Latest HIPAA News

HIPAA Enforcement Update Provided by OCR’s Iliana Peters

Posted by HIPAA Journal

Office for Civil Rights Senior Advisor for HIPAA Compliance and Enforcement, Iliana Peters, has given an update on OCR’s enforcement activities in a recent Health Care Compliance Association ‘Compliance Perspectives’ podcast.

OCR investigates all data breaches involving the exposure of theft of more than 500 healthcare records. OCR also investigates complaints about potential HIPAA violations. Those investigations continue to reveal similar non-compliance issues. Peters said many issues come up time and time again.

Peters confirmed that cases are chosen to move on to financial settlements when they involve particularly egregious HIPAA violations, but also when they relate to aspects of HIPAA Rules that are frequently violated. The settlements send a message to healthcare organizations about specific aspects of HIPAA Rules that must be addressed.

Peters said one of the most commonly encountered problems is the failure to conduct a comprehensive, organization-wide risk assessment and ensure any vulnerabilities identified are addressed through a HIPAA-compliant risk management process. Several recent settlements have highlighted just how frequently HIPAA covered entities get risk assessments wrong, either failing to conduct them at all, not conducting them frequently enough or conducting them to the standard demanded by HIPAA.

Peters pointed out that privacy violations are occurring frequently, with many HIPAA-covered entities still unsure of the allowable uses and disclosures of PHI. OCR recently announced two settlements have been reached with covered entities that have impermissibly disclosed patients’ health information to employers and the media.

Peters explained that the healthcare industry is not doing a good job at preventing cybersecurity incidents and that warrants attention, but it is important for OCR not to just focus on the hot topics and ‘sexy’ issues. OCR is also focussed on the lack of safeguards for paper records and the failure to secure removable media.

In the case of the latter, there have been numerous instances where ePHI has been exposed as a result of the failure to use encryption. Peters pointed out that if “[a device] can walk away from your enterprise, it will walk away.” OCR has settled cases with several organizations in recent months as a result of the lack of appropriate safeguards and policies and procedures covering removable devices.

Peters explained that OCR has been working on sharing penalties or other recoveries with individuals that have been harmed by privacy violations, although that has been a challenging process as it is difficult to determine and quantify harm. OCR is working on an advanced notice of proposed rulemaking and will be seeking advice from the public on how funds should be shared.

OCR is also working on initiatives to improve privacy protections at non-HIPAA covered entities. For instance, patients are being encouraged to share their health data with research organizations and through the “All of Us” initiative. For those programs to be as successful as they should be, patients need to be sure their data will be protected. OCR is providing advice to organizations and partners to ensure that patient data are protected, even if they are collected and stored by non-HIPAA-covered entities.

Peters also spoke of dealing with Certified EHR technology and how HIPAA applies to cloud computing, malware, and ransomware.

You can listen to the Compliance Perspectives podcast via this link.

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Impermissible Disclosure of HIV Status to Employer Results in $387,000 HIPAA Penalty

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The Department of Health and Human Services’ Office for Civil Rights (OCR) has announced a new HIPAA settlement to resolve violations of the HIPAA Privacy Rule.

St. Luke’s-Roosevelt Hospital Center Inc., has paid OCR $387,200 to resolve potential HIPAA violations discovered during an OCR investigation of a complaint about an impermissible disclosure of PHI.

In September 2014, OCR received a complaint about a potential privacy violation involving a patient of St. Luke’s Spencer Cox Center for Health. In the complaint, it was alleged that a member of St Luke’s staff violated the privacy of a patient by faxing protected health information to the individual’s employer.

The information in the fax was highly sensitive, including the patient’s sexual orientation, HIV status, sexually transmitted diseases, mental health diagnosis, details of physical abuse suffered, medical care and medications. Instead of faxing the information, the data should have been sent to a personal post box as requested.

The investigation revealed that the incident was not the only time that the HIPAA Privacy Rule had been violation in such a fashion. A similar incident occurred nine months previously when a patient’s PHI was sent via fax to an office where he volunteered.

The Privacy Rule violations in both cases were particularly serious due to the highly sensitive nature of information that was disclosed. In the resolution agreement, OCR said the impermissible disclosures were egregious.

HIPAA Rules require covered entities to safeguard patients’ protected health information at all times. However, the investigation revealed that St Luke’s had failed to do that on two occasions, violating 45 C.F.R. § 164.530(c)(2)(i). Further, after the first impermissible disclosure, St Luke’s failed to address vulnerabilities in their compliance program to prevent further impermissible disclosures from occurring. Had those vulnerabilities been addressed, the second privacy violation may have been avoided.

In addition to paying OCR $387,200, St Luke’s is required to adopt a corrective action plan. The CAP involves reviewing and updating policies and procedures covering allowable uses and disclosures of PHI and training staff members on policy and procedural updates.

OCR issued a press release announcing the HIPAA settlement in which OCR director Roger Severino said “Individuals cannot trust in a health care system that does not appropriately safeguard their most sensitive PHI,” explaining “Covered entities and business associates have the responsibility under HIPAA to both identify and actually implement these safeguards.” OCR consideration the nature of the breach and the extent of the harm caused when deciding an appropriate settlement amount.

May is not yet over, but already there have been nine HIPAA settlements between OCR and covered entities to resolve HIPAA violations discovered during the investigation of complaints and data breaches. At the current rate of almost two settlements a month, OCR will double last year’s record breaking number of HIPAA enforcement penalties. The increase in HIPAA penalties shows that OCR is taking a much harder line on covered entities that fail to comply with HIPAA Rules.

Two of the most recent penalties have resulted from complaints involving HIPAA violations relating to one or two patients. It is no longer just large scale data breaches that merit financial penalties. Any severe violation of HIPAA Rules can result in a HIPAA fine.

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Leading Cause of Healthcare Data Breaches in April was Hacking

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The monthly Breach Barometer Report from Protenus shows a significant reduction in the number of exposed healthcare records in April, with 232,060 records exposed compared to more than 1.5 million in March. The number of reported data breaches also fell from 39 to 34.

The report offers some further good news. The time taken by healthcare organizations to report security incidents also fell last month. 66% of breaches were reported within the 60-day time period allowed by the Health Insurance Portability and Accountability Act Breach Notification Rule. While it is good news that the trend for reporting data breaches more promptly is continuing, there is still plenty of room for improvement.

Protenus reports that in April, it took an average of 51 days from the date of the breach to discovery, and an average of 59 days from the discovery of a breach to the submission of a breach report to the HHS’ Office for Civil Rights.

The data for the Protenus Breach Barometer report was supplied by Databreaches.net, which uncovered one of the worst breaches of the year to date. The theft of psychotherapy notes, substance abuse histories, health histories and the personally identifiable information of 4,229 patients of Bangor Health Center in Maine. That incident was one of 16 hacking incidents reported in April.

Hacking/IT incidents were cited as the cause of 47% of data breaches reported in April, followed by insider incidents (29%), and loss and theft of devices/PHI (15%). The cause of 9% of the breaches is currently unknown.

Hacking was the cause of the largest data breach of the month. The incident, which was reported by Harrisburg Gastroenterology, affected 93,323 individuals.

Out of the 16 hacking/IT incidents reported in April, five were related to ransomware infections and three incidents were phishing attacks. There were five breaches due to insider errors and four incidents involving insider wrongdoing.

While the majority of data breaches involved electronic protected health information, healthcare organizations must ensure appropriate controls are in place to secure physical PHI. Five of the breaches reported in April involved the theft or exposure of physical PHI.

There were two business associate data breaches in April and two reported by health plans. The majority of the breaches (79.41%) were reported by healthcare providers.

Texas was the worst affected state with 4 breaches, followed by Michigan, Ohio and New York, each with three incidents.

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Healthcare Organizations Reminded of HIPAA Rules Relating to Ransomware

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Following the recent WannaCry ransomware attacks, the Department of Health and Human Services has been issuing cybersecurity alerts and warnings to healthcare organizations on the threat of attack and steps that can be taken to reduce risk.

The email alerts were sent soon after the news of the attacks on the UK’s NHS first started to emerge on Friday May 12, and continued over the course of the week. The alerts provided timely and pertinent information for U.S. healthcare organizations allowing them to take rapid action to counter the threat.

While the Office for Civil Rights has previously sent monthly emails to healthcare organizations warning of new threats in its cybersecurity newsletters, the recent alerts were sent much more rapidly and frequently, with four email alerts and conference calls made with industry stakeholders alerting them to the imminent threat.

Whether this was a one off in response to a specific and imminent major threat or the HHS plans to issue more timely alerts remains to be seen. However, the rapid communication of the ransomware threat almost certainly helped many healthcare organizations take prompt action to reduce risk.

Fortunately, attacks on organizations in the United States appear to have been limited, with the Department of Homeland Security saying fewer than 10 U.S. companies have reported being attacked.

In the email alerts, healthcare organizations were reminded of the need to implement data security measures to reduce the risk of malware and ransomware attacks. OCR also issued guidance on HIPAA specific to the threat from WannaCry ransomware.

OCR reiterated that a ransomware attack that involved the encryption of patients ePHI is presumed to be a HIPAA breach, reminding covered entities to report attacks within 60 days, as is required by the HIPAA Breach Notification Rule.

OCR also advised healthcare organizations that breach reports– and patient notifications – are required if data have been compromised that have not been encrypted by the entity to NIST specifications.

In the event of a breach, covered entities were told to contact their local FBI filed office, submit details of the incident to the FBI’s Internet Crime Complaint Center and report the incident to US-CERT. OCR also emphasized that reporting ransomware attacks to other federal organizations or law enforcement bodies does not constitute a HIPAA-compliant breach report. OCR must be notified of the incident separately.

Threat intelligence sharing can prevent other organizations suffering similar attacks and OCR encourages the sharing of cyber threat information. However, the HIPAA Privacy Rule does not permit the sharing of PHI. When cyber threat information is shared with federal agencies, law enforcement, or an Information Sharing and Analysis Organization (ISAO), covered entities must ensure that PHI is not shared. Doing so would be a HIPAA violation and could result in action being taken against the organization in question.

OCR also reminded organizations that compliance with the HIPAA Security Rule helps covered entities prepare for ransomware attacks and respond appropriately if systems are compromised and data are encrypted.

Further information on HIPAA and ransomware attacks can be found in an OCR factsheet available on this link.

Healthcare organizations were also reminded that they can request and unauthenticated scan of their public IP addresses from the Department of Homeland Security.

US-CERT’s National Cybersecurity Assessment & Technical Services (NCATS) provides an objective third-party perspective on an organizations cybersecurity posture and can conduct a broad assessment scanning for known vulnerabilities at no cost to stakeholders. The service allows healthcare organizations to be proactive and take steps to reduce risk prior to exploitation by malicious individuals.  Requests can be made by emailing NCATS on NCATS_INFO@hq.dhs.gov

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WannaCry Ransomware Encrypted Hospital Medical Devices

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The WannaCry ransomware attacks on NHS hospitals in the UK have been widely publicized, but the extent to which U.S. healthcare organizations were affected is unclear. However, news has emerged that WannaCry ransomware has been installed on hospital systems and succeeded in encrypted medical device data.

The ransomware targeted older Windows versions and more recent operating systems that had not been updated with the MS17-010 patch that addressed the exploited vulnerability in Server Message Block 1.0 (SMBv1). The attacks claimed more than 200,000 victims around the globe.

So far, two healthcare organizations in the United States have confirmed they experienced a WannaCry ransomware attack that affected Bayer MedRad devices. The devices are power injector systems used to monitor contrast agents administered to improve the quality of imaging scans, such as MRIs.

Bayer told Forbes, “If a hospital’s network is compromised, this may affect Bayer’s Windows-based devices connected to that network.” In both cases that were reported to Bayer, the issue was resolved within 24 hours and systems were brought back online.

Bayer is not the only device manufacturer that was affected by the ransomware attacks. According to HITRUST, reports were received from healthcare organisations that had Siemens devices encrypted by the ransomware. Siemens has not publicly confirmed that was the case with U.S hospitals, only that the company had been working with the NHS to help resolve the attacks.

HITRUST has been issuing updated information on the WannaCry ransomware attacks and confirmed that evidence has been uncovered suggesting other unnamed medical devices were impacted, in addition to Siemens and Bayer devices.

HITRUST also said indicators of compromise were confirmed via the HITRUST Enhanced IOC program well in advance of the attacks on Friday, pointing out that organizations that had already applied HITRUST CSF controls related to End Point protection and patch management would have appropriately addressed the threat – specifically Control References “09.j Controls Against Malicious Code” and “10.m Control of Technical Vulnerabilities.”

HITRUST also said organizations that leveraged the HITRUST CyberAid program have not been affected by the recent WannaCry ransomware attacks.

While the attacks using Friday’s WannaCry ransomware variant were halted after a researcher identified a kill switch, researcher Matt Suiche identified a second variant that referenced a different domain. He registered that domain and prevented attacks with the second variant, mostly in Russia.

Kaspersky Lab’s Costin Raiu said another version has been identified, with this one lacking the kill switch. While that version is spreading, it appears not to be capable of encrypting files as the ransomware component is corrupted.

What should be of particular concern, not just for healthcare organizations but all businesses, is a threat issued by Shadow Brokers – the group that released the ETERNALBLUE exploit used in Friday’s attacks. Shadow Brokers plans to release further exploits in a similar fashion on a monthly basis, including exploits for vulnerabilities in Windows 10.

Ransomware and other malware attacks on the same scale as WannaCry could become frequent events, highlighting the importance of updating software and applying patches promptly.

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WannaCrypt Ransomware Attacks Stopped, But Only Briefly

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The global WannaCrypt ransomware attacks that hit NHS Trusts in the UK hard on Friday have spread to the United States, affecting many U.S. organizations, including FedEx. Figures this morning indicate there were more than 200,000 successful attacks spread across 150 countries over the weekend.

Fortunately, the variant of the ransomware used in the weekend attacks has been neutralized. On Saturday afternoon, a blogger and security researcher in the UK identified a kill switch and was able to prevent the ransomware from claiming more victims.

While investigating the worm element of the ransomware campaign, the researcher ‘Malware Tech’ found a reference to a domain in the code. That domain had not been registered, so Malware Tech purchased and registered the domain. Doing so stopped the ransomware from encrypting files.

The ransomware performs a domain check prior to encrypting files. If the ransomware is able to connect with the domain in the code, the ransomware exists and does not encrypt any files. If the connection fails, the ransomware continues and starts encrypting files. The purpose of this check is believed to be an attempt to avoid analysis by security researchers.

The good news is that by registering the domain the ransomware attacks have been thwarted. The bad news is that while the version of the ransomware used in Friday’s attacks has been neutralized, a new version of the ransomware – without the kill switch – has reportedly been released already. Heimdal Security said a new version – a Uiwix strain – does not feature the kill switch.

Other security researchers have yet to confirm whether the new variant exists, but even if no new version has been released, it is only a matter of time before that happens.

WannaCrypt Ransomware Attacks Spread Like WildFire

The WannaCrypt ransomware attacks started in Europe with the NHS hit particularly hard. 61 NHS Trusts experienced ransomware infections, which spread rapidly through their networks encrypting all vulnerable devices. The attacks resulted in data being encrypted and computer and telephone systems being taken out of action. Hospitals were forced to cancel operations while IT teams worked around the clock to restore encrypted data. The NHS is still experiencing major disruptions to services.

The attacks took advantage of a vulnerability that was patched by Microsoft on March 13, 2017. Many organizations failed to install the update, even though the vulnerability was categorized as critical and an exploit for the vulnerability was released online last month.

Unfortunately for many organizations, the NHS included, the patch could not be applied to unsupported Windows versions such as Windows XP. Many hospitals still have computers running on the outdated Windows version, even though Microsoft stopped issuing patches on April 8, 2014. Many of the attacks affected older versions of Windows that could not be patched. Microsoft said in a recent blog post that the attacks were not performed on computers running Windows 10.

Microsoft Takes Unusual Step of Issuing a Patch for Unsupported Windows Versions

In response to the WannaCrypt ransomware attacks, Microsoft has taken a highly unusual step of issuing a patch for Windows XP, even though the operating system has not been supported for more than 3 years. The patch also addresses the vulnerability in Windows 8 and Windows Server 2003. Microsoft said in a blog post on the WannaCrypt ransomware attacks that “This decision was made based on an assessment of this situation, with the principle of protecting our customer ecosystem overall, firmly in mind.” Healthcare organizations should ensure the patch is applied promptly to prevent future attacks using the exploit.

Microsoft may have issued an emergency patch for unsupported Windows versions, although other vulnerabilities remain unpatched and could potentially be exploited. Any healthcare organization still using Windows XP or other unsupported software is therefore taking a big risk. Continued use of unsupported software is a recipe for disaster as well as a potential HIPAA violation.

Useful Links on the WannaCrypt Ransomware Attacks

US-CERT Ransomware Alert

FBI Indicators Associated With WannaCrypt Ransomware

HHS Update: International Cyber Threat to Healthcare Organizations

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Massive Ransomware Attack Hits NHS: Global Warning Issued as Attacks Spread

Posted by HIPAA Journal

The UK’s National Health Service (NHS) has experienced its worst ever ransomware attack, with the infection rapidly spreading to multiple NHS trusts taking computer systems out of action and forcing hospitals to cancel operations.

The attack occurred on Friday and affected as many as 40 hospital trusts, causing chaos. The NHS has been working around the clock to bring its computer systems back online and to recover encrypted data.

The massive ransomware attack involved Wanna Decryptor 2.0 ransomware or WannaCry/WanaCryptor as it is also known. There is no known decryptor.

The attackers were threatening to delete data if the ransom was not paid within 7 days, with the ransom amount set to double in three days if payment was not made. The ransom demand was reportedly $300 (£230) per infected machine. NHS Trusts saw the ransomware infection rapidly spread to all computers connected to their networks.

While the NHS was one of the early victims, the attack has spread globally with the Spanish telecoms company Telefonica also hit, along with FedEx, Universities in China, the German Rail operator and the Russian Interior Ministry. Infections are still spreading globally at an alarming pace.

Avast has reported there have been at least 57,000 worldwide infections in 100 countries. Infections are expected to grow over the next few days. This is already the largest ransomware attack in history, according to Mikki Hypponen of F-Secure.

The Department of Health and Human Services and the Department of Homeland Security have issued alerts about the threat, with the HHS saying yesterday there is evidence of the attack affecting U.S organizations.

Laura Wolf, Critical Infrastructure Lead at the HHS advised all healthcare organizations to “exercise cyber security best practices – particularly with respect to email.”

While the ransomware variant has been spread via spam email, the massive global attack is believed to have involved an exploit called ETERNALBLUE. The exploit was released by Shadow Brokers last month, after allegedly being stolen from the NSA. The exploit has been combined with a self-replicating payload that spreads without any user action required.

The exploit is for a vulnerability in Server Message Block 1.0 (SMBv1), which was patched by Microsoft in March, 2017 (MS17-010).

Any organization that has not yet installed the patch is advised to do IMMEDIATELY.

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PHI of Thousands of Patients of Bronx Lebanon Hospital Center Exposed Online

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Highly sensitive medical records of thousands of patients of New York’s Bronx Lebanon Hospital Center have been exposed online. Those records were reportedly accessible for three years as a result of a misconfigured backup server.

The exposed records were uncovered by researchers at the Kromtech Security Research Center after conducting a “regular security audit of exposed rsync protocols on Shodan,” a search engine that can be used to find networked devices. Rsync backup servers are used for transferring files between computer systems and for file syncing.

The records were not encrypted nor protected with a password and could have been downloaded by any individual who knew where to look.

It is currently unclear exactly how many patient records were exposed, with initial reports indicating tens of thousands of patients may have been affected. NBC’s Mary Emily O’Hara recently reported that the breach has impacted at least 7,000 individuals.

The misconfiguration allowed the researchers to view highly sensitive information including names, addresses, medical diagnoses, health histories and highly sensitive data including HIV statuses, reports of domestic violence, sexual assaults and addiction histories.

It was not initially clear to whom the data belonged, although the records were eventually traced to the Bronx Lebanon Hospital Center, with the backup device linked to iHealth Innovations, a Louisville, KY-based IT services and records management company.

In a recent blog post, MacKeeper researcher Bob Diachenko explained that efforts were made by Kromtech to contact the owners of the data, with assistance provided by Databreaches.net. In a statement provided to databreaches.net, Diachenko confirmed there has been no improper usage of the data by the Kromtech researchers.

While the majority of data appear to relate to patients of the Bronx Lebanon Hospital Center, it is unclear at this stage whether patients of other healthcare providers have also been affected.

iHealth has confirmed that a breach has occurred and the incident has been investigated. While the investigation is ongoing, iHealth says the investigation revealed that only one individual had accessed the data – the Kromtech researcher who discovered the error.

The server has now been reconfigured to prevent further access and the investigation is continuing, with a third-party cybersecurity company called in to validate iHealth’s analysis. The breach has been reported to law enforcement and Bronx Lebanon Hospital Center is assisting with the investigation.

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Guidance on Securing Wireless Infusion Pumps Issued by NIST

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The National Institute of Standards and Technology (NIST), in collaboration with the National Cybersecurity Center of Excellence (NCCoE), has released new guidance for healthcare delivery organizations on securing wireless infusion pumps to prevent unauthorized access.

Infusion pumps, and many other medical devices, used to interact only with the patient and healthcare provider; however, advances in technology have improved functionality and now the devices can interact with a much wider range of healthcare systems and networks.  The additional functionality of the devices has allowed vulnerabilities to be introduced that could be easily exploited to cause patients to come to harm.

Wireless infusion pumps are of particular concern. Vulnerabilities could be exploited by malicious actors allowing drug doses to be altered, the functioning of the infusion pumps to be changed or patients’ protected health information to be accessed.  Typically, the devices have poor cybersecurity protections in place to prevent unauthorized access.

The risks introduced by the devices have been widely reported in recent years. While no cyberattacks are known to have resulted in patients coming to harm, there is considerable potential for malicious actors to hack the devices unless action is taken to improve device security.

The 246-page guidance on securing wireless infusion pumps was written following collaboration with a wide range of security companies following a January 2016 request submitted in the federal register.

NIST and NCCoE conducted questionnaire-based risk assessments to analyze risk factors and signed a Cooperative Research and Development Agreement with B. Braun Medical Inc, Baxter Healthcare Corporation, Becton, Dickinson and Company, Cisco, Clearwater Compliance, DigiCert, Hospira Inc., Intercede, MDISS, PFP Cybersecurity, Ramparts, Smiths Medical, Symantec Corporation, TDi Technologies, Inc., and The MITRE Corporation, all of which helped to develop an example solution.

The guidance offers best practices that can be adopted to improve the security of wireless infusion pumps, mitigate vulnerabilities and protect against threats. The document includes a list of potential vulnerabilities and a questionnaire-based risk assessment that can be used by healthcare organizations to identify risks. The risk assessment maps security characteristics to HIPAA Security Rule requirements and available cybersecurity standards.

“Based on our risk assessment findings, we apply security controls to the pump’s ecosystem to create a ‘defense-in-depth’ solution for protecting infusion pumps and their surrounding systems against various risk factors,” explained NIST in the guidance.

Several commercially available technologies and tools are available to healthcare organizations that allow them to plug vulnerabilities and make it harder for unauthorized individuals to gain access to the devices, some of which have been detailed in the report along with product installation guides and suggested configurations.

NIST says, “Ultimately, we show how biomedical, networking, and cybersecurity engineers and IT professionals can securely configure and deploy wireless infusion pumps to reduce cybersecurity risk.”

The guidance on securing wireless infusion pumps (NIST Special Publication 1800-8) can be downloaded on this link.

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