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Study: 30 Percent of Patient Data Breaches Involve Business Associates

September 21, 2016
by Heather Landi
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So far in 2016, third-party data breaches have impacted 4.5 million patients, indicating that third-party business associates pose an alarming risk to patient data, according to a new report from Protenus and DataBreaches.net.

Breaches involving business associates or vendors accounted for a disproportionate amount of affected patients and breached records for the first eight months of 2016, with 30 percent of breaches and 35 percent of breached records reported to the U.S. Department of Health and Human Services’ (HHS) public breach portal are a direct result of third parties, according to the report.

In fact, the report authors contend that based on data form HHS, the 193 breach incidents that occurred through August 2016 impacted 12,801,481 patients. Based on an analysis by Protenus and DataBreaches.net, there were at least 4.5 million patients affected by a breach involving a third party vendor or business associate, for a mean of 79,008 patients or records per incident. The mean number of records per incident for the 135 incidents that did not involve third parties was 62,004.

“It appears, then, that breaches originating with third parties were associated with 27 percent more affected patients per incident than originating at providers or health plans,” the report authors wrote.

The study authors note community physicians, affiliates, and certain vendors often have extensive access to patient data in the electronic health record (EHR). And, the increased number of users with EHR access creates a huge vulnerability for healthcare systems and a headache for compliance teams. While vendors are often long-time trusted partners, relationships that add a large number of new EHR users or provide vendor employees with access to patient data create significant patient privacy monitoring challenges.

The Health Insurance Portability and Accountability Act (HIPAA) Omnibus Rule requires all covered entities have Business Associate Agreements (BAAs) in place by September 22, 2014 to govern and regulate how electronic protected health information (ePHI) flows between covered entity and the business associate and spells out what business associates need to do to comply with HIPAA requirements. However, many business associates operate without BAAs in place.

In the past year, HHS’s Office of Civil Rights (OCR) has penalized healthcare organizations and their vendor partners with large fines for potential HIPAA privacy violations. Oregon Health and Science University agreed to a $2.7 million settlement and OCR alleges it found that OHSU stored over 3,000 individuals’ ePHI in a cloud computing system without any BAA with the cloud computing vendor.

Catholic Health Care Services, a business associate providing management and information technology services to six skilled nursing facilities, agreed to pay $650,000 as part of a settlement for potential violations stemming from a data breach due to the theft of a mobile device.

Advocate Health Care Network will pay $5.55 million to settle charges stemming from multiple breaches, one of which involved a hacking incident at its business associate. HHS OCR charged Advocate Health with failing to obtain written business associate contracts.

According to the report, DataBreaches.net examined the rate and impact of third-party breaches in 2016 and conducted a month-to-month recap which indicated that 60 breach incidents were attributable to third parties. According to the report authors, third-party vendor breaches are more frequent than HHS’s breach portal tool suggests. A close reading of HHS’s closing notes for incidents makes clear that BAs and vendors are involved in more incidents than the tool reports, the report authors note.

“It appears that when covered entities report incidents, they often do not recognize that there is a way to indicate that a business associate had been responsible for the breach. There is an  option labeled, ‘Are you a Covered Entity filing on behalf of a Business  Associate?’ but some entities think, ‘I’m not filing on their behalf,’ so they  don’t pick that option,” the report authors wrote.

“If HHS/OCR wants entities to take business associate security seriously, it would help if the public breach tool yielded a more accurate estimate of what percent of breaches and records were a result of business associates or third parties,” the report authors stated.

An examination of third-party incidents indicates that insider and external incidents appeared equal in terms of frequency, however, this might not tell the whole story in terms of impact or risk of harm. For instance, a hacking incident involving vendor Bizmatics earlier this year, which was previously reported by Healthcare Informatics, affected multiple healthcare providers and so far it appears that those incidents affected up to 150,000 patients, most it’s likely even more patients were impacted.

In order to protect patient information, the report authors assert that healthcare institutions and their partners to focus on, and invest in, collaborative, on-going, and continuous processes that will protect the institution’s data over time.

The report outlines a number of recommendations to reduce business associate risk. For healthcare organizations, a top priority is to ensure up-to-date BAAs are in place. “Have a process to both standardize and regularly review this process, as these documents form the legal core of your BA management program,” the report authors wrote.

Healthcare organizations also need to retain and update human resources data to understand individual users and their roles within the system. And, healthcare organizations need to effectively manage the identities of individuals with access to EHR systems, whether an employee or a BA.

Additionally, healthcare organizations need to implement a proactive security posture rather than a reactive one, such as deploying a privacy analytics platform to identify and resolve privacy violations quickly and efficiently.

The report also recommends healthcare organizations take steps to understand the risks associated with subcontractors to business associates or vendors by asking to review the sBAAs (Subcontractor Business Associate Agreements) with BAs that have access to an extensive amount of the organization’s data.

The report authors also recommend that HHS amend its breach portal to more accurately reflect the prevalence and scope of third-party breaches. “In the interim, we encourage covered entities to require greater physical and technical safeguards for PHI held by third parties and to audit compliance with those requirements throughout the year,” the report authors wrote.

 

 

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Targeting Third Party Risk: Leading CISOs Detail Efforts to Secure the Healthcare Supply Chain

December 18, 2018
by Heather Landi, Associate Editor
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Healthcare information security leaders are faced with the dauting challenge of securing information systems and data at a time when the cyber threat landscape is evolving rapidly and becomingly increasingly complex.

Most patient care organizations’ supply chains are filled with third parties who support the care delivery process and require access to patient information. Properly vetting and monitoring these third parties is a major challenge, and in some cases, insurmountable for many organizations who simply don’t have the expertise or resources, according to healthcare IT security leaders.

Many healthcare chief information security officers (CISOs) have found that effectively assessing the security posture up and down the supply chain is expensive given the complexity of the risks posed by privacy and security concerns, as well as an everchanging regulatory landscape. Currently, the process of managing third-party risk is often inefficient and time-consuming, for both vendors and providers, while still leaving organizations vulnerable to security threats.

During a recent webinar, sponsored by HITRUST, focused on healthcare cybersecurity and managing third party risk, John Houston, vice president, privacy and information security at the 40-hospital UPMC health system in Pittsburgh, outlined a number of factors that have made third-party risk management increasingly challenging and complex.

“There has been a fundamental change in IT, and a rapid move to the cloud. At the same time, we all see an increasingly complex cyber threat landscape where the threats are more sophisticated, and the technology solutions are more sophisticated as our business requirements are changing. It’s an increasingly complex landscape,” Houston said.

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He further noted, “As a result, there is a lot of confusion about how we best ensure our information is secure and available, and what is reasonable in terms of trying to achieve that. And finally, we are all worried about risk, and the biggest risk is patient safety. We worry about the cost of litigation and penalties, but first and foremost, we need to think about ensuring that we are able to deliver the best care to our patients.”

The stakes are changing, Houston noted, as federal regulators are investigating and penalizing organizations for failure to monitor third parties’ security practices, and hackers are increasingly targeting medical devices, he said.

“From a CISO perspective, we need to ensure that we are applying proper oversight over all of this. We can’t assume third parties are doing the right thing,” he said.

What’s more, healthcare organizations are increasingly reliant on cloud technology. A year ago, Nuance Communications, a provider of voice and language tools, was knocked offline when the company was hit with the Petya ransomware virus.

“I was around during Y2K, and about 95 percent of all our applications at UPMC, we ran within the data center, on premise. About 95 percent of newly acquired applications were run on on-premise, there was little on the cloud. In that environment, it falls upon the entity to secure data within its possession,” he said.

Contrast that with today’s environment, as Houston noted that “very little of what we acquire today runs on-premise. In some way, shape or form, at least one copy of the data is in the cloud.”

Studies have estimated that by 2023 no more than 25 percent of applications will be run on-premise in an organization’s data center, with about 75 percent run in the cloud, Houston said. “Many copies of our data end up in the cloud, and it’s not just one cloud provider. We get services from a lot of different vendors, all of which are in the cloud. That speaks to the fact we, as CISOs, can no longer directly secure our own information. We are dependent upon third parties to secure our data for us. We can’t simply trust that they are going to adequately secure that information.”

From a healthcare CISO’s perspective, a vendor’s IT and data security practices should be at least as effective as the provider’s security posture, Houston said. “I should expect nothing less. As soon as I expect less, that’s a sign of defeat.”

Across the healthcare industry, ineffective security, compliance and assurance methods drive cost and confusion within organizations and across third parties, according to IT leaders.

While most healthcare organizations are taking the right steps to monitor and screen vendors and their products and services during the pre-selection and on-boarding phases and are also conducting security risk assessments, it’s still not enough to protect IT systems, data, and, most importantly, patients, said Taylor Lehmann, CISO at Wellforce, the Burlington, Mass.-based health system that includes Tufts Medical Center and Floating Hospital for Children. “We are still seeing breaches, and the breaches are still coming after we do all this screening,” he said.

“We’re not being effective and it’s difficult to be effective with the current paradigm,” Houston added.

From the CISO’s perspective, there are inefficiencies in the third-party supply chain ecosystem. Suppliers are commonly required by their customers to respond to unique questionnaires or other assessment requests relating to their risk management posture. Vendors often must fill out questionnaires with 300-plus questions. What’s more, there’s no assurance or audit of the information the vendor provides, and the process is completely inefficient for suppliers who are audited 100 times annually on the same topics, but just different questions, Lehmann and Houston noted. What's more, the security assessment often occurs too late in the process.

“We’re creating a lot of waste; we’re taking time away from our organizations and we’re taking time away from suppliers,” Lehmann said. “The current way we’re doing supply chain risk management, it doesn’t work, and it doesn’t scale, and there is an opportunity to improve.”

To address these issues, a group of CISOs from a number of healthcare organizations established the Provider Third Party Risk Management (TPRM) Initiative to develop a standardized method to assess the risk management posture of third-party suppliers to healthcare firms. Launched this past August, the founding member organizations for the Provider TPRM Council include Allegheny Health Network, Cleveland Clinic, University of Rochester Medical Center, UPMC, Vanderbilt University Medical Center and Wellforce/Tufts University. Working with HITRUST and PwC, the Council aims to bring uniformity and consistency to the process while also reducing the burden on providers and third parties.

The healthcare industry, as a whole, will benefit from a common set of information security requirements with a standardized assessment and reporting process, Lehmann noted.

In the past four months, the governing members have been expanded to include Nuance, The Mayo Clinic, Multicare, Indiana University Health, Children’s Health Dallas, Phoenix Children’s Hospital, and Banner Health.

The Provider TPRM initiative is increasing membership and gaining momentum as security leaders from both healthcare providers and their suppliers embrace the unified approach, Lehmann said.

One of the goals for the Council is to address the inefficiencies found in the third-party supply chain ecosystem. By reducing the multiple audits and questionnaires, the financial savings will allow business partners to invest in substantive risk reduction efforts and not redundant assessments, the Council leaders say.

“By reducing wasted effort and duplication, suppliers will find their products and services will be acquired more quickly by healthcare providers. This will also reduce the complexity of contracts and provide third parties with better visibility regarding the requirements to do business with providers,” said Omar Khawaja, VP and CISO of Allegheny Health Network and Highmark Health. Khawaja’s organization is a founding participant and governing member of the Provider TPRM initiative.

As part of this initiative, going forward, provider organizations that join the effort will require third-party vendors to become HITRUST CSF Certified within the next two years, by September 2020. The HITRUST CSF Certification will serve as the standard for third parties providing services where they require access to patient or sensitive information and be accepted by all the Council’s organizations. HITRUST CSF is an industry privacy and security framework that is continuously evolving with the changing cyber landscape.

 “After September 1, 2020, third parties without certification cannot do business with participants,” Khawaja said.

Houston added, “We recognize that there are limitations in our current processes, and what we’re putting in place is at least as good or better than what we’re already doing. This will lead to faster onboarding, less waste, better transparency, and simpler compliance.”

By choosing to adopt a single comprehensive assessment and certification program, healthcare organizations represented by the council are prioritizing the safety, care, and privacy of their patients by providing clarity and adopting best practices that their vendors can also adopt, while providing vendors the expectation of what it takes to do business with their organizations.

“It provides transparency,” Houston said “It sends a message to suppliers that we’re an open book about what it takes to do business. That’s powerful.”

Moving forward, the Provider TPRM initiative will focus on adding business associates to the effort to increase membership and impact, Lehmann said. “The simple fact is, many of us are pushing this through our supply chain and there are organizations that may not have a process or low maturity process. But, through the efforts of council members, more suppliers will show up, which is means safer products are possible to purchase.”

Further, the program will likely develop additional requirements on vendors such as breach response and monitoring security threats and alerts observed as third-party vendors.

The Council also plans to focus on certification programs for smaller vendors. “A lot of innovation in healthcare is coming from smaller companies, and we understand there is a gap between what those companies can do with respect to cyber. We’re not lowering our standards, but we want to be thoughtful and create a certification program for those areas. We want to do business and we need a vehicle to bring them in in a safe and secure way,” Lehmann said.

“We want to build a community of health providers working together, business associates working together, to share information,” Lehmann said. “We want to better inform ourselves and align other programs, like cyber insurance, to enable more effective planning throughout the supply chain. The things we learn through these relationships can translate to other aspects of our organizations.”


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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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