- The first HIPAA risk assessment requirement is mentioned in the Security Rule: 45 CFR 164.308. This rule requires CE and BA to conduct an ‘accurate assessment of the potential vulnerabilities and risks to the integrity, confidentiality, and availability of PHI.’
- The second HIPAA risk assessment requirement is mentioned in the Breach Notification Rule 45 CFR 164.402. This rule is applied only when there is an impermissible use, access, acquisition, and disclosure of unsecured protected health information.
- The Office of Civil Rights was responsible for creating and releasing a downloadable Security Risk Assessment (SRA) tool that helps organizations identify vulnerabilities.
- To conduct a successful HIPAA risk assessment, an organization must identify where protected health information is maintained, stored, and transmitted.
- Penalties for violating HIPAA can go as high as $5.5 million and are charged with failing to determine risks to the ePHI.
HIPAA risk assessment is a foundational requirement for implementing the Security Rule. All Business Associates (BA) and Covered Entities (CE), including vendors and healthcare organizations, are mandated to perform the HIPAA risk assessment to protect ePHI (Protected Health Information) from potential threats.
The 2021 OCR (Office of Civil Rights) breach investigation report explained a need for entities to improve risk analysis, risk management, and audit control among others. A well-performed risk assessment assures entities and patients that healthcare data is protected from vulnerabilities. It maintains the privacy of ePHI and prevents it from falling into the hands of cybercriminals. Moreover, adhering to risk management and policies averts compliance violations, which can lead to penalties and criminal charges.
HIPAA Risk Assessment Requirements
Before conducting HIPAA risk assessment Covered Entities and Business Associates need to have the following requirements ready.
1. Adhering to Security Risk Analysis Requirements
The first requirement for carrying out HIPAA risk assessment is mentioned in the Security Rule: 45 CFR 164.308 – Security Management Process. This rule requires CE and BA to conduct an ‘accurate assessment of the potential vulnerabilities and risks to the integrity, confidentiality, and availability of PHI.’ Without a security risk analysis, the Business Associates and the Covered Entities can’t implement and develop effective procedures and policies to safeguard ePHI, from risks and vulnerabilities.
Apart from this, it is necessary to comply with all the eight standards of the Administrative Safeguards, only to fulfill all HIPAA risk assessment requirements of the 45 CFR 164.308. Another aspect to remember is that failure to assign a Security Officer, conduct awareness training, and build a backup plan are all HIPAA violations, even if there is no breach of ePHI.
2. Complying with the Breach Notification Rule
The Breach Notification Rule 45 CFR 164.402 mentions the second HIPAA risk assessment requirement. This rule is applied only when there is an impermissible use, access, acquisition, and disclosure of unsecured protected health information. Breach risk assessment is considered optional because the rule states that any impermissible disclosure is assumed to be a breach unless a low probability of compromise can be shown via risk assessment.
However, if Covered Entities and Business Associates were to skip this step, it may cause business disruptions and leave a negative impact on the users served by the organization, also there’s a bad compliance review by the OCR.
3. SRA Tool to Conduct Risk Assessment
Conducting a HIPAA risk analysis can be complex as it involves examining every aspect of an organization. It can produce complications and confusion for new and small medical practices with limited resources and those with no prior experience complying with HIPAA regulations. The Office of Civil Rights undertook the responsibility of creating and releasing a downloadable Security Risk Assessment (SRA) tool that can help small and medium-sized practices with HIPAA risk assessment.
The SRA tool helps organizations in identifying vulnerabilities, however as stated in the User Guide ‘the SRA tool doesn’t guarantee HIPAA compliance.’ Further, there are over 156 questions in the tool related to the availability, confidentiality, and integrity of PHI, but there are no suggestions on how to assign risk levels or how to impose policies.
To conduct a successful HIPAA risk assessment, an organization must identify where protected health information is maintained, stored, and transmitted. The scope of the HIPAA risk analysis takes into account all ePHI, stored on every electronic media such as hard drives, CDs, floppy disks, smart cards, and other storage devices. It also includes cloud storage.
Data can include ePHI and previous documents on a risk assessment that covers potential threats and vulnerabilities. Moreover, data also include policies and procedures adopted and updated by the Covered Entities to comply with the provisions of the Security Rule.
5. A HIPAA Risk Assessment Template
A risk assessment template acts as a reference point for Covered Entities and Business Associates for conducting a successful risk analysis. It entails the following aspects for conducting a risk assessment:
- Defining key terminologies of risk assessment such as threats, vulnerabilities, SRA tool, addressable and required specification implementation, etc.
- Scope of the risk analysis
- Ways to collect data for analysis
- Identifying plausible threats and vulnerabilities to organizations
- Impact of these vulnerabilities and threats
- Current security measures to tackle data breaches and cyber attacks
- Determining risk levels for healthcare data
- Documenting risk analysis and periodic reviews
- Process of reporting breaches to the OCR
Penalties for HIPAA Non-Compliance
Penalties for non-compliance with HIPAA regulations depend on the number of affected patients by ePHI breach and the level of negligence involved. Fines are also issued if an individual or an organization claims to have ‘no idea’ of HIPAA violation categories. There’s little excuse for not knowing a legal requirement.
A majority of the penalties are listed under the ‘Willful Neglect’ category, where the organizations ‘should have known’ or ‘knew’ their responsibilities in protecting the ePHI. Penalties for violating HIPAA can go as high as $5.5 million and are charged with failing to determine risks to the ePHI. Fines are also issued for data breaches, for not conducting risk assessments, and if there are gaps in security measures.
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