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HIPAA: Five Steps to Ensuring Your Risk Assessment Complies with OCR Guidelines

July 14, 2017
by Janice Ahlstrom, R.N., and Kenneth Zoline
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The Health Insurance Portability and Accountability Act of 1996 (HIPAA) and healthcare technology have changed significantly over the past 20 years. Covered entities and their business associates face an ever-evolving risk environment in which they must protect electronic protected health information (ePHI). Although healthcare security budgets may increase this year, the cost of implementing and maintaining adequate security controls to protect an entity’s ePHI far exceeds what is often budgeted. As a result, some ePHI may be under-protected and vulnerable to data breach. A long-term, consistent and cost-conscious approach to HIPAA compliance is needed.

Risk analysis: The foundation of an effective HIPAA compliance plan

Risk analysis is one of four required HIPAA implementation specifications that provide instructions to implement the Security Management Process standard. To further clarify risk analysis, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) released guidance on the risk analysis requirement in July 2010. The HIPAA Security Rule states that an organization must conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity and availability of ePHI held by the organization.

Janice Ahlstrom, R.N.


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Additionally, security risk analysis must be performed in order to comply and attest to Meaningful Use of electronic health records as required by the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009.

With the OCR increasing enforcement efforts with a second year of random audits for both covered entities and their business associates related to HIPAA compliance, risk analysis plays a critical role. Organizations need to comply with the HIPAA risk analysis requirement if they are to be fiscally responsible and avoid returning Meaningful Use Medicare and Medicaid payments, avoid OCR fines and avert the cost of breach notification efforts.

Kenneth Zoline

Risk analysis – Five steps to getting it right

Today, we find a range of compliance issues and tools used to conduct risk analysis when providing services. Often, HIPAA risk assessment reports do not meet the guidance defined by OCR or support complete review of the security rule controls. Checklists of policies and procedures, penetration test results and IT assessments barely scratch the surface of the data security safeguards. The wide variance in HIPAA risk analysis scope and reporting suggests that many organizations may not truly understand the HIPAA Security Rule and how to conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity and availability of ePHI held by the organization as defined by the OCR. The five steps below should put you on the right track to be compliant with OCR guidelines.

1. Evaluate your current HIPAA risk assessment

The following components should be included in your current risk assessment efforts:

  • Identification of assets that create, store, process or transmit ePHI and the criticality of the data
  • Identification of threats and vulnerabilities to ePHI assets, the likelihood of occurrence and the impact to the organization along with a risk rating
  • Evaluation and documentation of the administrative, physical and technical safeguards for the organization, by department where applicable, and for each application with ePHI
  • Evaluation and documentation of the security measures currently used to safeguard ePHI. Are the controls configured and used properly? What are the vulnerabilities?
  • Evaluation of HIPAA policies and procedures – are the documents dated, signed, reviewed periodically and available?

If all of the above items are not included in the scope of your risk assessment, the assessment may not be acceptable with an OCR audit.

2. Select the right HIPAA risk assessment tool

The OCR highlights two tools in its 2010 guidance that provide a framework for risk assessment:

Security Risk Assessment Tool (SRA) - developed by the Office of the National Coordinator for Healthcare Information Technology (ONC). The ONC’s SRA user guide walks users through 156 questions with resources to help understand the context of each question. It also allows users to factor in the likelihood and impact to ePHI in the organization. The tool functions on mobile devices as well. It can be downloaded from HealthIT.gov. The tool is geared towards smaller practices and while a good starting point, it does not take into consideration many of the complexities of larger organizations.

Risk Assessment Toolkit - developed by a team of Health Information Management Systems Society (HIMSS) professionals. The HIMSS Risk Assessment guide and data collection matrix contains a PDF user guide, Excel workbooks with NIST risk analysis references, application and hardware inventory workbooks, HIPAA Security Rule standards, implementation specifications and a defined safeguards workbook. The safeguards are numbered 1-92 and correspond to the Security Scorecard workbook.

The scorecard differentiates numbered safeguard components to be assessed for the organization, by department and within applications that contain ePHI. The HIMSS Risk Assessment toolkit is available at: http://www.himss.org/himss-security-risk-assessment-guidedata-collection-matrix. The tool includes NIST Special Publication 800-30 Revision 1 guidance for completing a risk assessment.

3. Determine the risk analysis frequency

One of the most prevalent challenges in complying with the HIPAA Security Rule’s risk analysis requirement is determining the frequency or triggering conditions for performing a risk analysis.

The HIPAA Security Rule and 2010 OCR risk analysis guidance state that risk analysis should be “ongoing” to document and update security measures as needed. The security rule states that continuous risk analysis should be completed to identify when updates are needed. OCR guidance notes that the frequency of performance will vary among covered entities.

Some covered entities may perform these processes annually or as needed (e.g., bi-annual or every three years) depending on circumstances of their environment. Typically, covered entities that are attesting to Meaningful Use and complying with the spirit of the security rule will conduct an annual HIPAA risk assessment.

4. Perform the risk assessment: insource or outsource

HIPAA does not specify who should perform the risk assessment. Some organizations insource, some outsource and some do both – alternating between insourcing and outsourcing. For example, an organization may hire external resources to conduct the HIPAA risk assessment every other year, and on the off year, the organization may choose to conduct it internally. Where practical, a separation of duties should exist between the HIPAA risk assessment team and the systems implementers and operations staff. Hiring an outside professional to conduct the risk analysis reduces risk by providing an impartial assessment from someone who was not involved in the implementation of your systems or the development of your policies, procedures and security controls.

5. Support cost savings without sacrificing risk assessment quality

How do you contain costs in performing a HIPAA risk analysis? Use an industry standard tool for assessment and stick with it. The industry standard tools also help to define a clear scope of effort. Often organizations can become disconcerted trying to conduct a self-assessment with a previous year’s report provided by an outside professional.

Final analysis: What could be missed, overlooked or found?

Healthcare organizations must implement strong data security safeguards. Doing so supports compliance with the HIPAA Security Rule, reduces risk and helps ensure the confidentiality, integrity and availability of the ePHI the organization creates, receives, maintains or transmits. Conducting internal risk analysis along with annual risk assessments that leverage a professional services provider every other year also reduces risk and maximizes the value of the resources engaged. Finally, leveraging an industry standard toolkit will help your organization be comfortable with conducting self-assessments on alternating years while saving time and money.



Janice Ahlstrom, R.N., director of risk, internal audit and cybersecurity, Baker Tilly janice.ahlstrom@bakertilly.com

Kenneth Zoline, manager of technology risk and cybersecurity, Baker Tilly kenneth.zoline@bakertilly.com

Baker Tilly is a Chicago-based advisory firm.


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Healthcare’s “RegTech” Opportunity: Avoiding a 2008-Style Crisis

September 21, 2018
by Robert Lord, Industry Voice, Co-Founder and President of Protenus
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In the financial crisis of 2007 to 2009, the financial industry suffered a crisis of trust. A decade later, banks and other financial institutions are still working to regain the confidence of consumers and regulators alike. In 2008 and 2009, while working at one of the world’s top hedge funds, I had a front-row seat to the damage that occurred to our economy, watching as storied corporate institutions fell or were gravely damaged. Today, as co-founder of a health technology company, I see healthcare is approaching a similarly dangerous situation. We must get ahead of the curve to avoid disaster.

Like finance, healthcare is a highly-regulated industry where non-compliance can result in severe financial and reputational consequences for healthcare companies, and severe impact on people’s lives. We deal with HIPAA, MACRA, HITECH, and hundreds of other foreboding acronyms on a daily basis. A lot of attention goes to the terrific and important work of clinical decision support, wellness apps, and other patient care technologies, but problems in the back office of hospitals must be addressed as well. One of these problems is the amount and complexity of healthcare regulation, and our healthcare system’s inability to keep up.

In finance, where I spent the early part of my career, the adoption of what is termed “RegTech” (regulatory technology) was driven by the increasing complexity of financial technology and infrastructure sophistication.  As trades moved faster, and as algorithms, processes and organizations became more complex, the technologies needed to ensure regulatory compliance had to move in tandem.  The crisis we experienced in 2008 was partially the result of the inability of the industry’s regulatory capabilities to keep up with the pace of technological change.  In many ways, the industry is still playing a catch-up game.

As healthcare professionals, looking to the lessons learned by our colleagues in finance can help us predict patterns and stay ahead of the curve. Right now, I’m seeing alarming parallels to challenges faced in finance a decade ago.


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Robert Lord

The burden of regulation across our industry is simply staggering.  Thirty-nine billion dollars of regulatory burden is associated with healthcare annually, which is about $1,200 per patient, per year. Despite this high cost, we still have $1 trillion of fraud, waste and abuse in our healthcare system. With so much regulation, why are we seeing so little yield from that burden? In many cases, it’s because we’re merely checking boxes and not addressing core risks؅. Like finance, there was a great deal of effort on compliance with regulations, but not enough attention on addressing important systemic risks.

This is not to say I am against good regulation; in fact, many regulations serve to protect patients and improve care. The problem is that there are so many demands on healthcare systems, that compliance and regulation is often reduced to checking boxes to ensure that minimum defensible processes are built, and occasionally spot-checking that things look reasonable. We currently have nowhere near 100 percent review of activities and transactions that are occurring in our health systems every day, though our patients deserve nothing less. However, unless overburdened and under-resourced healthcare providers and compliance professionals can achieve leverage and true risk reduction, we’ll never be able to sustainably bend our compliance cost curve.

Systemic problems are often not discovered until something goes horribly wrong (e.g., Wall Street every decade or so, the Anthem data breach, etc.). Today In the financial industry, RegTech provides continual, dynamic views of compliance or non-compliance and allows management, compliance professionals and regulators to check compliance in real-time. They can view every record, understand every detail, and automate investigations and processes that would otherwise go undetected or involve lengthy and labor-intensive reviews.

The real promise of these new capabilities is to allow compliance professionals and regulators to perform the truest form of their jobs, which is to keep patient data secure, ensuring the best treatment for patients, and creating sustainable financial models for healthcare delivery. RegTech will open up lines of communication and help create conversations that could never have been had before—conversations about what’s not just feasible for a person to do, but what’s right to do for the people whom regulation seeks to protect.

No longer bound by limited resources that lead to “box-checking,” compliance officers can use new and powerful tools to ensure that the data entrusted to them is protected. At the same time, healthcare management executives can be confident that the enterprises they manage will be well served by risk reducing technological innovation.  Patients, the ultimate beneficiaries of healthcare RegTech, deserve as much.

Robert Lord is the co-founder and president of Protenus, a compliance analytics platform that detects anomalous behavior in health systems.  He also serves as a Cybersecurity Policy Fellow at New America.


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HIPAA Settlements: Three Boston Hospitals Pay $1M in Fines for “Boston Trauma” Filming

September 20, 2018
by Heather Landi, Associate Editor
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Three Boston hospitals that allowed film crews to film an ABC documentary on premises have settled with the U.S. Department of Health and Human Services, Office for Civil Rights (OCR) over potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule.

According to OCR, the three hospitals—Boston Medical Center (BMC), Brigham and Women’s Hospital (BWH) and Massachusetts General Hospital (MGH)—compromised the privacy of patients’ protected health information (PHI) by inviting film crews on premises to film "Save My Life: Boston Trauma," an ABC television network documentary series, without first obtaining authorization from patients.

OCR reached separate settlements with the three hospitals, and, collectively, the three entities paid OCR $999,000 to settle potential HIPAA violations due to the unauthorized disclosure of patients’ PHI.

“Patients in hospitals expect to encounter doctors and nurses when getting treatment, not film crews recording them at their most private and vulnerable moments,” Roger Severino, OCR director, said in a statement. “Hospitals must get authorization from patients before allowing strangers to have access to patients and their medical information.”

Of the total fines, BMC paid OCR $100,000, BWH paid $384,000, and MGH paid $515,000. Each entity will provide workforce training as part of a corrective action plan that will include OCR’s guidance on disclosures to film and media, according to OCR. Boston Medical Center's resolution agreement can be accessed here; Brigham and Women’s Hospital's resolution agreement can be found here; and Massachusetts General Hospital's agreement can be found here.

This is actually the second time a hospital has been fined by OCR as the result of allowing a film crew on premise to film a TV series, with the first HIPAA fine also involving the filming of an ABC medical documentary television series. As reported by Healthcare Informatics, In April 2016, New York Presbyterian Hospital (NYP) agreed to pay $2.2 million to settle potential HIPAA violations in association with the filming of “NY Med.”

According to OCR announcement about the settlement with NYP, the hospital, based in Manhattan, violated HIPAA rules for the “egregious disclosure of two patients’ PHI to film crews and staff during the filming of 'NY Med,' an ABC television series.” OCR also stated the NYP did not first obtain authorization from the patients. “In particular, OCR found that NYP allowed the ABC crew to film someone who was dying and another person in significant distress, even after a medical professional urged the crew to stop.”

The OCR director at the time, Jocelyn Samuels, said in a statement, “This case sends an important message that OCR will not permit covered entities to compromise their patients’ privacy by allowing news or television crews to film the patients without their authorization. We take seriously all complaints filed by individuals, and will seek the necessary remedies to ensure that patients’ privacy is fully protected.” 

OCR’s guidance on disclosures to film and media can be found here.

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Independence Blue Cross Notifies 17K Patients of Breach

September 19, 2018
by Rajiv Leventhal, Managing Editor
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The Philadelphia-based health insurer Independence Blue Cross is notifying about 17,000 of its members that some of their protected health information (PHI) has been exposed online and has potentially been accessed by unauthorized individuals.

According to an article in HIPAA Journal, Independence Blue Cross said that its privacy office was informed about the exposed information on July 19 and then immediately launched an investigation.

The insurer said that an employee had uploaded a file containing plan members’ protected health information to a public-facing website on April 23. The file remained accessible until July 20 when it was removed from the website.

According to the report, the information contained in the file was limited, and no financial information or Social Security numbers were exposed. Affected plan members only had their name, diagnosis codes, provider information, date of birth, and information used for processing claims exposed, HIPAA Journal reported.

The investigators were not able to determine whether any unauthorized individuals accessed the file during the time it was on the website, and no reports have been received to date to suggest any protected health information has been misused.

A statement from the health insurer noted that the breach affects certain Independence Blue Cross members and members of its subsidiaries AmeriHealth HMO and AmeriHealth Insurance Co. of New Jersey. Fewer than 1 percent of total plan members were affected by the breach.

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