HIPAA

Anthem Agrees to Record $16 Million Settlement for Alleged HIPAA Violations

Posted by Matthew Siegel on October 16, 2018
HIPAA / No Comments

In the wake of the largest U.S. health care data breach in history, Anthem, Inc., has agreed to pay $16 million to the Office for Civil Rights, which is a record settlement for alleged HIPAA violations. According to the Department of Health and Human Services (“HHS”), the previous high was a $5.55 million settlement paid in 2016. In addition to the monetary payment, Anthem has also agreed to take “substantial” corrective action to help prevent a similar breach from occurring in the future.

The settlement arose out of a 2014 breach involving the electronic protected health information (“ePHI”) of nearly 79 million people. On January 29, 2015, Anthem discovered that hackers had gained accessed to its IT system through a persistent threat attack. Further investigation revealed that hackers had sent spear phishing emails to one of Anthem’s subsidiaries and at least one employee took the bait. Through that seemingly simple act, the hackers were then able to infiltrate Anthem’s system and compromise its stored ePHI, consisting of names, social security numbers, medical identification numbers, addresses, dates of birth, email addresses, and employment information. Continue reading…

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FTC Overturns ALJ’s LabMD Decision and Reasserts its Role as a Data Security Enforcer

Posted by Health Law Informer Author on August 25, 2016
Federal Trade Commission, HIPAA, OCR / No Comments

On July 29, 2016, the Federal Trade Commission (“FTC” or “Commission”) reversed an FTC administrative law judge’s (“ALJ”) opinion which had ruled against the FTC, finding that the Commission had failed to show that LabMD’s conduct caused harm to consumers to satisfy requirements under Section 5 of the FTC Act. In reversing the ALJ, the FTC issued a unanimous opinion and final order that concluded, in part, that public exposure of sensitive health information was, in itself, a substantial injury.

The FTC initially filed a complaint against LabMD in 2013 under Section 5 of the FTC Act, alleging that the laboratory company failed to “provide reasonable and appropriate security for personal information on its computer networks,” which the FTC claimed lead to the data of thousands of consumers being leaked. The complaint resulted from two security incidents that occurred several years prior, which the FTC claimed were caused by insufficient data security practices.

In its opinion, the FTC concluded that the ALJ had applied the wrong legal standard for unfairness and went on to find that LabMD’s data security practices constituted an unfair act or practice under Section 5 of the FTC Act. Specifically, the Commission found LabMD’s security practices to be unreasonable – “lacking even basic precautions to protect the sensitive consumer information on its computer system.” The Commission stated that “[a]mong other things, [LabMD] failed to use an intrusion detection system or file integrity monitoring; neglected to monitor traffic coming across its firewalls; provided essentially no data security training to its employees; and never deleted any of the consumer data it had protected.” As a result of these alleged shortcomings in data security, medical and other sensitive information for approximately 9,300 individuals was disclosed without authorization.

Further, and perhaps more importantly, the Commission concluded that “the privacy harm resulting from the unauthorized disclosure of sensitive health or medical information is in and of itself a substantial injury under Section 5(n), and thus that LabMD’s disclosure of the [ ] file itself caused substantial injury.” Thus, contrary to the findings of the ALJ, the Commission essentially held that the mere exposure of sensitive personal and health information into the public domain may be enough to constitute a substantial injury for purposes of Section 5, without any proof that the information was ever misused.

As a result, the FTC ordered LabMD to establish a comprehensive information security program, obtain independent third party assessments of the implementation of the information security program for 20 years, and to notify the individuals who were affected by the unauthorized disclosure of their personal information and inform them about how they can protect themselves from identity theft or related harms.

Takeaway: While LabMD has announced its intention to appeal, the FTC’s decision reinforces its role as an enforcer of data security, even in the health care arena, where OCR has been the traditional enforcer of HIPAA and health care data breaches.   Thus, in addition to OCR, health care entities must continue to monitor FTC enforcement actions to see if there are any additional or conflicting data security standards mandated by both agencies.   Any companies handling PHI should, therefore, continue to ensure that their data security policies and procedures are being implemented and followed in accordance with industry standards. Inadequate security safeguards may contribute to data breaches resulting in government investigations and enforcement actions – not just by OCR, but the FTC as well.

For more information about the FTC’s opinion, contact Gregory M. Fliszar or a member of Cozen O’Connor’s Health Law team.

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ALJ Rules Against FTC in LabMD Data Security Action: Sets High Bar for Proving Consumer Harm

Posted by Health Law Informer Author on November 20, 2015
Federal Trade Commission, FTC, HIPAA / No Comments

shutterstock_157454741Last June we wrote about the FTC’s enforcement action against LabMD, a medical testing laboratory, which was forced to wind down its business because of the costs associated with challenging the FTC since 2013. Using its broad enforcement authority under Section 5 of the FTC Act, the FTC alleged that LabMD failed to “provide reasonable and appropriate security for personal information on its computer networks,” which the FTC claimed lead to the data of thousands of consumers being leaked.

On November 13, 2015, Chief Administrative Law Judge D. Michael Chappell ruled in favor of LabMD, dismissing the FTC’s complaint because the FTC “fail[ed] to prove that [LabMD’s] alleged unreasonable data security caused, or is likely to cause, substantial consumer injury, as required by Section 5(n) of the FTC Act, [LabMD’s] alleged unreasonable data security cannot properly be declared an unfair act or practice in violation of Section 5(a) of the FTC Act.” Notably, Judge Chappell concluded that Continue reading…

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Physician Group to Pay $750,000 to Settle a HIPAA Violation

Posted by Health Law Informer Author on September 03, 2015
HHS, HIPAA, OCR / No Comments

In August 2012, a Physician Group—comprising of nearly 20 physicians—reported its HIPAA breach to HHS, which resulted from a laptop bag containing the employee’s laptop and a computer server backup being stolen from an employee’s car in July 2012. According to the Resolution Agreement between HHS and the Physician Group, the laptop did not contain ePHI, but the portable, unencrypted server backup in the employee’s bag did. The backup contained ePHI for 55,000 individuals. To settle this matter, the Physician Group has agreed to pay $750,000.

Although stolen laptops and lack of encryption is nothing new in the world of HIPAA breaches, this situation stands out for a few reasons:

  •  The Physician Group did not conduct “an accurate and thorough” risk assessment;
  •  The significance of encryption extends not only to desktop computers and laptops, but also to portable devices, including but not limited to computer server backups; and
  • This is a notable fine for a Physician Group of less than 20 physicians.

For more information regarding this incident and HIPAA compliance, including the importance of encryption and risk assessments, contact J. Nicole Martin or any member of Cozen O’Connor’s healthcare law team.

 

 

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OCR Announces Another HIPAA Settlement and Warns Not to Forget About Paper Records

Posted by Health Law Informer Author on May 04, 2015
HHS, HIPAA, OCR / No Comments

On April 27, 2015, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) announced that Cornell Prescription Pharmacy (“Cornell Pharmacy”) had entered into a resolution agreement to settle, without an admission of liability or wrongdoing, potential HIPAA violations. As part of the resolution agreement Cornell Pharmacy will pay $125,000 and enter into a two-year corrective action plan (“CAP”) focused on correcting the alleged deficiencies in its HIPAA compliance program.

Cornell Pharmacy is a small, single store pharmacy located in Denver, Colorado that specializes in compound medications and providing services for local hospice agencies. OCR began an investigation into the pharmacy after it received a media report from a Denver news agency that protected health information (“PHI”) belonging to Cornell Pharmacy was apparently disposed of and found in an unlocked, publicly accessible dumpster. The documents were not shredded and contained the PHI of approximately 1,610 of Cornell Pharmacy’s patients.   After conducting its investigation, OCR concluded that Cornell Pharmacy failed to implement any written policies and procedures as required by HIPAA’s Privacy Rule, and further failed to provide training on the Privacy Rule to its workforce members.

This settlement is instructive as OCR again highlights the importance of having updated and comprehensive HIPAA policies and procedures in place, including policies on the proper disposal of PHI, and on training all staff on those policies and procedures.   Further, in this year of massive cyber-attacks and other breaches of electronic data, this HIPAA settlement serves to remind covered entities and business associates not to forget about protecting their paper records as well.   As stated by OCR in its press release, “Even in our increasingly electronic world, it is critical that policies and procedures be in place for secure disposal of patient information, whether that information is in electronic form or on paper.” As discovered by Cornell Pharmacy, a breach or other improper disclosure of paper PHI can also result in significant consequences.

For further information please contact the author, Gregory M. Fliszar (Philadelphia, PA), or other members of Cozen O’Connor’s healthcare team.

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Another Health Plan Hit By Massive CyberAttack and Class Actions Follow

Posted by Health Law Informer Author on March 30, 2015
Affordable Care Act, CMS, cyberattacks, cybercriminals, cybersecurity, HHS, HIPAA, HITECH, Privacy, Uncategorized / No Comments

Coming fresh off the heels of the Anthem data breach Premera Blue Cross announced on March 17th that it was the victim of a “sophisticated” cyberattack that may have exposed the personal information of approximately 11 million of its members.  Premera has approximately 6 million members residing in the State of Washington, 250,000 members residing in Oregon and 80,000 members residing in Alaska.  Premera stated that the cyberattack began sometime in May of 2014 but was not discovered until the end of January 2015.   According to Premera, the information exposed may include social security numbers, bank account information, and medical and financial information, including clinical information.

Three state insurance commissioners (Washington, Oregon and Alaska) have already launched a joint investigation and a market conduct examination of Premera related to the breach.  The joint investigation will include on-site reviews of Premera’s financial books, records, transactions, and Premera’ cybersecurity.  The Washington Insurance Commissioner has expressed concern over the length of time (approximately six weeks) it took for Premera to notify his office of the attack.  Alaska’s governor ordered all state agencies to review their online security safeguards as well as those put in play by their business associates.  Premera is also conducting an internal forensic investigation by a cybersecurity firm and is cooperating with the FBI in a criminal investigation.

Combined with the cyberattacks on Community Health Systems and Anthem, this is the third large attack on a member of the health care industry announced in the last seven months, and these three breaches may have collectively impacted approximately 95.5 million people.   As these attacks illustrate, health information is now a high priority target for cybercriminals.  Currently a complete health record may be worth at least ten times more than credit card information on the black market as health records often include a wealth of personal information that can be used for identity theft and to file false health insurance claims.  Further, the data security protections currently in place in the health care industry tend to lag behind those in the banking and financial sector, which makes the information vulnerable to attack by those who view the valuable information as “low hanging fruit.”

Similar to the Anthem and the Community Health Systems breaches, Premera was immediately hit by a proposed class action accusing Premera of negligence and inadequate security.  The March 26, 2015 Complaint alleges that Premera breached its duty of care by failing to secure and safeguard the personal and health information of its members and negligently maintaining a system that it knew was vulnerable to a security breach.  The Complaint further alleges that Premera has a duty to secure and safeguard the personal health information of its members under HIPAA and its failure to implement security and privacy safeguards was a violation of HIPAA.  The Complaint also alleges violations of state consumer protection laws and data disclosure laws.

As evident by the Anthem and Premera breaches, a single security incident resulting in a data breach can have significant consequences for health care companies and business associates that include government investigations, class action lawsuits, and a hit to the organization’s reputation.  To manage this risk, we encourage all companies handling health information to conduct comprehensive risk assessments and to create, review and update their data security policies and procedures to ensure that they are doing enough to adequately protect the health information maintained on their IT systems and elsewhere in their organization.

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Cybersecurity Attack on Anthem, Inc. Highlights the Cybersecurity Risks for All Companies Handling Electronic Medical Records

Posted by Health Law Informer Author on February 09, 2015
cyberattacks, cybercriminals, cybersecurity, FBI, Healthcare, HIPAA, HITECH / No Comments

Health care providers, insurers and all who handle information on their behalf were put on notice last week that cybersecurity must be a high priority for their organizations. Anthem, Inc. (“Anthem”), the nation’s second largest health insurer, revealed on February 4, 2015 that its information technology (“IT”) system was victimized by a “very sophisticated” cyberattack that exposed the birthdates, social security numbers, street and email addresses and employee data (including income information) of approximately 80 million customers and employees. Anthem noted that the hackers apparently did not get any health information or credit card numbers in the attack, but that the hack did yield medical information numbers. Anthem discovered the breach on its own on January 29th and contacted the FBI, which has started an investigation into the matter.

Large hospitals and health insurers are not the only ones at risk. As the Anthem attack illustrates, health information is a high priority target for cybercriminals. Currently a complete health record may be worth at least ten times more than credit card information on the black market as health records often include a treasure trove of personal information that can be used for identity theft and to file false health insurance claims. Further, the cybersecurity protections currently in place in the health care industry tend to lag behind those in the banking and financial sector, which makes the information vulnerable to cyberattacks by criminals who view the information as “low hanging fruit.”

Failure to have robust cybersecurity programs in place can have a devastating effect on any organization that experiences a data breach. Anthem has already been hit with putative class action lawsuits in Alabama, California, Georgia and Indiana alleging that Anthem did not have adequate security procedures in place to protect its customers and it is likely that more suits will follow. In addition to the FBI’s investigation into attack, Attorney Generals in New York, Connecticut and Massachusetts have indicated that they will be reaching out to Anthem for more information about the attack, the company’s security measures and how it plans to prevent future attacks.

The Anthem breach was the largest in the health care industry so far and may be a harbinger of things to come. The FBI and other security experts have been warning that the health care industry is a key target for cybercriminals, and a single security incident resulting in a data breach can have significant and immediate consequences that include government investigations, class action lawsuits, and a hit to the organization’s reputation. To manage this risk, we encourage all companies handling health information to create, review and update their data security policies and procedures to ensure that they are doing enough to adequately protect the health information maintained on their IT systems and elsewhere in their organization.

To learn more about strategies you can use to manage your exposure, join me at the upcoming panel discussion on “Cybersecurity and Healthcare: The Key to Limiting Your Risk is being Informed” at the Greater Philadelphia Alliance of Capital and Technologies seminar on Thursday, February 26, 2015 in West Conshohocken, Pennsylvania. Click here to register.

If you cannot make the event or would like to discuss your cybersecurity needs with me directly, please contact me, Greg Fliszar, at gfliszar@cozen.com.

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With a New Year Rolls in a New OIG Work Plan

Posted by Health Law Informer Author on December 12, 2014
ACA, HHS, HIPAA, Medicaid, Medicare, OIG / No Comments

Recently, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) released its Work Plan for Fiscal Year 2015 (“Work Plan”).  The OIG protects the integrity of HHS programs by identifying fraud and abuse and by suggesting improvements to HHS programs.  The Work Plan informs the public of new and ongoing reviews that OIG plans to pursue during the current fiscal year.

For Fiscal Year 2015 and beyond, OIG intends to focus on emerging payment, eligibility, management, and IT systems security vulnerabilities in the ACA programs, such as the health insurance marketplace.  OIG stated that it would also focus on the efficiency and effectiveness of payment policies in inpatient and outpatient settings, for prescription drugs, and in managed care.

Some specific new items of note include: (1) identifying clinical laboratories that routinely submit improper Medicare claims, (2) reviewing the rate of and reasons for transfers from group homes or nursing facilities to emergency departments as a potential indicator of poor quality, (3) identifying Medicaid MCO payments made on behalf of deceased or ineligible beneficiaries, and (4) assessing the extent to which hospitals comply with the contingency planning requirements of HIPAA.

The Work Plan is a valuable resource annually published by the OIG for providers to identify potential compliance risk areas.

Cozen O’Connor recently published another blog of the Work Plan with the Work Plan’s specific focus on HIPAA and/or information technology that the OIG will examine and address during Fiscal Year 2015.

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OIG’s New Work Plan Focuses on the Security of Health Information

Posted by Health Law Informer Author on December 04, 2014
CMS, HHS, HIPAA, OIG / No Comments

On October 31, 2014, The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released its Work Plan for fiscal year (FY) 2015.  The Work Plan summarizes “new and ongoing reviews of activities that OIG plans to pursue with respect to HHS programs and operations during the current fiscal year and beyond.”  In the Work Plan OIG identified several areas related to HIPAA and/or information technology that it will examine and address during FY 2015.

As a new addition to the Work Plan, OIG will determine the extent to which hospitals comply with the contingency requirements of HIPAA.  HIPAA’s Security Rule requires covered entities and their business associates to have in place a contingency plan that establishes policies and procedures for responding to an emergency or other event (such as, for example, natural disasters, system failures, terrorism) that damages systems containing electronic protected health information (ePHI).  These policies and procedures must, at a minimum, include data backup plans, data recovery plans and plans to continue to protect the security of ePHI while operating in emergency operations mode.  In the Work Plan OIG advises that it will compare contingency plans used by hospitals with government and industry recommended practices. 

As part of the Work Plan, OIG will continue to examine whether the Centers for Medicare & Medicaid Services’ (CMS) oversight of hospitals’ security controls over networked medical devices is sufficient to protect ePHI.   The OIG noted that computerized medical devices such as dialysis machines, radiology systems and medication dispensing systems that use hardware, software and networks to monitor a patient’s condition and transmit and/or receive data using wired or wireless communications pose a growing threat to the security and privacy of personal health information. 

OIG also plans to continue to perform audits of covered entities receiving incentive payments for the use of electronic health records (EHRs) and their business associates (including cloud providers) to determine whether they are adequately protecting ePHI created or maintained by certified EHR technology.  In addition, OIG will review the adequacy of CMS’ oversight of states’ Medicaid system and information controls.  Prior OIG audits found that states often fail to have in place adequate security features, potentially exposing Medicaid beneficiary information to unauthorized access.

As to future endeavors, the Work Plan stated that other areas under consideration for new work include the security of electronic data, the use and exchange of health information technology, and emergency preparedness and response efforts.  In addition, OIG advises that in FY 2015 and beyond, it will continue to focus on IT systems security vulnerabilities in health care reform programs such as health insurance marketplaces. 

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“LoProCo”, 12,915 Complaints, and Other Lessons from OCR/NIST

Posted by Health Law Informer Author on September 26, 2014
ACA, CMS, HHS, HIPAA, HITECH, Privacy / No Comments

 

12,915 complaints were reported in 2013 to the Department of Health and Human Services Office of Civil Rights (“OCR”) according to Illiana L. Peters, Senior Adviser for HIPAA Compliance and Enforcement.  Cozen O’Connor attended Ms. Peters’ presentation at the Safeguarding Health Information: Building Assurance through HIPAA Security conference on September 22-23, 2014.  The conference was hosted jointly by OCR and the National Institute of Standards and Technology (“NIST”).  Below are a few discussion points worth mentioning from the conference:

  • Between September 2009 and August 31, 2014, OCR investigated 1176 reports involving breach of Protected Health Information (“PHI”) where more than 500 individuals were affected and approximately 122,000 reports affecting less than 500 individuals.
  • According to Ms. Peters, 60% of the large breaches could have been prevented by encrypting the covered entities and business associates’ laptops and mobile devices.
  • Theft and loss continues to be the most common cause of breaches but OCR expects that IT hacking will continue to rise as a significant breach risk.
  • Since 2009, consumer complaints regarding HIPAA violations continue to rise.
  • Covered entities and business associates should already have in place business associate agreements that have been updated for the Omnibus Rule.
  • Business associates must comply with all of the HIPAA Security Rules applicable to covered entities, “PERIOD.”
  • Given the known risks of hacking, theft and loss and the direct guidance from OCR, covered entities and business associates must recognize that inadequate security, inadequate physical and technical safeguards is not acceptable.
  • OCR expects that covered entities and business associates will be familiar with recent corrective actions, resolution agreements such as Parkview, NYP/Columbia, Concentra, QCA, Skaget County, Adult & Pediatric Dermatology, P.C., and Affinity Health Plan, Inc.

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