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.

Author: Steve Alder has many years of experience as a journalist, and comes from a background in market research. He is a specialist on legal and regulatory affairs, and has several years of experience writing about HIPAA. Steve holds a B.Sc. from the University of Liverpool.