Using AI in Healthcare: Key Compliance Considerations for Tools and Devices

Artificial intelligence (AI) is revolutionizing healthcare. From smart diagnostic tools and virtual assistants to AI-enabled devices like smart glasses or wearable monitors, this technology helps providers streamline workflows, improve accuracy, and enhance patient engagement. But as these tools become more common in clinical and administrative settings, it’s critical to ensure they’re used safely, ethically, and in compliance with HIPAA.

Understanding AI in Healthcare

There are two main types of AI in use:

Generative AI tools like ChatGPT, Microsoft Copilot, or Google Gemini create content such as summaries, letters, or code in response to prompts.
AI-enabled devices, such as smart speakers, wearables, or augmented reality glasses, use AI to analyze, record, or transmit data—often in real time.

Both types offer impressive capabilities but also introduce significant risks when it comes to handling Protected Health Information (PHI).

Why Privacy and Security Matter

Many AI tools and devices rely on cloud-based services, always-on sensors, and integrations with third-party platforms. While convenient, these features can unintentionally expose patient data if the technology isn’t properly secured or used appropriately. For example, smart glasses with built-in transcription features could capture PHI without authorization, or a chatbot could generate inaccurate content that influences care decisions.

The risk isn’t just technical, it’s regulatory. Any misuse of AI in a healthcare setting could lead to HIPAA violations, patient complaints, or even the Office for Civil Rights (OCR) enforcement action.

Responsible Practices for Use of AI in Healthcare

To help healthcare practices adopt AI safely, here are a few essential strategies:

Include AI in Your Security Risk Analysis

Conduct a thorough Security Risk Assessment that includes all AI tools and AI-enabled devices in your practice. Look for risks like unsecured data transmission, uncontrolled access, or third-party data exposure. Regular audits will help you maintain compliance and quickly address emerging threats.

Vet Your Vendors and Tools

Ensure that any AI technology you bring into your organization is HIPAA-compliant. This includes confirming proper data handling practices, secure infrastructure, and signing Business Associate Agreements where required.

Train Your Team

Educate staff on what AI tools and devices are approved, how they should be used, and, most importantly, what to avoid. Make sure they understand not to enter PHI into non-approved platforms and to always verify AI-generated content before relying on it.

Update Your Policies

Your employee handbook and internal policies should clearly define how AI is used in your organization. List approved tools, identify who can use them, and outline consequences for improper use. This helps set expectations and protect your organization from unintentional violations.

Monitor and Adjust

As AI capabilities grow, your use of the technology will likely evolve. Regularly reassess how tools and devices are used, stay updated on privacy regulations, and make policy adjustments as needed.

As AI continues to evolve, its impact on healthcare will only grow, bringing both exciting advancements and critical compliance considerations. Whether you’re using generative AI for clinical decision support or AI-enabled devices in your practice, staying informed and proactive is key to protecting patient privacy and ensuring HIPAA compliance.

Want to Strengthen Your Practice’s AI Compliance?

Download our free, AI in Healthcare Compliance Checklist to help you track safeguards across tools and devices.

For a deeper dive into responsible AI adoption, check out our online course, Exploring AI in Healthcare. This course is specifically designed for Practice Administrators, Compliance Officers, and healthcare leadership to guide safe, strategic, and HIPAA-compliant use of AI tools and AI-enabled devices in your organization.