HIPAA Compliance News

OCR Reminds Healthcare Organizations of HIPAA Rules for Disposing of Electronic Devices and Media

Posted by HIPAA Journal

In its July Cybersecurity Newsletter, the Department of Health and Human Services’ Office for Civil Rights has reminded HIPAA covered entities about HIPAA Rules for disposing of electronic devices and media.

Prior to electronic equipment being scrapped, decommissioned, returned to a leasing company or resold, all electronic protected health information (ePHI) on the devices must be disposed of in a secure manner.

HIPAA Rules for disposing of electronic devices cover all electronic devices capable of storing PHI, including desktop computers, laptops, servers, tablets, mobile phones, portable hard drives, zip drives, and other electronic storage devices such as CDs, DVDs, and backup tapes.

Healthcare organizations also need to be careful when disposing of other electronic equipment such as fax machines, photocopiers, and printers, many of which store data on internal hard drives. These devices in particular carry a high risk of a data breach at the end of life as they are not generally thought of as devices capable of storing ePHI.

If electronic devices are not disposed of securely and a data breach occurs, the costs to a healthcare organization can be considerable. Patients must be notified, it may be appropriate to pay for credit monitoring and identity theft protection services, and third-party breach response consultants, forensic investigators, and public relations consultants may need to be hired. OCR and/or state attorneys generals may conduct investigations and substantial financial penalties may be applied. Breach victims may also file lawsuits over the exposure of their financial information.

The costs all add up. The 2018 Cost of a Data Breach Study conducted by the Ponemon Institute/IBM Security highlighted the high cost of data breaches, in particular healthcare data breaches. The average cost of a breach of up to 100,000 records was determined to be $3.86 million. Healthcare data breaches cost an average of $408 per exposed record to mitigate, while the cost of data breaches of one million or more records was estimated to be between $40 million and $350 million.

It is not possible to ensure that all ePHI is disposed of securely if an organization does not know all systems and devices where PHI is stored. A full inventory of all equipment that stores ePHI must be created and maintained. When new equipment is purchased the list must be updated.

A full risk analysis should be conducted to determine the most appropriate ways to protect data stored on electronic devices and media when they reach the end of their lifespan.

Organizations must develop a data disposal plan that meets the requirements of 45 C.F.R. §164.310(d)(2)(i)-(ii). Paper, film, or other hard copy media should be shredded or destroyed such that the PHI cannot be read or otherwise cannot be reconstructed. OCR notes that “Redaction is specifically excluded as a means of data destruction.”

Electronic devices should be “cleared, purged, or destroyed consistent with NIST Special Publication 800-88 Revision 1, Guidelines for Media Sanitization,” to ensure that ePHI cannot be retrieved. If reusable media are in use, it is important to ensure that all data on the devices are securely erased prior to the devices being reused. Before electronic devices are scrapped or disposed of, asset tags and corporate identifying marks should be removed.

Third party contractors can be used to dispose of electronic devices, although they would be considered business associates and a business associate agreement would need to be in place. All individuals required to handle the devices must be aware of their responsibilities with respect to ePHI and its safe handling and should be subjected to workforce clearance processes.

Organizations should also consider the chain of custody of electronic equipment prior to destruction. Physical security controls should be put in place to ensure the devices cannot be stolen or accessed by unauthorized individuals and security controls should cover the transport of those devices until all data has been destroyed and is no longer considered ePHI.

The OCR newsletter, together with further information on secure disposal of ePHI and PHI, can be found on this link (PDF).

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NIST/NCCoE Release Guide for Securing Electronic Health Records on Mobile Devices

Posted by HIPAA Journal

The HIPAA Security Rule requires HIPAA-covered entities to ensure the confidentiality, integrity, and availability of electronic protected health information at all times. Healthcare organizations must ensure patients’ health is not endangered, their privacy is protected, and their identities are not compromised.

A range of physical, technical, and administrative controls can be implemented to secure ePHI on servers and desktop computers, but ensuring the same level of security for mobile devices can be a major challenge.

Mobile devices offer many benefits for healthcare providers. They can improve access to protected health information, ensure that data can be accessed anywhere, and they help healthcare providers improve coordination of care.

However, when ePHI is stored on mobile devices such as laptops, tablets and mobile phones, or is transmitted using those devices, it is particularly vulnerable. Mobile devices are easy to lose, are often stolen, and data transmitted through mobile devices can also be vulnerable to interception. In healthcare, mobile device security is a major concern.

Despite security concerns, the majority of healthcare providers are either using mobile devices or plan to implement a mobile device initiative. Mobile device usage by healthcare providers is expected to increase significantly over the next two years.

To help healthcare organizations take advantage of mobile devices without violating the HIPAA Security Rule and patient privacy, the National Institute of Standards and Technology (NIST) and The National Cybersecurity Center of Excellence (NCCoE) has produced a new guide – Securing Electronic Health Records on Mobile Devices.

The guide focuses on healthcare organizations that use mobile devices to review, update, and exchange electronic health records and addresses risks such as the loss or theft of devices, the hacking of devices, connecting to untrusted networks, and interaction between mobile devices and other systems.

The guide explains how ePHI can be secured on mobile devices without having a negative impact on delivering quality care and offers straightforward and detailed advice on securing electronic health records on mobile devices.

The guide explains how IT professionals can implement a security architecture to improve device security and better protect ePHI that is accessed, stored, or transmitted through mobile devices. The guide explains how commercially available and open-source technologies and tools can be deployed as part of a layered cybersecurity strategy to ensure ePHI can be accessed and shared securely.

The guide maps security characteristics to NIST standards and best practices and to the HIPAA Security Rule and includes a detailed architecture and capabilities that address security controls. The guide provides detailed information on automated configuration of security controls for ease of use and addresses both in-house and outsourced implementations.

The guide serves as a how-to guide to implement NIST’s security solution, or it can be taken as a starting point and customized to suit each individual organization. Since the guide is modular, healthcare providers can choose to implement the parts to suit their own needs.

”All healthcare organizations need to fully understand the potential risk posed to their information systems, the bottom-line implications of those risks, and the lengths that attackers will go to exploit them,” wrote NIST/NCCoE in the guide. “Assessing risks and making decisions about how to mitigate them should be continuous to account for the dynamic nature of business processes and technologies, the threat landscape, and the data itself. The guide describes [NIST’s] approach to risk assessment. We recommend that organizations implement a continuous risk management process as a starting point for adopting this or other approaches that will increase the security of EHRs. It is important for management to perform regular periodic risk review, as determined by the needs of the business.”

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HHS Secretary Alex Azar Promises Reforms to Federal Health Privacy Rules

Posted by HIPAA Journal

At a July 27 address at The Heritage Foundation, Secretary of the Department of Health and Human Services (HHS), Alex Azar, explained that the HHS will be undertaking several updates to health privacy regulations over the coming months, including updates to the Health Insurance Portability and Accountability Act (HIPAA) and 45 CFR Part 2 (Part 2) regulations.

The process is expected to commence in the next couple of months. Requests for information on HIPAA and Part 2 will be issued, following which action will be taken to reform both sets of rules to remove obstacles to value-based care and support efforts to combat the opioid crisis. Rule changes are also going to be made to remove some of the barriers to data sharing which are currently hampering efforts by healthcare providers to expand the use of electronic health technology.

These requests for information are part of a comprehensive review of current regulations that are hampering the ability of doctors, hospitals, and payers to improve the quality healthcare services and coordination of care while helping to reduce healthcare costs.

That process has already commenced with the Centers for Medicare & Medicaid Services (CMS) already having proposed one of the most fundamental changes to Medicare in recent years – A change to how physicians are paid for basic evaluation visits.

At present there are currently five tiers of payments for visits, with payments increasing for visits of increasing complexity. While this system makes sense, in practice in involves a considerable administrative burden on physicians, requiring them to justify why they are claiming for a visit at a higher tier. The CMS has proposed reducing the five tiers to two. That simple change is expected to save physicians more than 50 hours a year – more than a week’s work – with that time able to be diverted to providing better care to patients.

The CMS has also submitted a request for information of issues with Stark’s Law, which prevents physicians from referring patients to other physicians/practices with which they have a financial relationship, except in certain situations. Requests for information on HIPAA, Part 2, and the Anti-Kickback Statute will follow.

Healthcare providers that wish to voice their concerns about issues with HIPAA, Part 2, and the Anti-Kickback Statute should consider preparing comments and suggestions for policy updates to address those issues, ready for submission when the HHS issues its requests for information.

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Investigation Launched Over Snapchat Photo Sharing at M.M. Ewing Continuing Care Center

Posted by HIPAA Journal

Employees of a Canandaigua, NY nursing home have been using their smartphones to take and share images and videos of at least one resident and share the content with others via Snapchat – a violation of HIPAA and a serious violation of patient privacy.

The privacy breaches occurred at Thompson Health’s M.M. Ewing Continuing Care Center and involved multiple employees. Thompson Health has already taken action and has fired several workers over the violations. Now the New York Department of Health and the state attorney general’s office have got involved and are conducting investigations.

The state attorney general’s Deputy Press Secretary, Rachel Shippee confirmed to the Daily Messenger that an investigation has been launched, confirming “The Medicaid Fraud Control Unit’s mission includes the protection of nursing home residents from abuse, neglect and mistreatment, including acts that violate a resident’s rights to dignity and privacy.”

Thompson Health does not believe the images/videos were shared publicly and sharing was restricted to a group of employees at the care center. Thompson Health is contacting the families of the residents impacted by the breach to offer an apology.

This is not the first time that Thomson Health has discovered an employee had taken pictures and videos without people’s knowledge. In January, a camera was discovered in a unisex bathroom at Thompson Hospital. When the camera was taken down it was discovered that the memory card had been removed. The matter was reported to law enforcement although the employee responsible has not been identified.

M.M. Ewing Continuing Care Center is far from the only nursing home to discover that residents have been photographed and videoed without consent with videos and images shared on social media networks.

An investigation into the sharing of images of abuse of nursing home residents was launched by ProPublica in 2015. The investigation revealed the practice was commonplace, with several nursing home employees discovered to have performed similar acts. The investigation revealed there had been 22 cases of photo sharing on Snapchat and other social media platforms and 35 cases in total since 2012.

More recently, a nursing assistant at the Parkside Manor assisted-living facility in Kenosha, WI., was discovered to have taken photos of an Alzheimer’s patient and posted the images of SnapChat. When the violation was discovered, the nursing assistant was fired for the HIPAA breach.

The high number of cases involving these types of HIPAA violations prompted the CMS to take action in 2016. The CMS sent a memo to state health departments reminding them of their responsibilities to ensure nursing home residents were not subjected to any form of abuse, including mental abuse such as the taking of demeaning and degrading photos and videos and having the multimedia content shared on social media networks.

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Federal Court Rules in Favor of Main Line Health in Age Discrimination Case Over HIPAA Violation

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In 2016, Radnor, PA-based Main Line Health Inc., terminated an employee for violating Health Insurance Portability and Accountability Act (HIPAA) Rules by accessing the personal records of a co-worker without authorization on two separate occasions.

In such cases, when employee or patient records are accessed without authorization, employees face disciplinary action which can include termination. Gloria Terrell was one such employee who was terminated for violating company policies and HIPAA Rules. Main Line Health fired Terrell for “co-worker snooping.”

Terrell filed an internal appeal over her termination and maintained she accessed the records of a co-worker in order to obtain a contact telephone number. Terrell said she needed to contact the co-worker to make sure a shift would be covered, and this constituted a legitimate business reason for the access as she was unable to find the phone list with employees’ contact numbers.

After firing Terrell, Main Line Health appointed a significantly younger person to fill the vacant position. Terrell took legal action against Main Line Health in September 2016 claiming age discrimination. In the lawsuit, Terrell claimed Main Line Health had experienced similar snooping incidents in the past and failed to apply the same rules for younger employees. Terrell claimed she knew of three younger co-workers who were not terminated following the discovery of HIPAA violations. However, Terrell could not substantiate those assertions and all three employees denied they had been involved in any improper accessing of patient records.

Main Line Health explained appropriate training on HIPAA Rules and company policies had been provided to staff on multiple occasions and that there were established policies related to the protection of confidential employee and patient information. Those policies clearly state disciplinary action will be taken if company policies and HIPAA Rules are violated, which may include immediate discharge from employment.

Main Line Health maintained Terrell was terminated for a legitimate, non-discriminatory reason, and since the case failed to raise a triable issue, Main Line Health was entitled to a summary judgement.

Terrell’s case (Gloria Terrell v. Main Line Health, Inc., et al – Civil action No. 17-3102) went to federal court in the Eastern District of Pennsylvania. U.S District Court Judge Richard Barclay Surrick recently granted Main Line Health’s summary judgement, ruling Terrell failed to establish a viable age discrimination claim.

“In short, other than her own subjective beliefs, Plaintiff has offered no evidence from which a reasonable factfinder could conclude that Defendant’s proffered reason for terminating her lacks credibility. She has provided no evidence to support a finding of discrimination,” wrote Judge Barclay Surrick. “Although one may have reservations about the wisdom of terminating an employee with Plaintiff’s experience and tenure for electronically accessing a phone number that had already been made available to co-workers in paper form, it is not for this Court to sit as a super-personnel department that re-examines an entity’s business decisions.”

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Healthcare Worker Charged with Criminally Violating HIPAA Rules

Posted by HIPAA Journal

A former University of Pittsburgh Medical Center patient information coordinator has been indicted by a federal grand jury over criminal violations of HIPAA Rules, according to an announcement by the Department of Justice on June 29, 2018.

Linda Sue Kalina, 61, of Butler, Pennsylvania, has been charged in a six-count indictment that includes wrongfully obtaining and disclosing the protected health information of 111 patients.

Kalina worked at the University of Pittsburgh Medical Center and the Allegheny Health Network between March 30, 2016 and August 14, 2017. While employed at the healthcare organizations, Kalina is alleged to have accessed the protected health information (PHI) of those patients without authorization or any legitimate work reason for doing so.

Additionally, Kalina is alleged to have stolen PHI and, on four separate occasions between December 30, 2016, and August 11, 2017, disclosed that information to three individuals with intent to cause malicious harm.

Kalina was arrested following an investigation by the Federal Bureau of Investigation. The case was taken up by the Department of Justice and she is being prosecuted by Assistant United States Attorney, Carolyn Bloch, on behalf of the federal government.

If found guilty on all counts, Kalina faces up to 11 years in jail and could be ordered to pay a fine of up to $350,000. The sentence will be dictated by the seriousness of the offenses and any prior criminal history.

The Department of Justice is taking a hard line on individuals who violate HIPAA Rules and impermissibly access and disclose PHI with malicious intent. There have been several other cases in 2018 that have seen former healthcare workers indicted for criminal HIPAA violations, with three cases resulting in imprisonment.

In June 2018, a former employee of the Veteran Affairs Medical Center in Long Beach, CA, Albert Torres, 51, was sentenced to serve 3 years in jail for the theft of protected health information and identity theft. Torres pleaded guilty to the charges after law enforcement officers discovered the records of 1,030 patients in his home.

In April, 2018, former receptionist at a New York dental practice, Annie Vuong, 31, was sentenced to serve 2 to 6 years in jail for stealing the PHI of 650 patients and providing that information to two individuals who used the data to rack up huge debt’s in patients’ names.

In February, a former behavioral analyst at the Transformations Autism Treatment Center in Bartlett, TN, Jeffrey Luke, 29, was sentenced to 30 days in jail, 3 years supervised release, and was ordered to pay $14,941.36 in restitution after downloading the PHI of 300 current and former patients onto his personal computer.

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OCR Draws Attention to HIPAA Patch Management Requirements

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Healthcare organizations have been reminded of HIPAA patch management requirements to ensure the confidentiality, integrity, and availability of ePHI is safeguarded.

Patch Management: A Major Challenge for Healthcare Organizations

Computer software often contains errors in the code that could potentially be exploited by malicious actors to gain access to computers and healthcare networks.

Software, operating system, and firmware vulnerabilities are to be expected. No operating systems, software application, or medical device is bulletproof. What is important is those vulnerabilities are identified promptly and mitigations are put in place to reduce the probability of the vulnerabilities being exploited.

Security researchers often identify flaws and potential exploits. The bugs are reported to manufacturers and patches are developed to fix the vulnerabilities to prevent malicious actors from taking advantage.

Unfortunately, it is not possible for software developers to test every patch thoroughly and identify all potential interactions with other software and systems and still release patches in a timely manner.

Therefore, IT departments must test the patches before they are applied. IT teams must also ensure that patches are applied on all vulnerable systems and no device is missed.

With so many IT systems and software applications in use and the frequency that patches are released, patch management can be a major challenge for healthcare organizations.

HIPAA Patch Management Requirements

The HHS’ Office for Civil Rights has recently drawn attention to the importance of patching in its June 2018 cybersecurity newsletter. OCR explains the HIPAA patch management requirements and how patching vulnerable software is an essential element of HIPAA compliance. OCR describes patch management as “the process of identifying, acquiring, installing and verifying patches for products and systems.”

“Security vulnerabilities may be present in many types of software including databases, electronic health records (EHRs), operating systems, email, applets such as Java and Adobe Flash, and device firmware,” wrote OCR. “Identifying and mitigating the risks unpatched software poses to ePHI is important to ensure the protection of ePHI and in fulfilling HIPAA requirements.”

Patch management is not specifically mentioned in the HIPAA Security Rule, although the identification of vulnerabilities is covered in the HIPAA administrative safeguards under the security management process standard.

Vulnerabilities to the confidentiality, integrity, and availability of ePHI should be identified through an organization’s risk analyses – 45 C.F.R. § 164.308(a)(1)(i)(A) – and subjected to HIPAA-compliant risk management processes – 45 C.F.R. § 164.308(a)(1)(i)(B).

Patch management is also covered under the security awareness and training standard – 45 C.F.R. § 164.308(a)(5)(ii)(B) – protection from malicious software – and the evaluation standard – 45 C.F.R. § 164.308(a)(8).

Discovering Vulnerabilities and Possible Mitigations

To ensure patches can be applied, it is essential for IT teams to have a complete inventory of all systems, devices, operating systems, firmware, and software installed throughout the organization. Regular scans should also be conducted to identify unauthorized software – shadow IT – that has been installed.

The United States Computer Emergency Readiness Team (US-CERT) and the Industrial Control Systems Cyber Emergency Response Team (ICS-CERT) provide up to date information on new vulnerabilities, mitigations, and patches. Covered entities should regularly check their websites and, ideally, sign up for alerts. Information on vulnerabilities and patches should also be obtained from software vendors and medical device manufacturers.

The Patch Management Process

In order for a HIPAA-covered entity to ensure HIPAA patch management requirements are satisfied and vulnerabilities to the confidentiality, integrity, and availability of ePHI are reduced to an acceptable level, robust patch management policies and procedures need to be developed and implemented.

OCR suggests the patch management process should include:

  • Evaluation: Determine whether patches apply to your software/systems.
  • Patch Testing: Test patches on an isolated system to determine if there are any unforeseen or unwanted side effects, such as applications not functioning properly or system instability.
  • Approval: Following testing, approve patches for deployment.
  • Deployment: Deploy patches on live or production systems.
  • Verification and Testing: After deployment, continue to test and audit systems to ensure patches have been applied correctly and that there are no unforeseen side effects.

Resources:

NIST Special Publication 800-40 Guide to Enterprise Patch Management Technologies (Revision 3) is an excellent resource covering best practices for patch management.

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Unencrypted Hospital Pager Messages Intercepted and Viewed by Radio Hobbyist

Posted by HIPAA Journal

Many healthcare organizations have now transitioned to secure messaging systems and have retired their outdated pager systems.

Healthcare organizations that have not yet made the switch to secure text messaging platforms should take note of a recent security breach that saw pages from multiple hospitals intercepted by a ‘radio hobbyist’ in Missouri.

Intercepting pages using software defined radio (SDR) is nothing new. There are various websites that explain how the SDR can be used and its capabilities, including the interception of private communications. The risk of PHI being obtained by hackers using this tactic has been well documented.  All that is required is some easily obtained hardware that can be bought for around $30, a computer, and some free software.

In this case, an IT worker from Johnson County, MO purchased an antenna and connected it to his laptop in order to pick up TV channels. However, he discovered he could pick up much more. By accident, he intercepted pages sent by physicians at several hospitals. The man told the Kansas City Star he intercepted pages containing highly sensitive information including the page below:

“RQSTD RTM: (patient’s name) 19 M Origin Unit: EDOF Admitting: (doctor’s name) Level of Care: 1st Avail Medical Diagnosis: TONSILAR BLEED, ANEMIA, THROMBOCYTOPENIA”

It was not necessary to be in close vicinity of a hospital to intercept the pages and view PHI. Pages were picked up from hospitals and medical centers in Blue Springs, MO; Harrisonville, MO; Liberty, MO; Kansas City, KS; Wichita, KS; and even hospitals further away in Kentucky and Michigan.

Reporters from the Kansas City Star made contact with several of the patients whose information was exposed to confirm the information was correct. Understandably, the patients were shocked to find out that their sensitive information had been obtained by unauthorized individuals, as were the hospitals.

While not all hospitals responded, some of those that did said they are working with their vendors to correct the problem to ensure that pages cannot be intercepted in the future.

Intercepting pages is illegal under the Electronic Communications Protection Act, although hacking healthcare networks or conducting phishing campaigns to obtain protected health information is similarly illegal, yet that does not stop hackers.

HIPAA-covered entities should take note of the recent privacy violations and should consider implementing a secure messaging solution in place of pagers; however, in the meantime they should contact their vendors and explore the options for encrypting pages to prevent ePHI from being intercepted.

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District Court Ruling Confirms No Private Cause of Action in HIPAA

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Patients who believe HIPAA Rules have been violated can submit a compliant to the Department of Health and Human Services’ Office for Civil Rights, but they do not have the right to take legal action, at least not for the HIPAA violation. There is no individual private cause of action under HIPAA law.

Several patients have filed lawsuits over alleged HIPAA violations, although the cases have not proved successful. A recent case has confirmed once again that there is no private cause of action in HIPAA, and lawsuits filed solely on the basis of a HIPAA violation are extremely unlikely to succeed.

Ms. Hope Lee-Thomas filed the lawsuit for an alleged HIPAA violation that occurred at Providence Hospital in Washington D.C., where she received treatment from LabCorp. Ms. Lee-Thomas, who represented herself in the action, claims that while at the hospital on June 15, 2017, a LabCorp employee instructed her to enter her protected health information at a computer intake station.

Ms. Lee-Thomas told the LabCorp employee that the information was in full view of another person at a different computer intake station and took a photograph of the two computer intake stations.

On July 3, 2017, Ms. Lee-Thomas submitted a complaint with the hospital alleging a violation of HIPAA and filed a complaint with the HHS’ Office for Civil Rights. Later, a complaint was filed with the District of Columbia Office of Human Rights (OHR) claiming the hospital had failed to make appropriate accommodations for patients to preserve their privacy.

On November 15, 2017, the HHS informed Ms. Lee-Thomas that her claim would not be pursued and OHR similarly dismissed her complaint on November 28, 2017, in both cases on the grounds that she failed to state a claim. OHR suggested Ms. Lee-Thomas had the right to bring a private action before the D.C. Superior Court and she proceeded to do so.

LabCorp removed the case to the U.S. Court of Appeals for the District of Columbia Circuit, and filed a motion to dismiss, again for the failure to state a claim. Ms. Lee-Thomas failed to respond to the motion to dismiss.

In a June 15 ruling, District Court Judge Rudolph Contreras confirmed that HIPAA does permit financial penalties to be issued when patients’ privacy is violated in breach of HIPAA Rules, but civil and criminal penalties are pursued by the Department of Health and Human Services’ Office for Civil Rights and state attorneys general. In his ruling, Judge Contreras confirmed there is no private cause of action in HIPAA.

Even if there was a private cause of action, it would be unlikely that this case would have proved successful as no harm appears to have been caused as a result of the alleged HIPAA violation.

While lawsuits are likely to be dismissed when based on HIPAA violations alone, that does not mean legal action cannot be taken by patients whose privacy has been violated. There is no private cause of action in HIPAA, but the privacy of personal information is covered by state laws.

Laws have been passed in all 50 states that require notifications to be issued to consumers when their personal information has been exposed, and several states also require companies to implement ‘reasonable safeguards’ to ensure personal data of state residents are protected.

A HIPAA violation can be reported to OCR to investigate, and action may be taken against the covered entity in question by OCR, but if the sole basis of any legal action is a violation of HIPAA Rules, the case is unlikely to be successful.

Victims of privacy violations who wish to take legal action should look at potential violations of state laws rather than HIPAA violations.

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