6 Steps to HIPAA Risk Assessment Success

Healthcare and life sciences entities, beware. With the increased digitization of medical records worldwide comes a surge in data breaches. Ransomware was the #1 cybersecurity threat in 2021 against the healthcare industry. Healthcare cyber attacks increased by 50% in 2020, and there is a 75.6% chance that at least five million records will be breached in the next 12 months. 

The cost: $408 per Protected Health Information (PHI) record, for a total of up to $7 billion in the US alone. That’s higher than the cost associated with data breaches in any other industry.

The numbers don’t lie, and the concern is real. Performing regular HIPAA risk assessments is key to keeping your PHI secure and compliant with relevant regulations. In this post, we’ll show you the steps to take to successfully perform HIPAA risk assessments and keep your PHI as safe as it can be.

What is a HIPAA risk assessment?

As defined by the HHS’ HIPAA Security Rule, companies that are directly subject to HIPAA regulations (otherwise known as “covered entities”) must apply appropriate administrative, physical, and technical safeguards to their electronic PHI (ePHI). 

Practically speaking, this rule mandates regular and thorough auditing of any potential risks, threats, or vulnerabilities that could violate the covered entity’s ePHI regarding integrity, accessibility, and confidentiality. 

Assessments are either handled internally or by third-party organizations. Internal HIPAA risk assessments are generally more affordable yet can be clouded by bias and, at times, ineffective. Conversely, third-party HIPAA risk assessments provide an added layer of unbiased validation by adding a set of eyes with no vested interest in the data at hand.

While no specific rules exist as to how a HIPAA risk assessment should be conducted, it does stipulate that healthcare and life sciences entities provide proof that the assessment has been completed. The goals are to understand your threat landscape, and establish appropriate safeguards to mitigate any risk and protect your ePHI effectively.

Who is subject to HIPAA risk assessment requirements?

The entities and organizations subject to HIPAA risk assessment requirements are as follows:

Covered Entities 

These are healthcare organizations that directly handle ePHI, such as hospitals, medical clinics, labs, pharma entities, healthcare professionals, insurance companies, and clearinghouses.

Business Associates

These are non-healthcare industry entities, such as third-party technology vendors, consultants, lawyers, and accountants, who have access and utilize ePHI for various purposes that are not necessarily directly related to medical treatment in the here-and-now.

All business associates and covered entities must perform and document thorough, end-to-end risk assessments for any PHI they create, collect, use, or hold onto, regardless of the volume of ePHI they handle.

Why Compliance with HIPAA Risk Assessment Regulation Is Critical

Compliance with HIPAA risk assessment regulations is important, first and foremost, because it is required. A failure to comply could lead to extremely hefty penalties. Fines are capped at $1.5 million per calendar year for a breach’s duration, and there’s even the possibility of jail time. 

Punitive action aside, compliance with HIPAA risk assessment is essential because it protects PHI confidentiality under HIPAA. It thereby allows ePHI to be safely accessed and utilized to provide patients with the best possible care, wherever they may be. The portability of ePHI is critical for persons moving from one place of work and insurance package to another. It’s also vital for people traveling or those shopping around for more affordable healthcare coverage. In all of these cases, covered entities and business associates need to have access to ePHI without compromising its integrity or putting it at risk of infiltration. 

6 Steps to HIPAA Risk Assessment Success

Successful HIPAA risk assessments share certain preparatory methods in common. Following the six steps outlined below can help your healthcare or life sciences organization maximally comply with prevalent regulations and keep your ePHI secure.

1. Refamiliarize yourself with HIPAA regulations

Go over the HIPAA Privacy, Security, and Breach Notification Rules to ensure you remember and understand exactly what is required. Rather than reading explanatory articles on the Rules, it’s recommended that you go to the original source documents. This will help you avoid any (potentially costly) misinterpretations and misunderstandings.

2. Assess your ePHI scope and access 

Next, determine the scope of your risk assessment in terms of current and potential risks to the access, integrity, and confidentiality of your ePHI. How is your ePHI currently secured? Are your documents encrypted? Do you have a document management solution that automates procedures for data archival and access? Who has access to them, and have provisions been made to protect against unauthorized access? This initial assessment should span all digital and physical media storage types, so you can better understand where risks may present.

3. Appraise your current security situation

Now that you know where your ePHI is stored within your organization, who can access it, and when, it’s time to document all organizational efforts to protect it. Note whether these measures are HIPAA compliant. Documentation should include all data storage locations, how the data was collected in the first place, and which strategies are in place to ensure the data’s safe transmission and storage over time. 

4. Identify cyber vulnerabilities and threats          

The information you’ve collected so far will help you further assess and pinpoint any gaps in your ePHI protection protocols, making your organization vulnerable to cyber threats and attacks. Once again, you must carefully document your findings. Any vulnerabilities or threats that are unique to your organization and its security environment should be listed so that they can be resolved before they are exploited.

5. Determine your HIPAA risk level

Assign risk levels to all of the vulnerabilities and threats identified to prioritize protection and resolution activities better. To do so, analyze the likelihood of each vulnerability or threat being exploited, and said exploitations’ effects on the organization. Once you’ve created a list of vulnerabilities and threats in order of risk severity, you can create and schedule a list of responses and control recommendations according to their urgency.

6. Finalize your documentation

Collate all of the insights you’ve gleaned from the HIPAA risk assessment process into a single, highly organized document. It will serve as a guideline for pressing reparative action, as well as protective and preventive measures your security teams should take. Your final document should clearly indicate the type(s) of ePHI you work with, existing vulnerabilities, and optimized data protection strategies that comply with HIPAA Rules.

HIPAA Risk Assessment and QMS

HIPAA compliance may seem tricky, but HIPAA risk assessments don’t have to be tedious and time-consuming. Using a QMS system offers organizations an efficient way to perform HIPAA-compliant internal risk assessments per NIST SP 800-30 risk analysis standards. It also allows for better, more efficient, and effective management of all regulatory data and documentation. 

With a QMS system in place, you can streamline data sharing with one core solution – from submission management and validation to product information and lifecycle management. Integration with document control and other system capabilities provides flexible, complete, and cost-effective risk assessment process automation.


Performing a HIPAA risk assessment may seem overwhelming at first, but following the six steps outlined above will help you successfully navigate the process. They will make it easier to identify and document your organization’s risk landscape in accordance with HIPAA Rules so that you can protect your ePHI. 

While many HIPAA tools on the market provide value in identifying weaknesses in your organization’s cybersecurity, a QMS solution can help provide comprehensive, tailored ePHI management that complies with HIPAA Rules.

Regulatory Compliance