Ensuring Regulatory Compliance in Healthcare Printing: What You Need to Know

Print accuracy and security are critical components for staying compliant with the ever-changing world of healthcare. With fines, civil action, and even criminal charges as possible penalties, finding a print partner who can strictly adhere to regulatory standards is essential. Read on to learn more about which regulations impact healthcare printing, and how a quality commercial printer can help you keep your healthcare print practices on the straight and narrow.

The Importance of Compliance in Healthcare Printing

On the one hand, compliance in healthcare printing is a simple act of self-preservation. No institution can survive repeated, flagrant regulatory violations that come with ever-increasing legal penalties. But it’s also about something much more important than simply avoiding punishment. 

Healthcare information and labeling regulations are fundamentally about protecting patients. Their privacy, health, and safety can all be harmed by careless printing errors or sloppy security. So, partnering with a commercial printer that can meet or exceed regulatory standards isn’t just good business sense – it’s also the ethical course of action.

Regulations Impacting Healthcare Printing

Unfortunately, there’s no single government office or law that covers all of the regulations that apply to healthcare printing. Rather, it’s a patchwork of statutes and guidelines spread across several administrative bodies. Different types of healthcare printing can be subject to different sets of regulations, including:

• HIPAA: Established in 1996, this federal act lays out the standards for preventing the disclosure of sensitive health information without a patient’s consent.
• Title 21 of the Code of Federal Regulations: The code outlining the Food and Drug Administration (FDA) regulations, including guidelines on printed labeling and warnings on drugs and medical devices.

Best Practices for Compliant Healthcare Printing

The specific type of healthcare printing you’re doing will dictate the specific rules and regulations that need to be followed. For example, general healthcare print marketing describing your company is not usually regulated as tightly as the labeling applied to specific drug packaging. However, there are also a few overarching healthcare printing best practices that should always be observed.

• Secure Print Workflows: All healthcare print file transmissions should be encrypted, and any server that houses healthcare documents should be protected with robust access controls. Access records should also be maintained  using digital audit trails, which log every time a document is accessed and by whom.
• Tamper-Proof & Security Features: Print finishes and enhancements like tamper-proof seals, watermarks, and confidentiality sheets should be implemented whenever it is appropriate to protect patient safety and confidentiality.
• Restricted Access: Print facilities handling sensitive healthcare information should have robust physical access restrictions, including badge-controlled access and 24/7 video surveillance.

Wallace Carlson Prioritizes Security and Confidentiality

At Wallace Carlson, we take data security extremely seriously. That’s why we’ve implemented multiple layers of protection, both digital and physical, to protect our clients’ sensitive and proprietary information. All files uploaded to our system are protected using 256-bit SSL (Secure Sockets Layer) encryption. Access to those files is user and password-protected. And our print facilities all require badge-access and are subject to continuous video monitoring. 

So, whatever your commercial printing needs are, we’re prepared to help your healthcare enterprise get the job done. Reach out to Wallace Carlson today to get started!