Security Risk Analysis (SRA) is required under HIPAA. It helps organizations find weaknesses in how Protected Health Information (PHI) is handled, stored, and shared. The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) is more strict about enforcing these rules. In early 2025, more than $6 million in fines were given for HIPAA violations. This shows that all healthcare providers, big or small, must do regular and detailed SRAs to keep patient data safe.
Healthcare places, even small medical offices and radiology centers, have been fined because they did not do enough SRAs or failed to tell patients quickly after a data breach. For example, Vision Upright MRI was fined $5,000 after a breach exposed medical images of over 21,000 patients. This happened because of an unsafe server and poor risk analysis. Other places like PIH Health and Northeast Radiology also show how missing timely risk checks and not following breach rules can cause fines.
Security risk analysis is not something done just once; it must be ongoing. It has to change as technology and threats change. OCR Acting Director Anthony Archeval said, “A failure to conduct a risk analysis often foreshadows a future HIPAA breach.” Because of this, healthcare leaders must find better ways to meet these rules.
Artificial Intelligence (AI) helps healthcare practices handle the hard parts of risk analysis by doing many tasks automatically and giving smart insights. Instead of only using manual checks and old-style audits, AI tools can look through systems, watch networks, and check data flows in real time. This helps find weaknesses, strange activities, and gaps in compliance faster.
AI-driven software helps practices complete SRAs by:
Censinet RiskOps™ is one tool used in healthcare IT to automate risk checks and monitor compliance. Nordic Consulting shared that using Censinet helped them increase vendor checks and spend less time on each without hiring more staff.
By adding AI in risk analysis, healthcare practices can better protect patient data while lowering their workload.
AI brings good tools but also some challenges in rules and ethics.
AI systems that work with PHI are called Business Associates under HIPAA. This means they must sign Business Associate Agreements (BAAs) with healthcare providers to share responsibility for protecting patient data. But not all AI providers sign BAAs. For example, OpenAI does not sign BAAs for ChatGPT, so it cannot be used safely with electronic PHI. Other companies like Google have AI tools that do follow these rules.
Another issue is AI “hallucinations.” This happens when AI gives wrong or misleading answers because it misunderstands data patterns. These errors need careful checking by humans, especially when AI helps with compliance or clinical decisions. Mistakes could harm patient privacy or security.
Also, laws about AI are likely to change as the technology grows. The Biden Administration’s Executive Order on AI and projects like the AI Bill of Rights want balanced AI development—encouraging new ideas while protecting privacy, safety, and fairness.
Healthcare providers must check AI tools carefully, have strong contracts, and control who can access data.
Protecting patient privacy is a key ethical challenge with AI in healthcare. AI depends on large datasets, often with private and detailed patient information, to do tasks like scheduling or treatment plans. It is important to be clear about how data is used, get patient permission, and make sure algorithms do not have bias.
Third-party AI vendors have an important role in data privacy. They bring advanced technology but can also cause risks like data leaks if not handled right. To reduce these risks, healthcare groups should do strict checks, including:
Programs like HITRUST’s AI Assurance help healthcare groups use AI safely. They combine AI risk rules from groups like the National Institute of Standards and Technology (NIST) and the International Organization for Standardization (ISO). This gives a clear way to keep AI systems open, responsible, and secure during their creation and use.
The move to digital healthcare adds more challenges. Digital tools have replaced many old analog methods. This has improved care, access to medical facts, and decision support for doctors. But it also raises risks for cybersecurity.
Healthcare groups must protect PHI from weak systems, cyberattacks, and outdated rules. Studies show many still have trouble keeping data secure and protecting patient privacy. This causes leaks and breaches.
Good data governance is important. It means always updating policies, controlling who can use data, and checking system activity. This helps keep data quality high and follows the law when using AI or other digital tools.
Breaches and breaking rules can cost money and damage reputations. These risks make it very important for healthcare leaders to keep patient trust and follow U.S. laws.
Besides helping with risk analysis, AI can also automate daily workflows in healthcare compliance. This lets staff spend more time on patient care and less on paperwork and manual tasks.
Examples of AI and automation in security and compliance are:
With these automated workflows, healthcare practices can keep up with changing technology and rules without much extra work.
For healthcare groups in the U.S. wanting to use AI safely in risk analysis and compliance, here are some tips:
Healthcare practices rely more on technology every day, and AI will have a bigger role in operations and compliance. Because OCR is enforcing rules more strictly and data breaches can cause legal and money problems, medical practice leaders should think carefully about how AI can help their Security Risk Analysis work.
By using AI automation, putting privacy and security first, and following laws, healthcare groups in the U.S. can better protect patient information and stay compliant in a fast-changing digital world.
AI in healthcare refers to technology that simulates human behavior and capabilities, significantly transforming how medical practices operate. AI solutions can enhance various tasks, including scheduling, patient education, and medical coding.
AI tools that access Protected Health Information (PHI) must comply with HIPAA regulations. AI companies that have access to PHI are considered Business Associates and must sign a Business Associate Agreement (BAA) to ensure shared responsibility for data protection.
A BAA is a legal document that outlines the responsibilities of a Business Associate in protecting PHI. It defines the relationship between a Covered Entity and the Business Associate.
Not all AI companies are willing to enter into BAAs. For example, OpenAI does not sign BAAs for ChatGPT, making it non-compliant for sharing ePHI.
Some tech companies, like Google, are open to signing BAAs for their healthcare AI tools, making them compliant options for handling PHI under HIPAA.
AI hallucinations refer to errors where the AI generates inaccurate or nonsensical results, often due to misinterpreting patterns in the data. It’s crucial to verify AI outputs for accuracy.
As AI evolves, more legislation is expected to emerge regarding AI use in healthcare. The OCR will likely release new guidance to address compliance and new technology risks.
The SRA is vital for identifying vulnerabilities in a healthcare practice’s safeguards regarding PHI. Regular completion helps ensure compliance and prevent breaches.
Vision Upright MRI was fined $5,000 for a significant data breach due to a lack of an SRA and failure to notify affected patients promptly.
AI-driven compliance software can simplify tasks like conducting SRAs and reporting breaches, helping practices maintain compliance, reduce risks, and avoid fines.