Enhancing Data Security in FDA-Regulated Industries with AS2

In this article, we’ll explore the significance of AS2 in aligning with FDA standards and how it enhances data security for FDA submissions.

Data breaches are a major concern for industries regulated by the FDA (Food and Drug Administration), as they manage highly sensitive and critical data, such as medical records and pharmaceutical formulas. To ensure the secure submission of regulatory data, which is a highly standardized process, the FDA established the Electronic Submissions Gateway (ESG) in 2006. The FDA ESG serves as a centralized transmission point for regulatory submissions, allowing companies to submit premarket and postmarket information electronically. The ESG offers two submission modes: WebTrader for manual, low-volume submissions and AS2, a secure protocol for automated, high-volume transmissions. AS2 is widely preferred due to its ability to handle larger volumes of data securely, using encryption and digital signatures to protect sensitive information during transmission. As data security becomes increasingly critical, leveraging AS2 for FDA submissions helps FDA-regulated industries meet compliance standards while mitigating the risk of data breaches.

The Role of AS2 in Data Security

AS2 is a protocol designed for secure data transmission between trading partners over the internet, frequently used in industries such as healthcare, pharmaceuticals, and other sectors regulated by the FDA. AS2 ensures that the exchanged data is encrypted, verified, and can be transmitted with non-repudiation (proof of origin and receipt).

Key advantages of AS2 include:

Data Integrity and Security: AS2 provides encryption using certificates and algorithms to ensure that the data is secure during the transmission and can be trusted. Also by using digital signatures, the sender can sign the message, and the receiver can verify the signature to ensure the message was not tampered with.
Non-repudiation: AS2 guarantees that the sender cannot deny having sent a message, and the receiver cannot deny having received it.
Receipts (MDNs): AS2 supports MDNs, which are acknowledgments sent back to the sender that verify the message’s receipt and integrity.
Compliance: It meets the strict data privacy and security rules set by the FDA and other regulators.

FDA Data Security Guidelines

Earlier this year, the FDA distributed draft guidance for Data Integrity and Compliance. The guidance was issued due to ‘increasingly observed cGMP violations involving data integrity during cGMP inspections.’ It added that ‘these data integrity-related cGMP violations have led to numerous regulatory actions, including warning letters, import alerts, and consent decrees.’ The FDA’s recently issued data security guidelines aim to improve cybersecurity in regulated industries. They address increasing concerns about data integrity and privacy. The key aspects of these guidelines include:

Data Encryption: The FDA urges encrypting sensitive data, both at rest and in transit, to guard against unauthorized access.
Data Integrity: Measures to ensure that transmitted data remains intact and unaltered. This is critical as data must be managed from CMC (chemistry, manufacturing and controls) throughout the product life-cycle. This includes adhering to ALCOA+ guidelines, ensuring data must be Attributable, Legible, Contemporaneously recorded, Original or a true copy, and Accurate.
Audit Trails: Complete logs of data access and transmission are vital for monitoring and reconstructing actions if a breach occurs. Audit trails must be time-stamped and tamper-proof and should capture all events associated with data creation, modification and deletion.
Third-Party Risk Management: Companies must ensure that all third-party partners meet strict security standards to prevent supply chain vulnerabilities.

How AS2 Aligns with FDA Guidelines

AS2 is naturally aligned with the FDA’s data security guidelines, making it a perfect solution for industries handling sensitive data, such as pharmaceuticals and medical records. The protocol’s inherent encryption mechanisms using certificates and standard algorithms, such as AES and 3DES, ensure that critical data is safeguarded from unauthorized access during transmission. Furthermore, the use of digital signatures provides a reliable way to verify the authenticity and integrity of the data, which supports the FDA’s focus on preventing tampering and ensuring secure data handling.

Additionally, AS2’s ability to generate Message Disposition Notifications (MDNs) ensures the successful receipt and processing of a message or indicates any errors. By enabling secure and compliant data exchanges, AS2 also simplifies the process of maintaining FDA compliance when working with third-party vendors, ensuring that all partners meet the same security standards required by the FDA.

The AS2 protocol logs all message transmissions and receipts in detail, including timestamps for sending, receiving, and failed deliveries. These logs offer a complete audit trail, aligning with the FDA’s audit and compliance standards. The AS2 protocol also supports message compression, which helps reduce the size of transmitted data, a valuable feature when submitting large files to the FDA.

To wrap up, we at Aayu Technologies offer two tailored solutions to assist you to streamline your FDA ESG submissions. MFT Gateway is a cloud based hosted SaaS solution that simplifies submission processes, where you can sign up for a free trial to get started right away - no credit card needed.

Alternatively, for organizations that prefer an on-premise solution, we offer AS2 Gateway, used by one of the largest pharmaceutical companies globally. It is designed for regulatory submissions and includes features like submission tracking, automated notifications, and large file support.

Both solutions simplify complex FDA submission workflows with user-friendly dashboards that track acknowledgments and display real-time submission statuses for each entry. If you have any questions or need further guidance, feel free to reach out to us anytime through Aayu Technologies.