Organizations across every industry print and mail many types of communications to customers, members, or patients. Some of these fall into a niche category of regulated print and mail. These types of documents are unique because they must adhere to compliance and regulatory requirements.
In this article, we’ll answer all your questions about regulated print and mail.
What Is Regulated Print and Mail?
Regulated print and mail describes the production and dissemination of sensitive documents and statements that must comply with industry regulations. Those include things like HIPAA, PCI DSS, FISMA, SOC I&II, and other vertical-specific rules.
To ensure compliance with creating and mailing these letters, businesses or their print and mail partners must have many checks and balances in place. It’s more than having a certificate of compliance. It’s a sophisticated strategy, workflows, and auditing that creates an infrastructure and culture of compliance.
What Are the Main Pillars of Regulated Print and Mail?
To build a foundation to ensure proper production of these communications, an organization needs several pillars.
Compliance Beyond the Basics
Meeting the requirements of HIPAA, PCI DSS, and other rules requires documentation, processes, and controls. However, that’s just the start of operating a truly compliant operation.
To have a truly compliant system, you need all these things.
Embedded and Reliable Accuracy
One of the most crucial aspects of being compliant is to ensure that each page of a mailing arrives at the correct address. It may seem simple, but in high-volume operations, it’s challenging. Technology has been a key component in fortifying this.
Using intelligent insertion solutions can boost accuracy. It works by using 2D barcodes printed on each page. A camera reads this information and tells the inserter which pages to fold into each envelope. Another camera records this. With such a system, we’ve been able to achieve an industry-leading 99.9999% accuracy rating.
A commitment to compliance also means regular auditing of processes to determine any deviation and correct it. Many regulated print and mail providers use Lean Manufacturing to conduct those.
Compliance also needs constant review of any new regulations or changes in existing ones to respond. Having a dedicated Compliance Officer can fulfill this requirement.
Advanced Data Security Measures
Another principle for regulated print and mail is protecting consumer data, specifically PII (personally identifiable information) and PHI (protected healthcare information). To do this at scale, there are several protocols needed, including:
- Secure file processing via SFTP (Secure File Transmission Protocol) to safely transfer files
- PGP data encryption while data is at rest and in transit
- Full disk encryption and an encrypted hypervisor-level system backup
- Network segmentation
- User-level security
- Business continuity and true redundancy
- Vulnerability monitoring and scanning
- Proactive cybersecurity actions like penetration testing
- Multi-factor authentication
- Firewalls and IPS (Intrusion Protection System)
Industry-Specific Measures
The industry with the most regulations is healthcare. That’s because PII and PHI are involved in communications. HIPAA-compliant mailings have detailed requirements about how to secure data and its use. Meeting these laws includes access controls, monitoring, and auditing.
HITRUST is another component that helps you create a compliance framework to support HIPAA. It provides another layer of security and privacy.
SOC I&II are not mandatory, but indeed a best practice. It’s a robust review of processes to demonstrate that internal controls are in place and working.
What Are the Other Differences Between Regulated and Standard Print and Mail?
Compliance, security, controls, and protocols define the most significant differences between these two classes. There are other considerations, as well.
There shouldn’t be any “mixing” of regulated and standard operations. You should not combine these two types of mail. They have different workflows and should be separate.
Physical security must also be in place. Access to areas where production is occurring should be limited to only those who need it. There should also be camera monitoring of facilities. Proper disposal of any printed material not used must be part of the protocols, as well.
Is Your Regulated Print and Mail Truly Compliant and Secure?
If this article has you contemplating your own operations for regulated communications, it’s time to do an assessment. Whether you do this in-house or outsource it, there’s no room for error. You can get started with a no-cost consultation with our experts.
