Author Archives: HIPAA Journal

CMS Investigating 75,000-Record Breach of Federally Facilitated Exchanges Direct Enrollment System

The Centers for Medicaid & Medicare Services (CMS) has discovered hackers have gained access to a health insurance system that interacts with the website and have accessed files containing the sensitive information of approximately 75,000 individuals.

On October 13, 2018, CMS staff discovered anomalous activity in the Federally Facilitated Exchanges system and the Direct enrollment pathway used by agents and brokers to sign their customers up for health insurance coverage. On October 16, the CMS confirmed there had been a data breach and a public announcement about the cyberattack was made on Friday October 19, 2018.

While the number of files accessed only represents a small fraction of the total number of consumer records stored in the system, it is still a sizable and serious data breach. The files contained information supplied by consumers when they apply for healthcare plans through agents and brokers, including names, telephone numbers, addresses, Social Security numbers, and income details.

While the CMS has confirmed that the files have been accessed by unauthorized individuals, it is currently unclear whether any files were actually stolen by the attackers.

The investigation into the cyberattack is ongoing and the CMS is currently working on implementing new security controls to prevent further attacks. The Direct Enrollment system has been temporarily taken offline to allow the security updates to be applied. The CMS expects the system to be offline for about a week. It will be back online for the upcoming enrollment period that commences on November 1.

“Our number one priority is the safety and security of the Americans we serve. We will continue to work around the clock to help those potentially impacted and ensure the protection of consumer information,” said CMS Administrator Seema Verma.

The CMS notes that the attack only affected the system used by agents and brokers. There has not been a breach of the website which is used by consumers to personally sign up for health insurance coverage. “I want to make clear to the public that and the Marketplace Call Center are still available,” said Verma.

The CMS will be sending notification letters to all individuals whose personal information has been exposed and will be providing further information on the steps they can take to prevent misuse of their data. The CMS will release further information about the breach as and when it becomes available.

The post CMS Investigating 75,000-Record Breach of Federally Facilitated Exchanges Direct Enrollment System appeared first on HIPAA Journal.

Webinar: Triaging Healthcare Emergency Preparedness Today

In September, more than 200 healthcare professionals responded to a HIPAA Journal request to participate in an Emergency Preparedness and Security in Healthcare survey by Rave Mobile Security.

The study identified the biggest safety concerns in healthcare, the most common types of emergencies experienced by healthcare providers over the past two years, and the methods used by healthcare providers to communicate with employees during those emergency situations.

Rave Mobile Security Chief Operating Officer, Todd Miller, will be discussing the key findings of the survey in a free webinar – Triaging Healthcare Emergency Preparedness Today – taking place on Thursday October 25 (2pm-3pm ET).

Click here to register for the webinar

The expert panel will feature:

Kevin McGinty, Safety & Emergency Management Coordinator, Middlesex Hospital

Kevin has over 10 years of experience in healthcare safety, environment of care, security and emergency management. At Middlesex Hospital, Kevin handles all aspects of safety and emergency management and is actively involved with all-hazards planning. He chairs life safety, hazardous materials and emergency management committees. Kevin has a bachelor’s degree in criminology. He is a member of the American College of Healthcare Executives and is active in the Connecticut Hospital Association. He has certifications as a healthcare environmental manager.

Patrick J. Turek, MPA, CEM, System Director of Emergency Management, Hartford HealthCare
Patrick has nine years of experience in emergency management. His mission at Hartford Healthcare is to create a more prepared, response-ready and resilient healthcare system to ensure the continuity of care for patients and to support its clinical and nonclinical team members during emergencies. He holds a Bachelor of Art in Criminology from Central Connecticut State University and a Master of Public Administration from the University of Connecticut. Patrick is a Certified Emergency Manager from the International Association of Emergency Managers.

Note: This is not a HIPAA Journal-sponsored event. HIPAA Journal has no commercial relationship with Rave Mobile Safety. HIPAA Journal is promoting industry events that might be of interest to readers. HIPAA Journal welcomes suggestions for further events that might be of interest to our readers.

The post Webinar: Triaging Healthcare Emergency Preparedness Today appeared first on HIPAA Journal.

Ransomware Attack Impacts 16,000 National Ambulatory Hernia Institute Patients

On September 13, 2018, the National Ambulatory Hernia Institute in California experienced a ransomware attack that resulted in certain files on its network being encrypted.

According to the breach notice uploaded to the healthcare provider’s website, the attackers were potentially able to gain access to demographic data of patients recorded prior to July 19, 2018.

In total, 15,974 patients have had some of their protected health information exposed as a result of the attack. The information potentially accessed by the attackers was limited to names, addresses, birth dates, diagnoses, appointment dates and times, and Social Security numbers. Patients who visited National Ambulatory Hernia Institute facilities for the first time after July 19, 2018 were unaffected by the breach.

Due to the sensitive nature of the exposed information, the National Ambulatory Hernia Institute has advised affected patients to obtain identity monitoring services for a period of at least one year. The breach notice does not state whether those services are being provided to patients free of charge.

The National Ambulatory Hernia Institute explained that all data have now been transferred to an off-site server and additional controls have been purchased and implemented to prevent further attacks, including a more robust firewall and antivirus software solutions. The investigation into the breach is ongoing.

The National Ambulatory Hernia Institute did not state what type of ransomware was used in the attack, only that “the attack was tied to an email address”

That email address has previously been associated with a variant of CrySiS/Dharma ransomware called gamma. Gamma ransomware ransoms are not fixed and are not stated on the ransom demands. Victims must email the attackers to find out how much it will cost for the keys to unlock files. No mention was made about whether the ransom demand was paid to regain access to data.

The post Ransomware Attack Impacts 16,000 National Ambulatory Hernia Institute Patients appeared first on HIPAA Journal.

FDA and DHS to Increase Collaboration and Better Coordinate Efforts to Improve Medical Device Cybersecurity

The U.S. Food and Drug Administration (FDA) and the Department of Homeland Security (DHS) have announced a memorandum of agreement to implement a new framework to increase collaboration and improve coordination of their efforts to increase medical device security.

The security of medical devices has long been a concern. Cybersecurity flaws in medical devices could potentially be exploited to cause patients harm, and with an increasing number of medical devices now connecting to healthcare networks, it is more important than ever to ensure adequate protections are in place to ensure patient safety and threats are rapidly identified, addressed and mitigated.

Medical devices are a potential weak point that could be exploited to gain access to healthcare networks and sensitive data, they could be used to gain a foothold to launch further cyberattacks that could prevent healthcare providers from providing care to patients. Vulnerabilities could also be exploited to deliberately cause harm to patients. While the latter is not believed to have occurred to date, it is a very real possibility.

Both the FDA and DHS are aware of the threat posed by medical devices and have working to strengthen cybersecurity. The two agencies have collaborated in the past on medical device cybersecurity and vulnerability disclosures, although the new agreement formalizes the relationship between the two agencies.

The FDA has been proactive in developing a robust program to address medical device cybersecurity concerns,” explained FDA Commissioner Scott Gottlieb, M.D. “But we also know that securing medical devices from cybersecurity threats cannot be achieved by one government agency alone.”

Under the new agreement, information sharing will be increased between the two federal agencies to improve understanding of new medical device security threats. When vulnerabilities are discovered, both departments will work closely together to assess the risk that the vulnerabilities pose to patient safety. The agencies will also coordinate the testing of the vulnerabilities.

By working more closely together, the two agencies will be able to eliminate duplication of activities and will be able to work more efficiently at identifying and mitigating threats. “Through this agreement, both agencies are renewing their commitment to working with not only each other, but also all stakeholders to create an environment of shared responsibility when it comes to coordinated vulnerability disclosure for identifying and addressing cybersecurity risks,” wrote the FDA.

DHS will remain as the central coordination center for medical device vulnerabilities through the National Cybersecurity and Communications Integration Center (NCCIC), which will continue to be responsible for coordinating information sharing between medical device manufacturers, security researchers and the FDA.

The FDA’s Center for Devices and Radiological Health will use its considerable technical and clinical expertise to assess the risk vulnerabilities pose to patient health and the potential for patients to come to harm from exploitation of vulnerabilities. This information will then be shared with DHS through regular, ad hoc, and emergency communication calls.

“Ensuring our ability to identify, address and mitigate vulnerabilities in medical devices is a top priority, which is why DHS depends on our important partnership with the FDA to collaborate and provide actionable information. This agreement is another important step in our collaboration,” said Christopher Krebs, Undersecretary for the National Protection and Programs Directorate at DHS.

The post FDA and DHS to Increase Collaboration and Better Coordinate Efforts to Improve Medical Device Cybersecurity appeared first on HIPAA Journal.

Webinar: TitanHQ and Datto Networking Discuss Enhanced Web Content Filtering

Earlier this year, spam and web filtering solution provider TitanHQ partnered with Datto Networking, the leading provider of MSP-delivered IT solutions to SMBs.

The new partnership has allowed Datto to enhance security on the Datto Networking Appliance with enterprise-grade web filtering technology supplied by TitanHQ.

The new web filtering functionality allows users of the appliance to carefully control the web content that can be accessed by employees and guests and provides superior protection against the full range of web-based threats.

TitanHQ and Datto Networking will be holding a webinar that will include an overview of the solution along with a deep dive into the new web filtering functionality.

Webinar Details:

Datto Networking & Titan HQ Deliver Enhanced Web Content Filtering

Date: Thursday, October 18th

Time: 11AM ET | 8AM PT | 4PM GMT/BST


John Tippett, VP, Datto Networking

Andy Katz, Network Solutions Engineer

Rocco Donnino, EVP of Strategic Alliances, TitanHQ

Click here to register for the webinar

The post Webinar: TitanHQ and Datto Networking Discuss Enhanced Web Content Filtering appeared first on HIPAA Journal.

The HIPAA Risk Analysis: Guidance and Tools for HIPAA Covered Entities and Business Associates

The HIPAA Risk analysis is a foundational element of HIPAA compliance, yet it is something that many healthcare organizations and business associates get wrong. That places them at risk of experiencing a costly data breach and a receiving a substantial financial penalty for noncompliance.

The HIPAA Risk Analysis

The administrative safeguards of the HIPAA Security Rule require all HIPAA-covered entities to “conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of electronic protected health information.” See 45 C.F.R. § 164.308(u)(1)(ii)(A).

The risk analysis is a foundational element of HIPAA compliance and is the first step that must be taken when implementing safeguards that comply with and meet the standards and implementation specifications of the HIPAA Security Rule.

If a risk analysis is not conducted or is only partially completed, risks are likely to remain and will therefore not be addresses through an organization’s risk management process – See § 164.308(u)(1)(ii)(B) – and will not be reduced to a reasonable and appropriate level to comply with the § 164.306 (a) Security standards: General Rules.

A HIPAA risk analysis is also necessary to determine whether it is reasonable and appropriate to use encryption or whether alternative safeguards will suffice – See 45 C.F.R. §§ 164.312(a)(2)(iv) and (e)(2)(ii).

A risk analysis should also be used to guide organizations on authentication requirements – See 45 C.F.R. § 164.312(c)(2) – and the methods that should be used to protect ePHI in transit – See 45 C.F.R. § 164.312(c)(2).

If risks are allowed to persist, they can potentially be exploited by hackers and other malicious actors resulting in impermissible disclosures of ePHI.

During investigations of data breaches, the Department of Health and Human Services’ Office for Civil Rights looks for HIPAA compliance failures that contributed to the cause of the breach. One of the most common violations discovered is a failure to conduct a comprehensive, organization-wide risk analysis. A high percentage of OCR resolution agreements cite a risk analysis failure as one of the primary reasons for a financial penalty.

Requirements of a HIPAA Risk Analysis

The HIPAA Security Rule states that a risk analysis is a required element of HIPAA compliance, but does not explain what the risk analysis should entail nor the method that should be used to conduct a risk analysis. That is because there is no single method of conducting a risk analysis that will be suitable for all organizations, nor are there any specific best practices that will ensure compliance with this element of the HIPAA Security Rule.

OCR has explained the requirements of a HIPAA risk analysis on the HHS website. HHS guidance on risk analysis requirements of the HIPAA Security Rule is also available as a downloadable PDF (36.1 KB), with further information available in the NIST Risk Management Guide for Information Technology Systems – Special Publication 800-30 (PDF – 480 KB).

A Security Risk Assessment Tool to Guide HIPAA-Covered Entities Through a HIPAA Risk Analysis

The risk analysis process can be a challenge. To make the process easier, the HHS’ Office of the National Coordinator for Health Information Technology (ONC), in collaboration with the Office for Civil Rights, has developed a downloadable security risk assessment tool that guides HIPAA-covered entities through the process of conducting a security risk assessment.

After downloading and installing the tool, healthcare organizations can enter information and a report will be generated that helps them determine risks in policies, processes and systems and details some of the methods that can be used to mitigate weaknesses when the user is performing a risk assessment.

On October 15, 2018, ONC updated the tool (version 3.0). The aim of the update was “to make it easier to use and apply more broadly to the risks of the confidentiality, integrity, and availability of health information. The tool diagrams HIPAA Security Rule safeguards and provides enhanced functionality to document how your organization implements safeguards to mitigate, or plans to mitigate, identified risks,” wrote ONC.

The new features include an updated and enhanced user interface, a modular workflow, custom assessment logic, a progress tracker, threat and vulnerability ratings, more detailed reports, assess tracking, business associate track, and several enhancements to improve the user experience.

Use of the tool will not guarantee compliance with HIPAA or other federal, state, or local laws, but it is incredibly useful tool for guiding HIPAA-covered entities and business associates through the process of conducting a HIPAA-compliant risk analysis.

The updated Security Risk Assessment Tool can be downloaded from the website on this link.

The post The HIPAA Risk Analysis: Guidance and Tools for HIPAA Covered Entities and Business Associates appeared first on HIPAA Journal.

FDA Issues Warning About Flaws in Medtronic Implantable Cardiac Device Programmers

The U.S. Food and Drug Administration (FDA) has issued a warning about vulnerabilities in certain Medtronic implantable cardiac device programmers which could potentially be exploited by hackers to change the functionality of the programmer during implantation or follow up visits. Approximately 34,000 vulnerable programmers are currently in use.

The programmers are used by physicians to obtain performance data, to check the status of the battery, and to reprogram the settings on Medtronic cardiac implantable electrophysiology devices (CIEDs) such as pacemakers, implantable defibrillators, cardiac resynchronization devices, and insertable cardiac monitors.

The flaws are present in Medtronic CareLink 2090 and CareLink Encore 29901 programmers, specifically how the devices connect with the Medtronic Software Distribution Network (SDN) over the internet. The connection is required to download software updates for the programmer and firmware updates for Medtronic CIEDs.

While a virtual private network (VPN) is used to establish a connection between the programmers and the Medtronic SDN, there is no check performed to establish whether the programmer is still connected to the VPN before software updates are downloaded. This would give hackers the opportunity to install their own updates and alter the functionality of the devices.

The flaws in the programmers were identified by security researchers Billy Rios and Jonathan Butts last year. Medtronic was notified about the flaws but has been slow to take action. An advisory was eventually issued in February 2018, but it has taken until now for action to be taken to correct the vulnerability.

Medtronic is now preventing the programmers from connecting to the SDA to receive software updates. Instead, future updates must be performed by Medtronic through a USB connection. Any attempt to update the device via the SDN will now trigger an “Unable to connect to local network” or “Unable to connect to Medtronic” error message.

The FDA reviewed the cybersecurity vulnerabilities and has confirmed that the flaws could be exploited to cause patients to come to harm. On October 5, 2018, the FDA approved the Medtronic network update that blocks the programmer from accessing the Medtronic SDN.

The FDA recommends that the programmers continue to be used for programming, testing and evaluation of CIED patients. The internet connection is not a requirement for normal operation.

Both the FDA and Medtronic have confirmed that no reports have been received to suggest that the vulnerabilities have been exploited and no patients are known to have come to harm.

The post FDA Issues Warning About Flaws in Medtronic Implantable Cardiac Device Programmers appeared first on HIPAA Journal.

$16 Million Anthem HIPAA Breach Settlement Takes OCR HIPAA Penalties Past $100 Million Mark

OCR has announced that an Anthem HIPAA breach settlement has been reached to resolve potential HIPAA violations discovered during the investigation of its colossal 2015 data breach that saw the records of 78.8 million of its members stolen by cybercriminals.

Anthem has agreed to pay OCR $16 million and will undertake a robust corrective action plan to address the compliance issues discovered by OCR during the investigation.

The previous largest ever HIPAA breach settlement was $5.55 million, which was agreed with Advocate Health Care in 2016. “The largest health data breach in U.S. history fully merits the largest HIPAA settlement in history,” said OCR Director Roger Severino.

Anthem Inc., an independent licensee of the Blue Cross and Blue Shield Association, is America’s second largest health insurer. In January 2015, Anthem discovered cybercriminals had breached its defenses and had gained access to its systems and members’ sensitive data. With assistance from cybersecurity firm Mandiant, Anthem determined this was an advanced persistent threat attack – a continuous and targeted cyberattack conducted with the sole purpose of silently stealing sensitive data.

The attackers first gained access to its IT systems on December 2, 2014, with access continuing until January 27, 2015. During that time the attackers stole the data of 78.8 million plan members, including names, addresses, dates of birth, medical identification numbers, employment information, email addresses, and Social Security numbers.

The attackers gained a foothold in its network through spear phishing emails sent to one of its subsidiaries. They were then able to move laterally through its network to gain access to plan members’ data.

Anthem reported the data breach to OCR on March 13, 2015; however, by that time OCR was already a month into a compliance review of Anthem Inc. OCR took prompt action after Anthem uploaded a breach notice to its website and media reports started to appear indicating the colossal scale of the breach.

The OCR investigation uncovered multiple potential violations of HIPAA Rules. Anthem chose to settle the HIPAA violation case with no admission of liability.

OCR’s alleged HIPAA violations were:

  • 45 C.F.R. § 164.308(u)(1)(ii)(A) – A failure to conduct a comprehensive, organization-wide risk analysis to identify potential risks to the confidentiality, integrity, and availability of ePHI.
  • 45 C.F.R. § 164.308(a)(1)(ii)(D) – The failure to implement regularly review records of information system activity.
  • 45 C.F.R. § 164.308 (a)(6)(ii) – Failures relating to the requirement to identify and respond to detections of a security incident leading to a breach.
  • 45 C.F.R. § 164.312(a) – The failure to implement sufficient technical policies and procedures for electronic information systems that maintain ePHI and to only allow authorized persons/software programs to access that ePHI.
  • 45 C.F.R. § 164.502(a) – The failure to prevent the unauthorized accessing of the ePHI of 78.8 million individuals that was maintained in its data warehouse.

“Unfortunately, Anthem failed to implement appropriate measures for detecting hackers who had gained access to their system to harvest passwords and steal people’s private information,” said Roger Severino. “We know that large health care entities are attractive targets for hackers, which is why they are expected to have strong password policies and to monitor and respond to security incidents in a timely fashion or risk enforcement by OCR.”

In addition to the OCR HIPAA settlement, Anthem has also paid damages to victims of the breach. Anthem chose to settle a class action lawsuit filed on behalf of 19.1 million customers whose sensitive information was stolen. Anthem agreed to settle the lawsuit of $115 million.

2018 OCR HIPAA Settlements and Civil Monetary Penalties

Given the size of the Anthem HIPAA settlement it is no surprise that 2018 has seen OCR smash its previous record for financial penalties for HIPAA violations. The latest settlement takes OCR HIPAA penalties past the $100 million mark.

There have not been as many HIPAA penalties in 2018 than 2016(13), although this year has seen $1.4 million more raised in penalties than the previous record year and there are still 10 weeks left of 2018. The total is likely to rise further still.

OCR Financial Penalties for HIPAA Violations (2008-2018)

Year Settlements and CMPs Total Fines
2018 1 $24,947,000
2017 1 $19,393,000
2016 2 $23,505,300
2015 3 $6,193,400
2014 5 $7,940,220
2013 5 $3,740,780
2012 6 $4,850,000
2011 6 $6,165,500
2010 13 $1,035,000
2009 10 $2,250,000
2008 7 $100,000
Total 59 $100,120,200


HIPAA Fines and CMPs

Largest Ever Penalties for HIPAA Violations

Year Covered Entity Amount Settlement/CMP
2018 Anthem Inc $16,000,000 Settlement
2016 Advocate Health Care Network $5,550,000 Settlement
2017 Memorial Healthcare System $5,500,000 Settlement
2014 New York and Presbyterian Hospital and Columbia University $4,800,000 Settlement
2018 University of Texas MD Anderson Cancer Center $4,34,8000 Civil Monetary Penalty
2011 Cignet Health of Prince George’s County $4,300,000 Civil Monetary Penalty
2016 Feinstein Institute for Medical Research $3,900,000 Settlement
2018 Fresenius Medical Care North America $3,500,000 Settlement
2015 Triple S Management Corporation $3,500,000 Settlement
2017 Children’s Medical Center of Dallas $3,200,000 Civil Monetary Penalty

The post $16 Million Anthem HIPAA Breach Settlement Takes OCR HIPAA Penalties Past $100 Million Mark appeared first on HIPAA Journal.

Most Common Healthcare Phishing Emails Identified

A new report by Cofense has revealed the most common healthcare phishing emails and which messages are most likely to attract a click.

The 2018 Cofense State of Phishing Defense Report provides insights into susceptibility, resiliency, and responses to phishing attacks, highlights how serious the threat from phishing has become, and how leading companies are managing risk.

The high cost of phishing has been highlighted this week with the announcement of a settlement between the HHS’ Office for Civil Rights and Anthem Inc. The $16 million settlement resolved violations of HIPAA Rules that led to Anthem’s 78.8 million record data breach of 2015. That cyberattack started with spear phishing emails. In addition to the considerable cost of breach remediation, Anthem also settled a class action lawsuit related to the breach for $115 million. Even an average sized breach now costs $3.86 million to resolve (Ponemon/IBM Security, 2018).

Previous Cofense research suggests that 91% of all data breaches start with a phishing email and research by Verizon suggests 92% of malware infections occur as a result of malicious emails. Cofense cites figures from Symantec’s 2018 Internet Security Threat Report which suggests that on average, 16 malicious email messages are delivered to every email user’s inbox every month.

Cofense is the leading global provider of human-driven phishing defense solutions, which are used by half of Fortune 500 companies to improve resiliency to phishing attacks. For its latest report, Cofense analyzed the responses to more than 135 million phishing simulations sent through its platform and approximately 50,000 real phishing threats reported by its customers.

Cofense notes that out of the potentially malicious emails reported by end users, one in ten were confirmed as malicious. Half of those messages were phishing emails designed to get end users to disclose credentials.

Across all 23 industry sectors that were represented in the study, 21% of reported crimeware emails contained malicious attachments. By far the most common theme for phishing emails were fake invoices, which accounted for six of the ten most effective phishing campaigns of 2018 to date.

While fake invoices are often used in phishing attacks on healthcare organizations, they are only the third most common type of phishing email (16.5%). In all other industry sectors, fake invoices were the most common phishing threat. The second most common healthcare phishing emails were alerts of new messages in a mailbox (25.5%). The most common healthcare phishing emails were fake payment notifications (58%).

Cofense data shows that the most effective methods for reducing risk from phishing are training and phishing simulations. Technical email security solutions are essential, but they do not block all malicious messages. Only through training and simulations can end users be conditioned to recognize and respond appropriately to malicious messages. The industries with the highest resiliency to phishing attacks are those that train more often.

Cofense suggests that to get the most out of phishing simulation exercises they should focus on active threats. Training is recommended at least every quarter to condition employees to look for and report phishing emails. Companies that encourage reporting of potential phishing threats rather than scolding employees for failing phishing tests tend to have greater success.

The full list of recommendations for security awareness training and phishing simulations can be found in the Cofense State of Phishing Defense Report, which is available on this link.

The post Most Common Healthcare Phishing Emails Identified appeared first on HIPAA Journal.