing the breached entity, “Enforcement efforts should rightly focus on investigating and prosecuting the attackers.”

Most healthcare organizations take significant steps to prevent successful cyberattacks. The AHA said that when an attack occurs, an investigation is necessary to determine how access to systems and data was gained. Lessons can be learned, safeguards improved, and details of the vulnerabilities and threats should then be shared widely to allow other healthcare organizations to prevent similar attacks.

The AHA suggested there should be “A safe harbor for HIPAA covered entities that have shown, perhaps through a certification process, that they are in compliance with best practices in cybersecurity, such as those promulgated by HHS, in cooperation with the private sector.”

The AMA suggests that “OCR could revise [the HIPAA Security Rule] to include a new clause stating that covered entities that adopt and implement a security framework – such as the NIST Cybersecurity Framework – or take steps toward applying the Health Industry Cybersecurity Practices – the primary publication of the Cybersecurity Act of 2015 Task Group – are in compliance with the Security Rule.”

The AMA also suggests that OCR should change its approach to securing health information from issuing penalties for failures to providing positive incentives to encourage healthcare organizations to improve security and better protect health information.

CHIME stated that the current policy that calls for breaches to be reported and listed on the OCR breach portal in perpetuity is unduly punitive and that there should be a mechanism for removing breached entities from the listings once they have taken actions to correct vulnerabilities that contributed to the breach.

The HHS is now assessing all comments and feedback received in relation to its RFI and will determine which aspects of HIPAA Rules should be changed. A notice of proposed rulemaking will then be issued, although the HSS has not provided a time frame for doing so.

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Aetna Settles HIV Status Breach Case with California AG for $935,000

Posted by HIPAA Journal

Hartford, CT-based health insurer Aetna has agreed to pay the California Attorney General $935,000 to resolve alleged violations of state laws related to a 2017 privacy violation that exposed state residents’ HIV status.

On July 28, 2017, Aetna’s mailing vendor sent letters to plan members who were receiving HIV medications or pre-exposure prophylaxis to prevent them from contracting HIV. The letters contained instructions for their HIV medications; however, information about the HIV medications was clearly visible through the window of the envelopes, resulting in the impermissible disclosure of highly sensitive information to postal workers, friends, family members, and roommates.  Approximately 12,000 individuals were sent letter, 1,991 of whom lived in California.

The privacy breach was a violation of HIPAA Rules, and according to California Attorney General Xavier Becerra, also a violation of several California laws including the Unfair Competition Law, the Confidentiality of Medical Information Act, the Health and Safety Code (section 120980), and the State Constitution.

In addition to the financial penalty, the settlement agreement requires Aetna to designate an employee to implement and maintain its mailing program, oversee compliance with state and federal laws, and the management of external vendors to ensure they handle medical data in compliance with state and federal laws and Aetna’s policies and procedures. Aetna is also required to complete an annual privacy risk assessment to evaluate compliance with the terms of the settlement for the next three years.

“A person’s HIV status is incredibly sensitive information and protecting that information must be a top priority for the entire healthcare industry,” said Attorney General Bercerra. “Aetna violated the public’s trust by revealing patients’ private and personal medical information.”

The privacy violation has proven expensive for Aetna. In January 2018, Aetna settled a class action lawsuit filed on behalf of victims of the breach for $17,161,200. Also in January, Aetna agreed to pay the New York Attorney General $1,150,000 to settle its case and resolve alleged HIPAA violations and breaches of state law.

A further $640,170.59 was paid to settle a multi-state action by Attorneys General in New Jersey, Connecticut, Washington, and the District of Columbia. The latest settlement brings the total financial penalties issued to date in relation to the breach to $2,725,170.59.

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Oregon Health Information Property Act Proposes Paying Patients to Share Their Healthcare Data

Posted by HIPAA Journal

The Oregon Health Information Property Act proposes patients should be allowed to give authorization to their healthcare providers to sell on their health data and to receive payment in exchange for allowing their data to be used by third parties.

Currently, the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule limits the allowable uses and disclosures of ‘Protected Health Information.’ HIPAA-covered entities are only permitted to use or disclose PHI for purposes related to the provision of treatment, payment for healthcare, or healthcare operations. While there are some exceptions, other uses and disclosures are prohibited unless consent is first obtained from patients.

The HIPAA Privacy Rule covers PHI, which is identifiable patient information. If PHI is stripped of information that allow an individual to be identified, it is no longer considered PHI and is no longer subject to Privacy Rule controls. That means that if a HIPAA-covered entity de-identifies PHI, they can then sell that information on for profit. That information can be valuable to research organizations and other entities.

Senate Bill 703, dubbed the Oregon Health Information Property Act, is sponsored by Senator Floyd Prozanski (D-Eugene) and has the support of than 40 co-sponsors. Essentially, the bill would see consumers health information treated in a similar way to property and would allow them to profit from its sale.

The Oregon Health Information Property Act

The Oregon Health Information Property Act has three main components:

  1. It would require HIPAA-covered entities and their business associates and subcontractors to obtain a signed authorization from consumers before they de-identify PHI to sell on to third parties.
  2. Consumers could choose if they want to receive payment in exchange for giving authorization to allow their health data to be sold.
  3. The bill also prevents consumers from being discriminated against for refusing to sign an authorization or choosing to receive payment.

HIPAA-covered entities are able to profit from selling de-identified data so it is argued that patients should receive a cut of the payment; however, despite having attracted considerable support, concern has been voiced about the impact of these authorizations.

The bill, in its current form, does not place any limitations on the uses of health data once authorization has been provided. Information could therefore be used for a wide range of purposes once authorization has been given – Reasons that may not necessarily be listed on the authorization form.

The bill also makes no distinction between an individual’s protected health information, health information or de-identified data. By signing a form to receive a small payment, consumers would be relinquishing their privacy and important protections afforded by HIPAA, which could have various unintended repercussions.

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Analysis of 2018 Healthcare Data Breaches

Posted by HIPAA Journal

Our 2018 healthcare data breach report reveals healthcare data breach trends, details the main causes of 2018 healthcare data breaches, the largest healthcare data breaches of the year, and 2018 healthcare data breach fines. The report was compiled using data from the Department of Health and Human Services’ Office for Civil Rights (OCR).

2018 Was a Record-Breaking Year for Healthcare Data Breaches

Since October 2009, the Department of Health and Human Services’ Office for Civil Rights has been publishing summaries of U.S. healthcare data breaches. In that time frame, 2,545 healthcare data breaches have been reported. Those breaches have resulted in the theft, exposure, or impermissible disclosure of 194,853,404 healthcare records. That equates to the records of 59.8% of the population of the United States.

The number of reported healthcare data breaches has been steadily increasing each year. Except for 2015, the number of reported healthcare data breaches has increased every year.

Healthcare data breaches 2009-2018

In 2018, 365 healthcare data breaches were reported, up almost 2% from the 358 data breaches reported in 2017 and 83% more breaches that 2010.

2018 was the worst year in terms of the number of breaches experienced, but the fourth worst in terms of the number of healthcare records exposed, behind 2015, 2014, and 2016. The last two years have certainly seen an improvement in that sense, although 2018 saw a 157.67% year-over-year increase in the number of compromised healthcare records.

healthcare records exposed 2009-2018

2018 Healthcare Data Breaches by Month

Healthcare data breaches in 2018 by month

Healthcare Records Exposed Each Month in 2018

records exposed in healthcare data breaches in 2018 by month

Largest 2018 Healthcare Data Breaches

Rank Name of Covered Entity Covered Entity Type Individuals Affected Type of Breach
1  AccuDoc Solutions, Inc. Business Associate 2,652,537 Hacking/IT Incident
2 Iowa Health System d/b/a UnityPoint Health Business Associate 1,421,107 Hacking/IT Incident
3 Employees Retirement System of Texas Health Plan 1,248,263 Unauthorized Access/Disclosure
4 CA Department of Developmental Services Health Plan 582,174 Theft
5 MSK Group Healthcare Provider 566,236 Hacking/IT Incident
6 CNO Financial Group, Inc. Health Plan 566,217 Unauthorized Access/Disclosure
7 LifeBridge Health, Inc Healthcare Provider 538,127 Hacking/IT Incident
8 Health Management Concepts, Inc. Business Associate 502,416 Hacking/IT Incident
9 AU Medical Center, INC Healthcare Provider 417,000 Hacking/IT Incident
10 SSM Health St. Mary’s Hospital – Jefferson City Healthcare Provider 301,000 Improper Disposal

Click for further information on the largest healthcare data breaches of 2018.

Causes of 2018 Healthcare Data Breaches

The biggest causes of healthcare data breaches in 2018 were hacking/IT incidents (43.29%) and unauthorized access/disclosures (39.18%), which together accounted for 82.47% of all data breaches reported in 2018. There were 42 theft incidents (11.5%) reported in 2018, 13 cases (3.56%) of lost PHI/ePHI, and 9 cases (2.47%) of improper disposal of PHI/ePHI.

Causes of 2018 Healthcare Data Breaches

There was a 5.33% annual increase in hacking/IT incidents – 158 breaches compared to 150 in 2017. While the number of hacking/IT-related breaches rose only slightly, the breaches were far more damaging in 2018 and resulted in the theft/exposure of 161.89% more healthcare records. The mean breach size of hacking/IT incidents in 2017 was 23,218 records and in 2018 it rose to 57,727 records in 2018 – A year-over-year increase of 148.63%.

2018 saw an even larger increase in unauthorized access/disclosure incidents. 14.4% more incidents were reported in 2018 than 2017 and 146.49% more healthcare records were exposed in unauthorized access/disclosure incidents than the previous year. The mean breach size of unauthorized access/disclosure incidents in 2017 was 9,893 records and 21,316 records in 2018 – An increase of 115.47%.

Loss, theft, and improper disposal incidents all declined in 2018. Loss incidents fell from 16 to 13 year-over-year (-18.75%), improper disposal incidents fell from 11 to 9 (-18.18%), and theft incidents fell from 56 in 2017 to 42 in 2018 (-25%).

While there was a reduction in the number of cases of theft and improper disposal year-over-year, the severity of those two types of breaches increased in 2018. The mean breach size of theft incidents rose from 6,908 records in 2017 to 16,605 records in 2018 – A rise of 140.37%. Improper disposal incidents increased from a mean of 2,802 records in 2017 to 37,794 records in 2018 – A rise of 1,248.82%.

There was a slight reduction in the severity of loss incidents, which fell from an average of 2,461 records in 2017 to 2,305 – A fall of 6.33%.

records exposed by breach cause

Location of Breached Protected Health Information

The breakdown of 2018 healthcare data breaches by the location of breached PHI highlights the importance of increasing email security and providing further training to healthcare employees. 33.42% of all healthcare data breaches in 2018 involved email. Those breaches include phishing attacks, other unauthorized email access incidents and misdirected emails.
While healthcare organizations may be focused on preventing cyberattacks and improving technical defenses, care must still be taken with physical records. There were 81 breaches of physical PHI such as charts, documents, and films in 2018. Paper/films were involved in 22.19% of breaches.

The next most common location of breached PHI was network servers, which were involved in 20.27% of breaches in 2018. These incidents include hacks, ransomware attacks, and malware-related breaches.

Location of Breached Protected Health Information

2018 Healthcare Data Breaches by Covered Entity Type

Given the relative percentages of healthcare providers to health plans, it is no surprise that more healthcare provider data breaches occurred. 74.79% of the year’s breaches affected healthcare providers, 14.52% occurred at health plans, and 10.68% affected business associates of HIPAA-covered entities.

2018 Healthcare Data Breaches by Covered Entity

Business associate data breaches were the most severe, accounting for 42% of all exposed/stolen records in 2018, followed by healthcare provider breaches and breaches at health plans.  The mean breach size for business associate data breaches was 140,915 records, 53,471 records for health plan data breaches, and 17,974 records for healthcare provider data breaches.

2018 Healthcare Data Breaches by Covered Entity (records)

States Worst Affected By 2018 Healthcare Data Breaches

Being the two most populated states, it is no surprise that California and Texas were the worst affected by healthcare data breaches in 2018. Only four states avoided healthcare data breaches in 2018 – New Hampshire, South Carolina, South Dakota, Vermont.

Number of Breaches State
38 California
32 Texas
19 Illinois
18 Florida
18 Massachusetts
16 New York
14 Missouri
11 Pennsylvania
10 Iowa, Michigan, Minnesota, Wisconsin
9 Maryland, Ohio, Oregon
8 Arizona, North Carolina, Virginia
7 Georgia, New Jersey, Tennessee, Washington
6 Colorado, Kansas, Nevada
5 Arkansas, Indiana, Nebraska, New Mexico, Utah
4 Connecticut, Kentucky
3 Alaska, Louisiana, Mississippi, Montana, Rhone Island
2 Alabama, District of Columbia, Oklahoma, Wyoming
1 Hawaii, Idaho, Maine, North Dakota, West Virginia
0 New Hampshire, South Carolina, South Dakota, Vermont

HIPAA Fines and Settlements in 2018

The HHS’ Office for Civil Rights is the main enforcer of HIPAA Rules and has the authority to issue financial penalties for violations of Health Insurance Portability and Accountability Act (HIPAA) Rules. State attorneys general also play a role in the enforcement of HIPAA compliance and can also issue fines for HIPAA violations.

In 2018, OCR issued 10 financial penalties to resolve HIPAA violations that were discovered during the investigation of healthcare data breaches and complaints.

Summary of 2018 HIPAA Fines and Settlements

The financial penalties issued by OCR in 2018 totaled $25,683,400, making 2018 a record-breaking year for HIPAA penalties.

2018 HIPAA fines and penalties total

12 financial penalties were issued by state attorneys general over violations of HIPAA Rules.

You can read more about the – HIPAA fines and settlements in 2018 here.

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December 2018 Healthcare Data Breach Report

Posted by HIPAA Journal

November was a particularly bad month for healthcare data breaches, so it is no surprise that there was an improvement in December. November was the worst month of the year in terms of the number of healthcare records exposed (3,230,063) and the second worst for breaches (34). December was the second-best month for healthcare data breaches with 23 incidents reported, only one more than January.

2018 Healthcare Data Breaches

In total, 516,370 records were exposed, impermissibly disclosed, or stolen in breaches reported in December: A considerable improvement on November. Were it not for the late reporting of the Adams County breach, December would have been the best month of the year to date in terms of the records exposed. The Adams County breach was experienced in March 2018, confirmed on June 29, yet reporting to OCR was delayed until December 11.

2018 Healthcare Data Breaches - Records Exposed

Largest Healthcare Data Breaches in December 2018

Rank Name of Covered Entity Covered Entity Type Individuals Affected Type of Breach
1 Adams County Healthcare Provider 258,120 Unauthorized Access/Disclosure
2 JAND Inc. d/b/a Warby Parker Healthcare Provider 177,890 Hacking/IT Incident
3 University of Vermont Health Network – Elizabethtown Community Hospital Healthcare Provider 32,470 Hacking/IT Incident
4 The Podiatric Offices of Bobby Yee Healthcare Provider 24,000 Hacking/IT Incident
5 Choice Rehabilitation Business Associate 4,309 Hacking/IT Incident
6 Virtual Radiologic Professionals, LLC Healthcare Provider 2,568 Hacking/IT Incident
7 Kent County Community Mental Health Authority Healthcare Provider 2,284 Hacking/IT Incident
8 Butler County Board of County Commissioners Health Plan 1,912 Unauthorized Access/Disclosure
9 Barnes-Jewish Hospital Healthcare Provider 1,643 Hacking/IT Incident
10 Tift Regional Medical Center Healthcare Provider 1,045 Hacking/IT Incident

Causes of December 2018 Healthcare Data Breaches

The healthcare industry experiences more insider breaches than other industry sectors, although in December, hacking/IT Incidents outnumbered unauthorized/access disclosure incidents by almost two to one. Eight of the top ten data breaches for the month were hacks, ransomware attacks, and other IT incidents.

While unauthorized access/disclosure incidents usually impact fewer individuals that hacking breaches, that was not the case in December. The largest breach of the month was the unauthorized accessing of a network server by a former employee of Adams County, WI.

In total, 264,049 healthcare records were exposed in the 7 unauthorized access/disclosure incidents reported in December. The mean breach size was 37,721 records and the median breach size was 911 records.

250,404 healthcare records were exposed in the 13 hacking/IT incidents. The mean breach size was 19,261 records and the median breach size was 1,643 records.

There were two theft incidents reported in December and one case of improper disposal of paper records. No lost devices were reported.

Causes of December 2018 Healthcare Data Breaches

Location of Breached Protected Health Information

Phishing attacks continue to plague healthcare organizations and December was no exception. The largest phishing incident reported in December affected 32,470 patients of Elizabethtown Community Hospital. The PHI was contained in a single email account.

Three email accounts were compromised at Kent County Community Mental Health Authority, although they only contained the PHI of 2,200 individuals.

The most common location of breached PHI in December was email, although network server breaches were more severe. The two largest December 2018 healthcare data breaches were network server incidents which impacted 436,010 individuals – 84.43% of the total number of breached records in December.

Location of Breached Protected Health Information

Data Breaches by Covered-Entity Type

Health plans made it through November without reporting any data breaches, although they didn’t fare so well in December. 6 health plan data breaches were announced in December; however, all were relatively small, with only the breach at Butler County Board of County Commissioners impacting more than 1,000 plan members (1,912).

One data breach was reported by a business associate of a HIPAA-covered entity, although a further three breaches had some business associate involvement. The remaining 16 breaches were reported by healthcare providers.

Data Breaches by Covered-Entity Type

Healthcare Data Breaches by State

In December 2018, healthcare organizations in 13 states reported PHI breaches. Minnesota was the worst affected state with a total of four breaches followed by Arizona with three. There were two breaches reported by healthcare organizations based in each of California, Missouri, New York, Ohio, and Wisconsin, and a single breach was experienced in each of Georgia, Illinois, Kentucky, Massachusetts, Michigan, and Pennsylvania.

HIPAA Fines and Settlements in December 2018

The Department of Health and Human Services’ Office for Civil Rights (OCR) agreed two settlements with HIPAA-covered entities in December to resolve violations of HIPAA Rules. OCR finished the year on ten fines and settlements, the same number as 2017. (You can view all 2018 HIPAA fines and settlements here).

Advanced Care Hospitalists, a Florida Contractor Physicians’ Group, was investigated by OCR following the submission of a breach report in April 2014. The report stated the PHI of 400 patients had been subject to unauthorized access, although the number of individuals affected was subsequently increased to 8,855 patients.

OCR confirmed there had been a preventable impermissible disclosure of PHI, and found that a business associate had been engaged without first entering into a business associate agreement. Additionally, insufficient security measures had been implemented and there had been no effort to comply with HIPAA Rules prior to April 1, 2014. Advanced Care Hospitalists and OCR settled the HIPAA violation case for $500,000.

On June 7, 2013, OCR received a complaint about Pagosa Springs Medical Center, a critical access hospital in Colorado, which had failed to terminate access to a web-based scheduling calendar after an employee’s contract had been terminated. The OCR investigation confirmed the former employee accessed the calendar on two occasions after leaving employment.

For the failure to terminate employee access and the lack of a business associate agreement with Google covering Google Calendar resulted in a financial penalty of $111,400 for Pagosa Springs Medical Center.

There were two financial penalties issued by state Attorneys General in December to resolve violations of HIPAA Rules.

The Massachusetts Attorney General fined McLean Hospital $75,000 over a breach of 1,500 patients PHI. The information was stored on backup tapes that had been taken offsite by an employee. When the employee was terminated, McLean Hospital was unable to recover two of the backup tapes.

The New Jersey Attorney General issued a financial penalty of $100,000 to EmblemHealth over an impermissible disclosure of PHI. In 2016, an EmblemHealth mailing had Social Security numbers printed on the outside of envelopes. This was the second fine for EmblemHealth in relation to the breach. The New York Attorney General had previously settled its case with EmblemHealth for $575,000 earlier in the year.

 

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Revised Common Rule Now Effective

Posted by HIPAA Journal

The updated Federal Policy for the Protection of Human Subjects (45 CFR part 46), otherwise known as the Common Rule, is now in effect. The compliance date of the revised Common Rule was January 21, 2019.

The Common Rule governs federally funded research on human subjects and was introduced in 1991. The Common Rule was amended in 2015 and underwent a major revision in 2017 to improve protections for research subjects while easing the administrative burden on researchers, especially for low-risk research.

The compliance date of the revised Common Rule was initially January 19, 2018; however, two days before the compliance date, an interim final rule was published which delayed the compliance date initially for six months, and subsequently for another six months.

Regulated entities were required to comply with the pre-2018 version of the Common Rule until January 20, 2019, with the exception of three provisions of the revised Common Rule which aimed to reduce the administrative burden on researchers.

Those three provisions, which could be adopted between July 2019 and January 20, 2019, were:

  • A change to the definition of research, which exempted certain research activities such as public surveillance activities to monitor the spread of disease, journalistic activities, and criminal investigations.
  • Eliminating the requirement for continuing reviews of certain categories of research that are considered low-risk
  • Eliminating the requirement that institutional review boards (IRB) review grant applications or other funding proposals related to the research

Now that the compliance date has arrived, regulated entities that receive federal funding for research now need to work quickly to implement all of the changes to the Common Rule, including the above three principles if they have not already been adopted.

Notable changes in the revised Common Rule are detailed below:

Consent Forms

Consent forms can be long and complex, but the changes to the Common Rule will make it easier for voluntary research subjects to find the information they need.

Consent forms need to include a concise explanation at the start of the document in which all of the key information about the study is clearly explained, including the purpose of the study, the risks and benefits, and appropriate alternative treatments that may be beneficial to the research subject.

Future uses of research data must also be specified and a statement must also be included on the consent form which explains if and when the results of the study will be made available to the research subject.

A statement will need to be included, if applicable, explaining that biospecimens may be used for commercial profit and whether the research subject will receive a share of that profit.

IRBs do not need to obtain informed consent in cases of obtaining information or biospecimens for screening, recruiting, or determining eligibility of prospective subjects, under certain circumstances.

Consent forms for clinical trials that are conducted by or supported by a Federal department or agency require an approved consent form which must be posted online or made available on a federal website that serves as a depository for consent forms.

Broad Consent

The final rule allows for the optional use of broad consent for the storage and secondary use of identifiable private information and biospecimens in lieu of obtaining study-specific informed consent.

Study Reviews by Single IRB

One notable change for federally funded studies that require IRB approval is the requirement to have a single IRB oversee research studies that are conducted at multiple sites. Compliance with this aspect of the revised Common Rule is not mandatory until January 21, 2020.

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