FDA/DEA Regulatory Compliance: EPCS

The DEA's EPCS Regulation

"Electronic Prescriptions for Controlled Substances" revises DEA's regulations to provide practitioners with the option of writing prescriptions for controlled substances electronically. The regulations will also permit pharmacies to receive, dispense, and archive electronic prescriptions.

The DEA’s requirements for EPCS include:

• (16) The digital signature functionality must meet the following requirements:
• (i) The cryptographic module used to digitally sign the data elements required by part 1306 of this chapter must be at least FIPS 140–2 Security Level 1 validated. FIPS 140–2 is incorporated by reference in Section 1311.08.
• ....
• (iii) The electronic prescription application's private key must be stored encrypted on a FIPS 140–2 Security Level 1 or higher validated cryptographic module using a FIPS-approved encryption algorithm. FIPS 140–2 is incorporated by reference in Section 1311.08.

In addition, in “§1311.205 Pharmacy application requirements” in the same DEA publication, the section states:

• (b) The pharmacy application must meet the following requirements:
• (4) For pharmacy applications that digitally sign prescription records upon receipt, the digital signature functionality must meet the following requirements:
• (i) The cryptographic module used to digitally sign the data elements required by part 1306 of this chapter must be at least FIPS 140–2 Security Level 1 validated. FIPS 140–2 is incorporated by reference in Section 1311.08.
• ....
• (iii) The pharmacy application's private key must be stored encrypted on a FIPS 140–2 Security Level 1 or higher validated cryptographic module using a FIPS-approved encryption algorithm. FIPS 140–2 is incorporated by reference in Section 1311.08.

Encryption and Key Management

Make your data unreadable to others through strong, centrally managed, file, volume and application encryption combined with simple, centralized key management that is transparent to processes, applications and users.

Access Policies and Privileged User Controls

Restrict access to encrypted data through access policies and user controls that permit data to be decrypted only for authorized users and applications, while allowing privileged users to perform IT operations without the ability to see protected information.

Security Intelligence

Logs that capture access attempts to protected data provide high value security intelligence information that can be used with a Security Information and Event Management (SIEM) solution and for compliance reporting.