HIPAA compliance should be embedded in the DNA of any healthcare organization or business storing or processing PHI. But it’s tricky to manage, and even if organizations are 99.9% sure they’re fully compliant, there’s always that tiny room for doubt – and it’s starting to take its toll.
Healthcare organizations are still among the most targeted and heavily fined industries for data breaches. In fact, in 2024, the average cost of a healthcare data breach was $9.77 million, maintaining the sector’s position as the most expensive industry for data breaches for the 14th consecutive year. The year also witnessed the largest healthcare data breach in U.S. history when UnitedHealth’s technology unit, Change Healthcare, was hacked, affecting the personal information of 100 million people. Jaw-dropping, right? And yet another reminder why healthcare security can’t be taken lightly.
So, how are Covered Entities (CEs) and Business Associates (BAs) keeping up with complex HIPAA laws and regulations, and how can they ensure they’re always on course? Cue: Automation; revolutionizing healthcare compliance – and we’re not sorry about it.
What is HIPAA compliance and why does it matter?
HIPAA compliance is a federal law that applies to all organizations that handle or process Protected Health Information (PHI).
The Privacy Rule – one of HIPAA’s core rules – dictates how organizations must legally collect, store, handle, and dispose of PHI. This rule also defines the two types of organizations subject to it and, therefore, legally obligated to comply with HIPAA: Covered Entities (CEs) and Business Associates (BAs).
For these two types of organizations, HIPAA establishes a national standard for safeguarding and managing PHI. It requires the implementation of specific policies, controls, risk management practices, and security protocols to meet this standard.
HIPAA compliance is not just about meeting regulatory requirements – it refers to an organization’s ability to abide by the federal law and whether or not they are taking all necessary steps to foster a culture of security compliance and trust across both internal and external processes. Failing to do so is a criminal offense and can result in harsh fines or even criminal charges.
The Breach Notification Rule and the Security Rule are two additional critical components, designed to ensure patients’ sensitive data remains private and secure. Let’s break it down real quick.
What is the Breach Notification Rule?
This rule requires covered entities and their business associates to provide notification following a breach of unsecured PHI. A breach is an impermissible use or disclosure under the Privacy Rule that compromises the security or privacy of PHI. Key aspects include:
- Notification Obligation: In case of a breach, entities must notify affected individuals, the Secretary of Health and Human Services (HHS), and, in certain cases, the media.
- Timeliness of Notification: Notifications must be provided without unreasonable delay and no later than 60 days following the discovery of a breach.
- Content of the Notification: The notification must include a description of the breach, the types of information involved, steps individuals should take to protect themselves, what the entity is doing to investigate and mitigate the breach, and contact information.
What is the Security Rule?
This rule specifies a series of administrative, physical, and technical safeguards for covered entities to ensure the confidentiality, integrity, and security of electronic PHI (e-PHI). It includes:
- Administrative Safeguards: Policies and procedures designed to clearly show how the entity will comply with the act, covering areas like training, emergency response, and access control.
- Physical Safeguards: Controlling physical access to protect against inappropriate access to protected data, such as facility access controls, workstation use, and device and media controls.
- Technical Safeguards: This involves technology and the policy and procedures for its use that protect e-PHI and controls access to it. It includes access control, audit controls, integrity controls, and transmission security.
Together, these rules form a part of the broader HIPAA regulations designed to protect sensitive patient health information from being disclosed without the patient’s consent or knowledge.
💡 If you’re still wrapping your head around compliance and what it means for your business, here’s everything you need to know about HIPAA and whether or not your organization is subject to compulsory compliance.
GET COMPLIANT 90% FASTER WITH AUTOMATION
What is healthcare compliance software?
The importance of compliance can’t be overstressed – and neither can the sheer workload it creates. In addition to the vast amount of work that goes into staying compliant, its effectiveness depends entirely on the capacity and capabilities of an organization’s workforce.
This highlights some of the most critical and persistent challenges of HIPAA compliance:
- Manual efforts fall short in the face of modern cybersecurity threats.
- Accuracy and efficiency rarely align when paired with a full schedule and consistent workflows.
- The risk of human error transcends all industries, policies, and processes.
- Collating vast amounts of data is time-consuming, and organizations can’t obtain data, analyze processes, train staff, conduct risk assessments, and implement changes at once. By the time these tasks are completed, the organization may have already been non-compliant – and at risk – for an extended period.
Staying HIPAA compliant demands non-stop attention, precision, and an ongoing investment in cybersecurity resources. Unfortunately, manual compliance methods are no match for today’s advanced cybersecurity threats. Manual data entry, audits, evidence collection, and risk assessments are time-consuming, error-prone, and often too slow to address real-time risks.
This is where automated compliance for healthcare comes in – the real hero in achieving HIPAA compliance. HIPAA compliance automation dramatically improves accuracy, saves time, and ensures consistent application of policies across every layer of your operations.
Automated HIPAA compliance tools explained
Automated HIPAA compliance tools continuously monitor your environment, collect evidence, and identify compliance gaps in real-time, ensuring you’re always compliant. Instead of playing catch-up, healthcare organizations can proactively manage their compliance posture and focus more on delivering quality patient care.
By investing in HIPAA compliance automation, organizations significantly reduce audit preparation time, improve risk detection, streamline operations, and strengthen defenses against costly violations. It’s important to note that while automation greatly reduces the risk of human error and simplifies complex processes, it shouldn’t fully replace human oversight. The most effective strategies combine automated tools with expert guidance for well-rounded compliance and GRC management.
These tools tackle healthcare’s toughest compliance challenges – streamlining processes, collecting evidence, minimizing errors, tailoring controls, and delivering real-time risk insights.
🎯 Compliance, checkmate.
Powered by some of the most advanced tech, automated solutions continuously track compliance activities and aligns them with HIPAA’s regulatory standards. The result? Bulletproof policies and procedures that help organizations reach continuous compliance up to 90% faster.
Why healthcare organizations are turning to HIPAA compliance automation
HIPAA compliance is a battle best faced head-on – but what if it didn’t have to be a battle at all?
Here are the key benefits of how data automation helps healthcare organizations (and all those that need to be HIPAA compliant) stay HIPAA compliant and dodge breaches and fines:
Improved workflow and patient safety culture
For those in the healthcare industry, chaos is no stranger, and employees are praised for their ability to think on their feet and make time-sensitive decisions. Naturally, when it comes to making quick but critical decisions, the admin and processes behind them are time and resources that could be better spent elsewhere.
Through data compliance automation, healthcare professionals can refocus the time spent on manual processes (that are more susceptible to error), redirect it towards their other responsibilities, and ensure a consistent patient safety culture, despite their day-to-day responsibilities.
Decreased risk of fines and violations
As HIPAA is a federal law, the fines and penalties that come from violations or data breaches are brutal. Through automating compliance, organizations mitigate the risk of human error, as well as non-consistent compliance, and therefore ensure that they have implemented the correct controls and policies to prove due diligence. Although breaches still occur (even in HIPAA-compliant organizations), proving compliance during the event of a breach and following the correct breach notification protocol significantly decreases and potentially nullifies any penalties or financial consequences.
Real-time compliance tracking
You’re either 100% compliant or not at all. Compliance is contingent on the sustainability and consistency of everyday processes. Therefore, ensuring compliance requires an intentional and proactive approach to ensure no gaps or potential threats.
Through automation, healthcare organizations can ensure compliance through real-time reporting and analytics and be alerted immediately on any instances of non-compliance. The average data breach takes roughly 194 days to identify and 64 days to contain. That’s about 258 days too long.
Automation ensures that when there is a violation or potential risk of a breach, you can intercede immediately and take the necessary precautions before it’s a major breach.
More efficient self-audits
As there is no official and independent audit that confirms if an organization is HIPAA compliant, organizations are left with the responsibility of determining whether they are HIPAA compliant or not themselves. How? Through HIPAA self-assessments.
Naturally, this is the most critical step, as it’s the ultimate indicator of HIPAA compliance. The Office for Civil Rights (OCR) only conducts official audits and investigations in case of a suspected violation or breach. Needless to say, the goal is to keep the OCR out of the audit process and to have a diligent, thorough, and robust self-assessment process that tests all organizational policies and controls with their ability to comply with the HIPAA rules.
This is no small ask and is nearly impossible to conduct effectively and efficiently when relying on manual processes and insight. With everything needed to get HIPAA compliant in one place, smart automation tools accompanied by expert guidance allow CEs and BAs to prepare for their self-assessment quickly and efficiently, and become HIPAA compliant. Automated evidence collection, 24/7 control monitoring, security awareness training, policy center are just some of the features that make this happen.
Stay ahead of HIPAA compliance requirements
As with any law, there are constant updates and changes in legislation to improve the standards and controls. The HHS releases updates to notify organizations in the case of any addendums or changes regarding HIPAA. The Office for Civil Rights (OCR) is responsible for routine guidance or implementation queries. However, navigating the legal jargon and intricate policies and exceptions of HIPAA is a risky and time-consuming responsibility. It requires extreme attention to detail and confidence in your understanding and interpretation.
Unfortunately, ignorance or lack of understanding does not offer organizations a get-out-of-jail-free card. Automated compliance software should always be aligned with the most recent HIPAA rules and regulations, mitigating this risk by ensuring that nothing is left to chance.
Top HIPAA compliance risks in healthcare and how to avoid them
Unfortunately, the healthcare industry has been dealt a lousy hand regarding data risks and threats. With over 93.5% of all identify theft incidents originating from stolen healthcare records – there’s a colossal target on any organization that has contact with PHI, which is now worth 50 times more than credit card data on the dark web.
Despite this, common compliance threats remain widespread, often due to overlooked or poorly managed processes. The good news? Many of these risks can be mitigated with relatively straightforward solutions.
Lack of due diligence
Correct policies and procedures are non-negotiable regarding compliance. Yet, there is still too much room for potential breaches and violations. In fact, 55% of insider threat incidents involve negligent employees. Due diligence processes include annual risk assessments and continuously reviewing external and internal business arrangements, conflicts of interest, and any potential gaps in the system. However, this will always only be as strong as the organization’s ability to review, analyze and adapt them accurately.
Incorrect or inefficient security controls
HIPAA’s Security Rule sets out a list of security controls required to meet HIPAA standards for protecting e-PHI. However, many organizations still fail to effectively implement and manage the correct security controls. For many, data security has become contingent on finding secure, accessible, and reliable technology.
Poor security awareness training
Regular security awareness training is mandatory for HIPAA compliance. But how much protection does it truly provide? Employees need to actively apply what they learn during training to their daily responsibilities. In 2024, 50% of organizations reported testing their employees on HIPAA training at least annually, marking an improvement from previous years.
So, how can an organization ensure employees take their training seriously? Well, Scytale offers security awareness training that allows you to track and monitor employee progress – ensuring that everyone is on the same page when it comes to HIPAA compliance.
GET HIPAA COMPLIANT 90% FASTER
Top 10 features of HIPAA compliance automation software
Although automated data compliance reinvents the way CEs and BAs approach HIPAA compliance, it’s still crucial to use compliance software solutions that provide the necessary functionality and features.
The following features should be included in your HIPAA compliance automation tool (and it’s no coincidence that Scytale exhausts this list).
| Feature | Description |
| HIPAA risk assessment | Automatically assesses areas where your organization’s PHI is at risk. |
| HIPAA self-assessment | Allows you to complete your HIPAA self-audit with all requirements through the tool. |
| HIPAA awareness training | Ensures your employees are learning and maintaining best practices to protect patients’ PHI. |
| Customized HIPAA controls | A list of controls customized to your organization’s specific operations. |
| Continuous control monitoring | Monitors your controls 24/7 and alerts you immediately if there is any non-compliance. |
| Custom policy templates | Provides HIPAA-aligned policy templates. |
| Automated evidence collection | Collects evidence of your HIPAA controls automatically. |
| HR compliance management automation | Includes automated HR onboarding & offboarding security practices. |
| Vendor risk management | Manages vendor security assessments efficiently and tracks their compliance. |
| Expert support and guidance | Allows you to receive human support from a dedicated team of GRC experts. |
Automate HIPAA compliance with Scytale
If your organization needs to ensure HIPAA compliance, trade the anxiety for automation. At Scytale, we provide everything you need to get (and stay) HIPAA compliant in one centralized compliance hub – and 90% faster.
FAQs
What is HIPAA compliance software?
HIPAA compliance software helps healthcare organizations manage all aspects of protecting patient data, following HIPAA rules automatically. It monitors risks, enforces security measures, collects audit evidence, and makes compliance faster and easier.
What are the main challenges healthcare providers face with data compliance?
Healthcare providers struggle with manual processes, employee errors, outdated security controls, and constant updates to regulations. Staying consistently compliant is time-consuming and resource-intensive without the right tools.
How does automation reduce the risk of HIPAA violations?
Automation continuously monitors your compliance status, flags risks early, and ensures the right controls are always in place. It cuts down on human error and helps detect breaches much faster.
What are the key features of HIPAA compliance automation tools?
Top features include automated risk assessments, continuous control monitoring, HIPAA policy templates, staff training management, vendor risk tracking, automated evidence collection, and a dedicated team of GRC experts to guide you through your HIPAA compliance journey from start to finish.
