Category Archives: Electronic Health Records

Ransomware Groups Declare War on US Hospitals

A recent phase of the ongoing two-pronged cyber war between Russia/Iran/North Korea and China against the United States has taken an ugly turn.  The Russian faction has launched various sophisticated ransomware attacks against healthcare providers and hospital systems across the United States.  

As stated in an October 28, 2020 Alert from the Cybersecurity & Infrastructure Security Agency (CISA), there is “credible information of an increased and imminent cybercrime threat to U.S. hospitals and healthcare providers.”  In addition to the CISA Alert, cybersecurity firms battling this latest threat have shared how these latest attacks are perpetrated.

Our current healthcare cyber battle is further complicated given an October 1, 2020 Advisory from U.S. Department of the Treasury’s Office of Foreign Assets Control (OFAC) reminding ransomware victims against conducting business with those on the OFAC list – including specific ransomware groups such as the Russia-based group behind the Dridex malware.  The OFAC advisory is likely driven by the FBI – which has long advocated against victims making ransomware payments.  No matter what the motivation, however, OFAC has exacerbated the current crisis given the OFAC Advisory warns the primary civil combatants against making violative ransomware payments, namely companies “providing cyber insurance, digital forensics and incident response, and financial services that may involve processing ransom payments (including depository institutions and money services businesses).”

Over the past several years, the cybersecurity community has seen a tremendous uptick in the deployment of ransomware – even leading to board level scrutiny.   No different from SQL injection exploits that were commonly warned against so many years ago yet still remain an exposure for so many websites, ransomware will not go away anytime soon.  The necessary cyber defensive skillset is far from fully disbursed to potential victims.  For example, indicators of compromise (IOCs) shared with the cybersecurity community would likely be ignored by most IT staff given they do not even have the means of searching internally for IOCs within their network.

Taking into consideration the old adage:  “If you fail to plan, you plan to fail,” healthcare providers and hospital systems should immediately seek out specialized cybersecurity experts who are currently fighting this battle before it is too late.

University of Rochester Medical Center Gets Hit with a $3 Million HIPAA Fine

On November 5, 2019, the University of Rochester Medical Center (URMC) agreed to a corrective action plan and payment of $3 million due to the 2013 and 2017 loss of an unencrypted flash drive and theft of an unencrypted laptop, respectively.

The apparent reason for the large fine was the fact that “in 2010, [the Office for Civil Rights (OCR)] investigated URMC concerning a similar breach involving a lost unencrypted flash drive and provided technical assistance to URMC. Despite the previous OCR investigation, and URMC’s own identification of a lack of encryption as a high risk to ePHI, URMC permitted the continued use of unencrypted mobile devices.”

As with most OCR enforcement actions, there is typically an industry wide message with each large fine – in this case there are two, namely the failure to encrypt will simply no longer be tolerated and once given a pass by OCR be sure not to waste it.

UPDATE:  December 3, 2019

In keeping with its apparent practice of announcing HIPAA violation resolutions in clusters, on November 7, 2019, OCR announced a $1.6 million penalty against  the Texas Health and Human Services Commission for violations of the Privacy and Security Rules had between 2013 and 2017.  The primary breach occurred when “an internal application was moved from a private, secure server to a public server and a flaw in the software code allowed access to ePHI without access credentials.”  OCR also determined that  in addition to the impermissible disclosure, there was a failure “to perform an accurate, thorough, and enterprise-wide risk analysis that meets the requirements of45 C.F.R. § 164.308(a)(l)(ii)(a) [Security Rule].”  Interestingly, the OCR applied its new civil money penalty caps published in April

And, on November 27, 2019, OCR revealed its enforcement settlement with a hospital network that sent bills to patients containing “the patient names, account numbers, and dates of service” of 577 other patients.  Sentara Hospitals – based in Virginia and North Carolina, did not think such information was protected health information (PHI) and only notified the 8 patients where there was also a disclosure of treatment information.  Given that Sentara “persisted in its refusal to properly report the breach even after being explicitly advised of their duty to do so by OCR”, it was stuck with a $2.175 million penalty.  Given that PHI has been interpreted to include healthcare payment information linked to a specific individual, Sentara was obviously taking a chance when it ignored OCR’s advice. On the other hand, protected health information is expressly defined to mean “individually identifiable health information” so there was at least a colorable argument that payment information – even if related to the provision of healthcare, is not “health information” in any direct sense. 45 CFR § 160.401.

Providing some year-end advice that should also not be disregarded, on December 2, 2019, OCR released its Fall 2019 Cybersecurity Newsletter focusing on ransomware and how covered entities and business associates should apply the Security Rule as a mitigation tool against this threat. 

These latest announcements were clustered to push one primary message, namely do not disregard explicit counsel from OCR given that when it comes to the OCR it most certainly holds a grudge when ignored. In addition, CE’s and BA’s are well advised to deploy an enterprise-wide risk analysis that determines whether there are out-facing vulnerabilities that should be patched. And finally, as shown by the significant amount assessed against the University of Rochester Medical Center, future disregard of encryption as a risk mitigation tool will likely lead to enhanced penalties going forward.

Maine Bans ISPs From Selling Personal Information Lacking in Consent

On June 6, 2019, Maine joined a chorus of state legislatures moving on data privacy – this time requiring providers of broadband Internet services to obtain express consent before using a consumer’s personal information.  Specifically, the new Maine law reads:  “A provider may use, disclose, sell or permit access to a customer’s customer personal information if the customer gives the provider express, affirmative consent to such use, disclosure, sale or access. A customer may revoke the customer’s consent under this paragraph at any time.”  

Maine’s law is even more restrictive than California’s Consumer Privacy Act which will deploy an “opt out” mechanism requiring the consumer to inform data processors of their preference.   Both Californians and Mainers will have to wait until 2020 to benefit from their respective data privacy laws – with the Maine statute taking effect on July 1, 2020. 

As reported in The Hill, tech lobbyists are now exerting their best efforts on obtaining a federal law that will moderate this and other consumer privacy state gains – which is not surprising given even stricter data privacy laws percolating in other states.   Whether or not certain data privacy provisions die in a preemption skirmish, data rights will continue their reimagination by market forces so lobbyists alone can never prevail in their clients’ war against true individual data ownership.

OCR Snags $3 Million HIPAA Settlement For Insecure Web Server

On May 6, 2019, the Office for Civil Rights (OCR) announced that Tennessee-based Touchstone Medical Imaging agreed to pay $3,000,000 and adopt a corrective action plan that includes the adoption of business associate agreements, completion of an enterprise-wide risk analysis, and additional comprehensive policies and procedures applying HIPAA Rules. Touchstone – which provides diagnostic medical imaging services, was notified in May 2014 by the FBI that one of its FTP servers allowed uncontrolled access to protected health information (PHI).  This uncontrolled access “permitted search engines to index the PHI of Touchstone’s patients, which remained visible on the Internet even after the server was taken offline.”

During OCR’s investigation, Touchstone acknowledged that the PHI of more than 300,000 patients was exposed including, names, birth dates, social security numbers, and addresses.  OCR’s investigation found that Touchstone “did not thoroughly investigate the security incident until several months after notice of the breach”.  As a result, Touchstone’s notification to individuals affected by the breach was considered untimely.   

Given last year’s summary judgment win by OCR and the facts presented by the Touchstone incident, it is not surprising that this significant settlement – which was one of the largest to date, was reached.  FTP servers have long been a threat vector – even if set up and run properly, so not unlike the clarion calls initiated for encryption and social engineering training, back office IT support should be sophisticated enough to adopt a means of file transfer that applies state of the art security.

OCR wins $4.3 million HIPAA Victory against MD Anderson

On June 18, 2018, the the Office for Civil Rights (OCR) posted a press release announcing its summary judgment victory against the University of Texas MD Anderson Cancer Center (MD Anderson) – a ruling that will require MD Anderson to pay $4,348,000 in civil money penalties to OCR.   According to the press release, this is only the second HIPAA summary judgment victory in OCR’s history and the $4.3 million is the fourth largest amount ever awarded to OCR for HIPAA violations.

The June 1, 2018 Administrative Law Judge’s decision ultimately hinged on a stolen unencrypted laptop and several lost unencrypted USB thumb drives containing “identifying information such as patient names, addresses, and Social Security numbers; and clinical information such as diagnoses, assessments, prognoses, and treatment regimes” of a total of 33,500 individuals.  Decision at 2.

The hefty fine was based on the fact MD Anderson knew encryption was an essential risk management tool since 2006 yet did not get around to fully deploying encrypted devices until after the losses in question.  According to the ALJ, MD Anderson before then made only “half-hearted and incomplete efforts at encryption”.  Decision at 5.

According to the ALJ:

The question is whether Respondent took the necessary steps to address the risk that it had identified – the potential for data loss due to the storage of ePHI on unencrypted devices. As I have explained, the failure to address that risk is the sum and substance ofRespondent’s noncompliance. Had it done so, then unauthorized acts by Respondent’s employees might be relevant to the issue of compliance. But, failure by Respondent to take the security measures that it had identified as necessary renders irrelevant the issue of whether employees were playing by the rules, because that failure created a risk whether or not Respondent’s employees did so.

Decision at 14 (emphasis in original).

This latest OCR action may very well be appealed given the jurisdictional arguments made by MD Anderson.  No matter what the final appellate result, however, the ruling should slam the lid on any covered entity ever questioning again whether encryption is worth the cost of deployment.     Whether it is from a state enforcement action or OCR settlements based on vendor negligence, laptops stolen from a car, or a USB thumb drive improperly taken from an IT department, when it comes to encryption an ounce of prevention is definitely worth at least a pound of cure.

WannaCry provides a wakeup call for more training on email exploits

On May 12, 2017, WannaCry ransomware infections reportedly took hold of 200,000 computer systems in 150 countries.  The rise of ransomware has been a function of how cheap financial data has become to obtain on the dark web and the desire of criminals to branch out with other sources of income.

Ransomware is quite effective given it purposefully seeks to panic victims into clicking additional links thereby causing a user’s system to become infected with more pernicious malware.  For example, after seeing a screen blink on and off several times ransomware victims may next see the following message on their screen:  “Your computer has been infected with a virus. Click here to resolve the issue.”  Clicking on that link, however, will download additional malware to the system – thereby precluding possible quick fixes to the initial exploit.  It is such additional malware – coupled with very vulnerable legacy systems and procedures, that likely helped WannaCry promulgate so quickly.

Given slow patching and continued widespread use of legacy Windows products, Microsoft sought to slow the spread of WannaCry by offering free patches for its older Windows systems such as Windows XP.  Although helpful in curtailing replication, timely patching will not completely stem this threat.   Newer exploits such as WannaCry likely exist – and will continue to exist for some time, given the underlying code was reportedly created by the National Security Agency and is only a small sample of the “treasure trove” of spying tools released by WikiLeaks in March.  In fact, the WikiLeaks released material includes the source code used to evade anti-virus detection so entry-level hackers apparently now have the ability to immediately up their game.

Given that healthcare data is now considered the most valuable data by thieves, it is no surprise that the healthcare industry was especially hit hard by the WannaCry ransomware exploit.  Succumbing to WannaCry, Britain’s hospital network canceled or delayed treatments for thousands of patients.   In an effort to stem the tide in the US, HHS quickly offered covered entities access to loss prevention resources – including a link to its ransomware fact sheet and a link to the US-CERT response to WannaCry.  US-CERT offered last year helpful tips regarding ransomware loss mitigation techniques.

It is suggested that covered entities take to heart HHS’s desire to warn regarding ransomware exploits.  Given that OCR recently fined a covered entity $2.4 million simply for placing the name of a patient on a press release, ignoring HHS warnings regarding ransomware will likely result in significant penalties to HIPAA covered entities should they fall prey to such an exploit.

In addition to security procedures and implementations – such as whitelisting acceptable programs, aggresive email settings, and limiting user permissions, proper training remains the best antidote to both an exploit as well as an OCR or some other regulatory fine if an exploit ultimately succeeds.  And, the best training remains having users react to a continuous barrage of decoy exploits aimed at sharpening their skills.

Today’s phishing exploits that are being used to transmit ransomware often rely on some other person’s scraped contact information so that they can appear to come from known associates of the user.  These exploits may also use content that appear relevant to the user – such as a bar association communication.    And, finally the links themselves are masked so that it is not even possible to accurately determine where a link takes the user.   Given these indicia of authenticity, users often click on the embedded link rather than hit the delete button.  After exposure to numerous training exploits users are in a much better position to make sound decisions on how to treat actual exploits.  During the course of security training, it is suggested that some form of reward be given to those users who score the highest on the phishing training exercises – any money spent today to build an effective training program will pay significant dividends down the road.

OCR’s April settlements reinforce HIPAA priorities

On March 24, 2017, the Office for Civil Rights (OCR) announced the first settlement and corrective action plan involving a wireless health services provider when it announced a $2.5 million settlement with CardioNet –  a provider of “remote mobile monitoring of and rapid response to patients at risk for cardiac arrhythmias.”   According to the Resolution Agreement and Corrective Action Plan, CardioNet sustained breaches of unsecured electronic protected health information (ePHI) resulting from lost laptops.  And, given that the lost laptops in question were unencrypted, CardioNet’s Corrective Action Plan required that CardioNet provide HHS with a certification that “all laptops, flashdrives, SD cards, and other portable media devices are encrypted, together with a description of the encryption methods used.”

In keeping with OCR’s apparent practice of announcing resolutions in groups – with a distinctive lesson to be made with each resolution, there was another settlement announced on April 20, 2017.  This time a fine of $31,000 was levied against the Center for Children’s Digestive Health (“CCDH”) after it could not produce a business associate agreement.  According to the negotiated Resolution Agreement and Corrective Action Plan, protected health information (PHI) was released to a third-party vendor who stored inactive paper medical records for patients of CCDH without satisfactory assurances in the form of a written business associate agreement that the vendor would appropriately safeguard the PHI in the vendor’s possession or control.  As done in the past when it came to the need for properly-worded business associate agreements, OCR made the point that business associate agreements are a necessary component of the HIPAA framework and the failure to have one when necessary would be a costly error.  See 45 C.F.R § 164.502(e).

And finally, on April 12, 2017, OCR announced a settlement and corrective action plan based on a covered entity’s failure to have an adequate risk management plan in place.  Specifically, on January 27, 2012, Metro Community Provider Network (“MCPN”), a federally-qualified health center filed a breach report with OCR indicating that a hacker accessed employees’ email accounts and obtained 3,200 individuals’ ePHI through a phishing incident.

OCR’s investigation revealed that MCPN took necessary corrective action related to the phishing incident; however, the investigation also revealed that MCPN failed to conduct a risk analysis until mid-February 2012. Prior to the breach incident, MCPN had not conducted a risk analysis to assess the risks and vulnerabilities in its ePHI environment, and, consequently, had not implemented any corresponding risk management plans to address the risks and vulnerabilities identified in a risk analysis. When MCPN finally conducted a risk analysis, that risk analysis, as well as all subsequent risk analyses, were insufficient to meet the requirements of the Security Rule.

Despite being a non-profit that provides primary medical care, dental care, pharmacies, social work, and behavioral care services “to approximately 43,000 patients per year, a large majority of who have incomes at or below the poverty level”, MCPN was hit with a $400,000 fine for its lack of an adequate risk management plan.

To sum up, this most recent grouping of OCR settlements highlights yet again the need for encryption, business associate agreements, and a working risk management plan.  Given that OCR settlements often take years to mature, investigative costs and legal expenses should also be factored into the mix when weighing the benefits of initial compliance.   With this latest round of settlements, it, however, appears clearer and clearer that an ounce of prevention is worth a pound of cure.

Horizon settles state HIPAA claims based on lost laptops

On February 15, 2017, Horizon Healthcare Services, Inc. (“Horizon”) agreed to pay New Jersey authorities $1.1 million to resolve alleged HIPAA Privacy and Security Rule violations based on the November 2013 theft of two unencrypted laptops.  The stolen laptops compromised the privacy of 687,838 New Jersey policyholders.  This settlement comes on the heels of the Third Circuit reversing the dismissal of a putative class action filed against Horizon based on the same laptop incident.

After acknowledging that vendor moving company employees may have stolen the laptops, the Complaint recounts numerous alleged HIPAA violations.   Complaint ¶ 17, 43.  Horizon ultimately agreed by way of its consent judgment to a corrective action plan (“CAP”) and third-party audit – with $150,000 of the consent judgment as a “suspended penalty” that would be automatically vacated if the CAP was in material compliance two-years after entry of the judgment.

This costly Horizon incident provides several takeaways that never get old – encrypt all laptops and use an IT asset management plan that ensures the IT team can track all laptops with network access.   Most importantly, unlike Horizon never make any exceptions.  Complaint ¶ 23 (“As a result of the procurement of the MacBooks outside of Horizon BCBSNJ’s established process, certain MacBooks were not configured with approved encryption, data deletion and other software required by corporate policy.”).

OCR’s latest expensive HIPAA lessons

On January 18, 2017, the Office for Civil Rights (OCR) announced a HIPAA settlement based on the disclosure of unsecured electronic protected health information (ePHI) by MAPFRE Life Insurance Company of Puerto Rico (MAPFRE) stored in a USB storage device.    Simply put, a thumb drive stolen in 2011 from MAPFRE’s IT department cost it an astounding $2.2 million as a “resolution amount” in addition to a fairly onerous corrective action plan.

Apparently, the fact that MAPFRE is the U.S. subsidiary of a large “global multinational insurance company headquartered in Spain” played some role in the harsh fine.  The USB data storage device included complete names, dates of birth and Social Security numbers and impacted 2,209 individuals.   Given that MAPFRE’s lack of encryption was an adverse mitigating factor for OCR, covered entities should bite the bullet and continue to encrypt all devices touching ePHI no matter what the budget constraints.

Another recent HIPAA settlement allowed OCR to shine a light on something else of concern to HHS, namely the need to report breaches within the 60-day reporting window applicable to breaches impacting 500 or more patients.  On January 9, 2017, OCR issued a press release that says it all:  “First HIPAA enforcement action for lack of timely breach notification settles for $475,000”.  Rather than report within 60 days, Presence Health – a large health care network serving Illinois, took 104 days to report the loss of “paper-based operating room schedules, which contained the PHI of 836 individuals.”  A spokesman from Presence Health said in a statement that contact and financial information were not even compromised.

As done in the past when it came to the need for properly-worded business associate agreements, undergoing a comprehensive risk analysis, and cooperating in investigations, covered entities should be appreciate the examples made of MAPFRE and Presence Health – encrypt and timely report after a breach.

OCR focuses on HIPAA business associate agreements with $750,000 settlement

On April 20, 2016, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) announced that provider group Raleigh Orthopaedic Clinic, P.A. of North Carolina (“Raleigh Orthopaedic”) agreed to pay $750,000 to settle charges that it potentially violated the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Privacy Rule “by handing over protected health information (“PHI”) for approximately 17,300 patients to a potential business partner without first executing a business associate agreement.”

OCR initiated its investigation of Raleigh Orthopaedic following receipt of a “breach report” on April 30, 2013.  OCR’s investigation indicated that Raleigh Orthopaedic released x-ray films and related protected health information of 17,300 patients to an entity contracted to transfer the x-ray images to electronic media in exchange for harvesting the silver from the films.  Raleigh Orthopedic did not execute a business associate agreement with this entity prior to turning over the x-rays and PHI.

In addition to the $750,000 payment, Raleigh Orthopaedic ultimately agreed to revise its policies and procedures to: “establish a process for assessing whether entities are business associates; designate a responsible individual to ensure  business associate agreements are in place prior to disclosing PHI to a business associate; create a standard template business associate agreement; establish a standard process for maintaining documentation of a business associate agreements for at least six (6) years beyond the date of termination of a business associate relationship; and limit disclosures of PHI to any business associate to the minimum necessary to accomplish the purpose for which the business associate was hired.”

Raleigh Orthopaedic would have avoided a fine of $750,000, devoting time to a three-year investigation, and the stigma of a Corrective Action Plan if only someone on staff ensured that released PHI was subject to a properly worded business associate agreement. Given that HHS even offers model business associate agreement language there is really no excuse for any covered entity or business associate not to use this simply contractual safeguard — especially given that it is mandated.  Moreover, there really is no excuse for not having a standard process in place that documents the use and maintenance of business associate agreements — even the smallest of practice groups has an office manager who could implement this process.