HIPAA News

Patients in Connecticut Can Now Sue Healthcare Providers for Privacy Violations

Posted by HIPAA Journal

There is no private cause of action in the Health Insurance Portability and Accountability Act, so patients are not permitted to sue healthcare providers for privacy violations.

However, there have been rulings in several states, including New York, Missouri, and Massachusetts, allowing patients to file lawsuits against healthcare providers over unauthorized and negligent disclosures of medical records.

Following a ruling by the Connecticut Supreme Court last week, Connecticut residents will be permitted to file lawsuits for damages following negligent disclosures of medical records that have resulted in harm.

The legal precedent was set by the Supreme Court in the case Byrne v. Avery Center for Obstetrics & Gynecology.

Emily Byrne filed a lawsuit against Avery Center for Obstetrics and Gynecology (ACOG) after her medical records were disclosed to a man seeking custody of her child in a paternity suit.

ACOG was issued with a subpoena to appear before an attorney and supply Byrne’s medical records. ACOG did not challenge the subpoena, made no attempt to limit disclosure, and simply mailed a copy of Byrne’s medical file to the New Haven Regional Children’s Probate Court, where the records were made available to the man seeking custody of her child.

Byrne and her attorney, Bruce L. Elstein of Trumbull, claimed this amounted to negligence and breach of contract. ACOG claimed that under HIPAA Rules, patient consent was not required before medical records were disclosed in response to a subpoena.

Byrne argued that HIPAA creates a standard of care for patient medical records, and Avery violated that standard by releasing her records. Byrne lost the case in the Superior Court, which ruled that HIPAA does not permit private suits to be filed against healthcare providers for HIPAA violations. Byrne appealed, and the case was heard by the Supreme Court, which ruled in 2014 that HIPAA could be used as a standard of care for common law claims.

The case went before the Supreme Court for a second time after the trial court deferred the case as no courts had addressed the issue of negligence.  The Supreme Court disagreed with ACOG’s argument that patient consent is not required before medical records are disclosed in response to a subpoena, saying federal laws require the provider to have “satisfactory assurances” that a patient has been given notice about the request.

In this case, satisfactory assurances had not been obtained. Justice Dennis G. Eveleigh wrote, “the defendant did not even comply with the face of the subpoena.”

In the ruling, Justice Eveleigh wrote, “The dispositive issue in this appeal is whether a patient has a civil remedy against a physician if that physician, without the patient’s consent, discloses confidential information obtained in the course of the physician-patient relationship.’’

“We agree with the majority of jurisdictions that have considered the issue, and conclude that the nature of the physician-patient relationship warrants recognition of a common-law cause of action for breach of the duty of confidentiality in the context of that relationship.”

“Finally, we have a remedy in Connecticut that recognizes that there is a duty of confidentiality, the breach of which can lead to compensation for damages,” said Elstein.

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Largest Healthcare Data Breaches of 2017

Posted by HIPAA Journal

This article details the largest healthcare data breaches of 2017 and compares this year’s breach tally to the past two years, which were both record-breaking years for healthcare data breaches.

2015 was a particularly bad year for the healthcare industry, with some of the largest healthcare data breaches ever discovered. There was the massive data breach at Anthem Inc., the likes of which had never been seen before. 78.8 million healthcare records were compromised in that single cyberattack, and there were also two other healthcare data breaches involving 10 million or more records. 2015 was the worst ever year in terms of the number of healthcare records exposed or stolen.

2016 was a better year for the healthcare industry in terms of the number of healthcare records exposed in data breaches. There was no repeat of the mega data breaches of the previous year. Yet, the number of incidents increased significantly. 2016 was the worst ever year in terms of the number of breaches reported by HIPAA-covered entities and their business associates. So how have healthcare organizations fared in 2017? Was 2017 another record-breaking year?

Healthcare Data Breaches Increased in 2017

The mega data breaches of 2015 were fortunately not repeated in 2017, and the decline in massive data breaches continued in 2017.

Last year, there were three breaches reported that impacted more than one million individuals and 14 breaches of more than 100,000 records.

In 2017, there was only one reported data breach that impacted more than 500,000 people and 8 breaches that impacted 100,000 or more individuals. The final total for individuals impacted by breaches last year was 14,679,461 – considerably less than the 112,107,579 total the previous year.

The final figures for 2017 cannot yet be calculated as there is still time for breaches to be reported to OCR. The HIPAA Breach Notification Rules allows covered entities up to 60 days to report data breaches of more than 500 records, so the final figures for 2017 will not be known until March 1, 2018. However, based on current data, 2017 has been a reasonably good year in terms of the number of exposed healthcare records. The current total stands at 3,286,498 records – A 347% reduction in breached records year on year.

While it is certainly good news that the severity of breaches has reduced, that only tells part of the story. Breaches of hundreds of thousands of records have reduced, but breaches of more than 10,000 records have remained fairly constant year over year. In 2015, there were 52 breaches of 10,000 or more records. That figure jumped to 82 in 2016. There were 78 healthcare data breaches in 2017 involving more than 10,000 records.

The bad news is there has been a significant rise in the number of healthcare data breaches in 2017.  As of January 4, 2017, there have been 342 healthcare security breaches listed on the OCR breach portal for 2017. It is likely more incidents will be added in the next few days.

The final total for 2015 was 270 breaches, and there were 327 breaches reported in 2016. The severity of healthcare security incidents may have fallen, but the number of incidents continues to rise year on year.

 

reported healthcare data breaches in 2017

 

Unfortunately, there is little evidence to suggest that the annual rise in healthcare data breaches will stop in 2018. Many cybersecurity firms have made predictions for the coming year, and they are united in the view that healthcare data breaches will continue to increase.

The 20 Largest Healthcare Breaches of 2017

The list of the 20 largest healthcare data breaches of 2017 is listed below.

Position Breached Entity Entity Type Records Exposed Cause of Breach
1 Commonwealth Health Corporation Healthcare Provider 697,800 Theft
2 Airway Oxygen, Inc. Healthcare Provider 500,000 Hacking/IT Incident
3 Women’s Health Care Group of PA, LLC Healthcare Provider 300,000 Hacking/IT Incident
4 Urology Austin, PLLC Healthcare Provider 279,663 Hacking/IT Incident
5 Pacific Alliance Medical Center Healthcare Provider 266,123 Hacking/IT Incident
6 Peachtree Neurological Clinic, P.C. Healthcare Provider 176,295 Hacking/IT Incident
7 Arkansas Oral & Facial Surgery Center Healthcare Provider 128,000 Hacking/IT Incident
8 McLaren Medical Group, Mid-Michigan Physicians Imaging Center Healthcare Provider 106,008 Hacking/IT Incident
9 Harrisburg Gastroenterology Ltd Healthcare Provider 93,323 Hacking/IT Incident
10 VisionQuest Eyecare Healthcare Provider 85,995 Hacking/IT Incident
11 Washington University School of Medicine Healthcare Provider 80,270 Hacking/IT Incident
12 Emory Healthcare Healthcare Provider 79,930 Hacking/IT Incident
13 Salina Family Healthcare Center Healthcare Provider 77,337 Hacking/IT Incident
14 Stephenville Medical & Surgical Clinic Healthcare Provider 75,000 Unauthorized Access/Disclosure
15 Morehead Memorial Hospital Healthcare Provider 66,000 Hacking/IT Incident
16 Primary Care Specialists, Inc. Healthcare Provider 65,000 Hacking/IT Incident
17 Enterprise Services LLC Business Associate 56,075 Unauthorized Access/Disclosure
18 ABCD Pediatrics, P.A. Healthcare Provider 55,447 Hacking/IT Incident
19 Network Health Health Plan 51,232 Hacking/IT Incident
20 Oklahoma Department of Human Services Health Plan 47,000 Hacking/IT Incident

The Largest Healthcare Data Breaches of 2017 Were Due to Hacking

One thing is abundantly clear from the list of the largest healthcare data breaches of 2017 is hacking/IT incidents affect more individuals than any other breach type. Hacking/IT incidents accounted for all but three of the largest healthcare data breaches of 2017.

In 2016, hacking incidents only accounted for 11 out of the top 20 data breaches and 12 of the top 20 in 2015. Hacking incidents therefore appear to be rising.

 

healthcare data breaches in 2017 (hacking)

 

The rise in hacking incidents can partly be explained by the increase in ransomware attacks on healthcare providers in 2017. Healthcare organizations are also getting better at discovering breaches.

Other Major Causes of Healthcare Data Breaches in 2017

Unauthorized access/disclosures continue to be a leading cause of healthcare data breaches, although there was a slight fall in numbers of these incidents in 2017. That decrease is offset by an increase in incidents involving the improper disposal of physical records and electronic devices used to store ePHI.

 

healthcare data breaches of 2017 (Unauthorized access/disclosures)

 

The use of encryption for stored data is more widespread, with many healthcare organizations having implemented encryption on all portable storage devices and laptops, which has helped to reduce the exposure of ePHI when electronic devices are stolen.

 

Healthcare Data Breaches of 2017 (loss/theft)

Minimizing the Risk of Healthcare Data Breaches

This year saw OCR publish the preliminary findings of its HIPAA compliance audits on HIPAA-covered entities. The audits revealed there is still widespread non-compliance with HIPAA Rules.

One of the biggest problems was not a lack of cybersecurity defenses, but the failure to conduct an enterprise-wide risk analysis.

Even with several layers of security, vulnerabilities are still likely to exist. Unless a comprehensive risk analysis is performed to identify security gaps, and those gaps are addressed, it will only be a matter of time before they are exploited.

Complying with HIPAA Rules will not prevent all data breaches, but it will ensure healthcare organizations achieve at least the minimum standard for data security, which will prevent the majority of healthcare data breaches.

There is a tendency to invest cybersecurity budgets in new technology, but it is important not to forget the basics. Many healthcare data breaches in 2017 could have been prevented had patches been applied promptly, if secure passwords had been chosen, and if cloud storage services and databases had been configured correctly. Many data breaches were caused as a result of employees leaving unencrypted laptops in risky locations – in unattended vehicles for instance.

Phishing remains one of the main ways that malicious actors gain access to protected health information, yet security awareness training is still not being provided frequently. As a result, employees are continuing to fall for phishing and social engineering scams. Technological solutions to block phishing emails are important, but healthcare organizations must also educate employees about the risks, teach them how to recognize scams, and reinforce training regularly. Only then will organizations be able to reduce the risk from phishing to an acceptable and appropriate level.

Insiders continue to be a major threat in healthcare. The value of data on the black market is high, and cash-strapped healthcare employees can be tempted to steal data to sell to identity thieves. Healthcare organizations can hammer the message home that data theft will be discovered and reported to law enforcement, but it is the responsibility of healthcare organizations to ensure policies and technologies are implemented to ensure that the unauthorized accessing of records – theft or snooping – is identified rapidly.  That means frequent audits of access logs and the use of automated monitoring solutions and user behavior analytics.

2017 was a bad year for ransomware attacks and extortion attempts on healthcare organizations. There is no sign that these attacks will slow in 2018, and if anything, they are likely to increase. Ensuring data is backed up will allow organizations to recover files in the event of an attack without having to pay a ransom. The rise in sabotage attacks – NotPetya for example – mean data loss is a real possibility if backups are not created.

By getting the basics right and investing in new technologies, it will be possible for the year on year rise in data breaches to be stopped. But until healthcare organizations get the basics right and comply with HIPAA Rules, healthcare data breaches are likely to continue to rise.

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HHS Publishes Final Rule on Confidentiality of Substance Use Disorder Patient Records

Posted by HIPAA Journal

The Department of Health and Human Services has published its final rule on the Confidentiality of Substance Use Disorder Patient Records, altering Substance Abuse and Mental Health Services Administration (SAMHSA) regulations.

The aim of the update is to better align regulations with advances in healthcare delivery in the United States, while ensuring patient’s privacy is protected when treatment for substance abuse disorders is sought. The final rule addresses the permitted uses and disclosures of patient identifying information for healthcare operations, payment, audits and evaluations.

The last substantial changes to the Confidentiality of Alcohol and Drug Abuse Patient Records (42 CFR part 2) regulations were in 1987. In 2016, SAMHSA submitted a Notice of Proposed Rulemaking in the Federal Register proposing updates to 42 CFR part 2. The proposed updates reflected the development of integrated health care models and the use of electronic exchange of patient information, while still ensuring patient privacy was protected to prevent improper disclosures.

After considering public comments, a final rule was published by SAMHSA in January 2017, which incorporated greater flexibility for disclosures within the healthcare system while still continuing to protect the confidentiality of substance use disorder records.

A supplemental notice of proposed rulemaking was also issued and public comments were sought on those additional proposals, which covered disclosures related to payment and healthcare operations that can be made to contractors, subcontractors, and legal representatives by lawful holders under the part 2 rule consent provisions, and disclosures for purposes of carrying out Medicaid, Medicare or Children’s Health Insurance Program (CHIP) audits or evaluations.

SAMHSA has now considered all 55 comments received, and has finalized its proposed revisions, taking those comments into consideration.

Several of the commenters sought better alignment with the Health Insurance Portability and Accountability Act (HIPAA) and/or the Health Information Technology for Economic and Clinical Health (HITECH) Act to promote better information flow, provide greater discretion for providers and administrators of services, the establishment of uniform workable regulations with respect to treatment, payment and operations, and to promote more innovative models of health care delivery.

SAMHSA has attempted to align the revisions with HIPAA and the HITECH Act as far as is possible, but explained, “It is important to note that part 2 and its authorizing statute are separate and distinct from HIPAA, the HITECH Act, and their implementing regulations.”

“Part 2 provides more stringent federal protections than other health privacy laws such as HIPAA and seeks to protect individuals with substance use disorders who could be subject to discrimination and legal consequences in the event that their information is improperly used or disclosed.”

Comments were received suggesting SAMHSA should make it easier for healthcare providers using alternative payment models to share records, as the lack of information about substance abuse disorders could negatively affect patient care.

There was considerable disagreement in the comments about whether care coordination and case management should be included in the list of permissible activities under payment and health care operations.

SAMHSA has decided not to include care coordination and case management and the list of permissible activities that SAMHSA considers to be payment and health care operations, and the list is ‘substantively unchanged.’

SAMHSA has also included language in the regulatory text that clarifies disclosures to contractors, subcontractors and legal representatives are not permitted for activities related to a patient’s diagnosis, treatment, or referral for treatment.

SAMHSA will continue to review all of the issues raised in the comments and will explore ways to better align Part 2 with HIPAA and HITECH, including future additional rulemaking for 42 CFR part 2.

A public meeting will also be held prior to March 21, 2018, to determine the effects of 42 CFR part 2 on patient care, health outcomes, and patient privacy. Stakeholders will be given the opportunity to provide input on implementation of part 2, including the changes adopted in the final rule.

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2017 HIPAA Enforcement Summary

Posted by HIPAA Journal

Our 2017 HIPAA enforcement summary details the financial penalties paid by healthcare organizations to resolve HIPAA violation cases investigated by the Department of Health and Human Services’ Office for Civil Rights (OCR) and state attorneys general.

2017 saw OCR continue its aggressive pursuit of financial settlements for serious violations of HIPAA Rules. There have been 9 HIPAA settlements and one civil monetary penalty in 2017.

In total, OCR received $19,393,000 in financial settlements and civil monetary penalties from covered entities and business associates to resolve HIPAA violations discovered during the investigations of data breaches and complaints.

Last year, there were 12 settlements reached with HIPAA-covered entities and business associates, and one civil monetary penalty issued. In 2016, OCR received $25,505,300 from covered entities to resolve HIPAA violation cases.

Summary of 2017 HIPAA Enforcement by OCR

Listed below are the 2017 HIPAA enforcement activities of OCR that resulted in financial penalties for HIPAA-covered entities and their business associates.

Covered Entity Amount Type Violation Type
Memorial Healthcare System $5,500,000 Settlement Insufficient ePHI Access Controls
Children’s Medical Center of Dallas $3,200,000 Civil Monetary Penalty Impermissible Disclosure of ePHI
Cardionet $2,500,000 Settlement Impermissible Disclosure of PHI
Memorial Hermann Health System $2,400,000 Settlement Careless Handling of PHI
21st Century Oncology $2,300,000 Settlement Multiple HIPAA Violations
MAPFRE Life Insurance Company of Puerto Rico $2,200,000 Settlement Impermissible Disclosure of ePHI
Presense Health $475,000 Settlement Delayed Breach Notifications
Metro Community Provider Network $400,000 Settlement Lack of Security Management Process
St. Luke’s-Roosevelt Hospital Center Inc. $387,000 Settlement Unauthorized Disclosure of PHI
The Center for Children’s Digestive Health $31,000 Settlement Lack of a Business Associate Agreement

OCR’s 2017 HIPAA enforcement activities have revealed covered entities are continuing to fail to comply with HIPAA Rules in key areas: Safeguarding PHI on portable devices, conducting an organization-wide risk analysis, implementing a security risk management process, and entering into HIPAA-compliant business associate agreements with all vendors.

Throughout 2016 and 2017, many covered entities have failed to issue breach notifications promptly. In 2017, OCR took action for this common HIPAA violation and agreed its first HIPAA settlement solely for delaying breach notifications to patients.

HIPAA Desk Audits Revealed Widespread HIPAA Violations

In late 2016, OCR commenced the much-delayed second phase of its HIPAA-compliance audit program. The first stage involved desk audits of 166 HIPAA-covered entities – 103 audits on the Privacy and Breach Notification Rules, and 63 audits on the Security Rule. 41 desk audits were conducted on business associates on the Breach Notification and Security Rules.

While the full results of the compliance audits have not been released, this fall OCR announced preliminary findings from the compliance audits.

Covered entities were given a rating from 1 to 5 for the completeness of compliance efforts on each control and implementation specification. A rating of 1 signifies full compliance with goals and objectives of the standards and implementation specifications that were audited. A rating of 5 indicates there was no evidence that the covered entity had made a serious attempt to comply with HIPAA Rules.

Preliminary Findings of HIPAA Compliance Audits on Covered Entities

Listed below are the findings from the HIPAA compliance audits. A rating of 5 being the worst possible score and 1 being the best.

Preliminary HIPAA Compliance Audit Findings (2016/2017)
HIPAA Rule Compliance Controls Audited Covered Entities Given Rating of 5 Covered Entities Given Rating of 1
Breach Notification Rule (103 audits) Timeliness of Breach Notifications 15 67
Breach Notification Rule (103 audits) Content of Breach Notifications 9 14
Privacy Rule (103 audits) Right to Access PHI 11 1
Privacy Rule (103 audits) Notice of Privacy Practices 16 2
Privacy Rule (103 audits) Electronic Notice 15 59
Security Rule (63 audits) Risk Analysis 13 0
Security Rule (63 audits) Risk Management 17 1

 

Almost a third of covered entities failed to issue breach notifications promptly and next to no covered entities were found to be fully compliant with the HIPAA Privacy and Security Rules.

OCR has delayed the full compliance reviews until 2018. While some organizations will be randomly selected for a full review – including a site visit – OCR has stated that poor performance in the desk audits could trigger a full compliance review. Financial penalties may be deemed appropriate, especially when there has been no attempt to comply with HIPAA Rules.

Attorneys General Fines for Privacy Breaches

The HITECH Act gave state attorneys general the authority to pursue financial penalties for HIPAA violations and assist OCR with the enforcement of HIPAA Rules. Relatively few state attorneys general exercise this right. Instead they choose to pursue cases under state laws, even if HIPAA Rules have been violated.

Notable 2017 settlements with healthcare organizations and business associates of HIPAA covered entities have been listed below.

Covered Entity State Amount Individuals affected Reason
Cottage Health System California $2,000,000 More than 54,000 Failure to Safeguard Personal Information
Horizon Healthcare Services Inc., New Jersey $1,100,000 3.7 million Failure to Safeguard Personal Information
SAManage USA, Inc. Vermont $264,000 660 Exposure of PHI on Internet
CoPilot Provider Support Services, Inc. New York $130,000 221,178 Late Breach Notifications
Multi-State Billing Services Massachusetts $100,000 2,600 Failure to Safeguard Personal Information

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New Bill Aims to Change HIPAA Rules for Healthcare Clearinghouses

Posted by HIPAA Journal

A new bill (H.R. 4613) has been introduced to the U.S House of Representatives by Congresswoman Cathy McMorris Rodgers (R-Washington) that proposes changes to the Health Information Technology for Economic and Clinical Health (HITECH) Act and HIPAA Rules for healthcare clearinghouses.

The Ensuring Patient Access to Healthcare Records Act of 2017 is intended to modernize the role of healthcare clearinghouses in healthcare, promote access to and the leveraging of health information, and enhance treatment, quality improvement, research, public health and other functions.

Healthcare clearinghouses are entities that transform data from one format to another, converting non-standard data to standard data elements or vice versa. Healthcare clearinghouses are considered HIPAA-covered entities, although in some cases they can be business associates. The bill – Ensuring Patient Access to Healthcare Records Act of 2017 – would see all healthcare clearinghouses treated as covered entities.

Healthcare clearinghouses gather health data from a wide range of sources, therefore they could hold a complete set of records for each patient. If patients are allowed to obtain copies of their health records from healthcare clearinghouses, it could make it easier for patients treated by multiple providers to obtain a full set of their health records.

“Whether it’s because of a move to a new state, switching providers, an unexpected visit to the emergency room, or a new doctor, patients must track down their own records from numerous different sources based on what they can or cannot remember. It shouldn’t be this burdensome,” said Rodgers. “Our bill gives patients the ability to see a snapshot of their health records at just a simple request, allowing them to make better, more informed healthcare decisions in a timely manner.”

While the bill could improve data access for patients, it has been suggested that patients are unlikely to benefit. Healthcare clearinghouses may have longitudinal health records from multiple sources, but in many cases, they only have claims data rather than a full set of clinical data. Even if patients could be provided with copies, it may not prove to be particularly useful.

Patients can choose which healthcare providers they use, but since a healthcare clearinghouse is not chosen by patients, they are unlikely to know which healthcare clearinghouses actually hold their data. Patients rarely have any dealings with healthcare clearinghouses.

The bill would “allow the use of claims, eligibility, and payment data to produce reports, analyses, and presentations to benefit Medicare, and other similar health insurance programs, entities, researchers, and health care providers, to help develop cost saving approaches, standards, and reference materials and to support medical care and improved payment models.”

This is not the first time that the Ensuring Patient Access to Healthcare Records Act has been introduced. None of the previous versions of the bill have made it to the floor and have attracted considerable criticism. In his Healthcare Blog, Adrian Gropper, MD expressed concern over a previous version of the bill (Senate bill S.3530).

“Extending Covered Entity status to data brokers seems like a quantitative shift and possibly a benefit to patients. But the deceptive part is that unlike today’s Covered Entities (hospitals, pharmacies, and insurance companies), data brokers do not have to compete for the patient’s business,” said Gropper. “By giving the infrastructure business the right to use and sell our data without consent or even transparency, we are enabling a true panopticon – an inescapable surveillance system for our most valuable personal data.”

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$2.3 Million 21st Century Oncology HIPAA Settlement Agreed with OCR

Posted by HIPAA Journal

A 21st Century Oncology HIPAA settlement has been agreed with the Department of Health and Human Services’ Office for Civil Rights (OCR) to resolve potential HIPAA violations discovered during the investigation of a 2015 breach of 2.2 million patients’ PHI.

The breach in question was discovered by the Federal Bureau of Investigation (FBI) in 2015. The FBI informed 21st Century Oncology on November 13 and December 13, 2015, that an unauthorized individual accessed and stole information from one of its patient databases.

21st Century Oncology conducted an investigation with the assistance of a third-party computer forensics company and discovered the network SQL database was potentially first accessed on October 3, 2015. The database was accessed through Remote Desktop Protocol from an Exchange Server within 21st Century Oncology’s network. The database contained the protected health information of 2,213,597 individuals.

As occurs after all data breaches that impact more than 500 individuals, OCR conducted an investigation into the 21st Century Oncology data breach. That investigation uncovered multiple potential violations of HIPAA Rules.

OCR determined that 21st Century Oncology failed to conduct a comprehensive, organization-wide risk assessment to determine the potential risks to the confidentiality, integrity, and availability of electronic protected health information, as required by 45 C.F.R. § 164.308(a)(1)(ii)(A).

21st Century Oncology was also determined to have failed to implement sufficient measures to reduce risks to an appropriate and acceptable level to comply with 45 C.F.R. § 164.306(A).

21st Century Oncology also failed to implement procedures to regularly review logs of system activity, including audit logs, access reports, and security incident tracking reports, as required by 45 C.F.R. §164.308(a)(1)(ii)(D).

The breach resulted in the impermissible disclosure of the protected health information of 2,213,597 patients.

Further, protected health information of patients was disclosed to business associates without first entering into a HIPAA-compliant business associate agreement and obtaining satisfactory assurances that HIPAA requirements would be followed.

To resolve those potential HIPAA violations, 21st Century Oncology agreed to pay OCR $2.3 million. In addition to the financial settlement, 21st Century Oncology has agreed to adopt a comprehensive corrective action plan (CAP) to bring its policies and procedures up to the standards demanded by HIPAA.

Under the CAP, 21st Century Oncology must appoint a compliance officer, revise its policies and procedures with respect to system activity reviews, access establishment, modification and termination, conduct an organization-wide risk assessment, develop internal policies and procedures for reporting violations of HIPAA Rules, and train staff on new policies.

21st Century Oncology is also required to engage a qualified, objective, and independent assessor to review compliance with the CAP.

Separate $26 Million Settlement Resolves Meaningful Use, Stark Law, and False Claims Act Violations

In addition to the OCR settlement to resolve potential HIPAA violations, 21st Century Oncology has also agreed to a $26 million settlement with the Department of Justice to resolve allegations that it submitted false or inflated Meaningful Use attestations in order to receive incentive payments. 21st Century Oncology self-reported that employees falsely submitted information relating to the use of EHRs to avoid downward payment adjustments. Fabricated reports were also submitted, and the logos of EHR vendors were superimposed on reports to make them appear genuine.

The settlement also resolves allegations that the False Claims Act was violated by submitting or enabling the submission of claims that involved kickbacks for physician referrals, and also violations of the Stark Law, which covers physician self-referrals.

According to the Department of Justice, “The Stark Law prohibits an entity from submitting claims to Medicare for designated health services performed pursuant to referrals from physicians with whom the entity has a financial relationship unless certain designated exceptions apply.”

“We appreciate that 21st Century Oncology self-reported a major fraud affecting Medicare, and we are also pleased that the company has agreed to accept financial responsibility for past compliance failures,” said Middle District of Florida Acting U.S. Attorney Stephen Muldrow.

In addition to paying the settlement amount, 21st Century Oncology has entered into a 5-year Corporate Integrity Agreement with the HHS’ Office of Inspector General (OIG).

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Email Top Attack Vector in Healthcare Cyberattacks

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A recent study conducted by HIMSS Analytics for email security firm Mimecast has revealed 78% of healthcare organizations have experienced a ransomware or malware attack in the past 12 months.

Far from ransomware or malware attacks being occasional events, many of the healthcare organizations that participated in the survey have experienced more than a dozen malware or ransomware attacks in the past year.

While there are several possible ways that ransomware and malware can be installed, healthcare providers rated email as the number one attack vector.

When asked to rank attack vectors, Email was rated as the most likely source of a data breach by 37% of respondents, with the second most likely source of a data breach being ‘other portable devices’, ranked as the main threat by 10% of organizations.

59% of organizations ranked email first, second, or third as the most likely attack vector. In second place was laptops, which were ranked 1, 2, or 3 by 44% of organizations.

Given the frequency of email based attacks this year, it is no surprise that healthcare organizations believe email-related security attacks will continue to cause problems, and that they are likely to increase or significantly increase in the future.

A recent study conducted by Malwarebytes showed ransomware attacks are already 62% more prevalent that 2016, and have occurred at almost 2,000 times the rate in 2015. The 2017 Verizon Data Breach Report suggests 72% of all malware used to target the healthcare industry is ransomware.

Those findings were backed up by the HIMSS Analytics survey. Ransomware was seen as the most serious threat by 83% of respondents. Malware was rated second, followed by spear phishing attacks and Business Email Compromise (BEC) attacks.

The importance of securing email is clear. Email is used to communicate protected health information by approximately 80% of healthcare organization. Email is also rated as an essential communication tool and is considered critical by 93% of respondents, while 43% said email was mission critical and that their organization could not tolerate email downtime.

It is understandable given the frequency of email-based attacks and the importance of email in healthcare that organizations have a high level of concern about cybersecurity and their ability to repel email-based attacks.

Resilience to ransomware and malware attacks was rated as the top initiative for building a cyber resilience strategy, while training employees to be more security aware is the second highest priority over the following 12 months. Securing email was third.

David Hood, Cyber Resilience Strategist for Healthcare at Mimecast said, “This survey clearly demonstrates that email is a mission-critical application for healthcare providers and that cyberthreats are real and growing – surprisingly, even more so than the threats to Electronic Medical Records (EMRs), laptops and other portable electronic devices. It’s encouraging that protecting the organization and training employees are top initiatives for next year, but the survey suggests the industry has work to do.”

Mimecast provided five suggestions on how healthcare organizations can reduce the risk of email-based threats:

  1. Train employees on the risks associated with email and provide real-time reminders rather than relying on an annual training session.
  2. Analyze all inbound email attachments and scan for malware and malware downloaders
  3. Implement a web filtering solution to check URLs when a user clicks, not just at the point emails enter the organization.
  4. Inspect outbound emails and check that protected health information is not being sent to individuals unauthorized to receive it, and also to check emails to determine whether email accounts may have been compromised.
  5. Finally, it is essential that data backups are regularly performed to ensure that in the event of a ransomware attack, healthcare organizations do not face data loss and are not forced to pay ransoms.

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

Posted by HIPAA Journal

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

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

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

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

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

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

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

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

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

Specifically, the judgement requires Cottage Health to:

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

The post Cottage Health Fined $2 Million By California Attorney General’s Office appeared first on HIPAA Journal.

HIPAA Privacy Complaints

Posted by Amber Moffat

HIPPA Complaint

HIPAA Journal published an article online this week addressing client HIPAA violation complaints and whether or not health care providers are equipped to properly address these complaints. According to the article, in order for an efficient response to be conducted, policies should be developed covering the complaints procedure and staff must be trained to handle HIPAA privacy complaints correctly. Also, patients must also be clearly informed how they can make a HIPAA privacy complaint if they feel that their privacy has been violated or HIPAA Rules have been breached. This should be clearly stated in your Notice of Privacy Practices.

For more information and to view the full article visit HIPAA Journal’s website here.

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