Former OCR Advisor on HIPAA Compliance and Data Breaches: “This is a Management Problem, Not a User Problem” | Healthcare Informatics Magazine | Health IT | Information Technology Skip to content Skip to navigation

Former OCR Advisor on HIPAA Compliance and Data Breaches: “This is a Management Problem, Not a User Problem”

April 13, 2017
by Heather Landi
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The Department of Health and Human Services’ Office for Civil Rights (OCR) has stepped up its enforcement activities in recent years, and 2016 was a very busy year in Health Insurance Portability and Accountability Act (HIPAA) enforcement activity. In fact, last year saw unprecedented levels of enforcement actions, fines and aggregate HIPAA penalties being assessed. This past year also saw HHS OCR launch Phase 2 of its HIPAA Privacy, Security and Breach Notification Audit program.

According to Law360, in 2016, payments of $23 million were made to OCR to resolve potential noncompliance with HIPAA Security and Privacy rules, which represents a 300 percent increase over the previous annual record of $7.4 million in 2014. There were 13 enforcement actions in 2016, a significant increase over the previous annual record of seven actions. In August, as previously reported by Healthcare Informatics, OCR announced the largest settlement to date, as Advocate Health Care Network agreed to pay $5.55 million in a settlement with HHS stemming from data breaches affecting the protected health information (PHI) of 4 million people.

And, so far this year, the upswing in HIPAA enforcement activity has continued. In February, Hollywood, Fla.-based Memorial Healthcare Systems (MHS) agreed to pay HHS $5.5 million to settle potential HIPAA violations stemming from two health system employees inappropriately accessing patient information. Additionally, in February, OCR fined Children’s Medical Center of Dallas $3.2 million due to data breaches resulting from the losses of encrypted mobile devices that contained unsecured ePHI of about 6,260 individuals, as reported by Healthcare Informatics.

There is a distinction between a settlement and a civil money penalty. In the case of Children’s Medical Center of Dallas, the fine was the result of what OCR described as the hospital’s non-compliance “over many years with multiple standards of the HIPAA Security Rule.” Further, OCR officials stated that despite Children's knowledge about the risk of maintaining unencrypted ePHI on its devices as far back as 2007, Children's issued unencrypted BlackBerry devices to nurses and allowed its workforce members to continue using unencrypted laptops and other mobile devices until 2013.

To date, it is unclear what the new Trump administration’s priorities will be with regard to HIPAA enforcement, yet the enforcement activities in 2016 and so far in 2017 should serve as a wake-up call to healthcare organizations regarding the importance of safeguarding PHI. And beyond complying with HIPAA Security and Privacy rules to avoid OCR penalties, security best practices also can help mitigate the risk of data breaches. David Holtzman, vice president of compliance strategies at CynergisTek, an Austin, Texas-based cybersecurity consulting firm, notes that surveys of consumer attitudes have consistently shown that patients lose trust in healthcare organizations that have breaches. “A healthcare organization is only as good as the trust its patients put in it,” he says.

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David Holtzman

Holtzman previously served on the health information privacy team at the Department of Health and Human Services’ Office for Civil Rights (OCR/HHS), where he served as the senior advisor for health information technology and the HIPAA Security Rule. He recently spoke with Healthcare Informatics Associate Editor Heather Landi about HIPAA compliance issues, data security and why hospital executives need to sit up and take notice of OCR’s enforcement activity.

Last year, we saw record levels of enforcement actions from OCR. Why did we see a rise in enforcement action last year and will this continue?

I would actually pin this back to the middle of 2015 when we began to notice an uptick in the OCR’s enforcement activity, and quite frankly, to give credit where credit is due, then-OCR director Jocelyn Samuels made it a priority to engage in a more aggressive stance to resolving enforcement actions at OCR with formal enforcement. OCR has always had the authority to enforce the HIPAA privacy and security and now the breach notification rules. Prior to the passage of the HITECH Act (The Health Information Technology for Economic and Clinical Health Act), OCR was directed to attempt to resolve matters informally through voluntary compliance. And the HITECH Act, with its increase of penalties for HIPAA violations, also directed that the agency would be able to keep any fines or penalties collected for use for health information privacy enforcement or education, and also required the agency to levy a penalty when it found willful neglect.

There also has been an increase in cyber criminals targeting the healthcare industry. Is the rise in OCR enforcement activity correlated to that?

The answer is no. When you look at the enforcement actions that are being taken by OCR, they are resulting from mostly incidents involving breaches that, at their root cause, are largely due to failure to perform an information security risk analysis or failure to safeguard ePHI stored on portable and mobile devices, like encrypting laptops, or broader management indifference to putting in place safeguards after their information security risk analysis identifies areas needing attention.

Does OCR prefer to settle and educate when it finds compliance problems?

Every year, OCR receives tens of thousands of breach reports and consumer complaints alleging incidents that could be violations of the HIPAA rules. It is administratively convenient to attempt to resolve cases where there are indications that organizations have not fully complied with the privacy or security rules, when in fact, statistically, OCR resolves more than 9 out of 10 compliance reviews informally through the voluntary compliance of the organization. Generally, the OCR enforcement actions will take place when there is evidence of some unreasonable amount of neglect or management indifference to having reasonable and appropriate policies, procedures or safeguards for PHI.

What are the regulatory implications for hospitals associated with these kinds of data breach incidents?

There’s a distinction between those organizations that choose to seek a resolution agreement and a correction action plan with the OCR. The resolution agreement calls for paying a set fine which is usually a greatly reduced amount than what could have been sought as a civil money penalty. So long as they carry out the actions called for in the corrective action plan. And the terms of corrective action plans can vary, but generally involve OCR supervision from one to three years, during which time, the covered entity or business associate must take certain specified steps to implement policies and procedures as well as conduct thorough information security risk analysis and lower the risk to PHI as indicated by the risks analysis. When OCR levies a civil monetary penalty, that civil monetary penalty requires the covered entity or business associate to pay a fine, but does not carry any obligation for the organization to mitigate its compliance state. In seeking formal enforcement, the rules governing how OCR and other federal agencies can levy a penalty require developing evidence that meets a very high standard of proof.

What are some best practices that hospitals can leverage to avoid OCR penalties for noncompliance and to mitigate their risk of breach?

To reduce the risk of breach, and to reduce your organization being a target to malware or ransomware or cyber incidents, there is no substitute for thorough enterprise-wide information risk analysis and developing a risk management plan to mitigate or address the gaps identified through the risk analysis. The second and equally important activity is to train your staff and physicians to be familiar with your organizations policies for safeguarding PHI as well as the real threat posed by email communications that masquerade as legitimate messages and that may contain links to malware. The best way to combat this scourge is through a phishing exercise that identifies those who are enticed to open these communications and then educate these workforce members on how to avoid the threat.

What are some of the policies, procedures and technologies organizations should be using to safeguard PHI on mobile devices and laptops?

This is not a user problem, this is a management problem. These are management failures. Managers who are responsible for information systems and information security must make sure they take the basic steps to inventory those devices which are handling electronic protected health information and to ensure that they are not capable of sharing or storing or creating PHI unless they have the appropriate safeguards to either encrypt the data that is stored or transmitted through the device, or they are physically protected from unauthorized access and loss.

Last year, OCR launched a new initiative aimed at giving its regional offices increased investigatory and enforcement authority to investigate small breaches [a breach impacting fewer than 500 individuals]. How will this impact healthcare organizations?

OCR’s information systems were upgraded earlier in 2016 to better manage and provide useful data of breaches under 500 [individuals] reported to OCR. Prior to this upgrade, data from small breaches was not readily accessible or indexed in a way that made it useful for enforcement activity. With the enhancement to OCR’s program information management systems, reports of small breaches contain the same information and are retrievable in the same manner as large breaches. This allows the regional investigators the ability to identify and review breach reports filed by a covered entity or business associate of small breaches, allowing for identifying trends and repeated instances of incidents of the same or similar cause. In reality, an organization that has suffered a large breach can expect to undergo scrutiny for incidents of small breaches it had also reported.

Do you think with the rise in OCR enforcement activity it will get the attention of data security leaders at healthcare organizations?

OCR’s activity is forcing executives to stand up and take notice. Nothing gets the attention of the C-suite like a seven-figure penalty or fine that is levied against an organization that is doing things the same way they are. It’s good business to safeguard your most important assets, which are the information that you are creating or maintaining about your most important activity, which is your mission of care, and providing healthcare or providing services to healthcare organizations.


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Assessing the New Cybersecurity Practices Publication: Why Small and Medium-Sized Care Organizations Have Reason to Rejoice

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A new set of voluntary cybersecurity practices just released by HHS offers practical advice and conceptual supports that fill information gaps
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How helpful will the new set of voluntary cybersecurity practices that the Department of Health and Human Services (HHS) released in late December, be, to the leaders of patient care organizations? Only time will tell, as part of the value of the release will only be made manifest as the leaders of patient care organizations move forward to implement some of those practices, and the potential success of such implementations is in some way measured and benchmarked.

But the release is a first start, at least. As Healthcare Informatics Associate Editor Heather Landi reported on January 2, HHS released the set of practices in the form of a publication “that marks the culmination of a two-year effort that brought together over 150 cybersecurity and healthcare experts from industry and the government under the Healthcare and Public Health (HPH) Sector Critical Infrastructure Security and Resilience Public-Private Partnership.”

“Cybersecurity is everyone’s responsibility. It is the responsibility of every organization working in healthcare and public health.  In all of our efforts, we must recognize and leverage the value of partnerships among government and industry stakeholders to tackle the shared problems collaboratively,” Janet Vogel, HHS Acting Chief Information Security Officer (CISO), said in a statement published with the release of the new publication.

Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients (HICP), the primary publication of the Cybersecurity Act of 2015, Section 405(d) Task Group, aims to raise awareness, provide vetted cybersecurity practices, and move organizations towards consistency in mitigating the current most pertinent cybersecurity threats to the sector,” HHS officials stated. “It seeks to aid healthcare and public health organizations to develop meaningful cybersecurity objectives and outcomes. The publication includes a main document, two technical volumes, and resources and templates.”

The overall publication consists of several sections, the first being the HICP, which “examines cybersecurity threats and vulnerabilities that affect the healthcare industry. It explores five current threats and presents 10 practices to mitigate those threats; “Technical Volume 1: Cybersecurity Practices for Small Health Care Organizations,” which offers cybersecurity practices for small healthcare organizations; “Technical Volume 2: Cybersecurity Practices for Medium and Large Health Care Organizations”; the “Resources and Templates” portion, which “includes a variety of cybersecurity resources and templates for end users to reference”; and a Cybersecurity Practices Assessments Toolkit, which “helps organizations prioritize their cyber threats and develop their own action plans using the assessment methodology outlined in the Resources and Templates volume”—that last section being still under development as of Jan. 2.

As Landi reported, “The HICP publication aims to provide cybersecurity practices for this vast, diverse, and open sector to ultimately improve the security and safety of patients. The main document of the publication explores the five most relevant and current threats to the industry. It also recommends 10 cybersecurity practices to help mitigate these threats.”

What’s more, she wrote, “The main document presents real-life events and statistics that demonstrate the financial and patient care impacts of cyber incidents.  It also lays out a call to action for all industry stakeholders, from C-suite executives and healthcare practitioners to IT security professionals, that protective and preventive measures must be taken now. The publication also includes two technical volumes geared for IT and IT security professionals, one focusing on cybersecurity practices for small healthcare organizations, and one focused on practices for medium and large healthcare organizations.”

Among the salient statistics reported in the HICP:

  • Fifty-eight percent of malware attack victims are small businesses.
  • In 2017, cyber-attacks cost small and medium-sized businesses an average of $2.2 million.
  • Sixty of small businesses go out of business within six months of an attack.
  • And, 90 percent of small businesses do not use any data protection at all for company and customer information.

How does that translate into impacts on smaller healthcare organizations? Among other incidents, the HICP notes that:

  • A popular orthopedic practice announced that its computer system was hacked via breach of a software vendor’s log-in credentials. This breach put just under a half-million people at risk of identity theft. Of those, 500 patient profiles appeared for sale on the dark web. The information for sale included names, addresses, social security numbers, and other personally identifiable information (PII). Although not posted for sale, pertinent PHI such as X-ray results and medical diagnoses were also stolen.

 

  • A rural hospital had to replace its entire computer network after a ransomware cyber-attack froze the hospital’s electronic health record (EHR) system. Doctors were unable to review their patients’ medical histories or transmit laboratory and pharmacy orders. Officials were unable to restore essential services and could not pay the ransom for the return of their system. After consultations with the Federal Bureau of Investigation and cybersecurity experts, hospital officials made the difficult decision to replace the entire system.
  •  

Of particular practicality is some of the very basic advice given to the leaders of smaller healthcare organizations. To wit: “Doctors and nurses know that hand sanitizing is critical to prevent the spread of germs. That does not mean health care workers wash up as often as they should. Similarly, we know that cybersecurity practices reduce the risk of cyber-attacks and data breaches. Just as we are able to protect our patients from infection, we should all work towards protecting patient data to allow physicians and caregivers to trust the data and systems that enable quality health care. Just as health care professionals must wash their hands before caring for patients, health care organizations must practice good ‘cyber hygiene’ in today’s digital world, including it as a part of daily universal precautions,” the HICP notes. “Like the simple act of hand-washing, a culture of cyber-awareness does not have to be complicated or expensive for a small organization. It must simply be effective at enabling organization members to protect information that is critical to the organization’s patients and operations. Your organization’s vigilance against cyber-attacks will increase concurrently with your and your workforce’s knowledge of cybersecurity. This knowledge will enable you to advance to the next series of cybersecurity Practices, expanding your organization’s awareness of and ability to thwart cyber threats.”

Meanwhile, both smaller and larger patient care organizations will benefit from the technical supports, including a Security Risk Assessment Tool, a set of recommendations on medical devices and cybersecurity, and an incident response risk management handbook.

What this set of resources does is to fill a gap between theory and technical practice in a key area. Will it shift the entire landscape of cybersecurity for patient care organizations? No, that would be a far-too-ambitious goal. But the healthcare IT leaders of smaller and medium-sized patient care organizations in particular, will welcome practice advice and supports, as they move forward in their journeys around cybersecurity. Any such journey is inherently challenging, and federal publications and resources like these will be of real value in moving patient care organization HIT leaders forward.

 

 

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HHS Releases Voluntary Healthcare Cybersecurity Practices

January 2, 2019
by Heather Landi, Associate Editor
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In late December, the Department of Health and Human Services (HHS) released voluntary cybersecurity practices to the healthcare industry with the aim of providing practice guidelines to cost-effectively reduce cybersecurity risks.

The “Health Industry Cybersecurity Practices (HICP): Managing Threats and Protecting Patients” publication aims to provide guidance to healthcare organizations of all types and sizes, ranging from local clinics to large hospital systems.

The industry-led effort was in response to a mandate set forth by the Cybersecurity Act of 2015 Section 405(d), to develop practical cybersecurity guidelines to cost-effectively reduce cybersecurity risks for the healthcare industry.

According to HHS, the publication marks the culmination of a two-year effort that brought together over 150 cybersecurity and healthcare experts from industry and the government under the Healthcare and Public Health (HPH) Sector Critical Infrastructure Security and Resilience Public-Private Partnership.

“Cybersecurity is everyone’s responsibility. It is the responsibility of every organization working in healthcare and public health.  In all of our efforts, we must recognize and leverage the value of partnerships among government and industry stakeholders to tackle the shared problems collaboratively,” Janet Vogel, HHS Acting Chief Information Security Officer (CISO), said in a statement.

While technologies are vital to the healthcare industry and help provide life-saving treatments and improve patient care, these same technologies are vulnerable to myriad attacks from adversaries, ranging from criminals and hacktivists to nation-states, according to HHS. These technologies can be exploited to gain access to personal patient data or render entire hospital systems inoperable. Recent cyber-attacks against the nation’s healthcare industry continue to highlight the importance of ensuring these technologies are safe and secure.

“The healthcare industry is truly a varied digital ecosystem. We heard loud and clear through this process that providers need actionable and practical advice, tailored to their needs, to manage modern cyber threats. That is exactly what this resource delivers; recommendations stratified by the size of the organization, written for both the clinician as well as the IT subject matter expert,” Erik Decker, industry co-lead and Chief Information Security and Privacy Officer for the University of Chicago Medicine, said in a statement.

The HICP publication aims to provide cybersecurity practices for this vast, diverse, and open sector to ultimately improve the security and safety of patients. The main document of the publication explores the five most relevant and current threats to the industry. It also recommends 10 cybersecurity practices to help mitigate these threats.

The main document presents real-life events and statistics that demonstrate the financial and patient care impacts of cyber incidents.  It also lays out a call to action for all industry stakeholders, from C-suite executives and healthcare practitioners to IT security professionals, that protective and preventive measures must be taken now. The publication also includes two technical volumes geared for IT and IT security professionals, one focusing on cybersecurity practices for small healthcare organizations, and one focused on practices for medium and large healthcare organizations.

 

Related Insights For: Cybersecurity

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CynergisTek, Protenus Partner on Privacy Monitoring Programs

December 26, 2018
by Heather Landi, Associate Editor
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CynergisTek, Inc., an Austin, Texas-based healthcare cybersecurity firm, is partnering with Protenus, a healthcare compliance analytics company, to combine the companies’ technology tools and services with a focus on patient privacy monitoring programs.

The partnership will grant health systems access to Protenus’ analytics platform that leverages artificial intelligence to gather data related to potential patient privacy risks, along with CynergisTek’s patient privacy monitoring services.

According to the Protenus research, insider incidents accounted for 23 percent of all breaches that occurred at health systems in Q3 2018. This figure will only continue increasing, indicating that now more than ever, health systems need a cost-effective solution to meet the daily challenges of managing patient privacy.

To address this need, CynergisTek and Protenus formed a preferred partnership to combine CynergisTek’s healthcare consulting experience and privacy programs with Protenus’ healthcare analytics technology to offer health systems both the people, processes, and technology components of a strong patient privacy monitoring program, according to the companies.

“As health systems face mounting challenges in creating and maintaining robust patient privacy monitoring programs, we identified a need to partner with a company offering complementary services so that health systems can act on the insights uncovered by our analytics,” Nick Culbertson, CEO and co-founder of Protenus, said in a statement.

 “Data privacy is evolving as a dominate theme in conversations, both in healthcare and other industries, and health systems need to take an end-to-end approach to patient privacy to truly address this complex and mission-critical challenge,” Mac McMillan, CEO and president of CynergisTek, said in a statement.

 

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