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HHS OCR Issues Guidance on Ransomware Attacks and HIPAA Breaches

July 12, 2016
by Heather Landi
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Is a ransomware attack on a healthcare organization’s or business associate’s computer system a breach under the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule? If the electronic protected health information (ePHI) has been encrypted as a result of ransomware, then yes, according to newly released guidance from the U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR).

Unless the covered entity or business associate can demonstrate that there is a “...low probability that the PHI has been compromised,” based on the factors set forth in the Breach Notification Rule, a breach of PHI is presumed to have occurred, according to the HHS ransomware and HIPAA guidance. This means that a healthcare organization, or a business associate, that has been subjected to a ransomware attack “must comply with the applicable breach notification provisions, including notification to affected individuals without unreasonable delay, to the Secretary of HHS, and to the media (for breaches affecting over 500 individuals) in accordance with HIPAA breach notification requirements," the OCR guidance stated, citing federal regulations under 45 C.F.R. 164.400-414.

HHS OCR released the ransomware and HIPAA guidance at a time when healthcare organizations are increasingly faced with new cybersecurity threats. The guidance aims to provide healthcare organizations with information about ransomware attack prevention and recovery from a healthcare sector perspective, including the role HIPAA has in assisting HIPAA covered entities and business associates to prevent and recover from ransomware attacks, and how HIPAA breach notification processes should be managed in response to a ransomware attack.

According to HHS, a recent U.S. government interagency report indicates that, on average, there have been 4,000 daily ransomware attacks since early 2016 (a 300 percent increase over the 1,000 daily ransomware attacks reported in 2015). Ransomware exploits human and technical weaknesses to gain access to an organization’s technical infrastructure in order to deny the organization access to its own data by encrypting that data, HHS stated.

The guidance seems to be line with recent calls from the industry and legislators for HHS to develop guidance that recognizes the differences between ransomware and traditional data breaches under the HIPAA Privacy Rules. As previously reported by Healthcare Informatics, Representatives Ted Lieu (D-Los Angeles County) and Will Hurd (R-San Antonio) recently wrote a letter to Deven McGraw, Deputy Director of the Office of Civil Rights (OCR) under HHS calling on federal regulators to treat ransomware attacks as breaches under the Health Information Technology for Economic and Clinical Health (HITECH) Act and recommend guidance that “aggressively requires reporting of ransomware attacks to regulators.”

In the letter, Reps. Hurd and Lieu wrote, "If the provider or other party providing care would be either unable to care for the patient or unable to provide information critical to the care for the person, swift patient notification is paramount, but if the ransomware does not affect patient safety then patient notification may be unnecessary."

Specifically addressing the issue of whether or not the presence of ransomware constitutes a breach under the HIPAA rules, the HHS guidance states that it is a “fact-specific determination.” A breach under the HIPAA Rules is defined as “…the acquisition, access, use or disclosure of PHI in a manner not permitted under the [HIPAA Privacy Rule] which compromises the security or privacy of the PHI,” according to HHS, citing federal code 45 C.F.R. 164.402.

“When electronic protected health information (ePHI) is encrypted as the result of a ransomware attack, a breach has occurred because the ePHI encrypted by the ransomware was acquired (i.e., unauthorized individuals have taken possession or control of the information), and thus is a “disclosure” not permitted under the HIPAA Privacy Rule,” the HHS guidance stated.

As stated above, if a healthcare organization can demonstrate a “low probability” that the PHI has been compromised, then a breach notification is not required.

According to the HHS guidance, in order to demonstrate that there is a low probability that the PHI has been compromised because of a breach, healthcare organizations have to conduct a risk assessment considering at least four of the following factors:

  • The nature and extent of the PHI involved, including the types of identifiers and the likelihood of re-identification
  • The unauthorized person who used the PHI or to whom the disclosure was made
  • Whether the PHI was actually acquired or viewed
  • The extent to which the risk to the PHI has been mitigated

The agency also states that a thorough evaluation of the ransomware attack as a result of a security incident response could help reveal the exact type and variant of malware discovered, the algorithmic steps undertaken by the malware and whether or not the malware propagated to other systems, and this could help organizations with the risk assessment process.

And, HHS encourages organizations to also consider if there is a high risk of unavailability of the data, or high risk to the integrity of the data, as such additional factors may indicate compromise. “In those cases, entities must provide notification to individuals without unreasonable delay, particularly given that any delay may impact healthcare service and patient safety,” the HHS guidance stated.

In addition, HHS also recommends organizations consider the impact of the ransomware on the integrity of the patient data (PHI). The agency states that frequently ransomware, after encrypting the data it was seeking, deletes the original data and leaves only the data in encrypted form. “An entity may be able to show mitigation of the impact of a ransomware attack affecting the integrity of the PHI through the implementation of robust contingency plans including disaster recovery and data backup plans,” the HHS guidance stated.

“Test restorations should be periodically conducted to verify the integrity of backed up data and provide confidence in an organization’s data restoration capabilities,” HHS stated, also noting that organizations should consider whether or not PHI has been exfiltrated.

Regarding ePHI that was already encrypted by the organization to comply with HIPAA, the HHS guidance states that the HIPAA breach notification provisions apply to “unsecured PHI,” which is PHI that is not secured through the use of a technology or methodology. If the ePHI is encrypted by the healthcare organization in a manner consistent with the Guidance to Render Unsecured Protected Health Information Unusable, Unreadable, or Indecipherable to Unauthorized Individuals, then the organization is not required to conduct a risk assessment to determine if there is a low probability of compromise, and breach notification is not required, HHS stated.

However, the HHS guidance notes that even if the PHI is encrypted, additional analysis may still be required to ensure the encryption solution has rendered the affected PHI “unreadable, unusable and indecipherable to unauthorized persons.”

As an example, the HHS guidance cites a laptop encrypted with a full disk encryption solution in a manner consistent with HHS guidance that is properly shut down and powered off and then lost or stolen. The data on the laptop would be unreadable, unusable and indecipherable to anyone other than the authenticated user. “Because the PHI on the laptop is not “unsecured PHI”, a covered entity or business associate need not perform a risk assessment to determine a low probability of compromise or provide breach notification,” HHS stated.

In contrast, according to the guidance, if the laptop is powered on and in use by an authenticated user, who then performs an action (clicks on a link to a malicious website, opens an attachment from a phishing email, etc.) that infects the laptop with ransomware, there could be a breach of PHI. “If full disk encryption is the only encryption solution in use to protect the PHI and if the ransomware accesses the file containing the PHI, the file containing the PHI will be transparently decrypted by the full disk encryption solution and access permitted with the same access levels granted to the user,” the HHS guidance stated.

“Because the file containing the PHI was decrypted and thus ‘unsecured PHI’ at the point in time that the ransomware accessed the file, an impermissible disclosure of PHI was made and a breach is presumed. Under the HIPAA Breach Notification Rule, notification in accordance with 45 CFR 164.404 is required unless the entity can demonstrate a low probability of compromise of the PHI based on the four factor risk assessment,” the HHS guidance also stated.

 

 

 

 

 

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Florida Provider Pays $500K to Settle Potential HIPAA Violations

December 12, 2018
by Heather Landi, Associate Editor
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Florida-based Advanced Care Hospitalists PL (ACH) has agreed to pay $500,000 to the Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services (HHS) to settle potential HIPAA compliance failures, including sharing protected health information with an unknown vendor without a business associate agreement.

ACH provides contracted internal medicine physicians to hospitals and nursing homes in west central Florida. ACH provided services to more than 20,000 patients annually and employed between 39 and 46 individuals during the relevant timeframe, according to OCR officials.

Between November 2011 and June 2012, ACH engaged the services of an individual that claimed to be a representative of a company named Doctor’s First Choice Billings, Inc. (First Choice). The individual provided medical billing services to ACH using First Choice’s name and website, but allegedly without the knowledge or permission of First Choice’s owner, according to OCR officials in a press release published last week.

A local hospital contacted ACH on February 11, 2014 and notified the organization that patient information was viewable on the First Choice website, including names, dates of birth and social security numbers. In response, ACH was able to identify at least 400 affected individuals and asked First Choice to remove the protected health information from its website. ACH filed a breach notification report with OCR on April 11, 2014, stating that 400 individuals were affected; however, after further investigation, ACH filed a supplemental breach report stating that an additional 8,855 patients could have been affected.

According to OCR’s investigation, ACH never entered into a business associate agreement with the individual providing medical billing services to ACH, as required by the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules, and failed to adopt any policy requiring business associate agreements until April 2014. 

“Although ACH had been in operation since 2005, it had not conducted a risk analysis or implemented security measures or any other written HIPAA policies or procedures before 2014. The HIPAA Rules require entities to perform an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of an entity’s electronic protected health information,” OCR officials stated in a press release.

In a statement, OCR Director Roger Severino said, “This case is especially troubling because the practice allowed the names and social security numbers of thousands of its patients to be exposed on the internet after it failed to follow basic security requirements under HIPAA.”

In addition to the monetary settlement, ACH will undertake a robust corrective action plan that includes the adoption of business associate agreements, a complete enterprise-wide risk analysis, and comprehensive policies and procedures to comply with the HIPAA Rules. 

In a separate case announced this week, a Colorado-based hospital, Pagosa Springs Medical Center, will pay OCR $111,400 to settle potential HIPAA violations after the hospital failed to terminate a former employee’s access to electronic protected health information (PHI).

Pagosa Springs Medical Center (PSMC) is a critical access hospital, that at the time of OCR’s investigation, provided more than 17,000 hospital and clinic visits annually and employs more than 175 individuals.

The settlement resolves a complaint alleging that a former PSMC employee continued to have remote access to PSMC’s web-based scheduling calendar, which contained patients’ electronic protected health information (ePHI), after separation of employment, according to OCR.

OCR’s investigation revealed that PSMC impermissibly disclosed the ePHI of 557 individuals to its former employee and to the web-based scheduling calendar vendor without a HIPAA required business associate agreement in place. 

The hospital also agreed to adopt a substantial corrective action plan as part of the settlement, and, as part of that plan, PSMC has agreed to update its security management and business associate agreement, policies and procedures, and train its workforce members regarding the same.

“It’s common sense that former employees should immediately lose access to protected patient information upon their separation from employment,” Severino said in a statement. “This case underscores the need for covered entities to always be aware of who has access to their ePHI and who doesn’t.”

Covered entities that do not have or follow procedures to terminate information access privileges upon employee separation risk a HIPAA enforcement action. Covered entities must also evaluate relationships with vendors to ensure that business associate agreements are in place with all business associates before disclosing protected health information. 

 

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Eye Center in California Switches EHR Vendor Following Ransomware Incident

December 11, 2018
by Rajiv Leventhal, Managing Editor
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Redwood Eye Center, an ophthalmology practice in Vallejo, Calif., has notified more than 16,000 patients that its EHR (electronic health record) hosting vendor experienced a ransomware attack in September.

In the notification to the impacted patients, the center’s officials explained that the third-party vendor that hosts and stores Redwood’s electronic patient records, Illinois-based IT Lighthouse, experienced a data security incident which affected records pertaining to Redwood patients. Officials also said that IT Lighthouse hired a computer forensics company to help them after the ransomware attack, and Redwood worked with the vendor to restore access to our patient information.

Redwood’s investigation determined that the incident may have involved patient information, including patient names, addresses, dates of birth, health insurance information, and medical treatment information.

Notably, Redwood will be changing its EMR hosting vendor, according to its officials. Per the notice, “Redwood has taken affirmative steps to prevent a similar situation from arising in the future. These steps include changing medical records hosting vendors and enhancing the security of patient information.”

Ransomware attacks in the healthcare sector continue to be a problem, but at the same time, they have diminished substantially compared to the same time period last year, as cyber attackers move on to more profitable activities, such as cryptojacking, according to a recent report from cybersecurity firm Cryptonite.

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Report: 30 Percent of Healthcare Databases Exposed Online

December 10, 2018
by Heather Landi, Associate Editor
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Hackers are using the Dark Web to buy and sell personally identifiable information (PII) stolen from healthcare organizations, and exposed databases are a vulnerable attack surface for healthcare organizations, according to a new cybersecurity research report.

A research report from IntSights, “Chronic [Cyber] Pain: Exposed & Misconfigured Databases in the Healthcare Industry,” gives an account of how hackers are tracking down healthcare personally identifiable information (PII) data on the Dark Web and where in the attack surface healthcare organizations are most vulnerable.

The report explores a key area of the healthcare attack surface, which is often the easiest to avoid—exposed databases. It’s not only old or outdated databases that get breached, but also newly established platforms that are vulnerable due to misconfiguration and/or open access, the report authors note.

Healthcare organizations have been increasingly targeted by threat actors over the past few years and their most sought-after asset is their data. As healthcare organizations attempt to move data online and increase accessibility for authorized users, they’ve dramatically increased their attack surface, providing cybercriminals with new vectors to steal personally identifiable information (PII), according to the report. Yet, these organizations have not prioritized investments in cybersecurity tools or procedures.

Healthcare budgets are tight, the report authors note, and if there’s an opportunity to purchase a new MRI machine versus make a new IT or cybersecurity hire, the new MRI machine often wins out. Healthcare organizations need to carefully balance accessibility and protection.

In this report, cyber researchers set out to show that the healthcare industry as a whole is vulnerable, not due to a specific product or system, but due to lack of process, training and cybersecurity best practices. “While many other industries suffer from similar deficiencies, healthcare organizations are particularly at risk because of the sensitivity of PII and medical data,” the report states.

The researchers chose a couple of popular technologies for handling medical records, including known and widely used commercial databases, legacy services still in use today, and new sites or protocols that try to mitigate some of the vulnerabilities of past methods. The purpose of the research was to demonstrate that hackers can easily find access to sensitive data in each state: at rest, in transit or in use.

The researchers note that the tactics used were pretty simple: Google searches, reading technical documentation of the aforementioned technologies, subdomain enumeration, and some educated guessing about the combination of sites, systems and data. “All of the examples presented here were freely accessible, and required no intrusive methods to obtain. Simply knowing where to look (like the IP address, name or protocol of the service used) was often enough to access the data,” the report authors wrote.

The researchers spent 90 hours researching and evaluated 50 database. Among the findings outlined in the report, 15 databases were found exposed, so the researchers estimate about 30 percent of databases are exposed. The researchers found 1.5 million patient records exposed, at a rate of about 16,687 medical records discovered per hour.

The estimated black-market price per medical record is $1 per record. The researchers concluded that hackers can find a large number of records in just a few hours of work, and this data can be used to make money in a variety of ways. If a hacker can find records at a rate of 16,687 per hour and works 40 hours a week, that hacker can make an annual salary of $33 million, according to the researchers.

“It’s also important to note that PII and medical data is harder to make money with compared to other data, like credit card info. Cybercriminals tend to be lazy, and it’s much quicker to try using a stolen credit card to make a fraudulent purchase than to buy PII data and run a phishing or extortion campaign. This may lessen the value of PII data in the eyes of some cybercriminals; however, PII data has a longer shelf-life and can be used for more sophisticated and more successful campaigns,” IntSights security researcher and report author Ariel Ainhoren wrote.

The researchers used an example of hospital using a FTP server. “FTP is a very old and known way to share files across the Internet. It is also a scarcely protected protocol that has no encryption built in, and only asks you for a username and password combination, which can be brute forced or sniffed

by network scanners very easily,” Ainhoren wrote. “Here we found a hospital in the U.S. that has its FTP server exposed. FTP’s usually hold records and backup data, and are kept open to enable backup to a remote site. It could be a neglected backup procedure left open by IT that the hospital doesn’t even know exists.”

According to the report, hackers have three main motivations for targeting healthcare organizations and medical data:

  • State-Sponsored APTs Targeting Critical Infrastructure: APTs are more sophisticated and are usually more difficult to stop. They will attempt to infiltrate a network to test tools and techniques to set the stage for a larger, future attack, or to obtain information on a specific individual’s medical condition.
  • Attackers Seeking Personal Data: Attackers seeking personal data can use it in multiple ways. They can create and sell PII lists, they can blackmail individuals or organizations in exchange for the data, or they can use it as a basis for further fraud, like phishing, Smishing, or scam calls.
  • Attackers Taking Control of Medical Devices for Ransom: Attackers targeting vulnerable infrastructure won’t usually target healthcare databases, but will target medical IT equipment and infrastructure to spread malware that exploits specific vulnerabilities and demands a ransom to release the infected devices. Since medical devices tend to be updated infrequently (or not at all), this provides a relatively easy target for hackers to take control.

The report also offers a few general best practices for evaluating if a healthcare organization’s data is exposed and/or at risk:

  • Use Multi-Factor Authentication for Web Applications: If you’re using a system that only needs a username and password to login, you’re making it significantly easier to access. Make sure you have MFA setup to reduce unauthorized access.
  • Tighter Access Control to Resources: Limit the number of credentials to each party accessing the database. Additionally, limit specific parties’ access to only the information they need. This will minimize your chance of being exploited through a 3rd party, and if you are, will limit the damage of that breach.
  • Monitor for Big or Unusual Database Reads: These may be an indication that a hacker or unauthorized party is stealing information. It’s a good idea to setup limits on database reads and make sure requests for big database reads involve some sort of manual review or confirmation.
  • Limit Database Access to Specific IP Ranges: Mapping out the organizations that need access to your data is not an easy task. But it will give you tighter control on who’s accessing your data and enable you to track and identify anomalous activity. You can even tie specific credentials to specific IP ranges to further limit access and track strange behavior more closely.

 

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